(Jcrc) 2014 Annual Report

Joint Clinical Research Center (JCRC)

2014 ANNUAL REPORT

“For Quality Health Care Services”

Table of Contents

Contents Table of Contents ...... ii List of Tables ...... iv List of Figures ...... v List of Acronyms ...... vi Foreword ...... ix Chairman Board of Directors ...... ix Executive Summary ...... x JCRC Management Team ...... xii Brief about JCRC ...... xiv JCRC Network Coverage: ...... xiv Vision ...... xiv Mission ...... xiv Core Values:...... xiv 1.0 Laboratory Services ...... 1 1.1 JCRC Tuberculosis Laboratory ...... 3 1.2 CFAR Laboratory ...... 5 2.0 RESEARCH ...... 5 3.0 Clinical Care: ...... 9 3.1 Out Patient Services ...... 12 3.2 Inpatient Services; ...... 17 4.0 Training at JCRC: ...... 19 4.1. The International Clinical Operational and Health Services Research (COHRE) Training Program. 19 4.2. INTERNATIONAL EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARDS (IEARDA) ...... 19 5.0 Institutional Strengthening ...... 24 5.1. Human Resources; ...... 24 5.2. Stores ...... 24 5.3 Estates ...... 25 5.4 Information Technology: ...... 26 5.5. Business Development: ...... 27 5.6. Resource Mobilisation: ...... 28 6.0 JCRC Regional Centres of Excellence: ...... 31 6.1. Mbarara RCE ...... 31 6.2 Fort-Portal ...... 33 6.3 Kakira ...... 34

6.4 Gulu ...... 35 6.5 Mbale RCE: ...... 40 THALAS PROJECT ...... 43 SCIPHA PROJECT ...... 49 JCRC Plans for 2015:...... 52 Ongoing Researches at JCRC ...... 53 JCRC Laboratory Coverage ...... 59

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List of Tables

Clinic Attendance for Kampala...... 10

Patients that picked ARVs for the Kampala site...... 10

SCIPHA Prevention activities in Gulu...... 37

SCIPHA Care activities in Gulu...... 37

SCIPHA Gulu Club assessment support...... 38

THALAS project indicators based on PMP 2010-2015...... 47

Research Studies at JCRC...... 53

List of Figures

JCRC Kampala CD4 and Viral Load Performance…………… …………………..2

Laboratory tests for 2014…………………………………… …………………….3

JCRC Lubowa Clinical Attendance Patterns………………………………………9

Clients picking ARVs by age category…………………………………………….9

Clients picking ARVs by Regimen Category………………………………………11

Client picking ARVs by sex category……………………………………………...11

JCRC sources of Funds…………………………………………………… ……..29

Patients recruited for the REALITY study at Gulu…………………….………….32

SCIPHA III HIV prevention among key populations………………… . …………49

List of Acronyms

ANC Anti natal care

PLHIV People Living with HIV/AIDS

CSW Commercial Sex Workers

EMTCT Elimination of Mother to Child Transmission

TB Tuberculosis

UNCHE Uganda National Council of Higher Education

WHO World Health Organisation

ICEA Integrated Clinical Enterprises Application

SCIPHA Strengthening Civil Society for Improved HIV/AIDS and OVC service delivery

IUD Intra-uterine Device

PEP Post Exposure Prophylaxis

RCE Regional Centre of Excellence

FP Family Planning

STAR-EC Strengthening TB and HIV & AIDS Responses in East-Central Uganda (STAR-EC) project

STAR-SW Strengthening TB and HIV & AIDS Responses in South-West Uganda (STAR-SW) project

USAID United States Agency for International Development

TREAT Timetable for Regional Expansion of Anti-Retroviral Treatment/Therapy

SUSTAIN Strengthening Uganda’s Right to Essential Medicines

THALAS Targeted HIV/AIDS and Laboratory Sevices

MOH Ministry of Health

COHRE Collaboration with Health Services Research

IARDA International Extramural Association Research Development

CWRU Case Western Reserve University

CAP College of American Pathology

CFAR Centre for AIDS Research

IPs Implementing Partners

OVC Orphans and Vulnerable Children

IDI Infectious Disease Institute

MUJHU Makerere University Johns Hopkins University

CHAPAS A Randomized Trial to determine the Pharmacokinetics of Ritonavir boosted lopinavir in Sprinkle and Tablet formulation in HIV infected Children in Africa

DART Development of Anti Retroviral Therapy in Africa

ARROW Anti Retroviral Therapy to Watoto

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PATRON

Board of Trustees

Chairman: Prof. J. Epelu Opio

Prof. Peter .N. Mugyenyi Mr. Ben Okello Prof. Nelson Dr. Jesse Kagimba (Executive Director –JCRC) Luwum Ssewankambo

Dr. Jane Aceng Dr. James Makumbi Dr. Jessica Jita Mr. Richard Masereje (Board Secretary)

Prof. Manfred Dietrich Dr. Cissy Kityo Tom Barry (x-official (External Advisor) (ex-official) (ex-official)

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Foreword

Chairman Board of Directors

Prof. Opio Epelu:

It is 23 years since Joint Clinical Research Center (JCRC) was founded more than two decades ago to serve as a national AIDS research Centre. Born as collaboration between Makerere University’s School of Medicine and Uganda’s Ministries of Health (MoH) and Defense, JCRC has continued to undertake research that has continued to inform the HIV/AIDs policy process and clinical practice in Uganda and beyond.

The centre has grown from strength to strength and 2014 has been yet another successful year of accomplishment. Guided by the 2014-2018 Strategic Plan, the management of the centre has steered the centre in the right direction and the board is in agreement and approves the direction the centre is headed in attaining its Vision of a “Vibrant Self Sustaining Centre of Excellence in Medical Research, Training and Health Care Services”.

To our partners, collaborators and funders, we are grateful for your continued support and confidence in us. To our esteemed clients and study participants, we thank you for trusting in us and we commit ourselves to giving you the best possible care in the years to come. To the JCRC staff that tirelessly work to conduct quality medical research and training, provide equitable and sustainable HIV/AIDS care and other health care services in Uganda and other parts of Africa, we thank you for your commitment in setting the highest standard of care in the region.

Finally I thank our patron, H.E, Y.K.Museveni, for the continued support and guidance.

Prof. Opio Epelu

Chairman Board of Directors

Executive Summary

I congratulate the board and all staff upon completing yet another successful year 2014. This annual report seeks to highlight the key achievements attained and how the challenges have been addressed. JCRC has made great achievements in research and continued to address local and global HIV/AIDS prevention, care and treatment efforts. The 4 core business areas at JCRC of Research, Clinical care, Laboratory services and Training have continued to register tremendous achievements notably;

The Quality Laboratory Work at JCRC resulted in the selection of the Laboratory as a regional centre for HIV resistance testing monitoring in East and Central Africa by Pharm Access Africa Studies to Evaluate Resistance (PASER). This year 2014, JCRC won a competitive contract to offer Specialized HIV laboratory testing services to Evaluate the Effectiveness and Impact of the Prevention of Mother to Child Transmission of HIV Program in Malawi.

Over 28 studies are being conducted at JCRC Kampala and the RCEs, majority of which are clinical trials. In a related development, JCRC Scientists turned out 20 research publications in International peer reviewed medical and scientific journals. The Collaboration with Research Partners such as ACTG and funders such as Gilead among others continues to grow with a number of studies being conducted through such collaborations.

The gradual shift of the JCRC Clinic from Mengo to Lubowa (Head Quarters) continues and is expected to be completed early 2015. Meanwhile the Lubowa clinic has expanded to include a Dental wing and cardiology sections.

The short training programs continue to be offered at Lubowa and the collaboration with Health Services Research (COHRE), International Extramural Associates Research Development (IEARDA), and Fogarty Research fellowship programs have continued to provide scholarships to support research students for Masters degrees and PHDs. These programs have continued to support and mentor students that wish to pursue further studies in Internal Medicine and pediatrics, while supporting frontline workers in skill development to provide HIV/TB services. All training mechanisms follow nationally recommended curricula and utilize trainers recommended by the relevant regulatory authorities.

The year 2015 provides yet another opportunity for JCRC to grow the private clinical services as part of JCRC Strategy towards sustainability. This will see the expansion of the private clinical services, introduction of more researches, expanding the laboratory services to include the x advanced high safety (P3) Laboratory and expanding the training services. We therefore look forward to another eventful year.

Yours Sincerely,

Prof. Peter .N. Mugyenyi

Executive Director – JCRC

JCRC Management Team

Prof. Peter N. Mugyenyi FRCP ScD Executive Director JCRC

Dr. Cissy Kityo Deputy Executive Director

Dr. Samson Kibende Tom Barry Dr. Francis Ssali Bosco Nsabimana D/Director Admin Finance Director Head Clinical Services Head Human Resources

Fred Byaruhanga Dr. William Tamale Dr. Kizito Hilda Sr. Deborah Masira Business Dev’t Head Adult Clinic Head Pediatric Clinic Head Nursing Manager

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James Nkalubo Gabriel Komaketch Ociti Paul Rose Byaruhanga Incharge Laboratory Head Data & IT Head Pharmacy Head Counseling

Jelliffe Lubwama Annet Namara Dr. Henry Mugerwa Ann Nakirijja Head Audit Ag. Head Stores Head Research Head Training

Michael Kabugo Dr. Fiona Kalinda Dr. Abbas Lugemwa Dr. Abach James THALAS COP SCIPHA Project Head Mbarara & Head JCRC Gulu Coordinator Kabale RCEs

Dr. Sheila Kabahenda Dr. Dickens Alfred Tumwesigye Nsubuga Kiwanuka Head JCRC F/Portal Atwongyeire Head Transport Head Estates Head JCRC Mbale and Kakira

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Brief about JCRC

The Joint Clinical Research Centre (JCRC) is an indigenous autonomous Organization established in 1991 as a limited liability not-for-profit company. It is a joint-venture between the Uganda Ministry of Health (MoH), Ministry of Defense and Makerere College of Health Sciences. The Centre was established to respond and provide a scientific approach to the national HIV&AIDS crisis. Over the years, various institutions and organizations such as USAID, WHO, Case Western Reserve University (CWRU), FHI, NIH, European and Developing Countries Clinical Trials Partnership (EDCTP), Medical Research Council (MRC), have partnered with JCRC for medical Research Grants to study HIV, tuberculosis (TB), malaria and other tropical diseases. JCRC also competitively wins and implements HIV/AIDS projects and was the first recipient of PEPFAR funding in December 2013 for ART scale up across Uganda under the TREAT program. Between the period December 2003 to June 2010, JCRC established 52 ART sites and 25 outreaches across the country and being the largest provider of ART in Africa before transitioning these sites MOH for mainstreaming into the national HIV/care network. A follow on 5 year project (THALAS) which ends in June 2015 was awarded. JCRC also implemented a community project across 19 districts of Uganda (SCIPHA) increasing the mobilization towards increased HIV/AIDS treatment in the country but JCRC’s core business remains research work in which JCRC runs various international and national clinical researches.

JCRC Network Coverage: JCRC headquarters are located at Lubowa Complex, off Entebbe Road, Wakiso district, with a regional network of 6 Regional Centres of Excellence (RCEs) strategically located at Kakira, Mbale, Gulu, Fort Portal, Mbarara, and Kabale.

Vision A vibrant self sustaining centre of excellence in medical research, training and health care services

Mission To conduct quality medical research and training, provide equitable and sustainable HIV/AIDS care and other health care services in Uganda and other parts of Africa

Core Values: Integrity, Confidentiality, Compassion, Mutual Respect, Teamwork, Accountability, Continuous Learning and Excellence.

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1.0 Laboratory Services

JCRC operates the largest reference laboratory network in Uganda strategically located in all the five regions of the country with the main site at Kampala (Lubowa). Others being Kakira, Mbale, Gulu, Mbarara, and Fort-Portal Regional Centres of Excellence (RCEs). The laboratories are equipped with modern state-of-the-art technology that offers diagnostic and monitoring tests to support several care and research programmes nationally and internationally. The laboratory network also has capacity to carry out advanced tests, including; DNA/PCR, Dry Blood Spot ELISA, Viral Loads as well as Resistance testing and all these support Research & Treatment services of the centre with some researches carried out in these sites.

The Laboratory is comprises of the Clinical Chemistry, Hematology, Microbiology, Immunology, and Virology. Has with 34 staff members comprising of Research scientists, Medical Technologist, Medical Technicians, Data and Record Clerks, with qualification of advanced Diplomas, Bachelors, Masters and PhDs.

A section of the JCRC Laboratory Team at Lubowa

The Laboratory has been able to attain the following Accomplishments

1. JCRC lab was chosen to be the regional centre for HIV resistance testing monitoring in East and Central Africa by Pharm Access Africa Studies to Evaluate Resistance (PASER) 2. JCRC won a competitive contract contract to provide Specialized HIV laboratory testing services (85,254 HIV Dry Blood Spot ELISA and 9,680 DBS HIV DNA over a four year period.) to Evaluate the Effectiveness and Impact of the Prevention of Mother to Child Transmission of HIV Program in Malawi 1

3. Established quality control/quality assurance programmes in all RCES. 4. JCRC was able to register all analytes for External Quality Assurance (EQA), The lab headquarter in Lubowa has all tests registered with the College of American Pathologists (CAP) while the rest are registered with other providers like United Kingdom National Quality Assurance System (UKNEQAS). All lab equipment are regularly serviced and maintained to a fully functional state in all RCEs. 5. All scientific staff have registered and passed for competency assessment examinations of the University of Washington and approved by the College of American Pathologists. 6. Streamlined lab management structure across the various JCRC centers. 7. Procured the laboratory Information Systems (LIMS) 8. Improved processes for samples referral within and outside JCRC 9. Improved processes for acquisition/updating and maintenance of lab infrastructure, equipment and consumables. 10. Improved quality assurance systems. 11. Performance on External Quality assurance assessments scores range between 80 – 100%. 12. Acquired a Reverse Osmosis unit for ultra pure water. 13. Improve the functionality of the Repository Unit and is in the process of relocating the unit to the site in Lubowa 14. Over 90% of the laboratory has successfully relocated from Mengo to Lubowa (HQs) with the exception of the TB section.

Fig.1 Shows CD4 and Viral Load tests done at the Kampala site over a period of 11 month. Key Tests done at JCRC for a period of 11 month 4500 4000 3500 3000 2500 2000

Numbers 1500 CD4 1000 500 Viral Loads 0

Months

Note: Other tests done at the Kampala Laboratory within a period of 11 month include;

The overall performance of the laboratory for a period of 11 month include; Microbiology (6195), Hematology (8351), Chemistry (44,404), Virology (30452) and Immunology (26,845) respectively. Below is a graphical representation.

Laboratory Tests done for 11 Month

6195 Microbiology 26845 8351 Heamatology Chemistry 44404 Vorology 30452 Immunology

Fig.2 Shows overall laboratory test done.

Collaborating Laboratories:

1.1 JCRC Tuberculosis Laboratory The JCRC-CWRU Collaborative Tuberculosis Laboratory is operated jointly by the Uganda-Case Western Reserve University Research Collaboration and the Joint Clinical Research Centre as a model research laboratory whose main function is to offer top level microbiology support for tuberculosis clinical trials conducted by researchers from Uganda, the United States and Europe. The research activities of the lab have over the years expanded beyond clinical trials to various areas of TB research including basic and translational research. Also, researchers using the lab now come from all corners of the world. In addition to research work, the lab performs routine tests for diagnosis and monitoring progress of tuberculosis treatment.

The lab is equipped with to Bio-safety Level III (BSL-3) facility which enables it to be safely used for open cultures manipulations and performance of various liquid and solid medium culture techniques. Among other significant pieces of equipment, the lab is equipped with three 6-foot Class II Type A Bio-safety cabinets; two BACTEC MGIT 960 instruments, one BACTEC 9120 instrument, three CO2 incubators, one Roche LightCycler 480 Real-Time PCR instrument and accessories for HAIN Line probe assay techniques. There is abundant refrigeration and freezer capacity for long-term storage of reagents, specimens and isolates. This year saw acquisition of the GeneXpert instrument that has drastically cut down turnaround time for TB detection.

Achievements for the TB Laboratory;

1. This year saw the successful completion of three main studies:

a) DMID Protocol # 10-0042: Adult CD8+ Study - CD8+ T cell responses in latent TB infection and Pulmonary TB in HIV infected and un-infected Ugandan adults. b) DMID Protocol # 09-0109: Paediatric CD8+ Study - Novel CD8+ diagnostics for childhood tuberculosis c) TBTC Study 29: Evaluation of Rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis

2. The lab attracted two new studies:

a) TBTC Study 26, which is a platform for assessment of TB treatment outcomes. It is an observational study of individuals treated for pulmonary TB. Embeded in this study is a sub study that will compare performance of different solid media for use in TB clinical trials b) DMID Protocol # 13-0018: Novel CD*+ T cell diagnostics for childhood tuberculosis also abbreviated ViTi study. This work is a continuation from DMID protocol 09-0109.

At IRB level is TBTC Study 31: Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis. This is a randomized, open-label, controlled phase 3 clinical trial. 3. The lab continues to participate in External Quality Assessment (EQA) program to maintain International standards. These are administered by:

a) Instand - the German Supranational Lab for EQA services for a. Smear microscopy, b. Culture and Isolation of TB bacilli c. Drug Susceptibility Test. b) College of American Pathologists (CAP) for a. Smear microscopy, b. Culture, Isolation and Identification c. Drug Susceptibility testing c) WHO Proficiency Program Administered through the National TB Reference Laboratory Wandegeya- s Supranational lab that also supervises TB labs in East and Central Africa: i. Smear Microscopy ii. Drug Susceptibility testing In addition, the lab is audited annually by SMILE/WESTAT.

4. In terms of staff capacity building, two staff members completed their Masters degree from Makerere University while a third left in October for PhD studies in Australia.

5. The TB lab is set to relocate to Lubowa in a state-of-the-art P3 lab facility in the first quarter of 2015. Installation is in the final stages. This facility will vastly improve safety and increase capacity of the lab to attract more TB related studies to JCRC.

1.2 CFAR Laboratory Centre for AIDS Research Centre (CFAR) laboratory has been doing collaborative HIV research with Joint Clinical Research Centre (JCRC) for more than fifteen years with the emphasis being put on HIV drug resistance. JCRC was the first HIV care centre to provide antiretroviral therapy (ART) in Africa. With patients on treatment, there emerged an inevitable need to monitor patients’ response and emerging resistance to drugs. For the last twelve years, CFAR laboratory has been offering drug resistance testing services for patient care as well as for collaborative research studies. Drug resistance testing for collaborative studies involved samples CHAPAS, ARROW and DART; these are all UK Medical Research Council and AIDS Clinical Unit collaborative projects. Furthermore drug resistance testing was performed on the EARNEST study samples which were funded by EDCTP. Within the last six years the CFAR laboratory has been running tests for PASER and MARCH. These are longitudinal studies that are monitoring drug resistance from childhood to adulthood on patients on antiretroviral therapy. These two longitudinal studies are a collaboration with the Amsterdam Institute of Global Health and Development.

Targets for 2015

As a drug resistance lab, in order to extend the services to more regions in Africa, there is need to diversify these services. To this end, the laboratory is in the process of acquiring a next generation sequencing technology which has the capacity to detect drug resistance mutations that are present at a level lower than that detected by the regular sequencing techniques. This will help with detection of eminent mutations early enough before they get to very high levels.

2.0 RESEARCH 5

Research is the core businesses of joint Clinical Research Centre (JCRC). Research at JCRC has tremendously contributed to both local and international scientific advances in the fight against the HIV pandemic. JCRC has continued to take a leading role in conducting high quality research in basic science research, operational research, epidemiological research, clinical trials (including some of the largest HIV clinical trials in the world e.g. ARROW and DART and the social science research in both adults and children. Over 300 publications in high impact peer reviewed journals have been achieved. A number of this research has led to guidelines and policy changes. As a result, JCRC has over time been able to attract partnerships and collaborations with a number of both local and international organizations as well as accumulated expertise and infrastructure to perform internationally acceptable research. Currently, 28 studies are being conducted at the JCRC Kampala and at the RCEs, majority of which are clinical trials. A number of other studies are lined up to start in the first quarter of 2015.

Research Achievements in 2014

1. During 2014, over 20 publications in international peer reviewed scientific journals were made. 2. JCRC received recognition for being a top recruiting site in the START study, BREATHER study and 2 of the ACTG protocols. The ARROW study coordinated at JCRC received an award from the British Medical Journal. 3. Compiled a list of all studies carried out at JCRC since 2000 and is now accessed on the JCRC website (www.jcrc.org.ug). 4. 10 research presentations in form of abstracts were made at international fora such as CROI 2014 in Melbourne, Australia, World congress of cardiology scientific session in Melbourne among others. Also 2 presentations were made in the JCRC coordinated annual HIV update meeting in Kampala. 5. Collaborative research with other partners both local (e.g IDI, Nsambya Hospital, UVRI/MRC), regional (Kenya, Malawi, Zimbabwe and Zambia) as well as international (MRC-UK, ACTG) partners has been successfully conducted. Notably, Dr Robert Salata who is the Liaison Investigator to the ACTG’s Joint Clinical Research Centre (JCRC) in Kampala, was recognized and praised by the different international ACTG sites for his outstanding work in the field of HIV/AIDS and research. 6. JCRC has partnered with pharmaceutical corporations like GILEAD and DNDi to test and develop new drug products. Due to the in the standard of research at JCRC, GILEAD 6

has expanded her partnership with JCRC by introducing 2 more research projects this year in addition to the already ongoing 2 other protocols 7. Several abstracts from studies conducted at JCRC were submitted for presentation in the upcoming CROI 2015 in Seattle, USA. 2 of them have already been accepted for presentation, among which are 6 from EARNEST study alone. 8. Electronic archiving of all research work conducted at the JCRC was done. 9. 2 PhD students are being supported to carry out their research at JCRC. They are being supervised and mentored by some of the senior and seasoned researchers at the institution. 10. In a bid to foster teamwork, monthly study coordinators'/trial managers’ forum was established and meets regularly to share experience and improve research conduct across all the studies conducted at JCRC. This has led to innovative ways of problem solving and creatively overcoming day to day challenges of research administration and conduct. 11. Together with the training department, monthly research oriented CMEs/CPDs are being conducted. These help orient all the staff in different departments at JCRC about each and every study running at the centre and the RCEs. 12. Majority of staff members including those at RCEs have received training and mentorship in grants writing. Staff members from the research and grants office were able to participate in the NIH training in grants writing and administration that took place in Dar el salaam in June 2014 and the 3-day Annual workshop for the association of research administrators in Africa (ARAA) in Kampala in December 2014.

Deputy Executive Director, Dr Cissy Kityo addressing the START study participants on World AIDS day 2014 at JCRC Mengo campus.

3.0 Clinical Care:

The JCRC Kampala clinic with support from the THALAS project is operationally organized to deliver friendly services for the various categories of clients to which end an exclusive child and adult clinic as well as a private clinic are in place. In total, 15,280 clients received treatment at JCRC Kampala during 2014 of which 1,119 were enrolled into care with children under 15 years accounting for 2.1%. JCRC also operates a private clinic which provides HIV services to both adults and children who are able to pay for the services, and contributes to income generation.

The following graphical presentations represent the clinic performance during the year.

Fig 2: Showing JCRC Clinic attendance Patterns

Fig 3: Clients who picked ARVS by age

Table 1: The JCRC Kampala Clinic Attendance

Age of Client M F T Naive Less than 2 years 4 8 12 1 2-4 46 35 81 9 5-14 571 573 1,144 254 15+ 571 8292 14043 44 Total 6372 8900 15280 308

Table 2; Patients that picked ARVS

Age of Client M F T % Less than 2 years 4 7 11 0.1 2-4 42 30 72 0.5 5-14 474 416 890 5.9 15+ 5729 8270 13999 93.5 Total 6372 8900 15280 308

Other clinic achievements included;

1. A total of 375 male patients comprising of 33.5% and 744 female clients comprising of 66.5% were newly recruited into care. 2. 29 children transferred into the Adult clinic (13 male & 16 female) 3. 974 of which 5 and 969 were children and adults respectively transferred into JCRC ART/HIV care. 4. 14972 patients of which 10279, 4523 and 170 are on 1st line, 2nd line and 3rd line respectively

Fig 4. Client ART Regimen

Fig 5. Client ART regimen by sex

5. A total of 318 (4 children & 314 adults)patients were switched to second line regimens 6. 6,568 (1846 male & 4492 female) patients received OI treatment 7. This FY 2013/14, 200 new TB cases were targeted for treatment. For the completed period the JCRC Kampala Clinic screened all the 15,280 patients who came for services, which resulted in identification of 548 suspects who were linked to TB microscopy, GeneXpert and/or X-ray yielding 196 confirmed TB cases who were started on anti-TB treatment. This number is 98% of the targeted 200 clients. Although the Kampala clinic majorly attends to HIV +ve patients, among the 196 new TB patients 173 (88.3 %) were HIV positive.

For the cohorts of one year prior to the reporting period, the clinic followed up 339 TB patients; 106 patients completed treatment, 14 patients were transferred out to other facilities while 23 patients died. 8. 9980 patients were assessed for malnutrition; 3544 males and 6436 females. For the reporting period, 256 patients were acutely malnourished (66 patients with severe acute malnutrition and 190 with moderate acute malnutrition). 239 received RUTF which is 120% of the targeted 200 children and adults. 9. A total of 1819 clients accessed HIV counselling services and 1742 clients took the test. 362 were found to be HIV positive. 10. 66 clients were counselled tested and provided with ARVs for PEP. More than half were due to claimed condom accidents during sexual encounters while about one quarter were due to sexual assault 11. A total of 1742 clients took an HIV test, which is 116% of the targeted 1500 clients. These were 384 clients for DNAPCR and 1358 clients for Rapid tests. Of the 1742 clients who took the HIV test, 362 tested HIV positive; 136 males and 226 females. 12. 4615 patients (55% of the targeted 8400) were provided with at least one FP service and assessment shows that 100 percent actually used the FP method provided to them. 483 were provided with FP counseling. 86141 pieces of condoms were supplied to 3614 patients, 288 women were provided with 288 vials of Depo and 51 women provided with 158 cycles of microgynon

Some of the Outpatient Clinic Staff at Lubowa

3.1 Out Patient Services 3.1.1 Pediatrics

The total number of children in the paediatric clinic has remained relatively stable at 1,241 predominately because of the prevention of mother to child transmission (PMTCT) strategy countrywide under fives in the clinic making up only 6.6% of the total pediatric clinic population. The clinic however continue to receive children as referals in from other health units 12 for specialized care, to participate on various researches, babies spilling over from failed mother to child prophylaxis or from children especially adolescents who have been tested late.

Services offered

The main activities therefore remain: Research, Care and treatment of HIV infected children and prevention of mother to child transmission of HIV (PMTCT).

Research: The paediatric clinic has participated in a number of clinical trials that have influenced policy for care and treatment. Currently there are 5 active clinical trials running which are basically addressing new formulations of ARVs that favour adherence (especially among adolescents) and those that reduce risk of drug resistance as well as a qualitative study for adolescents. These are the Gilead 106 and 160 protocols, PAINT, PENTA 16 (Breather) and ViiV studies. MARCH is currently exiting it’s participants from the trial. We anticipate two further studies to start during the course of the year 2015.

Care and treatment: The clinic also has a largely adolescent population with 58.5% above the age of 12 years. Over this year the clinic has been actively initiating children less than 15 years of age onto ARVS as per the recent national guidelines. However disclosure in this age group remains a challenge (UNCST guidelines: start the process of disclosure by age 8 years) although currently more than 95% of children above 12 years are fully aware of their HIV status.

PMTCT: Follow up of exposed children has been strengthened with the creation of the mother- baby point within the paediatric clinic. The clinic works hand in hand with the adult PMTCT side of the eMTCT clinic to ensure timely start and switch of ARV therapy of pregnant and hopeful mothers to be, carrying out counseling with emphasis on young child and infant feeding. The mother baby point has also offered a continuum of care for exposed babies resulting in early identification of HIV positive babies, nutritional support and early referrals of children requiring other specialized consultation. With the help of expert patients within the clinic, male involvement started to pick up among this group.

2015 Targets:

1. Strengthen PMTCT services to reach HIV negative baby rate of 100%. 2. Introduce private services within the pediatric clinic

3.1.2 Nursing

With a total of 41full time and 5 locum nurses, the Nursing Department continues to be committed to providing competent, compassionate, innovative and accessible nursing care to its patients.

The department has 4 main sections namely Adult, Paediatric, Private and in-patient where nurses are fully engaged in providing health care services. Nursing is spearheaded by the following staff;

A nurse taking a patient’s Blood Pressure at the Lubowa ward.

All nurses are engaged in research & actively take part in different protocols as coordinators or study nurses.

Special clinics within OPD supported by Nurses are; Chest Clinic (TB), Mental Health, Prevention of Mother to Child Transmission (PMTCT), Family Planning and Nutrition.

3.1.3 Pharmacy

The pharmacy department is divided into the drug logistics section on one hand and the clinical section (comprising research, treatment and care components) on the other. The latter section has pediatric and adult units.

The department is headed by an experienced pharmacist with nearly 15 years of post-registration experience, most of which was in HIV/AIDS Research, treatment and care as well as ARV Logistics Management.

The Clinical section has 4 pharmacists and 6 pharmacy technicians who are highly experienced with each having clocked not less than 5 years of HIV/AIDS Research, treatment and care.

Showing some of the Pharmacy members at JCRC Lubowa

Management of Research drugs

As a vital part of a vibrant research institution, JCRC pharmacy department is actively involved in all drug-related research activities through:

 Participation in protocol development (where necessary), reviews and implementation  Advising the PIs and other investigators on regulatory requirements for conduct of drug- related clinical trials, including processing of necessary approvals from Uganda’s drug regulatory authority upon delegation by the PIs in total compliance with existing policies.  Importation, proper storage and handling of clinical trials materials, as well as total accountability of the clinical materials in accordance with the protocol and established JCRC procedures and guidelines.  Mentorship and supervision of the RCE pharmacies, using appropriate tools, in order to develop and enhance their capacity to effectively participate in researches since the RCEs are increasingly taking on more research projects.

JCRC has also embarked on research on novel ARVs in collaboration with multinational pharmaceuticals corporations (MNCs). This is indeed a milestone not only for JCRC but Uganda and Africa at large since this kind of research is usually undertaken mainly in developed countries.

Whereas a number of studies were successfully completed during the year e.g. EARNEST and CHAPAS-3 studies, there are nonetheless a number of drug-related studies which are on-going. These include WAVES, REALITY, a number of ACTG protocols, etc. A number of protocols were approved and commenced during the year while others are still under regulatory reviews and are planned to commence in 2015. 15

For the multi-centre clinical trials e.g. REALITY, JCRC pharmacy continues to serve as the central repository for all Ugandan sites. The activities include quantification, ordering, and processing all necessary import documentations as well as proper storage, distribution to all sites in Uganda, total accountability of the clinical trials materials and destruction of unused or returned study materials in compliance with protocol requirements and national regulations.

General Treatment and Care

In addition to the involvement in research activities, the pharmacy department in Kampala currently offers pharmaceutical care to over 12,000 clients most of whom are on ART under THALAS. These include the corporate clients who are served at the pharmacy at JCRC Mengo. Patients under THALAS are served mainly at the Lubowa pharmacy.

The pharmacy at Lubowa campus has two dispensing windows; the adult Out- patient window and the paediatric window. The paediatric unit is normally busy during the holidays when students and pupils are on holidays and towards the beginning of the school term.

Working closely with the Adherence and Counselling departments, pharmacy team actively monitors patients’ adherence to ART.

JCRC is currently the largest and leading facility providing the latest third line ART in Uganda to more than 150 patients, most of whom are participants in the JCRC research cohort but also JCRC continue to receive referrals from other HIV treatment centres and hospitals

Some third line ARVs used in the treatment of resistant HIV.

Note; the future of this advanced care is uncertain due to funding gap. Other services handled at the pharmacy are PMTCT services and PEP

Drug Logistics Management:

JCRC has developed a robust drug logistics management system that ensures constant supply of ARVs and other major OI drugs to achieve the six “rights” of logistics cycle, namely: the right commodities (ARVs and OI drugs), the right quantities, the right conditions, the right place, the right time and the right cost.

As a result of the robust logistics management system, JCRC has been able to avoid stock-out of ARVs in its programs and also provide buffer drugs to MoH and other IPs. The logistics cycle entails product selection; forecasting and ordering; inventory management and distribution (where applicable) and use. Drug selection is in accordance with MOH and WHO treatment guidelines. Adequate capability and experience has been developed to forecast and quantity drug needs, including the use of MOH-approved tools to quantify and order commodities, including drugs.

JCRC has established a good inventory management system, anchored on skilled personnel and appropriate infrastructures that make it possible to rationally decide on when and how much to order or issue commodities and how to maintain appropriate stock-levels of all products to avoid shortages or overstocking. The infrastructure includes a big purpose-built warehouse/store and MIS to support the inventory management functions. There are established guidelines on Proper Stores Management, including how to handle products of short shelf life in order to minimize wastages through expiration.

Additionally, the pharmacies at both Mengo and Lubowa campuses as well as the RCE facilities have sizeable storage facilities. Not only can these infrastructures and capabilities be harnessed to handle study materials for multiple research projects which can run concurrently, but also offer opportunities for contract logistics management to other IPs and procurement agencies for example, URC contracted JCRC to handle their Logistics deliveries because of the infrastructure and experience attained over time. JCRC has the capacity to do more given this robust cost- effective distribution system that includes use of own delivery trucks for large quantities of commodities or contract courier services for delivery of smaller orders.

3.2 Inpatient Services;

3.2.1 Ward JCRC also operates an in-patient ward at JCRC Lubowa where patients are admitted for further management. A High Dependency Unit will be operational in 2015 to cater for patients who need closer monitoring and treatment.

Some of the Nurses that work at the Lubowa Ward.

Other Clinic Achievements;

1. JCRC successfully relocated most of the inpatients from Mengo to Lubowa a more modern facility with over 50 beds and large space. 2. JCRC managed to secure uninterrupted treatment for all patients on 1st and 2nd line ART as well as patients referred to JCRC by other facilities after failing on these stages to be managed on third line and salvage therapy. By the end of the year, over 200 patients were started on third line therapy and the number continued to grow. 3. Ensured uninterrupted HIV care to close to 20,000 patients in care in Kampala including 1,774 OVCs. 4. Upgrade of the nurses’ station for better service delivery in the in-patient ward at Lubowa was completed. 5. Nurses attended different trainings in and outside JCRC including; Pain Management, Mental education (on-going, online), Proposal development writing, Gender and social diversity, Responsible Conduct of Research, only to mention a few. This knowledge has enhanced the standard of patient care and Research. 6. The Patient waiting time reduced to an average of 26.6 minutes (Nurses Visit), 29.6 minutes (Doctors Visit) and 25.7 minutes (Lab/Phlebotomy). This has improved patient management. 7. Over 4,500 patients were seen at the private clinic at Mengo. This private clinic provides paid for services on appointment for both children and adults.

4.0 Training at JCRC

In 2002, JCRC started the process of ART service expansion in Uganda and setting up RCEs in selected regions like Mbale. With this came the need to train other service providers to support the provision of HIV care. In 2003, with the award of TREAT and demand for continued scale up of ART in the African region came the need for increased capacity building for health workers in order to provide adequate HIV/AIDS care. The JCRC then established a training department in order to strengthen and enhance human capacity to provide quality clinical care and contribute to quality HIV care, treatment and research programs through pre and in- service training. The training programs target; Health care workers providing care (clinical and laboratory services), staff involved in clinical research, community support groups to support HIV care delivery at the grass roots and students under the student internship program. Approaches to training used include, on job training, coaching and mentoring, Placements in clinics and laboratories, workshops and continuing medical education.

Projects such as IEADA and COHRE support the training wing at JCRC

4.1. The International Clinical Operational and Health Services Research (COHRE) Training Program. The goal of COHRE is to strengthen the national capacity to address the public health and scientific challenges of the evolving HIV and TB epidemic in Uganda through conducting training, mentoring upcoming scientists and operationalizing research findings. This training program is funded by Forgarty International Centre (FIC). COHRE collaborating institutions include: JCRC (Awardee Institution), Makerere University, Mbarara University of Science and Technology (MUST), Kampala City Council (KCC), Uganda National TB and Leprosy Program (NTLP), Uganda Ministry of Health and Gulu University in Uganda. The USA collaborating Intuitions on COHRE are; University of Georgia (UGA) and Case Western Reserve University (CWRU).Through consultative meetings among COHRE Faculty member, and other key personnel from partner institutions, training needs are identified, prioritized and those which are related to goal of the program are implemented. The program continues to support long-term training (Masters, PhDs), intermediate (fellowships) and short-term non- degree trainings in Uganda.

4.2. INTERNATIONAL EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARDS (IEARDA) INTERNATIONAL EXTRAMURAL ASSOCIATES RESEARCH DEVELOPMENT AWARDS (IEARDA) is based at Joint Clinical Research Centre (JCRC). The goal of (EARDA) grant is to develop cadres of research administrators that can address current and future NIH and other funding agencies’ grants policies and procedures, and to strengthen the research and grant administrative infrastructure at JCRC and its affiliated institutions. IEARDA collaborating institutions include: JCRC (Awardee Institution), Uganda Christian University Mukono and Ndejje University.

Participants attending the 2014 National HIV Update Meeting at Serena Hotel

Some Training Achievements of 2014

1. The JCRC Blended Clinical and Laboratory Training Programs business plan was developed. This will refocus and strengthen the JCRC training programs by introducing new clinical and laboratory themes, coupled with in-service training, and employing cutting edge technology to deliver them more economically and at scale.

2. During 2014, JCRC conducted courses using e learning platforms, that included a course in Responsible Conduct for Research that attracted 81researchers, scientists and lecturers from JCRC, Mbarara University and Makerere University, IDI, MUJHU among others.

3. The training department conducted training for 21 community liaison volunteers from divisions of Kampala and selected villages in Wakiso and Mpigi to help conduct community based monitoring and assessment for least adherent patients on ART.

4. The 6th Annual HIV update meeting took place in September 2014 and involved over 160 clinicians who were able to interact with local and international HIV/AIDS care and research specialist.

5. JCRC continuing professional education for staff this year addressed; Palliative care in HIV management, Mental Health in HIV management, Adolescent Sexual and

Reproductive Health needs for prenatally infected adolescents and nutritional care for PLHAs among others.

6. Special training for Health care providers (121) from facilities in Gulu and Mbarara region that included implementing HIV/TB collaborative activities, M&E of HIV programs, comprehensive HIV care and management training and Training of trainer’s course for TB microscopy and EQA were conducted.

7. JCRC continuing support to public universities included support for academic curricular for MSc Public Health and MMed Psychiatry for Gulu University and development of research policies for Ndejje and Mukono Universities. Staff in targeted universities have been trained in Grants writing and award administration and management, Manuscript writing and publication, Mentorship and student supervision and research methodologies and administration.

8. 11 students pursing masters programs from Mbarara University of Science and Technology (MUST), Uganda Christian University and Makerere University (MaK) have received mentored research scholarships under the JCRC training programs to facilitate them complete their post graduate training.

9. The student placement and fellowship program has given opportunity to 32 students pursuing under graduate courses in various universities to get hands on training and exposure in advanced care and research at JCRC.

10. Degree training: As part of the contribution to post graduate degree programs in the country, COHRE offered research mentorship scholarships to 11 Mashers degree students.

11. Mentorship and Student supervisor training workshop was held for 47 participants including junior /senior lecturer, teaching assistants, professors, deans of students, research administrators, researchers, administrators, project officers /coordinators, counselors, nurses, academic registrar, research assistants and medical officers. The training workshop took place from 11th August to 15th August 2014 at Lake View Regency Hotel, Mbarara.

12. 45 participants received training in Grants Writing and Award Management Training Worship at Mbarara between September 30th to 4th October 2014 at Lake View Regency Hotel Mbarara

13. 37 trainees comprising of Doctors, Medical officers, enrolled nurses, Clinical Officers, Nursing Officers, counselors were trained in implementing HIV/TB Collaborative Activities. Workshop took place (from 30th June to 4th July 2014 at Church Hill Hotel Gulu.

14. 241 participants completed a course on Responsible Conduct of Research Course (RCR). This course is hosted at JCRC website. The goal of this RCR supplement is to increase (through training) on the number of, multidiscipline professionals of research scientists and academicians with values, attitudes, in-depth knowledge and skills on the research ethics concepts and their applications in clinical, social and public health research. It also aims at improving and maintaining the integrity of the research process and

protection of research participants. The JCRC’s 7 Regional Centre of Excellence (Kampala, Kakira, Mbala, Mbarara, Kabale, Gulu and Fort/Portal) act as recruiting sites.

15. COHRE supported a review and Development for a Masters in Public Health and Masters of Medicine in Psychiatry at Gulu University and Public Health (MPH) between 13th October 2014 at Imperial Royal Hotel.

16. COHRE training program supports a 2 year Masters in Public Health at Mbarara University of Science and Technology (MUST) by offering support to the MPH program in terms of funds to: purchase some essential text books for the department book bank; stationary; Internet access, field placement and supervision; Community attachment costs; Community attachment field visits; Stationery and cartridge; photocopying machine maintenance and servicing by pre qualified companies by MUST. The program emphasizes problem-oriented learning and the acquisition of competencies in public health by field exposure. Trainees who come from diverse disciplines including clinical, statistics and social science

17. PhD HSR program at Makerere University School of Public Health. This started in 2008 with support from the COHRE training program. MakSPH is currently reviewing the MHSR curriculum as required by University regulations and COHRE will provide support towards this review.

18. 41 participants received training in Introduction to Research Ethics with support from the IEARDA program. This was a three days training workshop from 15h to 16th October 2014 at the Joint Clinical Research Centre (JCRC) Lubowa training hall. The general objective of the course was to teach basic research ethics, ethical dilemmas in biomedical and social research, multi sites clinical trials and reporting research misconduct. The training was attended by trainees from JCRC, Uganda Christian University Mukono, Ndejje University and MildMay Uganda.

The following courses are planned by IEARDA during 2015.

Non –Degree courses and workshops

i). Manuscript writing, publication and intellectual property rights

ii). Resarch Ethics and IRB compliance in resarch process , scientifc resarch misconduct and professional developmnet

iii). Training of trainer sin mentorship

iv). Data collection methods and use of facility based data and data management

v). Introduction to dissemination and implementation research

Note: training programs at JCRC remain critical in supporting country expansion and improvement in HIV/AIDS care provision focusing on TB/HIV management, ART management (among adults and children), data & logistics management, psycho social support, focused community involvement, Lab service provision. The future plan for JCRC is to develop a 22 training institute that offers academic programs with emphasis on supporting chronic care and terminal illnesses, laboratory management and improved diagnostic capabilities and Research competences.

5.0 Institutional Strengthening

This forms the administrative arm of JCRC and it comprises of the departments of Human Resources, Transport, Business Development, Finance, Audit, Stores, Estates and Information Technology.

5.1. Human Resources;

1. Performance appraisal for all staff was done for the renewal of their employment contracts. A more comprehensive and performance based appraisal tool was developed and approved by management and its application has been discussed by all JCRC staff. 2. All Job descriptions for JCRC staff were reviewed and updated making them more practical, clear and accurate to effectively define organizational needs. 3. A job evaluation and grading exercise was done to evaluate and grade jobs of equal value and contribution together. At the end of exercise, job grades/salary scales were developed which resulted in fair and equal reward/benefit management scheme. 4. A communication policy was developed and approved by the Board of Trustees. 5. New staff recruited to include among others; the Head Human Resource and Development, Chief Programmer, Head Audit, Fort Portal RCE Head, Head Procurement and Disposal Unit and the Human Resource Officer. All these were oriented into the operations of JCRC for better understanding of the Institution. 6. An audit and update of all personnel files in line with the human resource manual was carried out. 7. JCRC conducted weekly continuous medical education (CME) trainings to all JCRC staff. Managers also underwent a training in finance for none finance managers to help them understand good financial management practices.

5.2. Stores The JCRC store is comprised of 5 staff the Stores manager, Stores Officer, Store keeper and 2 Stores Assistants. This department has three sections, the Drugs and Clinical, Laboratory and General supplies. These sections are attached to Stores staffs that are accountable.

JCRC Store Stocked with ARVs and Other Supplies.

Store Accomplishments for 2014:

1. In June 2014 the store successfully carried out stock taking for the 2013/14 financial year. 2. Store received 2 additional computers which eased stock management in regards to stock reconciliation and data management. 3. Improved records management. Each stock item has stock/bin cards updated as and when receipt and issues are made. 4. Store staff benefited from internal trainings and CMEs at JCRC which improved the staff knowledge and understanding of the HIV/AIDS environment. 5. Monthly stock reconciliations are regularly done. 6. Spot checks on double issues started to avoid unnoticed issues causing shortages. 7. Store staff have protective gear (store coats, boots, face masks and gloves)

5.3 Estates The Estates department supports the centre in a number of ways which include among others; housekeeping, gardening, laundry services, administrative, maintenance of premises and structures, maintenance of machines and equipment, maintenance of utilities, and general operational support.

JCRC Estates personnel servicing a generator.

Achievements;

1. Successfully transferred a number of laboratories and equipments from Mengo to Lubowa in an effort to relocate to the new campus.

2. Proper maintenance of machines and equipment at Mengo, Lubowa, and in RCEs.

3. Maintained sustainable flow of clean linen for patients on the Ward.

4. Maintained an infection free work environment, by cleaning, and clean management of garbage/waste.

5.4 Information Technology: Accomplishments;

1. Recruited a Chief programmer (Application Development Unit-ADU) 2. Established IT service desk and recruited the ICT support officer. 3. Business Intelligence unit created with 4 staff supporting the section. 4. Internet connectivity was upgraded to 10Mbps,enabling proper communication 5. Improved Internet connectivity for laboratory at Lubowa with the connection of Local Area Network (LAN) extended to the LAB Block. 6. The Local Area Network was reorganised into VLANs; Guest Wireless Network separated from the main JCRC Network for increased security.

7. 25 computers were procured and distributed to different departments. 8. Data Backup tapes were procured and daily backup done & stored offsite hence enabling safe business continuity. 9. Recabling of the server room was completed thus avoiding data loss 10. Procured a server hardware to host LIMS 11. Procured 2 servers (Reporting & Production servers)for NAVISION and ICEA

5.5. Business Development:

The Business Development Office supports the development, implementation and Monitoring of business growth at JCRC in addition to spearheading strategic interventions for continued business. Among the accomplishments for 2014 include;

1. Regular Monitoring of the 2014-2018 Strategic Plan: This was done through regular reporting (Quarterly) as well as meetings to assess implementation progress and put in place the needed interventions to accomplish the plans. 2. JCRC 2014 Business Plan:

The Business Office worked with Consultants from USAID's Leadership, Management and Governance (LMG) Project to work with JCRC in development of the 2014 Business Plan. A training workshop was held starting 12th-15th March, 2014 at the JCRC training room which provided a platform for discussion and generation of ideas that eventually informed the new business opportunities. This exercise was attended by the JCRC board members and heads of business units who contributed to the revised Business Plan. This Business training had two aims;

a. To train JCRC managers in business planning for health to equip management team with skills in business planning to support the sustainability efforts. b. To review the Business Plan and develop a new one ready for funding.

The approved Business Plan promotes two Business Opportunities;

i. JCRC Expanded Health Services Delivery Model and ii. JCRC Blended Clinical and Laboratory Training Model

3. The Business office conducted a Business partnership visit to the different partners working with JCRC particularly at the regional level. 29 partners were visited to assess prospects of growing further the business partnerships of which half of the partners visited had never worked with JCRC before. This helped promote JCRC especially to the new partners.

4. 25 MoUs with different partners were signed. Services offered among others include; Research and Laboratory, Training, Treatment & Care, Incineration, transport & Logistics services. This is a positive sign towards JCRC’s sustainability. These add to the already existing MoU list that is updated regularly and shared with the Finance team for coordinated efforts.

5. JCRC with Support from the USAID's Leadership, Management and Governance (LMG) Project was able to to among other things; i. Renew the institutional manuals to include; the Procurement manual, the Human resources manual, the Finance and the Audit Manual. ii. Provide training in Financial Control on USAID allowable and unallowable costs iii. Proposal and grants writing 6. JCRC Management and Staff received training in in Fraud detection by A US RIG Cairo Representative; Mr. Elghazaly Salah conducted a Fraud and Abuse Prevention training at JCRC Lubowa. In addition, JCRC Staff members were trained on USAID regulations and compliance requirements

Mr. Elghazaly Salah conducting a Fraud and abuse Prevention training at JCRC Lubowa

5.6. Resource Mobilisation:

JCRC was able to utilize its previous surplus carried forward from the financial year 2012/2013 to 2013/2014. The financial year to June 2014 was quite challenging with USAID project THALAS & EU major studies winding down resulting in an overall reduction of grant income of 9%. JCRC has increased its portfolio of new projects, studies, extensions and income generating activities and expansion of private clinical services including cardiology and dental unit thus significantly mitigating the effect of the reduction. Overall expenditure rose by 8% as creditor arrears were significantly reduced and improving our current liquidity position. Going forward, JCRC will continue to seek a wider portfolio and sustainable sources of income through provision of high quality medical research, training and health care services while seeking to improve efficiency in all areas while reducing operational and management costs

Fig 6.JCRC Sources of Funds to 30th June 2014 Grants over UGX 100 million only identified 28

PENTA 16 / BREATHER ARROW NOURISH 1% 1% MRC UK EDCPT Chapas 3 JBS GILEAD 2% 2% 1% 1%

START MEDTRONIC 3% 2% USAID MSH Star E 4%

REALITY 4% USAID THALAS 33%

WAVES - Gilead 7%

ACTG & Case Western Reserve University 7%

Accrued Income SCIPHA - Civil Society 7% Fund 16% EDCPT Earnest Trial 10%

6.0 JCRC Regional Centres of Excellence:

6.1. Mbarara RCE The Joint Clinical Research Centre (JCRC) Mbarara Branch is located within the mai Regional Referral Hospital and mainly involved in research work and patient care. During the year of implementation, the JCRC Strategic plan guided RCE in developing its 2014 RCE work plan which formed the basis of implementation and achievements for 2014.

Partners served during the year include; The Medical Research Council-United Kingdom Clinical Trials Unit, The Medical Research Council-Entebbe, Makerere Joint Aids Program-MJAP, Infectious Diseases Research Collaboration-IDRC, Elizabeth Glazier Pediatric Aids Foundation- EGPAF, The Epicentre/Italian/ Mbarara University Research Laboratories, Medtronic ( Rheumatic heart disease) Cohort Team, The Aids Support organisation-TASO,Kitagata Hospital, Ibanda Hospital, The Uganda Peoples’ Defense Forces-UPDF 2nd Division, Mbarara University under the Departments of Internal Medicine and Paediatrics. Contacts with key partners in the region helped during patient referrals under research, care for patients failing on second-line therapy and provision of laboratory services under program contracts.

Mbarara RCE provided HIV Viral load testing services to Mbarara Regional Referral Hospital, Mbarara Municipal Council HIV Clinic, Bwizibera Health Centre IV and other MJAP supported facilities in the region. The RCE continued to offer standby laboratory services to Italian/ Mbarara University Research laboratory, the MEDTRONIC (Rheumatic Heart Disease) patient cohort for Mbarara region was established in collaboration with the Mbarara University Departments of Internal Medicine and Paediatrics while the contract with EGPAF-STARSW for provision of Viral load to Western Uganda sites was successfully concluded, in addition, The RCE continued to offer data management and counseling services to this growing cohort of patients. In addition, 2 contracts were signed for provision of private laboratory services.

Accomplishments;

1. Total revenue of Ushs 123,636,000 revenue was raised from businesses generated locally, Ushs 103,329,000 in dept was recovered and about Ushs 73,285,000 is still outstanding and will be with support from the headquarters. 2. All RCE staff received training in Good Clinical Practice with support from MRC-UK and the REALITY TRIAL team in addition to the Research and Grants writing training. 3. 100% improvement in Turnaround time (TAT) for all laboratory tests was realized; TAT for CD4 Count, CBC+Diff., Chemistries to a maximum of 8 hours while TAT for Viral Load reduced to a maximum of 8 working days. 4. The RCE Grants committee actively participated in the writing and submission of PACF grant together with the Kampala team. 5. The RCE staff participated in two research publications; the Europe Africa Research Network for Evaluation of Second-line Therapy-EARNEST Trial main publication and Dr. Lugemwa Abbas participated in the EARNEST TRIAL sub analysis of “peripheral neuropathy at first-line failure and on second-line in sub-Saharan Africa’’ which was completed and accepted for poster presentation at CROI 2015 in Washington, USA. 31

6. The centre successfully started the REALITY (Reduction of Early Mortality in Adults and Children starting Antiretroviral Therapy) Clinical Trial. In terms of patients recruited, the centre is among the biggest sites and the overall best performer in Trial data management and entry.

Fig.7 Reality Patients

Patients Recruited under REALITY 250

197 200

150 111 115 100 Patients Recruited 100

0 Fort Portal Mbale Mbarara Gulu

7. The centre attracted 3 studies; the ViiV study assessing social challenges of growing up with HIV among adolescents, the Social Sciences sub study of REALITY Clinical Trial and Rheumatic heart disease study/cohort in collaboration with the MEDTRONIC team. 8. The EARNEST Clinical Trial was successfully closed with no patient lost to follow up and all queries resolved.

Future Plans

1. Mbarara RCE will continue patient recruitment into REALITY Trial from the current 197 patients to above the 240 patients by end of February 2015, while upholding quality conduct of all the available studies at the RCE. 2. With renovations and building face-lift the centre plans to expand the scope of services offered at the RCE to include; private general hospital pharmacy and laboratory services on top of strengthening private HIV clinical and lab services. 3. To locally attract at least two new partners in either research or patient care and ensure the existing partners are served well and maintained. 4. Participate in at least two publications and ensure that at least two RCE staff make presentations or attend an international conference. 5. The laboratory to at least attain SLIPTA star 4 and to do EQA proficiency test on all tests offered at the RCE.

6.2 Fort-Portal Fort portal Regional Center of Excellence is located in the Rwenzori region within Buhinga regional referral hospital.

Front View of JCRC F/Portal and Some of the JCRC Staff

It is a vibrant center of excellence in research and health care services and offers the following services;

1. Research; the centre currently manages 3 research trials at the site; PASER-M; successfully conducted and exited patients, await data analysis; MARCH, Ongoing follow up. The exit process of the participants began September 2014; REALITY, Ongoing recruitment, follow up and exit of participants. 2. Private Clinic: the centre operates a private clinic that is steadily growing currently with 23 clients .The clinic offers HIV and non-HIV health care services. 3. Laboratory services; A wide range of private laboratory services are offered to the region that supports hospitals and private clinics around the region to offer quality health care services. 4. Community Outreach. With the support of the SCIPHA project; the centre was able to reach out and help the Most At Risk Persons (MARPS) in regards to prevention, care and treatment of HIV of those in hard to reach areas of Bundibugyo, Kasese, Masindi, Hoima and around Kabarole.

JCRC SCIPHA Kabarole team with the Village Health Team (VHTs) during the 2014 World AIDS Day celebrations in Fortportal.

The F/Portal RCE head (Dr. Kabahenda) together with the SCIPHA staff and the Village Health Team(VHTs) Members at the 2014 World Aids Day celebrations in Fort-portal. H.E President Yoweri Museveni was the Guest of Honour. The SCIPHA project together with the VHTs work amongst the most at risk persons in the community eg fisher folks, commercial sex workers, long distance drivers and provide prevention, care and treatment for HIV/AIDS.

Future Plans

1. Establish a private pharmacy at the site to boost the private clinic and also boost the income of the RCE 2. Work with Head Office to improve servicing for Laboratory equipments. 3. Private clinic; Increased sensitization especially among the cooperate clients with access to health insurance. 4. Increase partnerships with hospitals and clinics around the region to run private samples.

6.3 Kakira The RCE/laboratory located in the outskirts of Jinja Municipality is a Viral Load hub for the Eastern and Northern region because of the samples referred from those regions. The clients served during the year were mainly SUSTAIN/THALAS project, STAR-EC and the private individuals. The man lab services offered included; Viral Loads, CD4, diagnosis of opportunistic infection, CBC, RNA and other toxicity monitoring investigations.

The center has 5 members of staff; 1 Medical Officer, 2 Lab technologists, and 2 support staff. 34

Accomplishments for the year

1. 6,231 Viral loads, 1,211 CD4 assays and 69 tests for private clients were done. 2. The Regional Centre of Excellence Laboratory staff participated in coaching, Mentoring and training of under graduate laboratory science students from Makerere University Kampala, in addition to tele-mentoring of MoH lab staff. 3. The lab standard improved to STAR 3.

Future strategies

1. Establish a satellite clinic at Jinja town to boost the private clinic. This site will work as a sample collection as well as a point for picking results. 2. Increase the frequency of the radio talk show to at least 4 times a month 3. Work closely with the local administration to sensitize the public of the services available.

6.4 Gulu JCRC Gulu RCE is strategically located in the northern district of Gulu at Koro approximately 4km along Kampala Gulu high way.

Gulu RCE is equipped with spacious modern laboratory, including a number of consultation rooms for clinical services as well as children play area. Gulu RCE acts as amajor hub for specialized Laboratory services in northern region, it receives test samples from as far as Kaabong in the north east and Moyo in the west Nile regions.

Front view of JCRC Gulu at Kooro

The Clinical Department

Gulu RCE currently has three (3) medical staff, one medical Doctor, and two nurses whose main work is to see study participants under the REALITY trial. The centre also realized increase in the number of private clients with 25 that access their free drugs (ARVs) from the national ART sites while paying for their laboratory investigations at JCRC Gulu.

Laboratory services at Gulu RCE

Gulu RCE main lab is managed by 2 lab Techs including the laboratory manager and the lab processes 3 core specialized tests; CD4, CBC, and Blood Chemistry mainly for studies, organizations (TASO, WATOTO etc) as well as private patients.

Laboratory technologist preparing to processed CBC samples JCRC Gulu Core lab

Collaborating Institutions

Gulu RCE works with many partners like Gulu Independent Hospital, AAR, Maristopes Uganda Gulu, Bank of Uganda and IMC and in advanced discussions with NUHITES to be a backup lab and to offer mentorship to Anaka hospital and Atiak which are 2 NUTITES sites in Amuru District. The centre continues to lay strategies to increase the collaborations.

Projects at GULU RCE:

Currently the centre has 2 active projects of SCHIPHA and REALITY clinical trial. The SCIPHA project implements a comprehensive HIV Prevention Care and support services in the districts of Lira, Amolatar and Agago. REALITY study monitors 115 clients.

SCIPHA activities at Gulu include among others Prevention and care and below is how the project performed.

Table 3 SCIPHA Prevention activities in Gulu

Activity Number of people reached

HCT 9454

BCC 12156

Condom distributed 184611

Table 4 SCIPHA Care Activities in Gulu RCE

Activity Number reached

Cotrimoxazole 4593

PHDP 4631

OI 48888

Youths attending an HIV Counseling and testing services program carried out at Lira Bus Park.

The SCIPHA project works with groups in the communities which comprise of the HIV positive men and women. These groups help in mobilization and sensitization in the communities and are engaged in income generating activities which include VSLA which the project supports by providing startup capital.

Table 5 SCIPHA club assessment /support details

S/O CLUB NAME DISTRICT STATUS

1 Namasale Baba club Amolatar Supported

2 Can Ber ilwak Lira Supported

3 Ogur baba club Lira Supported

4 Kati-keni baba club Agago Supported

5 Awelo mama club Amolatar Assessed

6 Awe I par Lira Assessed

7 Mwony Apio Agago Assessed

8 Kwo mit Agago Assessed

9 Agago disability club agago Assessed

Challenges experienced in the implementation of the SCIPHA activities include;

1. Shortage of testing kits. 2. Late funding to the CSOs 3. Busy schedules of health workers delayed early start to activities.

The THALAS at GULU

The centre also participated in the implementation of the THALAS project as it wound up activities across all RCES. A total of 1274 viral load tests were done for the project before successfully transiting the viral load testing to MOH/CPHL.

Selected Accomplishments for GULU 2014

1. The laboratory was assessed and is currently at star 3. 2. The centre successfully transitioned all THALAS viral load testing to CPHL 3. The 115 study participants for the RAELITY trial are successfully monitored. 4. The centre resumed private clinical services currently managing 25 patients.

General challenge that faced Gulu RCE during the year 2014.

1. Inadequate funding to effectively operate the centres activities following the end of the THALAS support after transiting the Viral Load activities to MoH.

GULU RCE Future Plans;

1. Strengthen the private clinic by establishing a private pharmacy. 2. Explore possibilities of providing services beyond the Uganda boarders as far as South Sudan. 3. Provide Training in HIV comprehensive care of clinicians, nurses, clinical officers and counselors as well as training Laboratory technicians/assistants in specialized HIV procedures. 4. Position the centre to provide more opportunities for placements for both local and international students. 5. Strengthen the laboratory to continue to provide specialized laboratory services as well as support clinical trials and researches in the region.

6.5 Mbale RCE: Since its inception in 2004, Mbale RCE has contributed greatly to HIV/AIDS Care and treatment, laboratory services and research in Eastern Uganda. 2014 experienced reduced levels of activities as most HIV/AIDS care services were transitioned to Ministry of Health with research and contractual work making the core of the centres work.

The centre has 1 Clinician, 1 clinical trial manager / research nurse, 1 Counselor, 2 Technologists, one laboratory technician, 1 regional data manager, 1 laboratory data officer, 1 finance/ administrative assistant, 1 Community Engagement Officer, 3 District Data Assistants, 1 driver, and two support staff.

The RCE successfully executed a number of JCRC research protocols, namely PASER, MARCH, REALITY, SCIPHA project and the successful transition of the THALAS Viral Load activities to MoH. The laboratory also provided diagnosis for a number of research partners among others; Global Health Uganda, Infectious Diseases Research Collaboration (IDRC) and Mbale Clinical Research Group.

A researcher carrying out malaria parasite cultures at the Mbale Laboratory

The community SCIPHA project which among others supports care, Prevention and income generating activities provided a platform for increased mobilization of the public towards accessing treatment.

A counselor demonstrates female condom usage to pregnant women and youth out of School in Soroti Pamba slum

HCT for Truck drivers in the cattle corridors of Katakwi

A meeting of the MAMAS club in Katakwi district, Usuk County. Mamas clubs are useful in mobilizing for HCT prevention and care services in the rural community.

Selected Achievements for the year for Mbale RCE:

1. Institutionalized data Quality Assurance Processes through meetings, data quality checks, and patient file reviews. 2. 2 new strategic partnerships with two health centre IVs especially to enable us get participants for the REALITY trial were born. The existing partnerships with the Mbale Clinical Research Group and IDRC were strengthened. 3. Coordination meetings with key partners were held through meetings and email and this improved referral systems between the partnerships. 4. Improvement of data management was realized through strengthening the paper based data capture system by increasing coordination meetings with the research partners. No data backlog was experienced and billing reports were submitted on time.

Challenges and Constraints; 1. With fiscal constraints, it was not possible to raise seed money for the private clinic to expand working space and improve on ambience. As a result, the centre postponed introduction of psychotherapy services, private clinic among others.

Way Forward 1. Re-brand the Mbale laboratory to provide comprehensive health care services 2. Work towards increasing the scope of lab services by introducing new tests in microbiological culture and drug sensitivity testing, CMV/L and Thyroid tests, etc. 3. Intensify efforts with HQs towards attaining the new Mbale RCE complex at Kalongo.

THALAS PROJECT

Brief overview of THALAS Project

Targeted HIV/AIDS and Laboratory Services (THALAS) Project, is a 5-Year USAID funded project, awarded to JCRC on 10th June 2010, as a follow on to TREAT project. THALAS mandate is to provide quality HIV/AIDS care and treatment, laboratory, PMTCT and TB/HIV services to patients at the Kampala/Lubowa site. In integrating TB/HIV/AIDS services, JCRC partners with MOH, SUSTAIN, STAR EC, STAR SW, and MJAP among other partners. The project is expected to end in June 2015.

THALAS Project Objectives;

1. To ensure the provision of HIV/AIDS care & treatment, laboratory, PMTCT and TB/HIV services within public regional referral and district hospitals

2. To enhance the quality of HIV/AIDS care &treatment, laboratory, PMTCT, and TB/HIV services at regional referral and district hospitals

3. To increase the stewardship by MOH to provide sustainable quality HIV/AIDS care &treatment, laboratory, PMTCT and TB/HIV services within the public health system.

THALAS Project Deliverables Deliverable 1: Transitioning clients supported under the TREAT program to SUSTAIN and other USAID supported district- based Partners.

Deliverable 2: Maintaining the current client base of 32,200 clients receiving antiretroviral therapy (ART) with essential ART and laboratory services as required throughout the transition of existing clients served under TREAT to SUSTAIN and USAID supported district based partners.

Deliverable 3: Provision of integrated TB/HIV/AIDS services at the JCRC Kampala site to an estimated 18000 clients.

Deliverable 4: Provision of specialized laboratory services through seven sites in Kampala, Gulu, Mbale, Kakira, Fort Portal, Mbarara and Kabale.

Deliverable 5: Provide external quality assurance (EQA) and coaching, mentoring and training for laboratories supported by SUSTAIN.

Deliverable 6: Develop sustainability or exit strategy for continued provision of integrated TB/HIV/AIDS services at the Kampala site.

THALAS Project Achievements for Y4 THALAS focused on consolidating achievements of the previous years as well as improving the quality and accessibility of HIV/AIDS and TB services at the JCRC Kampala/Lubowa clinic. 1. THALAS implemented activities aimed at improving the quality of life of children and adults living with HIV/AIDS that get services from JCRC Kampala clinic through provision of integrated TB/HIV/AIDS services. 2. Advanced laboratory services continued to be provided at the JCRC Lubowa patients while Viral Load at the RCES was transitioned to MoH sites. 3. THALAS transitioned training and mentoring of laboratory personnel at the 13 Regional Referral and 7 General hospitals supported by SUSTAIN, to CPHL and SUSTAIN project. 4. The JCRC clinic Utilized HIV testing and counseling (HTC) as an entry point into all other HIV prevention and care interventions. For this reporting period, 1,819 clients were counseled, and of these, 1,742 (96 %) were tested for HIV and received results, resulting in 116 % of the target set of 1,500. 5. The HCT services led to identification of 362 new HIV positive patients who were linked into care. 1,119 new clients were enrolled into HIV care and 468 newly started on ART. The cumulative number of new patients enrolled on ART for the year stood at 2,693. 6. 15,280 patients visited the clinic for at least one clinical service, and of these 8.1% were children below 15 years. Overall, 14,972 patients are currently active on antiretroviral treatment, and 6.5% of these are children enrolled on ART. The low percentage of children on ART is a result of the robust prevention of mother to child transmission of HIV program at the JCRC Kampala/Lubowa clinic. 7. Consolidated Implementation of Option B+ strategy. 556 clients (311 new pregnant women and 245 revisits) attended counseling sessions for PMTCT. A total of 313 pregnancies occurred within the cohort of clients and all the mothers were provided with eMTCT services including ART (Option B+) as recommended by MOH. During the reporting period 215 deliveries were reported. The babies are being followed up while 15 babies died. 8. JCRC strengthened reproductive health education and family planning services for patients. Provision and use of Family Planning services increased during this reporting period. Family planning services include male and female condoms, depo-provera, implant and IUD. A cumulative total of 4,615 clients were provided with at least one FP service and assessment illustrated that 100% used the FP method provided to them. 9. The majority of clients who get services at the JCRC Kampala clinic(s) are served on outpatient basis. Some clients do present with opportunistic infections. A total of 6,338 outpatients were diagnosed with OIs and treatment provided. 10. 230 patients with complicated conditions received advanced care through the inpatient state of the art facility with expert clinicians and health workers. A number of health care facilities in Uganda, refer patients to the JCRC clinic for advanced HIV care and management. The most common conditions registered include respiratory problems, nervous system problems, skin, gastrointestinal tract, genitourinary, cardiovascular and musculo skeletal conditions.

11. During Program Year (PY)4, the JCRC TB clinic located at Mengo was recognized as the best performing TB unit in Kampala Capital City Authority. TB/HIV collaborative interventions including screening of all patients visiting the clinic for TB using the Intensified Case Finding tool, TB treatment and follow up and TB infection control are fully integrated in the clinic operations at Lubowa. 12. A total of 15,280 clients (100 %) were screened for TB leading to identification of 642 TB presumed cases; of these 548 had sputum microscopy and/or GeneXpert test which led to confirmation of TB in 196 patients. Through the follow-up mechanism at the clinic, 339 TB patients were followed up: 23 patients died while 14 transferred out to other facilities for follow up monitoring. 13. THALAS worked closely with SCMS and JMS to ensure uninterrupted drug supply to patients. JCRC continued to build on the successful drug logistics experience for the past ten years. Collaboration with National Medical Stores (NMS) was strengthened, resulting in increased access to cotrimoxazole, fluconazole, family planning supplies and morphine. Discussions are on-going with MOH, to ensure JCRC is included on MOH master list for essential drugs supplied by NMS.

14. In line with the national guidelines for nutrition interventions for people living with HIV/AIDS, MUAC was incorporated at JCRC Kampala clinic to assess and categorize patient’s nutritional status. Over the PY4 9,980 patients were assessed for nutrition; 256 were found malnourished of whom 190 had moderate while 66 had severe malnutrition. The clinic reported inadequate supply of RUTF from RECO Industries, which led to 93.3 % coverage for RUTF. Discussions are continue with RECO industries to ensure adequate supplies.

15. The JCRC network of laboratories in Uganda continued to play a significant role in HIV/AIDS prevention, diagnosis and treatment monitoring, by providing timely and accurate information for use in patient management and disease surveillance. These labs served as back up for leading HIV/AIDS partners in Uganda including STAR-EC, STAR-E, STAR-SW, and SUSTAIN. For this reporting period, 26,937 Viral Loads tests were done. The combined output of the labs were 17,946 CD4 tests; 1,284 HIV Rapid tests; 2,431 CBC; 2,527 RFTs, 1800 LFTs and 548 TB tests. In preparation for the transition of Viral load services to CPHL hubs by end of September 2014, stakeholder meetings were held with all regional referral hospital key staff and SUSTAIN project staff. Efforts were made to ensure a smooth transition by engaging all stakeholders.

16. . JCRC lab staff are member of the MoH Laboratory Technical and advisory committee. The lab staff participated in Quality Assurance and Laboratory Policy Sub-committees. The JCRC team participated in the activities towards the development of MOH National Health Professions Authority which will regulate all health professionals’ councils. In addition, lab team participated in the WHO/SLMTA training program which is being implemented to enhance performance of laboratories in the country. In August and September 2014, JCRC seconded a laboratory expert to facilitate the MoH SLMTA training of the second cohort, with laboratory staff from 52 MoH hospital laboratories across Uganda. On 8th August 2014, Mr. Charles Munafu, a JCRC staff was recognized for his outstanding contribution to improvement of laboratory services in Uganda. CDC outgoing Country Director Dr. Tadesse Wuhim presented the award on behalf of CPHL.

17. JCRC was recognized and received an award from National Forum of People Living with HIV/AIDS Networks in Uganda (NAFOPHANU), for outstanding contribution and provision of quality HIV/AIDS services to PLHA in Uganda. The ceremony was graced by UNAIDS representative in Uganda, and key HIV/AIDS stakeholders in Uganda.

18. JCRC is in the process of strengthening ICT systems, including Laboratory Information Management System(LMIS), Integrated Clinic Enterprise Application(ICEA) and upgrading current finance Management system to Dynamics NAV 2013. This followed MSH Leadership Management and Governance (LMG) Project, funded by USAID identified an ICT consultant to undertake ICT analysis aimed at improving information management systems across the organization. Mr. Jerry Henzel completed the ICT assessment and a report was shared with JCRC and USAID in November 2013. The JCRC management agreed with the findings and recommendations. An ICT implementation Work Plan and budget was developed, and approved by USAID. The changes are intended to ensure JCRC’s institutional sustainability, beyond THALAS Project.

19. Working closely with MOH, JCRC hosted the 6th Annual HIV update meeting on 17th – 19th September 2014, funded by Simply Speaking in collaboration with University of Wisconsin, University of Minnesota and US commissioner Bud Selig. The meeting highlighted HIV research findings conducted in Uganda and globally including presentations from International HIV/AIDS conferences (CROI and IAC). The meeting gave an opportunity to clinicians to learn and share experiences in HIV/AIDS practice. The PEPFAR Uganda Country coordinator participated and gave a key note address at the meeting.

20. In a bid to foster compliance with USG funding terms and conditions, JCRC staff were trained in USAID Fraud prevention by a US RIG Cairo representative, Mr. Elghazaly Salah. In addition, LMG Project finance expert trained JCRC staff in USAID rules and regulations and compliance requirements.

THALAS PROJECT FY 2014 ACHIEVEMENTS SUMMARY Table 6. Y4 THALAS project indicators based on pmp 2010-2015 ACTIVITY INDICATOR Targeted Achieved %

Number of adults and children Newly enrolled on ART 1200 468 39

Number of adults and children current on ART 11,784 14972 127

Number of adults and children receiving a minimum of one 20101 15280 clinical care service 76

Number of patients receiving cotrimoxazole 20101 9531 47

Number of HIV positive patients who started TB treatment 300 173 58

Number of HIV positive pregnant women newly enrolled into 60 25 HIV/AIDS care 42

% HIV positive patients screened for TB 85% 100% 118

Number of new TB/HIV patients provided care and treatment 290 196 68

Number of couples who received HCT and results 790 252 32

Number of family planning clients who used family planning 10,000 4615 methods 46

Number of clients provided with psychosocial support including 2000 1450 mental health support 73

Number of patients provided with advanced care((admissions) 300 230 77

Number of malnourished patients provided with RUTF 240 239 99.6

Number of patients provided with HCT 1800 1742 97

Number of Lab tests conducted for clinical monitoring VL 15000 26,937 179.6

CD4 40000 17,946 45

THALAS Challenges FY5; 1. As a result of the project design, JCRC could not implement outreaches to enroll high risk groups in Kampala and Wakiso districts. HCT numbers continued to be low and only patients that are able to visit the clinic are served. 2. Implementation of Integrated Clinic Enterprise Application (ICEA) system, delayed resulting into continued use of manual systems which affect efficiency and effectiveness of operations. 3. Increased demand for HIV/AIDS services has resulted in many patients visiting JCRC Lubowa clinic. However, THALAS has experienced budget cuts for the last 4 years and yet the JCRC Lubowa clinic continues to enroll new patients which necessitate additional staffing not possible under the current funding arrangement. 4. During year 4 THALAS experienced increased demand for specialized lab tests from 20 SUSTAIN supported sites, yet THALAS was scaling down this activity and was advised to transition viral load tests to CPHL by end of September 2014.

SCIPHA PROJECT

The Strengthening Civil Society for Improved HIV/AIDS and OVC service delivery (SCIPHA) project is a Civil Society funded project (CSF) implemented by the Joint Clinical Research Centre(JCRC) in 5 regions 19 districts of Uganda namely Amolater, Agago, Lira, Arua, Nebbi ,Koboko, Moyo, Soroti, Tororo, Katakwi, Kabarole, Kasese, Bundibugyo, Hoima, Masindi, Kalangala, Kiboga, Mpigi & Mityana

The project which has been operational since January 2011 completed its second 11 month extension phase SCIPHA III (Feb- Dec 2014) and is preparing for the 3rd extension Jan- Dec 2015.SCIPHA employs a lead agency and implements HIV/AIDS prevention, treatment and care services through existing structures including 21 indigenous CSO, 75 sub county health facilities ,525 VHT members and 75 Community owned resource persons who are PLHIV. The project targets Most at risk populations(key populations) like Fisher folk, long distance truck drivers, Commercial sex workers, Boda Boda riders, Uniformed personnel, Incarcerated populations, people with disabilities, Youth out of school, Discordant couples, Pregnant women and PLHIV

During SICPHA III implemented Jan- Dec 2014 the project by September 2014 was on track in achieving all its targets .SCIPHA reached 100,768 individuals of the key populations achieving 101% of the set target. This included 20,099 fisher folk(89%), 3,853 CSWs(77%),3,883 truckers(258%), 52,000 YOS(92%),4219 uniformed personnel(168%), 3,171 prisoners(211%)

Fig 9 SCIPHA III HIV prevention prevention among key populations

25,000 22,500 20,099 20,000

15,000

10,000 5,000 3,853 3,883 3,171 4,219 5,000 1,500 1,500 2,500 Annual Target Cumulative Achievment 0

Altogether 5,814 Pregnant women were mobilized for HCT and referred for ANC achieving 116% of the project target while 2,320 HIV positive pregnant women were provided/referred

49 for EMTCT reaching 232% of the target. 124,852 individuals were reached with BCC messages,83,000 IEC materials were distributed achieving 83% of the target while 2,554,000 condoms were distributing achieving 254% of the set target

SCIPHA provided HIV care services to 27,745 PLHIV at community level. Services offered included Septrin prophylaxis, TB and OI screening, CD4 testing, adherence monitoring & psychosocial support at community level. 7,135 HIV positive children and adolescents were cared for at community level and linked to care. Other services included clinical and growth monitoring, ART adherence counseling, dewarming, immunization, social service, psychosocial support and linkage to ART. This was attained because of establishing child and youth friendly services during outreaches e.g. counselors who undergone pediatric and adolescent counseling training provided the services while Toys, games and sanitary pads were availed to children and adolescents. PLHIV were linked to the appropriate peer support groups.

SCIPHA employed the 4 tent model outreach which delivers a comprehensive package of HIV/AIDS services and this attracted many clients to the out reaches. The moon light outreaches targeted CSWs and truckers while safe sailing boat targeted fisher folk. SCIPHA also worked closely with coordinators of key populations and PLHIV coordinators to mobilize the key populations and PLHIV for services.

To address the harmful socio cultural and other structural drivers of the epidemic the project conducted mini assessments among opinion leaders to determine the drivers in each districts. SCIPHA also conducted in depth assessments among the fisher folk, CSWs and truckers to determine their knowledge on HIV/AIDS, attitudes, practice, myths and misconceptions which could increase their risk of getting HIV. SCIPHA worked closely with district political and religious leaders and collaborated with different cultural leaders including Buganda, Toro, Rwenzururu, Batwa, Alur, Teso, Langi to address the cultural drivers of the epidemic.

The project worked closely with 19 district leaders in support supervision of implementing sub grantee CSO activities and also participated in national and district events e.g labor day, Philly Bongoley Lutaaya memorial day, EMTCT launches and World AIDS day celebrations by providing a comprehensive package of HIV/AIDS services during the ceremonies

The high lights of this year were the peer support clubs formed e.g. Mama clubs for EMCT mentorship, mobilization of communities for HIV services as well as economic empowerment; Baba clubs to increase male involvement in HIV/AIDS services, PWD, YOS and discordant couple clubs. SCIPHA has supported formation of 128 peer support groups consisting of 73 mama ,34 Baba,4 people with disabilities(PWD).4 discordant couple ,6 youth out of school(YOS), and 5 children clubs and these clubs have improved quality of life of PLHIV, enhanced HIV prevention in supported communities and empowered PLHIV economically

Kiboota Mama club IGA activities in Kabarole district

In the coming year 2015 the project which has received an extension to Dec 2015,SCIPHA IV, will consolidate its achievements as well as enhance Sexual and reproductive health and gender mainstreaming into all project activities. Advancing advocacy and networking agenda will also be a priority for the project. Capacity building efforts for CSOs including training, mentorship and coaching on different aspects e.g. Governance, Finance , management, M&E ,proposal writing, resource mobilization and technical areas will be emphasized for purposes of sustainability

JCRC Plans for 2015:

1. Implement The JCRC Expanded Health Service Delivery Model, which will see the integration of comprehensive clinical and laboratory services offered in Kampala, the 3 Regional Centres of Excellence (Mbarara, Gulu and Mbale), and 2 satellite clinics in each of the 3 RCE regions. This model is intended at; a. Bringing a wide range of quality health care services (Comprehensive) closer to the population b. Supporting the centre towards self sustainability. 2. Complete the TB and P3 Labs. 3. Attain accreditation with the College of American Pathologists (CAP). 4. Fully install and implement the Management Information System for the Clinic (ICEA), Laboratory (LIMS) and Finance (Systems Nav. 2013). 5. Automate freezer temperature readings 6. Marketing and selling of di-oinized water. 7. Equip the store among other things complete the cold storage room, improve ventilations as well as complete the installation of the shelves. 8. Strengthen the proposal & Grants writing teams by recruiting a grants manager 9. Introduce a number of Quality Improvement Initiatives enhancing the quality of patient care, safety and work life. 10. Complete relocation of the private clinic from Mengo including among others the relocation of the Chest clinic 11. Land scalping and leveling of Lubowa compound to enable more lawn mowing than trimming in order to cut costs and enable efficiency. 12. Fast-track the process of registering the JCRC training institute with the UNCHE as an accredited training institute and implement the training courses as stipulated in the JCRC Training Business Plan.

Table 7 Ongoing Researches at JCRC 2014

Study Project Description AIDS CLINICAL TRIALS GROUP (ACTG) Studies (i) A5288 Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure. (ii) A5279 Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals With Latent Tuberculosis Infection (iii) A5278 It is a PK Study Enrolled all participants from study A5264. (iv) A5274 Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER) (v) A5297 An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r- Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <350 Cells/mm3 (vi) A5264 A Randomized Evaluation of Antiretroviral Therapy Alone or With Delayed Chemotherapy Versus Antiretroviral Therapy With Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) AMC 067 (vii) A5263 A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings. This is carried out in conjunction with Uganda Cancer Institute. (viii) A5225 A Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis START Strategic Timing of AntiRetroviral Treatment. Should ART be delayed until CD4 drops below 350 cells/mm3 or be initiated with CD4 above 500 cells/mm3 Pulmonary sub study The purpose of this study is to find out if starting anti-retroviral therapy (START) (ART) at CD4 above 500 (early ART group) slows the rate of decrease in lung function over time compared to waiting to start ART until the CD4+ drops below 350 (deferred ART group). BREATHER The study compares two different ways for children and young people with HIV to take anti-HIV (antiretroviral) medicines. Short-Cycle Therapy (SCT) (5 days on/2 days off) in young people with chronic HIV infection or continuously. SALIF The purpose of this study is to demonstrate noninferiority in terms of the percentage of patients who have plasma human immunodeficiency virus- type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL

Switching At Low HIV-1 after 48 weeks of randomized treatment with tenofovir disoproxil RNA Into Fixed Dose fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) versus Combinations (SALIF) TDF/FTC/efavirenz (TDF/FTC/EFV). GILEAD Studies Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (i) WAVES Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women (WAVES) (ii) Protocol 0106 A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents (iii) Protocol 0160 A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG)Administered With a Background-Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects (iv) Protocol 0117 A Phase 3, Two Part Study to Evaluate the Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment- Experienced Adults REALITY A randomised controlled trial to investigate three methods to reduce early Reduction of EArly mortality in adults, adolescents and children aged 5 years or older starting mortaLITY in HIV-infected antiretroviral therapy (ART) with severe immuno-deficiency. The three Adults and Children methods are: Starting Antiretroviral (i) increasing the potency of ART with a 12 week induction period using 4 Therapy antiretroviral drugs from 3 classes (ii) augmented prophylaxis against opportunistic/bacterial infections and helminths for 12 weeks (iii) macronutrient intervention using ready-to-use supplementary food for 12 weeks. PASER-M This study is investigating the emergence of drug resistant viral strains PharmAcess African among individuals on HAART. It is also investigating the emergence of Studies to Evaluate viral drug resistant strains among individuals who have recently acquired Resistance - Monitoring. HIV infection ART-A The aim of this project is to develop and evaluate affordable, subtype- Affordable Resistance independent assays for use in monitoring HIV drug resistance in Africa. Testing in African Laboratory Settings. MARCH The aim of this study is to determine what proportion of children on Monitoring Antiretroviral antiretroviral therapy achieve HIV Drug resistance (HIVDR) prevention as Resistance in Children. measured by viral load suppression; and what the HIVDR mutational patterns are in patients not achieving HIVDR prevention. RAL The aim of the study is; 1) To investigate the mecahenism by which Raltegravir alter decay, by directly assessing and comparing the effects of the Raltegravir versus combination ART in HIV infected individuals on the 54

Decay Kinetics of HIV with decay of defined cell type and FDC pool in peripheral LTs and gut. 2) To the Integrase Inihibitor assess the ability of Raltegravir to enhance CD4 T-cell reconstitution in Raltegravir GALT and the pharmacokinetics of Raltegravir in the LN and GALT. PAINT A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Efficacy of TMC278 in Human Immunodeficiency Virus Infected Adolescents. Rheumatic Heart Disease The study is investigating the role of HIV and auto-antibodies among (RHD) study patients with rheumatic heart disease in Uganda: LABLITE Lablite is investigating strategies to roll out HIV treatment safely and cost- effectively in real-life settings in sub-Saharan Africa. The project is working closely with ministries of Health in 3 countries in Africa (Malawi, Zimbabwe and Uganda. It aims to inform national and international policy on how best to use the limited funds available to increase coverage of HIV treatment. ViiV social science study The study explores the challenges and factors affecting adolescents as they live and grow with HIV infection. CHAKA This study explores the mental health issues in children living with HIV. Mental health among HIV infected CHildren and The study is being conducted at JCRC by one of our collaborators / Adolescents in KAmpala partners – Medical Research Council – Entebbe. and Masaka, Uganda. Oral Cancer and the Study objective: To correlate if the hBD3 and hBD2 expression profile in discovery of a Novel oropharyngeal cancer can serve as a biomarker for severity of disease and Diagnostic Biomarker Pilot HIV/HPV status. Study Uganda The study is conducted in conjunction with the Uganda Cancer institute Establishing the Prevalence The study aims to: 1) Establish the prevalence of HPV in oropharyngeal of Human Papilloma Virus- cancer in HIV-negative and HIV-infected adult Ugandans. Related Oropharyngeal 2) Determine the HPV genotypes isolated from oropharyngeal cancer in Carcinomas, and which HIV negative and HIV-infected adults Ugandans. Genotypes are Involved, in Kampala, Uganda The study is conducted in conjunction with the Uganda Cancer institute

2014 Research Publications

1. Musiime V, Cook A, Kayiwa J, Zangata D, Nansubuga C, Arach B, Kenny J, Wavamunno P, Komunyena J, Kabamba D, Asiimwe AR, Mirembe G, Abongomera G, Mulenga V, Kekitiinwa A, Kityo C, Walker SA, Klein N, Gibb DM; CHAPAS-3 trial team. Anthropometric measurements and lipid profiles to detect early lipodystrophy in antiretroviral therapy experienced HIV-infected children in the CHAPAS-3 trial. Antivir Ther. 2014;19(3):269-76. doi: 10.3851/IMP2695. Epub 2013 Oct 25. 2. Goodall RL, Dunn DT, Pattery T, van Cauwenberge A, Nkurunziza P, Awio P, Ndembi N, Munderi P, Kityo C, Gilks CF, Kaleebu P, Pillay D; DART Virology Group and Trial Teams. Phenotypic and genotypic analyses to guide selection of reverse transcriptase inhibitors in second-line HIV therapy following extended virological failure in Uganda.J Antimicrob Chemother. 2014 Jul;69(7):1938-44. doi: 10.1093/jac/dku052. Epub 2014 Mar 14. 3. Kityo C, Gibb DM, Gilks CF, Goodall RL, Mambule I, Kaleebu P, Pillay D, Kasirye R, Mugyenyi P, Walker AS, Dunn DT; DART Trial Team. High level of viral suppression and low switch rate to second-line antiretroviral therapy among HIV-infected adult patients followed over five years: retrospective analysis of the DART trial.PLoS One. 2014 Mar 13;9(3):e90772. doi: 10.1371/journal.pone.0090772. eCollection 2014. 4. Jaganath D, Walker AS, Ssali F, Musiime V, Kiweewa F, Kityo C, Salata R, Mugyenyi P. HIV-Associated Anemia After 96 Weeks on Therapy: Determinants Across Age Ranges in Uganda and Zimbabwe.AIDS Res Hum Retroviruses. 2014 Jun;30(6):523-30. doi: 10.1089/aid.2013.0255. Epub 2014 Feb 7. 5. Gupta RK, Goodall RL, Ranopa M, Kityo C, Munderi P, Lyagoba F, Mugarura L, Gilks CF, Kaleebu P, Pillay D; DART Virology Group and Trial Team. High rate of HIV resuppression after viral failure on first-line antiretroviral therapy in the absence of switch to second-line therapy.Clin Infect Dis. 2014 Apr;58(7):1023-6. doi: 10.1093/cid/cit933. Epub 2013 Dec 18. 6. Nichols BE, Sigaloff KC, Kityo C, Mandaliya K, Hamers RL, Bertagnolio S, Jordan MR, Boucher CA, Rinke de Wit TF, van de Vijver DA. Averted HIV infections due to expanded antiretroviral treatment eligibility offsets risk of transmitted drug resistance: a modeling study.AIDS. 2014 Jan 2;28(1):73-83. doi: 10.1097/01.aids.0000433239.01611.52. 7. Fillekes Q, Kendall L, Kitaka S, Mugyenyi P, Musoke P, Ndigendawani M, Bwakura- Dangarembizi M, Gibb DM, Burger D, Walker AS; ARROW Trial Team. Pharmacokinetics of zidovudine dosed twice daily according to World Health Organization weight bands in Ugandan HIV-infected children.Pediatr Infect Dis J. 2014 May;33(5):495-8. doi: 10.1097/INF.0000000000000143. 8. Boltz VF, Bao Y, Lockman S, Halvas EK, Kearney MF, McIntyre JA, Schooley RT, Hughes MD, Coffin JM, Mellors JW; OCTANE/A5208 Team. Low-frequency nevirapine (NVP)-resistant HIV-1 variants are not associated with failure of antiretroviral therapy in women without prior exposure to single-dose NVP. J Infect Dis. 2014 Mar 1;209(5):703- 10. doi: 10.1093/infdis/jit635. Epub 2014 Jan 16. 9. Musiime V, Fillekes Q, Kekitiinwa A, Kendall L, Keishanyu R, Namuddu R, Young N, Opilo W, Lallemant M, Walker AS, Burger D, Gibb DM. The pharmacokinetics and acceptability of lopinavir/ritonavir minitab sprinkles, tablets, and syrups in african HIV- infected children.J Acquir Immune Defic Syndr. 2014 Jun 1;66(2):148-54. doi: 10.1097/QAI.0000000000000135. 56

10. Bwakura-Dangarembizi M, Kendall L, Bakeera-Kitaka S, Nahirya-Ntege P, Keishanyu R, Nathoo K, Spyer MJ, Kekitiinwa A, Lutaakome J, Mhute T, Kasirye P, Munderi P, Musiime V, Gibb DM, Walker AS, Prendergast AJ; Antiretroviral Research for Watoto (ARROW) Trial Team. A randomized trial of prolonged co-trimoxazole in HIV-infected children in Africa. N Engl J Med. 2014 Jan 2;370(1):41-53. doi: 10.1056/NEJMoa1214901. Erratum in: N Engl J Med. 2014 Jan 30;370(5):488. Dosage error in article text. 11. Goodall RL, Dunn DT, Pattery T, van Cauwenberge A, Nkurunziza P, Awio P, Ndembi N, Munderi P, Kityo C, Gilks CF, Kaleebu P, Pillay D; DART Virology Group and Trial Teams. Phenotypic and genotypic analyses to guide selection of reverse transcriptase inhibitors in second-line HIV therapy following extended virological failure in Uganda. J Antimicrob Chemother. 2014 Jul;69(7):1938-44. doi: 10.1093/jac/dku052. Epub 2014 Mar 14. 12. Hamlyn E, Fidler S, Stöhr W, Cooper DA, Tambussi G, Schechter M, Miro JM, Mcclure M, Weber J, Babiker A, Porter K; SPARTAC Trial Investigators. Interleukin-6 and D- dimer levels at seroconversion as predictors of HIV-1 disease progression. AIDS. 2014 Mar 27;28(6):869-74. doi: 10.1097/QAD.0000000000000155. 13. Longosz AF1, Morrison CS, Chen PL, Arts E, Nankya I, Salata RA, Franco V, Quinn TC, Eshleman SH, Laeyendecker O. Immune responses in Ugandan women infected with subtypes A and D HIV using the BED capture immunoassay and an antibody avidity assay.J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):390-6. doi: 10.1097/QAI.0000000000000006. 14. Kaye DK, Kakaire O, Nakimuli A, Osinde MO, Mbalinda SN, Kakande N. Lived experiences of women who developed uterine rupture following severe obstructed labor in Mulago hospital, Uganda.Reprod Health. 2014 Apr 22;11:31. doi: 10.1186/1742-4755- 11-31. 15. Kaye DK, Kakaire O, Nakimuli A, Osinde MO, Mbalinda SN, Kakande N. Male involvement during pregnancy and childbirth: men's perceptions, practices and experiences during the care for women who developed childbirth complications in Mulago Hospital, Uganda. BMC Pregnancy Childbirth. 2014 Jan 31;14:54. doi: 10.1186/1471-2393-14-54. 16. Boulware DR, Meya DB, Muzoora C, Rolfes MA, Huppler Hullsiek K, Musubire A, Taseera K, Nabeta HW, Schutz C, Williams DA, Rajasingham R, Rhein J, Thienemann F, Lo MW, Nielsen K, Bergemann TL, Kambugu A, Manabe YC, Janoff EN, Bohjanen PR, Meintjes G; COAT Trial Team. Timing of antiretroviral therapy after diagnosis of cryptococcal meningitis. N Engl J Med. 2014 Jun 26;370(26):2487-98. doi: 10.1056/NEJMoa1312884. 17. Robertson EJ, Najjuka G, Rolfes MA, Akampurira A, Jain N, Anantharanjit J, von Hohenberg M, Tassieri M, Carlsson A, Meya DB, Harrison TS, Fries BC, Boulware DR, Bicanic T. Cryptococcus neoformans ex vivo capsule size is associated with intracranial pressure and host immune response in HIV-associated cryptococcal meningitis. J Infect Dis. 2014 Jan 1;209(1):74-82. doi: 10.1093/infdis/jit435. Epub 2013 Aug 14. 18. Moses L. Joloba, John L. Johnson , Pei-Jean I. Feng, Lorna Bozeman, Stefan V. Goldberg, Karen Morgan, Phineas Gitta, Henry W. Boom , Charles M. Heilig, Harriet Mayanja-Kizza, Kathleen D. Eisenach. (2014), What is the most reliable solid culture medium for tuberculosis treatment trials? http://dx.doi.org/10.1016/j.tube.2014.03.002

19. Charles M. Heilig, Pei-Jean I. Feng, Moses L. Joloba, John L. Johnson ,Karen Morgan, Phineas Gitta, W. Henry Boom , Harriet Mayanja-Kizza,Kathleen D. Eisenach , Lorna Bozeman, Stefan V. Goldberg. (2014), How we determined the most reliable solid 57

medium for studying treatment of tuberculosis http://dx.doi.org/10.1016/j.tube.2014.02.006

20. Nicholas I. Paton, M.D., Cissy Kityo, M.Sc., Anne Hoppe, Ph.D., Andrew Reid, M.R.C.P., Andrew Kambugu, M.Med., Abbas Lugemwa, M.D., Joep J. van Oosterhout, Ph.D., Mary Kiconco, M.P.H., Abraham Siika, M.Med., Raymond Mwebaze, M.Med., Mary Abwola, M.Med., George Abongomera, M.Sc., Aggrey Mweemba, M.Med., Hillary Alima, M.P.H., Dickens Atwongyeire, M.B., Ch.B., Rose Nyirenda, M.Sc., Justine Boles, M.Sc., Jennifer Thompson, M.Sc., Dinah Tumukunde, M.P.H., Ennie Chidziva, Dipl.G.N., Ivan Mambule, M.B., Ch.B., Jose R. Arribas, M.D., Philippa J. Easterbrook, M.D., James Hakim, F.R.C.P., A. Sarah Walker, Ph.D., and Peter Mugyenyi, F.R.C.P., for the EARNEST Trial Team Assessment of Second-Line Antiretroviral Regimens for HIV Therapy in Africa N Engl J Med 2014;371:234-47. DOI: 10.1056/NEJMoa1311274 21. Adrienne K Chan, Deborah Ford, Harriet Namata, Margaret Muzambi, Misheck J Nkhata, George Abongomera, Ivan Mambule, Annabelle South, Paul Revill, Caroline Grundy, Travor Mabugu, Levison Chiwaula, Fabian Cataldo, James Hakim, Janet Seeley, Cissy Kityo, Andrew Reid, Elly Katabira, Sumeet Sodhi, Charles F Gilks and Diana M Gibb. The Lablite project: A cross-sectional mapping survey of decentralized HIV service provision in Malawi, Uganda and Zimbabwe.

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