ihri.org

ANNUAL REPORT 2021

ANNUAL REPORT 2020

ihri.org

ANNUAL REPORT 2020

ANNUAL REPORT 2020

3 ANNUAL REPORT 2020

Foreword

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2020 has been the first, yet possibly most maintained and even further optimized during memorable year for all of us at IHRI. We are the COVID-19 pandemic. Moreover, we have been grateful to every single challenge faced during our strengthening our team, readying ourselves for transition process, making us strong, resilient, more implementation research on mental health agile, positive, persevering and, most importantly, and chemsex, primarily through capacity-building extremely proud of one another. Nothing can opportunities brought to us by TREAT Asia/amfAR. stop us now from serving our people and our communities. Working without fear, without To strengthen client-centered health services exclusivity, without boundaries, is what we long through capacity-building, IHRI has expanded for. its technical assistance and implementation facilitating roles to , Lao PDR, Nepal, New partnerships established during our the and a few other countries in the most difficult times mean a lot to us. Both the Asia-Pacific through many bilateral and regional determined trust and kind blessings bestowed events supported and/or hosted by USAID EpiC upon our team from old friends around the world project, FHI 360, UNAIDS, WHO, Unitaid, SKPA, are priceless, and we can only ensure you, as a IAS, APTN and APCOM. It is immensely humbling word of thanks, that we will continue to do our for us to be recognized as a regional center of best and not let any of you down. education and research in key areas including PrEP, trans health, same-day ART and chemsex by Along with working to establish our Pribta and our neighboring countries. Tangerine Clinics at the Building as Bangkok’s most inclusive sexual health In contrast, things have moved very slowly this hub, IHRI continues to make strides through year with regards to getting key population-led key achievements aligning with our mission health services (KPLHS) to be officially endorsed statement. COVID-19 has only brought forth by the Ministry of Public Health, an innovation to our clinical and implementation achievement which will allow further movement research studies on pre-exposure prophylaxis towards full domestic financing by the National (PrEP), same-day antiretroviral treatment Health Security Office for KPLHS sustainability. (ART) initiation, differentiated service delivery However, we have been successful in including (DSD), HIV self-testing, point-of-care sexually recommendations on key population-led PrEP transmitted infection (STI) testing, trans health, service and same-day ART service as part of the acute HIV and HIV cure. Telehealth, Xpress next version of Thailand’s National Guidelines services, self-sampling and delivery of drugs via on HIV/AIDS Treatment and Prevention through courier were quickly and efficiently integrated evidence-based advocacy for public health into study implementation to ensure continuity policy change. of services and to maintain safety and quality of study conduct. Same-day ART telehealth was We wish all of you a lighter and less stressful New selected by the International AIDS Society (IAS) as Year full of success and serenity, and look forward to one great example of how ART initiation can be updating you with more achievements next year!

Nittaya Phanuphak, M.D., Ph.D. Executive Director Institute of HIV Research and Innovation

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AFRIMS Armed Forces Research Institute of ACRONYMS Medical Sciences

AND AHI Acute HIV infection

ABBREVIAIONS amfAR the Foundation for AIDS Research

ART antiretroviral therapy

ARV antiretroviral

ASSIST Alcohol, Smoking and Substance Involvement Screening Test

ATS amphetamine-type stimulants

BMA Bangkok Metropolitan Administration

CAB LA long-acting cabotegravir

CBO community-based organization

CETH Center of Excellence in Transgender Health

CHIMERA Capacity development for HIV and Mental Health Research in Asia

CNS central nervous system

CSF cerebrospinal fluid

CT Chlamydia trachomatis

FTC emtricitabine

GARDP Global Antibiotic Research and Development Partnership

HCV Hepatitis C Virus

IHRI Institute of HIV Research and Innovation

KP key population

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KPLHS Key Population-Led Health Services

MHRP US Military HIV Research Program

MOPH Ministry of Public Health

MRI magnetic resonance imaging

MSM men who have sex with men

NCD non-communicable diseases

NHSO National Health Security Office

NG Neisseria gonorrhoeae

POC point-of-care

PrEP pre-exposure prophylaxis

RSAT Rainbow Sky Association of Thailand

SDART Same-Day Antiretroviral Therapy

STI sexually transmitted infection

SWING Service Workers in Group Foundation

TDF tenofovir disoproxil fumarate

TGW transgender women

UHC Universal Health Coverage

UNAIDS The Joint Programme on HIV/AIDS

USAID United States Agency for International Development

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IHRI’S 2020 accomplishments

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Almost HIV 106 self-testing 210 10,000 68kits participants key population Thai nationals receiving enrolled to the lay providers in were HPTN 083 study by IHRI 15 provinces delivered certified for PrEP to Thai are transgender HIV health provided by key 15-19 years women services population lay providers old adolescents 53%

transgender 3,657 women clients received HIV testing at the Tangerine clients tested Community Health Clinic 4,459 HIV positive at the Thai Red Cross Anonymous Clinic received 75% same-day treatment of those who tested positive for HIV were of transgender women HIV-positive 91% linked into treatment clients were reached 2,075 clients and care through social media at the 10 hospitals in 5 provinces received same-day treatment 7 community-based organizations received technical assistance from the Tangerine Academy, serving over

1,400 clients HIV-positive 3,201 clients utilized one of seven DSD Nearly models in 4 hospitals in 50 Thailand Partners in Nepal, Myanmar healthcare providers and the Philippines received from 14 different provinces in 655 technical assistance from the Thailand attended the participants with acute HIV infection enrolled Tangerine Academy on Transgender-Competent in the RV254 cohort study, the largest Acute HIV transgender health. Care Training. cohort study in the world.

More 2.6% 1,495 than 614 participants clients enrolled to the 40 at the community-based of those Point-of-Care substantial 15 health centers received tested positive HIV viral load and papers were rapid HCV antibody for HCV Point-of-Care STI published in abstracts testing since its infection and testing study in 4 peer reviewed were accepted for implementation in were referred community-based journals in AIDS2020 November 2020 accordingly organizations 2020

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Give the community the tools and they will end AIDS in Thailand

The first 106 key population lay providers certified for HIV health services in Thailand

In response to the national strategy for ending training, practicum, and mentoring, which led to AIDS by 2030 and the ministerial regulation competency assessment and certification. As of endorsed by the Ministry of Public Health August 30, 2020, 106 KP lay providers working (MOPH) in June 2019 to allow trained and at 17 health services in 15 provinces have been certified key population (KP) lay providers to successfully certified. This first class of KP lay legally provide HIV services, the Institute of HIV providers participated in a certification ceremony Research and Innovation (IHRI) and community- presided over by Dr. Praphon Tangsrikeatkul, based organization (CBO) partners, through Assistant Minister to the Prime Minister’s Office, the United States Agency for International on July 30, 2020. Since the establishment of Development (USAID) Community Partnership ENGAGE in 2018, by the end of 2020, KP lay Project and its technical assistance platform providers trained under the ENGAGE have (ENGAGE), provided capacity building to KP provided HIV services to more than 60,000 clients lay providers in 25 of Thailand’s provinces via across Thailand.

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Towards sustainability

The success from ENGAGE represents a systematic and other relevant organizations throughout process for capacity building and certification of the country. The National Health Security Office KP lay providers for HIV services. It also provides (NHSO), the main domestic funding source for a model for the development and scale up of the the national health care scheme, is also planning Thailand national certification system for KP lay to use this manual to assess organizations that providers according to the ministerial regulation. request funding/service fee reimbursement from NHSO. These developments may well allow KP In addition, the Manual of HIV Quality Service lay providers and community health centers Standards, a joint effort between ENGAGE, the to be allocated compensation and service fees Department of AIDS and STIs and the Thailand through domestic financing mechanisms, which MOPH – U.S. CDC Collaboration (TUC), was will contribute to the continuous and sustainable endorsed and formally launched on April 13, 2020. development of Key Population-Led Health The manual has since been distributed to CBOs Services (KPLHS).

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PrEP all the way

Let them lead PrEP

KP-led pre-exposure prophylaxis (PrEP) implementation. As NHSO continues to provision through community-based scale up with the aim for PrEP under UHC clinics continues to be the cornerstone to be available for all, community clinics of PrEP services in the country. In 2020, under technical support from IHRI will shift the NHSO launched their PrEP pilot from international to sustainable domestic phase, through which PrEP counselling, financing. laboratory, and medication costs are included under Universal Health Coverage Furthermore, IHRI has been working (UHC) for 2,000 new clients. Through their towards expanding PrEP services in partnership with IHRI and the Thai Red Southeast Asia by providing technical Cross AIDS Research Centre, the Service assistance to Lao People’s Democratic Workers in Group Foundation (SWING) and Republic and Myanmar in creating the Rainbow Sky Association of Thailand demand, reviewing national guidelines, (RSAT) Bangkok were able to fill their and setting up PrEP services, while allocated slots of new PrEP users for the advocating for community mobilization pilot within just three months of project and empowerment.

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PrEP Anywhere, Everywhere

During Thailand’s brief lockdown at the earliest Mobile PrEP services were also utilized this year stage of the COVID-19 pandemic, telehealth as another differentiated approach for PrEP became a vital tool to remotely connect providers delivery. IHRI has written standard operating and clients, allowing PrEP to be refilled at a procedures and implemented a dry run of distance. Telehealth services were incorporated services at SWING and RSAT Bangkok. KP lay to enable providers to contact their clients, providers employ outreach strategies for HIV assess their adherence while being at risk, and testing at locations where KPs often meet refill PrEP through courier services. Since the their sexual partners, such as saunas, bars, COVID-19 situation in Thailand has improved and and restaurants. These outreach services are the lockdown has been lifted, telehealth remains therefore ideally suited for integration with an important tool for clients who have difficulty mobile PrEP, and IHRI will continue to explore the accessing the community-based clinics. most optimal methods of service integration.

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STANDUP-TEEN: The power of young people

In 2020, The STANDUP-TEEN study was case of a reactive test result. So far, 68 kits have launched. STANDUP-TEEN aims to address high been delivered to participants and used, with 1 HIV incidence and low PrEP coverage among reactive test. Recruitment of the study is ongoing, young men who have sex with men (MSM) and and results will provide insight into current HIV transgender women (TGW) aged below 20 years, epidemiology among this vulnerable group, as by exploring the role of HIV self-testing in the well as the effect of HIV self-testing on uptake of uptake of and retention in PrEP services. PrEP.

During the recruitment phase of the study, The second phase is the main study period, STANDUP-TEEN is promoted via online and which aims to expand HIV self-testing and offline platforms, allowing adolescents to access PrEP services to 600 young MSM and TGW in the study and receive a free HIV self-testing 4 provinces (Bangkok, Chonburi, Chiang Mai kit, including instruction materials and a link and Songkhla) to increase HIV testing and PrEP to an instruction video. The kits are delivered uptake, utilizing innovative approaches such as to a place of choice to ensure participants can delivery of HIV self-testing kits and PrEP, online perform the test at a time and place they feel supervision and virtual study visits, online tools comfortable. During the entire testing process, for data collection and the use of the Yacool! an online counselor is available to support the Application to collect data on PrEP adherence HIV self- testing process, provide virtual pre- and and sexual activity. This phase has started in post-test counseling and guide linkage to care in December 2020.

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HPTN 083: Inject for the future

The use of tenofovir disoproxil fumarate/ America. As one of the study sites, IHRI enrolled emtricitabine (TDF/FTC) has been shown to be 210 participants (53% of whom were TGW) into highly effective as an HIV PrEP option, but for the trial. Results from an interim data analysis people who have difficulty with or simply prefer demonstrated that CAB LA was superior in the not to take pills, oral PrEP might not be a good prevention of HIV acquisition compared to daily fit. The HPTN 083 study aimed to compare the TDF/FTC, with a 66% reduction in incident HIV effectiveness of long-acting cabotegravir (CAB LA) infection among study participants receiving CAB injected once every 8 weeks to the daily oral use of LA injections compared to TDF/FTC. Given this TDF/FTC pills in the prevention of HIV acquisition superiority and the excellent safety of CAB LA, the among MSM and TGW. Study participants were comparison between the two PrEP options was randomly assigned to receive either CAB LA or stopped, and CAB LA is now offered to all study TDF/FTC, but participants and study staff were participants. With CAB LA, another option is added unaware of which option they were receiving. The to the HIV prevention toolkit, ensuring that even study enrolled 4,750 HIV-uninfected participants those people who can’t take daily pills can still from 43 sites in Africa, Asia, and North and South protect themselves effectively from HIV.

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Transgender Health: from head to toe

Tangerine Community Health Clinic: the one and only

Tangerine Community Health Clinic is the first-of- was around 20%, and rapidly went up to 70% its-kind clinic that offers comprehensive health during the outbreak. services for transgender people. The services As soon as the COVID-19 pandemic hit, the include sexual health, gender-affirming hormone emergency orders forced us to curtail in-person treatment and referrals for gender-affirming visits. We had to rapidly adjust to telehealth surgery and legal assistance. In 2020, Tangerine as a method of differentiated service delivery. provided over 1,680 HIV tests and linked 91% of PrEP telehealth or PrEP delivery was one of those who tested positive for HIV into treatment the first adjustments to be implemented to and care. ensure that clients could continue to receive their PrEP refills. During the tele-consultation, Back in May 2019, Tangerine integrated the individuals are asked to go to the nearby model of Xpress service into the clinic to laboratory for necessary lab testing. Once the respond to the growing number of clients and pictures of the results are shared, a 3-month complaints of overcrowding waiting area. The PrEP supply will be delivered to their homes. service provision allows self-screening, sexual During the pandemic, we have also increased history reporting and laboratory test results our communication channels and introduced texted directly through their phone. Prior to the “Trans Health Helpline” to provide health-related COVID-19 outbreak, the uptake of Xpress service support to the transgender community. Self-

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collection for chlamydia and gonorrhea diagnosis was also implemented to improve STI testing rates among our clients, marking the first setting in Thailand where self-collection options have been made available. Since the implementation, we have detected over 60 asymptomatic infections or an STI rate of 30% among our clients who traditionally do not get tested, subsequently linking them to treatment and preventing further transmission.

Social media remains an important vehicle for generating demand for HIV and other transgender health services. Unlike previous years, this year we adopted a new strategy and collaborated with micro- and nano-influencers to promote our health service packages to reach broader segments of the transgender population. Around 75% of all transgender clients are reached through these social media influencers.

Not only the health services were interrupted by the COVID-19 pandemic, many of clients were also temporarily removed from the workforce and have lost their jobs and their income. In our efforts to support and ensure that no one is left behind, we were granted the global Gilead CARES (COVID-19 Acute Relief and Emergency Support). Together with our affiliated KP- led organizations, we were able to provide emergency stipend funds to over 80 MSM, TGW and transgender women sex workers who were greatly affected by COVID-19 and could not receive any COVID-19 related government assistance or financial support from the government due to their vulnerable legal status.

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PrEP in the City

IHRI in collaboration with the USAID LINKAGES campaign aims to raise awareness and to increase Thailand Project managed by FHI 360, TUC, uptake of PrEP among Thai transgender women, Bangkok Metropolitan Administration (BMA) which is a part of Thailand’s National Strategy to and the Joint United Nations Programme on HIV/ End AIDS among this vulnerable population. The AIDS (UNAIDS) Asia-Pacific Office successfully campaign also hopes to empower transgender launched the PrEP in the City campaign, the first women to take control of their health, to PrEP campaign for transgender women in Asia, destigmatize transgender identity and ultimately designed and produced by transgender women. to increase transgender visibility in society. The campaign portrays the daily lives of ordinary transgender women who integrated PrEP into The campaign was featured on the UNAIDS their routine, highlighting the gain framing website: https://www.unaids.org/en/ messages around PrEP use which focus mainly resources/presscentre/featurestories/2020/ on the benefit of PrEP instead of clients’ risk. The december/20201209_prep-transgender-thailand.

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Tangerine Academy for Transgender Health: turn knowledge into practice

In Thailand In the region To respond to the growing interest in The demand for technical assistance within and need for transgender health services the region also grew despite the pandemic. throughout Thailand and the region, we In the second half of the year, the Tangerine established the Tangerine Academy for Academy team discussed with partners Transgender Health as a regional technical in Philippines, Nepal and Myanmar plans assistance platform for the development for collaboration and technical assistance and sharing of tools, training curricula, and on transgender health, HIV program and learning resources to support further roll- clinic set-up. Additionally, we assisted out of HIV and health service models for Myanmar with its first National Community transgender people. Despite the disruption Consultation on HIV and Health Services caused by the pandemic, we continue to for Transgender People in Myanmar. At the provide technical support to seven local end of the consultation, key barriers and CBOs, serving over 1,400 clients. During recommendations for action were identified the year, a meeting was also held for which will be taken forward to make the our partners to share their experiences envisioned clinic a reality in Myanmar. and lessons learned to help improve the ongoing transgender health program. As a pioneer leader in transgender health, Moving forward, the team will be expanding Tangerine Academy held a webinar on the scope of our technical assistance to “Transgender Health and HIV in Asia: two more CBOs to improve the lives of Where are we in 2020?” to exchange the transgender community throughout new knowledge and interventions on Thailand. transgender health and HIV in the region. The three-hour long webinar attracted over 120 participants from the region.

To continue our mission, Tangerine Academy is developing Dynamic Learning Hub, the digital learning platform that is designed to deliver an engaging and interactive learning experience for lay providers, healthcare providers or anyone who might be interested in the topics of transgender health. The Dynamic Learning Hub is expected to launch in early 2021.

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Transgender care providers’ network

In collaboration with the Faculty of Medicine, partnership with CETH, hosted a Transgender- , we established the Competent Care Training in Bangkok, Thailand Center of Excellence in Transgender Health on September 14-15, 2020. Nearly 50 healthcare (CETH), which will serve as an institutionalized providers from 14 different provinces in resource hub on transgender health in Thailand attended the training to increase their Thailand and the region. CETH’s mission is knowledge, understanding and skills needed to increase access to gender-affirming care to provide transgender-competent HIV and services and improve the well-being of the health services. The Handbook of Transgender transgender community. Due to a lack of access Healthcare Services, Thailand’s first guideline on to transgender-competent health services, transgender health, was also introduced during Tangerine Academy for Transgender Health, in the training.

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Moving forward with transgender health research

In the upcoming year, the transgender health team plans to conduct numerous research studies on transgender health. Building upon our previous study known as the iFACT study, two more studies will be conducted to: 1) evaluate the potential pharmacokinetic drug-drug interaction between feminizing hormone therapy and PrEP among transgender women and 2) evaluate the pharmacokinetic drug-drug interaction between masculinizing hormone therapy and PrEP among transgender men.

At the regional level, we will be establishing the first multisite, prospective observational cohort study for transgender people in Thailand, and the Philippines. The data obtained from this cohort will be crucial for informing a holistic healthcare policy for transgender people, and multi-level interventions to tackle the multi-level risks faced by this vulnerable population.

While studies related to physical and social aspects of the transgender health community are increasing, mental health issues are often underprioritized, especially in relation to HIV. Hiransuthikul A, Himmad L, Kerr SJ, Janamnuaysook R, Dalodom T, Phanjaroen K, As a result, there is an urgent need to increase Pankam T, Kongkapan J, Mills S, Vannakit R, research capacity in Thailand and in the region for Phanuphak P, Phanuphak N. Drug-drug integrating HIV and mental health, in order to generate interactions among Thai HIV-positive the data needed to guide public health policies and transgender women undergoing feminizing improve clinical care and patient outcomes. As part of hormone therapy and antiretroviral therapy: CHIMERA (Capacity development for HIV and Mental the iFACT study. Clin Infect Dis. 2020 Jan Health Research in Asia), IHRI has collaborated with 16:ciaa038. doi: 10.1093/cid/ciaa038. Epub the Foundation for AIDS Research (amfAR) TREAT Asia ahead of print. PMID: 31942947. Program to strengthen the capacity in implementation science research and mental health at the Tangerine Yang F, Janamnuaysook R, Boyd MA, Community Health Clinic. Phanuphak N, Tucker JD. Key populations and power: people-centred social innovation in By the end of the program, the research network will Asian HIV services. Lancet HIV. 2020 have built a team of Asia-Pacific-based researchers Jan;7(1):e69-e74. doi: 10.1016/S2352- with the capacity to lead a regional HIV-mental health 3018(19)30347-9. Epub 2019 Dec 7. PMID: implementation science research agenda that will 31818717 inform public health policy and improve the quality of clinical care.

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Differentiate HIV Treatment

Same-day ART: breaking through the pandemic

Since July 2017, IHRI has been managing Same-Day Positive feedback from providers and clients called Antiretroviral Therapy (SDART) Initiation Service in for its continuation after the lifting of COVID-19 which antiretroviral therapy (ART) naïve clients start restrictions. The provision of client-centered ART on the same day of HIV diagnosis at the Thai services tailored to their needs can further increase Red Cross Anonymous Clinic. At the beginning of client satisfaction. Telehealth, specifically, eases the COVID-19 outbreak, IHRI rapidly adapted the the financial burden of clients having to travel to service at the Thai Red Cross Anonymous Clinic the clinic and limits their loss of income and time. by incorporating a telehealth follow-up option. Incorporating telehealth into the SDART service To comply with physical distancing measures and has proved to be an acceptable, feasible, and travel restrictions, the telehealth follow-up option safe option to further differentiate ART initiation allows clients to receive virtual clinical consultation services in the setting of an HIV testing center. IHRI and targeted physical examination for adverse will explore the applicability to the hospital setting event assessment and management, followed by in 2021. ART delivery to their doorstep.

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The COVID-19 pandemic pointed out the need for We designed“ the service the health system to cut down on non-essential with convenience for care and provide remote care, including for HIV everyone in mind so we treatment. Dispensing and mailing 3-6 months choose the tools that can of ART, at our partnered hospitals, allows clients be found anywhere, which to limit their physical contact and travel during the lockdown. Despite the logistical limitations are smartphone and LINE during the outbreak, hospitals showed resilience messaging application in adjusting their services to meet the needs and ensure the safety of people living with HIV. In the upcoming year, IHRI’s intention is to provide technical assistance to allow the continuation of Physician” these ART mailing and multi-month dispensing models beyond the COVID-19 period. Additionally, IHRI will be able to document the impact of the COVID-19 outbreak on the methods of ART refill and health outcomes of ART recipients. It’s very convenient“ for the patient including myself. It saves traveling cost, and time. I don’t have to take leave from work to see the doctor. This makes it more convenient

TGW” client

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Differentiated service delivery for ART maintenance: one size doesn’t fit all

Many different models for differentiated ART In the past year, our additional work on DSD for maintenance services exist in several hospitals in ART maintenance has focused predominantly Thailand, each tailoring the differentiated service on task-shifting, decentralization, and reducing delivery (DSD) model to fit the need of their visit frequency for ART refill to reduce the burden specific settings. To document these different on the health system. To additionally meet the models, as well as client characteristics and diverse health needs and preferences of people clinical outcomes, IHRI started data collection living with HIV, and to provide a client-centered, as part of the DSD-ART study. Data from 3,201 holistic care package, IHRI will develop a training clients accessing ART maintenance services course on non-communicable diseases (NCDs) through one of seven different models has been and mental health management for community- collected, with planned follow-up of two years. based DSD-ART service providers. This course With this documentation, we aim to provide will equip key population lay providers with the real-world data on different models, switching skills needed to provide counseling and monitor patterns between models, and virological clients with stable NCD and monitor their mental outcomes. health.

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Acute HIV and HIV Cure

Acute HIV infection and HIV cure are the The backbone of these efforts is the RV254 focus of SEARCH at IHRI. SEARCH is a prospective cohort study which screens partnership that began in 2005 with the goal around 40,000 consenting individuals of accomplishing mutual objectives in HIV/ each year who present for HIV testing, to AIDS research in the South-East Asia region identify 50 to 100 with acute HIV infection between the TRCARC (2005-2020) and (AHI). Through diagnosing HIV in the acute now IHRI and the US Military HIV Research stage overnight through our collaboration Program (MHRP). with the Armed Forces Research Institute of Medical Sciences (AFRIMS), investigators SEARCH’s mission is to elucidate the are provided with the opportunity to interplay between viral and host factors understand the events immediately during the establishment of HIV infection following infection. This creates a unique and the mechanisms that underlie its chance to look at the virus and the cells’ persistence. By understanding these activity at various places in the body early factors, we aim to identify strategies that in the infection. Study participants undergo can support more effective immunological neurological and neuropsychological responses to HIV infection and lead to evaluation combined with brain imaging. control or clearance of the virus without the Blood, lymph node, gut tissue and need for lifelong ART. cerebrospinal fluid are also captured in

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consenting volunteers and tested by The RV254 participants serve as a valuable virological and immunological assays resource for the increasing interest in among 53 collaborators at 45 institutions the field of HIV cure. Four studies which globally, to make sure that the samples and explored the potential of HIV remission, data provided by the volunteers optimally incorporating treatment interruption with serve science and the global effort to find therapeutic HIV vaccine, broadly neutralizing an HIV cure. The RV254 cohort study is antibodies and drugs targeting the HIV complemented by the RV304 study in which reservoir have been completed through IHRI enrolls volunteers who are either HIV participants who joined RV254. negative or living with chronic HIV infection who serve as controls that allow for correct The field is currently moving towards interpretation of the data generated in combining interventions that decrease the RV254. so-called latent HIV reservoir, which needs to be limited to attain HIV remission, with From more than 400,000 samples screened interventions that boost the immune system since 2009, 840 individuals with acute HIV to control whatever HIV reservoir remains. infection were identified of whom 655 Two studies related to HIV cure/remission have enrolled in the cohort and started are currently in preparation. ART within 1-2 days, making this the largest cohort of volunteers identified in acute As these studies demand a lot from infection globally. The first participants volunteers with very little promise of entered their 11th year on study in 2020 immediate personal gain or benefit, a and the very low attrition rate (only 5% behavioral study team independent from withdrawn or lost to follow-up over 10 the clinical study team and led by Prof. years), excellent ART adherence (98% of Gail Henderson of the University of North volunteers have undetectable viral load) Carolina is conducting interviews among and high participation in optional invasive RV254 participants. The aim is to explore procedures make this cohort unique. To the expectations, intentions, decision date, more than 70 substantial papers making and decision satisfaction of RV254 generated through the RV254 study participants related to HIV remission have been published in peer reviewed trials. More than 400 RV254 participants journals to date, 17 of these in 2020, and completed a survey regarding their ideas manuscripts continue to be generated. about, understanding of, expectations of, and intentions towards functional HIV cure Screening for RV254 will start including studies. In addition, participants who were CBO partner clinics in 2021, as the vast actually approached to join functional cure majority of acute HIV infections are now studies have been interviewed about their diagnosed in key populations and the CBOs decision to join or not join, and subsequent play a leading role in HIV testing among key satisfaction with their decision after the populations. respective studies were completed.

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Neuro HIV

The setting of IHRI’s RV254 cohort study and examination, mood disorders screening, the RV304 study (which enrolls volunteers who neurocognitive assessment and optional are either HIV negative or living with chronic lumbar punctures and magnetic resonance HIV infection to serve as controls that allow for imaging (MRI) of the brain. Our findings of correct interpretation of the data generated in detectable of HIV-1 and inflammatory markers RV254) offers a unique research opportunity of the brain and the cerebrospinal fluid (CSF) to investigate the interactions between HIV-1 suggest that HIV-1 invades the CNS within days and the central nervous system (CNS) at the after transmission. Abnormal neurological time of AHI. Our NeuroHIV work is guided by signs, lower neurocognitive performance and the International NeuroHIV Cure Consortium depression symptoms are detected in early (www.inhcc.net) and executed with academic acute infection. Our recent work on CSF indicates collaborators at Yale, UCSF, Missouri Institute that diversification of HIV-1 replication occurs of Mental Health, Oregon Health Sciences early in acute infection, leading to so-called University, Weill Cornell School of Medicine, viral compartmentalization in the CNS. Yet, MRI and University of Hawaii. Our NeuroHIV work studies suggest that the neuroinvasion at acute characterizes the participants’ neurological infection leads to limited disruptions in brain profiles through required neurological connectivity even in this early period.

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Since nearly all RV254 participants initiate ART Moving forward within days of acute HIV diagnosis, the cohort So-called single cell capability has been offers the opportunity to examine the CNS benefit established on-site in Bangkok which allows of treating HIV-1 infection at the earliest point analysis of the entire genetic messaging of of infection. CSF studies reveal that markers of a single cell for millions of cells at the same initial inflammation are significantly reduced time. This in turn allows for the combination after 6 months of treatment and trend towards of information on immunologic messages by levels seen in people without HIV after two years. these cells with what we see in the CNS during RV254 participants also show a lower frequency AHI and cure studies, as well as investigation of so-called CSF HIV escape, a phenomenon in of how the body’s genetic messaging may which HIV is detectable in CSF despite being help HIV persist in the CNS. Meanwhile a fully suppressed in blood, when compared to specific type of artificial intelligence (machine individuals who are diagnosed and treated learning) will generate novel insight into during chronic HIV infection. The absence the pathogenesis of AHI, treatment for the of immunodeficiency-related complications CNS and HIV complications by through-put observed in these AHI participants, as compared of very large amounts of RV254 and RV304 to participants diagnosed and treated during data. Entering the twelfth year of the cohort, chronic infection, makes RV254 a desirable RV254 will continue to provide important model to further examine the neuropsychiatric longitudinal data about mental health effects of prolonged ART use. Two reports about and non-communicable diseases of HIV- the safety profile of Dolutegravir-based ART positive individuals who initiate ART at the usage were recently published based on the earliest point of infection. Finally, data and cohort’s experience. They showed less impact on sociodemographic parameters collected in neuropsychological status in our study cohort, the cohort allow for new investigations into in particular on depression, than earlier studies the interplay between HIV-1 and substance and no study drug discontinuations associated use in the brain. with dolutegravir, also contrasting with earlier publications.

The neurological data collected before and after treatment interruption in several completed HIV cure studies has been analyzed. In RV254 participants, with brief and closely monitored treatment interruption, analysis reveals minimal adverse CNS effects. These studies provide an important reference for the design of future HIV-1 cure studies that the cohort continues to investigate.

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Sexually transmitted infections (STIs)

Integrated POC HIV viral load and POC STI testing in KPLHS

Since August 2019, point-of-care (POC) testing combined and tested together. This practice for Chlamydia trachomatis (CT) and Neisseria can reduce costs by eliminating the need for gonorrhoeae (NG) and HIV viral load has been testing of three separate compartments, while integrated into the community drop-in centers avoiding missed infections by selecting only in 4 priority provinces (Bangkok, Chonburi, one compartment for screening. Findings Songkhla and Chiang Mai). These services are from this assessment showed high agreement provided as part of a research study which between pooled samples and separate samples. aims to strengthen the capacity of trained KP Furthermore, among 1,270 participants enrolled lay providers to manage STIs, while addressing as of September 2020, 13% had CT infection, 8% the high STI burden among key populations had NG infection, while 6% had both CT and NG living with or without HIV. As part of the study, infection. These findings indicate that pooled a validation assessment of pooled sampling CT/NG testing performed by KP-lay providers in was conducted. Pooled sampling refers to CBOs is feasible and should be implemented to samples from three compartments (urethral, facilitate access to STI testing services for at risk pharyngeal, and anal) from one participant being populations in Thailand.

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FIND: market research for POC gonorrhea testing

To encourage demand for NG POC tests and challenges once they are brought onto the identify barriers for market entry of these market, IHRI and FIND conducted a national tests, IHRI has cooperated with FIND to market assessment to understand the STI conduct market research in Thailand. FIND is context in Thailand in order to select the a global non-profit organization working on appropriate gonorrhea POC test and identify innovative diagnostics. Because in general strategies to implement the test in near new diagnostic products often experience future.

Addressing gonococcal antimicrobial resistance (AMR)

Zoliflodacin

The global burden of morbidity and Development Partnership (GARDP), IHRI mortality resulting from NG infections is has been preparing to initiate in early 2021 significant and contributes to increasing HIV a phase III multi-center study to evaluate transmission. To date, NG has developed the efficacy and safety of zoliflodacin, a resistance to all antibiotics used for routine promising single-dose oral antibiotic, to therapy by all known bacterial antimicrobial treat NG infection. A maximum of 1,092 resistance mechanisms. Identifying new participants from the Netherlands, South treatment options for multi-drug resistant Africa, Thailand and the USA will be recruited gonorrhoea is a key element of the WHO into this study, of which approximately global action plan to control the spread 500 will be recruited in Thailand. For IHRI, and impact of gonococcal AMR. Sponsored approximately 180 will take part in this by the Global Antibiotic Research and study.

Bexsero Vaccine

Despite decades of vaccine research, no to prevent infection of the CNS caused by vaccines against NG have been successful Neisseria meningitidis type B, might also in preventing human disease. However, work in preventing infection with NG. This novel approaches to vaccine development study will enroll approximately 2,200 men for Neisseria meningitidis serogroup B, have and women, 18-50 years old, from four clinics suggested protection against NG. The main in the United States, and two international purpose of the Bexsero study is to learn if a sites in Thailand. For IHRI, approximately 500 vaccine that is usually given as two injections will take part in this study.

30 ANNUAL REPORT 2020

Emerging Health Issues

Substance use services and HIV

Use of amphetamine-type stimulants (ATS) is common among MSM and TGW, and is associated with high-risk behavior for HIV infection. IHRI is conducting a study to look at the pattern of ATS Risk and other substance use and relationships with High adherence to ART or PrEP, HIV incidence, and 7.2% incidence of other STIs among Thai MSM and TGW. Initial results show that injection of crystal methamphetamine was higher in HIV-positive Moderate participants than in HIV-uninfected participants. Other substance use (tobacco, alcohol) and 43.3% specific sexual practices (selling sex, group sex) are associated with ATS use, and should prompt careful screening for ATS use. The study used the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) questionnaire for the screening of substance use, and to assess the level of risk participants have. Low The test score categorizes risk into mild, moderate 49.5% or high risk. In the study, 74.8% reported using substances with 49.5%, 43.3%, and 7.2% categorized as low, moderate, and high-risk users, respectively. To those with moderate or high risk a brief intervention (BI) was administered to help address drug use.

Substance use and Hepatitis C infection

An epidemic of sexually transmitted Hepatitis C clients (2.6%) tested positive, and referral for infection (HCV) among MSM has been emerging confirmatory testing and treatment initiation in recent years, likely due to rough or prolonged for those with confirmed HCV infection through sexual activities as a result of illicit drug use. the C-Free project – which provides community- To address the increasing proportion of clients based HCV treatment at CBOs – has successfully engaging in these chemsex activities and the started. IHRI plans to scale up HCV screening to resulting increased risk of HCV infection, IHRI all partnered community-based clinics and set has implemented rapid HCV antibody testing for up referral routes for those who tested positive clients accessing services at our partnered CBOs. across those provinces. Furthermore, IHRI will The services were introduced in November develop chemsex training manuals for KP lay 2020 at SWING and RSAT Bangkok, and since providers to be able to counsel and provide harm implementation 617 clients were tested. Sixteen reduction strategies to clients.

31 ANNUAL REPORT 2020

Anal HPV and risk for anal (pre)-cancer among Thai MSM with AHI

IHRI is conducting a longitudinal, persistence and anal HSIL incidence observational study of HPV infection and in HIV-positive MSM, and that these anal high grade squamous intraepithelial measures will be significantly lower lesions (HSIL) among HIV-positive Thai when compared to historical controls MSM who initiate ART during AHI. The of chronically-infected HIV-positive Thai hypothesis is that early HIV diagnosis MSM. This study enrolled 96 self-identified and early ART within the first 4 weeks MSM in the SEARCH010/RV254 cohort who of infection will mitigate immunological initiated ART during the acute phase of HIV and virological factors that increase HPV infection.

Stigma and discrimination related to COVID-19

During the COVID-19 outbreak, there have study to explore the types of stigma and been increasing reports of individuals discrimination prevalent, and associated that have been affected by the virus factors. Moreover, through this study, we experiencing some form of stigma and hope to explore the effects of preparing discrimination. The effects of being communities prior to the return of stigmatized may have an impact on COVID-19 patients and launch public the mental health of individuals. IHRI campaigns to reduce this unnecessary rapidly launched a mixed methods health burden.

32 ANNUAL REPORT 2020

SARS-CoV-2 serology in the context of HIV PrEP and ART

The effect of HIV on severity and mortality of pre-exposure prophylaxis and treatment of HIV. COVID-19 is currently clear. In some settings, This project is conducted with support from PLHIV have been underrepresented among amfAR’s TREAT Asia program, under the IeDEA those with severe COVID-19, possibly because Asia-Pacific network. Stored plasma specimens SARS-CoV-2 might invoke less severe immune from various studies under IHRI, SEARCH and responses in those with treated HIV infection. Thai Red Cross Anonymous Clinic, are being Studies are underway to evaluate the potential tested for proteins from Coronaviruses by the for boosted protease inhibitors (used in ART Vaccine Immunology Program at the Vaccine regimens for HIV) to treat COVID-19, while at Research Center at the US National Institutes the same time there has been growing interest of Health in Bethesda, USA. Findings will shed in exploring the use of TDF and FTC (currently light on longitudinal COVID-19 serology patterns used as PrEP for HIV) as possible prophylaxis prior to and after the local COVID-19 lockdown for COVID-19. To clarify the effect of PrEP and among Thai adults using ARVs for HIV PrEP ART on SARS-CoV-2 serology, IHRI is examining or treatment, and will be compared to HIV- serology patterns among Thai adults taking negative individuals not on PrEP. First results and not taking antiretroviral drugs (ARVs) for are expected in the first quarter of 2021.

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IHRI’s Board of Directors and Senior Advisors

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Board of Directors Senior Advisors

Professor Emeritus Dr. Praphan Phanuphak Petchsri Sirinirund Senior Research President and Policy Advocacy Advisor

Thanyawee Puthanakit Dr. Mark de Souza Vice-President Senior Laboratory Advisor

Kath Khangpiboon Vice-President

Ronnapoom Samakkeekarom Treasurer

Nittaya Phanuphak Pungpapong Secretary

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IHRI staff

36 ANNUAL REPORT 2020

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Management team

Dr. Nittaya Phanuphak Executive Director Dr. Reshmie Ramautarsing Program and Technical Director Dr. Somchai Sriplienchan Acute Clinical Research Manager Dr. Nittaya Phanuphak Dr. Reshmie Ramautarsing Dr. Somchai Sriplienchan Dr. Nipat Teeratakulpisan Dr. Eugene Kroon Dr. Nipat Teeratakulpisan Medical Service Director Dr. Eugene Kroon Medical Doctor Supervisor Jutamas Nualnok Operations Director Nitiya Chomchey Jutamas Nualnok Nitiya Chomchey Siriporn Nonenoy Peeraporn Kaewon Supabhorn Pengnonyang Research Quality Management Manager Siriporn Nonenoy Clinical Research Program Manager Peeraporn Kaewon Clinical Trial Monitoring Manager Supabhorn Pengnonyang Program Manager (Capacity Development and Advocacy) Rena Janamnuaysook Rapee Trichavaroj Krittaporn Termvanich Varaporn Pothipala Darakul Srichoorom Rena Janamnuaysook Program Manager (Transgender Health) Rapee Trichavaroj Laboratory Manager Krittaporn Termvanich Communications Manager Varaporn Pothipala Resource Mobilization Development Marisa Sanguankwamdee Ratchapong Kanaprach and Performance Manager Darakul Srichoorom Finance and Accounting Manager Marisa Sanguankwamdee Strategic Planning and Analysis Manager Ratchapong Kanaprach IT and Data Management Manager

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17 Medical Service Team End Audio Stop Video Security Participants Chat Share Screen Record Reactions Dr. Nipat Teeratakulpisan Medical Service Director

Dr. Supanat Thitipatarakorn Research Physician

Rapee Trichavaroj Dr. Nipat Teeratakulpisan Dr. Supanat Thitipatarakorn Rapee Trichavaro Nantana Tantibul Laboratory Manager

Nantana Tantibul Laboratory Officer

Waraporn Singlod Laboratory Officer

Patta Phumesin Laboratory Officer

Waraporn Singlod Patta Phumesin Onaroon Surisarn Kanchanok Rurkoukos Onaroon Surisarn Nurse

Kanchanok Rurkoukos Counselor

Sunate Posayawattanakul Pharmacist

Sunate Posayawattanakul Katawut Tarawat Atif Ngoh Katawut Tarawat Pharmacist

Atif Ngoh Pharmacist Assistant

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Clinical Research

Siriporn Nonenoy Program Manager (Clinical Research) Thunyasuta Prasit Research Nurse Supervisor

Piranun Hongchookiat Research Nurse Supervisor

Siriporn Nonenoy Thunyasuta Prasit Piranun Hongchookiat Supawan Promkaewto Supawan Promkaewto Research Nurse

Achiraya Chanta Research Nurse

Shareefah Hayikateh Research Nurse

Aphakan Klinsukontakul Research Nurse

Achiraya Chanta Shareefah Hayikateh Aphakan Klinsukontakul Warisa Tathian Warisa Tathian Research Nurse

Khanittha Janthawilai Research Assistant

Thanyapat Chaya-ananchot Research Assistant

Sumitr Tongmuang Senior Care and Counseling Officer

Khanittha Janthawilai Thanyapat Chaya-ananchot Sumitr Tongmuang Jirat Makphol Jirat Makphol Care and Counseling Officer

Kittichai Promjantuek Care and Counseling Officer

Atipan Phoungphu Care and Counseling Officer

Kantanat Kanetrat Care and Counseling Officer

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Transgender Health

Rena Janamnuaysook Program Manager (Transgender Health)

Pintusorn Getwongsa Technical Support Officer

Rena Janamnuaysook Pintusorn Getwongsa Linrada Himmad Peevara Srimanus Linrada Himmad Program Officer

Peevara Srimanus Program Officer

Kritima Samitpol Tangerine Clinic Supervisor

Tidarat Amatsombat

Kritima Samitpol Tidarat Amatsombat Phongdanai Chumnanwet Artsanee Chancham Research Nurse

Phongdanai Chumnanwet Research Nurse

Artsanee Chancham Senior Care and Counseling Officer

Jiratchaya Kongkapan Care and Counseling Officer

Jiratchaya Kongkapan Jeeranuch Rueannak Jeeranuch Rueannak Care and Counseling Officer

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Dr. Reshmie Ramautarsing 10 Program and Technical Director End Audio Stop Video Security Participants Chat Share Screen Record Reactions Tanat Chinbunchorn (MD) Technical Support Manager Sorawit Amatavete Technical Support Officer Dr. Reshmie Ramautarsing Tanat Chinbunchorn (MD) Sorawit Amatavete Sita Lujintanon Sita Lujintanon Junior Technical Support Officer Noppawith Thammasiha Junior Technical Support Officer Maytinee Numkerd Junior Technical Support Officer Nitthanun Kulsinsub Junior Technical Support Officer Noppawith Thammasiha Maytinee Numkerd Nitthanun Kulsinsub Chonthicha Hanaree Chonthicha Hanaree Navigator Chotika Prabjuntuek Navigator Jirayut Sripanjakun Navigator Narukjaporn Thammajaruk Senior Program Officer

Chotika Prabjuntuek Jirayut Sripanjakun Narukjaporn Thammajaruk Nonchaya Nakchang Nonchaya Nakchang Program Officer Sangusa Promthong Acting Program Officer Sudarat Thongsuksangcharoen Program Assistant Waraporn Sirisakyot Program Administrative Officer

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Acute Clinical Research

Dr. Somchai Sriplienchan Acute Clinical Research Manager Dr. Eugene Kroon Medical Doctor Supervisor

Dr. Carlo Sacdalan Research Physician

Dr. Somchai Sriplienchan Dr. Eugene Kroon Dr. Carlo Sacdalan Dr. Phillip Chan Dr. Phillip Chan Research Physician

Peeriya Prueksakaew Head of Research Nurse

Somporn Tipsuk Research Nurse

Suwanna Pattamaswin Research Nurse

Peeriya Prueksakaew Somporn Tipsuk Suwanna Pattamaswin Khunthalee Benjapornpong Khunthalee Benjapornpong Research Nurse

Nisakorn Ratnaratorn Research Nurse

Chutharat Munkong Research Nurse

Kamonkan Tangnaree Research Nurse

Nisakorn Ratnaratorn Chutharat Munkong Kamonkan Tangnaree Nicha Tulmethakaan Nicha Tulmethakaan Research Nurse

Jarawee Wattana Research Nurse

Sangla Boonla Nurse Assistant

Siriporn Sangthong Nurse Assistant

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Research Quality Management Team

Nitiya Chomchey Research Quality Management Manager Peeraporn Kaewon Clinical Trial Monitoring Manager

Nitiya Chomchey Peeraporn Kaewon Suchintana Chumseng Suwittra Chaemchuen Suchintana Chumseng Senior Clinical Trial Monitoring Officer

Suwittra Chaemchuen Senior Clinical Trial Monitoring Officer

Rungnapa Phunpang Clinical Trial Monitoring Officer

Siri-orn Parkpicharoen Clinical Trial Monitoring Officer

Rungnapa Phunpang Siri-orn Parkpicharoen Napasawan Chinlaertworasiri Patsadaporn Narawin Napasawan Chinlaertworasiri Regulatory Supervisor

Patsadaporn Narawin Regulatory Officer

Duanghathai Suttichom Acute Clinical Trial Monitoring Manager

Jintana Intasan Clinical Trial Monitoring Supervisor

Duanghathai Suttichom Jintana Intasan Kultida Poltavee Hathairat Savadsuk Kultida Poltavee Clinical Trial Monitoring Officer

Hathairat Savadsuk Clinical Trial Monitoring Officer

Tassanee Luekaseuk Study Co and International Regulatory Supervisor

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13 End Audio Stop Video Security Participants Chat Share Screen ResourceRecord Mobilization,Reactions Development and Performance Leave

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Capacity Development and Advocacy Team Varaporn Pothipala Resource Mobilization Development and Performance Manager Supabhorn Pengnonyang Program Manager (Capacity Development and Advocacy)

Gregory Carl Senior Capacity Building Supervisor

Sataporn Waewklaihong Curriculum and Training Specialist Supabhorn Pengnonyang Gregory Carl Thanthip Sungsing Competency and Quality Marisa Sanguankwamdee Coordinator Strategic Planning and Analysis Manager

Jeeranchaya Hemavisan Capacity Development and Advocacy Officer

Sataporn Waewklaihong Thanthip Sungsing Tanya Vierra Strategies Analyst

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Operation Support Team

Jutamas Nualnok Operations Director

Sunantha Boonsawai Administrative and General Affairs Supervisor

Sukanya Yuchuchaimongkol Acting Human Resources Supervisor

Jutamas Nualnok Sunantha Boonsawai Sukanya Yuchuchaimongkol Saranya Panakhiao Administrative Officer

Udomporn Limsawat Procurement Officer

Valanyu Lertreechadar Human Resources Officer

Sasiwan Srikhaw Project Operations Officer

Saranya Panakhiao Udomporn Limsawat Valanyu Lertreechadar

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12.22

Statistics Management Leave

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Jitsupa Peelay Biostatistician IT and Data Management

Ratchapong Kanaprach IT and Data Management Manager Pravit Mingkwanrungruang Data Management Supervisor

Phanu Srivachiraroj Database Programmer

Ratchapong Kanaprach Pravit Mingkwanrungruang Phanu Srivachiraroj Noppadol Kaewryungfarthai Noppadol Kaewryungfarthai Database Programmer

Routhairat Suttichom Clinical Data Officer

Lertkwan Suwannarat Clinical Data Officer

Nuttawoot Photisan Chiraporn Taya Clinical Data Officer Biostatistician Routhairat Suttichom Lertkwan Suwannarat Nuttawoot Photisan Kulthida Chaikul Kulthida Chaikul Clinical Data Officer

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Namfon Markhlur Data Entry Officer

Rattana Sungsongkiat Data Entry Officer Chatchawan Tanadngan Namfon Markhlur Rattana Sungsongkiat Thanunthorn Uengthong Thanunthorn Uengthong IT Supervisor

Sirinun Sutapanich Information Technology Officer

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Finance and Accounting

Darakul Srichoorom Finance and Accounting Manager

Kessareewan Punarumit Finance and Accounting Supervisor

Nattawut Kosinsene Finance and Accounting Supervisor

Duangdao Chuangchan Finance and Accounting Officer Darakul Srichoorom Kessareewan Punarumit 12.22 Chalit Suwanwatcharachat Finance and Accounting Officer Communications Leave

Nattawut Kosinsene Duangdao Chuangchan

Krittaporn Termvanich Communications Manager

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Panuwat Tapim Content Designer

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WHERE INNOVATION MEETS IMPLEMENTATION