Preventive Technologies Agreement (PTA) Advancing the Science of HIV Prevention the U.S

END-OF-PROJECT REPORT Preventive Technologies Agreement (PTA) Advancing the Science of HIV Prevention The U.S. Agency for International Development (USAID) awarded the Preventive Technologies Agreement (PTA) to FHI 360 in 2009. The PTA End-of-Project Report: Advancing the Science of HIV Prevention provides an overview of the results and accomplishments of the five-year PTA project.

For additional information on particular activities or technical areas undertaken by the PTA, please see the PTA website at http://www. fhi360.org/projects/preventive-technologies-agreement-pta

Photo credits: cover and page 2, Jessica Scranton cover and page 16, Leigh Wynne/FHI 360 page 4, Sarah Mullins/FHI 360 cover and page 17, Jessica Scranton cover and page 5, Natasha Mack/FHI 360 page 18, Ian Taylor page 7, Natasha Mack/FHI 360 cover and page 22, Sarah Mullins/FHI 360 cover and page 9, Jessica Scranton page 23, James Kilonzo, Courtesy of Photoshare page 10, Michele Lanham/FHI 360 page 24, Jessica Scranton page 11, Natalie Eley/FHI 360 cover and page 25, Kim Best cover and page 12, Michele Lanham/FHI 360 page 26, Kim Best page 15, Jessica Scranton page 27, Jessica Scranton Table of Contents

Introduction 2 HIV Prevention for Women Integration of HIV Prevention and Reproductive Health Technologies Research Support, Field Support, and Product Quality and Compliance

HIV Prevention Clinical Trials 5 CAPRISA 004 CAPRISA 104 and 106 FEM-PrEP

Support for HIV Prevention Research 9 Science Facilitation Good Communication Practices Assuring Stakeholder Involvement

Microbicide Implementation 12 Gender and Male Engagement in Microbicide Introduction Communicating about Microbicides with Women in Mind Preparing for Microbicide Delivery: Assessing Integration of Services

Other Social Behavioral Evidence 16 Evaluating Messages about Abstinence Addressing Barriers to Informed Consent

Family Planning and HIV Integration 17 Biomedical Research Behavioral Research Programmatic Research Research Utilization Youth

Support for Field Activities 22 Botswana Kenya Malawi South Africa

Product Quality and Compliance 25 Development of International Standards Capacity Building Production Surveillance Field Complaints Inter-Laboratory Proficiency Trials Innovative Techniques for Quality Assurance

Moving Forward 27

Appendix: Publications 28 Introduction

According to the Joint United Nations Programme in biostatistics, data management, research eth- on HIV/AIDS, more than 35 million people world- ics, regulatory affairs, research dissemination and wide are still living with HIV, and more than utilization, adult education, field program manage- 2 million people are being newly infected each ment, and product quality assurance. This multi-dis- year. In 2009, the U.S. Agency for International ciplinary team — a strength of FHI 360’s approach Development (USAID) awarded FHI 360 the five- to prevention research — contributed to the PTA’s year Preventive Technologies Agreement (PTA) evolving research and research support agenda. to help develop selected HIV prevention technologies and strategies to advance the global HIV This report summarizes five years of PTA- prevention and health supported accomplishments in HIV prevention research, the integration of HIV prevention and re- KEY RESOURCE agenda. FHI 360 and its partners achieved productive health technologies, and technical lead- The Preventive these goals by generat- ership and support for HIV prevention research, Technologies Agreement ing knowledge about field activities, and product quality and compli- biomedical, behavioral, ance. The appendix at the back of the report lists http://www.fhi360.org/ and programmatic solu- the more than 150 peer-reviewed journal articles, projects/preventive- technologies-agreement-pta tions to HIV prevention technical briefs, and practical tools developed and and providing scientific disseminated under the agreement. support and technical assistance to governments and nongovernmental HIV Prevention for Women organizations in 15 countries. Research to identify an HIV prevention method Prevention research under the PTA focused on that women could control, which accounted for women in sub-Saharan Africa, who have a continu- the greatest portion of work completed under the ing need for effective woman-controlled meth- PTA, first focused on the efficacy of products con- ods of HIV prevention. The Joint United Nations taining antiretroviral (ARV) drugs. The PTA sup- Programme on HIV/AIDS reports that 70% of new ported the CAPRISA 004 study of tenofovir gel in infections each year happen in this geographic South Africa and implemented FEM-PrEP in three area. A disproportionate 57% of people living with African countries. FEM-PrEP was a randomized HIV there are women. Gender norms in many controlled trial of oral Truvada — a combination of cultural contexts translate into women’s lack of the ARV drugs tenofovir disoproxil fumurate and control over their sexual lives, leaving many unable to negotiate condoms without risking suspicion or emtricitabine used to prevent HIV in an approach even violence from their partners. known as pre-exposure prophylaxis (PrEP). Both trials included intensive social, behavioral, and During the PTA, FHI 360 brought together a community components to address the many chal- professional team of experts in clinical, epidemio- lenges of conducting sophisticated randomized logical, behavioral, and operations research and controlled trials in resource-poor settings.

2 PTA End-of-Project Report Although CAPRISA 004 demonstrated partial women who did not adhere to the study product effectiveness of tenofovir gel, adherence to the during the FEM-PrEP trial was also conducted to study regimen was a challenge in both CAPRISA find out why these women had not taken Truvada 004 and FEM-PrEP. For the FEM-PrEP trial as directed. in particular, a question remained: Why did so many women in the trial not use the products? During the past five years, studies such as HIV prevention technologies — the focus of the CAPRISA 004, iPrEx, Partners PrEP, the TDF2 PTA — do not exist in a social vacuum, and their trial, and the Bangkok Tenofovir Study have use depends on several contextual factors. For shown the effectiveness or partial effectiveness example, life situations that make individuals of ARV-based prevention when used as directed. vulnerable to disease also make it difficult for As part of USAID’s shared vision and strategic them to fulfill the requirements of a clinical trial, plan for microbicide introduction, the PTA sup- including product adherence. ported preparation for the eventual rollout of such products into national health systems by exploring With questions about adherence looming large, personal, social, and structural dynamics likely to the attention of PTA-funded HIV prevention influence women’s use of the products outside of research later turned toward more behavioral and clinical trials. Studies focused on delivering micro- social science research in Kenya and South Africa. bicide services through the health system, creat- Both qualitative and quantitative data from the ing demand for products through communication CAPRISA 004 and FEM-PrEP trials were analyzed activities, and adapting a gender analysis tool to to better understand women’s perceptions of trial identify and address potential barriers in specific participation and HIV risk and their motivations service contexts. for adherence and study retention. Research with

NORTH AMERICA

LATIN AMERICA/ THE CARIBBEAN

SOUTH AMERICA

Advancing the Science of HIV Prevention 3 Integration of HIV Prevention and Research Support, Field Support, and Reproductive Health Technologies Product Quality and Compliance

Contraception is a proven strategy for prevent- Under the PTA, FHI 360 helped facilitate the ing new HIV infections. By preventing unintended HIV prevention research and programs of other pregnancies in women with HIV, contraception can USAID cooperating agencies, such as CONRAD, reduce HIV-positive births and, by extension, the and programs funded by the National Institutes number of children needing HIV treatment, care, of Health. This was accomplished through tech- and support. Contraception in the form of cor- nical, clinical, regulatory, quality assurance, data rect and consistent condom use can also prevent management, biostatistical, communications, and the sexual transmission of HIV, thereby contrib- behavioral leadership and support. In addition to uting to the prevention of HIV both in infants supporting core-funded activities, USAID country and in the general population. Under the PTA, missions in Botswana, Kenya, Malawi, and South FHI 360 built on work begun under the USAID- Africa accessed FHI 360’s technical assistance supported Contraceptive and Reproductive Health for HIV prevention through buy-ins to the PTA on Technologies Research and Utilization program, an as-needed basis. To complement this work, by conducting research and research utilization FHI 360 provided technical assistance to USAID’s activities to improve the integration of HIV preven- contraceptive security and logistics program, en- tion and reproductive health programs. Activities suring that USAID’s reproductive health commodi- focused on gaining a better understanding of how ties — including a high volume of condoms — met best to reach women and youth at risk of HIV with international quality standards. family planning (FP) and HIV prevention information and services, determining the cost-effectiveness of specific configurations of services, and providing information and technical assistance to national programs as they move forward with developing models of FP/HIV integration.

4 PTA End-of-Project Report HIV Prevention Clinical Trials

Two biomedical HIV prevention clinical trials study pills, two other trials (both among women) conducted with support from the PTA — CAPRISA were not able to demonstrate the effectiveness of 004 and FEM-PrEP — were instrumental in test- Truvada. ing and preparing for the introduction of new HIV prevention options for women. Both were The PTA-supported FEM-PrEP trial, conducted large-scale trials that collected information on the among women at high risk of HIV infection in long-term safety and effectiveness of new prod- Kenya, South Africa, and Tanzania, was among the ucts, but only after they had passed several other two trials that were unable to demonstrate effec- rigorous tests of safety and acceptability. Both tiveness because of low adherence. However, be- CAPRISA 004 and FEM-PrEP examined whether cause of the extensive specific formulations of ARV drugs, typically used social, behavioral, and KEY RESOURCES to treat HIV, could also safely prevent new HIV community research conducted as part of infections. CAPRISA 004 FEM-PrEP, the trial Most microbicides for women have been formu- was able to contribute http://www.fhi360.org/projects/caprisa-004-tenofovir- lated as vaginal gels that are intended to be used much-needed data on gel-trial daily or to be used around the time of sexual activ- factors affecting adher- ity. Led by the Centre for the AIDS Programme ence to the study pills. It FEM-PrEP was also able to con- of Research in South Africa (CAPRISA) at the http://www.femprep.fhi360. University of KwaZulu-Natal, CAPRISA 004 was tribute data on how trial org the first study to show the effectiveness of a vagi- participants perceive nal gel (1% tenofovir used before and after sex) in their HIV risk and on preventing HIV acquisition among women. With behaviors related to participants that can inform support from the PTA, FHI 360 provided technical future trials of novel HIV prevention technologies. assistance to the trial, including statistical design and analysis, behavioral assessment, evaluation of CAPRISA 004 safety reports for trial participants, clinical monitoring and project management, ethical and safety CAPRISA 004 was a randomized, placebo-con- oversight, and communications. trolled clinical trial that assessed the effectiveness and safety of a vaginal gel containing 1% tenofo- ARV drugs can also be formulated as pills and used vir for the prevention of HIV infection in South as PrEP. One example is Truvada, which combines African women. The study achieved an important two ARV drugs into a single pill taken once a day. scientific breakthrough, providing the first evi- Some clinical trials have shown that Truvada can dence that a microbicide gel can reduce HIV and prevent HIV infection, leading the U.S. Food and genital herpes infection in women. Drug Administration in 2012 to approve the drug as PrEP for men and women at high risk of HIV in- After its results were announced in 2010, the fection. However, because of low adherence to the CAPRISA 004 trial gained international attention.

Advancing the Science of HIV Prevention 5 Science Magazine recognized it as one of the top Tenofovir gel could fill an important HIV preven- 10 scientific achievements of 2010, and USAID tion gap by empowering women who are unable to awarded CAPRISA 004 its prestigious Science successfully negotiate mutual faithfulness or con- and Technology Pioneers Prize in 2014. The prize, dom use with their male partners. Since women established in 2013, recognizes excellence in the with genital herpes are much more likely to be- use of science and technology to solve the latest come infected with HIV, the additional protection challenges in human of tenofovir gel against herpes creates a second KEY PARTNERS development. mechanism whereby the gel may have an impact in preventing HIV. Should current studies of tenofovir Bill & Melinda Gates Foundation CAPRISA partnered gel confirm the results of CAPRISA 004, wide- Centre for the AIDS Programme with FHI 360 and spread use of the gel could prevent more than half of Research in South Africa CONRAD to conduct a million new HIV infections in South Africa alone the trial, which in- over the next decade. Columbia University cluded 889 women CONRAD at high risk of HIV infection at an urban CAPRISA 104 and 106 Gilead Sciences site and a rural Because good adherence is necessary for re- site in KwaZulu- Gladstone Institutes searchers to be able to assess the efficacy of any Natal, South Africa. potential biomedical HIV prevention product and IMPACT Research and Women in the trial to assure effectiveness if a product is rolled out, Development Organization were randomly as- FHI 360 in collaboration with CAPRISA sought to signed either the 1% Institute for Tropical Medicine better understand adherence to 1% tenofovir gel. tenofovir gel or a The results of two separate PTA-supported stud- JOSHA Research placebo gel and ad- ies, both involving participants from CAPRISA’s vised to use it up to Kilimanjaro Christian Medical tenofovir gel trials, highlighted the challenges of 12 hours before sex Centre both supporting and measuring adherence. and again as soon as London School of Hygiene & possible within 12 CAPRISA 104 Tropical Medicine hours after having In a mixed-method study known as CAPRISA 104, SCT Consulting sex, for a maximum conducted in parallel with the groundbreaking of two doses within CAPRISA 004 trial, approximately 400 CAPRISA Setshaba Research Center 24 hours. 004 participants were interviewed to explore how Technology Innovation Agency variations in their gel use may have influenced Results showed that the gel’s effectiveness. The study demonstrated University of North Carolina at the 1% tenofovir gel that nested observational studies allow detailed Chapel Hill was 39% effective in behavioral data to be collected in real time reducing a woman’s University of KwaZulu-Natal with large-scale HIV prevention trials. Although risk of becoming statistical modeling was limited because of biases University of San Francisco infected with HIV related to self-reported adherence, this approach and 51% effective in is promising if combined with measurements preventing herpes simplex virus type-2 infection. of biomarkers. The CAPRISA 104 study also These protective effects increased as adherence generated descriptive findings on the relationship to the product’s dosing regimen increased. For between adherence and the extent to which example, women who used the gel in more than women told their male partners that they were 80% of their sex acts had a 54% reduction in HIV participating in the study, that the study was about infections, whereas those who used the gel in less HIV prevention, and that the study required use of than half of their sex acts had a 28% reduction in a vaginal gel. HIV infections.

6 PTA End-of-Project Report CAPRISA 106 These nuances of partner disclosure led to the design of a second study, known as CAPRISA 106, conducted in parallel with a follow-on 1% tenofovir gel trial called CAPRISA 008. Led by CAPRISA investigators, CAPRISA 008 randomized former CAPRISA 004 participants to receive tenofovir gel either in conjunction with FP services or in the same way they had received the gel in the successful CAPRISA 004 trial. The CAPRISA 106 study, led by FHI 360 in collaboration with CAPRISA, qualitatively examined adherence among women who did and did not disclose information about the trial and the gel to their partners. It also examined the acceptability of the gel among male partners and men in the community, and described the experiences and perspectives of FEM-PrEP providers and gel recipients regarding the delivery of tenofovir gel in the context of FP. FEM-PrEP was a randomized, placebo-controlled clinical trial to assess the safety and effectiveness Unlike most ARV-based prevention trials, whose of a daily dose of Truvada to prevent HIV infection participants do not know whether they have among HIV-negative women who were at higher been randomly assigned to receive a placebo risk of HIV exposure. The trial was conducted in or an active product of unknown effectiveness, 2010 and 2011 among 2,120 volunteers from four CAPRISA 008 was an open-label study. sites in Kenya, South Africa, and Tanzania. Low ad- Participants were openly provided with tenofovir herence to the study pills prevented the trial from gel and information about the promising results of being able to determine whether Truvada could CAPRISA 004. Open-label trials like this one can reduce the risk of HIV infection in the study popu- reveal more about adherence and acceptability lation. The results did, however, provide a wealth than placebo-controlled trials because the women of information that will help guide future clinical know they are getting an active product that has trials and programs of PrEP for HIV prevention. some evidence of being protective against HIV if used as directed. Adherence rates

Preliminary results of CAPRISA 106 indicated that Although 95% of the FEM-PrEP participants women and men perceive disclosure of 1% teno- reported that they usually or always took their fovir gel use as beneficial when it is negotiated assigned study pills, objective data suggested and socially supported, and that non-disclosure otherwise. Analyses of drug concentrations in the is practical and acceptable in some relationships. blood of a small group of participants found that Furthermore, both men and women in the study only 12% had actually achieved good adherence perceived tenofovir gel as having the potential to (i.e., were estimated to have taken the study drug address limitations in the current mix of HIV pre- at least four times per week in the preceding 28 vention methods. days). Fear of being terminated from the trial was

Advancing the Science of HIV Prevention 7 the main reason participants cited for over-report- with drug concentrations from PBMCs alone. The ing adherence. concentrations from the two sources were well correlated, suggesting that drug concentrations Factors affecting adherence in upper layer packed cells could be used as as a Participants who perceived some HIV risk or liked new and simpler measure of adherence to ARV the color of the pills were more likely to adhere drugs. All blood samples for the FEM-PrEP trial to the study drug. In contrast, the main reasons were analyzed at the University of North Carolina participants gave for not adhering — and the main at Chapel Hill. reasons partners, the community, and other participants discouraged adherence — were concerns Method for verifying safe drug levels about possible side effects or about taking a drug Chemistry reference ranges (CRRs) are used to that had not yet been proven to be effective or interpret drug safety in a particular population. safe for HIV prevention. Women using oral contra- The FEM-PrEP study team used a simple and ceptive pills at enrollment had lower adherence inexpensive method to verify the CRRs in three to the study pills and a higher rate of pregnancy, of the trial’s study sites. The method the team suggesting that these women in particular may used resulted in different classifications of liver have had difficulty adhering to a daily pill regimen. and kidney toxicities than would have been found These findings reinforced the key role of adher- using CRRs provided by the manufacturer. This ence in HIV prevention studies and the need to finding suggested that verification of CRRs should determine better approaches to support adher- be standard practice in clinical trials conducted in ence in future PrEP programs. settings where normal chemistry ranges have not been validated in the local population. Risk perception Even though 68 participants became infected Effectiveness of injectable contraceptives with HIV during the trial, perceptions of HIV risk Many factors may affect the effectiveness of a were low, particularly among participants from the drug, including the length and conditions of its South African sites. Among all the women who storage and individual characteristics that could became infected with HIV, more than half reported influence a drug’s metabolism and action. During before seroconversion that they had no chance FEM-PrEP, levels of medroxyprogesterone acetate of becoming infected with HIV in the next four in the blood were lower than expected among weeks. Future risk-reduction interventions should Kenyan participants who were using the inject- incorporate women’s HIV risk perceptions into the able depot-medroxyprogesterone acetate (DMPA). HIV prevention discourse, as they are likely impor- These low levels likely reduced contraceptive tant precursors to any risk-reduction measures. efficacy, reflected in the nine pregnancies that occurred among DMPA users in Kenya. The FEM- New way to measure adherence PrEP investigators could not confirm whether this When Truvada is metabolized in the body, the finding was due to a difference in metabolism by substances that are produced can be identified in this population of Kenyan women, due to vari- peripheral blood mononuclear cells (PBMCs) — able quality of the DMPA product, or due to other certain kinds of immune cells that need to be iso- unknown factors. FHI 360 subsequently tested lated from whole blood to be examined. Truvada samples of product from the same manufacturer metabolites in PBMCs have been used as markers that was used in the Kenyan study site and found of long-term adherence to the drug. However, that the samples contained appropriate concen- isolating PBMCs from blood is expensive, complex, trations of medroxyprogesterone acetate. and not feasible in many settings. Drug concentrations from upper layer packed cells, which which are much easier to isolate and contain both PBMCs and red blood cells, were compared

8 PTA End-of-Project Report Support for HIV Prevention Research

As part of the PTA’s efforts to advance research the PTA, FHI 360 provided data management and on new HIV prevention and contraceptive meth- biostatistical support for this research, which com- ods, FHI 360 provided support to partners and pared different dosing regimens, assessed wheth- global technical leadership in study design, data er use at different phases of a woman’s menstrual management, and biostatistical analysis. FHI 360 cycle or in conjunction with hormonal contracep- also worked with partners to increase the en- tives affected the gel’s safety and effectiveness, gagement of a wide range of stakeholders in the and evaluated several vaginal tablets containing research process and to improve communication different ARV drugs. about the conduct of research and its results. Safety and effectiveness of the SILCS diaphragm Science Facilitation The PTA supported CONRAD’s trial of the safety Under the PTA, FHI 360 conducted or advised on and contraceptive effectiveness of the SILCS dia- secondary analyses of data from completed HIV phragm (being mar- prevention trials, served on the scientific advi- keted in Europe as KEY RESOURCES sory board of the International Partnership for the Caya diaphragm) Microbicides, and contributed to the international by assisting with Communications Handbook for discussion on how laboratory test results are used data management Clinical Trials to determine an HIV diagnosis. By providing data and biostatistical http://communicationsclintrials. management and analysis for CONRAD’s product analysis, providing org development program, the PTA also contributed regulatory audits, to clinical evaluation of the safety and effective- and monitoring sev- Stakeholder Engagement Toolkit ness of microbicide candidates, a pivotal trial of eral study sites. The for HIV Prevention Trials the safety and effectiveness of a new diaphragm, PTA also supported http://www.fhi360.org/resource/ and methodological advances to improve the ef- the preparation stakeholder-engagement-toolkit- ficiency of product development. of a submission to hiv-prevention-trials request the approval Safety and effectiveness of microbicide of the U.S. Food and candidates Drug Administration to market the SILCS dia- Once the CAPRISA 004 trial had shown that phragm as a medical device in the United States. 1% tenofovir gel could reduce the risk of infec- The SILCS diaphragm, developed by PATH, differs tion with HIV and herpes simplex virus type-2, from traditional diaphragms in that it is made of CONRAD developed an extensive research portfo- silicone (which is more durable than latex) and lio to evaluate the gel and other potential microbi- comes in only one size, which makes it easier to cides. (CONRAD and the International Partnership provide. for Microbicides hold the license to develop 1% tenofovir gel for eventual market approval.) Through

Advancing the Science of HIV Prevention 9 Methodological advances for microbicide trials Communications handbook for clinical trials The PTA also worked with CONRAD on a method- The PTA spearheaded an effort, in collabora- ological study exploring subtle changes in biological tion with the multi-partner Microbicides Media markers of inflammation that could signal problems and Communications Initiative (MMCI), to docu- with the safety of vaginal microbicide products. ment and share These biomarkers could help researchers identify, the lessons the early in product development, the microbicide can- group’s members didates that could fail later safety evaluations. had learned about communication Good Communication Practices in HIV prevention trials. The Effective communication can build public sup- result was the port for research, enabling studies to proceed Communications and paving the way for the acceptance of new Handbook for products or interventions. But too often, the need Clinical Trials, for a communication strategy is overlooked until published by a crisis arises or a study ends. Through the Good FHI 360 and the Communication Practices for Microbicides initia- MMCI in 2010. tive, FHI 360 sought to integrate communication Offering practical guidance on how to anticipate planning and ongoing communication support into and respond to the special communication chal- its microbicide research from the beginning. lenges posed by clinical research, the handbook features more than 40 contributions from re- Communication strategies and dissemination searchers and communication experts who share FHI 360’s communication specialists worked with ideas, tips, and lessons learned from their experi- multidisciplinary teams at FHI 360 to develop ences in Africa, Asia, Europe, Latin American, and and implement comprehensive communication the United States. strategies for PTA-supported microbicide and PrEP trials and to disseminate the results of those More than 2,000 copies of the Communications trials. Monitoring of media coverage revealed that Handbook were distributed to individuals working coverage of the trials was extensive and largely on HIV prevention trials in more than 125 organi- balanced and accurate, regardless of whether the zations in 33 countries. In a survey of handbook trial results were positive or negative. users that the PTA conducted with AVAC in 2013, respondents said they found the handbook useful and easy to use. Almost 82% agreed that the topics covered in the handbook helped them do their job.

FHI 360 worked with the MMCI to promote the use of the handbook and to enhance the resource based on feedback from users. A CD version was launched at the International AIDS Conference in 2012. And in 2014, the PTA produced a user-friendly online version of the handbook, with additional resources such as videos, slide presentations, and new case studies.

10 PTA End-of-Project Report Assuring Stakeholder Involvement based advocates, the toolkit was designed to help research teams deepen their relationships with Many people have a stake in the conduct and partners, measure stakeholder engagement, and outcome of a clinical trial, from members of address community concerns in ways that create the communities where the research is done to opportunities for dialogue. policymakers and regulatory officials. The benefits of involving Launched at the International AIDS Conference these groups at in 2012, the toolkit was disseminated widely in every stage of a pdf format on flash drives to research teams in trial are widely the field. Based on user feedback, it was also recognized, but made available in print, on CD, and on the FHI 360 little system- website, along with the Toolkit Quick Guide — a atic guidance new electronic resource is available on developed to accompany how to engage the toolkit. The quick KEY PARTNERS stakeholders guide includes hyper- effectively and links to tools and other AVAC efficiently. resources in the tool- CONRAD kit, including Microsoft Under the PTA, Word or Excel files of all International Partnership FHI 360 collabo- the tools, which allow for Microbicides rated with AVAC users to adapt them as Microbicides Media to fill that gap by needed. and Communications developing a Stakeholder Engagement Toolkit for Initiative HIV Prevention Trials. The 200-page toolkit offers Under the PTA, FHI 360 research teams a step-by-step guide to working also developed a half-day PATH with a wide range of stakeholders before, during, training session on the Population Council and after a trial. Based on best practices and the use of the Stakeholder experience of clinical trial experts and community- Engagement Toolkit. The session was pilot-tested at the annual meeting of the HIV Prevention Trials Network in 2014, providing members of this global research network with enhanced skills, systems, and tools for ensuring stakeholder involvement in HIV prevention research.

Advancing the Science of HIV Prevention 11 Microbicide Implementation

Now that several clinical trials have shown the Addressing gender effectiveness of oral PrEP — and CAPRISA 004 FHI 360 took USAID’s approach to gender analysis, has shown that a vaginal adapted it to the context of microbicide introduc- KEY RESOURCES microbicide gel can reduce tion, and conducted gender analyses in Kenya and women’s risk of infection, Gender and Male South Africa (in partnership with Sonke Gender Engagement in with a confirmatory study Justice). Each gender analysis included a desk Microbicide Introduction under way — the next review of relevant literature and population-level challenge will be to ensure http://www.fhi.org/ data, a policy analysis, and interviews with more access to the products and projects/gender-and- than 30 key stakeholders. microbicides encourage their use. USAID’s shared vision and strategic Stakeholders thought microbicides should be Communicating about plan for microbicide intro- an option for all women, particularly when they Microbicides with duction, which includes a va- experience difficulty negotiating condom use. They Women in Mind riety of work conducted un- warned that marketing only to women at the high- http://www.fhi360.org/ der the PTA, aims to speed est risk of HIV infection could stigmatize microbi- projects/communicating- that process by beginning cide products. To maximize access, stakeholders about-microbicides- now to prepare for eventual recommended that microbicides be made available women-mind-project microbicide introduction. free of charge and through health services that women and youth already access.

Gender and Male Engagement in Most stakeholders acknowledged that support Microbicide Introduction from male partners could facilitate access to, acceptance of, and consistent use of microbicide Microbicides hold promise as an HIV preven- products, and they recommended promoting posi- tion method that women could control, or at tive male engagement. The stakeholders affirmed, least initiate, if an effective product is licensed however, that women have the right to choose for introduction. However, women are still likely whether to tell male partners about microbicide to face gender-related barriers to accessing and use and thought health care providers should be using microbicides. Furthermore, male partners trained to help women decide whether and how will likely play a role in the effective use of the to do so. technology. During the PTA, FHI 360 and partners implemented gender analyses in two countries Based on recommendations from stakeholder to identify gender-related barriers to access and meetings in both Kenya and South Africa, FHI 360 use, and ways to address them. They also worked and partners developed products — including ad- with partners to collect and analyze data on male vocacy materials and technical briefs — to facilitate engagement and to develop recommendations for use of the findings and promote attention to engaging men in future microbicide research and gender issues in future microbicide programs. The product introduction. team also produced a guide to support replication

12 PTA End-of-Project Report of the gender analyses in other countries that may be planning for microbicide introduction.

Engaging men How can programs balance the promotion of microbicides as a method that is revolutionary because it does not require men’s involvement with the reality that a man often plays an important role in its effective use? With support from USAID, FHI 360 and partners explored this question during the PTA.

A consultation involving 22 experts in FP, community health, HIV prevention, and male engagement in women’s health programs convened in January ally, and continuing to bring up microbicides until 2013 to help guide the design of formative re- resistant partners acquiesced. search to identify the best strategies for engaging Among men who were aware of a partner’s micro- men in microbicide programs without disempow- bicide use, involvement ranged from opposition to ering women. FHI 360 and colleagues from the agreement (or non-interference) to active support. Kenya Medical Research Institute then conducted Both men and women expressed a desire for men 98 interviews and two focus group discussions to have access to information and to be able to with women, men, health care providers, and talk with a health care provider about microbicides. community advisory board members in Kisumu, However, men rarely went to the clinic during the Kenya — many of whom had been directly involved trials because of their work schedules, fear of in microbicide trials. FHI 360 also partnered with HIV testing, and stigma. Based on these findings, researchers from the University of Amsterdam, the team developed a detailed summary of the Population Council, and RTI International to ex- evidence on male engagement in microbicides plore qualitative data they had collected on male and recommendations for engaging men in future engagement microbicide research and product introduction. during the previous MDP 301, Carraguard, and Communicating about Microbicides with VOICE micro- Women in Mind bicide trials, respectively. The PTA’s Communicating about Microbicides with Women in Mind project explored how to market In November a microbicide gel so that women at risk of acquir- 2013, FHI 360 ing HIV could use it in a variety of contexts — from convened intimate relationships to commercial sex — while another PTA- avoiding the association with infidelity that often supported ex- stigmatizes condom use. pert consultation to review the Developing microbicide messages and findings from these studies and the formative re- materials search in Kenya. Key findings included that women After reviewing the literature on microbicides in steady partnerships preferred to have their and HIV prevention for women and meeting with partners agreement to use microbicides. Women experts, FHI 360 worked with partners in Kenya to used several strategies to obtain partner approval, develop audience-centered communication strate- including using the product for a while before tell- gies, messages, and materials about a microbicide ing their partners, giving men information gradu- gel. Development of the materials involved

Advancing the Science of HIV Prevention 13 extensive consultations with potential users of mi- The assessment revealed that the way the ma- crobicides and with other key stakeholders in four terials framed the benefits of microbicides had Kenyan cities. In-depth interviews, focus group important effects on the attitudes of some groups. discussions, and a For example, messages about sexual pleasure and Local Project Advisory message develop- other benefits generated more interest in use Committee ment workshop with than messages about HIV prevention for men and members of the local women who identified themselves as married and Representatives of: project advisory com- monogamous. Among younger participants and Kenya National AIDS & STI mittee were all part those who were married, materials that focused Control Programme (Chair) of the consultations. on the HIV prevention messages generated more negative attitudes toward microbicides than did Department of Health The literature re- materials that were not HIV-framed. Older, single Promotions, Ministry of view, meetings with participants were the least affected by the way the Public Health and Sanitation experts, and consul- materials were framed. Family Health Options of tations guided the Kenya design of all materials. The study also included a series of focus groups A Kenyan firm, Artful with young women and female sex workers International AIDS Vaccine Eyes Productions, (FSWs) to assess the effectiveness of the flip- Initiative developed prototype charts for community education. Following these Kenya Medical Research materials for aware- discussions, interest in gel use increased from Institute ness-raising (posters, 40% to 57% among the young women and from TV storyboards, and 65% to 83% among the FSWs. The desire to LVCT Health radio spots), in-depth abandon condoms for use of a less effective gel National AIDS Control education (flip charts, decreased among the young women and remained Council, Ministry of State in an informational bro- low among the FSWs after participating in the the Office of the President chure, and a counsel- educational ses- ing algorithm), and sions. In-depth National Organization of Peer Educators digital media (website interviews with and social media con- health care provid- Network of People Living cepts). Awareness- ers suggested that with HIV and AIDS in Kenya raising materials were the materials that PSI Kenya framed in two ways: HIV-framed materials Sex Workers Outreach highlighted the HIV Programme prevention benefit of microbicides, and materials that were not HIV-framed focused primarily on other benefits such as empowerment, greater intimacy, and increased sexual pleasure.

Assessing the impact of the materials After two rounds of pretesting and subsequent revision of the materials, FHI 360 conducted a study to assess the potential impact of the materials and their messages. In a survey of 600 women and 200 men who previewed the awareness-raising materials, interest in using a microbicide gel was high. Almost 80% said they would be somewhat or very interested in using the gel if it were available.

14 PTA End-of-Project Report had been developed would help them effectively health facilities in Kenya and the factors that facili- counsel women about microbicides. tated or impeded service delivery.

Based on the study’s results, FHI 360 drafted The results highlighted several challenges com- recommendations for developing communica- mon to integrating HIV testing and counseling tion strategies and a guide that describes how into FP and outpatient services and to integrat- programs can adapt the awareness-raising mate- ing reproductive health, infectious disease, and rials for use in other countries or with other HIV psychosocial support into prevention products. Strategic development of services for HIV-positive communication materials will help ensure that clients who are not KEY PARTNERS everyone who might benefit from new HIV preven- eligible for antiretroviral Kenya Medical Research tion products can do so. treatment (ART). Lack Institute of HIV test kits, overbur- Kenya Ministry of Health Preparing for Microbicide Delivery: dened staff, insufficient Assessing Integration of Services training, and issues of pri- Kenya National AIDS & STI vacy and space all made Control Programme integration difficult. Preparing health care providers and systems for Population Council microbicide introduction will require a better The data were shared understanding of service integration. In Kenya, the RTI International with key stakeholders in Ministry of Health’s decision to introduce a pack- Sonke Gender Justice March 2014 at a work- age of integrated reproductive health, HIV, and shop in Nairobi, where AIDS services in public health facilities nationwide University of Amsterdam offered an opportunity to study what happens in participants discussed the the real world when health facilities are charged challenges of integration with integrating an additional service. and proposed recommendations for overcoming them. Implementation of these recommendations In collaboration with the Ministry of Health’s will help improve the current rollout of integrated National AIDS & STI Control Programme and its services and will prepare public health facilities Reproductive Health and Maternal Services Unit, for the introduction of additional services, such as FHI 360 documented the extent to which inte- provision of microbicides and other forms of ARV- grated services were being delivered in 15 public based prevention, when they become available.

Advancing the Science of HIV Prevention 15 Other Social Behavioral Evidence

With PTA support, FHI 360 provided information sage may be associated with a woman’s previous ex- and data on knowledge, attitudes, and protective perience. For example, women with recent condom and risk behaviors related to the prevention of HIV experience may benefit more from an abstinence- and sexually transmitted infections (STIs) among plus-condoms message, and women without this populations who are vulnerable to HIV infection. experience may benefit from an abstinence-only One study examined message. Ultimately, providers should weigh condom the impact of messages history when determining the most appropriate KEY RESOURCE about abstinence among counseling message for an individual patient. A Toolkit for Developing Jamaican women with Bilingual Lexicons for curable STIs. Another International HIV Prevention Addressing Barriers to Informed Consent investigated clinical trial Clinical Trials participants’ comprehen- Even for well-educated clinical trial volunteers who http://www.popcouncil.org/ sion of informed consent, are familiar with the research process, comprehen- uploads/pdfs/2013HIV_ the results of which were sion of informed consent materials may be challeng- LexiconDatabase.pdf used to create a tool to ing. Add in the language barriers and unique technical help overcome barriers to terms that are common in HIV prevention research, KEY PARTNERS comprehension. and comprehension becomes even more difficult. National Institute for Researchers from FHI 360, the Population Council, Medical Research in Evaluating Messages the University of North Carolina at Chapel Hill, Tanzania about Abstinence and the National Institute for Medical Research in Population Council Tanzania collaborated to develop a way to ensure In a randomized controlled that important technical terms do not lose their University of North Carolina trial among 300 Jamaican meaning when translated into local languages for at Chapel Hill women with curable use in HIV prevention trials. Through focus group STIs or other reproduc- U.S. Centers for Disease discussions with women in Tanzania, the researchers tive tract infections, the Control and Prevention identified four questioning techniques that are all women were assigned to important to use when deciding how to best trans- abstinence-only or absti- late technical terms. nence-plus-condoms messaging during counseling. During the week after STI treatment, researchers FHI 360 and the Population Council used the study evaluated the level of prostate-specific antigen (a results to create a toolkit to help other researchers biomedical marker for semen exposure) in the blood improve the translation of clinical research terms. to compare the levels of unprotected intercourse The toolkit includes seven steps that researchers between the two groups. The findings showed no can use to create a bilingual lexicon of technical statistical evidence supporting the effectiveness of terms for their specific HIV prevention trial. The one counseling message over the other for helping researchers can then use their lexicon to translate women avoid unprotected sex during the treatment informed consent forms and to facilitate all other period. Rather, the effectiveness of a particular mes- important communication with trial volunteers.

16 PTA End-of-Project Report Family Planning and HIV Integration

Under the PTA, FHI 360 conducted biomedical, be- well as 207 women who were taking combined havioral, and programmatic research to broaden the oral contraceptives but were ineligible for ART. evidence base on how the FP and HIV fields intersect Comparison of ovulation rates and pregnancy rates and how they can be better integrated in practice. between the two groups showed similar rates of FHI 360 also implemented a portfolio of research both, suggesting that ART containing nevirapine has utilization activities to no notable effect on contraceptive effectiveness. ensure that emerging KEY RESOURCES or underused evi- Behavioral Research AIDS Journal Supplement: dence was commu- Family Planning and HIV nicated to and used Behavioral research focused on understanding the by audiences globally http://journals.lww.com/ contraceptive needs and preferences of key popula- aidsonline/toc/2013/10001 and at the country tions. A study in Kenya found that infrastructure, level. A large portion provider-client interaction, and couple dynam- Prezi: Integrating Family of this work focused ics were the top three barriers preventing FSWs Planning into HIV Programs on youth and their from obtaining contraceptives. Drop-in centers http://prezi.com/ unique sexual and were the most preferred model of service delivery, mwk7mypyw9q7/integrating- reproductive health mobile clinics were the least preferred model, and family needs. participants strongly supported the provision of Interagency Youth Working contraceptives from peer educators. In Bangladesh, Group Biomedical formative assessments among FSWs and women http://www.iywg.org Research Contraceptive need and use — FSWs in Bangladesh

Select Family Planning and Biomedical research Hotel FSWs Street FSWs (n=354) (n=323) HIV Integration Resources conducted under % % the PTA contributed http://www.fhi360.org/ Contraceptive need resource/select-family- evidence on Unmet need 25 36 planning-and-hiv-integration- the safety and resources effectiveness of Met need 67 55 contraceptive No need 8 9 methods for women Non-condom modern 47 35 living with HIV, including women on ART. FHI 360 method use and partners conducted a non-randomized clinical Consistent condom 33 25 trial in South Africa and Uganda to investigate use (5 of 5 most whether ART affects the effectiveness of oral recent acts with each contraceptives. The trial enrolled 196 women who partner type) were taking both combined oral contraceptives Doesn’t want a child 84 86 and ART containing the drug nevirapine, as within the next year

Advancing the Science of HIV Prevention 17 who inject drugs revealed that contraceptive knowledge and use was high among women who for the most part did not want to get pregnant in the near future. For instance, more than 90% of the FSWs were using condoms, and 37% were using dual methods — primarily condoms with either oral contraceptive pills or injectables. However, the findings also showed that condom use was inconsistent. Although important, KEY PARTNERS increased access to FP information and Ashokti Punorbashon Nibash services might not be Community-based integration Bangladesh Women’s Health enough to alleviate In Uganda, where HIV prevalence is rising but Coalition this problem, as FSWs testing rates remain low, village health teams and women who inject Community Health, offer a nationwide government-supported plat- drugs both felt they Rehabilitation, Education, form for community-based reproductive health had little control when and Awareness services. Under the PTA, FHI 360 collaborated a partner did not want with the Uganda Ministry of Health to evaluate CONRAD to use condoms. an intervention in which village health teams that Durjoy Nari Shangha were already providing FP services (including Elizabeth Glaser Pediatric Programmatic injectable contraceptives) were trained to offer AIDS Foundation Research HIV testing and counseling. Between May 2012 and September 2013, 36 trained members of Gold Star-Kenya PTA-supported village health teams delivered HIV testing and Interagency Task Team programmatic counseling services. The findings suggested that on Prevention of HIV in research generated the practice was safe, effective, and acceptable Pregnant Women, Mothers, evidence about to the community. During dissemination meet- and their Children effective, feasible ings in April 2014, stakeholders agreed that Kenya Ministry of Health models for key policymakers and technical experts should delivering integrated help refine and adapt the approach, which could South Africa National FP/HIV services inform the revision of Uganda’s national village Department of Health in both clinic- and health team strategy. Southern Africa community- Development Community based contexts HIV care and treatment centers and measured Uganda Ministry of Health An evaluation of a “facilitated referral” model for the impact of the FP/HIV integration at 12 HIV care and treatment University of Washington models on a range centers (CTCs) in Tanzania found that the model Women’s Health Research of contraceptive- had a positive overall effect on FP use among Unit related outcomes. CTC clients. Among sexually active female clients, Integrated service dual method use increased by 16% after the World Health Organization delivery interventions intervention. All CTC providers stated that FP Zambia Prevention, Care, and were also evaluated integration was feasible and a good addition, Treatment Partnership II to determine how although there were implementation challenges. well they were being In stakeholder discussions during dissemination implemented, to of the research, the chief medical officer of the document the technical and financial support Ministry of Health and Social Welfare expressed required to meet quality standards, and to inform his support for moving forward with scaling strategies for scale-up and replication. up integrated FP and HIV care and treatment

18 PTA End-of-Project Report services in Tanzania. He endorsed the direct generalized epidemics. They also drew attention provision of FP methods — condoms, oral to issues that have been underrepresented in the contraceptive pills, injectables, and implants — by global FP/HIV dialogue, such as preconception service providers at all HIV CTCs in the country. care for women living with HIV and the contraceptive needs of key populations living in Prevention of mother-to-child transmission countries with concentrated epidemics. Two studies supported by the PTA — one in South Africa and one in Uganda — evaluated the ef- Journal supplements fect of interventions to increase contraceptive Representatives of FHI 360 and the University use among postpartum clients of prevention of of Washington guest edited an AIDS journal mother-to-child transmission (PMTCT) services. supplement dedicated to expanding the evidence In South Africa, a counseling intervention did not on how the fields of FP and HIV are interrelated substantially improve knowledge and attitudes and how they can be better integrated in policies related to long-acting and permanent methods of and programs. contraception among postpartum women; use of Produced with the methods was low at baseline and remained support from the PTA, unchanged. In Uganda, results of an intervention the October 2013 to involve men in FP/PMTCT services also had a supplement offered limited effect on FP outcomes. Only 14% of male original research, and female clients interviewed in facilities where cutting-edge reviews, the intervention was implemented reported dual and thought-provoking method use, defined as using condoms along with opinion pieces on another contraceptive method. Less than a third topics ranging from the reported using condoms every time they had sex. effects of hormonal More favorably, among men in the community contraception on HIV who participated in a study-sponsored educa- to promising practices tional workshop, the percentage who reported in the integration of FP that they had accompanied their wives to a health and HIV services. The facility or had ever been tested for HIV increased PTA also supported a supplement to the Journal after the workshop. The results of both studies of the International AIDS Society, highlighting revealed valuable information about the health challenges and opportunities associated systems challenges that must be overcome to sup- with women’s use of ARV-based prevention port effective, sustainable integrated services. To technologies. The supplement will be published in broaden contraceptive options for PMTCT clients, September 2014. providers must be equipped with the competence, motivation, and management support to offer an Family planning and HIV integration at scale expanded range of services. The Zambia Prevention, Care, and Treatment Partnership II is a large HIV program funded by Research Utilization the U.S. President’s Emergency Plan for AIDS Relief that has scaled up FP/HIV integration in an Throughout the PTA, FHI 360 implemented intentional and substantial way. For this reason, strategic research utilization activities to FHI 360 sought to document this program’s expe- increase support for and use of FP/HIV riences. By describing how the program undertook integration evidence among HIV policymakers, FP/HIV integration, including identifying factors donors, opinion leaders, and implementers. that facilitated success and obstacles that ham- These efforts galvanized support among pered progress, the case study offered practical funders and policymakers for more widespread guidance to HIV implementers on how to put implementation of FP/HIV integration in FP/HIV integration goals into widespread practice.

Advancing the Science of HIV Prevention 19 Webinar series follow-on south-to-south exchange, to inform the development of Botswana’s own national integra- FHI 360 hosted a series of webinars on current topics related to reproductive health and HIV integration strategy. As a result of the visit to South Africa, tion: FP/HIV integration in Asia, safer contraception FHI 360 provided technical assistance to South for women living with HIV, and hormonal contra- Africa’s National Department of Health between ception and HIV. The webinars provided technical 2011 and 2013 to develop a new national policy on updates on the topics, addressed pressing questions contraception. The policy supports the integration from the perspective of experts in the field, and of FP and HIV services. engaged participants in interactive discussions. Each Monitoring integration webinar had 20 to 60 live participants, made up Recognizing the need to measure the implementa- primarily of technical experts, donors, government tion of integrated services, FHI 360 tested the feasi- representatives, implementing partners, health care bility of using existing data sources (such as service providers, and researchers. Many more people ac- registers and routine reports) to monitor service cessed the webinar content via archived materials delivery and calculate integration-related indicators. and video streams on YouTube. The study was conducted in four African countries: Synthesis of evidence-based practices Ethiopia, Rwanda, Tanzania, and Uganda. Results Evidence for the effective integration of FP and showed three indicators as the most feasible for HIV services is growing, and a broad array of guid- PMTCT programs to collect: the proportion of ance documents and tools are available to support service delivery points that offer integrated FP/HIV integrated programming. With support from the services, the proportion of HIV-positive women who PTA, FHI 360 reviewed research findings, program receive a FP method, and the proportion of women experiences in the field, and technical guidance who are tested for HIV when accessing FP services. to identify and synthesize evidence pertaining to Widespread endorsement of these indicators could the rationale for integrating FP and HIV services, increase support for FP/HIV integration and in- facilitators of and barriers to successful integration, crease the amount of data produced from routine and the impact of integrated FP and HIV services. monitoring to document the extent and impact of A 12-page brief and narrated web-based Prezi were integrated FP/HIV services. developed to summarize this evidence and make recommendations for institutionalizing and scaling Youth up integrated FP and HIV services. On average, it can take 10 to 15 years for new re- Integration in southern Africa search results to be put into practice. With UNICEF Interest in FP/HIV integration by the Southern estimating that 2,500 young people become Africa Development Community grew substan- infected with HIV each day and the World Health tially during the PTA. To build the capacity of local Organization estimating that 16 million girls give stakeholders in this region to advance effective birth each year, 10 to 15 years is too long. Through integration, an expert in FP/HIV integration from the PTA, FHI 360 quickly put research results related FHI 360’s research utilization team was paired with to youth sexual and reproductive health into the a representative of Kenya’s Ministry of Health who hands of people with the means to use them and the had helped lead Kenya’s own integration efforts. will to help institutionalize new, improved practices. The two visited ministries of health, implementing partners, funders, and FHI 360 staff in three key Interagency Youth Working Group countries — Botswana, Mozambique, and South During the PTA, FHI 360 managed the technical Africa — to share evidence, experiences, and les- content for USAID’s Interagency Youth Working sons learned on FP/HIV integration. As a result of Group (IYWG) — the only source of global the visit to Botswana, the Botswana Ministry of information about preventing both unintended Health sent a delegation of eight staff to Kenya in a pregnancy and HIV among youth. On behalf of the

20 PTA End-of-Project Report IYWG, FHI 360’s research utilization youth team living with HIV and the experiences and concerns synthesized evidence-based information, developed they have with HIV care and treatment. Little was new resources and tools, and disseminated these known about the HIV prevention behaviors of ado- materials to audiences around the world. Combined lescents on ART in sub-Saharan Africa before this with strong internal and external partnerships, these study, the results of which can be used to strength- activities helped highlight promising programs and en HIV care and treatment services for this impor- approaches across tant group of youth. IYWG Knowledge sectors and geo- Management Stats graphic locations Interviews with adolescents living with HIV, their and reached a broad families, and their health care providers showed InfoNet – more than 100 audience using a that adolescents face barriers to adhering to ART issues distributed twice and practicing safe sex, such as fear of stigma and monthly to more than variety of innovative rejection if they disclose their HIV status. The results 5,000 individuals approaches to shar- ing knowledge. also showed that alcohol use was related to ART YouthLens – 21 issues adherence and that adolescents who lived in homes FHI 360 developed where their HIV status was known were more likely IYWG website – visited the content for to report better adherence. Overall, these findings by 30,000 people from 199 countries the IYWG website support strengthening programs to address adoles- and blog, produced cents’ self-management skills with a focus on alcohol E-forums – hosted 9 Youth InfoNet (a use and family engagement. Culturally acceptable e-forums with a total of twice-monthly elec- strategies are clearly needed to address the sexual 5,812 participants tronic summary of and reproductive health needs of adolescents living Twitter – 1,181 followers new journal articles with HIV and support HIV prevention behaviors. and other publica- Facebook – 564 “likes” tions on youth), Answer the Call campaign produced YouthLens Facebook page – 1,876 “likes” (a series of briefs on trending topics Blog – 200 posts related to youth IYWG resources – distributed sexual and reproduc- more than 2,500 copies tive health), hosted global technical meetings and e-forum discussions, and managed the IYWG social media accounts. The resources that were developed, which are all available on the IYWG website, include Positive Connections: Leading Information and Support Groups for Adolescents Living with HIV, It’s About More than Just Sex: Curricula and Educational Materials to Help Young People Achieve Better Sexual and Reproductive Health, Promoting Partner Reduction, Evidence- Based Guidelines for Youth Peer Education, and Young People Most at Risk of HIV.

Research on adolescents living with HIV A PTA-supported study conducted by FHI 360 and three ART clinics in the Copperbelt Province of Zambia sought to better understand the sexual and reproductive health of adolescents (ages 15 to 19)

Advancing the Science of HIV Prevention 21 Support for Field Activities

Through the PTA, FHI 360 provided local technical sex with men in three districts. The results of the support to USAID field missions and their imple- integrated behavioral and biological surveillance menting partners to study and evaluate preven- survey suggested that both FSWs and men tion technologies and strategies and to implement who have sex with men (whose behaviors are evidence-based programs. In Botswana, an inte- stigmatized and illegal in Botswana) could be grated behavioral and biological surveillance survey contributing to the generalized HIV epidemic and among key populations are in urgent need of better access to HIV and STI resulted in updates to services. The study was historic, for the first time KEY RESOURCE the country’s national presenting findings on HIV and STI disease burden Botswana Behavioral and STI guidelines. A similar in these key populations, raising awareness of Biological Surveillance Survey survey was conducted this burden, and contributing to the government’s in Malawi, but the data commitment to expanded action. Based on http://www.fhi360.org/ were still being analyzed the survey’s findings, Botswana’s national STI resource/2012-mapping-size- as of June 30, 2014. In treatment guidelines were updated to encourage estimation-behavioral-and- Kenya, outreach workers clinicians to perform anal examinations and collect biological-surveillance-survey- bbss-hivsti conducted more than comprehensive sexual histories for men who have 12,000 door-to-door sex with men. The Ministry of Health also appointed outreach activities to a local nongovernmental organization to provide reach domestic workers with HIV prevention infor- HIV and STI services directly to key populations, mation. In South Africa, mobile service units, techni- and additional policy and programmatic changes cal assistance to the national PMTCT program, and based on the results are possible. support to a program for newly diagnosed people living with HIV ensured access to reproductive Kenya health and HIV services for thousands of people. Furthermore, a palliative care project demonstrated According to the Kenya Union of Domestic, Hotels, the importance of community health workers in Educational Institutions, Hospitals and Allied providing palliative care as an integral component of Workers (KUDHEIHA), an estimated 1.8 million comprehensive care for people living with HIV. domestic workers are employed in Kenya. Because domestic work takes place in private homes, Botswana the house girls, house boys, drivers, gardeners, and guards who typically perform the work may In Botswana, the estimated HIV prevalence in the not have access to the sexual and reproductive general population is one of the highest in the health information and services they need. To world. In 2012, the Botswana Ministry of Health, raise awareness about sexual and reproductive with technical assistance from FHI 360, set out health and to equip domestic workers with life to estimate the population sizes and HIV and STI skills for making informed sexual and reproductive prevalences among FSWs and men who have health decisions, the Domestic Workers Sexual

22 PTA End-of-Project Report and Reproductive Health project was initiated in Malawi Nairobi in May 2013. Implemented by the National Organization of Peer Educators in collaboration In 2013, with technical assistance from FHI 360, with KUDHEIHA and with technical assistance from the Malawi Ministry of Health conducted the coun- FHI 360, the project provided training for domes- try’s third national biological and behavioral surveil- tic workers to become peer educators, sensitized lance survey to better understand the HIV epidemic health practitioners to the sexual and reproductive and maximize the use of available resources for HIV health needs of domestic workers, and conducted prevention. Data were collected on HIV prevalence, sexual and reproductive health outreach activities. STI prevalence, and risk factors among During the PTA, more than 500 domestic workers FSWs and other key KEY PARTNERS were trained to serve as peer educators, and out- populations at high Botswana Ministry of Health reach workers conducted more than 12,000 door- risk of infection in to-door meetings with domestic workers. The 14 districts from I Choose Life project resulted in a key health systems change: three regions. The Joint United Nations selected government health facilities extended results will be used to Programme on HIV/AIDS their hours, allowing domestic workers increased inform strategic deci- Kenya Union of Domestic, access to sexual and reproductive health preven- sions, policies, and tion and treatment services. The project also iden- Hotels, Educational ongoing efforts to Institutions, Hospitals and tified youth as an important population to target, prevent HIV and other Allied Workers enabling the project to address sensitive sexual STIs in Malawi. and reproductive health issues that affect young Malawi Ministry of Health domestic workers. Through the capacity building South Africa Makhuduthamaga Umbrella efforts of FHI 360 and the National Organization National AIDS of Peer Educators, KUDHEIHA hopes to continue With PTA support, Commission in Malawi the project and eventually support additional ef- FHI 360 in South forts to address the sexual and reproductive health Africa used mobile National Organization of needs of domestic workers in Kenya. service units to Peer Educators in Kenya ensure access to re- National Statistical Office of productive health and Malawi HIV services for more than 30,000 people, South Africa National provided technical Department of Health assistance to the U.S. Centers for Disease national PMTCT Control and Prevention program, helped Wits Health Consortium coordinate a program to support newly diagnosed people living with HIV, and strengthened palliative care services.

Mobile service units FHI 360 converted four Toyota minivans into spaces for counseling, testing, and client examinations and trained home-based care volunteers to use the spaces to provide integrated reproductive health and HIV services. These mobile service units trav- eled long distances to provide integrated services

Advancing the Science of HIV Prevention 23 to four remote and underserved provinces, reaching supports newly diagnosed people living with HIV more than 30,000 individuals within short dis- who are not yet eligible for ART. The I-ACT program tances from their homes. Based on requests from helps people living with HIV connect to care and the district health offices, the minivans expanded support, which can help delay the need to initiate their services to include a range of comprehensive ART. A large component of this involves maintaining primary care services — HIV and STI prevention and a network of community-based support groups education, tuberculosis screening, STI treatment, and well-trained support-group facilitators. Apart cervical cancer education, and treatment for minor from providing psychosocial support, I-ACT support ailments. In September 2013, FHI 360 transitioned groups offer six core educational sessions to give the four mobile service units to three Provincial newly diagnosed people living with HIV opportunities Departments of Health, which continue to provide to network with other newly diagnosed individuals. the traveling services. Through its involvement in the I-ACT program, FHI 360 trained more than 400 support-group Prevention of mother-to-child transmission facilitators and other members of the program. services In collaboration with South Africa’s National Palliative care Department of Health, FHI 360 improved the overall The Integrated Community Palliative Care project performance of selected PMTCT sites by promot- was developed to link South Africa’s existing health ing FP counseling and referrals through training and systems with support mechanisms for community technical assistance. Using South African and in- care, such as home-based care, hospice, and sup- ternational standards for PMTCT quality assurance port groups. The project integrated these support and improvement processes, FHI 360 refined the mechanisms throughout primary health care facili- current training course for auxiliary nurses and lay ties and their multidisciplinary teams, ART sites counselors. The new training course equips these and their interdisciplinary care teams, community health care providers with the knowledge and skills home-based care groups, and communities and necessary to strengthen PMTCT services, includ- families themselves. This integrated service deliv- ing HIV testing and counseling, provision of ARV ery contributed to the provision of a continuum of prophylaxis, counseling and support for safe infant palliative care from diagnosis to wellness support to feeding practices, and counseling on FP. end-of-life care.

Integrated access to care and treatment FHI 360 partnered with the Wits Health Consortium In collaboration with the Department of Health, to support the project’s pilot model in the primary FHI 360 helped coordinate the Integrated Access health care sites of Charlotte Maxeke Johannesburg to Care and Treatment (I-ACT) program in Northern Academic Hospital. The Wits Health Consortium Cape Province. I-ACT is a national program that provides comprehensive palliative care services, including pain management, to all hospital wards and disciplines across all illnesses, including HIV and AIDS. The consortium also provides clients and families with continuous holistic support through its home visit services, hospice, and ART site. In Limpopo Province, FHI 360 provided training and technical assistance to the Makhuduthamaga Umbrella organization, which then built the capacity of four community-based organizations and four clinics to provide palliative care. Training activities focused on strengthening the capacity of community health workers, nurses, spiritual leaders, and traditional healers to provide the care.

24 PTA End-of-Project Report Product Quality and Compliance

Through the PTA, FHI 360’s Product Quality Production Surveillance and Compliance (PQC) Division provided comprehensive product quality assurance and Evaluating and monitoring manufacturers, sam- technical assistance to USAID’s contraceptive pling and testing products, conducting audits security and logistics program. A variety of and providing technical assistance, and handling activities were conducted to ensure that USAID’s product complaints and investigations all ensure reproductive health commodities were of the low risk and protection for condom and contra- highest quality and met international quality Surveillance Stats ceptive users. During the standards. PTA, more than 3 billion Products evaluated for male condoms (7,818 compliance with USAID Development of International Standards lots) were distributed contract specifications:* through USAID programs, Donor organizations use internationally • 7,818 lots of male with the PQC Division condoms recognized product-performance standards testing all lots prior when procuring products for use in developing • 131 lots of female to shipment. An addi- countries. During the PTA, the PQC Division condoms tional 492 lots of female represented USAID’s interests in the standards condoms, lubricants, • 148 lots of lubricants community by leading technical committee intrauterine devices, and meetings of the International Organization • 122 lots of intrauterine hormonal contraceptives devices for Standardization and ASTM International. were similarly evaluated. Through this work, FHI 360 helped guide new Several lots of contracep- • 36 lots of oral and revised performance standards for male tives were also tested for contraceptive pills and female condoms, intrauterine devices, product stability. • 34 lots of injectable synthetic condoms, and diaphragms. contraceptives

Field Concerns • 21 lots of the implant Capacity Building Jadelle By effectively respond- In collaboration with the World Health ing to field concerns, the * Lot size varied depending on the product and the size of Organization and the United Nations Population PQC Division has gained the order. For male and female Fund, the PQC Division supported in-country the reputation as the go- condoms, the maximum size national quality assurance laboratories through in- to independent third-par- reached more than 400,000 products per lot. country workshops focused on training laboratory ty laboratory for investi- staff to test condoms and contraceptives. These gating complaints about trainings were conducted in Botswana, Djibouti, product quality. In response to complaints about Dominican Republic, Ecuador, Ethiopia, Fiji, Ghana, cracked oral contraceptive pills in Bangladesh, Kenya, Namibia, Tanzania, Thailand, and Zambia. the PQC Division tested 68 lots, determining

Advancing the Science of HIV Prevention 25 that exposure to high heat and humidity had Innovative Techniques for Quality likely caused the cracking. Tests also showed that Assurance the pharmaceutical efficacy of the product had not been affected. The PQC Division in collaboration with Supply However, the PQC Chain Management Systems and Muhimbili KEY PARTNERS Division advised University of Health and Applied Sciences in American National that the product be Tanzania was instrumental in the development of Standards Institute destroyed to main- near-infrared spectroscopy screening libraries for tain a low risk for cotrimoxazole tablets. This collaboration led the ASTM International USAID and poten- PQC Division to develop screening libraries for all International Organization tial consumers. In a contraceptive pharmaceuticals. for Standardization different scenario in Ghana, the PQC John Snow, Inc. Division worked with (USAID|DELIVER PROJECT) USAID, the World Muhimbili University of Health Organization, Health and Applied Sciences and the Global Fund to prevent the Supply Chain Management distribution of more Systems than 20 million poor- United Nations Population quality condoms Fund procured through World Health Organization non-USAID funds. This was achieved by providing results of a third-party investigation to Ghana’s national testing laboratory, which had initially identified the problem.

Inter-Laboratory Proficiency Trials

Annual PTA-supported inter-laboratory proficiency trials for male condoms were conducted among national, manufacturer, and independent testing laboratories. The trials were essential for understanding competencies within the laboratories, which can help USAID and the PQC Division manage product complaints raised by a country and can serve as a valuable reference for USAID and missions to respond with sound statistical data. At least 27 laboratories participated in each annual trial, and the 2011 trial was completed with a record 34 laboratories participating.

26 PTA End-of-Project Report Moving Forward

USAID’s funding of the PTA over the past five • More exploration of how to promote years enabled FHI 360 and its partners to conduct interventions for women with different HIV research and to support activities that helped mold prevention needs, including adolescents the evolving field of HIV prevention technologies. • Implementation science to identify models of As a result, the field is better prepared for the high-quality integrated FP/HIV services that eventual rollout of microbicide products and the national health programs will be able to scale up implementation of HIV prevention services to women in sub-Saharan Africa.

It is clear from research supported through the Evolving Research Agenda PTA and other funding sources that there is no silver bullet for HIV prevention. Effective HIV prevention efforts that rely on biomedical technologies will require improved understanding of the interplay among biological, social, and behavioral Product aspects of HIV transmission. Social and economic ecacy inequalities that increase women’s vulnerabilities to HIV infection in resource-poor countries must also be identified and addressed through policy and programs at the community, national, and global levels if dramatic reductions in the number of people infected with HIV are to be achieved. Adherence/ acceptability FUTURE RESEARCH

• Identification of better measurements of adherence (already under way) to help clarify what adherence will look like outside of placebo-controlled clinical trials Service delivery/policy • Continued development of new ARV-based technologies that meet the varying needs of women in different circumstances and different stages of life, rather than a focus solely on products that reduce user involvement

• Evaluation of social and structural interventions (including adherence support) to complement biomedical interventions

Advancing the Science of HIV Prevention 27 Appendix: Publications

Below is a list of PTA-supported publications, organized by topic and type of document. For journal articles, the first three authors are listed. Only those documents that were published or accepted for publication by June 30, 2014, are reported here.

HIV Prevention Clinical Trials Title Authors Journal Journal Articles – CAPRISA 004 Effectiveness and safety of tenofovir gel, an Abdool Karim, Q., S.S. Science antiretroviral microbicide, for the prevention of Abdool Karim, J.A. Frohlich HIV infection in women Contraceptive choices, pregnancy rates, and Sibeko, S., C. Baxter, N. American Journal outcomes in a microbicide trial Yende of Obstetrics & Gynecology Recruitment of high risk women for HIV Karim, Q.A., A.B. Kharsany, Trials prevention trials: baseline HIV prevalence and J.A. Frohlich sexual behavior in the CAPRISA 004 tenofovir gel trial Epidemiological impact of tenofovir gel on the HIV Williams, B.G., S.S. Abdool Journal of Acquired epidemic in South Africa Karim, Q.A. Karim Immune Deficiency Syndromes Co-enrollment in multiple HIV prevention trials - Karim, Q.A., A.B. Kharsany, Contemporary experiences from the CAPRISA 004 Tenofovir gel K. Naidoo Clinical Trials trial Drug concentrations after topical and oral Karim, S.S., A.D. Kashuba, L. Lancet antiretroviral pre-exposure prophylaxis: Werner implications for HIV prevention in women Antiretroviral prophylaxis: a defining moment in Karim, S.S., Q.A. Karim Lancet HIV control A drug evaluation of 1% tenofovir gel and Gengiah, T.N., C. Baxter, L.E. Expert Opinion tenofovir disoproxil fumarate tablets for the Mansoor on Investigational prevention of HIV infection Drugs Design challenges facing clinical trials of the Grobler, A.C., S.S. Abdool AIDS effectiveness of new HIV-prevention technologies Karim Safety of tenofovir gel, a vaginal microbicide, Sokal, D.C., Q.A. Karim, S. Antiviral Therapy in South African women: results of the Sibeko CAPRISA 004 Trial

28 PTA End-of-Project Report HIV Prevention Clinical Trials Title Authors Journal Monitoring microbicide gel use with real-time Gengiah, T.N., M. Upfold, A. AIDS and Behavior notification of the container's opening events: Naidoo results of the CAPRISA Wisebag study Assessing adherence in the CAPRISA 004 Macqueen, K.M., AIDS and Behavior tenofovir gel HIV prevention trial: results of a M.A. Weaver, F. van nested case-control study Loggerenberg Adherence in the CAPRISA 004 tenofovir gel Mansoor, L.E., Q. Abdool AIDS and Behavior microbicide trial Karim, N. Yende-Zuma Impact of an adherence intervention on the effec- Mansoor, L.E., Q.A. Karim, L. AIDS and Behavior tiveness of tenofovir gel in the CAPRISA 004 trial Werner Disclosure of microbicide gel use to sexual Mngadi, K.T., S. Maarschalk, AIDS and Behavior partners: influence on adherence in the A.C. Grobler CAPRISA 004 trial Measuring adherence by visual inspection Gengiah, T.N., L.E. Mansoor, AIDS and Behavior of returned empty gel applicators in the M. Upfold CAPRISA 004 microbicide trial Journal Articles – FEM-PrEP Preexposure prophylaxis for HIV infection among Van Damme, L., A. Corneli, New England African women K. Ahmed Journal of Medicine Adherence support approaches in biomedical HIV Amico, K.R., L.E. Mansoor, AIDS and Behavior prevention trials: experiences, insights and future A. Corneli directions from four multisite prevention trials Elevated liver transaminases, human immune Ahmed, K., M. Malahleha, J. Journal of AIDS and deficiency virus (HIV) seroconversion and rapid Deese HIV Research progression to AIDS in a HIV prevention clinical trial participant: a case report Neurological syndrome in an HIV-prevention Owino, F., J. Mandala, J. International trial participant randomized to daily tenofovir Ambia, K. Agot Medical Case disoproxil fumarate (300 mg) and emtricitabine Reports Journal (200 mg) in Bondo, Kenya Implementing good participatory practice Mack, N., S. Kirkendale, P. Open Access guidelines in the FEM-PrEP Preexposure Omullo Journal of Clinical Prophylaxis Trial for HIV Prevention among African Trials Women: a focus on local stakeholder involvement Barriers and facilitators to pre-exposure Mack, N., J. Odhiambo, C.M. BMC Health prophylaxis (PrEP) eligibility screening and Wong Services Research ongoing HIV testing among target populations in Bondo and Rarieda, Kenya: results of a consultation with community stakeholders FEM-PrEP: adherence patterns and factors Corneli, A., J. Deese, M. Journal of the associated with adherence to a daily, oral study Wang International AIDS product for pre-exposure prophylaxis Society Widow cleansing and inheritance among the Luo Perry B., L. Oluoch, K. Agot Journal of the in Kenya: the need for additional women-centered International AIDS HIV prevention options Society Tenofovir diphosphate and emtricitabine triphos- Adams J.L., C. Sykes, P. Journal of Acquired phate concentrations in blood cells compared Menezes Immune Deficiency with isolated peripheral blood mononuclear cells: Syndrome a new measure of antiretroviral adherence?

Advancing the Science of HIV Prevention 29 HIV Prevention Clinical Trials Title Authors Journal Journal Articles – Site Identification and Development Initiative Correlation of prospective and cross-sectional Sexton, C.J., E.C. AIDS Research and measures of HIV type 1 incidence in a higher-risk Costenbader, D.T. Vinh Human Retroviruses cohort in Ho Chi Minh City, Vietnam HIV prevalence and incidence among women at Combes, S.L., A. AIDS Research and higher risk of infection in Addis Ababa, Ethiopia G-Yohannes, A. Kidane Human Retroviruses Determinants of prevalent HIV infection and late Zango, A., K. Dube, S. PLoS One HIV diagnosis among young women with two or Kelbert more sexual partners in Beira, Mozambique HIV incidence and prevalence among cohorts Feldblum, P.J., M.H. Latka, J. BMJ Open of women with higher risk behaviour in Lombaard Bloemfontein and Rustenburg, South Africa: a prospective study HIV incidence in a cohort of women at higher risk Dube, K., A. Zango, J. van de PLoS One in Beira, Mozambique: prospective study 2009- Wijgert 2012 Prevalence, incidence and determinants of Meque, I., K. Dube, P.J. PLoS One herpes simplex virus type 2 infection among HIV- Feldblum seronegative women at high-risk of HIV infection: a prospective study in Beira, Mozambique Assortativity coefficient-based estimation of Young, S.K., R.H. Lyles, L.L. Sexually population patterns of sexual mixing when cluster Kupper Transmitted size is informative Infections HIV prevalence and incidence in a cohort of Feldblum, P.J., S. Enosse, K. PLoS One women at higher risk for HIV acquisition in Dube Chokwe, southern Mozambique Pregnancy incidence and correlates in a clinical Chetty-Makkan, C.M., K. PLoS One trial preparedness study, North West province Fielding, P.J. Feldblum South Africa Journal Articles – All Other Studies Sexual behavior before and after pregnancy Rountree, W., P.J. Feldblum, AIDS and Behavior detection in four microbicide trials D. Taylor An adaptive design to bridge the gap between Taylor, D.J., A. Grobler, S.S. Clinical Trials Phase 2b/3 microbicide effectiveness trials and Abdool Karim evidence required for licensure Sexual behavior before and after pregnancy Rountree, W., P.J. Feldblum, AIDS and Behavior detection in four microbicide trials D. Taylor Performance of a rapid and simple HIV testing Crucitti, T., D. Taylor, G. Clinical and Vaccine algorithm in a multicenter phase III microbicide Beelaert Immunology clinical trial Predictors of pregnancy in microbicide trials Halpern, V., C.C. Lie, P. Contraception Feldblum Notes on the frequency of routinely collected and Taylor, D.J., C.C. Lie, M.A. AIDS and Behavior self-reported behavioral data in HIV prevention trials Weaver Baseline factors associated with incident HIV and Feldblum, P.J., C.C. Lie, M.A. Sexually Transmitted STI in four microbicide trials Weaver Diseases Adherence and its measurement in phase 2/3 Tolley, E.E., P.F. Harrison, E. AIDS and Behavior microbicide trials Goetghebeur

30 PTA End-of-Project Report HIV Prevention Clinical Trials Title Authors Journal Heterosexual anal intercourse has the potential McGowan, I., D.J. Taylor Sexually Transmitted to cause a significant loss of power in vaginal Diseases microbicide effectiveness studies What predicts non-retention in microbicide trials? Feldblum, P.J., V. Halpern, Contemporary C.C. Lie Clinical Trials Practice makes perfect: reduction in female Beksinska, M., J. Smit, C. Contraception condom failures and user problems with short- Joanis term experience in a randomized trial Briefs – Site Identification and Development Initiative Family Health International's Site Identification and Development Initiative (SIDI) Combined Cross-Sectional and Prospective HIV Incidence Study: The Site Identification and Development Initiative (SIDI) Josha Research Centre Bloemfontein, South Africa Rustenburg Research Centre of The Aurum Institute Rustenburg, South Africa Multiple and Concurrent Partners (MCP) Research: HIV Prevention Site Identification and Development Initiative (SIDI) Mozambique HIV Incidence Studies Expanded Cross-Sectional and Prospective Study for Measurement of HIV incidence in Chokwe, Mozambique Brief – All Other Studies SCOPE: Strategies to Combine PrEP with Prevention Efforts Reports – FEM-PrEP HIV Services Inventory Final Report: Sociobehavioral Research & Community Planning to Develop Site- Specific Pilot Intervention Plans for PrEP Rollout, Soshanguve, Pretoria, South Africa HIV Services Inventory Final Report: Sociobehavioral Research & Community Planning to Develop Site- Specific Pilot Intervention Plans for PrEP Rollout, Bondo and Rarieda, Nyanza Province, Kenya Considerations for Rolling Out Oral PrEP to Target Populations through Social Marketing in Bondo and Rarieda, Kenya Final Report: Sociobehavioral Research & Community Planning to Develop Site-Specific Pilot Intervention Plans for PrEP rollout, Soshanguve, Pretoria, South Africa

Support for HIV Prevention Research Title Authors Journal Journal Articles – Science Facilitation Baseline variation and associations between subject Fichorova, R.N., J.J. Lai, Cytokine characteristics and five cytokine biomarkers of J.L. Schwartz vaginal safety among healthy non-pregnant women in microbicide trials Colposcopy: still useful in microbicide safety trials? Mauck, C.K., D.H. Weiner, Sexually Transmitted J.J. Lai Diseases Three new female condoms: which do South- Joanis, C., M. Beksinska, Contraception African women prefer? C. Hart Toward early safety alert endpoints: exploring Mauck, C., J.J. Lai, D.H. AIDS Research and biomarkers suggestive of microbicide failure Weiner Human Retroviruses

Advancing the Science of HIV Prevention 31 Support for HIV Prevention Research Title Report – Good Communication Practices Communications Handbook for Clinical Trials: Strategies, Tips, and Tools to Manage Controversy, Convey Your Message, and Disseminate Results Tool – Good Communication Practices Communications Handbook for Clinical Trials Tool – Assuring Stakeholder Involvement Stakeholder Engagement Toolkit for HIV Prevention Trials

Microbicide Implementation Title URL Web Page – Communicating about Microbicides with Women in Mind Communicating about Microbicides http://www.fhi360.org/projects/communicating-about- with Women in Mind Project microbicides-women-mind-project Web Page – Gender and Male Engagement in Microbicide Introduction Microbicides and Gender http://www.fhi360.org/projects/gender-and-microbicides

Other Social Behavioral Evidence Title Authors Journal Journal Articles – Evaluating Messages About Abstinence Exploring discordance between biologic and self-reported Carter, M.W., AIDS and measures of semen exposure: a qualitative study among female A. Bailey, M.C. Behavior patients attending an STI clinic in Jamaica Snead Randomized controlled trial on the effectiveness of counseling Anderson, C., Sexually messages for avoiding unprotected sexual intercourse during sex- M.F. Gallo, T. Transmitted ually transmitted infection and reproductive tract infection treat- Hylton-Kong Diseases ment among female sexually transmitted infection clinic patients Biological markers of sexual activity: tools for improving measure- Gallo, M.F., M.J. Sexually ment in HIV/sexually transmitted infection prevention research Steiner, M.M. Transmitted Hobbs Diseases Intravaginal cleansing among women attending a sexually trans- Carter, M., West Indian mitted infection clinic in Kingston, Jamaica M. Gallo, C. Medical Anderson Journal Journal Article – Addressing Barriers to Informed Consent Lost in translation: assessing effectiveness of focus group Mack, N., C.B. PLoS One questioning techniques to develop improved translation of Ramirez, B. terminology used in HIV prevention clinical trials Friedland Tool – Addressing Barriers to Informed Consent A Toolkit for Developing Bilingual Lexicons for International HIV Prevention Trials

32 PTA End-of-Project Report Family Planning and HIV Integration Title Authors Journal Journal Articles – Biomedical Research Nevirapine-based antiretroviral therapy does Nanda, K., S. Delany- AIDS not reduce oral contraceptive effectiveness Moretlwe, K. Dube Journal Articles – Programmatic Research Integrating family planning services into Baumgartner, J.N. Health Policy and HIV care and treatment clinics in Tanzania: Planning evaluation of a facilitated referral model Factors impacting knowledge and use of long Crede, S., T. Hoke, D. BMC Public Health acting and permanent contraceptive methods Constant by postpartum HIV positive and negative women in Cape Town, South Africa: a cross- sectional study Expanding contraceptive options for PMTCT Hoke, T., J. Harries, S. Reproductive Health clients: a mixed methods implementation study Crede in Cape Town, South Africa Journal Articles – Research Utilization Family planning and HIV: two steps forward Wilcher, R., W. Cates Jr., AIDS J.M. Baeten Meeting the contraceptive needs of key Petruney, T., S.N. AIDS Research and populations affected by HIV in Asia: an Minichiello, M. McDowell Treatment unfinished agenda The importance of addressing gender inequality Ghanotakis, E., D. Journal of the Interna- in efforts to end vertical transmission of HIV Peacock, R. Wilcher tional AIDS Society The role of family planning in elimination of new Wilcher, R., T. Petruney, Current Opinion in HIV pediatric HIV infection W. Cates and AIDS Integration of family planning into HIV services: Wilcher, R., T. Hoke, S.E. AIDS a synthesis of recent evidence Adamchak Journal Articles – All Other Studies Progestogen-only contraceptive use among Kapp, N., K. Curtis, K. Contraception breastfeeding women: a systematic review Nanda Update to CDC's U.S. Medical Eligibility Centers for Disease Morbidity and Mortality Criteria for Contraceptive Use, 2010: revised Control and Prevention Weekly Report recommendations for the use of hormonal contraception among women at high risk for HIV infection or infected with HIV Evaluating the competing risks of HIV Rodriguez, M., M. Reeves, BJOG acquisition and maternal mortality in Africa: a A. Caughey decision analysis The World Health Organization-United Nations Mody, S.K., K. Ba-Thike, Journal of Obstetrics Population Fund Strategic Partnership Pro- M.E. Gaffield and Gynecological gramme's implementation of family planning Research guidelines and tools in Asia-Pacific countries Initiation of progestogen-only injectables on Kapp, N., M.E. Gaffield Contraception different days of the menstrual cycle and its effect on contraceptive effectiveness and compliance: a systematic review

Advancing the Science of HIV Prevention 33 Family Planning and HIV Integration Title Authors Journal Advance supply of emergency contraception: a Rodriguez, M.I., K.M. Contraception systematic review Curtis, M.L. Gaffield Retention of intrauterine devices in women Tepper, N.K., M.W. Contraception who acquire pelvic inflammatory disease: a Steenland, M.E. Gaffield systematic review When can a woman have an intrauterine device Whiteman, M.K., C.P. Contraception inserted? A systematic review Tyler, S.G. Folger Hormonal contraceptive use and female-to-male Polis, C.B., S.J. Phillips, AIDS HIV transmission: a systematic review of the K.M. Curtis epidemiologic evidence Effect of hormonal contraceptive methods on Phillips, S.J., K.M. Curtis, AIDS HIV disease progression: a systematic review C.B. Polis Postpartum education for contraception: a Lopez, L.M., J.E. Hiller, Obstetrical & systematic review D.A. Grimes Gynecological Survey Hormonal contraceptives for contraception in Lopez, L.M., D.A. Grimes, Cochrane Database of overweight or obese women M. Chen-Mok Systematic Reviews Pericoital oral contraception with Raymond, E.G., V. Halpern, American Journal levonorgestrel: a systematic review L.M. Lopez of Obstetrics & Gynecology Strategies to improve adherence and Halpern, V., L.M. Lopez, Cochrane Database of acceptability of hormonal methods of D.A. Grimes Systematic Reviews contraception (updated review) Progestin-only contraceptives: effects on weight Lopez, L.M., A. Edelman, Cochrane Database of M. Chen-Mok Systematic Reviews Quadriphasic versus monophasic oral Van Vliet, H.A., M. Raps, Cochrane Database of contraceptives for contraception L.M. Lopez Systematic Reviews Combination contraceptives: effects on weight Gallo, M.F., L.M. Lopez, Cochrane Database of D.A. Grimes Systematic Reviews Oral contraceptives for functional ovarian cysts Grimes, D.A., L.B. Jones, Cochrane Database of L.M. Lopez Systematic Reviews Theory-based interventions for contraception Lopez, L.M., E.E. Tolley, Cochrane Database of D.A. Grimes Systematic Reviews Triphasic versus monophasic oral contraceptives Van Vliet, H.A., D.A. Cochrane Database of for contraception Grimes, L.M. Lopez Systematic Reviews Combined oral contraceptive pills for treatment Arowojolu, A.O., M.F. Cochrane Database of of acne (updated review) Gallo, L.M. Lopez Systematic Reviews Progestin-only contraceptives: effects on weight Lopez, L.M. Cochrane Database of Systematic Reviews Steroidal contraceptives and bone fractures in Lopez, L.M., M. Chen, S. Cochrane Database of women: evidence from observational studies Mullins Systematic Reviews (updated review) Education for contraceptive use by women after Lopez, L.M., J.E. Hiller, Cochrane Database of childbirth (updated review) D.A. Grimes Systematic Reviews

34 PTA End-of-Project Report Family Planning and HIV Integration Title Authors Journal Expectant care versus surgical treatment for Nanda, K., L.M. Lopez, D.A. Cochrane Database of miscarriage (updated review) Grimes Systematic Reviews Hormonal and intrauterine methods for Tang, J.H., L.M. Lopez, S. Cochrane Database of contraception for women aged 25 years and Mody Systematic Reviews younger Pain management for tubal sterilization by Kaneshiro, B., D.A. Grimes, Cochrane Database of hysteroscopy L.M. Lopez Systematic Reviews Steroidal contraceptives: effect on carbohydrate Lopez, L.M., D.A. Grimes, Cochrane Database of metabolism in women without diabetes mellitus K.F. Schulz Systematic Reviews Oral contraceptives containing drospirenone for Lopez, L.M., A.A. Kaptein, Cochrane Database of premenstrual syndrome F.M. Helmerhorst Systematic Reviews Behavioral interventions for improving Lopez, L.M., D. Hilgenberg, Cochrane Database of contraceptive use among women living with HIV M. Chen Systematic Reviews Hormonal contraceptives for contraception in Lopez, L.M., D.A. Grimes, Cochrane Database of overweight or obese women M. Chen Systematic Reviews Theory-based interventions for contraception Lopez, L.M. Cochrane Database of Systematic Reviews Behavioral interventions for improving condom Lopez, L.M., C. Otterness, Cochrane Database of use for dual protection M. Chen Systematic Reviews Strategies to improve adherence and Halpern, V., L.M. Lopez, Cochrane Database of acceptability of hormonal methods of D.A. Grimes Systematic Reviews contraception Assessing the effect of hormonal contraception Polis, C.B., D. Westreich, AIDS on HIV acquisition in observational data: J.E. Balkus challenges and recommended analytic approaches Effect of concurrent use of anti-retroviral Hubacher, D., J. Liku, J. Journal of the therapy and levonorgestrel sub-dermal implant Kiarie International AIDS for contraception on CD4 counts: a prospective Society cohort study in Kenya Pregnancy outcomes with an IUD in situ: a Brahmi, D., M.W. Contraception systematic review Steenland, R.M. Renner Changes in contraceptive use following McCarraher, D.R., G. Studies in Family integration of family planning into ART Services Vance, U. Gwarzo Planning in Cross River State, Nigeria Briefs – Behavioral Research Do Female Sex Workers in Dhaka Need Family Planning Information and Services? Do Female Injecting Drug Users in Dhaka Need Family Planning Information and Services? Briefs – Programmatic Research Delivery of Integrated Family Planning and HIV Testing and Counseling Services by Village Health Teams Integrating Family Planning Services into HIV Care and Treatment Clinics through the Facilitated Referral Model

Advancing the Science of HIV Prevention 35 Family Planning and HIV Integration Title Briefs – Research Utilization Strengthening Family Planning in a Large-Scale PEPFAR-Supported HIV Program Integrating Family Planning into HIV Programs: Evidence-Based Practices Preventing Unintended Pregnancies and HIV Family Planning and HIV Services: Increased Efficiency and Impact through Integration Prevention of Mother-to-Child Transmission of HIV: FHI 360’s Strategic Approach Briefs – Youth Adolescents Living with HIV in Zambia: An Examination of HIV Care and Treatment and Family Planning HIV Prevention and Family Planning Use among Adolescents on ART: Preliminary Results from the Qualitative Phase Challenges and Potential Strategies for Supporting Adolescents Living with HIV in Ndola, Zambia: Results from a Study Dissemination Meeting Report – Research Utilization Making the Case for Integration: Tides Foundation’s Africa Family Planning and HIV Integration Fund Report – Youth Navigating Challenges, Charting Hope. A Cross-Sector Situational Analysis on Youth in Uganda. Volume 1: Main Report; Volume 2: Annexes; Executive Version Tool – Research Utilization Prezi: Integrating Family Planning into HIV Programs Tools – Youth Positive Connections It's About More than Just Sex Promoting Partner Reduction Evidence-Based Guidelines for Youth Peer Education Young People Most at Risk of HIV Website, Blog, and Other Information – Youth IYWG http://www.iywg.org Half the World http://www.iywg.org/blog Youth InfoNet http://www.iywg.org/content/youth-infonet YouthLens http://www.iywg.org/content/youthlens

36 PTA End-of-Project Report Support for Field Activities Title Brief – Kenya Training in the Use of Data for Decision Making Improves Kenya's Health System Report – Botswana 2012 Mapping, Size Estimation & Behavioral and Biological Surveillance Survey (BBSS) of HIV/STI among Select High-Risk Sub-Populations in Botswana Reports – Kenya Testing the A-B-C Approach for Infection Prevention and Averting Unintended Pregnancies among Youth in Institutions of Higher Learning: Assessment Report ABC PTA I, End of Project Report, May 2012 ABC PTA II, End of Project Report, October 2012 Life Skills Education in Kenya – A Comparative Analysis and Stakeholder Perspectives Health and Life Skills Project (HELP) among House Girls in Nairobi: An Evaluation of the Effect of HELP on House Girls' Vulnerability towards STI/HIV and Unintended Pregnancy Minimum Package for Reproductive Health (RH) & HIV Integrated Services Report – India Fulfilling the Contraceptive Needs of Sex Workers: Family Planning and HIV Integration in the Aastha Project

Advancing the Science of HIV Prevention 37 This work is made possible by the generous support of the American people through the U.S. Agency for International Development (USAID). Financial assistance was provided by USAID to FHI 360 under the terms of the Preventive Technologies Agreement (PTA), GHO A 00 09 00016-00. The contents of this report do not necessarily reflect the views of USAID or the United States Government.

FHI 360/headquarters 359 Blackwell Street, Suite 200 Durham, NC 27701 USA Tel: 1.919.544.7040 Fax: 1.919.544.7261 Website: www.fhi360.org

38 PTA End-of-Project Report