Issue 7 – September 2017

MPii participated in three international conferences, presenting results from several different areas of work. At the South Africa AIDS Conference in June, OPTIONS presented posters about its iterative process to create information, education, and communication (IEC) materials for the launch of oral PrEP at sex worker sites, as well as efforts to collect additional evidence about adolescent girls and young women demonstration projects to support future oral PrEP rollout.

In July at IAS 2017, OPTIONS presented two posters about the development of rollout scenarios in Kenya and Zimbabwe, which were used to inform the national oral PrEP implementation plans in both countries. Meanwhile, CHARISMA presented two posters at the international conference about the development and validation of the Social Benefits-Harms Tool (SBHT) and perspectives of male and female partners navigating dapivirine vaginal ring use.

Additionally, OPTIONS hosted two sessions at the International Health Economics Congress (IHEA) focused on discrete choice experiments (DCE) in South Africa. One session presented results from a DCE used to determine the key drivers of demand among women for new HIV prevention products, while the other presentation focused on how DCE can improve equity in access to socially marketed HIV prevention products.

The OPTIONS Consortium objective is to develop a streamlined, adaptable product delivery platform for current and future ARV-based HIV prevention options, with a particular focus on women.

• Plan 4 PrEP Toolkit offers support for oral PrEP introduction.
• OPTIONS and IPM collaborate to make the case for the dapivirine ring.
• Private sector landscape analysis supports country governments with oral PrEP implementation.
• Community dialogues in Zimbabwe aim to understand oral PrEP readiness.
• Regional guide for PrEP communications being developed.
• South Africa expands oral PrEP launch to six more sites.
• Operations research and KAP survey protocols approved.
• New Resources Added to PrEPWatch.

Plan 4 PrEP Toolkit offers support for oral PrEP introduction. OPTIONS, with work led by FSG, recently created Plan 4 PrEP: Toolkit for Oral PrEP Implementation to support national planning for oral PrEP rollout. The toolkit was developed based on experiences in South Africa, Kenya, and Zimbabwe, where OPTIONS supported the Ministries of Health and technical working groups (TWGs) in each country to develop a strategy for oral PrEP introduction. For example, Kenya recently launched oral PrEP at a national level and utilized these tools to support the planning. Plan 4 PrEP includes four steps. Implementers may use all four steps to guide the entire planning process or use only specific parts. Either way, it helps answer the tough questions that must be considered when preparing for oral PrEP introduction. The toolkit is particularly useful for policy makers, TWGs, or others planning for oral PrEP introduction at the national or sub-national level. In addition, it’s a useful tool for implementing partners and advocates pursuing oral PrEP rollout.

OPTIONS and IPM collaborate to make the case for the dapivirine ring. In close collaboration with IPM and other initiatives, OPTIONS developed a case for action for further investment in the dapivirine ring by global stakeholders. Led by FSG, OPTIONS used existing clinical trial and cost data, as well as impact modeling conducted by Avenir, to show why the dapivirine ring would be beneficial for adolescent girls and young women. It also highlights critical next steps for the ring.

Private sector landscape analysis supports country governments with oral PrEP implementation. While the majority of planned oral PrEP delivery will continue to be through the public sector, a significant number of women and girls at risk for HIV may prefer to access health services through the private sector. To support planning by country governments, international donors, and implementing agencies in Kenya, South Africa, and Zimbabwe, OPTIONS conducted a private sector landscape analysis to better understand the opportunities and considerations for delivering oral PrEP through the private sector. This work, conducted by FSG, includes a summary, along with analyses for Kenya, South Africa, and Zimbabwe. The analysis examines two major questions for each country:

• To what extent and why do women and girls at risk for HIV use private sector health services
• What are the opportunities and considerations for delivering oral PrEP through private sector channels for at-risk women and girls?

Community dialogues in Zimbabwe aim to understand oral PrEP readiness. In August, Pangaea started conducting oral PrEP community dialogues to help better understand perceptions, facilitators, and barriers that may influence oral PrEP delivery and use. More than 20 dialogues with adolescent girls and boys, adults, young people, female sex workers, people living with HIV, and religious and political leaders, among others were conducted. Information derived from the dialogues will be incorporated into the country’s oral PrEP implementation plan.

Regional guide for PrEP communications being developed. Market intelligence is underway in Kenya with AGYW, female sex workers, and serodiscordant couples to inform the content of the PrEP Communications Accelerator. The Accelerator will give governments, NGOs, and key stakeholders effective strategies and resources for developing communications to drive awareness, consideration, usage, and advocacy around PrEP in sub-Saharan Africa. Currently, OPTIONS is holding stakeholder interviews to get feedback on its utility, identify resource needs, and determine possible formats, while awaiting the completion of the market intelligence. Following the qualitative and quantitative outputs, McCann will develop the content for the Accelerator, with a goal of launching it in early 2018.

South Africa expands oral PrEP launch to six more sites. As of August 2017, South Africa has expanded oral PrEP implementation, as a part of combination HIV prevention, to 17 facilities working with high risk populations. Plans are underway to grow the number and diversity of sites providing PrEP. A consortium of partners continues to provide support to the National Department of Health and implementing sites for training, IEC material development and distribution, and monitoring and evaluation, among other items.

Operations research and KAP survey protocols approved. In South Africa, the ACCESS operations research protocol was approved by the local IRB and will begin data collection in September. ACCESS (Advancing PrEP: Comprehensive and Combined Evaluation of Services for Sex workers and Men who have sex with men (MSM)), which is co-funded by CHAI, will work to identify barriers and enablers to oral PrEP uptake, retention, and adherence in South Africa. In Kenya, South Africa, and Zimbabwe, the protocols for the provider knowledge, attitudes, and practices (KAP) surveys have been submitted to local ethics committees and will be submitted to the FHI360 IRB. The surveys focus on healthcare providers’ experiences when delivering oral PrEP or other reproductive health services. The results for South Africa will be available towards the end of 2017 and used to improve provider training on PrEP delivery. Zimbabwe is currently addressing comments from the medical council, then will resubmit the KAP protocol. Data collection is anticipated to be completed by November 2017.

New Resources Added to PrEPWatch. In addition to the Plan 4 PrEP Toolkit, dapivirine ring case for action, and private sector landscape analysis mentioned above, other resources have recently been added to PrEPWatch. The South Africa Implementation Pack provides a comprehensive overview of the country’s rollout of oral PrEP, from policy creation and site selection, to communications materials and M&E reporting processes. All materials used in the launch of oral PrEP to sex workers are included as well. It’s available on both the MPii Tools & Resources page and the South Africa Country close-up page. Additionally, a Landscape Analysis of Oral PrEP for Adolescent Girls and Young Women in Kenya was just completed. This analysis explores two topics. First, it investigates which questions will be addressed by the current slate of ongoing or planned demonstration projects. Second, it outlines which questions will remain unresolved. The analysis will be used to make decisions about investments in additional research (if needed). A similar analysis for South Africa is available as well.

POWER develops cost-effective and scalable models for implementation of ARV-based HIV prevention products for women.

• My PrEP decision support tool in production with additional demand creation tools in development.
• Final formative report completed.
• Cohorts in Cape Town, Johannesburg, and Kisumu launched.

My PrEP decision support tool in production with additional demand creation tools in development. In collaboration with Drs. Christine Dehlendorf and Nika Seidman of UCSF and Bedsider.org, POWER developed a digital PrEP decision support tool based on the My Birth Control tool. The decision support tool has been pre-tested at all three sites in Cape Town, Johannesburg, and Kisumu. Feedback from providers and young women has been integrated into the final version, which is currently in production and will be ready for use at the sites in the fall.

Additionally, a provider/patient flip chart, poster, and palm card are currently being developed as companion materials to the PrEP decision support tool to offer providers additional materials to help young women assess whether oral PrEP is right from them.

Final formative report completed. The POWER formative report was preliminarily completed in January 2017. As part of the mental models formative work, the team used a community-based survey to quantify key themes identified in the in-depth interviews with young women and men. Approximately 450 surveys were completed across the three POWER sites of Cape Town, Kisumu, and Johannesburg, and analysis was completed in the spring. The formative report was updated with the survey results and is available on PrEPWatch.

Cohorts in Cape Town, Johannesburg, and Kisumu launched. All three sites are enrolling young women into the POWER cohort, which integrates with three different health service models: a youth clinic in Johannesburg, a mobile van to reach youth in Cape Town (the Tutu Teen Tester), and a family planning clinic in Kisumu. As part of the cohort, young women are shown the educational video, “Get PrEPared: What African women need to know about PrEP,” developed for HPTN 082, and a brief motivational video developed in collaboration with McCann Global Health. In late 2017, the POWER cohorts will use the My PrEP decision support tool and provider flip charts as well.

EMOTION increases uptake and correct and consistent use of ARV-based HIV prevention products by women at high risk of HIV infection using an end-user centered strategy.

• Project VOGUE underway.

Project VOGUE underway. EMOTION is currently preparing for Project VOGUE, a socio-behavioral study comparing the human-centered design (HCD)-branded experience and product to unbranded product and standard of care, using objective markers of adherence. This is an open-label, staggered enrollment study in healthy, young (18- to 25-year olds), non-pregnant, HIV uninfected women, who are not at risk of pregnancy. Participants assigned to the control arm and the intervention arm will undergo the same number of visits and assessments. In an effort to reduce contamination between the control arm participants and intervention arm participants, recruitment of the control arm will begin first. Once a sufficient number of participants have completed the control arm, recruitment for the intervention arm will begin. This study will be conducted at MatCH Research Unit (MRU) in Durban. Approval from HREC (local IRB) has been received for this study.

All participants will be screened for participation in the study based on current guidelines for oral PrEP implementation. The control arm will receive oral PrEP, dispensed in accordance with current WHO and South African HIV Clinicians Society Guidelines. The intervention arm will receive oral PrEP in accordance with current guidelines, but the oral PrEP will come in branded starter package, with attendant adherence support. During enrollment of the intervention arm, the MRU site clinic will also be supplied with branded materials to help enhance participant understanding of oral PrEP and adherence to oral PrEP and to assist health care providers in explaining the benefits and risks of taking oral PrEP. Up to 300 women will be screened. so that 75 participants in each arm complete all study visits. All participants will take oral TDF/FTC daily for approximately three months, in accordance with current guidelines for the administration of oral PrEP. All components of the intervention arm are currently being prepared.

CHARISMA supports efforts to: increase women’s agency to safely use ARV-based HIV prevention, to engage male partners in HIV prevention, and to overcome harmful gender norms and reduce intimate partner violence (IPV).

• Clinic- and community-based interventions continue.
• Intervention evaluations and reporting planned.

Clinic- and community-based interventions continue. CHARISMA is piloting its clinic-based intervention as part of the HOPE (MTN-025) open-label dapivirine ring study at the Wits RHI Hillbrow site. As of early August, the CHARISMA Social Benefits-Harms Tool (SBHT) has been administered to 73 women enrolled in HOPE to assess partner support and select counseling modules for each woman. CHARISMA empowerment counseling on partner communication, ring disclosure, and/or intimate partner violence (IPV) have been provided to each enrollee. Fifty-seven women have completed their Month 1 CHARISMA visit, 32 women have completed their Month 3 visit, and six women have completed their final scheduled CHARISMA visit at Month 6. CHARISMA staff refer women to partner organizations for care or assistance as needed and track referral uptake. Staff also provide partner referrals for women who would like their partners to come to the clinic for additional information about the ring or for HIV counseling and testing.

Sonke Gender Justice is continuing CHARISMA’s community-based intervention, which aims to reduce IPV and increase men’s awareness, acceptance, and willingness to support their partners’ consistent use of microbicides. Sonke staff, with the help of community-action teams, hold informal group dialogues, tavern dialogues, soccer tournaments, and door-to-door outreach in two locations with the highest proportion of HOPE participants in Johannesburg: Hillbrow and Soweto. The community action teams have reached nearly 300 new community members, including unemployed men, by going door-to-door in hard-to-reach areas. Following a USAID visit to the field in July, the community action teams reported that the visit boosted their morale and helped them see how their work contributes to the broader landscape of HIV prevention and PrEP introduction programs.

Intervention evaluations and reporting planned. The team is conducting an interim evaluation of the clinic- and community-based components of the CHARISMA intervention. In partnership with USAID, the team is also assessing feasible expansion options within oral PrEP and other microbicide projects. Additionally, CHARISMA staff are continuing in-depth analyses of the formative data used to develop the intervention and will write manuscripts to report the findings.

GEMS informs policies and defines programmatic considerations related to use of ARV-based HIV prevention products and risk of resistance.

• Drug-resistance testing in Kenya progresses.
• GEMS prepares for drug-resistance testing in South Africa and Zimbabwe.
• Genital swabs testing begins and assay development is underway.
• Oral PrEP modeling continues.

Drug-resistance testing in Kenya progresses. The GEMS team is finalizing logistics to support in-country partners in collecting a blood sample from PrEP seroconverters. A sample collection kit has been prepared and will be distributed to high-volume PrEP clinics. In July, the GEMS Kenya team conducted a training of trainers session for county-level health workers to collect, store, and ship a dried blood spot sample to the laboratory. As a result, participants gained the skills to train other health workers in their individual counties.

GEMS prepares for drug-resistance testing in South Africa and Zimbabwe. The GEMS team has been finalizing logistics for dried blood spot (DBS) sample collection and shipment with the South African POWER team. GEMS has also been coordinating with the Anova Health Institute to monitor for HIV drug resistance as part of the national rollout at select Anova sites. GEMS and Anova are currently drafting a drug resistance monitoring protocol.

Meanwhile, GEMS, in collaboration with Pangaea Zimbabwe AIDS Trust (PZAT), has recently presented a proposed resistance monitoring plan to the Ministry of Health and Child Welfare (MOHCC). A GEMS representative met with the MOHCC, PSI, and other PrEP projects in August to plan next steps for drug resistance monitoring.

Genital swabs testing begins and assay development is underway. In collaboration with Partners PrEP and the Microbicide Trials Network (MTN), the GEMS laboratory team is continuing to test vaginal swabs from seroconverters to determine if drug resistance occurred in the genital tract (rather than the plasma) of women who seroconverted on active TDF/FTC product. The lab team is continuing to optimize next-generation sequencing protocols for dried blood spots.

Oral PrEP modeling continues. GEMS modelers have produced preliminary draft results on the impact of drug resistance on PrEP and ART. Modelers are currently performing further analyses and plan to review results with the South Africa National Department of Health and other stakeholders in the coming months.