Issue 3 – August 2016

On June 1, oral Pre-Exposure Prophylaxis (PrEP) and Test and Treat were made available for sex workers in South Africa by the National Department of Health. OPTIONS was among the many partners that supported this implementation. Eleven sites were selected for the initial implementation because they were already providing a comprehensive package of sexual reproductive health services and HIV treatment. Information, education and communication (IEC) materials, training materials, and monitoring and evaluation tools were prepared at a national level to support all of the sites and to ensure a standardized approach to the implementation of oral PrEP and Test and Treat. The IEC materials used in South Africa are available on PrEPWatch.

The sex worker population has responded well to oral PrEP and Test and Treat in the first few months of implementation. Social mobilization conducted by peer educators, the positive attitude of the health care teams, and skilled professional nurses all contributed to the effective delivery of the program. Challenges at some of the sites included delays in obtaining creatinine clearance results from the laboratories, resulting in loss of interest by clients; initial side effects having a negative impact on uptake; and a lack of social mobilization and information dissemination where peer educators were not present.

The WHO, is currently reviewing the implementation of oral PrEP and Test and Treat with the aim of identifying early lessons learned to inform continued implementation and make recommendations for further rollout.

The 21st International AIDS Conference in Durban was a celebration of the progress we have made in the last 16 years since the conference was last held in South Africa. Despite this progress, we know that young women around the world, particularly in sub-Saharan Africa, are two to three times more likely to acquire HIV than young men in their same age group.

In an effort to make unheard voices heard, the OPTIONS Consortium and WHO co-sponsored two workshops at AIDS 2016 that offered a forum for oral PrEP and ring users to share their thoughts, challenges, and needs regarding their sexual and reproductive health (SRH). To learn more about what was shared, read our OPTIONS blog, which was the feature story in July’s In Focus: End HIV for Her e-newsletter.

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.

• LVCT Health plays key role in development of Kenya’s PrEP section within ARV guidelines.
• Value chain situation analysis toolkit available on PrEPWatch.
• PrEP modeling moves forward in Kenya and Zimbabwe.
• New resource submission added to PrEPWatch.

LVCT Health plays key role in development of Kenya’s PrEP section within ARV guidelines. In July, Kenya launched “Guidelines on use of ARV drugs for treating and preventing HIV infection in Kenya – 2016 edition.” LVCT Health was part of the core technical experts who developed content for the HIV Testing Services (HTS) and Oral Pre-exposure Prophylaxis (PrEP) sections of the guidelines. The team also used lessons learned from its demonstration project to show that oral PrEP can be delivered to adolescent girls and young women to ensure this important population is included in PrEP rollout.

Value chain situation analysis toolkit available on PrEPWatch. The situation analysis toolkit that FSG developed is now available on PrEPWatch on the Guidelines & Tools for Program Planners page, as well as the MPii Tools & Resources page. The toolkit is designed to help implementers plan for oral PrEP introduction and rollout. It includes three templates to support the value chain situation analysis process, from data collection to presentation of findings. Completed situation analyses for oral PrEP in Kenya and Zimbabwe may also be found on PrEPWatch.

PrEP modeling moves forward in Kenya and Zimbabwe. OPTIONS modelers from Avenir and London School of Hygiene and Tropical Medicine are working closely with the country teams in Kenya and Zimbabwe and have started government engagement to ensure that the modeling work meets the countries’ respective needs. Using the Institute for Disease Modeling Epidemiological Modeling (EMOD) software, the modeling team has begun parameterizing the models and are exploring innovative ways of looking at the impact of PrEP for specific subpopulations of AGYW.

New resource submission added to PrEPWatch. Have a resource for PrEPWatch? Now you can submit your materials directly through the MPii Tools & Resources web page. Click on the “Submit your resource” button at the bottom of the page, fill out the form, upload your file(s), and click “submit.”

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

• Formative work begins at three sites.
• Cohort protocol developed.
• POWER plans a PrEP decision support tool.

Formative work begins at three sites. Formative work for POWER was initiated at all three sites – Kisumu, Cape Town, and Johannesburg, South Africa – in May. To date, the teams have completed 116 interviews with young women and men (Kisumu: 23; Cape Town: 54; and Johannesburg: 39) and 14 key informant interviews with health care providers and other key informants (Kisumu: 3; Cape Town: 8; and Johannesburg: 3). The team expects to complete all interviews by fall, then Carnegie Mellon University and RTI will conduct analysis. Preliminary themes, including young women’s interest in PrEP, feelings of increased control when imagining taking PrEP, and reporting that friends taking PrEP would influence their decision to try it, were presented at the USAID Cooperating Agencies meeting in July.

Cohort protocol developed. The POWER team developed the cohort protocol, including delivery procedures, delivery locations, questionnaires and data collection tools, and streamlined consents for young women. Sites will submit documents for regulatory review in August, and the cohort will begin enrolling young women by early 2017.

POWER plans a PrEP decision support tool. Using the information gathered from its mental models and interviews, POWER will develop an interactive PrEP decision support tool to be completed and launched in the cohort in early 2017. Modeled from My Birth Control, developed by Bedsider.org and UCSF, the interactive tool is aimed to help young African women make informed decisions about oral PrEP, with the hope of addressing barriers to PrEP delivery. These include limited provider and client knowledge, judgment from providers toward young unmarried African women, limited provider training regarding informed choice and patient-centered counseling, and limited time with patients in busy family planning clinics.

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.

• EMOTION completes human-centered design research.

EMOTION completes human-centered design research. From June 17 to July 2, EMOTION conducted its second phase of human-centered design (HCD) research (Kalahari II) in Johannesburg, Ladysmith, and Durban. In the field, they worked side-by-side with local partner Instant Grass, who provided linguistic and cultural translation, as well as strategic guidance from an on-the-ground perspective. At various times, they were joined by USAID representatives and other EMOTION partners (Abt Associates, Matchboxology and CAPRISA) while conducting live prototyping experiments, including brand and touchpoints for a holistic experience based on the design principles generated in Kalahari I. To date, EMOTION has conducted more than 288 interviews and interactions with young women, male partners, health care providers, and key influencers. Currently, CONRAD is working with IDEO to synthesize data for experience blueprint and design adjustments based on feedback from Kalahari II.

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).

• Landscape and secondary data analysis completed.
• Formative data collection nearly finished.
• Intervention planning underway.
• Scientific Advisory Group meeting convened.

Landscape and secondary data analysis completed. CHARISMA completed its landscape analysis and secondary data analysis, including a review of the context of gender and violence in South Africa and best practices for engaging men in women’s health. It also included data analysis on social harms experienced during microbicide trials and male partner involvement in product use.

Formative data collection nearly finished. The team has almost completed formative data collection at Wits RHI, located in the Hillbrow area of Johannesburg. Data collection included in-depth interviews with former ASPIRE trial participants about social harms and their male partners, focus groups with healthcare providers, as well as cognitive interviews with microbicide trial-experienced and trial-naïve women. A survey that includes potential items for the Social Benefits-Harms Tool (SBHT) is underway and should be concluded by the end of August 2016. The primary data captured through this formative research (i.e., IDIs, FGDs and survey), along with the country-stratified landscape analysis and secondary data analysis, are being analyzed to inform overall CHARISMA intervention design, including the content of the SBHT and counseling modules.

Intervention planning underway. The team is busy planning the CHARISMA intervention, which will include clinic- and community-based components.

The clinic-based component will be integrated into the HOPE (MTN-025) open-label dapivirine ring study around October 1 at the Wits RHI site in Hillbrow. To inform clinic-based intervention development, the team held an intervention planning workshop with the Task 2 data collection team and other key Wits RHI, Sonke Gender Justice, and RTI staff from the CHARISMA project. During the planning workshop, the group discussed CHARISMA counseling module content, procedures, and other intervention components. Site staff will provide counseling and support to HOPE participants to reduce their risk of intimate partner violence and to help them navigate partner dynamics to maximize product adherence.

For the community-based component, Sonke Gender Justice conducted a pilot workshop in Hillbrow aimed at promoting community-based male partner support of microbicide use and providing other gender and HIV-related male partner education. Based on the pilot, Sonke will refine the workshop curricula then implement it near the HOPE study site in Hillbrow.

Scientific Advisory Group meeting convened. The CHARISMA team hosted a Scientific Advisory Group meeting with an international group of IPV and HIV research and intervention experts on August 3, 2016. During the meeting, the CHARISMA team reported on the research findings informing CHARISMA intervention development, presented an overview of the planned intervention components, and received feedback from Scientific Advisory Group members. The SAG commended the team on their progress and offered suggestions on how the findings and data collection tools from CHARISMA could contribute to other work in the field, and vice versa.

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

• Specimen and data collection makes progress.
• Collaboration underway with other projects.
• Country work continues.
• Lab team moves forward.

Specimen and data collection makes progress. GEMS received approval from the Partners PrEP Study to obtain vaginal swab specimens from seroconverters on TDF/FTC with evidence of product adherence. GEMS submitted a similar request for samples from the VOICE study and are awaiting final approval. When obtained, these specimens will be used to assess the frequency of drug resistance. The team is also gathering published and unpublished data from PrEP trials for any seroconverter with resistance that was followed long term to assess the impact of resistance on future antiretroviral therapy.

Collaboration underway with other projects. GEMS established a partnership with POWER to collect dried blood spot (DBS) samples on seroconverters on PrEP. The team also held meetings with representatives from several PrEP demonstration projects and rollout programs to determine if DBS samples may be shipped to the University of Pittsburgh laboratory. GEMS hopes to collaborate with demonstration and rollout projects in South Africa, Zimbabwe, and Kenya to analyze resistance data on all PrEP users who acquire HIV.

Country work continues. The GEMS modeling team is working to calibrate their model to KwaZulu-Natal in South Africa. Additionally, country profiles are being developed to highlight country-specific PrEP implementation guidance related to HIV testing and resistance monitoring.

Lab team moves forward. The lab team has made progress with experimentation on HIV recovery from dried blood spot (DBS) samples. This work will inform the development of an assay that will allow us to more efficiently screen for HIV drug resistance by simultaneously analyzing samples collected from multiple patients. Additionally, the team is identifying country and regional laboratories to assess the capacity for local resistance testing.