Issue 8 – December 2017

To foster innovation and problem-solving within oral PrEP delivery, AVAC and LVCT Health, through OPTIONS, created six short documentary videos that offer lessons learned for implementers and policymakers. The “Providing Oral PrEP” videos capture real stories from end users and providers about their experiences with oral PrEP, looking closely at several IPCP demonstration project sites in Kenya where LVCT Health offers oral PrEP.

Launched at ICASA 2017, these videos were the Global Health feature article in The New York Times. Each video consists of a short case study of thematic challenges that emerged during the course of demonstration project. Oral PrEP users share their experiences, while program staff and providers describe tactics they developed, such as responsive counseling, peer support, and high-impact engagement with the community, to overcome those challenges and support oral PrEP use among those who need it. By capturing what helps or interferes with a woman’s uptake and adherence to oral PrEP, OPTIONS hopes to offer guidance for future HIV prevention product introduction efforts.

At ICASA 2017, held 4-9 December in Cote d’Ivoire, OPTIONS and WHO co-hosted a satellite session, titled “Making the case for PrEP for women: What we know and experiences to date.” More than 200 people attended the session, which reviewed current and new evidence about delivering oral PrEP to women, particularly adolescent girls and young women. Some questions explored were:

• How can we accelerate PrEP access and uptake for high-risk young women?
• What can we learn from the challenges and approaches taken in the Kenya and South Africa oral PrEP rollouts and DREAMS?
• Can women be reached through the private sector?

At ICASA 2017, OPTIONS presented the poster, “Involving young people in rollout of oral PrEP: The case in Kenya.”

In November, the GEMS team presented an oral session on the potential challenges that PrEP implementation may pose to HIV drug resistance emergence at the annual meeting for WHO HIVResNet, a global network advising WHO on the control and surveillance of HIV drug resistance.

At the Sexual Violence Research Initiative Forum, held 18-21 September in Rio de Janeiro, Brazil, CHARISMA presented, “Generating CHARISMA: Development of an intervention to help women build agency and safety in their relationships while using HIV prevention methods.” CHARISMA also presented an update on the clinic-based intervention at the MTN Annual Meeting on 21 September in Cape Town, South Africa.

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.

• OPTIONS develops communication strategy for Lesotho’s oral PrEP roll out.
• OPTIONS hosts dapivirine ring modeling stakeholder consultation.
• Operations research underway.
• PrEPWatch re-organized and new resources added.
• Mapping of PrEP trials and implementation projects updated.

OPTIONS develops communication strategy for Lesotho’s oral PrEP roll out. OPTIONS has been working closely with Jhpiego and Lesotho’s government to develop demand creation materials and a national communication strategy for oral PrEP. Work includes creating a rapid landscape analysis, adapting existing information, education, and communication (IEC) materials, material testing in-country with target audiences, and presenting revised materials to the technical working group (TWG). Preliminary posters were displayed at World AIDS Day activities, and materials will continue to be adapted as the communication strategy is finalized.

OPTIONS hosts dapivirine ring modeling stakeholder consultation. OPTIONS organized a dapivirine ring modeling stakeholder consultation on November 8 that gathered key stakeholders in a webinar to discuss the inputs and modeling questions around the ring. The primary discussion questions for the consultation were: “What assumptions should we use about uptake and adherence of both the ring and oral PrEP?” and “What scenarios would be useful for policymakers and donors in their decision-making?.”

Operations research underway. In South Africa, the ACCESS study has completed quantitative surveys with 27 providers and 283 clients, along with 20 qualitative in-depth interviews. 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 OPTIONS and CHAI, aims to identify barriers and enablers to oral PrEP uptake, retention, and adherence in South Africa. In another OPTIONS study, interviews have been completed with 27 staff members from seven ARV-based HIV prevention trials to better understand the recruitment strategies used to enroll high-risk women. A result validation webinar with interviewees and country-level programmatic staff is planned for early 2018.

PrEPWatch re-organized and new resources added. Recently, PrEPWatch.org underwent a re-organization to make materials and tools easier to locate. The new “PrEP Resources” section includes information on global guidance and national policies and guidelines; materials related to oral PrEP training, M&E, and demand creation; and resources for advocacy and implementation. More resources were added to the “Framework for Scaling Up PrEP” section to better support each step of the process. Additionally, the “Country Updates” section now includes additional countries as well as an updated, more robust presentation of country-specific updates. Please reach out to the AVAC team if you have any information to add!

Finally, please be sure to check out the literature review, “Adherence Metrics in the Oral PrEP Clinical Trials: Trends and Takeaways.” AVAC reviewed 189 oral PrEP studies that assess adherence with the aim of addressing the following question: Which adherence metrics are the most reliable for measuring adherence, and how do we know they are reliable? The literature review includes collation of studies by adherence metric, as well as efficacy and PK data for different modes of transmission.

Mapping of PrEP trials and implementation projects updated. The PrEP Trials and Implementation Projects mapping was updated by AVAC in October 2017. The overview tables are available on PrEPWatch. More detailed tables are available to individuals and organizations by request. Please send your request to Emily Donaldson.

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

• Cohorts in Cape Town, Johannesburg, and Kisumu enroll more than 200 young women.
• My PrEP decision support tool ready to launch; additional demand creation tools in development.
• POWER team meeting convened.

Cohorts in Cape Town, Johannesburg, and Kisumu enroll more than 200 young women. As of November 2017, 228 young women (ages 16-25) have enrolled in POWER cohorts in all three cities, at a total of four sites. The sites integrate three different health service models: a youth clinic in Johannesburg (WARD 21), a mobile van to reach youth in Cape Town (the Tutu Teen Tester), and a private (KMET) and public (JOOTRH) family planning clinic in Kisumu. Additionally, the team is collecting process evaluation indicators on a weekly and monthly basis and will be creating quarterly briefs that highlight key implementation lessons learned. The first brief will be available in the first quarter of 2018 and shared with other projects rolling out or scaling up oral PrEP.

My PrEP decision support tool ready to launch; 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. My PrEP has been pre-tested at all three sites in Cape Town, Johannesburg, and Kisumu, and feedback from providers and young women has been integrated in the final version, which is ready to be integrated into current delivery at each site.

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

POWER team meeting convened. The full POWER team met in Cape Town, South Africa in September 2017 to review early data, discuss initial challenges and success of delivery, and lay out a plan for ongoing delivery and possible ancillary sub-studies.

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 continues.

Project VOGUE continues. To-date, EMOTION has completed the first and second of its four project aims (known as Kalahari 1, 2, and Siyavala). Project VOGUE (EMOTION’s third project aim) is a socio-behavioral study that was originally designed to compare the human-centered design (HCD) branded experience and product to unbranded product and standard of care, using objective markers of adherence. Approval from the local IRB for the original study design and protocol has been received. In line with an ongoing process to respond to feedback from the MPii Project Advisory Committee (PAC), VOGUE’s study design is under discussion with USAID. Additionally, components of the intervention arm are being prepared following the results and guides from Kalahari 1 and 2 (HCD research) and Siyavala (the pilot messaging study building off Kalahari). Design iteration of the study starter kit is completed and clinical supply vendors are selected. Multiple items from the starter kit will be produced by early next year, and digital platforms and content will also be developed to help with participants’ adherence.

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-based intervention continues.
• Community-based intervention completed in September.
• CHARISMA pilot evaluation underway and effectiveness study planned.

Clinic-based intervention continues. CHARISMA is piloting its clinic-based intervention nested within the HIV Open Label Prevention Extension (HOPE) (MTN-025) dapivirine ring study at the Wits RHI Hillbrow site. As of October, the CHARISMA Social Benefits-Harms Tool (SBHT) has been administered to 94 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 along with referrals to external partner organizations that provide a list of services beyond the scope of the site as needed. Also, 79 women have completed their Month 1 CHARISMA visit, 67 women have completed their Month 3 visit, and 31 women have completed their final scheduled CHARISMA visit at Month 6.

Community-based intervention completed in September. Sonke Gender Justice worked with community action teams to reach more than 13,000 community members in Hillbrow and Soweto from July 2016 to September 2017 through informal group dialogues, tavern dialogues, soccer tournaments, and door-to-door outreach. Sonke facilitators reported that community members were very interested in receiving information about new HIV prevention products and had many questions about the dapivirine ring. Facilitators also reported that men were increasingly interested in discussing IPV and started to shift their conceptualization of IPV as a domestic issue to one of national importance. Local NGOs addressing violence and other community structures, such as soccer clubs, have expressed interest in continuing some aspects of the community-based intervention to address IPV, gender-based violence (GBV) and HIV prevention in their communities.

CHARISMA pilot evaluation underway and effectiveness study planned. The team is conducting an evaluation of both the clinic- and community-based components of the CHARISMA pilot intervention. Based on the findings, the team will adapt the intervention to improve feasibility and scalability, seeking stakeholder input on possibilities. In partnership with USAID, and based on findings from the pilot intervention and stakeholder feedback, the team will design a randomized controlled study to assess the effectiveness of the CHARISMA intervention to increase PrEP uptake and adherence and to reduce social harms and IPV in the context of an oral PrEP demonstration project for young women.

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

• Genital swabs testing begins and assay development is underway.
• Drug resistance testing in Kenya progresses.
• Drug resistance testing in South Africa planned.
• Collaboration in Zimbabwe begins.
• GEMS to offer technical assistance on drug resistance testing.
• Oral PrEP modeling progresses.

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.

Drug resistance testing in Kenya progresses. The national seroconverter protocol to collect a blood specimen on PrEP seroconverters is under review with NASCOP, prior to submission for ethics approval. It is concurrently undergoing an internal review by KEMRI investigators. In the meantime, GEMS has established a specimen collection and testing mechanism with POWER and Partners Scale-Up projects.

Drug resistance testing in South Africa planned. The GEMS team has 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 drafted a drug resistance monitoring protocol that was submitted for expedited ethics review.

Collaboration in Zimbabwe begins. GEMS held follow-up in-country meetings with the MOHCC, PSI, and other PrEP projects in October 2017, to plan next steps for drug resistance monitoring. This team of implementing partners drafted a protocol, led by MOHCC, to collect a blood specimen on PrEP seroconverters.

GEMS to offer technical assistance on drug resistance testing. Toolkit materials to support drug resistance testing in countries have been developed and reviewed by various stakeholders. These materials and GEMS support will be offered to countries interested in establishing a drug resistance monitoring plan. Ongoing conversations about this technical assistance have occurred with the WHO and partners in Lesotho, Namibia, and Tanzania.

Oral PrEP modeling progresses. Modelers continue to review and interpret results on the impact of drug resistance on PrEP and ART with modeling experts and stakeholders in South Africa.