Issue 5 – February 2017

Regional representatives of OPTIONS, POWER, CHARISMA, and GEMS shared country experiences and lessons learned from their current MPii work about how to address HIV prevention for adolescent girls and young women (AGYW) in Eastern and Southern Africa during “HIV prevention and sexual and reproductive health and rights for adolescent girls and young women.” Co-convened by PEPFAR/USAID, UNAIDS, and WHO/HRP, the three-day consultation, hosted by Namibia’s Ministry of Health, brought together more than 180 representatives from 12 countries. Namibia’s First Lady, the U.S. Ambassador to Namibia, and the Minister of Health and Social Services were among the key attendees who helped shaped the discussion.

OPTIONS presented two posters at CROI 2017 in February focused on modeling work in Kenya: “Cost-effectiveness of pre-exposure prophylaxis across counties in Western Kenya” and “HIV transmission in generalized, concentrated, and mixed epidemics in Western Kenya.” GEMS also presented the poster, “Does the E138A Mutation in ASPIRE Seroconverters Affect Susceptibility to Dapivirine?”

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.

• Government of Kenya ramps up oral PrEP launch.
• Zimbabwe lays groundwork for oral PrEP rollout.
• South Africa develops materials for continued oral PrEP rollout.
• South Africa offers refresher and new site training for oral PrEP program.
• Rollout scenario analyses completed for Kenya and Zimbabwe.
• Provider oral PrEP KAP landscape analysis finalized.
• Enhancements made and resources added to PrEPWatch.
• Blogs developed to share oral PrEP introduction experiences.

Government of Kenya ramps up oral PrEP launch. In January, LVCT Health participated in a technical working group (TWG) workshop to finalize documents and tools for the national oral PrEP launch planned for April 2017, as well as the launch plan to support implementing partners. LVCT Health also provided support to NASCOP with developing a county readiness assessment tool, which will be used by counties to establish what is already available and gaps that need to be filled for successful delivery of oral PrEP. In readiness for the launch, NASCOP has procured oral PrEP, and the PrEP TWG is discussing delivery channels and communications with different stakeholders. In particular, LVCT Health is supporting the adolescent and youth engagement forum on oral PrEP. Additionally, OPTIONS is working closely with the Kenyan TWG and the Jilinde project (Bridge to Scale) to develop the national communications strategy. McCann Global Health completed a communications landscape analysis of end users and key influencers, with input and support from AVAC, LVCT Health, and local stakeholders. It will be made available on PrEPWatch once finalized.

Zimbabwe lays groundwork for oral PrEP rollout. On World AIDS Day, Zimbabwe launched its updated ARV consolidated guidelines, which include oral PrEP. Prior to the launch, guidelines had been disseminated to national, provincial, and district health personnel. Provincial and district level teams expressed mixed feelings about the oral PrEP guidance, with some excited and some concerned about the added burden for health care workers. As part of the guidelines launch, Pangaea developed and distributed an oral PrEP fact sheet and is in the process of revising it based on initial feedback. Once completed, the fact sheet will be disseminated to districts and posted to PrEPWatch. The Zimbabwe MOHCC, together with Pangaea, will develop the oral PrEP implementation plan by June 2017. It will include job aids, as well as consolidation and adaptation of training materials into a national training manual for oral PrEP.

South Africa develops materials for continued oral PrEP rollout. Wits RHI collaborated with the Southern African HIV Clinicians Society and ANOVA to prepare a full training curriculum on oral PrEP for health care providers and all those involved in the provision of oral PrEP through combination HIV prevention services. The training curriculum contains a set of easy-to-use modules that can be modified and adapted to different training and/or country needs. In addition, Wits RHI worked with the NDOH and CHAI to develop job aids and an implementation package for sites that are providing oral PrEP in South Africa. The job aids include a workflow poster on HIV testing and oral PrEP initiation, and counseling job aids, primarily focused on adherence, incorporating the steps and key messages required for engaging with clients interested in oral PrEP, as well as those who have already initiated oral PrEP. The implementation package for partners and providers offers information for providing oral PrEP in the South African context. It includes an easy-to-use toolkit including the national guidelines, facility audit tool, training materials, M&E, and IEC materials, as well as the new job aids. This implementation package will be provided to partners in both print and digital format and will also be available to share via PrEPWatch with other stakeholders and countries that are interested in the South Africa experience.

South Africa offers refresher and new site training for oral PrEP program. Wits RHI and CHAI supported the NDOH in the implementation of a two-day “refresher” and new site oral PrEP training for the current rollout sites and five additional sex worker sites. The training was held on 24-25 January in Johannesburg for more than 100 site clinicians, counselors, and peer educators. The training was a forum for the current sites to share challenges and best practices with the opportunity for specific discussion on clinical management issues with the Southern African HIV Clinicians Society.

Rollout scenario analyses completed for Kenya and Zimbabwe. FSG, in collaboration with LVCT Health and Pangaea, are finalizing the oral PrEP rollout analyses for Kenya and Zimbabwe, which will be available on the MPii Tools & Resources page in early March. The rollout scenarios were created to help support in-country decision making around where to prioritize the delivery of oral PrEP. In Kenya, the initial analysis suggests that rolling out oral PrEP to the counties with the highest incidence would be most cost-effective and that the characteristics of the epidemic determine if a general population rollout, including AGYW, or a targeted rollout would be most beneficial. In Zimbabwe, the initial analysis finds that rolling out oral PrEP to the highest incidence districts would likely have the greatest impact. Using these analyses, FSG will develop a set of templates, which will be shared with other countries via PrEPWatch.

Provider oral PrEP KAP landscape analysis finalized. AVAC carried out a landscape analysis on the knowledge, attitudes, and practiced behaviors around oral PrEP among health care providers. This in-depth analysis and summary report is available on PrEPWatch. OPTIONS country partners are using this analysis to develop provider KAP surveys that address gaps identified and tackle country-specific questions. The protocols for this work are under development and will be implemented in all three OPTIONS countries.

Enhancements made and resources added to PrEPWatch. AVAC hosted a webinar with USAID OHA to receive feedback on the new “How to Scale Up PrEP” section on PrEPWatch. AVAC incorporated feedback from USAID and other OPTIONS partners and will officially launch the new section in the coming weeks. Stay tuned for more!

As part of the build out of PrEPWatch, AVAC created an “End-User Resources” page that includes a collection of materials developed by the Prevention Market Manager project, which is funded by The Bill & Melinda Gates Foundation. More resources and links were added to the sub-section “A Framework for Scaling Up PrEP,” including an interactive PrEP implementation timeline for South Africa under “Creating Policies, Plans, and Budgets.”

Finally, MPii posters and presentations from HIVR4P were added to the MPii Tools & Resources page, as well as full and abbreviated versions of the OPTIONS technical brief, “Addressing Gender to Ensure Effective PrEP Introduction.”

Blogs developed to share oral PrEP introduction experiences. OPTIONS has developed a series of blogs that share experiences and lessons learned from oral PrEP introduction in South Africa, Kenya, and Zimbabwe, and from specific demonstration projects and other implementation studies. These blogs include: insights from national-level planning for oral PrEP introduction in all three countries, lessons from the sex worker rollout in South Africa, and early lessons from demo projects across countries. These blogs may be found on the “News from the Field” PrEPWatch page, which will be launched in March and will continue to grow over the coming years as new insights emerge.

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

• POWER formative report finalized.
• Community survey about oral PrEP underway.
• POWER open label oral PrEP cohort launch scheduled.
• Pre-testing of oral PrEP decision support tool initiated.

POWER formative report finalized. The POWER team submitted the final report of the results from the formative work to USAID in January and will be available on PrEPWatch in March. The formative work consisted of mental models and key informant interviews with young women, men, and health care providers and other key stakeholders. The mental models methodology, led by Carnegie Mellon, is grounded in behavioral decision research. In-depth interviews (IDIs) with young women and men assessed how people interpret risk information, in this case HIV and pregnancy risks, and how they make subsequent choices, informed by their own intricate web of beliefs and theories – i.e., mental models. This analysis characterizes these mental models with respect to a specific decision, such as factors that would influence their decision to use oral PrEP. The key informant interviews, led by RTI International, focused on oral PrEP delivery for young African women and probed provider and opinion leaders about where, how, and to whom to deliver oral PrEP.

Community survey about oral PrEP underway. As part of the mental models formative work, the team is using a community-based survey to quantify some of the key themes identified in the in-depth interviews with young women and men. The survey was pre-tested in Cape Town and Kisumu in December and has already been completed in Cape Town (N=144). It was launched in late January in Johannesburg and Kisumu. POWER will use rapid analysis, and the results will augment the qualitative interviews as part of the mental models analysis.

POWER open label oral PrEP cohort launch scheduled. All three sites (Johannesburg, Cape Town, and Kisumu) are in the final stages of receiving IRB/ethics approvals, securing import permits for oral PrEP donation, and finalizing clinic flow and other clinical/lab/pharmacy processes. All three sites will complete site activation training and study launch in spring 2017. The POWER cohorts, where oral PrEP will be delivered to young women ages 16-25, will take place at a mobile youth clinic in Cape Town, a youth clinic in Johannesburg, and a family-planning clinic in Kisumu.

Pre-testing of oral PrEP decision support tool initiated. The POWER team is developing an oral PrEP decision support tool, My PrEP, with the digital version modeled from My Birth Control, created by Bedsider.org and UCSF. Pre-testing of the prototype at three sites initiated in December. The objective is to provide an interactive decision tool that offers graphic displays of the rationale for oral PrEP, HIV risks, efficacy, side effects, and adherence, to facilitate young women considering oral PrEP before they meet with a provider. Ultimately, My PrEP will be integrated with My Birth Control, since some young women may also be seeking contraceptive services.

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.

• Pilot messaging study completed.
• Socio-behavioral study underway.

Pilot messaging study completed. Project Siyavala, the pilot messaging study, builds on findings from Project Kalahari, which focused on the “End User Journey” for PrEP and resulted in recommendations for a communication strategy, brand identity, and product design. Project Siyavala focused on generating a deeper understanding of the behavior change stimuli required for consumers and medical professionals to achieve market and public health success.

Data were collected through Human-Centered Design (HCD)-based immersion sessions and interviews, during which participants were shown video messages and print campaign materials and participated in several data generation activities. These included facilitated group discussions, small group work ranking the messages from best to worst, and categorization of appealing messages by the key target audience segments of consumers and health care providers (HCPs). Transcripts from all immersion sessions and interviews were translated into English and rigorously analyzed. Analysis consisted of innovative scientific approaches to preserve the integrity of HCD findings while verifying the reliability, validity, and transferability of results. This portion of the project was overseen by Abt behavioral science researchers in collaboration with Matchboxology, a South African-based HCD firm. Multiple mixed-methods were applied, including quantitative analysis and descriptive statistics, negative hypothesis testing, thematic analysis, Grounded Theory, Phenomology, and Weick’s Model of Organizing.

Siyavala focused on extremely high HIV prevalence areas, as identified by the DREAMS Initiative. These include the peri-urban location of Orange Farm and the Soweto suburb of Protea North in Gauteng, the township of Khayelitsha in the Western Cape, and the rural area of Ngcolosi in the eThekwini District of KwaZulu Natal.

Insights gleaned from consumers (young women and influencers, such as male partners and mothers) were summarized. Key outcomes and recommendations from doctors, nurses, and pharmacists were also obtained. The Siyavala data download meeting on 6 February 2017 revealed all the methodology, insights, and recommendations to EMOTION consortium partners and USAID representatives. A detailed report is being finalized and will be made available in the coming weeks.

Socio-behavioral study underway. Project VOGUE is a socio-behavioral study comparing the HCD-branded experience and product to the unbranded product and standard of care, using objective markers of adherence. The unbranded standard arm of VOGUE will start in Q4 2017, and protocol development is ongoing. Elements defining HCD minimum desirable experience will also be finalized, and messaging/recruitment materials developed from Kalahari/Siyavala will be produced for Project VOGUE. Local ethics committee approvals will be obtained, and clinical supplies will be secured as well.

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 launched.
• Community-based intervention continues.
• Intervention evaluations and reporting planned.

Clinic-based intervention launched. CHARISMA received Wits RHI ethics approval to initiate the clinic-based component of the intervention into the HOPE (MTN-025) open-label dapivirine ring study at the Wits RHI Hillbrow site. Now, as participants are enrolled in HOPE, they are administered the Social Benefits-Harms Tool (SBHT) to determine their level of partner support, which helps identify which modules staff use to counsel women as they navigate ring use. To certify lay counselors on CHARISMA intervention techniques prior to initiation, the team conducted mock counseling sessions between trainers and lay counselors-in-training. Based on mock interview assessments, counselors achieved certification to use the CHARISMA counseling modules.

Community-based intervention continues. Sonke Gender Justice is continuing CHARISMA’s community-based intervention, which aims to reduce intimate partner violence (IPV) and increase men’s awareness, acceptance, and willingness to support their partners’ consistent use of microbicides. Sonke utilized multi-day workshops with male community members to initiate community action teams (CATs) in two locations with the highest proportion of HOPE participants in Johannesburg: Hillbrow and Soweto. The intervention now involves these teams by holding regular CAT meetings to prioritize and plan community-based activities. Sonke staff, with the help of CAT team members, hold informal group dialogues, tavern dialogues, soccer tournaments, and door-to-door outreach in the communities.

Intervention evaluations and reporting planned. The team is planning the interim evaluation of the clinic- and community-based components of the CHARISMA intervention and is assessing feasible scale-up options at additional HOPE sites and within oral PrEP demonstration projects. Currently, CHARISMA staff are conducting in-depth analyses of the qualitative 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.

• Genital swabs testing begins and assay development is underway.
• Initial oral PrEP modeling completed.
• Collaboration in Kenya and Namibia continues.

Genital swabs testing begins and assay development is underway. GEMS has collaborated with Partners PrEP and the Microbicide Trials Network (MTN) to obtain 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. Assay development for resistance testing in swabs is in progress, and GEMS has been evaluating methods to optimize the amount of HIV RNA obtained from a dried blood spot (DBS) sample. The lab team has been modifying standard HIV genotyping protocols for DBS to simplify the procedure while also working on adapting next-generation sequencing protocols to increase throughput and lower testing cost.

Initial oral PrEP modeling completed. GEMS is modeling the cost-effectiveness of different HIV-testing approaches for people starting and continuing on oral PrEP, as well as on potential use of resistance testing in people who have become infected despite being on oral PrEP. The modeling team has completed initial model calibration to KwaZuluNatal and disseminated preliminary results to colleagues. Currently, GEMS is exploring all feedback received to improve calibration.

Collaboration in Kenya and Namibia continues. GEMS is actively participating in NASCOP oral PrEP planning meetings and reviewing national training materials and tools. Additionally, the team has written a draft implementation plan that is currently under review by NASCOP, Bridge to Scale and DREAMS. The implementation plan describes how GEMS may support oral PrEP projects to collect dried blood spot (DBS) samples and analyze resistance on oral PrEP users who seroconvert. GEMS representatives also attended Kenya’s oral PrEP TWG meeting in November and participated in the Research and Implementation Science and Service Delivery/M&E subcommittee meetings. Finally, GEMS has continued discussions with the Namibia University of Science and Technology (NUST) and held meetings with NUST and other stakeholders, including the Namibia Ministry of Health and the Namibia Institute of Pathology, during a country visit in February.