Issue 4 – November 2016

The five MPii projects engaged participants at the HIV Research For Prevention Conference (HIV R4P) in October with a joint satellite session titled, “Sex, Intimacy, and HIV Prevention: What do women—and their partners—really want? Incorporating end-user input and developing a market launch strategy for PrEP.”

The session included presentations and a panel discussion showcasing how the work of EMOTION, OPTIONS, POWER, CHARISMA, and GEMS complement one another to create an integrated approach for PrEP delivery – from end-user insights and mental models to product development and market shaping communications.

More than 75 people attended the session, with one person noting that “this [discussion] should have been the opening plenary.”

Presentations focused on human-centered design (HCD) to complement existing data on end users experience with PrEP, development of the PrEP brand, messages, and packaging, approaches for evaluating PrEP delivery, and market shaping communications for the category of HIV prevention products. Additionally, the session included a panel discussion with representatives from all five MPii projects on how they are collaborating to engage end users and stakeholders in PrEP messaging, design, access, and uptake.

In addition, EMOTION presented a poster on the Project Kalahari findings, “Inspiring demand: Leveraging human centered design to improve microbicide uptake and adherence” and OPTIONS presented a poster, “Tapping into the unheard voices of end-users to deliver on pre-exposure prophylaxis (PrEP) for adolescent girls and young women.”

CHARISMA also presented two posters titled, “Disclosure of vaginal ring use to male partners in an HIV prevention study: impact on adherence” and “Relationships dynamics, agency, and trust in the context of microbicide use: Formative research results from the CHARISMA study in Johannesburg.” The team also gave a CHARISMA-associated oral presentation titled, “Frequency of partner-related social harms and their impact on adherence to the dapivirine vaginal ring during the MTN020/ASPIRE HIV Prevention Trial.”

Finally, GEMS gave an oral presentation, “HIV-1 resistance outcomes in seroconverters from the MTN-020/ASPIRE Dapivirine Vaginal Ring Study,” which reported resistance findings and amplified the importance of the meta-study conducted by the MPii projects.

AVAC has added a new section to PrEPWatch that offers a step-by-step framework for planning the introduction of oral PrEP, country-specific PrEP updates, case studies, key players, and tools. Based on OPTIONS work in Kenya, South Africa, and Zimbabwe, the “How to Scale Up PrEP” section outlines the steps in the process of rolling out oral PrEP and provides tools and resources for each step. Information is organized based on the FSG value chain, with information and tools on: creating policies, plans, and budgets; setting up systems for supply chain management; identifying and addressing delivery considerations and best practices; developing marketing and communications strategies to promote demand and uptake; and ensuring program quality and progress through monitoring and evaluation. New resources will be added as they become available, so users are encouraged to check these pages frequently.

This section is live, but we would love to hear feedback on the organization, content, or anything else you’d like to see! Please e-mail MPiiPrepwatch@optionsconsortium.org.

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.

• Project priorities selected for year two.
• Rollout scenario analyses underway.
• Country partners continue engaging with national TWGs.
• Resources and tools being developed to support PrEP rollout beyond core countries.
• Another resource added to PrEPWatch.

Project priorities selected for year two. OPTIONS identified two priorities for project year two: (a) support country efforts to identify and reach at-risk adolescent girls and young women (AGYW) for oral PrEP and (b) develop and provide tools, resources, and targeted technical assistance to OPTIONS core countries and others considering oral PrEP implementation. Some of the anticipated OPTIONS activities planned for the coming year include development of oral PrEP rollout scenarios, cost and impact modeling for oral PrEP and dapivirine ring, investment case for dapivirine ring, market shaping communications, oral PrEP provider training materials, provider surveys (knowledge, attitudes, practices, and beliefs), and ongoing support for national PrEP technical working groups (TWGs) in Kenya, South Africa, and Zimbabwe.

Rollout scenario analyses underway. OPTIONS is developing analyses that will help decision-makers assess the potential impact of introducing oral PrEP on HIV incidence and “readiness” for introducing oral PrEP under different scenarios (e.g., in certain counties or for specific populations). The rollout scenarios will be tailored to the needs of OPTIONS core countries (Kenya, South Africa, and Zimbabwe) and will focus on how to deploy resources by exploring questions such as:

• In which sub-national regions (e.g., districts, counties) does oral PrEP availability have the highest potential for impact on HIV incidence?
• What do we know about target populations for oral PrEP and how to reach them?
• What assets exist in these regions to support oral PrEP rollout? For example, what healthcare facilities are accessible?
• What NGO programs exist that could support rollout for target populations?
• How much existing knowledge and demand exists for analogous health products and services like HIV testing or contraception?
• What are the cost implications of making oral PrEP available to AGYW in these districts? (will not be incorporated until late 2017)

The analyses will be developed by FSG in close collaboration with OPTIONS country partners (LVCT Health, Pangaea Global AIDS, and Wits RHI) with input from OPTIONS modelers Avenir Health and the London School of Hygiene and Tropical Medicine (LSHTM). Initial drafts of the analyses will be available in January 2017 and will be refined periodically as new information becomes available.

Country partners continue engaging with national TWGs. Pangaea Global AIDS drafted the oral PrEP chapter of Zimbabwe’s national ARV consolidated guidelines, as well as an oral PrEP fact sheet that will be distributed with the guidelines in the coming months. In South Africa, some of the information, education, and communication (IEC) materials from the oral PrEP launch have been updated based on NDOH and partner feedback and are available on the MPii Tools and Resources and South Africa Close-Up pages on PrEPWatch. In Kenya, LVCT Health is participating in the NASCOP PrEP TWG meetings, as well as in several of the TWG subcommittees.

Resources and tools being developed to support PrEP rollout beyond core countries. The OPTIONS Consortium has identified several priority questions raised through the PrEP TWGs in Kenya, South Africa, and Zimbabwe and with input from other countries seeking to introduce oral PrEP. These questions highlight areas where tools and resources may help support oral PrEP rollout in other countries. To help fill this gap, the team is working on developing resources to inform oral PrEP rollout in non-OPTIONS countries based on the project’s experience within its three core countries. The first questions that will be addressed are “How do countries start the process of oral PrEP introduction?” and “What do we know about implementing oral PrEP to date from demonstration projects?” Stay tuned!

Wits RHI has been collaborating with the Southern African HIV Clinicians Society (SAHCS) and partners in the development of an oral PrEP provider training package. This resulted in two packages – the first was adapted for the NDoH rollout of oral PrEP for sex workers. The second, a more generic package, was used for a national training program in nine provinces for SAHCS members during the year. Out of this process, the need for a more flexible package was identified to cater to different healthcare provider audiences, in both the public and private sectors, with clinical, programmatic, communication, and sensitization modules. The generic package will be used in South Africa and can be adapted for other countries. Wits RHI is providing technical support and oversight for this revised package.

Another resource added to PrEPWatch. In addition to the new “How to Scale Up PrEP” section, the South Africa Value Chain Situation Analysis, which tracks the current state of oral PrEP rollout in the country, is now available on the MPii Tools and Resources and South Africa Close-Up pages on PrEPWatch.

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

• Initial results of formative work presented.
• Cohort protocol work continues.
• Oral PrEP decision support tool prototype being developed.

Initial results of formative work presented. The formative work in POWER consists of interviews with young women, men, and health care providers and other key informants. The in-depth interviews (IDIs) with young women and men are being analyzed using a mental models methodology, which is grounded in behavioral decision research. This method assesses how people interpret risk information 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 or set of decisions. All formative work (mental models with young women and men and IDIs with young women, men, health care providers, and other key informants) was completed in September. These activities are spearheaded by Carnegie Mellon University (mental models) and RTI International (IDIs).

A community-based survey associated with the mental models work is being implemented in November and December at selected sites. The survey will quantify some of the qualitative findings from the mental models and IDIs with young women and men.

The initial results of all formative work were presented to the POWER team at an in-person meeting at HIV R4P on 17 October. They will be disseminated more broadly with a final report completed by 31 December 2016.

Cohort protocol work continues. The POWER cohort protocol was finalized in late summer. All three sites (Kisumu, Cape Town, and Johannesburg) and the University of Washington have submitted the protocol for IRB review. Once all sites have regulatory approvals and drug import permits, sites will train staff on cohort procedures. The team aims to initiate the cohort in winter 2017.

Oral PrEP decision support tool prototype being developed. The POWER team is developing an oral PrEP decision support tool modeled from My Birth Control, developed by Bedsider.org and UCSF. Currently, a prototype of this tool is being developed for pre-testing at all three sites before the cohort begins.

The objective is to provide a decision tool about oral PrEP for young African women, some of whom will also be seeking contraceptive services. The formative work (mental models and IDIs) will inform the development of the tool, specifically identifying gaps in knowledge and young women’s preferences for how information is shared.

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.

• Human-centered design research completed.
• Pilot marketing study underway.

Human-centered design research completed. Project Kalahari (human-centered design research (HCD)) is focused on women who are at the highest risk of HIV, as defined by USAID/PEPFAR guidelines, and their circle of influencers including family, friends, male partners, and health care providers (HCPs). Kalahari is composed of two major phases: Kalahari I and II. Kalahari I is focused on conducting in-depth interviews (IDIs) in South Africa, obtaining feedback for eight PrEP products, synthesizing insights and design principles, and designing two preliminary products. Kalahari II is focused on design iteration based on findings from Kalahari I to deliver final recommendations for the selected products, packaging, brand, and experience blueprint. Ultimately, brand, packaging and communication materials designed in Kalahari for two selected products will be manufactured for quantitative socio-behavioral (SB) testing.

By September 2016, both phases of Kalahari were completed to lay out the foundation of EMOTION. Final recommendations have been synthesized for refining product attributes, packaging, messaging, and branding approaches based on end-user input and HCD principles. Brand values, naming, visual direction, graphic elements, color palette, and typography were also determined. An experience blueprint with system elements for a successful MDP (minimum desirable product) launch has been developed. Additionally, EMOTION compiled and shared its findings from Kalahari with Dalberg, which is conducting a HCD study of vaginal rings with IPM.

Pilot marketing study underway. Project Siyavala, the pilot marketing study, will test messaging developed from Kalahari in a variety of contexts along the user journey. Siyavala was kicked off in October 2016, and the field research began in early November in Johannesburg, Cape Town, and KwaZulu-Natal and will continue through the end of November. Messages tailored to inform HCPs, nurses, and pharmacists were developed. Siyavala uses controlled market behavior simulation methodology and will interact with more than 200 participants, including women, men, dating couples, and HCPs.

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 report finalized.
• Formative data collection and analyses completed.
• Results disseminated.
• Intervention design plan developed and data collection underway.

Landscape and secondary data analysis report finalized. The CHARISMA team completed a summary report of secondary analyses of social harms and male engagement in previous microbicide studies, as well as a landscape analysis of previous interventions aimed at reducing intimate partner violence (IPV) and encouraging male partner support for women’s HIV prevention. The report also included a comprehensive literature review on how women’s agency in and men’s support for HIV prevention have been measured, which was used to develop the Social Benefits-Harms Tool (SBHT). The team will soon be using the SBHT to assess where women are on the continuum of partner involvement/support, thereby allowing the CHARISMA counseling intervention to be tailored to women’s individual circumstances.

Formative data collection and analyses completed. The team completed formative data collection at Wits RHI and subsequent preliminary analyses to inform the CHARISMA intervention. Formative data were collected from ASPIRE (MTN-020) dapivirine ring study participants who reported social harms (SH) or IPV or who had “supportive” male partners during their use of a vaginal ring while in the trial. Data were also collected from male partners of ASPIRE trial participants, which allowed CHARISMA to investigate key issues at the intersection of male partners and microbicide use – ranging from positive support to violence – to inform the CHARISMA intervention design.

Results disseminated. Results were presented at HIV R4P (see Spotlight section for details) and media coverage of the results focused on the finding that participants who experienced IPV or other types of social harm were nearly 1.5 times more likely to report low adherence to the ring and how use of the ring improved after abused women disclosed the events to study staff. The articles stressed the need for simple ways to empower women to be adherent to HIV prevention strategies in the face of potential exposure to IPV. Currently, the team is drafting manuscripts for submission based on additional in-depth analyses.

Intervention design plan developed and data collection underway. The landscape and secondary data analyses, along with the formative data collection detailed above all informed the CHARISMA intervention design. The team developed a four-page brief summarizing the CHARISMA pilot intervention design and the evidence that was used to develop the pilot intervention. Copies of the brief were distributed at HIV R4P, and the team is developing a plan for further dissemination.

CHARISMA received approval from the National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) to integrate the clinic-based component of the intervention into the HOPE (MTN-025) open-label dapivirine ring study at the Wits RHI Hillbrow site. Thus far, the team has completed data collection using a field-based survey with 306 women, along with factor analysis, to determine which scale items to use in the SBHT, which will help identify women along a male partner support continuum. CHARISMA staff then developed the final SBHT version for implementation in the CHARISMA component of the HOPE study.

The CHARISMA counseling modules, counselor training manuals, counseling flipchart, and other tools were developed and submitted for ethics approval in early October 2016, and staff training at Wits RHI was completed at the end of September 2016. The CHARISMA team will implement the counseling intervention once ethics approval is received and counselors are certified to use the CHARISMA counseling modules.

Sonke Gender Justice started 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 has started involving these teams by holding CAT meetings, community dialogues, tavern dialogues, and door-to-door outreach in the communities.

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

• Collaboration in Kenya and South Africa moves forward.
• Oral PrEP modeling continues.
• Study concept sheets approved.
• Cost-effective strategies for HIV drug resistance surveillance continues.

Collaboration in Kenya and South Africa moves forward. The GEMS team began in-country work in Kenya and South Africa to introduce the GEMS project and establish partnerships. GEMS is working to create mechanisms for providing technical assistance for resistance monitoring in PrEP projects including policy development and the collection of data and samples from clients who seroconvert while using PrEP.

GEMS presented project overviews and discussed oral PrEP rollout plans with the USAID Missions in Nairobi and Pretoria. GEMS met with NASCOP in Kenya and the National Department of Health (NDoH) in South Africa to discuss policy considerations and potential activities related to resistance monitoring within each country. GEMS also met with Bridge to Scale, LVCT Health (Kenya), CHAI, and Wits RHI (South Africa) to discuss logistics for incorporating resistance testing into large-scale oral PrEP projects. Additionally, GEMS assessed resistance testing capacity at key laboratory settings in Kenya and South Africa. Several GEMS team members met one another at BARC-Lancet Laboratories in Johannesburg to discuss sample collection and shipment logistics from clinical sites implementing PrEP.

Oral PrEP modeling continues. GEMS is modeling 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 is initially based on the context of KwaZulu-Natal, and the calibration to data from this province is ongoing.

Study concept sheets approved. Partners PrEP and the Microbicide Trials Network (MTN) approved study concept sheets for GEMS to obtain vaginal swabs from seroconverters to determine if resistance occurred in the genital tract (rather than the plasma) of women who seroconverted on active product. GEMS is in the process of developing an assay to test the samples.

Cost-effective strategies for HIV drug resistance surveillance continues. GEMS is developing cost-effective strategies to improve HIV drug resistance (HIVDR) surveillance during oral PrEP implementation and beyond. The GEMS team is redesigning a newly developed Illumina next-generation sequencing-based HIVDR assay to increase the throughput capacity and improve the ability to detect drug resistance mutations over current genotyping methods. The new assay will reduce both the complexity and financial burden of current surveillance technologies. Current activities are focused on maximizing the amount of HIV RNA extracted from a dried blood spot, modifying the assay to be specific for HIV subtypes common in South Africa and Kenya and identifying steps in the assay that can be simplified for future technology transfer.