Photo Credit: Nagesh Borse, USAID
Since June 2016, MPii has worked closely with the USAID/Namibia mission and Namibian Ministry of Health and Social Services to provide technical assistance and support for the country’s HIV prevention programs.
Namibia’s National Strategic Framework (NSF) for HIV/AIDS emphasizes a comprehensive package of HIV prevention services. In July 2016, representatives from USAID/HQ and OPTIONS met with the USAID mission and the Namibian government, including the Ministry of Health and PEPFAR implementing partners, to provide support for the country’s HIV prevention initiatives. Since then, MPii’s virtual and in-person technical assistance has included reviewing the country’s anti-retroviral therapy (ART) guidelines, sharing lessons and tools from other countries in the region, hosting a Namibian delegation in South Africa to visit PrEP delivery sites, identifying regulatory gaps in having drugs approved as PrEP, and attending Namibia’s first AIDS conference in December 2016.
With MPii’s ongoing technical assistance and support, Namibia’s fifth edition of national HIV/AIDS guidelines were released on World AIDS Day 2016 and include a chapter providing recommendations for oral PrEP for people at substantially high risk of contracting HIV. Recently, the Namibian Medical Research Council (NMRC) announced the regulatory approval for generic oral PrEP, which will help the planned PrEP activities under PEPFAR in the country.
Namibia has also undertaken a data review of 43,000 sero-discordant partnerships to inform future programming for this population. Additionally, PrEP training protocols have been integrated into the national curriculum for nurse-initiated management of ART and national oral PrEP targets have been set for PEPFAR. Namibia is the first country to create national targets in its NSF that consider the overall prevention product pipeline during a five-year period.
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.
Kenya launches oral PrEP and continues work on communications strategy. In Kenya, LVCT Health supported NASCOP’s national oral PrEP launch by providing resources that informed the PrEP technical working group’s (TWG) implementation plan. FSG, in partnership with LVCT Health, created rollout scenarios that offered a guide for how to prioritize Kenya’s geographies and populations, which were included in the final implementation plan. AVAC analyzed oral PrEP information from implementing partners with support from LVCT Health to ensure involvement of all stakeholders, and LVCT Health supported the development and review of the PrEP implementation framework and adaptation of DREAMS tools. As part of the launch secretariat team, LVCT Health supported PrEP champions to attend the launch and developed an abstract book drawing lessons learned from oral PrEP and HIV self-testing projects in Kenya. The Introduction of oral PrEP in Kenya prezi presentation at the launch was put together by NASCOP and LVCT Health and designed by FSG.
Additionally, OPTIONS is working closely with NASCOP and PSK through Bridge to Scale’s Jilinde Project to develop a national communications strategy for oral PrEP. McCann Global Health completed a communications landscape and summary gap analyses that were used to inform the quantitative and qualitative market research protocol (to be implemented in June). The market research focuses on PrEP as a product category across multiple populations, including adolescent girls and young women, female sex workers, serodiscordant couples, people who inject drugs, and men who have sex with men.
OPTIONS holds modeling validation workshop in Kenya. On 20-21 April, OPTIONS collaborated with USAID, NASCOP, and NACC to co-host a modeling validation workshop. It gathered in-country stakeholders to discuss and provide feedback on the OPTIONS oral PrEP modeling assumptions, data inputs, and sources. Based on the feedback, the model will be revised and further analyses will be carried out. Prior to the modeling validation workshop, NASCOP held a national PrEP modeling meeting, where Dr. Sarah Masyuko of NASCOP highlighted Kenya’s modeling needs and asked all the modelers to highlight their capacity building plans for Kenya so that modeling skills may be grown within the country. Three modeling groups presented their work and future plans. The attendees also identified outstanding PrEP modeling gaps from NASCOP’s perspective.
Zimbabwe continues to lay groundwork for oral PrEP rollout. In Zimbabwe, FSG, in partnership with Pangaea Zimbabwe AIDS Trust (PZAT), created rollout scenarios that were presented to the PrEP technical working group (TWG) in February to inform the oral PrEP national implementation plan. As secretariat for the PrEP TWG, Pangaea will lead the development of the plan, working closely with the Ministry of Health and Child Care (MOHCC). As part of the implementation plan development, PZAT will conduct community dialogues to better understand oral PrEP from both a community and end-user perspective, as well as a knowledge, attitudes, and practices (KAP) survey to better understand existing gaps from a health service provider perspective. These activities will help establish training, demand creation, and advocacy needs that exist in the communities. Finally, PZAT also helped draft the Global Fund concept note that included oral PrEP.
South Africa develops materials for continued oral PrEP rollout. In South Africa, Wits RHI is co-hosting the adolescent girls and young women (AGYW) PrEP subcommittee with the National Department of Health (NDoH) and exploring how the AGYW-focused PrEP trials and implementation projects may provide relevant, evidence-based information to help inform national rollout. OPTIONS collaborated with the Southern African HIV Clinicians Society and Anova Health to develop a PrEP curriculum package, which has been shared with a several partners, including the other OPTIONS countries. Wits RHI also supported the NDoH in the development, design, and production of job aids to support health care workers, peer educators, and counselors at oral PrEP rollout sites. The adherence counseling job aid aims to assist counselors and health care workers with discussing oral PrEP initiation and adherence. “The Road to PrEP” poster details, in visual format, the steps required to refer HIV-positive clients for immediate test and treat, as well as the counseling and oral PrEP initiation for HIV-negative clients.
OPTIONS begins implementation science activities. Using information from the in-depth analysis and summary report on knowledge, attitudes, and practices (KAP) around PrEP among health care providers, Wits RHI, LVCT Health, and Pangaea are developing country-specific protocols and quantitative provider KAP surveys. Additionally, three implementation science protocols are currently in development: one led by FHI 360 and country partners titled, Reaching adolescent girls and young women for PrEP: Learning from HIV prevention trials and demonstration projects; one led by LSHTM and Wits RHI, titled Preferences for PrEP: Exploring the role of user characteristics and structural drivers on PrEP uptake; and one led by Wits RHI in collaboration with CHAI’s Prevention Market Manger Program titled, Operations research on South Africa oral PrEP implementation.
New resources added to PrEPWatch. In addition to the Kenya communications landscape and gap analyses, OPTIONS also added the oral PrEP rollout scenarios for Kenya and Zimbabwe on the MPii Tools & Resources page. Additionally, there is a summary of insights on AGYW from oral PrEP trials and implementation projects in South Africa, as well as the dapivirine ring social behavioral and modeling literature reviews.
The News from the Field page houses a series of blogs that share experiences and lessons learned from oral PrEP introduction in Kenya, South Africa, and Zimbabwe, and from specific oral PrEP trials and implementation projects. Blog topics include, “Early lessons from South Africa’s rollout of oral PrEP to sex workers,” “The road to PrEP introduction in South Africa (interactive timeline),” and “Early lessons from Kenya’s oral PrEP rollout planning.”
POWER develops cost-effective and scalable models for implementation of ARV-based HIV prevention products for women.
Mental models community surveys completed. As part of the mental models formative work, the team is using a community-based survey to quantify key themes identified in the in-depth interviews (IDIs) with young women and men. Approximately 450 surveys were completed and reviewed across the three sites: Cape Town, Kisumu, and Johannesburg. 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. Analysis is underway and results will augment the qualitative interviews as part of the mental models analysis. Then, the formative report will be updated with survey results and disseminated widely.
Training for POWER’s PrEP delivery cohort completed in Cape Town, Johannesburg, and Kisumu. The POWER cohort training prior to site activation was completed at all three sites in April. Over the course of three days at each site, representatives from the University of Washington, RTI, and the site teams collaboratively provided training about data collection, qualitative interviews, counseling and adherence, and lab and pharmacy procedures among other topics. The teams spent a full day mapping out clinic flow procedures together and did mock patient visits to identify efficiencies and avoid bottlenecks.
Site activation scheduled. All three sites – Cape Town, Kisumu, and Johannesburg – are finalizing IRB/ethics approvals and securing import permits for oral PrEP donation. Once these final regulatory approvals are received, each site will activate. 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.
My PrEP decision support tool undergoes cognitive testing. 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. In focus groups and key informant interviews with 20 community leaders, 30 young women, and five family planning providers in Kisumu, Kenya and Johannesburg and Cape Town, South Africa, respondents universally supported the use of an electronic tool to attract interest from young women. Young women appreciated the health-promoting approach and the opportunity to review information at their own pace prior to talking with a provider. Providers thought the tool would facilitate their counseling of young women about the basics of oral PrEP, including potential mild gastrointestinal side effects in the first few weeks, adherence, and effectiveness.
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. 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-old), 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. To reduce contamination between the control arm participants and intervention arm participants, recruitment of the control arm will begin first (Q4 2017). 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.
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 a branded starter package, along with attendant adherence support. During enrollment of the intervention arm, the MRU site clinic will also have branded materials to help enhance participants’ understanding of and adherence to oral PrEP. These branded materials will also assist healthcare 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.
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. 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. The CHARISMA Social Benefits-Harms Tool (SBHT) has been administered to 38 of the 41 women enrolled in HOPE. The SBHT assesses partner support and determines which CHARISMA counseling modules would be most beneficial for each woman. CHARISMA empowerment counseling on partner communication, ring disclosure, or intimate partner violence (IPV) have been provided to each enrollee. Twenty-four women have completed their Month 1 CHARISMA visit, and 13 women have completed their Month 3 visit. CHARISMA staff send women to referral partner organizations for care or assistance as needed and track referral uptake.
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. Sonke has recently formed alliances with two housing companies to host community dialogues close to where people live. Finally, a radio program on 1873 FM featured an interview with Sonke giving an overview of CHARISMA. With an estimated 350,000 listeners, most of them youth, this was a good platform for raising awareness of HIV prevention, microbicides, and IPV prevention.
Intervention evaluations and reporting planned. The team will conduct an interim evaluation of the clinic- and community-based components of the CHARISMA intervention and assess the feasible expansion options at additional HOPE sites and subsequently within other ring studies or oral PrEP demonstration projects. Additionally, CHARISMA staff are continuing 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. In collaboration with Partners PrEP and the Microbicide Trials Network (MTN), the GEMS laboratory team is testing 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. The lab is evaluating universal primers applicable for all HIV-1 subtypes.
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 model calibration to KwaZulu-Natal and has produced preliminary draft output results.
Collaboration in Kenya continues. The GEMS team is working closely with Kenyan partners including NASCOP, Jhpiego, and POWER to establish mechanisms to monitor for HIV drug resistance during oral PrEP rollout. The GEMS team recently attended the National PrEP Launch in Nairobi and met with in-country partners to coordinate logistics and procedures for HIV drug resistance testing on samples from seroconverters during PrEP rollout. The GEMS team is working to establish similar relationships in South Africa, Zimbabwe, and Namibia by engaging ministries of health and large-scale oral PrEP projects.
Resources being developed for training and M&E. GEMS is developing training materials for healthcare workers that include dried blood spot collection techniques and resistance test interpretation. Additional materials, such as job aids and fact sheets, are being developed to support healthcare workers and policy makers in countries preparing for drug resistance monitoring. Additionally, a resistance monitoring M&E framework and suggested indicators were developed for discussion at the WHO PrEP M&E and NASCOP M&E subcommittee meetings in April 2017.
EMOTION
“Project EMOTION: Creating HIV Prevention Products that Fit into Women’s Lives.” USAID Global Health Newsletter. May 2017.
GEMS
“Future technologies for monitoring HIV drug resistance and cure.” Current Opinion in HIV & AIDS. March 2017, Vol 12, Issue 2, p 182-189.