A New Oral PrEP Strategy Is On the Horizon, But Who’s Going to Get It?

Earlier this month, a new daily oral PrEP strategy using F/TAF (brand name Descovy), inched a step closer to availability—though not necessarily for all people who need it. It’s a mixed moment. More strategies are good, but it is unacceptable to skimp on research in ways that leave women or any other population out. The history of the AIDS epidemic is, in part, the history of moving ahead based on research in the bodies of people assigned male at birth—to the detriment of essential knowledge about what works for cis (and trans) women and transmen. This blog provides information on what happened at an Antimicrobial Drugs Advisory Committee meeting on F/TAF for PrEP, convened by the US regulatory body, the Food and Drug Administration (FDA)—and what needs to happen next.

What’s the New Strategy?

Gilead Sciences, the developer and patent holder for Descovy (F/TAF), submitted an application to license F/TAF as a daily oral PrEP strategy for HIV prevention. TAF and TDF (TDF is one of two drugs in the combination TDF/FTC that the FDA approved for PrEP in 2012) represent different prodrug versions of the same compound, tenofovir (TFV). A prodrug is a drug that works only after our bodies have processed, or metabolized, it. It gets activated as our bodies break it down. Many drugs just start working without this activation step, but tenofovir is not absorbed well without this step. TAF is similar to TDF in many ways, but TAF gets metabolized inside cells not the blood. Cells are where the drug needs to be to stop HIV from establishing infection. This difference—being activated at the site where protection is needed, versus in the blood—means that people need a lower dose of F/TAF compared to TDF/FTC to achieve protective drug levels. This also translates to a smaller pill for F/TAF.

How Is F/TAF Different from the Already-Approved TDF/FTC?

Gilead claims that the lower circulating blood levels for F/TAF (described above) might reduce the risk of some of the side effects seen with daily oral TDF/FTC for PrEP (as well as for treatment, for which both drugs have been approved). These include bone density loss and kidney function issues. While the side effect profiles of the two drugs are different, AVAC and other activists have pushed against any claims that F/TAF is “better PrEP”. We welcome strategies that reduce pill size and that may lower toxicities and side effects (less tenofovir in the blood could mean less risk of renal toxicity and bone density loss, both possible with long-term TDF use). But, we don’t want Gilead or anyone else to argue that F/TAF is “better” or “safer” PrEP unless the data clearly show that. As we wrote to the FDA, “Any claims of superiority of F/TAF are an overstatement of the data and, more importantly, will cause enormous confusion among both users and providers of PrEP… All labeling and marketing materials should clearly state these as equivalent daily oral PrEP options.” Click for more on concerns about how Gilead described F/TAF from AVAC, and the Treatment Action Group (TAG) and PrEP4All.

What Happened at the August 7th Hearing?

Gilead presented data from the Phase III DISCOVER trial of daily F/TAF as PrEP amongst men and transgender women who have sex with men. It showed that daily F/TAF is as safe and effective as daily TDF/FTC for HIV prevention in these populations. There is no similar efficacy trial amongst cisgender women, but Gilead did present data, including from a small USAID-funded pharmacokinetic study from research NGO CONRAD, that Gilead hoped would allow extrapolation of efficacy to support a PrEP indication for F/TAF in cisgender women. This CONRAD study of daily oral F/TAF in 72 HIV-negative cisgender women measured the levels of tenofovir (TFV) in the blood among participants. In that study, participants taking F/TAF for PrEP had protective levels of TFV in their blood. (This blood level—associated with a greater-than-90% reduction in risk of HIV acquisition—derived from efficacy trials of TDF/FTC in cisgender women.) The vaginal tissue concentrations in samples in the CONRAD study, though, did not allow the FDA to make any conclusions about protective levels for F/TAF. Since there is no consensus about which levels—blood or tissue—matter most in predicting efficacy, the FDA presentation found it could not conclude that this extrapolation was justified.

AVAC and partners, including TAG and PrEP4All, attended the Advisory Committee and submitted both written comments and presented during the open session of the meeting. The key points from AVAC’s testimony are at the end of this update; additional background materials from the meeting, including submissions from a number of organizations and individuals can be found here.

How Did the Committee Vote?

The Advisory Committee overwhelmingly voted to recommend F/TAF for PrEP in men who have sex with men (MSM) and transgender women by a vote of 16-2. But the committee split 10-8 against recommending F/TAF for PrEP in cisgender women. The panel’s recommendations are advisory to the FDA but are usually followed by the agency. This means that the FDA could approve F/TAF as PrEP for MSM and transgender women, without approving it for use in cisgender women. FDA is expected to announce its decision in early October.

What to Watch For

  • The FDA decision. Their decision is expected approximately two months from the time of the Committee meeting and vote. Advisory Committees provide the FDA with independent advice, but final decisions are made by FDA. The FDA could accept the Committee’s recommendation to approve F/TAF for MSM and transgender women (but not cisgender women), approve a label for all people at risk, or deny Gilead’s application altogether. Typically, the FDA accepts the Committee’s recommendation.
  • Regulatory filings in Europe and Africa, and WHO prequalification and guidelines. The DISCOVER study included sites in Europe, and Gilead will presumably be filing with the European Medicines Agency (EMA) for registration, and/or with national regulatory agencies in Europe.

    Will Gilead file for an MSM and transgender women indication for F/TAF in Africa, and would that make F/TAF use unsafe given the rampant homophobia and stigma still present in many communities?

    If registration will only be in Europe and the US, will Gilead file for WHO prequalification, which would allow F/TAF to be purchased by PEPFAR or the Global Fund? And how would WHO modify its PrEP guidance if F/TAF is approved by the FDA?

  • Safety and effectiveness data in cisgender women. Whether the FDA approves F/TAF for cisgender women or not, there is an urgent need to collect more data in cisgender women, as well as other populations that were not represented well or at all in the DISCOVER trial. AVAC has argued for full approval, with a clear requirement for Gilead to develop and implement a robust post-marketing research agenda to provide data on safety and effectiveness among cisgender women. Gilead has heard collective deep disappointment with their decision not to test F/TAF as PrEP in ciswomen—will they now act?
  • Pricing of F/TAF. Branded TDF/FTC, or Truvada, is shortly coming off patent in the US, finally opening the US market to generic TDF/FTC. What will this mean for pricing for branded F/TAF? The list price in the US for F/TAF is currently identical to TDF/FTC, but the generic price for F/TAF is unknown. It should be less expensive to produce F/TAF because it uses less active drug. Even so, Gilead will likely price it above, and possibly well above, the generic price for TDF/FTC. For public agencies, which still fund the majority of PrEP use either through programs like PEPFAR, national insurance schemes or health programs, any significant cost difference may lead them to stick with TDF/FTC. Gilead’s pricing of Truvada, which has limited PrEP uptake in the US, has been under criticism and legal challenge from groups like PrEP4All.

AVAC’s Bottom Line

  • The available data support approval of F/TAF as an additional non-inferior oral PrEP option. While Gilead representatives and researchers did present data at IAS 2019 that F/TAF was superior in safety and possibly in efficacy to F/TDF, claims of superiority of F/TAF are an overstatement of the available data and could cause confusion among both users and providers of PrEP. An indication that claims superiority could cause actual harm as potential TDF/FTC users delay initiation or current TDF/FTC users abandon PrEP use until F/TAF is later available. We were pleased that in their comments, the members of the Advisory Committee reinforced this view that if approved, F/TAF should not be marketed as superior to TDF/FTC.
  • We support labeling that includes cisgender women as a population that can benefit from F/TAF as PrEP. F/TAF and TDF/FTC represent different tenofovir prodrugs. Gilead did not plan an efficacy trial in cisgender women, hoping that bridging data would be sufficient. There are differing views about which biologic samples matter most in bridging across populations, but the data that were presented do, in our minds, support a label that includes cisgender women. While the Advisory Committee did not vote in favor of recommending F/TAF as PrEP for cisgender women, the comments from the committee members (irrespective of how they voted) did highlight the importance of requiring Gilead to collect this data in the most ethical and expeditious manner.
  • Any indication should be subject to specific post-marketing surveillance, Phase 4 studies and a robust Risk Evaluation and Mitigation Strategy (REMS). We know from earlier oral PrEP trials [of daily TDF/FTC] that efficacy in cisgender women can have wide confidence intervals. Recent data about lipid and weight-gain side effects of TAF compared to TDF, especially in women and individuals of African descent, make strict post-marketing surveillance critical. And, these post-marketing plans should also include other populations (e.g., adolescents and transgender men) that were not part of the DISCOVER trial.
  • Given the fundamental need for additional prevention options for cisgender women, AVAC believes the insufficient process for collecting data in Gilead’s product development plan for F/TAF thus far could be major setback in HIV prevention, and we join the chorus of advocates who are disappointed at Gilead’s lack of commitment to robust testing of this drug for PrEP in cisgender women. This is a unique situation, given that TAF is closely related to TDF, and not an entirely new product. Approving oral F/TAF for PrEP on the limited data is warranted in this case, but should not be the standard by which additional, novel PrEP options are tested and approved. We urge the FDA to hold product developers to a higher standard in drug development plans that will gain sufficient data across a range of populations in a timely and efficient manner, and in advance of regulatory submissions. Robust data across a range of populations at risk of infection must continue to be the standard, so that product development and regulatory approval can lead more seamlessly to acceptance, uptake and adherence by all populations who can – and should – benefit from innovation.

What’s New on AVAC.org and PrEPWatch.org

We don’t want you to miss a host of resources posted in recent weeks on AVAC.org and PrEPWatch. In case you missed them, these tools and resources will sharpen your take on the field.

Reporting on Global HIV Prevention

Check out these reports—recently published by AVAC and partners—for updates on funding trends in prevention and cure R&D, as well as a fresh look at places that have beaten back HIV with existing interventions:

Smarter Rollout

These articles and tools support advocates, implementers and decision-makers working on PrEP rollout today with an eye on future interventions tomorrow:

  • Reaching and Targeting More Effectivley: The application of market segmentation to improve HIV prevention programmes, by AVAC’s Anabel Gomez and others, and published in the Journal of the International AIDS Society, explores how to leverage the power of market segmentation for the promotion and uptake of primary prevention.
  • Just updated in July, AVAC’s Global PrEP Tracker on PrEPWatch.org provides the latest data on programs, number of enrollments by country, regulatory status and more.
  • A User’s Guide to PrEP Tools offers a handy table to navigate the many tools produced by different organizations to support policy makers, implementers, providers and others on PrEP access, uptake and continuation. Use this table to learn more about these tools, who they’re designed for, and when to use them.
  • The PrEP4Youth video series of public service announcements encourages adolescent girls and young women in South Africa to consider PrEP as an HIV prevention method. Created by the OPTIONS Consortium in collaboration with the South African National Department of Health, these videos feature popular actresses and put young women at the center with short empowering messages.

Apply to be an AVAC Fellow in 2020

AVAC would like to remind you that our call for applications for the 2020 class of AVAC Fellows is open until September 20. We encourage you to learn more about the program and share this information with your network!

Ushering in the Next Decade of the Fellows Program: Apply now to become a 2020 Fellow

AVAC is pleased to announce its call for applications for the 2020 Advocacy Fellows—leading us into the next decade of the program!

DOWNLOAD APPLICATION MATERIALS HERE.

The submission deadline for Advocacy Fellows applications is 20 September.

Seventy Fellows have moved through the program in its first 10 years, many of whom have gone on to become leaders in the HIV movement in their communities, countries and globally. As AVAC prepares for our 2020 Fellows Program, watch this space for information about activities and an evaluation marking 10 years of impact on HIV prevention advocacy and to chart the way forward for the program.

About the Program

AVAC’s Advocacy Fellows Program launched in 2009 to expand the capacity of advocates and organizations to accelerate, shape and monitor biomedical HIV prevention research and implementation worldwide. At AVAC, we believe effective and sustainable advocacy grows out of work that reflects organizational and individual interests, priorities and partnerships. The Fellows Program is guided by these principals.

The Advocacy Fellows Program supports emerging and mid-career advocates as they design and implement advocacy projects focused on HIV prevention research and implementation activities in their countries and communities. These projects address locally identified gaps and priorities. Fellows receive training, full-time financial support and technical assistance to plan and implement a targeted one-year project within host organizations working in HIV or related advocacy. Host organizations are critical partners in the program and Fellows’ projects can be an opportunity for an organization to further develop its own work in this field.

The Fellows Program focuses on low- and middle-income countries where clinical research on new biomedical HIV prevention options or HIV cure is planned or ongoing, or where there is demonstrated need for implementation of proven interventions including the integration of HIV and sexual and reproductive health.

HIV Prevention Research Advocacy Fellows are:

  • Emerging or mid-career community leaders and advocates involved or interested in advocacy around HIV prevention.
  • Individuals with some experience or education in the areas of HIV and AIDS, public health, international development or women’s rights.
  • Key populations such as young women, sex workers, gay men, other men who have sex with men, transgender people, people who inject drugs and those living with HIV.
  • Based in low- and middle-income countries where biomedical HIV prevention or cure clinical research is planned and/or where implementation of multi-intervention prevention packages is planned, ongoing or emerging.
  • Fluent English speakers.

Learn More

Prospective applicants or host organizations who want to learn more or have questions are encouraged to:

  • Watch two videos featuring past Fellows reflecting on their experience here and here.
  • Download the 2020 Advocacy Fellows Information Packet and application materials here.
  • Visit AVAC’s Fellows page for more information on the application process and to learn more about current and alumni Fellows.
  • Email the team at [email protected].
  • Listen to the recording of the 22 August informational conference call with the AVAC Fellows Team to learn more about the program.

Applications are due by 20 SEPTEMBER.

Please share this information with your networks and we look forward to receiving your application.

Follow the Money: HIV R&D Resource Tracking Reports 2018

Two new reports tracking resources for investment in HIV research and development are hot off the presses. The Resource Tracking for HIV Prevention R&D Working Group, a collaboration among AVAC, IAVI and UNAIDS, has launched its 15th annual report, HIV Prevention Research & Development Investments: Investing to end the epidemic, detailing overall 2018 investment and analysis of funding trends. And the Cure Resource Tracking Group, a collaboration between AVAC and the International AIDS Society, has also released its annual report, Global Investment in HIV Cure Research and Development in 2018.

These two reports represent powerful tools for advocacy. Both reports can be used to advance advocacy for a host of issues directly impacted by financial investments: the prevention crisis in the global HIV response is insurmountable without cutting-edge research and development and the scale-up of existing interventions, while cure research spearheads crucial innovation, and offers hope and inspiration to the millions affected by the epidemic.

Read on for links to downloads and key findings from each report:

Key Findings in Prevention R&D Funding

The report indicates an uptick after five consecutive years of declining investment. In 2018, funding for HIV prevention R&D increased by a modest 1.2 percent or US$13 million from the previous year, growing to US$1.14 billion. While the increase is encouraging, it’s the smallest net increase since 2003. This incremental growth impacted the various prevention categories differently. Investment increased for pre-exposure prophylaxis (PrEP), female condoms and prevention of vertical transmission (PMTCT) but decreased for voluntary medical male circumcision (VMMC), preventive vaccines, microbicides and treatment as prevention (TasP).

Despite the significant variation among these categories, donor trends remained more or less the same. Public sector (79 percent of overall or US$900 million) and philanthropic sector (14.4 percent of overall or US$164 million) investments remained mostly unchanged from 2017, while the private sector saw a 30 percent surge in investment, rising to at least 6.6 percent of overall funding or US$74.7 million in 2018. Actual commercial investment levels are higher as not all private companies responded to the Working Group’s request for data.

While US and European investment remained steady in 2018 compared to 2017, these figures are still the lowest in over a decade at US$829 million and EU$57.5 million, respectively. Outside the US, increases came from Australia, Canada, the European Commission, Germany and the UK, while declines were observed from Brazil, France and Japan. Global philanthropic levels also saw no change in 2018 and the Bill & Melinda Gates Foundation (BMGF) remained the preeminent funder in that category at US$149.7 million or 91 percent of all philanthropic sector investment.

In 2018, the US public sector and BMGF accounted for 86 percent of all funding. Citing the promise of the current R&D pipeline, the report cautions against this funding imbalance and the resulting impact on the longevity and sustainability of the field. Much hope can be drawn from the latest scientific strides: the ongoing efficacy trials for long-acting injectable PrEP and antibody mediated-prevention; the planned Phase III trial of a novel HIV vaccine regimen; and the dapivirine vaginal ring – another potential option for women. All of the above is contingent on sustainable financing and a diverse donor base that cushions against priority shifts from large donors.

Key Findings in Cure R&D Funding

The report estimates global investments in HIV cure research, which includes therapeutic HIV vaccines (for treatment) shows US$323.9 million in 2018, representing a 12 percent increase over the US$288.8 million invested in 2017. Compared to the US$88.1 million invested since tracking began in 2012, this is a 268 percent increase. The public sector accounted for the majority of funding, with the remaining US$19.7 million invested by philanthropies such as Aidsfonds, amfAR, the Bill & Melinda Gates Foundation, CANFAR, Institut Pasteur, Sidaction and Wellcome Trust.

We hope these reports will serve as tools for advocacy and inform public policy that accelerates scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

If your organization is a funder or recipient of HIV prevention grants and we don’t know you already please contact us at [email protected]!

An End to AIDS: A new report analyzing key prevention successes

AVAC is pleased to share a new report, Translating Progress into Success to End the AIDS Epidemic, produced in collaboration with amfAR and Friends of the Global Fight against AIDS, Tuberculosis and Malaria.

The report highlights six different places – London, Malawi, New South Wales, Rakai, San Francisco and Thailand – that have successfully reduced new HIV diagnoses and AIDS-related deaths through a combination of biomedical, policy, structural and rights-based interventions. The response in each location was tailored to its context and epidemic, but there are common elements that others can adapt to any context.

The report also includes a global timeline looking ahead to 2030, with “headlines of the future,” noting potential policy and research advances, as well as other social and structural changes that, based on current evidence, would directly impact progress on HIV.

Translating Progress into Success to End the AIDS Epidemic provides a roadmap for other cities, districts, states and countries to expand rights-based prevention and treatment today for immediate public health impact, while maintaining the long-term policy and research agendas for a sustainable end to the epidemic.

The bottom line is clear: Ending the epidemic is not simple anywhere, but possible everywhere.

The report was released today at a press conference at the IAS Conference on HIV Science 2019 in Mexico City with representatives from the collaboration. Link here for the press release announcing the publication of the report.

To learn more about the case studies and see a vision for a future where the end of the AIDS epidemic is within reach, you can find the full report at EndAIDS.org.

A Curtain Raiser for Prevention at IAS 2019

IAS 2019 is just ahead, July 21-24 in Mexico City. To help you prepare, read on for a round-up of research and happenings you won’t want to miss, a roadmap to guide you to sessions where HIV prevention is center stage, and how to follow on-site or from afar.

This year’s conference will feature data from late-breakers on highly anticipated research including:

For the full conference program go to the website for IAS 2019, and find your optimal schedule for following HIV prevention with AVAC’s conference roadmap, which can be sorted by timing, intervention or session type (Excel/PDF here).

Consider adding these satellite and conference events below, some hosted by AVAC and partners, to your calendar!

  • “Sticky Linkage”: Latest evidence and new strategies
    Sunday 21 July, 8:00-10:00, Palacio de Iturbide 1 y 2

    This session on approaches for improving ART initiation and retention will talk about challenges to the idea that the continuum of care is linear. The agenda includes the results of segmentation research aimed at improving linkage to treatment among South African men.

  • An HIV vaccine to prevent HIV acquisition
    Sunday 21 July, 17:00-19:00, Palacio de Valparaíso 1

    Learn more about the newest candidate for a vaccine to be investigated in a trial known as Mosaico. This session will provide an overview of pre-clinical work and next steps for the latest mosaic vaccine strategy.

  • Data from six locations inform the future of the HIV response
    Monday 22 July, 14:15-15:00

    This press conference will unveil a new analysis from amfAR, AVAC and Friends of the Global Fight of six case studies of progress toward epidemic control. From the report Translating Progress Into Success to End the AIDS Epidemic, the analysis identifies elements that accelerate the impact of treatment and prevention with implications for program, policy, implementation and advocacy. The press conference will only be open to journalists, but you can watch the livestream and watch for a future Advocates Network with links to the report post-launch.

Following from afar?

AVAC will offer comments and updates on Twitter and Facebook. Use the conference hashtag — #IAS2019.

Get the latest news on the conference at this dedicated page on the IAS 2019 website.

Interested in the events where AVAC is participating? Click here. And watch this space for additional updates.

Malawi Community-Based KP-Led Organizations Demand Transparency and Inclusion in the Planning and Implementation of the KPIF

Maureen is the African Regional Advocacy Advisor at AVAC.

As in-country planning for the Key Population Investment Fund (KPIF), a PEPFAR initiative to fund programs and organizations focused on key populations, key populations (KP) groups should take center stage in the process. Leaving them behind or out of the process would mean proceeding against their will.

In May, AVAC joined Civil Society Organizations (CSOs) in Zambia in the kick-off planning for the KPIF. The experience and lessons from the Zambia meeting provide insights into how to fully engage KP groups in the planning process—and the Zambia experience has ignited interest and enthusiasm among KP groups in different countries who are now more than ever eager to engage at all levels.

Different groups in different countries are now reaching out to their KPIF lead agencies to get more details and demand their seat at the table. (See AVAC’s Activist Guide to Influencing and Monitoring KPIF Rollout to see which agency is lead in your country and more.) Malawi is a case in point. KP-led CSOs in Malawi reviewed the contents of a KPIF proposal for Malawi in June. AVAC, joining as an observer, was on hand offering background information and lessons from the experience in Zambia. The result was a set of recommendations that helped key populations to participate meaningfully in the process of implementing the KPIF.

Background

Key populations in Malawi remain at highest risk of HIV infection. Due to high levels of stigma and discrimination both in the community and at facility level, access to HIV prevention and treatment services remain low among this group. More effort to improve service delivery will only yield results if the structural barriers to services are addressed. The KPIF funding can be leveraged to do just that—dismantle structural barriers. Following the news of the $100 million KPIF investment from PEPFAR, KP groups have been pushing to allocate funds to close gaps in implementation and address the dire needs that stem from them.

How are the key populations CSOs engaging with the process in Malawi?

In May, Malawi’s KP groups, led by the Centre for the Development of People, formed a coalition known as the Diversity Forum, to coordinate and unite KP voices around issues affecting them. Members have since used this forum to engage stakeholders on issues that affect key populations in Malawi.

In June, the Diversity Forum took part in a gathering of the KP Technical Working Group (KP TWG) where USAID presented a fully developed KPIF proposal. KP CSOs in the room felt they were left out of the initial process for developing the proposal and asked for time to review and provide feedback. Within days the Diversity Forum had facilitated a process that resulted in beefed-up coordination and a draft statement outlining current implementation gaps and key recommendations for the KPIF implementation.

The recommendations include:

  • CEDEP, the Secretariat of the Diversity Forum, should be named the host organization/grant manager for KPIF funds. CEDEP possesses the capacity to manage these funds, and has demonstrated long, sustained, meaningful engagement of LGBTQI+ and key populations. CEDEP maintains positive working relationships with all other LGBTQI+-led organizations, namely those with membership in the Diversity Forum. The Diversity Forum endorses CEDEP as host for the funds.
  • The Diversity Forum should be consulted at every stage of planning, proposal writing, implementation, monitoring and evaluation of KPIF-related activities and projects.
  • The Diversity Forum members should be present at all PEPFAR meetings and consultations pertaining to KPIF in Malawi; PEPFAR should issue formal invitations to the members of the Forum on these occasions.
  • PEPFAR should work to develop the technical capacity and ability to provide services of all the organizations that comprise the Diversity Forum.
  • PEPFAR should not lose sight of the role of the advocacy and activism undertaken by the organizations of the Diversity Forum in improving service uptake and delivery, mandates at the core of KPIF.

The Diversity Forum will follow up on the statement. The Forum also remains open to further engagement on its content, but the interest of Malawi’s civil society and all advocates working on behalf of key populations will not waver. The KPIF represents a vital resource in the struggle against discrimination and inequity. We can’t afford to see it squandered.

Keeping Tabs On—and Influencing—KPIF Rollout in Uganda

Kenneth is the Advocacy and Networking Officer at HEPS-Uganda.

In 2016, the Key Population Investment Fund (KPIF) was announced by PEPFAR leader Ambassador Deborah Birx at the UN High-Level Meeting. It took two years before this commitment materialized, and at the AIDS 2018 conference in Amsterdam, Ambassador Birx announced that the funds would finally be disbursed to selected awardees through PEPFAR agencies to existing cooperative agreements. The $100M (split between CDC and USAID) is meant to support scale-up of key population-led community approaches to expand and enhance HIV services. In Uganda, the $10m envelope of funding for KPIF is being implemented by CDC through existing implementing partners like The AIDS Support Organization (TASO) and Baylor.

Since the announcement, advocates and key population (KP) representatives have been at the forefront of planning for KPIF implementation, advocating that the fund must serve its primary purpose—expanding demand for and access to quality, effective HIV prevention, care, and treatment services for key populations; addressing structural barriers, reducing stigma, discrimination, and violence; promoting regular and meaningful engagement of KPs; promoting human rights without distinction; and supporting collection and analysis of epidemiologic data on KP subpopulations. Ugandan civil society representatives have kept a keen eye on every stage of the KPIF planning and implementation thus far.

Early on, key population and civil society representatives were involved in a consultative priority-setting meeting in October 2018. These KPIF priorities were echoed at the 2019 Regional Planning Meeting (annual meetings to make plans, set targets and define approaches for Country Operational Plans (COP)) and they were incorporated into the Strategic Direction Summary (a country-specific document that describes investments, targets and program strategy for the COP).

Furthermore, Sexual Minorities Uganda (SMUG) spearheaded the formation of the Uganda Key Population’s Consortium, and under the banner of the consortium, civil society and KP representatives of the PEPFAR core committee led nationwide popularization of the KPIF.

After the Regional Planning Meeting in March 2019, KPs and civil society representatives have continued to monitor the implementation of the KPIF. After CDC’s implementing partners sent out the first calls for application, advocates and some KP representatives set up a technical working group team that supported local community-based KP organizations to review applications and help strengthen the proposed interventions.

During this process, advocates observed that there were needlessly stringent requirements and that there was minimal dissemination of the call, which was contrary to the objectives of the KPIF. Additional issues raised by KP representatives and advocates included lack of experience by some of CDC’s implementing partners in working with KPs, blatant homophobia and the requirement that groups be fully registered with strong financial systems, which disqualified many community-based KP organizations (which the fund is ideally supposed to strengthen).

Advocates were able to successfully advocate for a formal advisory group, which includes civil society and key population representatives, to oversee the implementation of the fund. And in the meantime, CDC has halted the sub-granting process to address some of the issues raised by CSOs. Watch this space for further developments!

Be Heard! Resources for Activism in Planning for KPIF Rollout

In-country planning for the Key Population Investment Fund (KPIF), a PEPFAR initiative to fund programs and organizations focused on key populations, has finally begun. AVAC and a number of our partners have been working with KP-led organizations in KPIF countries to help them engage in and influence the ongoing country-level processes. AVAC has developed a new resource and documented some of its work to-date to help inform ongoing advocacy and action. Read on for more!

Activism in Action: Malawi, Uganda and Zambia

Lessons learned from the engagement experiences in Malawi, Uganda and Zambia are required reading for advocates and key population groups looking to make an impact during the in-country KPIF planning process.

In Zambia, KP-led CSOs came together to demand their space and put forward their recommendations on what should be included in the KPIF. In Malawi, the Diversity Forum, a newly established KP coalition, demanded accountability and transparency in the KPIF processes. And in Uganda, a formal advisory group, which includes civil society and key population representatives, was established to oversee implementation of the fund. These experiences, documented on the P-Values blog, highlight lessons learnt and next steps, which other civil society and KP groups can look to replicate or adapt.

KPIF Guide

An Activist’s Guide to Influencing and Monitoring KPIF Rollout, is designed to guide advocates as they engage with KPIF planning and implementation. The guide points to specific components of the KPIF and key things to watch out for in the coming months.

The Guide also includes a link to a survey for KP-led organizations in KPIF countries to assist in providing timely information and support on engagement. If this applies to you or your organization, please fill it out here!

What Women (and Girls) Want

Key findings from a review of HIV prevention projects in sub-Saharan Africa

A new report, What we know and don’t know about adolescent girls and young women and HIV prevention in sub-Saharan Africa: Mapping findings across completed, ongoing and planned projects, analyzes data from 49 projects in 20 countries to identify steps that will advance HIV prevention awareness, uptake and adherence by adolescent girls and young women (AGYW). Among the findings is the existence of a robust body of knowledge that explores young women’s attitudes about HIV prevention. But the field knows far less about the effect of communities on attitudes and behaviors related to prevention, even though that support is thought to be crucial to the uptake of HIV prevention. These and other findings in the report can inform implementers and policy makers now, and they also point to where more research is needed.

Adolescent girls and young women (AGYW) comprise the majority of new HIV infections in sub-Saharan Africa. According to UNAIDS, young women between the ages of 15 and 24 in sub-Saharan Africa are twice as likely to be living with HIV than young men of the same age, and 75 percent of all new infections in 15- to 19-year-olds are found in AGYW. Responding to the needs of AGYW is critical to ending the epidemic in the region. Many programs have implemented HIV prevention interventions aimed at AGYW, with varying success, as they confront the unique challenges, concerns and vulnerabilities faced by AGYW.

Oral PrEP is one such HIV prevention option, which is US FDA-approved, WHO-recommended, and demonstrated to be very effective in research studies. But, in many settings, implementers have faced challenges rolling out PrEP, a reminder that the efficacy of a product alone is not a predictor of real-world success. When people do not like a product, face structural or social barriers to accessing it, or have difficulty incorporating it into their daily lives—and thus don’t use it—efficacy by itself cannot overcome that.

So, what do AGYW need and want from a prevention product or program? What program features or social factors will galvanize them to use a product or participate in a program, continue with that intervention and ultimately champion it with their peers and communities? The report, produced by the the HIV Prevention Market Manager and Clinton Health Access Initiative (CHAI) and funded by the Bill & Melinda Gates Foundation, explores these questions, drawing from 49 projects focusing on AGYW in sub-Saharan Africa, for which HIV prevention is a primary objective. It examines 308 individual key findings reported by these projects to highlight what approaches have worked best and why, and where data gaps exist in the field. (Through the HIV Prevention Market Manager, AVAC has also undertaken human-centered design research in South Africa to better understand the factors that encourage or discourage AGYW’s engagement with HIV prevention.)

The report’s analysis maps the findings along two continuums, the social ecological model and behavior change framework. The number of findings along either of these continuum point to stronger or weaker areas of knowledge in the field. For instance, most findings focus on the individual and the initial “awareness” stage of behavior change, an indication that many AGYW are not yet using prevention methods and fewer have begun championing them with others.

Level of Knowledge SEM