Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

What’s Next for the Dual Prevention Pill (DPP)

Dear Advocate,  

The latest edition of the Journal of the International AIDS Society features newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The article, Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape, demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV. 

The DPP is the Multipurpose Prevention Technology (MPT) closest to market and the first-ever with PrEP. Following the recent successful conclusion of a bioequivalence study, where researchers demonstrated the active ingredients functioned in the body the same as when PrEP and oral contraception are taken separately, the DPP could be approved by regulators by late 2025. The DPP could be a desirable choice for women seeking an option that will meet multiple needs in their sexual and reproductive health (SRH). 

The research found that a significant proportion of family planning (FP) services in Kenya (22%), South Africa (11.4%) and Zimbabwe (17.3%) are delivered using the private sector (such as private provider networks, pharmacies, e-pharmacies and telemedicine). But these channels remain underutilized and represent a largely untapped — yet growing — delivery channel with great potential to expand access to PrEP.

“Addressing the underlying reasons why this is the case will be a prerequisite to DPP rollout, not just in these three countries, but in all countries with high HIV incidence where the private sector is a popular source for FP, such as Eswatini, Lesotho, Malawi, Namibia, Uganda and Zambia”. 

The authors write.

Based on these findings, regulators should update national guidelines to allow for more diverse PrEP delivery. Training on PrEP delivery could be expanded among nurses and other providers, as well as doctors. Clinics, pharmacies, telemedecine and e-pharmacies could offer PrEP.  Implementers and researchers should also undertake research to better understand willingness and ability to pay, how these factors align with the cost of DPP delivery, and what additional subsidy may be needed to ensure successful rollout of the DPP. 

This research supports a Market Preparation and Introduction Strategy that is guiding plans for how, where and to whom the DPP is introduced. Providing users a range of options to access the DPP in non-traditional channels will minimize stigma, improve convenience, and offer discretion — all of which are features that will increase overall uptake and continuation. See our resources on the DPP below. 

Harnessing private sector strategies for family planning to deliver the Dual Prevention Pill, the first multipurpose prevention technology with pre-exposure prophylaxis, in an expanding HIV prevention landscape

Working with colleagues, AVACers Cat Verde Hashim and Kate Segal published this research article in the Journal of the International AIDS Society. The researchers undertook qualitative research in Kenya, South Africa and Zimbabwe to prioritize private sector service delivery approaches for the introduction of the DPP.

Spotlight on MPTs Addressing STIs

This graphic outlines the development journey of multipurpose technologies (MPTs) that guard against STIs, including HIV, while also preventing pregnancy. It tracks the advancement of various potential products through different trial stages, emphasizing their combined protective roles. Excerpted from our Advocates’ Guide to Multipurpose Technologies.

MPT R&D Funding 2018-2021

This graphic tracks funding levels for a variety of multipurpose technologies for several years. Excerpted from our Advocates’ Guide to Multipurpose Prevention Technologies.

At A Glance: The MPT R&D Pipeline

This graphic shows the status of products in development. Excerpted from our Advocates’ Guide to Multipurpose Technologies.

Advocates’ Guide to Multipurpose Prevention Technologies (MPTs)

Multipurpose prevention technologies (MPTs) are products designed to simultaneously address more than one sexual and reproductive health concern. This advocates’ guide shows the pipeline of products in development, discusses why MPTs are needed, investment, and what advocates can do to push for MPT development and introduction.

PxPulse: The Advocacy Chronicles with Ruth Akulu

On this episode of the Advocacy Chronicles: a look at advocacy in Uganda for the Dual Prevention Pill (DPP), a new product combining oral PrEP and oral contraception.

Ruth Akulu is a Youth Representative of the Uganda Country Coordinating Mechanism Board for Global Fund, member of the DPP Civil Society Advisory Group, and a 2022 AVAC Advocacy Fellow. Akulu talks about her work to mobilize regulatory authorities to prepare for the DPP. And while she was at it, the establishment of a groundbreaking new initiative, the Product Regulator’s Engagement Committee, which is supporting ongoing engagement between government regulators and young women representing their communities.  

Listen to learn why the DPP is a priority for young women and HIV prevention, the challenges Ruth confronted and tactics that supported the success of this advocacy.

Listen

Resources

Avac Event

AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of women’s prevention

This session will be 9:30AM to 11:00AM Munich time.

Women need a range of HIV prevention options to meet different needs, preferences and life circumstances. Currently available pills, rings and injectables are necessary but insufficient. How might we accelerate the delivery of methods we have while developing additional ones – including systemic and non-systemic methods, short-acting and on-demand products, to complement longer-acting ones? Product developers and advocates are collaborating on new approaches to expedite R&D of additional HIV prevention options. Notably, MATRIX is taking a unique approach, endorsed by the CASPR network of advocates, that aims to improve the odds of success of new products – through development, delivery and use.

This session will focus on new efforts to identify and develop promising options, strategically engage all stakeholders, decolonize R&D and involve potential users in all their diversities throughout the process.

Speakers:

  • Jeanne Marrazzo, National Institute of Allergy and Infectious Diseases
  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Thesla Palanee-Phillips, Wits RHI

Followed by a moderated panel with:

  • Chimwemwe Chamdimba, African Medicines Regulatory Harmonization (AMRH) initiative- AUDA/NEPAD
  • Kelly Chibale, Holistic Drug Discovery and Development Centre -H3D, University of Cape Town
  • Nyaradzo Mgodi, University of Zimbabwe- Harare Health Research Centre
  • Jerop Ruth Limo, Ambassador for Youth and Adolescents Reproductive Health Program (AYARHEP)

Moderators:

  • Navita Jain, AVAC
  • Kenneth Ngure, Jomo Kenyatta University of Agriculture and Technology

Session Chairs:

  • Sharon Hillier, University of Pittsburgh / Magee-Womens Research Institute
  • Imelda Mahaka, Pangaea Zimbabwe

This satellite session will be co-hosted by CASPR and MATRIX, with support from USAID and PEPFAR.

Tracking PrEP Rollout & Learning Lessons

Accelerating the rollout of the full range of proven HIV prevention options depends on learning from what’s been done in the past and investing in coordination and innovation to put improved solutions in place. The Biomedical Prevention Implementation Collaborative (BioPIC) is doing just that. Over the last two years, BioPIC—a project led by AVAC with support from the Gates Foundation—has been gathering and sharing evidence on these critical lessons to ensure the next generation of HIV prevention products reaches everyone who needs and wants them with much greater speed and equity.  

What We’re Learning—Highlights from 2024 Convenings

An ongoing series of think tanks, convened by BioPIC and WHO since 2021, are generating key insights for people-centered product delivery. Below, read the latest reports from these think tanks that are informing decision-making on priorities for accelerating access to PrEP. Go to the BioPIC’s page on PrEPWatch to find reports on all think tanks since 2021.  

  • Early Insights from EBONI and PILLAR, February 2024: Early insights from ViiV Healthcare, the manufacturer of CAB for PrEP, from two CAB for PrEP implementation studies, EBONI and PILLAR. Conducted by ViiV in the US, these are among the first studies gathering data in real-world settings. Learn more
  • Taking Stock of PrEP Evidence, March 2024: An analysis of current data and priority evidence gaps. This inquiry was not focused on any one PrEP product, and its findings are informing the focus of future think tanks. Learn more
  • Linking Modellers with the Latest Implementation Science Evidence, March 2024: A consideration of the latest modelling data and insights on injectable cabotegravir (CAB) for PrEP. Read about the biggest takeaways from CAB for PrEP modelling here, and learn more about the big questions that require further inquiry here
  • Discussing Early Results from the SEARCH Dynamic Choice Study, April 2024: Professor Moses Kamya of Makerere University shares early insights from the SEARCH Dynamic Choice Study in Kenya and Uganda, which gave participants a choice between oral PrEP, PEP, and CAB for PrEP, and analyzes the role of choice in PrEP coverage. Watch here
  • PrEP and the Role of HIV Self-Testing, May 23: Highlights from the WHO guidance on use of self-testing (HIVST) as an innovative way to increase PrEP access and coverage and further simplify PrEP delivery. Panelists also share experiences with procurement, costing, rollout and scale-up. Watch Here

As other new biomedical HIV prevention products roll out, BioPIC will continue to hold strategic convenings, identify and address evidence gaps, and work to accelerate equitable product introduction. To learn more efforts to coordinate the introduction of CAB for PrEP, check out the JIAS article Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC). To learn what’s needed to better coordinate rollout for not-yet-approved products in Phase III clinical trials, check out BioPIC’s Adaptable Product Introduction Framework. 

We hope you will book mark these resources, and stay up to date on findings from future think tanks and webinars in 2024 on the BioPIC page of PrEPWatch.