What’s up with F/TAF for PrEP: Webinars on safety, trial design and $$$

Next week, on November 11th, 13th and 15th, AVAC and partners will continue the webinar series addressing key issues related to the US FDA’s October approval of F/TAF as PrEP and its supplemental approval directing drug maker Gilead to conduct a trial among cisgender women. See below for webinar details and registration links, and check out the first webinar in this series from last month for more background.

Dubbed Descovy by its maker Gilead, F/TAF has prompted heated discussion on several critical fronts. The recent FDA approval excluded “those who have receptive vaginal sex” due to insufficient data about safety and efficacy among cisgender women. Following this decision, Gilead is going forward with a new trial among cisgender women that will involve innovations to trial design. In addition, advocates have posed important questions about how the safety data compare between F/TAF (Descovy) and TDF/FTC (Truvada) and the implications for marketing and access. To explore these and related questions, AVAC, IRMA, TAG, WRI and The Well Project are hosting a series of webinars.

It’s Complicated- Implementation questions regarding price, programming and policies for Descovy as PrEP

November 11, 10:00 – 11:15am EST
Register here.
We’ll probe what Descovy’s market presence will mean and discuss the advocacy priorities to meet the challenges and opportunities. These questions are informed by the fact that Truvada (aka TDF/FTC) is set to go off patent next year, several generic options are waiting in the wings, and funding PrEP-related services in the US rely on key programs. The presentations will be moderated by Kathie Hiers, CEO of AIDS Alabama, and include Amy Killelea (NASTAD), Tim Horn (NASTAD), David Hardy (HIVMA and Johns Hopkins University), and James Krellenstein (PrEP4All).

Trial Design Takes a Step in the Post PrEP Era: What will Gilead’s study of F/TAF among cisgender women tell us about next gen PrEP and next gen trial design

November 13, at 10:00 – 11:15am EST
Register here.
The FDA’s October approval excluded F/TAF as PrEP “for those who have receptive vaginal sex.” Many voices have expressed outrage that Gilead’s strategy for F/TAF regulatory approval left women by the wayside. Gilead had previously claimed finding a relevant cohort of women would not be feasible. Gilead is designing a novel trial, planned to begin in Africa in 2020, to gather missing data about the safety and efficacy of F/TAF among cisgender women. What are the implications of this trial? In this webinar, the FDA’s Jeff Murray will present how an innovative design will enable a relatively smaller trial, and the questions it raises.

PK, PD and F/TAF: What does an advocate need to know about the pharmacology of safety and efficacy and today’s PrEP drugs

November 15, 1-2pm EST
Register here.
Leading pharmacologists including Angela Kashuba (UNC), Craig Hendrix (Johns Hopkins) and Pete Anderson (University of Colorado) will join in a discussion on the important pharmacokinetic and pharmacodynamic questions related to F/TAF and TDF/FTC. We’ll explore questions about what drug levels matter, and where in the body drug needs to be to protect against HIV.

Check out the first webinar in this series from last month where we explored the background science of F/TAF vs TDF/FTC as PrEP.

As always, the webinars will be recorded and posted on the AVAC website. And we welcome any questions in advance!

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

In case you missed it, this round-up of AVAC’s latest resources will keep your finger on the pulse of HIV prevention advocacy!

Planning for Rollout: Report

A new publication, The Dapivirine Ring: Key Learnings from Like-Product Introductions, from AVAC and the OPTIONS Consortium looks at the rollout of other public health interventions and how they overcame barriers to acceptance. Some of the cases come from interventions that offered partial protection, others from products that are vaginally inserted. The dapivirine ring shares both of these characteristics, and this report offers specific lessons to guide early planning for rollout.

Demanding Access to Data: Report

Hot off the presses, Data Watch: Data Accessibility from Global Funders of HIV, TB and Malaria Programming, published by amfAR and supported by AVAC’s COMPASS program, details which data are publicly available from each funder and which data are not. It focuses on the level of information available to grassroots advocates to monitor and understand how donor-funded programs for HIV, TB, and malaria are working in their own communities.

Designing Prevention That Works: Podcast

The latest episode of our Px Pulse podcast, Human-Centered Design and Prevention in the Real World, explores an intensive human-centered design project, Breaking the Cycle of Transmission, that is part of AVAC’s Prevention Market Manager program and is trying to better understand and design programs that help adolescent girls and young women chart a journey to HIV prevention.

Adapting for Impact at Scale: Event recording

On October 22nd, the CSIS Global Health Policy Center hosted an event on recent developments in HIV prevention and treatment technology and how to bring those interventions to scale. Speakers included ViiV CEO Deborah Waterhouse, PEPFAR leader Ambassador Deborah Birx, Elizabeth Glaser Pediatric AIDS Foundation CEO Chip Lyons, and AVAC’s Mitchell Warren. Watch the video to learn more about the successes and challenges in developing and delivering new products into existing service delivery, and how global programs, such as PEPFAR and the Global Fund, need to adapt. CSIS also launched a new report at the event: The Evolution and Future of HIV Prevention Technology: An HIV Policy Primer.

Getting PrEP to Everyone Who Needs It, F/TAF and Women in Trials: Webinar

Check out the webinar AVAC hosted, Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP, for a review of the data and to explore questions about the safety profile of F/TAF. In early October, the FDA approved DESCOVY as PrEP for HIV-negative individuals (weighing 35kg or more), except for those who have receptive vaginal sex, which prompted outcry over Gilead’s failure to include women in clinical trials, among other questions related to F/TAF.

Keeping Up With the Pipeline of Prevention R&D: Infographic

Download the most recent update to our infographic that tracks the pipeline of non-vaccine HIV prevention products, including oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals, implants and more. Also featured are the range of multipurpose prevention technologies in development, which aim to reduce the risk of HIV and STIs and/or provide effective contraception for women. And checkout the newest version of the Global PrEP Tracker on PrEPWatch.org that provides the latest data on programs, number of enrollments by country, regulatory status and more.

Data Watch: New report out on funding data for advocacy

amfAR has released a new report, Data Watch: Data Accessibility from Global Funders of HIV, TB, and Malaria Programming, which analyzes data availability across four of the key funders of global HIV, TB, and malaria programming: The Global Fund, PEPFAR, the President’s Malaria Initiative, and USAID TB programming.

The report details which data are publicly available from each funder and which data are not. It focuses on the level of information available to grassroots advocates to monitor and understand how donor-funded programs for HIV, TB, and malaria are working in their own communities. The report evaluates the adequacy of the data by looking at what is funded in a community, who is funded and whether the services are being delivered as contractually specified. Recommendations are made for each funder on how to increase their data transparency to ensure advocates remain informed and equipped to address any issues that might arise. The adoption of these recommendations can only improve transparency and, in doing so, aid the fight against the global HIV, TB and malaria epidemics.

This project was developed as part of COMPASS Africa (the Coalition to build Momentum, Power, Activism, Strategy and Solidarity) by amfAR and supported by AVAC.

New Episode of AVAC’s Podcast, Px Pulse! Human-Centered Design and HIV Prevention in the Real World

Our latest episode of the Px Pulse podcast looks at Breaking the Cycle of Transmission, a human-centered design project that’s shedding new light on how to bring HIV prevention to adolescent girls and young women.

The task is imperative. Four out of five new infections among adolescents in sub-Saharan Africa are in girls. Young women aged 15-25 are more than twice as likely as their male counterparts to be living with HIV, based on the latest figures from UNAIDS. The challenge is daunting—stigma, gender-based violence and other forms of inequality persist as serious barriers to prevention.

To overcome these barriers, AVAC and CHAI’s Prevention Market Manager project is applying strategies for understanding the needs of adolescent girls and young women through an approach known as human-centered design, or HCD.

In this episode of Px Pulse, we hear from AVAC’s Global Marketing Manager, Anabel Gomez, about the HCD project in South Africa that is trying to chart a path that will better support girls and young women on a journey to HIV prevention.

We also hear from two members of the team—Lesego Taule and Mpumi Mbethe—who helped lead discussions with girls and young women to understand their needs, hopes and challenges in communities where HIV rates are high.

And Anthony Ambrose of NACOSA, an implementer in South Africa, tells us how the research can be applied to programs, and how it changed the way he thinks about HIV risk.

For the full podcast episode, highlights and resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts to catch every episode!

Vaginas Deserve Better: Responding to recent F/TAF as PrEP approval

Yesterday, the US Food and Drug Administration (FDA) announced its approval of Gilead’s drug Descovy (also known as F/TAF) as daily oral PrEP for adults and adolescents, except those who have “receptive vaginal sex.”

 

AVAC and allies immediately decried the announcement, which lacked an acknowledgement of the gap in data on those at risk of HIV via vaginal sex. The announcement also failed to include any information about a funded plan and timeline for gathering the data necessary to understand if this drug prevents HIV infection among cisgender women.

 

The FDA has since posted its approval letter, which outlines a post-marketing commitment ON GILEAD to conduct a trial in cisgender women, with data expected in mid-2025. As Gilead plans and conducts this long-overdue trial, there’s vital work to be done around early and integrated Good Participatory Practice and community engagement starting now, not after the protocol is approved, and sustained throughout the life of the trial.

 

Join us and other advocates for the first of a two-part webinar series on F/TAF as PrEP. We’ll explore the science and research—and the community response to these developments.

 

Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP

 

As always, please send any comments or questions.

A 15-Year Review of the PEPFAR Support to Malawi: How Has It Succeeded?

Maureen is the African Region Advocacy Advisor for AVAC. This post originally appeared in the Petrie-Flom Center at Harvard Law School’s Bill of Health.

Malawi was listed as one of the six locations that have made remarkable progress towards ending the AIDS epidemic in a recent report produced by amfAR, AVAC and Friends of the Global Fight. Being one of the poorest countries on the list, Malawi has proven that ending the epidemic is possible anywhere.

But one would want to know what has contributed to this success!

Well, there are many factors. And funding from donors is one of them. The HIV/AIDS response in Malawi is largely funded by the Global Fund and PEPFAR. But for the sake of this blog I will focus on PEPFAR, a US government program launched in 2003 by then President George W. Bush. In 15 years of support, PEPFAR has led the world in funding the global HIV response.

In Malawi, PEPFAR has invested nearly $700 million since 2003, which has brought significant improvements in the HIV/AIDS response.

But as you know, funding alone does not guarantee success. There are other factors that have played a role, such as increasing efficiency in the use of the resources, linking funding to performance and impact, having the right policies in place and widening stakeholder involvement, just to mention a few.

PEPFAR’s attention to geographical locations that carry a high burden of HIV incidence has resulted in funds going where they are needed most. PEPFAR has fought hard for the adoption of evidence-based policies, which in turn led to the implementation of the highest impact interventions.

PEPFAR’s strong recommendation to shift from paper to electronic medical records (EMR) has been another game changer for the HIV response in Malawi. Shifting to EMR improved real time access to data throughout the health care system.

Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS), a PEPFAR program meant to reduce HIV infections among adolescent girls and young women, has been another remarkable initiative rolled out to three districts in Malawi. The program has helped improved the socio-economic wellbeing of adolescent girls and young women, thereby reducing their HIV risk.

The HIV response took another important leap forward when PEPFAR opened up its doors to civil society organizations (CSOs). For me, this was proof of the principle that the best results come when funding and policy decisions are made in the presence of everyone who matters.

I remember attending the first country operational plan (COP) meeting where CSOs were invited. It was a revolutionary moment. Having CSOs in the room changed the course of the discussion. For the first time, we had everyone who mattered in the room. The following year we did it again and we are still doing it now.

But there have been challenges too! The first two years following PEPFAR’s inclusion of CSOs, civil society received limited access to PEPFAR data — it was shared late or not at all. This made it difficult for CSOs to effectively engage in the process. CSOs advocated for a change, and PEPFAR leadership has responded by making the data available, though not always timely. But we are getting there.

The other challenge has been getting policies fully implemented. A policy on paper alone is as good as no policy at all. This has been a big challenge for Malawi largely due to limited funding. Malawians can point to a full range of policies now in place, but yet some of them are live only on the books such as the Pre-Exposure Prophylaxis (PrEP) and the T=T/U=U campaigns, both of which have proven to be highest impact interventions elsewhere!

Moving forward a few things need more attention.

We all love the DREAMS program, but only focusing on three districts is not enough. It is time to scale it up!

As we get closer to epidemic control it’s important that we start thinking about how are we going to sustain the gains made so far. PEPFAR has committed to direct 70 percent of the funding to host country governments or organizations by the end of 2020 — this is highly commendable. However, this should not only be on paper, it has to be fully implemented. Lack of capacity should not be an excuse. Deliberate effort must be made to fill any gaps in capacity.

We need to embrace the model of differentiated service delivery to meet the diverse needs of the community members! To date we still have community members who travel a distance of more than 20 kilometers on foot just to get their ART refill! This is not acceptable! We need to get the services closer to them!

And, above all, policies must be fully implemented.

Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP

Please join AVAC, the Treatment Action Group (TAG), The Well Project and the Women’s Research Initiative (WRI) on Monday, October 7 at 9-10am ET for an Advocates’ Debrief on the Science of Daily F/TAF vs. TDF/FTC as PrEP.

REGISTER HERE.

This webinar is the first in a two-part series, responding to advocates’ desire to better understand the research to date on F/TAF as PrEP, especially as it relates to its safety profile [compared to TDF/FTC] and the lack of robust data in cisgender women. This issue came into greater focus during an August 7 FDA advisory committee meeting at which Gilead’s regulatory submission of F/TAF for PrEP was discussed and debated.

On the webinar, AVAC, TAG, The Well Project and WRI representatives will be joined by researchers Andrew Hill (Senior Visiting Research Fellow in the Pharmacology Department at Liverpool University) and Monica Gandhi (Professor of Medicine and Associate Division Chief of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF/San Francisco General Hospital). They will share their take on the latest research, contextualize the August 7 discussion, and help to inform an advocacy agenda for next steps.

For background, check out AVAC’s blog for a recap of the advisory committee proceedings, as well as TAG and PrEP4All’s joint comment to the FDA.

The webinar will be recorded and posted online shortly after its conclusion.

Have a question or comment? Please be in touch!

A Movement for Cure, One Advocate at a Time

Jeanne Baron is AVAC’s Senior Editor and Producer of Px Pulse.

The Advocacy-for-Cure Academy, a partnership of AVAC and IAS, has been developing its cutting-edge curriculum, having completed two annual sessions and promising more in the years to come, just as the field of cure research and advocacy has accelerated on the heels of high-profile breakthroughs.

This is a time like no other before for cure research in HIV. The second person in the history of the virus was determined to be cured, announced in early 2019. This event came as heightened interest in the progress of cure-related research can be felt in standing-room-only sessions at scientific conferences. It’s no surprise that for every available seat at the most recent Advocacy-For-Cure Academy there were 10 times as many applicants who vied to fill them.

The Advocacy-For-Cure Academy has set out to prepare a generation of cure advocates. Over three days of the 2019 Academy in May, leading cure researchers and seasoned advocates explored the current strategies under investigation. They took a focused look at adult versus pediatric immune science and the implications for the cure strategies being pursued in different populations. They turned over the pros and cons of treatment interruption, boned up on points of advocacy around trial design for small, early-phase in human trials, and more.

Long-time advocate in HIV, Botswana’s Kennedy Mupeli of the Centre for Youth of Hope, who is also a former AVAC Fellow, was one of 27 applicants who won a seat at the Academy held in Gabarone, Bostwana.

“What I learned these couple of day—about things like latency-reversing agents [drugs that force latent HIV to express itself so that the immune system can find and kill it] or a therapeutic vaccine [a vaccine for inducing remission rather than prevention]—it’s going to be up to advocates to connect both communities and policy makers to this information.”

And Mupeli had no trouble explaining the value of this education, “Long-term ART, that’s what we have right now, but the failure to eradicate HIV in the long term is not acceptable. We need to bring hope to the community.”

Yet fundamental questions remain to be solved before a viable strategy can emerge. For one thing, scientists are struggling to measure the viral reservoir—a key consideration when trying to evaluate if an intervention has eliminated latent HIV. The uncertainty leaves researchers looking at treatment interruption (aka, analytic treatment interruption or ATI) as the only sure-fire method to learn if HIV is still in the body or not. But interrupting treatment to test an unproven strategy raises unique challenges and ethical questions, particularly when the trials may involve placebos to account for the number of individuals who naturally control the virus after treatment known as post-treatment control. The pressure is on.

“It’s time for a cadre of advocates with expertise in cure research to be at the table, pushing for advances that will empower affected communities and be centered in human rights,” said another attendee at the 2019 Academy, Ulanda Mtamba, Country Director of Advancing Girls’ Education in Africa and also a former AVAC fellow.

Among other things, the field needs advocates offering a critical eye on trial designs and helping communities understand the science as well as the risks and benefits of participating in research. This is all the more urgent, as Mupeli said, because the interest among researchers is not matched by even general awareness of these advances among communities most affected by HIV.

“Cure-related research is happening but no one has any idea of the work being done on this. I hear from many stakeholders in my community. They know about advances, we talk about 95-95-95, we talk about viral suppression, but nothing whatsoever about cure.”

But with the announcement earlier this year of the second known cure on record, awareness may be on the rise. The agenda in Gabarone featured an overview of the science behind the two only known cures to date—both involving bone marrow transplants among patients with cancer and HIV. Participants learned why these two cases cannot be scaled to the 37.9 million who are infected today, and why and how they do inform the science of other strategies like cell and gene therapy.

AVAC’s Jessica Salzwedel, who coordinates the Academy, said participants learned “when and if the cohort of people who have achieved long-term remission from a bone marrow transplant grows from 2 to something bigger, researchers might be able to find commonalities in their genes or in the immunologic pathways. If you can find a common thread among them you can use those pathways to find curative strategies—like a drug or a gene manipulator or a new target—that could be effective for a broader population.”

Attendees learned the basics of a widening number of strategies under investigation such as cell and gene therapy, latency reversal, immune-based strategies and block and lock.

Mtamba digested these new concepts but was just as rapt by a history lesson. A morning session by Kenya’s Maurine Murenga, founder of the Lean on Me foundation covered the role civil society played in major advances in HIV treatment and prevention. “That journey really struck me. Civil society has done so much. They had their demands and were not afraid. It just happened again around the guidelines the WHO has issued for dolutegravir. A battle may look impossible, but we can win. The ultimate goal is finding a cure and the time has come to fight for it.”

Since the 2019 Academy ended, both Mtamba and Mupeli have expanded their work in cure advocacy. Mtamba held a media training with Malawi journalists who were learning about cure for the first time and published stories. More trainings are planned for media and Malawi’s civil society. Mupeli who conducts trainings on HIV across Botswana now includes a section on cure, and he’s developing a cure manual to leave behind. “The idea is to expand this movement across Botswana.”

With the help of the Academy, it won’t just be Botswana that sees a growing movement.

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

A few important new resources are up on AVAC.org and PrEPWatch.org. Read on for highlights and links.

Global Guidance

Don’t miss AVAC’s Take on Updated WHO Guidance on Hormonal Contraception and HIV Risk. You’ll learn “business as usual” is a grave concern in light of the World Health Organization’s (WHO) updated guidance on “Hormonal Contraceptive Eligibility for Women at High Risk of HIV”. The changed status of the hormonal contraceptive DMPA stems from a review that was prompted by the results of the ECHO Trial.

F/TAF and Women

In our blog, “A New Oral PrEP Strategy Is On the Horizon, But Who’s Going to Get It?” you’ll get the details on a potential new oral PrEP strategy using F/TAF, which inched a step closer to availability—though not necessarily for all people who need it. The blog provides information on what happened at an Antimicrobial Drugs Advisory Committee meeting on F/TAF for PrEP, convened by the US Food and Drug Administration—and what needs to happen next.

PrEP and the Challenge of Continuation

Watch the webinar, Identifying PrEP Continuation Challenges and Approaches to Support Success, to hear implementers from Kenya (Jhpiego/Jilinde) and Zimbabwe (PZAT) share PrEP continuation challenges, successes, and approaches. And learn more about findings from a recent think tank our Prevention Market Manager project co-convened with a number of partners on defining impact and success in the context of PrEP, and key considerations for measuring and monitoring continued and effective use.

Fellows in 2020

Apply to become an AVAC fellow, or send this application to someone who you know belongs in AVAC’s 2020 class of Advocacy Fellows. AVAC’s Advocacy Fellows Program has been supporting and expanding the capacity of advocates and organizations to accelerate, shape and monitor biomedical HIV prevention research and implementation since 2009. Our Fellows have gone on to become leaders in the HIV movement in their communities, countries and globally. Don’t miss your chance to join the next class—deadline is September 20th!

AVAC’s Take on Updated WHO Guidance on Hormonal Contraception and HIV Risk

Today, the World Health Organization (WHO) released updated guidance on “Hormonal Contraceptive Eligibility for Women at High Risk of HIV”. The WHO updated guidance shifts DMPA, other progestogen-only injectables and IUDs to a MEC 1 classification, which states that the products can be used without restriction. The updated WHO recommendations follow a thorough review of the latest scientific evidence, including the recent results of the ECHO trial, which evaluated whether the risk of HIV differs with the use of three different safe and effective contraceptive methods: depot medroxyprogesterone acetate-intramuscular (DMPA-IM), also known as Depo-Provera, the copper intrauterine device (Cu-IUD) or a levonorgestrel (LNG) implant, also known as Jadelle.

About WHO’s Updated Guidance

The WHO updated guidance shifts DMPA, other progestogen-only injectables and IUDs to a MEC 1 classification, which states that the products can be used without restriction. This is a shift from the 2017 MEC 2 categorization of progestogen-only injectables, which states that the benefits of a product outweigh the theoretical or proven risks. From 2012 to 2016, DMPA and other related contraceptives were classified as a MEC 1 with a qualification—that the uncertainty around DMPA and HIV risk meant women at high risk of HIV who chose to use DMPA should receive HIV prevention services and counseling. (Click here for a background document on hormonal contraception and the WHO Medical Eligibility Criteria (MEC) system for contraceptives explains key issues in plain language.)

Now What?: AVAC’s perspective on the new WHO guidance

With this new guidance from WHO, DMPA and other progestogen-only contraceptives have their third distinct MEC classification in seven years. While the classification has changed, the context in which women receive HIV prevention and contraceptives and the number of choices available to them have not.

We are gravely concerned that this guidance will be used to justify a “business as usual” approach in which contraceptive procurement, program design, service delivery and counseling approaches go unchanged. This approach ignores women’s priorities and the clear imperative to transform services so that sexual and reproductive health and HIV concerns are addressed in the same place, at the same time, in a stigma-free environment.

The past seven years saw incremental adjustments in the range of methods available in some countries, but nothing approaching the investment and commitment needed from policy makers, funders and implementers of sexual reproductive health & rights (SRHR) and HIV services. These services continue to exist in vertical programs, even though integration is needed as an emergency response to the soaring HIV epidemic in young women—many of whom are far more concerned about avoiding pregnancy than preventing HIV.

The updated WHO guidance will simplify the messages about specific methods. However, meeting HIV and SRHR needs is a complex issue; so is the science around HIV risk and progestogen-only contraceptives. As the Civil Society Advocacy Working Group on HC-HIV noted, any increase in HIV risk associated with method use is unacceptable and the ECHO trial was not powered to eliminate the possibility of risk, but to detect with confidence a 50 percent increased hazard ratio.

This updated guidance reflects evidence on a level of risk determined by the scientific community to be relevant for public health and individuals; but women in all their diversity will want and need to be able to make their own determinations, which is why informed choice and provision of a full range of contraceptives, including alternatives to DMPA-IM, are essential.

The WHO should, with these guidelines, identify specific, actionable and monitorable ways to expand contraceptive method mix and integration of HIV, STI and SRHR products and services, sending a clear signal that the updated classification is not an excuse to preserve the status quo.

Every woman matters and no woman should have to choose between comprehensive sexual and reproductive health services and HIV prevention. Yet today, women’s access to services is under threat by funders who prioritize ideology over evidence and control over bodily autonomy. We must step up and do the challenging work of implementing women-led and -centered programs. If we don’t, the cost in lives will be even higher.

Additional Information about the ECHO Results

The ECHO trial, which released its results in June 2019, enrolled 7,829 women in eSwatini, Kenya, South Africa and Zambia. The women came from communities with high levels of HIV, but they were not recruited for the trial based on any specific risk factors for HIV. They were sexually active, and sought contraception. All of the women received HIV prevention counseling, condoms, HIV tests; a small number used PrEP, as it became available in their countries. The trial was designed with the statistical power to detect a 50 percent increase in risk associated with any method.

ECHO found no substantial difference in HIV risk among women in the trial arms. Based on the design, a smaller level of increased risk, especially below 30 percent, could not be ruled out. Though no method was associated with increased risk, the rates of HIV were alarmingly high in all groups of women: 3.8 percent across all of the participants. (This HIV incidence rate exceeds WHO’s threshold for defining populations as being at “substantial risk”, as stated in the WHO oral PrEP guidelines.) The ECHO trial also revealed concerningly high levels of other sexually transmitted infections (STIs) among women seeking contraceptive services, particularly younger women. Click here to read AVAC’s Understanding the Results of the ECHO Study.