There will be no issue next week. The NewsDigest will return on July 12, 2019. Happy Independence Day to those celebrating and a wonderful week to all!
In the days since the leaders of the ECHO Study announced their findings, AVAC has produced a number of resources to inform advocacy and action.
Tune in to a special episode of AVAC’s podcast, Px Pulse. The ECHO Trial Results: Time to Act features two veteran women’s advocates from Kenya and South Africa, Jaqueline Wambui and Yvette Raphael, who talk about what the high rates of HIV in the trial mean for advocacy now. Helen Rees and Nelly Mugo, members of the ECHO trial leadership team, explain the results and their implications, and James Kiarie of WHO shares the importance of the WHO guidelines and more. (And for background on the trial, you can also check out our pre-results podcast – The ECHO Trial: Preparing for Action.)
AVAC has published a comprehensive guide to interpreting the results of the trial in Understanding the Results of the ECHO Study. You’ll find concise information on the trial’s background, design and results, and a full section on next steps such as the WHO process for updating its guidelines and what you can do to get involved.
Webinar: What do the ECHO Study results mean for African women?
In case you missed it, AVAC and ICW-EA hosted a webinar on June 27th with Jared Baeten and Tim Mastro from the ECHO Consortium, and James Kiarie from WHO. In a discussion moderated by ICW-EA’s Lillian Mworeko, speakers discussed implications of the findings and took questions from members of the ECHO Global Community Advisory Group and other women’s health advocates.
Use these tools and find more at www.avac.org/echotrial to join the movement demanding informed-choice and expanded, integrated options for HIV prevention and sexual and reproductive health.
[UPDATE: Recording and slides from the webinar are now available below. And a link to Understanding the Results of the ECHO Study is now available as well.]
Please join women and our allies for a global webinar, Thursday, June 27, 9-10am EDT / 3-4pm SAST / 4-5pm EAT, on shaping the post-ECHO agenda for comprehensive sexuality and reproductive health and rights. This emerging agenda will inform an upcoming WHO meeting on this critical subject. Please join the leaders of the Civil Society Working Group on HC-HIV, members of the ECHO Global Community Advisory Group and young women advocates for this discussion with WHO and the ECHO Consortium Management Team members.
On June 13, the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study released its results. The study was designed to evaluate the risk of acquiring HIV among HIV-negative women who used one of three contraceptive methods: depot medroxyprogesterone acetate-intramuscular (DMPA-IM), also known as Depo-Provera, a copper intrauterine device (Cu-IUD), and a levonorgestrel (LNG) implant, also known as Jadelle. The study found that there was no substantial difference in HIV risk among women using any of these three methods. These results mark an important step for women’s health—the findings provide evidence that WHO and national ministries of health will hopefully use as they develop policies and programs that directly impact women’s lives.
What do the ECHO study results mean for African women: A webinar organized by the Civil Society Working Group on HC-HIV (co-convened by AVAC and ICW-EA) — Thursday, June 27
Prepare for the discussion with resources available on www.avac.org/echotrial, which are also highlighted below:
- HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial— The Lancet
- How Should We Listen to ECHO? — The Lancet commentary
- Watch the presentation of the ECHO study results from the SA AIDS Conference
- FP2020 and AVAC held a webinar, A Roadmap for Results: Understanding the ECHO Study Results, with the ECHO team following the results announcement. The webinar explained the trial, provided topline results, outlined next steps, and offered key advocacy messages to help all stakeholders understand the findings. Watch here.
- Visit the ECHO page for a statement from the Civil Society Working Group on HC-HIV on the study results, as well as a range of other public statements on the results and their implications.
In the coming days, AVAC will release Understanding the Results of the ECHO Study, a document designed to help advocates understand some of the issues related to the ECHO trial, the questions it was designed to answer, its findings and next steps. AVAC will also release the next episode of our Px Pulse podcast, where you will hear from members of the ECHO Trial team and leading women’s advocates discuss what they think about the results, so be on the lookout!
This diverse set of some of the latest resources on PrEPWatch.org will help program implementers from a variety of contexts plan for the rollout and scale-up of PrEP. Added to the already extensive tools and resources available on PrEPWatch.org are: country-specific Situation Analysis for Kenya, South Africa and Zimbabwe; Health Care Providers’ Knowledge, Attitudes and Practices (KAP) Relevant to Oral PrEP Service Provision to AGYW in Zimbabwe; PrEP Costing Guidelines; The Common Agenda for the Dapivirine Ring, and The Dapivirine Ring Introduction Matrix.
- Country-specific Situation Analysis for Kenya, South Africa and Zimbabwe, have been developed to assess factors that are crucial to the expansion of PrEP rollout. Each report explores the strengths, challenges and progress to date on planning and budgeting, supply-chain management, the status of infrastructure and human resources places where people can obtain PrEP, and how people learn about PrEP and are supported in taking it.
- Health Care Providers’ Knowledge, Attitudes and Practices (KAP) Relevant to Oral PrEP Service Provision to AGYW in Zimbabwe: This KAP study among health care providers in Zimbabwe explored questions about PrEP services for adolescent girls and young women. Health care providers serve as gatekeepers, encouraging or discouraging the use of new products or interventions. For example, providers report they have concerns about community backlash, or ambivalence about adolescent girls taking PrEP without their parents’ knowledge. They also report the need to balance concerns about adherence with the level of risk. The findings offer insights that can be applied to provider training and support. This report from Zimbabwe, and OPTIONS’ other KAP studies in Kenya and South Africa, may well be relevant to other places trying to enhance provider skills as part of the rollout of PrEP.
- PrEP Costing Guidelines lay out the elements of estimating the cost of PrEP and how to adapt them appropriately and transparently for different objectives. These guidelines are written for individuals whose task it is to collect, evaluate and utilize cost data, and who may have differing levels of familiarity with economics.
- Common Agenda for the Dapivirine Ring is for stakeholders working on aspects of planning for the introduction of the dapivirine vaginal ring, and summarizes key components for ring introduction, lists ongoing and planned efforts, and proposes next steps for streamlined and coordinated rollout.
- The Dapivirine Ring Introduction Matrix shows the findings from a pilot discussion in Zimbabwe that explored how to integrate a new prevention product such as the ring into existing programs already focused on oral PrEP. The pilot discussion included policy makers, regulators, researchers, implementers and other partners. This resource explores where existing capacity could also support the rollout of the ring, and it suggests where additional planning and assistance would be needed. The matrix also highlights how ring introduction can strengthen other prevention efforts, especially oral PrEP.
These and other tools being developed by the OPTIONS Consortium (which is co-led by FHI360, AVAC and WITS RHI) can be used in the planning for future HIV prevention products as well. The OPTIONS Consortium is a major contributor to the growing body of technical resources for delivering PrEP options at scale in key countries, and complements work being done by many other efforts and partners, including the Prevention Market Manager project that looks to accelerate PrEP access and also improve the introduction of prevention options still in the research and development pipeline. These efforts dovetail with AVAC’s advocacy programs to close the multi-year gap from proven efficacy to access that has stalled the delivery of prevention in the real world.
Taken together this body of work found on PrEPWatch.org, can serve as case studies and templates to help implementers work swiftly, improve the quality of the delivery of prevention products and maximize their impact.
Stay tuned for more updates, and find the latest at www.avac.org/echotrial.
Today at a satellite symposium at the South African AIDS Conference linked to a publication in The Lancet, the ECHO trial of contraceptive use and impact on HIV risk released its results. The Evidence for Contraceptive Options and HIV Outcomes Study, or ECHO, was designed to evaluate the risk of acquiring HIV in HIV-negative women who used the copper intrauterine device (Cu-IUD), a levonorgestrel (LNG) implant (Jadelle) and depot medroxyprogesterone acetate-intramuscular (DMPA-IM), also known as Depo-Provera.
The topline finding: There was no substantial difference in HIV risk among women using DMPA-IM, the LNG implant or the copper IUD. These are long-awaited data from the most rigorous trial of HIV and contraceptive interactions in history. They are an urgent call to action at a time when women’s reproductive health and rights are under threat in many countries, and the mobilization by and for women’s lives is vibrant and strong.
As AVAC and the women advocates who have led this work in Africa have said in the months and years prior to the result: ECHO must prompt action. Now is the time for investment in woman-centered programs that offer a full range of contraceptive choices and HIV prevention strategies at the same site and in the context of a true informed-choice approach. The ECHO results tell us this is the case. The women who made the trial possible deserve nothing less.
Find the AVAC press release here and commentary from Yvette Raphael in an op-ed on the results in the South African Mail & Guardian’s Bhekisisa health journalism center. And we hope you’ll read on and join us in the fight!
This update provides:
- Basics on the data release
- What are the topline trial findings?
- What do the results mean – including core messages coming from the HC-HIV Civil Society Advocacy Working Group, the Africa-based women’s network led by ICW EA, with AVAC
- Who should act—and how?
- Trial background
ECHO Data: The basics
What are the topline the trial findings?
The ECHO trial did not find any significant difference in HIV risk among women using the three methods studied: DMPA-IM, LNG implant and the copper IUD. Not very many women used pre-exposure prophylaxis, or PrEP, for HIV prevention during the trial; women who used DMPA-IM reported more condom use and fewer partners. These choices don’t seem to have made a difference in HIV risk.
All of the contraceptive methods tested were safe, effective and acceptable; the majority of women stayed on the method that they were assigned to use. Very few became pregnant while they were using the method.
There were high HIV incidence rates in all three arms of the trial. This does not mean that the methods increased women’s risk. These incidence rates are comparable to those seen in young women in these countries in other trials and contexts. What is notable, though, is that many trials with comparable incidence rates recruited women with specific HIV risk factors, such as numbers of partners, commercial sex work, sexually transmitted infections, etc. In ECHO, HIV risk factors were not part of enrollment criteria. The participants were sexually active young women looking for contraception. ECHO gives a stark picture of the risk facing these young women. HIV prevention services must meet them where they are—in contraceptive clinics and other related services.
What do the results mean?
The results are a clear call for contraceptive programs that offer more method choices, including DMPA-IM for women who want to start or continue it, along with comprehensive HIV prevention interventions. The new information from ECHO should be used to improve counseling, expand method choices and rapidly and urgently integrate HIV prevention and treatment with contraceptive programs. The level of HIV risk among eSwatini, Kenyan, South African and Zambian women in the trial was profoundly high. The majority of the participants were under 25, who were not identified as at high risk for HIV—but were simply sexually active and seeking contraception.
The HC-HIV Civil Society Working Group says:
The ECHO results are not “good news”. The women in the trial did not have any specific HIV risk criteria. They recruited women who wanted contraception and were sexually active. It is a wake-up call to put HIV prevention on site at every family planning clinic including PrEP and female condoms with peer support, trained providers.
A key question about DMPA-IM has been answered, but that does not mean the method can continue to dominate women’s contraceptive programs in East and Southern Africa. We don’t believe that DMPA-IM should continue to be the only long-acting method available. Black and brown women in East and Southern Africa want choices, dislike side effects and deserve equity with the high-quality contraceptive programs often available in high-income countries.
ECHO shows method mix is possible. Women use many things. Make it happen.
Women need strategies to prevent pregnancies and HIV infection at the same sites, from the same providers, in a rights-based, woman-centered context. Throughout ECHO, the risks of unplanned pregnancy and HIV were pitted against each other by scientists and normative agencies. Now is the time for integration. This has to include investigation—more research on how to deliver services that meet contraceptive and HIV needs well, what is driving HIV risk and how to address it, and more.
Who should act—and how?
- WHO should follow through on its commitment to rapidly convene a Guidelines Review Group (GRG), issuing a clarifying statement for countries in the interim. This GRG should include African women who have led advocacy on this effort for nearly a decade.
- Every east and southern African country must now make or implement, with full funding, a plan—with milestones—for expanding contraceptive method mix and uptake, and integrating HIV prevention into contraceptive service points.
- The upcoming WHO meeting in Zambia prompted by the ECHO results should generate a declaration of commitment to this, along with a commitment from funders to put money into this work and revisit the key milestones across the regions and in countries in one year’s time. This review could be guided by the method mix and choice indicators developed by FP2020 and the integration index piloted by the US group CHANGE.
- This review must be validated by “ground forces”—women who live and work and love in the places where this trial happened. There is nothing for us without us, nothing that can call itself a “woman-centered approach” with a straight face if it does not have women, especially young women, in the lead.
The Evidence for Contraceptive Options and HIV Outcomes Study, or ECHO, was designed to evaluate the risk of acquiring HIV in HIV-negative women who used the copper intrauterine device (Cu-IUD), a levonorgestrel (LNG) implant (Jadelle) and depot medroxyprogesterone acetate-intramuscular (DMPA-IM), also known as Depo-Provera. The trial also compared pregnancy rates among women using these methods, documented rates of method discontinuation and switching, and provides a valuable body of evidence about acceptability of these methods among African women.
Many women1 at risk for HIV are also concerned about avoiding or postponing pregnancy. Some observational studies have suggested that specific injectable contraceptives (e.g., DMPA-IM)2 can increase women’s risk of acquiring HIV, while other studies have not suggested this link between DMPA-IM and HIV risk. Before ECHO, very little was known about other methods and their relationship to HIV risk—no other randomized trial had been conducted on the relationship between HIV risk and a contraceptive method. ECHO was designed to gather high-quality information about how different methods affected risk—whether increasing or possibly decreasing it. One key goal for the trial was to gather information that could be used to shape the WHO classification of and, by extension, the service-delivery approaches for the three methods. In the past years, WHO has used its Medical Eligibility Criteria system for evaluating contraceptives to signal the theoretical possibility that DMPA and similar methods might increase HIV risk. This complex classification hasn’t translated into action in terms of women being informed about risks and benefits, or into procurement of additional alternative methods in most settings. ECHO was also designed to help understand acceptability of methods not widely used in the trial countries.
1 Throughout this document, “women and girls” refers specifically and exclusively to cisgender women and girls in all their diversities. Data on transgender women, hormonal contraception and HIV risk are not available.
2 The World Health Organization (WHO) identifies this “theoretical or possible risk” in its current classification of three products: DMPA-IM, NET-EN (another injectable that uses a different hormone from DMPA) and DMPA-Subcutaneous, also known as DPMA-SC and Sayana Press, which contains the same hormone as DMPA-IM but uses a different, simpler injectable delivery method.
The results of the ECHO Study (Evidence for Contraceptive Options in HIV Outcomes)—a trial designed look at whether three specific contraceptive methods (DMPA-IM, the Jadelle Implant and the Copper IUD) impact women’s HIV risk—will be announced on Thursday, June 13, 14:00–15:30 SAST / 8:00–9:30am EDT at the South Africa AIDS Conference (SA AIDS) in Durban.
Over the coming days and weeks there will be a number of opportunities to learn more, discuss the data and work with fellow advocates on what’s next. Read on for details:
- The results announcement session at SA AIDS will be livestreamed on Thursday, June 13 at 14:00–15:30 SAST / 8:00–9:30am EDT.
- Register for a webinar, A Roadmap for Results: Understanding the ECHO Study Results, which will be held following the results announcement (June 13, 17:00 SAST). Hosted by AVAC and FP2020, this webinar will explain the trial, provide topline results, outline next steps, and offer key advocacy messages to help all stakeholders understand the findings.
- Check out the newest episode of our Px Pulse podcast, which features our interview with two leaders from the ECHO team, Jared Baeten and Helen Rees. They talk about what the trial can and cannot tell us. And you’ll hear leading women’s advocates from several countries where the ECHO study took place share their demands as the ECHO trial raises the volume on an urgent conversation—how to empower African women around comprehensive sexual and reproductive health and rights.
- The week of June 17, AVAC and partners will host a webinar for advocates to look beyond the trial and shape an advocacy agenda for a women-centered, women-led future of informed choice and integration of HIV services and sexual and reproductive health and rights.
The ECHO Study randomly assigned HIV-negative women from eSwatini, Kenya South Africa, Zambia to use one of three contraceptive methods—the copper intrauterine device, the Jadelle implant, and DMPA-IM, also known as Depo. Women received counseling, HIV prevention and PrEP referrals where available. The data will show rates of new HIV infections among the three groups; the study is designed to see if any of the three methods impact women’s HIV risk. A key impetus for the trial was ongoing uncertainty about whether DMPA impacts women’s risk of HIV.
Stay tuned for additional information and advocacy opportunities as the story unfolds!