Inside the echo trial chamber

A woman gets contraceptives

By 13:50 Southern African time, June 13, the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study results at the 9th South African AIDS 2019 conference YouTube live stream session had over 350 people already signed in.

Eager to hear the ECHO results, a group of 11 journalists and three advocates were part of this audience, gathered at Pakachere Institute of Health and Development Communication boardroom, in Malawi.

The study was designed to compare the risk of acquiring HIV in women who used different contraception methods. Specifically, the study looked at three forms of birth control:  the copper-releasing intrauterine device (Cu-IUD or loop); a levonorgestrel (LNG) implant (Jadelle or Norplant); and depot medroxyprogesterone acetate-intramuscular (DMPA-IM or Depo-Provera). e trial was conducted from December 2015 and was concluded in October 2018.

A silent sigh of relief was noticed in the boardroom when Professor Jared Beaton of Washington School of medicine and Public Health presented the conclusion slide: “This well executed randomised trial did not find a substantial difference in HIV risk among the methods evaluated, and all (contraceptive) methods were safe and highly effective.”

The results bring to a rest the unresolved question as regards to whether some contraceptives, specifically increase a woman’s HIV acquisition risk or not.

However, while none of the contraceptive methods in the study increased HIV more than the other, overall HIV infection rates among the study population were very high at almost 4 percent.

The Civil Society Advocacy working group on HC HIV, an international CSO movement, notes that the ECHO trial results are of critical importance to women everywhere and particularly young women in East and Southern Africa, where uncertainty around link between DMPA and HIV risk has been of major concern for many years.

Before the ECHO trial, epidemiological and laboratory studies had tried to determine whether there is truly an increased risk of HIV acquisition associated with use of hormonal contraception, according to head of Sexual and Reproductive Health and Adolescent Child Health Research Program in Kenya, Doctor Nelly Mugo.

She said, in a meta-analysis looking at all the data across time, the magnitude of increased HIV risk was approximately 40 to 50 percent. The ECHO study, a randomised clinical trial and gold standard in research, was conducted in Zambia, Eswathini, Kenya and South Africa to finally determine whether this increase was true or not.

These countries were selected because women in southern and eastern Africa widely use Depo, the region also continues to be among the hardest hit by HIV and maternal mortality. It was important to work with affected communities to ensure the study provides evidence based on the population most in need of guidance on hormonal contraceptive use and any possible link with HIV acquisition.

Contraceptive choices are not readily available
Rare choice– African women are not usually given the opportunity to choose a method of their choice. Photos: Josephine Chinele

Doctor Mugo told the conference gathering: “Some observational data indicated that Depo had some risk because high HIV incidences happened to be in areas where this method was also highly used. IUD was used as a non-hormonal comparator while Jadelle was included to represent progestin based contraceptive.”

In its statement for advocates, AVAC, a US-based organisation that works in HIV prevention said the ECHO results 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,” reads part of the statement.

Lessons

AVAC's statement notes that even though there were high HIV incidence rates in all three arms of the trial, it does not mean that the methods increased women’s risk.

“These HIV 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, sex work, sexually transmitted infections, etc. In ECHO, HIV risk factors were not part of enrolment criteria,” reads the statement in part.

In the ECHO study, the only sexual behavioral eligibility criterion was being sexually active. This makes the high rates of HIV infection seen in this general population alarming.

The statement observed that 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.”

 “The women in this trial are our sisters and daughters and mothers who were simply seeking contraception,” says Lillian Mworeko, Executive Director of the International Community of Women Living with HIV/AIDS Eastern Africa and co-chair, with AVAC, of the Civil Society HC-HIV Advocacy working group, an Africa-based network of women and allies working on HIV and sexual and reproductive health and rights in the context of ECHO and beyond.

She added: “It is a wake-up call to put HIV prevention on-site at every family planning clinic including Pre Exposure Prophylaxis and female condoms with peer support and trained providers.”

Reactions

“The ECHO study results are a call to work together to ensure that services are provided to the benefit of women and girls,” said Beth Schlacheter, FP 2020 Executive Director.

“Women mostly get HIV or fall pregnant through sex yet these issues have been treated  separately….we know from this trial that contraceptive methods are safe and at this point  you have our commitment from FP 2020 to work from what has come from ECHO in the coming years,” she said.

 

 “The key question about DMPA has been answered but that does not mean the method can continue to dominate women’s contraceptive programs in East and Southern Africa,” said the Civil Society Advocacy Working Group

“We don’t believe that DMPA should continue to be the only long acting method. The women, who want choices and deserve equity with high quality contraceptive programs in high income countries,” reads the statement in part.

The Civil Society Working Group further notes that throughout the ECHO trials, 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.

It’s been observed that in east and southern African women who need contraceptives do not have enough choice on what to use, in most cases methods like injectable are just imposed on them.

The World Health Organisation welcomes the results saying it is glad that there is no HIV infection risk in using these contraceptive methods and that the methods have proven to be safe and efficient.

Doctor James Kiarie of the WHO’s Reproductive Health and Research said as the WHO is planning for its response to the ECHO results, it has some considerations in place.

“The first one is that women and girls should have a wide choice to safe contraceptives and the second consideration is that there is need to step up HIV prevention efforts, particularly for young women and girls,” he said.

Dr Kiarie disclosed that although the results are reassuring, the WHO will still have its experts to look into the results in its entirety in order to come up with its revised recommendations to countries.

“WHO will also support countries to strengthen their HIV and sexual reproductive health integration. We will have a meeting with 14 high burdened countries where all these issues will be discussed,” he said.

Why is ECHO important to Malawi?

According to the Malawi Demographic and Health Survey of 2015/16, half of Malawian women who use contraceptives use injectable Depo, 20 percent use implants and two percent use IUD.

This means the results of the ECHO trial will also inform the Malawi government’s decision making in terms of how to strengthen the integration of HIV services into family planning services.

Malawi is  one of the 14 high HIV-burdened countries that was part of the WHO meeting aimed at discussing the ECHO trial results and mapping the way forward on HIV services and family planning integration.

International Civil Society demands

 ● Women need strategies to prevent pregnancies and HIV infection at the same sites, from the same providers, in a rights-based, woman-centered context.

  • Every east and southern African country must now make or implement a fully funded plan with milestones for expanding contraceptive method mix and uptake and integrating HIV prevention into contraceptive service points.

● It is expected that the  WHO meeting held in Zambia recently  prompted by the ECHO results should generate a declaration of commitment  to integrating HIV prevention and family planning 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.