Kenya testing if contraceptive use increases risk of HIV infection

Kenya is among four African countries carrying out large-scale clinical trials to determine whether the use of contraceptives increases the risk of HIV infection in sexually-active women.

The trials, dubbed ECHO (Evidence for Contraceptive Options and HIV Outcomes) sponsored FHI 360 will also be conducted in South Africa, Swaziland and Zambia.

The study will examine whether there is any difference in the risk of HIV acquisition among women using contraceptives including the progestogen-only injectable depot medroxyprogesterone acetate (DMPA), a progestogen implant called Jadelle and the copper IUD.

The study at the Kenya Medical Research Institute, Kisumu, has 900 sexually-active HIV-negative participants aged 16 to 35. The women enrolled were randomly assigned by a computer to receive one of three highly effective, reversible contraceptives.

Women who were interested in joining the study learned about the procedures and the risks and benefits of participating through an informed consent process. The women will be observed for 18 months to see whether any of them will contract HIV.

The study will also compare side effects, pregnancy rates and women’s patterns of use for the three contraceptive methods.

PROGESTOGEN-ONLY INJECTABLES

According to Dr Imeldah Wakhungu, ECHO Study Coordinator Kemri RCTP Programme in Kisumu, cumulative evidence from observational studies indicates a possible increased risk of HIV acquisition in women using progesterone injectables (particularly with DMPA), but it is uncertain whether there is a causal relationship as opposed to just an observed association.

The ECHO study began enrolling participants in December 2015 with a plan to enroll 7,800 women. By August 2017, the study achieved its enrolment target. The total duration of the study in the field will be approximately 36 months from the first enrolment to the last follow-up visit.

The team anticipates that the results will be released in mid-2019. In March 2017, the World Health Organisation (WHO) released revised guidance on the use of hormonal contraceptives by women at high risk of HIV infection.

The WHO recommends that long-acting progestogen-only injectables (DMPA and NET-EN) should remain accessible to women at high risk of HIV, “because the advantages of these methods generally outweigh the possible increased risk of HIV acquisition.”

However, women at high risk of HIV who choose to use these methods should be counselled about the possible increased risk of HIV and how to reduce this risk.

The WHO recommendations are strongly rooted in women’s right to accurate information enabling them to make informed choices about their contraceptive methods. Women should have full access to the methods of their choice, regardless of their HIV risk.

It also recommends that women using contraceptives should be advised of ways to reduce their risk of acquiring HIV and other STIs.

“As the study goes forward, the ECHO research team will ensure that current participants receive an information sheet explaining the updated WHO guidance. All recruitment and informational material, as well as counselling messages for current participants, will be similarly updated,” said Dr Wakhungu.

The revised study protocol and materials will be reviewed by the ethical review committees overseeing ECHO.