In the Journals

ECHO trial: HIV risk does not differ by contraceptive method

In reassuring findings for women seeking birth control options, researchers said they found no substantial difference in risk for HIV infection among women assigned to use one of three contraceptive methods, including the injectable progestin-only depot medroxyprogesterone acetate or DMPA-IM, the predominant contraceptive in many African countries where HIV is common.

The results are from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study, a randomized, open-label clinical trial conducted in four African countries that compared DMPA-IM with a copper intrauterine device (IUD) and a levonorgestrel (LNG) implant.

Previous study findings had indicated that women who use DMPA-IM may be more susceptible to HIV.

“After decades of uncertainty, we finally have high-quality scientific evidence about the potential relationship between three different types of contraceptives and the risk of HIV from a rigorous randomized clinical trial,” Helen Rees, MD, MS, executive director of the Wits Reproductive Health and HIV Institute and a member of the ECHO trial consortium, said in a news release.

The study

There are currently 37 million people around the world living with HIV, and women comprise more than half of them, with most residing in sub-Saharan Africa. More than 700 million women around the world, including 58 million African women, use modern contraceptive methods, but 47% of women in Africa “have an unmet need for modern contraception,” Rees and colleagues wrote.

Between Dec. 14, 2015, and Sept. 12, 2017, the researchers randomly assigned 7,829 HIV seronegative women aged 16 to 35 years at 12 sites in eSwatini, Kenya, South Africa and Zambia to one of the three contraceptive methods. Study participants had to report not using injectable, intrauterine or implantable contraception for the previous 6 months, had to be seeking effective contraception and had to have no medical contraindications to the contraception methods. They had to agree to use the assigned contraception method for 18 months.

The researchers randomly assigned 2,609 women to receive an injection of 150 mg/mL DMPA-IM every 3 months, 2,607 to the copper IUD group and 2,613 to the LNG implant group. According to the study, 99% of participants were included in the modified intent-to-treat population, and contraceptive methods were used for 92% of 10,409 woman-years of follow-up time.

There were 397 reported HIV infections during the study period, resulting in an overall incidence of 3.81 per 100 woman-years (95% CI, 3.45-4.21). When stratified by contraceptive method, 143 HIV infections occurred among the DMPA-IM group, 138 in the copper IUD group and 116 in the LNG implant group. This resulted in an incidence of 4.19 (95% CI, 3.54-4.94), 3.94 (95% CI, 3.31-4.66) and 3.31 (95% CI, 2.74-3.98) per 100 woman-years, respectively.

For DMPA-IM, the HR for HIV acquisition in the modified intent-to-treat analysis was 1.04 (96% CI, 0.82-1.33) compared with the copper IUD, and 1.23 (96% CI, 0.95-1.59) compared with the LNG implant. The HR for the copper IUD was 1.18 (96% CI, 0.91-1.53) compared with the LNG implant.

Of the 12 women who died during the study, six were in the DMPA-IM group, five were in the copper IUD group and one was in the LNG implant group. The researchers reported serious adverse events for 2% of women in the DMPA-IM group, 4% in the copper IUD group and 3% in the LNG implant group. Moreover, adverse events leading to study discontinuation occurred for 4%, 8% and 9% of women, respectively.

A total of 255 pregnancies occurred, with 61 in the DMPA-IM group, 116 in the copper IUD group and 78 in the LNG implant group.

The researchers found no substantial difference in HIV risk among the different contraceptive methods, and reported that all three methods were safe and highly effective. However, they noted that HIV incidence was high, underscoring the need for integration of HIV prevention within contraceptive services.

Interpreting the results

In a related editorial, Lisa Miyako Noguchi, PhD, MSN, an associate in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, and Princess Nothemba Simelela, MD, assistant director-general for family, women, children and adolescents at WHO, called the results “largely reassuring” but noted “substantial” gaps in meeting the needs of women at risk for unplanned pregnancy and HIV infection.

“Many factors are driving unacceptably high rates of HIV acquisition in young women, but we have good reasons to believe that contraception is not one of them,” they wrote. “Decision-makers need to listen to the voices of women and girls — who continue to suffer and die not solely as a result of their unconscionable lack of access to high-quality contraceptive and HIV-related care but also to primary care, cancer prevention, mental health, safe abortion, violence prevention, and maternal health services. Therein lies the message we need to hear and amplify as we listen to results of ECHO.” – by Marley Ghizzone

Disclosures: Please see the study for all authors’ relevant financial disclosures. Noguchi and Simelela report no relevant financial disclosures.

In reassuring findings for women seeking birth control options, researchers said they found no substantial difference in risk for HIV infection among women assigned to use one of three contraceptive methods, including the injectable progestin-only depot medroxyprogesterone acetate or DMPA-IM, the predominant contraceptive in many African countries where HIV is common.

The results are from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study, a randomized, open-label clinical trial conducted in four African countries that compared DMPA-IM with a copper intrauterine device (IUD) and a levonorgestrel (LNG) implant.

Previous study findings had indicated that women who use DMPA-IM may be more susceptible to HIV.

“After decades of uncertainty, we finally have high-quality scientific evidence about the potential relationship between three different types of contraceptives and the risk of HIV from a rigorous randomized clinical trial,” Helen Rees, MD, MS, executive director of the Wits Reproductive Health and HIV Institute and a member of the ECHO trial consortium, said in a news release.

The study

There are currently 37 million people around the world living with HIV, and women comprise more than half of them, with most residing in sub-Saharan Africa. More than 700 million women around the world, including 58 million African women, use modern contraceptive methods, but 47% of women in Africa “have an unmet need for modern contraception,” Rees and colleagues wrote.

Between Dec. 14, 2015, and Sept. 12, 2017, the researchers randomly assigned 7,829 HIV seronegative women aged 16 to 35 years at 12 sites in eSwatini, Kenya, South Africa and Zambia to one of the three contraceptive methods. Study participants had to report not using injectable, intrauterine or implantable contraception for the previous 6 months, had to be seeking effective contraception and had to have no medical contraindications to the contraception methods. They had to agree to use the assigned contraception method for 18 months.

The researchers randomly assigned 2,609 women to receive an injection of 150 mg/mL DMPA-IM every 3 months, 2,607 to the copper IUD group and 2,613 to the LNG implant group. According to the study, 99% of participants were included in the modified intent-to-treat population, and contraceptive methods were used for 92% of 10,409 woman-years of follow-up time.

There were 397 reported HIV infections during the study period, resulting in an overall incidence of 3.81 per 100 woman-years (95% CI, 3.45-4.21). When stratified by contraceptive method, 143 HIV infections occurred among the DMPA-IM group, 138 in the copper IUD group and 116 in the LNG implant group. This resulted in an incidence of 4.19 (95% CI, 3.54-4.94), 3.94 (95% CI, 3.31-4.66) and 3.31 (95% CI, 2.74-3.98) per 100 woman-years, respectively.

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For DMPA-IM, the HR for HIV acquisition in the modified intent-to-treat analysis was 1.04 (96% CI, 0.82-1.33) compared with the copper IUD, and 1.23 (96% CI, 0.95-1.59) compared with the LNG implant. The HR for the copper IUD was 1.18 (96% CI, 0.91-1.53) compared with the LNG implant.

Of the 12 women who died during the study, six were in the DMPA-IM group, five were in the copper IUD group and one was in the LNG implant group. The researchers reported serious adverse events for 2% of women in the DMPA-IM group, 4% in the copper IUD group and 3% in the LNG implant group. Moreover, adverse events leading to study discontinuation occurred for 4%, 8% and 9% of women, respectively.

A total of 255 pregnancies occurred, with 61 in the DMPA-IM group, 116 in the copper IUD group and 78 in the LNG implant group.

The researchers found no substantial difference in HIV risk among the different contraceptive methods, and reported that all three methods were safe and highly effective. However, they noted that HIV incidence was high, underscoring the need for integration of HIV prevention within contraceptive services.

Interpreting the results

In a related editorial, Lisa Miyako Noguchi, PhD, MSN, an associate in the department of epidemiology at Johns Hopkins Bloomberg School of Public Health, and Princess Nothemba Simelela, MD, assistant director-general for family, women, children and adolescents at WHO, called the results “largely reassuring” but noted “substantial” gaps in meeting the needs of women at risk for unplanned pregnancy and HIV infection.

“Many factors are driving unacceptably high rates of HIV acquisition in young women, but we have good reasons to believe that contraception is not one of them,” they wrote. “Decision-makers need to listen to the voices of women and girls — who continue to suffer and die not solely as a result of their unconscionable lack of access to high-quality contraceptive and HIV-related care but also to primary care, cancer prevention, mental health, safe abortion, violence prevention, and maternal health services. Therein lies the message we need to hear and amplify as we listen to results of ECHO.” – by Marley Ghizzone

Disclosures: Please see the study for all authors’ relevant financial disclosures. Noguchi and Simelela report no relevant financial disclosures.