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May 15, 2022
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Study demonstrates African women’s long-term use and adherence to ART

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A study demonstrated that African women with HIV used ART for years and maintained high adherence, benefiting both themselves and their children.

“This study is based on an earlier clinical trial we completed in 2016 to assess the effect of ART in reducing perinatal transmission of HIV. That study was called PROMISE [and was] the largest perinatal HIV transmission multicountry study conducted in Africa and one non-African country,” Taha E. Taha, MBBD, PhD, MPH, MCM, professor of epidemiology and population, family and reproductive health at the Johns Hopkins Bloomberg School of Public Health, told Healio.

Source: NIAID.

Women and children can benefit from ART, which was demonstrated in the PROMOTE study by improvements in health outcome indicators. Source: NIAID.

Taha said PROMISE showed very low rates of HIV transmission to infants when mothers received combination ART.

“Upon completion of PROMISE, we became interested in following women who have already been on ART for approximately 5 years for another 5 years to assess the long-term impact of ART ... on health, safety and survival of both mothers and children,” Taha said.

Taha and colleagues enrolled 1,987 women on ART from high-enrolling study sites and followed them from 2016 to 2021 as part of the PROMOTE trial a longitudinal, multicountry study performed at eight sites in Malawi, South Africa, Uganda and Zimbabwe.

According to the study, after enrollment, researchers followed up with the women and their children every 6 months to collect information on medical history, ART use, adherence and health information, as well as to perform physical examinations.

Overall, the study showed retention rates of 96.5% for mothers and 94.3% for children at 12 months, and 88.9% and 85.4% at 42 months. Additionally, 89.1% of the women had an undetectable viral load at 42 months, although the study showed that this varied between 81.7% to 93.8% per site.

According to the study, maternal health improved over time, with the proportion of women with “excellent” to “very good” health increasing from 67.5% at baseline to 87.5% at 42 months, whereas the proportion of “unwell” participants who visited a health center declined from 14.7% to 2.8%, and those admitted to hospital declining from 1.5% to 1%.

The researchers also found that the desire to have more children was consistently high at some of the study sites, with the overall pregnancy rate being 17.6 (95% CI, 16.5-18.7) per 100 women-years, and mortality rates being 2.4 (95% CI, 1.4-3.9) per 1,000 person-years for mothers and 3.4 (95% CI, 2.2-5.1) per 1,000 person-years for children aged 0 to 9 years.

“Consistent use of ART for life is very good for women’s health, and it is safe,” Taha said. “It increases women’s survival, well-being, and accordingly, they can achieve their reproductive intentions.”

In an accompanying commentary, Dvora Joseph Davey, PhD, MPH, assistant professor of infectious diseases and epidemiology at the University of California, Los Angeles, said the results are encouraging and show that African cisgender women “are willing to be a part of a long follow-up period” and “continued using ART for years after pregnancy while maintaining high adherence and achieving high levels (>90%) of viral suppression.”

“First, this study is crucial to provide evidence to policymakers about the importance of interventions to improve ART continuation and adherence among women of reproductive age living with HIV,” Davey wrote. “Second, this study serves as a model for funders and researchers seeking to evaluate the longitudinal impact of new ART regimens (eg, long-acting ART), new prevention technologies (eg, long-acting pre-exposure prophylaxis), and multiple prevention technologies (products capable of addressing multiple sexual and reproductive health needs) for and with women who are pregnant or in the postpartum period.”

References:

Davey DJ. Lancet HIV. 2022;doi:10.1016/S2352-3018(22)00061-3.

Taha ET, et al. Lancet HIV. 2022;doi:10.1016/S2352-3018(22)00037-6.