Study title: Young People ART and Adherence Study

Lead Researcher(s)

Nyasha Dzavakwa

Funder(s)

European and Developing Countries Clinical Trials Partnership

Partner(s)

London School of Hygiene and Tropical Medicine, University of Zimbabwe, Ministry of Health and Child Care, Harare City Health Department

Background

Adherence to medication for chronic disease is known to be low in adolescence, and HIV infection is no exception. Multiple studies globally have reported lower adherence to antiretroviral therapy (ART) among young people with HIV compared to other age groups. Non-adherence to ART results in viral non-suppression and consequent increased risk of drug resistance, mortality and onward HIV transmission.

Study aim(s)

To investigate the effect of an electronic monitoring device (EMD)-informed adherence intervention to improve treatment adherence in young people living with HIV (YPLWH).

Study design

The YPAA trial was an open-label, individually randomized controlled study designed to evaluate the impact of electronic monitoring device (EMD)-informed text message reminders combined with adherence feedback on viral suppression. The trial targeted young people living with HIV (YPLWH) aged 16–30 years who were at risk of virologic failure (viral load >200 copies/ml) over a six-month period. The study recruited 200 YPLWH who had been on antiretroviral therapy (ART) for at least six months from HIV clinics at public hospitals in Harare and Chitungwiza, Zimbabwe. Participants were randomized 1:1 to either use an EMD with text message reminders and focused adherence feedback or receive the standard of care, which included enhanced adherence counseling routinely offered to individuals with a non-suppressed viral load.

The intervention lasted for six months, followed by an additional three-month follow-up to assess the sustainability of its effects. The primary outcome, measured at six months, was the proportion of participants achieving a viral load of <50 copies/ml. The study provided an opportunity to deliver early adherence feedback to improve treatment adherence, thereby optimizing HIV care among young people. Additionally, it assessed whether using an EMD resulted in sustained adherence behavior changes in YPLWH living in a low-income, high-HIV-prevalence setting. Findings from the study informed policy changes on adherence-enhancing interventions for young people failing on second- or third-line ART regimens.

Study dates

August 2023 - December 2024