Evaluating the LINK Model to Improve Postpartum HIV Prevention and PrEP Use Among Breastfeeding Women in Malawi

What this Trial Is About

Researchers are evaluating a postpartum prevention package called the LINK model to improve HIV prevention in postpartum women in Lilongwe, Malawi. This study aims to compare the effectiveness of the LINK model to the standard of care by examining PrEP persistence among women receiving services at randomized clinics. The study focuses on postpartum women breastfeeding and living without HIV, and will use data from medical records, surveys, and interviews to assess the intervention and its implementation. The LINK model integrates postpartum HIV testing and PrEP services with early infant vaccination visits. It includes HIV risk screening, male partner engagement to support HIV status awareness and PrEP persistence, and community-facility linkage with peer mothers who provide ongoing support to breastfeeding women using PrEP and follow-up for those who disengage from care. Twelve clinics are randomized to either the LINK model or standard care, with clinical staff and study-hired assistants delivering the intervention components alongside existing services. Participants include postpartum women breastfeeding and using PrEP, women attending infant vaccination visits, and relevant clinical and policy stakeholders. Data collection involves medical record reviews, surveys, dried blood spot tests to measure PrEP adherence, and in-depth interviews to explore acceptability and feasibility. The main outcome is the proportion of patients persisting with PrEP for six months without interruption, along with measures of PrEP uptake and adherence. The study will run for approximately 3.5 years with no longitudinal follow-up of individual participants.

Leveraging Infant Visit PrEP INtegration & tasK Shifting to Improve Post-partum HIV Prevention in Malawi