Cluster randomized trial on the effect of mother support groups on retention-in-care and PMTCT outcomes in Zimbabwe: study design, challenges, and national relevance.

Prevention of mother-to-child transmission (PMTCT) elimination goals are hampered by low rates of retention and antiretroviral treatment adherence. The Eliminating Pediatric AIDS in Zimbabwe (EPAZ) project is assessing whether mother support groups (MSGs) increase rates of retention-in-care of HIV-positive mothers and their exposed infants, increase male participation, and improve other maternal and infant health outcomes. EPAZ is a cluster randomized study involving 30 rural facilities in 2 health districts in Mutare province in eastern Zimbabwe. Facilities were randomly assigned to either the standard-of-care or intervention arms. We established MSGs for HIV-positive mothers at the 15 health facilities in the intervention arm. MSGs met every 2 weeks and were led by an HIV-positive mother who was appointed as MSG coordinator (MSG-C). MSG-Cs contacted nonattending patient-members of support groups by cell phone. If members still do not attend, MSG-Cs inform a health worker who initiates further outreach actions that are standard within the health system. At least 10 HIV-positive mothers are enrolled per facility. Enrollment started in July 2014. The primary outcome measure is retention-in-care of HIV-exposed infants at 12 months of age. Secondary outcome measures are: retention-in-care of HIV-positive mothers at 12 months postpartum, male participation, and other maternal and child health indicators. The study relies on routine health system data supplemented by additional data using tools created for the study. If shown to improve PMTCT retention outcomes, facility-based MSGs have the potential to be scaled up throughout the Zimbabwe National PMTCT program and could be considered in other country programs.

RCT Entities:   Population Interventions Outcomes