Delivery of antiretroviral therapy to HIV-infected women during the postpartum period: The Postpartum Adherence Clubs for Antiretroviral Therapy (PACART) trial

INTRODUCTION: The World Health Organization recommends initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women (“Option B+"); however, disengagement from care has been documented postnatally and thereafter. The community-based adherence club (AC) system has been widely implemented in Cape Town, South Africa, and provides HIV care to stable adults on ART, but women who initiated ART in antenatal care services are currently referred to local ART clinics postnatally. METHODS: The Postpartum Adherence Clubs for Antiretroviral Therapy (PACART) study is a pragmatic randomised controlled trial evaluating ACs to deliver long-term HIV care to women who initiated ART antenatally. Consecutive eligible women seeking care postnatally at a large primary health care facility in Cape Town were randomised to either the local ART clinic (standard of care), or the AC service. The primary objective is to compare maternal HIV viral suppression up to 24 months postpartum. Six study visits are scheduled through 24 months; measurements at each visit include phlebotomy for viral load and questionnaires assessing maternal health, infant health, and ART adherence. Qualitative interviews examining issues of ART adherence and retention, and assessments of costs and cost-effectiveness will also be done. RESULTS: Enrolment is complete, with 412 women enrolled. Follow-up visits are ongoing. DISCUSSION: There is an urgent need to improve ART delivery for maternal and child health. With a pragmatic trial design, we aim to assess use of the community-based AC system to improve maternal engagement in HIV care in the postpartum period and beyond.