OA28.03
Background: The HPTN071 (PopART) is a 5-year community randomized study of a combination HIV prevention package in 21 communities in Zambia and South Africa. HPTN071 is one of the first studies to evaluate a combined HIV prevention package (including universal HIV testing and ART for all HIV+individuals irrespective of CD4 count (UTT)) on HIV incidence at community-level.
Methods: 21 communities were randomly assigned to one of three study arms. The study intervention consists of door to door voluntary UTT with the offer of immediate ART to all individuals who test positive, plus other HIV preventive methods. Community HIV care providers (CHiPs) are responsible for the delivery of the intervention and linkage to care. Multi-disciplinary groups have been closely engaged in designing and developing the study protocol and include community representatives, community advisory boards, policy makers, government, ministries of health, care and service providers, funders and research teams.
Results: Trial initiation was preceded by two years of preparatory work. Early rapid formative research to identify local catalysts and barriers that could influence intervention proved invaluable, as have regular door to door and community mobilization activities. Study preparation required strengthening existing health care systems and improvement of supply chain management. Hiring and training of approximately 430 community based staff to deliver the intervention was done. Mechanisms to best deliver some clinic activities-routinely and in optimal time- are still being identified. Regular feedback on progress and challenges at all levels through sharing of process data is useful. Synchronization with other ongoing HIV preventive initiatives in these communities has been occurring.
Conclusions: Initiating a complex combination-prevention trial at a population level, that is integrated within current DoH facilities and therefore sustainable, requires multi-disciplinary approaches, time and effort.
