Adolescent to Adult Patient-centered HIV Transition (ADAPT): Study Protocol for a Cluster Randomized Trial

Abstract Background: Innovative strategies and protocols are required for effective provision of healthcare services and attainment of optimal positive health outcomes for adolescents living with HIV (ALHIV) as they transition to adult care.HIV-infected youth must learn to navigate a complex healthcare system as they transition from pediatric to adult care. Poorly planned transitions can result in non-adherence to ART, loss-to-follow-up in care and supportive services, with resultant negative health impact. This study evaluates two different approaches to the process of transition from pediatric to adult care in six facilities in Nigeria. Methods: ADAPT will use a cluster randomized intervention trial to measure the impact of Peer Transition Advocates (PTAs) versus Education Interventionists (EIs) approach to the process of transition of ALHIV, with imbedded psychosocial/social network analyses. The study will be conducted in 6 healthcare facilities (three tertiary and three secondary) in Northern and Central Nigeria. The unit of randomization (cluster) will be the facilities (n=180 per intervention arm, N=360), study participants 17-19 year-old ALHIV enrolled in the pediatric ART clinic for ≥12 months and know their HIV status. Sixty participants will be recruited pre-transition per site and followed up 12 months post-transition. Primary outcome measure will be proportion of ALHIV achieving successful transition and viral suppression 12 months post-transition comparing the two arms. Secondary outcome measures are proportion of ALHIV achieving ownership of care, improved quality of life, better transfer experience, and social support system measured by individual and ego-network evaluation tools correlating with successful transition. Discussion: ADAPT hypothesizes that by involving ALHIV in the study design, the PTA intervention will result in more successful transition and clinical outcomes in adult care. Further, we postulate that properly trained and supervised task-oriented peer support using lay workers assigned to track and guide each adolescent along the transition pathway in the clinic and in the community is the key starting point for transforming a dysfunctional system. Findings from ADAPT will guide institutions on best practices for transitioning ALHIV and other adolescents with chronic conditions in Nigeria and other resource-limited settings.