Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study
Condition: HIV; AIDS
Study type: Interventional

Summary: 
      One of the distinct challenges faced by emerging adults with HIV is the transition of their
      care from their long-term pediatric HIV provider to treatment within an adult HIV program.
      The consequences of an unsuccessful transition can range from difficult to catastrophic. The
      Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study is a prospective cohort
      trial of an innovative intervention targeting gaps in care that are major drivers of loss in
      the ART continuum of care cascade among adolescents and increasing missed opportunities to
      engage adolescents into care.
    

Detailed description: 
      The specific aims of ADAPT are: 1. To inform strategies for transition services in
      resource-limited settings; 2. To examine the developmental, clinical, and other factors that
      predict a successful transition; and, 3. To gain fundamental insight on implementation
      barriers among African adolescents through the application of the ego-network defined social
      support that will inform targets for structured intervention. ADAPT will be conducted in
      central, southern, and northern Nigeria at selected PEPFAR sites supported by the Institute
      of Human Virology, Nigeria. To address Aim 1 the investigators will conduct six focus groups
      including: Adolescent patients, parents and health care providers. To address aim 2, the
      investigators will conduct a cluster randomized clinical trial. The two interventions are
      based on prior evidence-informed engagement strategies: 1) educational interventions and 2)
      interventions that use a peer transition advocate who prepares the adolescent and their
      parents for transition. The investigators will enroll 300 patients (150 patients in each
      arm). The sites will be assigned to either the intervention arm or a control arm. The primary
      outcome will be successful transition, keeping two follow-up appointments within a nine
      months period following transition. Secondary outcomes, as recommended by focus group
      participants will also be measured. To examine the potential role of social network
      components and characteristics of both egos and alters on primary outcomes, a Generalized
      Estimating Equation (GEE) approach will be used to explore the associations between primary
      outcomes and factors at the ego, alter, and network levels. The finding from this study will
      guide institution of best practices for transitioning adolescents in Nigeria and other
      countries lower and middle income countries with similar challenges and potential for high
      impact.
    

Intervention name(s): PEPFAR Enhanced Standard of Care (PESCA); Peer Transition Advocate (PTA)
Intervention type(s): Other; Behavioral
Intervention description(s): Standardized materials will be provided to PEPFAR supported clinical sites to assist clinic teams with supporting patients in the transition from pediatric to adult medical care; The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues.
Other intervention name(s): Enhanced Standard of Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment