Clinical trial NCT02872805: Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study
Official title: Adolescent to Adult Patient-centered HIV Transition (ADAPT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
AIDS
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 298
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* HIV infected patients between the ages of 16-19 years of age
* Patients who have been in care at the study site facility for a minimum of 1 year
* Patients who plan to transition their HIV care to one of the selected study sites
* Patients who are able to provide informed consent

Exclusion Criteria:

* HIV infected patients who have significant cognitive impairments(e.g., Mental retardation)
* Patients planning to transition their HIV care outside the selected study facilities

Primary outcomes:
measure: Successful transition
timeFrame: 9 months after transition occurs
measure: Viral load suppression
timeFrame: 12 months after transition occurs
Secondary outcomes:
Other outcomes:
Locations:
city: Abuja
country: Nigeria
facility: Institute of Human Virology, Nigeria
state: FCT
Study officials:
affiliation: University of Maryland, Baltimore
name: Vicki J Tepper, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: