Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 216
- Locations
- 5
- Primary Endpoint
- Retention in care in care 6 months post-transfer
Study Overview
Brief Summary
The purpose of this study is to evaluate the comparative effectiveness of a comprehensive, coordinated transition protocol which includes an early introduction to the adult provider, an integrated case management team and a peer-facilitated organized support group on retention in care, viral suppression and psychosocial wellbeing among adolescents living with HIV.
Detailed Description
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of ACT, a coordinated protocol for transitioning adolescents living with HIV (ALHIV) from pediatric to adult care (Intervention Group; IG) versus the usual abrupt transfer to adult care (Control group; CG) on rates of retention in care and viral suppression, and differences in perceived psychosocial wellbeing. Twelve health facilities, two in each of the six geopolitical zones of Nigeria will be pair-matched and randomly assigned to either IG (N=6 health facilities) or CG (N=6 health facilities). A total of 216 ALHIV will be enrolled in the study over a 36-month period. The primary outcome will be the difference in the rate of retention between the groups. Secondary outcomes will be difference in the rate of viral suppression and the difference in perceived psychosocial wellbeing. Additionally, the investigators will conduct mediation/moderation analysis to examine the role of intermediate variables such as transition readiness, perceived mental health, social support, health locus of control, self-esteem and sexual risk behavior self-efficacy on the primary outcomes. Implementation factors will be assessed using the hybrid 2 model.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented HIV infection
- •Aware of HIV diagnosis
- •Currently on ART
Exclusion Criteria
- •Medically unstable
Arms & Interventions
Control
The control arm does not receive the ACT intervention.
ACT Intervention
Intervention activities include the three components of the ACT intervention: (1) alternating pediatric and adult clinic visits in the 12 month pre-transfer period (2) peer facilitated organized support group during the 24-month graduated transition period and (3) patient advocate and case management team to coordinate transfer process.
Intervention: ACT (Other)
Outcomes
Primary Outcomes
Retention in care in care 6 months post-transfer
Time Frame: 6 months
Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer
Retention in care 12 months post-transfer
Time Frame: 12 months
Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within the 1 year period post-transfer
Retention in care 24 months post-transfer
Time Frame: 24 months
Proportion of participants who had at least 2 clinical visits to an HIV provider separated by 6 months within a 1 year period during the second year post-transfer
Secondary Outcomes
- Viral Suppression(Enrollment, baseline (12 months), 24 and 36 months)
- Mental Health and Wellbeing(Enrollment, baseline (12 months), 24 and 36 months)
- Health Locus of Control(Enrollment, baseline (12 months), 24 and 36 months)
- Social Support(Enrollment, baseline (12 months), 24 and 36 months)
- Sexual Risk Behavior(Enrollment, baseline (12 months), 24 and 36 months)
- Transition Readiness(Enrollment, baseline (12 months), 24 and 36 months)
Investigators
Echezona Ezeanolue
Professor of Public Health and Pediatrics
University of Nevada, Las Vegas