NCT03152006

Adolescent Coordinated Transition Nigerian HIV+ Youth

Adolescent Coordinated Transition (ACT) to Improve Health Outcomes Among Nigerian HIV+ Youth

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
OTHER	ACT	Coordinated, graduated transition which includes an early introduction to the adult clinician during the PAPA pre-transfer period, a peer-facilitated organized support group aimed at improving transition readiness and addressing critical psychosocial skills including self-efficacy and locus of control and a case management team including a patient advocate who coordinates the transfer between pediatric and adult care teams.

Timeline

• Start date: 2017-06-28
• Primary completion: 2020-05-30
• Completion: 2021-06-30
• First posted: 2017-05-12
• Last updated: 2017-10-17

Locations

5 sites across 1 country: Nigeria