Adolescent Coordinated Transition Nigerian HIV+ Youth

Not Applicable

• Conditions: HIV/AIDS
• Interventions: Other: ACT

• Registration Number: NCT03152006
• Lead Sponsor: University of Nevada, Las Vegas

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 Timeline

• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2017-06-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-14
• Last Update Posted: 2017-10-17
• Primary Completion: 2020-05-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Documented HIV infection
• Aware of HIV diagnosis
• Currently on ART

Exclusion Criteria

• Medically unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT Intervention	ACT	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.

Primary Outcome Measures

Name	Time	Method
Retention in care in care 6 months post-transfer	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	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	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 Outcome Measures

Name	Time	Method
Viral Suppression	Enrollment, baseline (12 months), 24 and 36 months	Proportion of participants with undetectable viral load
Mental Health and Wellbeing	Enrollment, baseline (12 months), 24 and 36 months	Mental health continuum-short form Questionnaire
Health Locus of Control	Enrollment, baseline (12 months), 24 and 36 months	Health Locus of control / Self-esteem Questionnaire
Social Support	Enrollment, baseline (12 months), 24 and 36 months	Functional Social Support Questionnaire
Sexual Risk Behavior	Enrollment, baseline (12 months), 24 and 36 months	Sexual Risk Beliefs and Behavior Self Efficacy Questionnaire
Transition Readiness	Enrollment, baseline (12 months), 24 and 36 months	Transition Readiness Assessment Questionnaire

Trial Locations

Locations (5)

Centre for Clinical Care and Research; 🇳🇬 Abuja, Nigeria

Family Health International; 🇳🇬 Abuja, Nigeria

Center for Integrated Health Program; 🇳🇬 Abuja, Nigeria

Institute of Human Virology; 🇳🇬 Abuja, FCT, Nigeria

AIDS Prevention Initiative Nigeria; 🇳🇬 Lagos, Nigeria