Adolescent Coordinated Transition Nigerian HIV+ Youth

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.

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

Conditions
-----------------
HIV/AIDS

Intervention / Treatment
-----------------
* Other: ACT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV infection Aware of HIV diagnosis Currently on ART Exclusion Criteria: Medically unstable

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The control arm does not receive the ACT intervention. | |
| Experimental: ACT Intervention<br>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. | Other: ACT<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in care in care 6 months post-transfer | Proportion of participants who had at least 1 clinical visit to an HIV provider within the 6 months post-transfer | 6 months | 
| Retention in care 12 months post-transfer | 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 | 12 months | 
| Retention in care 24 months post-transfer | 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 | 24 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthcare transition, Adolescents, Nigeria