Adolescents Living With HIV (ALWH): Social Networks, Adherence and Retention

Study Overview
=================
Brief Summary
-----------------
human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) is the second leading cause of death in Africa. Adolescents living with HIV (ALWH) are at increased risk for HIV-related morbidity and mortality due to poor retention in HIV care and suboptimal antiretroviral therapy (ART) adherence. Despite having the world's largest population of Adolescents living with HIV (ALWH) (15-24 years, n=870,000), only 14% of South African ALWH are on ART, 12% are retained in HIV care 1-2 years after ART initiation, and 10% are virally suppressed. During treatment interruption, the effects of ART quickly reverse, increasing transmission risk, treatment resistance, and potentially fatal complications. Unless their treatment retention and adherence improves, ALWH will continue to transmit the virus to their sexual partners and die prematurely. While social support is often viewed as a bridge that joins ALWH to key resources within their environments, little is known about which types of social support are most impactful and from whom within their network, particularly among ALWH in endemic countries. Moreover, many South African ALWH lack social support from key social network members due to lack of HIV status disclosure, increasing their risk for poorer HIV-related outcomes when compare to their disclosed peers. Social network interventions (i.e., those that leverage the resources within one's network to improve behaviors and outcomes) that meet the needs of both ALWH who are disclosed and non-disclosed are needed, but lacking. Such inventions have the potential to facilitate appraisal support, during which ALWH receive targeted assistance with identifying appropriate and trustworthy people in their lives. More broadly, there exists a lack empirically supported interventions aimed at improving retention in HIV care and ART adherence for ALWH in low-middle income countries. This proposal follows the multiphase optimization strategy (MOST), a comprehensive framework for optimizing and evaluating multicomponent behavioral interventions.

Detailed Description
-----------------
This K08 focuses on the preparation phase, which consists of compiling information from various sources, including behavioral theory, scientific literature, secondary analyses of existing data, and formative research to inform a theoretical model. This model guides intervention-related decisions, such as the selection of intervention components. Piloting of intervention components and the identification and operationalization of an optimization criterion also occur in this phase. The investigators will first use social network analyses to elucidate network characteristics that influence ALWHs' retention and adherence (Aim 1), then use participatory methods to inform intervention development (Aim 2), and lastly assess intervention acceptability, feasibility, safety and evidence of efficacy (Aim 3). Aim 3 is the clinical trial component and described in detail below. Aim 1 will determine how ALWHs' social networks influence their retention in HIV care and ART adherence and Aim 2 will then focus on the development of a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence informed by Aim 1 and other relevant information. The goal of aim 3 is to assess intervention acceptability, feasibility, safety and evidence of efficacy through open piloting. The investigators will assess intervention acceptability, feasibility, safety, and evidence of efficacy using an iterative process enabling feedback and continuing quality improvement over the course of implementation. This approach involves the piloting of the network intervention developed in Aim 2. The rationale is that the best interventions for ALWH will consider their unique needs and include tailored components. The outcome of this Aim will be a feasible and acceptable social network intervention that will be tested in an adaptive intervention using future grant funding. The hypothesis for aim 3 is that the intervention will be acceptable, feasible, and safe, with trends towards improved ALWH retention in HIV care and ART adherence.

Official Title
-----------------
Understanding and Developing a Network-based Social Support Intervention to Improve Retention in Human Immunodeficiency Virus (HIV) Care and Antiretroviral Therapy Adherence for Adolescents Living With HIV

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

Intervention / Treatment
-----------------
* Behavioral: iEngage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reside in study area able to provide consent or assent agreeable to allowing the research team to have access to their clinic data to assess retention in human immunodeficiency virus- (HIV) care and antiretroviral therapy (ART) adherence each Adolescents living with HIV (ALWH) must recruit at least one social network member to participate in the intervention with them Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iEngage<br>The intervention is a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence. The specific intervention will be developed during Aim 2 of the study and uses qualitative findings, along with data from Aim 1, to develop an interventions that integrates participant feedback and borrows components from two existing interventions | Behavioral: iEngage<br>* The intervention is a network-based, social support intervention to improve Adolescents living with HIV (ALWH) retention in HIV care and antiretroviral therapy (ART) adherence<br>* Other names: network-based, social support intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: exit interviews | Measured using exit interviews | 12 month follow up | 
| Acceptability: exit interviews | Measured using exit interviews | 12 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HIV stigma & discrimination | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in HIV knowledge | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in autonomy | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in sense of community | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in basic psychological needs | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in social support | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in trust | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in relationship equity | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in agency | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in future orientation | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in mental health | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in healthcare access | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in physical health | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in housing stability | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in economic support | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in income | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in food security | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in food transportation | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in viral load | Gathered from existing medical records | baseline, 6 month, and 12 month follow up | 
| Change in ART adherence | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 
| Change in retention in HIV care | may include de novo questionnaire, interview | baseline, 6 month, and 12 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents