Adolescents Living With HIV (ALWH): Social Networks, Adherence and Retention
- Conditions
- HIV/AIDS
- Interventions
- Behavioral: iEngage
- Registration Number
- NCT04077047
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iEngage iEngage 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
- Primary Outcome Measures
Name Time Method Feasibility: exit interviews 12 month follow up Measured using exit interviews
Acceptability: exit interviews 12 month follow up Measured using exit interviews
- Secondary Outcome Measures
Name Time Method Change in viral load baseline, 6 month, and 12 month follow up Gathered from existing medical records
Change in autonomy baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in healthcare access baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in physical health baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in food transportation baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in HIV knowledge baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in mental health baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in income baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in sense of community baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in HIV stigma & discrimination baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in basic psychological needs baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in social support baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in trust baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in relationship equity baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in agency baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in future orientation baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in housing stability baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in economic support baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in food security baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in retention in HIV care baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Change in ART adherence baseline, 6 month, and 12 month follow up may include de novo questionnaire, interview
Trial Locations
- Locations (2)
Desmond Tutu Health Foundation
🇿🇦Cape Town, South Africa
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States