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

Last updated: November 26, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv Infections

Treatment

iEngage (tentative title)

iEngage

Clinical Study ID

NCT04077047
IRB00099951
5K08MH118965-02
  • Ages 15-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toassess retention in human immunodeficiency virus- (HIV) care and antiretroviraltherapy (ART) adherence

  • each Adolescents living with HIV (ALWH) must recruit at least one social networkmember to participate in the intervention with them

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: iEngage (tentative title)
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Desmond Tutu HIV Centre at the University of Cape Town

    Cape Town,
    South Africa

    Site Not Available

  • Desmond Tutu Health Foundation

    Cape Town,
    South Africa

    Active - Recruiting

  • Duke University Health System

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27101
    United States

    Active - Recruiting

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