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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077047
Enrollment
60
Registered
2019-09-04
Start date
2022-09-01
Completion date
2025-07-31
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

Adolescents

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.

Interventions

BEHAVIORALiEngage

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility: exit interviews12 month follow upMeasured using exit interviews
Acceptability: exit interviews12 month follow upMeasured using exit interviews

Secondary

MeasureTime frameDescription
Change in HIV stigma & discriminationbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in HIV knowledgebaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in autonomybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in sense of communitybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in basic psychological needsbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in social supportbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in trustbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in relationship equitybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in agencybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in future orientationbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in mental healthbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in healthcare accessbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in physical healthbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in housing stabilitybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in economic supportbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in incomebaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in food securitybaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in food transportationbaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in viral loadbaseline, 6 month, and 12 month follow upGathered from existing medical records
Change in ART adherencebaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview
Change in retention in HIV carebaseline, 6 month, and 12 month follow upmay include de novo questionnaire, interview

Countries

South Africa, United States

Contacts

PRINCIPAL_INVESTIGATORTiarney Ritchwood, PhD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026