An interventional study of iEngage in HIV/AIDS, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in 2 countries. Open to participants aged 15 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 60 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: network-based, social support intervention
Feasibility: exit interviews
Measured using exit interviews
Time frame: 12 month follow up
Acceptability: exit interviews
Measured using exit interviews
Time frame: 12 month follow up
Change in HIV stigma & discrimination
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in HIV knowledge
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in autonomy
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in sense of community
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in basic psychological needs
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in social support
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in trust
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in relationship equity
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in agency
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in future orientation
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in mental health
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in healthcare access
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in physical health
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in housing stability
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in economic support
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in income
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in food security
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in food transportation
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in viral load
Gathered from existing medical records
Time frame: baseline, 6 month, and 12 month follow up
Change in ART adherence
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
Change in retention in HIV care
may include de novo questionnaire, interview
Time frame: baseline, 6 month, and 12 month follow up
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Acquired Immunodeficiency Syndrome→
Wake Forest University Health Sciences