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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: iEngage

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiarney Ritchwood, PhD; Phone Number: 336-713-4238; Email: tritchwo@wakehealth.edu

Study Locations

• South Africa
  • Cape Town, South Africa
    • Desmond Tutu HIV Centre at the University of Cape Town
• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27101
      • Wake Forest University School of Medicine
      • Contact: Tiarney Ritchwood; Phone Number: 336-713-4238

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; 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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Tiarney Ritchwood, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB00099951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No