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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04077047
• Other study ID #: IRB00099951
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Tiarney Ritchwood, PhD
• Phone: 336-713-4238
• Email: tritchwo[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
South Africa	Desmond Tutu HIV Centre at the University of Cape Town	Cape Town
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: exit interviews	Measured using exit interviews	12 month follow up
Primary	Acceptability: exit interviews	Measured using exit interviews	12 month follow up
Secondary	Change in HIV stigma & discrimination	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in HIV knowledge	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in autonomy	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in sense of community	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in basic psychological needs	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in social support	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in trust	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in relationship equity	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in agency	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in future orientation	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in mental health	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in healthcare access	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in physical health	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in housing stability	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in economic support	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in income	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in food security	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in food transportation	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in viral load	Gathered from existing medical records	baseline, 6 month, and 12 month follow up
Secondary	Change in ART adherence	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up
Secondary	Change in retention in HIV care	may include de novo questionnaire, interview	baseline, 6 month, and 12 month follow up