Clinical trial NCT04077047: Adolescents Living With HIV (ALWH): Social Networks, Adherence and Retention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescents
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: exit interviews
timeFrame: 12 month follow up
measure: Acceptability: exit interviews
timeFrame: 12 month follow up
Secondary outcomes:
measure: Change in HIV stigma & discrimination
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in HIV knowledge
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in autonomy
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in sense of community
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in basic psychological needs
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in social support
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in trust
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in relationship equity
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in agency
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in future orientation
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in mental health
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in healthcare access
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in physical health
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in housing stability
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in economic support
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in income
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in food security
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in food transportation
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in viral load
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in ART adherence
timeFrame: baseline, 6 month, and 12 month follow up
measure: Change in retention in HIV care
timeFrame: baseline, 6 month, and 12 month follow up
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
Study officials:
affiliation: Wake Forest University Health Sciences
name: Tiarney Ritchwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: