Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
HIV/AIDS
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 15 years and 21 years
Gender
Both males and females

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, su...

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.

Tracking Information

NCT #
NCT04077047
Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Tiarney Ritchwood, Ph.D. Duke University