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ALWH: Social Networks, Adherence and Retention

Primary Purpose

HIV/AIDS

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
iEngage (tentative title)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Adolescents

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 HIV care and ART adherence
  • each ALWH must recruit at least one social network member to participate in the intervention with them

Exclusion Criteria:

  • None

Sites / Locations

  • Wake Forest University School of Medicine
  • Desmond Tutu HIV Centre at the University of Cape Town

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention pilot

Arm Description

Outcomes

Primary Outcome Measures

Feasibility: exit interviews
Measured using exit interviews
Acceptability: exit interviews
Measured using exit interviews

Secondary Outcome Measures

Change in HIV stigma & discrimination
may include de novo questionnaire, interview
Change in HIV knowledge
may include de novo questionnaire, interview
Change in autonomy
may include de novo questionnaire, interview
Change in sense of community
may include de novo questionnaire, interview
Change in basic psychological needs
may include de novo questionnaire, interview
Change in social support
may include de novo questionnaire, interview
Change in trust
may include de novo questionnaire, interview
Change in relationship equity
may include de novo questionnaire, interview
Change in agency
may include de novo questionnaire, interview
Change in future orientation
may include de novo questionnaire, interview
Change in mental health
may include de novo questionnaire, interview
Change in healthcare access
may include de novo questionnaire, interview
Change in physical health
may include de novo questionnaire, interview
Change in housing stability
may include de novo questionnaire, interview
Change in economic support
may include de novo questionnaire, interview
Change in income
may include de novo questionnaire, interview
Change in food security
may include de novo questionnaire, interview
Change in food transportation
may include de novo questionnaire, interview
Change in viral load
Gathered from existing medical records
Change in ART adherence
may include de novo questionnaire, interview
Change in retention in HIV care
may include de novo questionnaire, interview

Full Information

First Posted
August 21, 2019
Last Updated
September 27, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04077047
Brief Title
ALWH: Social Networks, Adherence and Retention
Official Title
Understanding and Developing a Network-based Social Support Intervention to Improve Retention in HIV Care and Antiretroviral Therapy Adherence for Adolescents Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention pilot
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
iEngage (tentative title)
Intervention Description
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: Masivukeni and LIFECommunity.
Primary Outcome Measure Information:
Title
Feasibility: exit interviews
Description
Measured using exit interviews
Time Frame
12 month follow up
Title
Acceptability: exit interviews
Description
Measured using exit interviews
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
Change in HIV stigma & discrimination
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in HIV knowledge
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in autonomy
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in sense of community
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in basic psychological needs
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in social support
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in trust
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in relationship equity
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in agency
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in future orientation
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in mental health
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in healthcare access
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in physical health
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in housing stability
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in economic support
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in income
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in food security
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in food transportation
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in viral load
Description
Gathered from existing medical records
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in ART adherence
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up
Title
Change in retention in HIV care
Description
may include de novo questionnaire, interview
Time Frame
baseline, 6 month, and 12 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 HIV care and ART adherence each ALWH must recruit at least one social network member to participate in the intervention with them Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiarney Ritchwood, PhD
Phone
336-713-4238
Email
tritchwo@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiarney Ritchwood, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Desmond Tutu HIV Centre at the University of Cape Town
City
Cape Town
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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ALWH: Social Networks, Adherence and Retention

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