A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam

"Sống Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam

The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence.

The project has the following Specific Aims:

1. Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on cognitive-behavioral therapy principles and delivered by telephone, using input from youth during intervention development.
2. Assess the feasibility, acceptability and preliminary efficacy of this innovative approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among YLHIV through a small pre-post study.
3. Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their relationships with ART adherence and psychosocial wellbeing via quantitative surveys and electronic adherence monitoring.

The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).

Study Overview

• Status: Completed
• Conditions: Hiv; Stigma, Social
• Intervention / Treatment: Behavioral: CBT-based supportive skills delivered by phone by lay coaches

Detailed Description

For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal stigma and implement a 12-week pre-post intervention study in which participants will receive the phone-based intervention developed in the first phase. YLHIV will use an electronic adherence monitoring device for their ART medications.

In the pre-post intervention study, each of 40 patients will be followed for a total of 16 weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be used to measure their adherence throughout the 16-week period. Study participation will involve two phases, with the following activities:

I. Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the investigators will provide each subject with a WPC and instruction on correct use. The investigators will select one medication for each WPC. While subjects continue to receive care as usual, the investigators will collect their adherence data using the WPC.

II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10 weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to the adherence information generated by the devices, as will their care providers.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Institute for Social Development Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• are between 18 and 24 years old
• are a patient at the OPC
• are expected to remain in care at the OPC for 3 months minimum(?)
• are currently on ART
• have primary responsibility for taking their own medications,
• self-report intrapersonal stigma via a brief screening questionnaire,
• are able to complete a short phone call from the location where they intend to be when participating in coaching sessions,
• agree to follow all study procedures, AND
• provide informed consent.

Exclusion Criteria:

• are below the age of 18 years or above the age of 24,
• are not currently on ART,
• live outside the clinic catchment area,
• are identified as having severe mental health issues as identified through screening, OR
• are not willing to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: Supportive life skills coaching; CBT-based supportive like skills delivered by phone by lay coaches	Behavioral: CBT-based supportive skills delivered by phone by lay coaches; 8-10 weekly coaching sessions delivered by telephone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrapersonal (self) Stigma	modified 21-item self stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)	change between Week 1-Week 12
Interpersonal Stigma	modified 21-item enacted stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)	change between Week 1 and Week 12
Depression	7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)	change between Week 1 and Week 12
Anxiety	7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)	change between Week 1 and Week 12
Adherence	%≥95% on-time adherence	Week 12 (endline)

Collaborators and Investigators

• Sponsor: University of New England
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Fogarty International Center of the National Institute of Health; Institute for Social Development Studies (ISDS)
• Investigators: Principal Investigator: Mary DeSilva, ScD, MS, University of New England

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: HIV; Stigma; Vietnam; Vulnerable groups
• Other Study ID Numbers: R21TW011085-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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