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

NCT04884867 | Completed

• 1 other identifier: R21TW011085-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Hiv; Stigma, Social

Keywords

HIV; Stigma; Vulnerable groups; Vietnam

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (1)

Supportive life skills coaching

EXPERIMENTAL

CBT-based supportive like skills delivered by phone by lay coaches

Behavioral: CBT-based supportive skills delivered by phone by lay coaches

Interventions

CBT-based supportive skills delivered by phone by lay coaches BEHAVIORAL

8-10 weekly coaching sessions delivered by telephone

Supportive life skills coaching

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New England: lead
• Institute for Social Development Studies (ISDS): collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Institute for Social Development Studies

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Mary DeSilva, ScD, MS

  University of New England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will use a wireless pill container to monitor their adherence passively. Participants, lay coaches, and clinicians will all be blinded to adherence monitoring.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: April 14, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

VN (1)