Clinical trial NCT04884867: A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam
Official title: "Sống Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Stigma, Social
Keywords: HIV
Stigma
Vulnerable groups
Vietnam
Lead sponsor: University of New England
Sponsor class: OTHER
Collaborators: name: Institute for Social Development Studies (ISDS)
name: Fogarty International Center of the National Institute of Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-05-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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. 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intrapersonal (self) Stigma
timeFrame: change between Week 1-Week 12
measure: Interpersonal Stigma
timeFrame: change between Week 1 and Week 12
measure: Depression
timeFrame: change between Week 1 and Week 12
measure: Anxiety
timeFrame: change between Week 1 and Week 12
measure: Adherence
timeFrame: Week 12 (endline)
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Institute for Social Development Studies
Study officials:
affiliation: University of New England
name: Mary DeSilva, ScD, MS
role: PRINCIPAL_INVESTIGATOR
References: