HIV Clinical Trial - A Psychosocial Tele-health Stigma Intervention for

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04884867
Study type	Interventional
Source	University of New England
Contact
Status	Completed
Phase	N/A
Start date	April 14, 2021
Completion date	May 15, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms