Clinical Trials Directory

Trials / Completed

CompletedNCT01689545

Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU

Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,175 (actual)
Sponsor
Johns Hopkins Bloomberg School of Public Health · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.

Detailed description

This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are: 1. What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs? 2. What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors 3. Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?

Conditions

Interventions

TypeNameDescription
BEHAVIORALIndividual levelIndex participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
BEHAVIORALStructural levelCommunity members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
BEHAVIORALIndividual level standard of careThe education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
BEHAVIORALStructural level standard of carePosters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.

Timeline

Start date
2007-12-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2012-09-21
Last updated
2014-06-05

Locations

1 site across 1 country: Vietnam

Source: ClinicalTrials.gov record NCT01689545. Inclusion in this directory is not an endorsement.