Skip to main content
OpenTrials
Completed

NCT Number: NCT01689545

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Behavior Chemically-Induced Disorders Mental Disorders Social Behavior Social Stigma Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Preventive Medicine

Thai Nguyen, Vietnam

About this study

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:

  • What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
  • What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Index participant

Inclusion criteria

  • laboratory confirmed HIV positive diagnosis
  • able and wiling to bring an injecting network member for screening
  • injected drugs in previous 6 months
  • planned residence in Thai Nguyen for next 24 months

Exclusion criteria

  • unwilling to provide locator information
  • unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
  • currently participating in other HIV or drug use intervention activities

Network member participant

Inclusion criteria

  • laboratory confirmed HIV negative diagnosis
  • injected or shared drug paraphernalia in past 6 months
  • interacts at least once a week with index participant

Exclusion criteria

  • unwilling to provide locator information
  • having psychological or cognitive impairment
  • currently participating in other HIV intervention

Treatment and study plan

Individual level

Behavioral

Index 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.

Structural level

Behavioral

Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.

Individual level standard of care

Behavioral

The 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.

Structural level standard of care

Behavioral

Posters 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.

Primary outcomes

  1. HIV injecting risk behavior

    Time frame: 2 years

    Change in self-reported use of new injecting equipment

  2. HIV sexual risk behavior

    Time frame: 2 years

    Change in self-reported condom use during sexual intercourse

Secondary outcomes

  1. HIV incidence

    Time frame: 2 years

    Change in HIV incidence among network members

Other outcomes

  1. Perceived HIV-related stigma

    Time frame: 2 years

    Change in self-reported perceived HIV-related stigma among index participants

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 21, 2012
Registry last updated
Jun 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.