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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01689545
First received: September 18, 2012
Last updated: June 4, 2014
Last verified: May 2014

September 18, 2012
June 4, 2014
December 2007
April 2013   (final data collection date for primary outcome measure)
  • HIV injecting risk behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in self-reported use of new injecting equipment
  • HIV sexual risk behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in self-reported condom use during sexual intercourse
Same as current
Complete list of historical versions of study NCT01689545 on ClinicalTrials.gov Archive Site
HIV incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change in HIV incidence among network members
Same as current
Perceived HIV-related stigma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change in self-reported perceived HIV-related stigma among index participants
Same as current
 
Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU
Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users

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.

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?
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV
  • Behavioral: Individual level
    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.
  • Behavioral: Structural level
    Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
  • Behavioral: Individual level standard of care
    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.
  • Behavioral: Structural level standard of care
    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.
  • Experimental: Individual level
    Interventions:
    • Behavioral: Individual level
    • Behavioral: Structural level standard of care
  • Experimental: Structural level
    Interventions:
    • Behavioral: Structural level
    • Behavioral: Individual level standard of care
  • Experimental: Combined individual & structural level
    Interventions:
    • Behavioral: Individual level
    • Behavioral: Structural level
  • Active Comparator: Standard of Care
    Interventions:
    • Behavioral: Individual level standard of care
    • Behavioral: Structural level standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2175
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT01689545
5R01DA022962
Yes
Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
Not Provided
Principal Investigator: Vivian F Go, PhD Johns Hopkins Bloomberg School of Public Health
Johns Hopkins Bloomberg School of Public Health
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP