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
  Purpose

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.


Condition Intervention
HIV
Behavioral: Individual level
Behavioral: Structural level
Behavioral: Individual level standard of care
Behavioral: Structural level standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • HIV incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in HIV incidence among network members


Other Outcome Measures:
  • Perceived HIV-related stigma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in self-reported perceived HIV-related stigma among index participants


Enrollment: 2175
Study Start Date: December 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual level 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 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: Structural level 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.
Experimental: Combined individual & structural level 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.
Active Comparator: Standard of Care 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.

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?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689545

Locations
Vietnam
Center for Preventive Medicine
Thai Nguyen, Vietnam
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Vivian F Go, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01689545     History of Changes
Other Study ID Numbers: 5R01DA022962
Study First Received: September 18, 2012
Last Updated: June 4, 2014
Health Authority: National Institutes of Health: National Institute on Drug Abuse

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV
drug abuse
social stigma
Vietnam

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014