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

Not Applicable
Completed
Conditions
HIV
Interventions
Behavioral: Structural level
Behavioral: Individual level standard of care
Behavioral: Individual level
Behavioral: Structural level standard of care
Registration Number
NCT01689545
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Brief 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?

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
2175
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Structural levelStructural level-
Standard of CareIndividual level standard of care-
Structural levelIndividual level standard of care-
Individual levelIndividual level-
Combined individual & structural levelIndividual level-
Standard of CareStructural level standard of care-
Individual levelStructural level standard of care-
Combined individual & structural levelStructural level-
Primary Outcome Measures
NameTimeMethod
HIV injecting risk behavior2 years

Change in self-reported use of new injecting equipment

HIV sexual risk behavior2 years

Change in self-reported condom use during sexual intercourse

Secondary Outcome Measures
NameTimeMethod
HIV incidence2 years

Change in HIV incidence among network members

Trial Locations

Locations (1)

Center for Preventive Medicine

🇻🇳

Thai Nguyen, Vietnam

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