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

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Individual level
* Behavioral: Structural level
* Behavioral: Individual level standard of care
* Behavioral: Structural level standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual level<br> | Behavioral: Individual level<br>* 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.<br>Behavioral: Structural level standard of care<br>* 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.<br>|
| Experimental: Structural level<br> | Behavioral: Structural level<br>* Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.<br>Behavioral: Individual level standard of care<br>* 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.<br>|
| Experimental: Combined individual & structural level<br> | Behavioral: Individual level<br>* 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.<br>Behavioral: Structural level<br>* Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.<br>|
| Active Comparator: Standard of Care<br> | Behavioral: Individual level standard of care<br>* 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.<br>Behavioral: Structural level standard of care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV injecting risk behavior | Change in self-reported use of new injecting equipment | 2 years | 
| HIV sexual risk behavior | Change in self-reported condom use during sexual intercourse | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence | Change in HIV incidence among network members | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, drug abuse, social stigma, Vietnam