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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: HIV

Treatments: Behavioral: Structural level; Behavioral: Structural level standard of care; Behavioral: Individual level; Behavioral: Individual level standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT01689545

5R01DA022962

Details and patient eligibility

About

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.

Full 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?

Enrollment: 2,175 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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2,175 participants in 4 patient groups

Individual level

Experimental group

Treatment:

Behavioral: Structural level standard of care

Behavioral: Individual level

Structural level

Experimental group

Treatment:

Behavioral: Structural level

Behavioral: Individual level standard of care

Combined individual & structural level

Experimental group

Treatment:

Behavioral: Structural level

Behavioral: Individual level

Standard of Care

Active Comparator group

Treatment:

Behavioral: Structural level standard of care

Behavioral: Individual level standard of care