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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01689545
Enrollment
2175
Registered
2012-09-21
Start date
2007-12-31
Completion date
2013-04-30
Last updated
2014-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV, drug abuse, social stigma, Vietnam

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?

Interventions

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.

BEHAVIORALStructural level

Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.

BEHAVIORALIndividual 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.

BEHAVIORALStructural 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.

Sponsors

Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
HIV injecting risk behavior2 yearsChange in self-reported use of new injecting equipment
HIV sexual risk behavior2 yearsChange in self-reported condom use during sexual intercourse

Secondary

MeasureTime frameDescription
HIV incidence2 yearsChange in HIV incidence among network members

Other

MeasureTime frameDescription
Perceived HIV-related stigma2 yearsChange in self-reported perceived HIV-related stigma among index participants

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026