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

NCT ID: NCT01689545

Last Updated: 2014-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-04-30

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:

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?

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Individual level

Group Type EXPERIMENTAL

Individual level

Intervention Type BEHAVIORAL

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.

Structural level standard of care

Intervention Type BEHAVIORAL

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.

Structural level

Group Type EXPERIMENTAL

Structural level

Intervention Type BEHAVIORAL

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

Individual level standard of care

Intervention Type BEHAVIORAL

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.

Combined individual & structural level

Group Type EXPERIMENTAL

Individual level

Intervention Type BEHAVIORAL

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.

Structural level

Intervention Type BEHAVIORAL

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

Standard of Care

Group Type ACTIVE_COMPARATOR

Individual level standard of care

Intervention Type BEHAVIORAL

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.

Structural level standard of care

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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
* 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


* unwilling to provide locator information
* having psychological or cognitive impairment
* currently participating in other HIV intervention
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivian F Go, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Center for Preventive Medicine

Thái Nguyên, Thai Nguyen, Vietnam

Site Status

Countries

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Vietnam

References

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Levintow SN, Pence BW, Powers KA, Sripaipan T, Ha TV, Chu VA, Quan VM, Latkin CA, Go VF. Estimating the Effect of Depression on HIV Transmission Risk Behaviors Among People Who Inject Drugs in Vietnam: A Causal Approach. AIDS Behav. 2021 Feb;25(2):438-446. doi: 10.1007/s10461-020-03007-9.

Reference Type DERIVED
PMID: 32833193 (View on PubMed)

Levintow SN, Pence BW, Ha TV, Le Minh N, Sripaipan T, Latkin CA, Vu PT, Quan VM, Frangakis C, Go VF. Depressive Symptoms at HIV Testing and Two-Year All-Cause Mortality Among Men Who Inject Drugs in Vietnam. AIDS Behav. 2019 Mar;23(3):609-616. doi: 10.1007/s10461-018-2318-8.

Reference Type DERIVED
PMID: 30357641 (View on PubMed)

Go VF, Frangakis C, Minh NL, Latkin C, Ha TV, Mo TT, Sripaipan T, Davis WW, Zelaya C, Vu PT, Celentano DD, Quan VM. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial. PLoS One. 2015 May 26;10(5):e0125909. doi: 10.1371/journal.pone.0125909. eCollection 2015.

Reference Type DERIVED
PMID: 26011427 (View on PubMed)

Other Identifiers

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5R01DA022962

Identifier Type: NIH

Identifier Source: org_study_id

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