Clinical trial NCT01689545: Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU
Official title: Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
drug abuse
social stigma
Vietnam
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 2175
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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?

Eligibility 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

Primary outcomes:
measure: HIV injecting risk behavior
timeFrame: 2 years
measure: HIV sexual risk behavior
timeFrame: 2 years
Secondary outcomes:
measure: HIV incidence
timeFrame: 2 years
Other outcomes:
measure: Perceived HIV-related stigma
timeFrame: 2 years
Locations:
city: Thai Nguyen
country: Vietnam
facility: Center for Preventive Medicine
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Vivian F Go, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.