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

NCT01689545 | Completed DMC

• 1 other identifier: 5R01DA022962
• Study Type: interventional
• Target: 2,175
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; drug abuse; social stigma; Vietnam

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• HIV incidence

  2 years

Other Outcomes (1)

• Perceived HIV-related stigma

  2 years

Study Arms (4)

Individual level

EXPERIMENTAL

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

Structural level

EXPERIMENTAL

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

Combined individual & structural level

EXPERIMENTAL

Behavioral: Individual level; Behavioral: Structural level

Standard of Care

ACTIVE COMPARATOR

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

Interventions

Individual level 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.

Combined individual & structural level; Individual level

Structural level BEHAVIORAL

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

Combined individual & structural level; Structural level

Individual level standard of care 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.

Standard of Care; Structural level

Structural level standard of care 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.

Individual level; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• laboratory confirmed HIV negative diagnosis
• injected or shared drug paraphernalia in past 6 months
• interacts at least once a week with index participant
• unwilling to provide locator information
• having psychological or cognitive impairment
• currently participating in other HIV intervention

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Center for Preventive Medicine

Thái Nguyên, Thai Nguyen, Vietnam

Location

Related Publications (3)

• 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.

  PMID: 32833193 DERIVED

• 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.

  PMID: 30357641 DERIVED

• 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.

  PMID: 26011427 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Social Stigma

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Vivian F Go, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: December 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 5, 2014

Record last verified: 2014-05

Locations

VN (1)