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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Individual level; Behavioral: Structural level standard of care; Behavioral: Structural level; Behavioral: Individual level standard of care

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?

• Study Type: Interventional
• Enrollment (Actual): 2175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Thai Nguyen, Vietnam
    • Center for Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard of Care	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.; 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.
EXPERIMENTAL: Individual level	Behavioral: 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.; 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.
EXPERIMENTAL: Structural level	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.; 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.
EXPERIMENTAL: Combined individual & structural level	Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV incidence	Change in HIV incidence among network members	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived HIV-related stigma	Change in self-reported perceived HIV-related stigma among index participants	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Investigators: Principal Investigator: Vivian F Go, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (ESTIMATE): September 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 5, 2014
• Last Update Submitted That Met QC Criteria: June 4, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: HIV; Vietnam; drug abuse; social stigma
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: 5R01DA022962 (NIH)