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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Individual level
Structural level
Individual level standard of care
Structural level standard of care
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, drug abuse, social stigma, Vietnam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Preventive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Individual level

Structural level

Combined individual & structural level

Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

HIV injecting risk behavior
Change in self-reported use of new injecting equipment
HIV sexual risk behavior
Change in self-reported condom use during sexual intercourse

Secondary Outcome Measures

HIV incidence
Change in HIV incidence among network members

Full Information

First Posted
September 18, 2012
Last Updated
June 4, 2014
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT01689545
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs? What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, drug abuse, social stigma, Vietnam

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual level
Arm Type
Experimental
Arm Title
Structural level
Arm Type
Experimental
Arm Title
Combined individual & structural level
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Individual level
Intervention Description
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
Intervention Name(s)
Structural level
Intervention Description
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
Intervention Name(s)
Individual level standard of care
Intervention Description
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
Intervention Name(s)
Structural level standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV injecting risk behavior
Description
Change in self-reported use of new injecting equipment
Time Frame
2 years
Title
HIV sexual risk behavior
Description
Change in self-reported condom use during sexual intercourse
Time Frame
2 years
Secondary Outcome Measure Information:
Title
HIV incidence
Description
Change in HIV incidence among network members
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Perceived HIV-related stigma
Description
Change in self-reported perceived HIV-related stigma among index participants
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian F Go, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Preventive Medicine
City
Thai Nguyen
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
32833193
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.
Results Reference
derived
PubMed Identifier
30357641
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.
Results Reference
derived
PubMed Identifier
26011427
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.
Results Reference
derived

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

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