Development of a Family Intervention to Address Drug Use and HIV in Vietnam

NCT ID: NCT01540188

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-04-30

Brief Summary

Vietnam is currently experiencing two epidemics -- injection drug use and HIV. HIV infection is rising rapidly, primarily among injecting drug users (IDUs). Most young IDUs keep daily contact with their family or live in their parent's home. The burden on their families is substantial, and even greater if the IDU is HIV+. In this study, the investigators conduct an intervention pilot to develop and evaluate a family intervention to improve outcomes over time for Vietnamese IDUs and their families. This two-year study is conducted in Phu Tho, a province located about 80 km from Hanoi, Vietnam's capital.

Two teams with complementary expertise collaborate to implement this study: the UCLA team and the Vietnamese team from the Vietnam National Institute of Hygiene & Epidemiology (NIHE). The study has two phases:

• In Phase 1, the investigators develop the content, format and an implementation plan for the intervention from a focus group of 10 service providers, administrators and community leaders, and through in-depth interviews with 40 IDUs (20 HIV+ and 20 HIV-) recruited from the local drug rehabilitation center (the "06 Center") and from two local communities (Duu Lau and Gia Cam), as well as in-depth interviews with 20 of the IDUs family members (FM). Based on the findings, the investigators collaborate on designing a Vietnamese-specific family intervention for IDUs and their family members.
• In Phase 2, the investigators pilot the intervention in the local commune health centers in Viet Tri, Phu Tho. Eighty IDUs (HIV+/HIV-) and 80 of their family members are recruited from 4 communes and the 06 Center in Viet Tri city, and randomized into a intervention group and a control group. After the 4-week intervention, 3-month and 6-month follow-ups are conducted to assess the effectiveness of the intervention. Participants randomized to the control group only complete the assessments (baseline, 3-, and 6-month) at the same time points.

Detailed Description

Vietnam is facing the challenge of dual epidemics -injection drug use and HIV. HIV infection is rising exponentially, primarily among injecting drug users (IDUs). Because Vietnamese are highly family oriented, most young IDUs have daily family contact or live in their parents' homes. The burden on the family is substantial, and even greater if the IDU is HIV+. The investigators hypothesize that with assistance, families can be part of the solution for both HIV and HIV+ IDU. This family intervention in Vietnam is based on the Social Action Theory and Social Network Theory, aimed at increasing families' capacities to effectively cope with the impact of IDUs and HIV. The study provides an opportunity to test culturally-specific intervention content and delivery. In addition, the intervention pilot will provide an opportunity to obtain project implementation experience in the local settings. The study also provides the opportunity to pilot test outcome measures.

The specific aims of the study are:

1. To document the challenges of drug use and HIV for IDUs and their family members;

2. To examine the acceptability and feasibility of a family-based intervention for IDU and their family members;

3. To examine whether the IDUs and family members in the intervention group, compared to those in the standard care group, will have significantly improved health, mental health, and quality of life outcomes, including health seeking, reduced sexual and drug use risk behaviors, increased HIV testing, and reduced caregiver burden; and

4. To examine how outcomes of the IDUs and family members are mediated by family indicators such as family cohesion, stress and symptom management, stigma and harm reduction, HIV disclosure, and treatment adherence.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Starndard care arm

Participants of the standard care arm are control groups of IDUs and family members. They do not attend intervention sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention arm

Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.

Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community

Group Type: EXPERIMENTAL

Family Intervention to Address Drug Use and HIV in Vietnam

Intervention Type: BEHAVIORAL

Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.

Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community

Interventions

Family Intervention to Address Drug Use and HIV in Vietnam

Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.

Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• IDUs:

• Age 18 or over
• Either HIV + or HIV- in blood test
• A current or past injection drug user
• Disclosure of drug use status and HIV positive status (if positive) to their family members
• Voluntary informed consent

Family members:

• Age 18 or over
• Immediate or extended family member of an IDU and living with the IDU.
• Previous knowledge of the drug use and HIV status (if positive) of the IDU.
• Voluntary informed consent

Exclusion Criteria

• IDUs :

• Inability to give informed consent
• Has not disclosed the drug use status and HIV status (if positive) to family member
• Not a current or past injection drug user

Family members:

• Inability to give informed consent
• Does not know the drug use status and HIV status (if positive) of the IDU in their family

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Li Li

Principal investigator, Professor-in-Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Li, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Commune health centers

Việt Trì, Phu Tho, Vietnam

Countries

Vietnam

Other Identifiers

R34DA029493

Identifier Type: NIH

Identifier Source: org_study_id

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