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

NCT01540188 | Completed Phase 1 DMC

• 1 other identifier: R34DA029493
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Drug user; Family member; Intervention; Community; Support

Outcome Measures

Primary Outcomes (2)

• Physical health

  The IDUs will be assessed using the Medical Outcomes Study (MOS) Short-Form 36 (SF-36). The MOS-SF-36 consists of the following domains: physical functioning; role limitation (physical); role limitation (emotional); social functioning; mental health; energy/vitality; pain; and general health perception. The score for each domain ranges from 0 to 100 with higher values indicating higher functional status.

  Changes from baseline to 3- and 6-month follow-up

• Mental health

  All of the participants including both IDUs and family members will be assessed by the Zung Self-Rating Depression Scale. This measure, developed by the World Health Organization, is a 20-item self-report scale that is widely used as a screening tool, covering affective, psychological and somatic symptoms associated with depression. Results from this measure will be used as an indicator of psychological (including psychosis) and emotional functioning that can be associated with drug use.

  Changes from baseline to 3- and 6-month follow-up

Secondary Outcomes (4)

• Drug use

  Changes from baseline to 3- and 6-month follow-up

• Sexual risk

  Changes from baseline to 3- and 6-month follow-up

• Caregiver burden

  Changes from baseline to 3- and 6-month follow-up

• Family/social support

  Changes from baseline to 3- and 6-month follow-up

Study Arms (2)

Starndard care arm

NO INTERVENTION

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

Intervention arm

EXPERIMENTAL

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

Behavioral: Family Intervention to Address Drug Use and HIV in Vietnam

Interventions

Family Intervention to Address Drug Use and HIV in Vietnam 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

Intervention arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator

Study Sites (1)

Commune health centers

Việt Trì, Phu Tho, Vietnam

Location

MeSH Terms

Conditions

Drug Misuse

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Li Li, Ph.D

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Professor-in-Residence

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 28, 2012
• Study Start: July 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

VN (1)