Clinical trial NCT01540188: Development of a Family Intervention to Address Drug Use and HIV in Vietnam
Official title: Development of a Family Intervention to Address Drug Use and HIV in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Quality of Life
Keywords: Drug user
Family member
Intervention
Community
Support
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
First posted: 2012-02-28
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Physical health
timeFrame: Changes from baseline to 3- and 6-month follow-up
measure: Mental health
timeFrame: Changes from baseline to 3- and 6-month follow-up
Secondary outcomes:
measure: Drug use
timeFrame: Changes from baseline to 3- and 6-month follow-up
measure: Sexual risk
timeFrame: Changes from baseline to 3- and 6-month follow-up
measure: Caregiver burden
timeFrame: Changes from baseline to 3- and 6-month follow-up
measure: Family/social support
timeFrame: Changes from baseline to 3- and 6-month follow-up
Other outcomes:
Locations:
city: Viet Tri
country: Vietnam
facility: Commune health centers
state: Phu Tho
Study officials:
affiliation: University of California, Los Angeles
name: Li Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: