Overview

This trial is active, not recruiting.

Condition drug dependence
Treatment intervention to address drug use and hiv in vietnam
Sponsor University of California, Los Angeles
Collaborator National Institute of Hygiene and Epidemiology, Vietnam
Start date July 2014
End date October 2016
Trial size 1800 participants
Trial identifier NCT02130921, RO1DA33609-01

Summary

This proposed study is an initiative for HIV prevention and care that integrates intervention efforts at multiple strata: Community Health Workers (CHWs), Injecting Drug Users (IDUs), and their Family Members (FMs). The proposed study will demonstrate the process of development, implementation, and evaluation of an intervention for CHWs, IDUs, and their FMs. One aim is to increase the CHWs' capacities to effectively interact with IDUs and FMs for HIV and drug use prevention and treatment. Using a combination of participatory action research and a randomized controlled trial design, this study has the potential to maximize PEPFAR impact in Vietnam and other PEPFAR-funded countries by identifying a sustainable mix of interventions and their implementation in different settings. The findings may benefit not only Vietnam but also a global audience by investigating enhanced methods for controlling the HIV epidemic.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Community Health Workers (CHWs) in the control group will be invited to one group lecture didactically reviewing medical ethics, and the attending CHWs will be requested to pay a home visit to participating IDUs and FMs after the lecture.
(Experimental)
Intervention for CHWs: 3 sessions will cover the understanding stigma and its impact, self-protection and universal precaution adherence, effective communication with patients and family members, and motivational enhancement for behavioral change. Intervention for IDUs: CHWs who participate in the intervention will be required to conduct 3 individual sessions with participating IDUs covering the following topics: physical health, risk reduction behaviors, mental health, and community integration. Intervention for FMs: CHWs who participate in the intervention will be required to conduct 2 group sessions with participating FMs covering the following topics: healthy family routine, coping with caregiver burdens, enhance family relationships, support positive behavior change.
intervention to address drug use and hiv in vietnam
Intervention for CHWs: 3 sessions will cover the understanding stigma and its impact, self-protection and universal precaution adherence, effective communication with patients and family members, and motivational enhancement for behavioral change. Intervention for IDUs: CHWs who participate in the intervention will be required to conduct 3 individual sessions with participating IDUs covering the following topics: physical health, risk reduction behaviors, mental health, and community integration. Intervention for FMs: CHWs who participate in the intervention will be required to conduct 2 group sessions with participating FMs covering the following topics: healthy family routine, coping with caregiver burdens, enhance family relationships, support positive behavior change.

Primary Outcomes

Measure
Community Health Worker (CHW) general prejudicial attitude
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Community Health Worker (CHW) Interaction with patients and family members
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) service satisfaction
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) drug use
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) sexual risk behavior
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) physical health
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) mental health
time frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Family Member (FM) mental health
time frame: Changes in baseline to 3-, 6-, 9-, and 12- months
Family Member (FM) family relations and family support
time frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Family Member (FM) Caregiver burden/coping
time frame: Changes from baseline to 3-,6-,9-, and 12-month follow-up

Secondary Outcomes

Measure
Community Health Worker (CHW) Service Referrals
time frame: Changes from baseline to 3-, 6-, 9-, and 12-month follow-up
Community Health Worker (CHW) job safety, support, and satisfaction
time frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Community Health Worker (CHW) knowledge and adherence to universal precautions
time frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Injecting Drug User (IDU) family and social support
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Injecting Drug User (IDU) Human Immunodeficiency Virus (HIV) testing
time frame: Changes from baseline to 12 month follow-up
Family Member (FM) social support
time frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Injecting Drug Users: - Age 18 or over - Having a history of drug use - Currently residing in the selected commune, and have no plan to move to other communes in the following year - Voluntary informed consent Family members of Injecting Drug Users: - Age 18 or over - Immediate or extended family member of the Injecting Drug User. - Previous knowledge of the drug use of the IDU. - Voluntary informed consent - Currently residing in the selected commune, and have no plan to move to other communes in the following year Community Health Workers: - Age 18 or over - Doctor, nurse, or other care provider working at the selected commune health centers - Informed consent Exclusion Criteria: Injecting Drug Users: - Those who have psychosis or neurological damage, or cannot understand the study purposes as judged by the interviewer in consultation with a clinic supervisor, will be excluded - Does not meet other inclusion criteria Family members of Injecting Drug Users: - Those who have psychosis or neurological damage, or cannot understand the study purposes as judged by the interviewer in consultation with a clinic supervisor, will be excluded - Does not meet other inclusion criteria Community Health Workers: - Inability to give informed consent - Does not meet other inclusion criteria

Additional Information

Official title Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
Principal investigator Li Li, Ph.D
Description Vietnam is currently facing an HIV epidemic that had affected approximately 280,000 people by the end of 2009. Injecting Drug Use (IDU) is principal driver of the HIV epidemic, contributing to between 32 % and 58 % of all HIV cases in various provinces. However, it has proven difficult to address the needs of IDUs, a high-risk group, given the prevalence of stigmatization and drug use in Vietnamese society. In addition, Vietnamese people are highly family oriented and most young IDUs have daily family contact of live in their parents' homes. Thus the burden on the family is substantial, and even greater if the IDU is HIV+. The study will be implemented in two provinces in Vietnam: Phu Tho and Vinh Phuc. A randomized controlled trial will be conducted to evaluate the impact of the intervention in 60 commune health centers. From each center we will recruit 5 Community Health Workers (CHWs), 15 Injecting Drug Users (IDUs), and 10 Family Members (FMs) (totaling 300 CHWs, 900 IDUs, and 600 FMs). The outcomes will be evaluated at 3-, 6-, 9-, and 12- month follow-up assessments. The specific aims of the study are as follows: 1. To develop and implement an integrated intervention, CHW CARE, for CHWs, IDUs, and their FMS in Vietnam 2. To evaluate the feasibility and operational procedures of the intervention with an implementation pilot, including process evalution and monitoring, and participants feedback. 3. To assess the impact of the intervention by comparing outcome measures of CHWs, IDUs, and FMs in the intervention group to those in the control group. 4. To explore the relationships between the intervention outcomes of CHWs, IDUs, and FMs.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.