Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial

NCT02130921 | Completed DMC

• 1 other identifier: R01DA033609-01
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Drug Dependence

Keywords

Stigma; HIV; CHWs; PLH; Injecting Drug Users; FM

Outcome Measures

Primary Outcomes (2)

• Community Health Worker (CHW) Interaction with patients

  Provider-Client interaction scale will be used.

  Changes from baseline to 3-, 6-, 9- and 12- month follow-up

• Injecting Drug User (IDU) drug use

  Urine test results

  baseline, 3-, 6-, 9- and 12- month follow-up

Secondary Outcomes (6)

• Community Health Worker (CHW) job safety, support, and satisfaction

  Changes from baseline to 3-, 6-, 9-, and 12- month follow-up

• Community Health Worker (CHW) knowledge and adherence to universal precautions

  Changes from baseline to 3-, 6-, 9-, and 12- month follow-up

• Injecting Drug User (IDU) family and social support

  Changes from baseline to 3-, 6-, 9- and 12- month follow-up

• Family Member (FM) social support

  Changes from baseline to 3-, 6-, 9-, and 12- month follow-up

• Community Health Worker (CHW) general prejudicial attitude

  Changes from baseline to 3-, 6-, 9- and 12- month follow-up

Study Arms (2)

Control

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.

Intervention

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.

Behavioral: Intervention to Address Drug Use and HIV in Vietnam

Interventions

Intervention to Address Drug Use and HIV in Vietnam BEHAVIORAL

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Community Health Workers:
• Inability to give informed consent

Sponsors & Collaborators

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

Study Sites (2)

Phú Thọ commune health centers

Phú Thọ, Vietnam

Location

Vĩnh Phúc commune health centers

Vĩnh Phúc, Vietnam

Location

MeSH Terms

Conditions

Substance-Related Disorders; Social Stigma

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 6, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

VN (2)