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

Primary Purpose

Drug Dependence

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Intervention to Address Drug Use and HIV in Vietnam
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Drug Dependence focused on measuring Stigma, HIV, CHWs, PLH, Injecting Drug Users, FM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phú Thọ commune health centers
  • Vĩnh Phúc commune health centers

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Community Health Worker (CHW) Interaction with patients
Provider-Client interaction scale will be used.
Injecting Drug User (IDU) drug use
Urine test results

Secondary Outcome Measures

Community Health Worker (CHW) job safety, support, and satisfaction
This will be assessed by perceived risk at work and institutional support. Additionally by job satisfaction using a 29-item scale.
Community Health Worker (CHW) knowledge and adherence to universal precautions
This will be assessed with the universal precautions knowledge scale.
Injecting Drug User (IDU) family and social support
This is measured by two instruments. Social Support Questionnaire (Short; SSQ6) is a 6-item assessment to measure satisfaction of social support. Number of social support providers is captured up to 9 people in various support dimensions (Sarason et al., 1983). Medical Outcomes Study- Social Support Scale (MOS-SS) is a 20-item scale that measures the strength of perceived social support available. The scale consists of five dimensions: emotional support, informational support, tangible support, positive social interaction, and affection
Family Member (FM) social support
This is measured by two instruments. Social Support Questionnaire (Short; SSQ6) is a 6-item assessment to measure satisfaction of social support. Number of social support providers is captured up to 9 people in various support dimensions (Sarason et al., 1983). Medical Outcomes Study- Social Support Scale (MOS-SS) is a 20-item scale that measures the strength of perceived social support available. The scale consists of five dimensions: emotional support, informational support, tangible support, positive social interaction, and affection.
Community Health Worker (CHW) general prejudicial attitude
A scale will be used
Family Member (FM) Caregiver burden/coping
Caregiver burden and coping scales will be used

Full Information

First Posted
May 1, 2014
Last Updated
October 11, 2018
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT02130921
Brief Title
Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
Official Title
Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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: To develop and implement an integrated intervention, CHW CARE, for CHWs, IDUs, and their FMS in Vietnam To evaluate the feasibility and operational procedures of the intervention with an implementation pilot, including process evalution and monitoring, and participants feedback. 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. To explore the relationships between the intervention outcomes of CHWs, IDUs, and FMs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Dependence
Keywords
Stigma, HIV, CHWs, PLH, Injecting Drug Users, FM

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Intervention to Address Drug Use and HIV in Vietnam
Intervention Description
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 Outcome Measure Information:
Title
Community Health Worker (CHW) Interaction with patients
Description
Provider-Client interaction scale will be used.
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Title
Injecting Drug User (IDU) drug use
Description
Urine test results
Time Frame
baseline, 3-, 6-, 9- and 12- month follow-up
Secondary Outcome Measure Information:
Title
Community Health Worker (CHW) job safety, support, and satisfaction
Description
This will be assessed by perceived risk at work and institutional support. Additionally by job satisfaction using a 29-item scale.
Time Frame
Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Title
Community Health Worker (CHW) knowledge and adherence to universal precautions
Description
This will be assessed with the universal precautions knowledge scale.
Time Frame
Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Title
Injecting Drug User (IDU) family and social support
Description
This is measured by two instruments. Social Support Questionnaire (Short; SSQ6) is a 6-item assessment to measure satisfaction of social support. Number of social support providers is captured up to 9 people in various support dimensions (Sarason et al., 1983). Medical Outcomes Study- Social Support Scale (MOS-SS) is a 20-item scale that measures the strength of perceived social support available. The scale consists of five dimensions: emotional support, informational support, tangible support, positive social interaction, and affection
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Title
Family Member (FM) social support
Description
This is measured by two instruments. Social Support Questionnaire (Short; SSQ6) is a 6-item assessment to measure satisfaction of social support. Number of social support providers is captured up to 9 people in various support dimensions (Sarason et al., 1983). Medical Outcomes Study- Social Support Scale (MOS-SS) is a 20-item scale that measures the strength of perceived social support available. The scale consists of five dimensions: emotional support, informational support, tangible support, positive social interaction, and affection.
Time Frame
Changes from baseline to 3-, 6-, 9-, and 12- month follow-up
Title
Community Health Worker (CHW) general prejudicial attitude
Description
A scale will be used
Time Frame
Changes from baseline to 3-, 6-, 9- and 12- month follow-up
Title
Family Member (FM) Caregiver burden/coping
Description
Caregiver burden and coping scales will be used
Time Frame
Changes from baseline to 3-,6-,9-, and 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li, Ph.D
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phú Thọ commune health centers
City
Phú Thọ
Country
Vietnam
Facility Name
Vĩnh Phúc commune health centers
City
Vĩnh Phúc
Country
Vietnam

12. IPD Sharing Statement

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

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