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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02130921
Enrollment
1800
Registered
2014-05-06
Start date
2014-07-31
Completion date
2018-05-31
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Dependence

Keywords

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

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: 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.

Interventions

BEHAVIORALIntervention 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.

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam
CollaboratorOTHER
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Community Health Worker (CHW) Interaction with patientsChanges from baseline to 3-, 6-, 9- and 12- month follow-upProvider-Client interaction scale will be used.
Injecting Drug User (IDU) drug usebaseline, 3-, 6-, 9- and 12- month follow-upUrine test results

Secondary

MeasureTime frameDescription
Injecting Drug User (IDU) family and social supportChanges from baseline to 3-, 6-, 9- and 12- month follow-upThis 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 supportChanges from baseline to 3-, 6-, 9-, and 12- month follow-upThis 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) job safety, support, and satisfactionChanges from baseline to 3-, 6-, 9-, and 12- month follow-upThis will be assessed by perceived risk at work and institutional support. Additionally by job satisfaction using a 29-item scale.
Family Member (FM) Caregiver burden/copingChanges from baseline to 3-,6-,9-, and 12-month follow-upCaregiver burden and coping scales will be used
Community Health Worker (CHW) general prejudicial attitudeChanges from baseline to 3-, 6-, 9- and 12- month follow-upA scale will be used
Community Health Worker (CHW) knowledge and adherence to universal precautionsChanges from baseline to 3-, 6-, 9-, and 12- month follow-upThis will be assessed with the universal precautions knowledge scale.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026