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Completed

NCT Number: NCT02130921

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

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.

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Key information

Conditions

Drug Dependence Behavior Chemically-Induced Disorders Mental Disorders Social Behavior Social Stigma Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phú Thọ commune health centers, Phú Thọ, Vietnam

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Community Health Worker (CHW) Interaction with patients

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

    Provider-Client interaction scale will be used.

  2. Injecting Drug User (IDU) drug use

    Time frame: baseline, 3-, 6-, 9- and 12- month follow-up

    Urine test results

Secondary outcomes

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

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

    This will be assessed by perceived risk at work and institutional support. Additionally by job satisfaction using a 29-item scale.

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

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

    This will be assessed with the universal precautions knowledge scale.

  3. Injecting Drug User (IDU) family and social support

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

    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

  4. Family Member (FM) social support

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

    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.

  5. Community Health Worker (CHW) general prejudicial attitude

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

    A scale will be used

  6. Family Member (FM) Caregiver burden/coping

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

    Caregiver burden and coping scales will be used

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 6, 2014
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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