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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of California, Los Angeles
Sponsor:
Collaborator:
National Institute of Hygiene and Epidemiology, Vietnam
Information provided by (Responsible Party):
Li Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02130921
First received: May 1, 2014
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Drug Dependence
Behavioral: Intervention to Address Drug Use and HIV in Vietnam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing the Role of Commune Health Workers in HIV and Drug Control: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Community Health Worker (CHW) general prejudicial attitude [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    The Community Health Workers (CHWs) will be assessed using the Prejudicial Evaluation Scale as well as by avoidance in providing services.

  • Community Health Worker (CHW) Interaction with patients and family members [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    Measures will include the type, frequency, and length of services in risk reduction. Additionally the Jefferson scale of physician empathy and a Provider-Client interaction scale will be used.

  • Injecting Drug User (IDU) service satisfaction [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    The IDU service satisfaction will be assessed with a client satisfaction questionnaire.

  • Injecting Drug User (IDU) drug use [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    The IDU will be assessed using a urine test and the Addiction Severity Index (ASI). The IDU drug use will be measured by a biomarker (Urine drug screen) at the baseline, since the drug rehabilitation sites routinely collect urine to test for drug use. Positive results will be interpreted as signifying drug use, regardless of self-report. Further, a drug avoidance self-efficacy scale and change assessment scale will be employed.

  • Injecting Drug User (IDU) sexual risk behavior [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    This is assessed with a condom use/condom use efficacy scale and by sexual behavior after alcohol/drug use and HIV disclosure (HIV +).

  • Injecting Drug User (IDU) physical health [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    The IDUs will be assessed using the Medical Outcomes Study (MOS) Short-Form 36 (SF-36). The MOS-SF-36 consists of the following domains: physical functioning; role limitation (physical); role limitation (emotional); social functioning; mental health; energy/vitality; pain; and general health perception. The score for each domain ranges from 0 to 100 with higher values indicating higher functional status. Additionally a rating of medication influences scale (HIV +) will be conducted. Data on medical history, health status, access to treatment and disclosure will also be collected.

  • Injecting Drug User (IDU) mental health [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up ] [ Designated as safety issue: No ]
    IDU mental health will be assessed by the Zung Self-Rating Depression Scale. This measure, developed by the World Health Organization, is a 20-item self-report scale that is widely used as a screening tool, covering affective, psychological and somatic symptoms associated with depression. Results from this measure will be used as an indicator of psychological (including psychosis) and emotional functioning that can be associated with drug use. In addition the ASI psychiatric scale will be used.

  • Family Member (FM) mental health [ Time Frame: Changes in baseline to 3-, 6-, 9-, and 12- months ] [ Designated as safety issue: No ]
    The Family Members will be assessed by the Zung Self-Rating Depression Scale. This measure, developed by the World Health Organization, is a 20-item self-report scale that is widely used as a screening tool, covering affective, psychological and somatic symptoms associated with depression. Results from this measure will be used as an indicator of psychological (including psychosis) and emotional functioning that can be associated with drug use.

  • Family Member (FM) family relations and family support [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up ] [ Designated as safety issue: No ]
    Family relations and family support will be assessed using a family functioning scale, a family environment scale, and through an examination of the family daily routine.

  • Family Member (FM) Caregiver burden/coping [ Time Frame: Changes from baseline to 3-,6-,9-, and 12-month follow-up ] [ Designated as safety issue: No ]
    This is assessed using the Perceived Caregiver Burden Scale (PCB) (Stommel et al., 1990). This scale has been used in our studies in Thailand and China (Lee et al., 2009b) to assess caregiver burden in terms of perceptions and feelings about family members' physical and emotional health, family relationships, social life, work, and finances. In addition a Coping with Illness questionnaire will be administered.


Secondary Outcome Measures:
  • Community Health Worker (CHW) Service Referrals [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12-month follow-up ] [ Designated as safety issue: No ]
    This is assessed with the frequency of service referrals made based on individual needs. Additionally through HIV testing and harm reduction treatment referrals.

  • Community Health Worker (CHW) job safety, support, and satisfaction [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up ] [ Designated as safety issue: No ]
    This will be assessed with the universal precautions knowledge scale.

  • Injecting Drug User (IDU) family and social support [ Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up ] [ Designated as safety issue: No ]
    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

  • Injecting Drug User (IDU) Human Immunodeficiency Virus (HIV) testing [ Time Frame: Changes from baseline to 12 month follow-up ] [ Designated as safety issue: No ]
    The IDU will be tested for HIV at the baseline and at the 12 month mark using a urine test.

  • Family Member (FM) social support [ Time Frame: Changes from baseline to 3-, 6-, 9-, and 12- month follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1800
Study Start Date: July 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
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

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

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.


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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130921

Contacts
Contact: Li Li, Ph.D 310-794-2446 lililili@ucla.edu

Locations
Vietnam
Commune health centers Completed
Vinh Phuc, Phu Tho, Vietnam
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Hygiene and Epidemiology, Vietnam
Investigators
Principal Investigator: Li Li, Ph.D University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Li Li, Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02130921     History of Changes
Other Study ID Numbers: RO1DA33609-01
Study First Received: May 1, 2014
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Stigma
HIV
CHWs
PLH
Injecting Drug Users
FM

ClinicalTrials.gov processed this record on October 23, 2014