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Drug DependenceNCT02130921

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

A study testing Intervention to Address Drug Use and HIV in Vietnam in people with Drug Dependence, run by University of California, Los Angeles at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Drug Dependence
What is being tested?
Intervention to Address Drug Use and HIV in Vietnam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,800 participants
Where
2 sitesVietnam
Study dates
Jul 2014to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • Community Health Workers:
  • Inability to give informed consent
  • Does not meet other inclusion criteria

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • Phú Thọ commune health centers

    Phú Thọ

  • Vĩnh Phúc commune health centers

    Vĩnh Phúc

Other trials in Vietnam

About this study

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.

Read the 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.
Conditions
Drug Dependence
Being tested
Intervention to Address Drug Use and HIV in Vietnam
Keywords
Stigma, HIV, CHWs, PLH, Injecting Drug Users, FM
Medical subject headings
Substance-Related Disorders, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention to Address Drug Use and HIV in VietnamBehavioural

    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.

Study groups in NCT02130921
Study groupRoleWhat they receive
ControlNo interventionCommunity 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.
InterventionExperimentalIntervention 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.
Receives: Behavioral: Intervention to Address Drug Use and HIV in Vietnam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Community Health Worker (CHW) Interaction with patients

    Provider-Client interaction scale will be used.

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

  2. Injecting Drug User (IDU) drug use

    Urine test results

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

Secondary outcomes (6)

  1. 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.

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

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

    This will be assessed with the universal precautions knowledge scale.

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

  3. 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

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

  4. 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.

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

  5. Community Health Worker (CHW) general prejudicial attitude

    A scale will be used

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

  6. Family Member (FM) Caregiver burden/coping

    Caregiver burden and coping scales will be used

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,800 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02130921
Sponsor's protocol ID
R01DA033609-01
Status last verified
Oct 2018
First submitted
1 May 2014
Last updated
12 Oct 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Intervention to Address Drug Use and HIV in Vietnam in people with Drug Dependence, run by University of California, Los Angeles at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Community Health Worker (CHW) Interaction with patients (time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02130921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.

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