- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293355
Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam
Study Overview
Detailed Description
The purpose of this study is to develop and pilot test intervention strategies at the provincial level (Aim 1), treatment agency level (Aim2), and community level (Aim 3). These strategies aim to strengthen both horizontal and vertical collaboration and networking among providers to better serve people living with HIV who use drugs (PLHWUD), including those who are already in treatment and those who need to be linked to service. Commune health workers (CHW) have great potentials to be mobilized to engage PLHWUD living in the community and to work with providers at treatment clinics to support PLHWUD treatment retention and adherence. E-technologies such as Facebook and e-chat will also be utilized to enhance provider-provider coordination and provider-patient interaction.
The Specific Aims of the study are as follows:
Aim 1: Develop and implement structural-level strategies by establishing a provincial coordination team to improve coordination and service integration.
Aim 2: Assess agency-level intervention outcomes on treatment-provider collaboration and service integration of OPC services and MMT programs.
Aim 3: Assess community provider-level intervention outcomes by evaluating whether: 1) CHW in the intervention group, compared to those in the control group, demonstrate improved levels of collaboration with other clinical agencies, communication with patients, and service referrals, and 2) PLHWUD in the intervention group, compared to those in the control group, demonstrate improvements in treatment initiation, retention and adherence, and other mental and biological outcomes.
Based on the findings from Aims 1 and 2 activities, this intervention will be conducted in four provinces of Vietnam(Bac Giang, Hai Duong, Nam Dinh, and Nghe An). Randomization will occur at the community level (20 communes assigned to the intervention group; 20 communes assigned to the control group).
CONTROL COMMUNE ACTIVITIES:
A total of 40 CHW from 20 communes assigned to the control group will be invited to participate in a one-time didactic lecture/meeting with other co-workers from their commune health centers to learn about the importance of service integration.
CHW(n=40) and PLHWUD(n=120) from the control commune health centers will participate in a baseline assessment and follow-up assessments at 3, 6, 9, 12-months.
INTERVENTION COMMUNE ACTIVITIES:
A total of 40 CHW from 20 communes assigned to the intervention group will be invited to participate in the intervention that will consist of two in-person sessions lasting approximately 90 minutes over two weeks with 8-10 CHW in each session.
Booster sessions of the intervention training will be offered to CHW once every month during the first three months and once every three months thereafter. The booster session will focus on CHW' reports of their experiences, reinforcement of efforts, and continued skill building for problem solving. CHW(n=40) and PLHWUD(n=120) from the intervention commune health centers will participate in a baseline assessment and follow-up assessments at 3, 6, 9, 12-months.
The efficacy of the intervention will be assessed at baseline, 3, 6, 9, and 12-month follow-ups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bắc Giang, Vietnam
- Commune Health Centers
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Nam Định, Vietnam
- Commune Health Centers
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Hải Dương
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Thành Phố Hải Dương, Hải Dương, Vietnam
- Commune Health Centers
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Nghe An
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Nghi An, Nghe An, Vietnam
- Commune Health Centers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
CHW:
- Age 18 or over
- Be a service provider to PLHWUD attending commune health centers in one of the 40 communes selected selected for the study
- Voluntary written informed consent
PLHWUD:
- Age 18 or over
- HIV positive (self-report)
- Currently using opiates or has a history of opiate use (self-report) and seeking services at the commune health centers in one of 40 communes selected from the study
- Has not received treatment services from OPC or MMT clinics (i.e., is treatment naive).
- Voluntary written informed consent
Exclusion Criteria:
CHW:
- Inability to give informed consent
PLHWUD:
- Inability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Standard of care
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Experimental: Intervention
The VPN intervention has 2 in-person sessions: 1) Providing training on service integration and team building for CHW and tools for them to network more effectively with OPC and MMT treatment providers as well as reach out to their patients; and 2) Learning to use effective communication tools such as motivational ruler and decision balance sheet to work more effectively with their patients and use Facebook group to facilitate collaboration among providers and e-chat for patient engagements. Sessions will occur once a week for two weeks, with each session featuring a different set of themes and relevant activities. |
Two in-person sessions will take place one week apart for the VPN intervention targeting CHW.
The intervention contents aim to utilize traditional communications tools and the latest technology to tackle challenges faced by service providers working in commune health centers and the impact of these challenges on their patients' treatment initiation, retention, and adherence.
In addition, booster sessions will be offered once every month during the first three months and once every three months thereafter.
The booster sessions will focus on participants' reports of their experiences, reinforcement of efforts, and continued skill building for problem solving.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PLHWUD's service utilization
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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This will be measured by PLHWUD's utilization of health services including OPC and MMT.
Both their access and adherence to treatments will be assessed.
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Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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CHW interaction with providers of other treatment agencies
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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This will be measured by a multi-item scale on interaction with other treatment providers
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Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PLHWUD's service satisfaction
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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PLHWUD's service satisfaction will be measured using a 12-item scale to evaluate patients' service satisfaction with MMT and OPC treatment based on the Texas Christian University Client Evaluation of Self and Treatment (TCU-CEST) forms.
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Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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CHW's patient-provider interaction with PLHWUD
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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CHW's communication and interaction with PLHWUD will be measured by a self-reported scale and the provider-patient communication logs.
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Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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CHW's service provision
Time Frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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Service provision such as patient referrals will be captured by the reported frequency and type of service referrals made in the past three months to other treatment clinics will also be documented.
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Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Li Li, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DA041008 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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