<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293355</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA041008</org_study_id>
    <nct_id>NCT03293355</nct_id>
  </id_info>
  <brief_title>Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam</brief_title>
  <official_title>Multilevel Integration Strategies to Enhance Service Provider Networks in Vietnam</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Hygiene and Epidemiology, Vietnam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is an urgent need for treatment service integration for People Living with HIV (PLH)&#xD;
      because many PLH have comorbid conditions, including substance use disorders and psychiatric&#xD;
      disorders, among others. Although providing integrated services to PLH who use drugs (PLHWUD)&#xD;
      has been proven to produce positive outcomes, multilevel challenges must be addressed,&#xD;
      including barriers at the policy, structural, and provider levels. Many countries, including&#xD;
      Vietnam, face challenges in the pursuit of multilevel integration of combination treatment&#xD;
      services and care. In Vietnam, injecting drug use accounts for nearly two-thirds of HIV&#xD;
      infection, and methadone maintenance therapy (MMT) services have rapidly expanded to 135&#xD;
      clinics with over 25,000 clients since 2008. There is a timely call as well as an opportunity&#xD;
      to identify, implement and evaluate new strategies to provide MMT and HIV treatment as an&#xD;
      integrated service system for PLHWUD. The study will take advantage of this window of&#xD;
      opportunity to explore and pilot integration strategies to address the multilevel challenges&#xD;
      associated with service integration in Vietnam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to develop and pilot test intervention strategies at the&#xD;
      provincial level (Aim 1), treatment agency level (Aim2), and community level (Aim 3). These&#xD;
      strategies aim to strengthen both horizontal and vertical collaboration and networking among&#xD;
      providers to better serve people living with HIV who use drugs (PLHWUD), including those who&#xD;
      are already in treatment and those who need to be linked to service. Commune health workers&#xD;
      (CHW) have great potentials to be mobilized to engage PLHWUD living in the community and to&#xD;
      work with providers at treatment clinics to support PLHWUD treatment retention and adherence.&#xD;
      E-technologies such as Facebook and e-chat will also be utilized to enhance provider-provider&#xD;
      coordination and provider-patient interaction.&#xD;
&#xD;
      The Specific Aims of the study are as follows:&#xD;
&#xD;
      Aim 1: Develop and implement structural-level strategies by establishing a provincial&#xD;
      coordination team to improve coordination and service integration.&#xD;
&#xD;
      Aim 2: Assess agency-level intervention outcomes on treatment-provider collaboration and&#xD;
      service integration of OPC services and MMT programs.&#xD;
&#xD;
      Aim 3: Assess community provider-level intervention outcomes by evaluating whether: 1) CHW in&#xD;
      the intervention group, compared to those in the control group, demonstrate improved levels&#xD;
      of collaboration with other clinical agencies, communication with patients, and service&#xD;
      referrals, and 2) PLHWUD in the intervention group, compared to those in the control group,&#xD;
      demonstrate improvements in treatment initiation, retention and adherence, and other mental&#xD;
      and biological outcomes.&#xD;
&#xD;
      Based on the findings from Aims 1 and 2 activities, this intervention will be conducted in&#xD;
      four provinces of Vietnam(Bac Giang, Hai Duong, Nam Dinh, and Nghe An). Randomization will&#xD;
      occur at the community level (20 communes assigned to the intervention group; 20 communes&#xD;
      assigned to the control group).&#xD;
&#xD;
      CONTROL COMMUNE ACTIVITIES:&#xD;
&#xD;
      A total of 40 CHW from 20 communes assigned to the control group will be invited to&#xD;
      participate in a one-time didactic lecture/meeting with other co-workers from their commune&#xD;
      health centers to learn about the importance of service integration.&#xD;
&#xD;
      CHW(n=40) and PLHWUD(n=120) from the control commune health centers will participate in a&#xD;
      baseline assessment and follow-up assessments at 3, 6, 9, 12-months.&#xD;
&#xD;
      INTERVENTION COMMUNE ACTIVITIES:&#xD;
&#xD;
      A total of 40 CHW from 20 communes assigned to the intervention group will be invited to&#xD;
      participate in the intervention that will consist of two in-person sessions lasting&#xD;
      approximately 90 minutes over two weeks with 8-10 CHW in each session.&#xD;
&#xD;
      Booster sessions of the intervention training will be offered to CHW once every month during&#xD;
      the first three months and once every three months thereafter. The booster session will focus&#xD;
      on CHW' reports of their experiences, reinforcement of efforts, and continued skill building&#xD;
      for problem solving. CHW(n=40) and PLHWUD(n=120) from the intervention commune health centers&#xD;
      will participate in a baseline assessment and follow-up assessments at 3, 6, 9, 12-months.&#xD;
&#xD;
      The efficacy of the intervention will be assessed at baseline, 3, 6, 9, and 12-month&#xD;
      follow-ups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PLHWUD's service utilization</measure>
    <time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CHW interaction with providers of other treatment agencies</measure>
    <time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
    <description>This will be measured by a multi-item scale on interaction with other treatment providers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PLHWUD's service satisfaction</measure>
    <time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHW's patient-provider interaction with PLHWUD</measure>
    <time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
    <description>CHW's communication and interaction with PLHWUD will be measured by a self-reported scale and the provider-patient communication logs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CHW's service provision</measure>
    <time_frame>Changes from baseline to 3-, 6-, 9- and 12- month follow-ups</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Linkage to Care</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VPN intervention has 2 in-person sessions:&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VPN</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        CHW:&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  Be a service provider to PLHWUD attending commune health centers in one of the 40&#xD;
             communes selected selected for the study&#xD;
&#xD;
          -  Voluntary written informed consent&#xD;
&#xD;
        PLHWUD:&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  HIV positive (self-report)&#xD;
&#xD;
          -  Currently using opiates or has a history of opiate use (self-report) and seeking&#xD;
             services at the commune health centers in one of 40 communes selected from the study&#xD;
&#xD;
          -  Has not received treatment services from OPC or MMT clinics (i.e., is treatment&#xD;
             naive).&#xD;
&#xD;
          -  Voluntary written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        CHW:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
        PLHWUD:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Commune Health Centers</name>
      <address>
        <city>Thành Phố Hải Dương</city>
        <state>Hải Dương</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commune Health Centers</name>
      <address>
        <city>Nghi An</city>
        <state>Nghe An</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commune Health Centers</name>
      <address>
        <city>Bắc Giang</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commune Health Centers</name>
      <address>
        <city>Nam Định</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Li Li</investigator_full_name>
    <investigator_title>Professor in Residence</investigator_title>
  </responsible_party>
  <keyword>People Living with HIV Who Use Drugs (PLHWUD)</keyword>
  <keyword>Community Health Workers (CHW)</keyword>
  <keyword>Multilevel Service Integration</keyword>
  <keyword>HIV/AIDS</keyword>
  <keyword>Vietnam</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293355
org study id: R01DA041008
nct id: NCT03293355
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is an urgent need for treatment service integration for People Living with HIV (PLH)
      because many PLH have comorbid conditions, including substance use disorders and psychiatric
      disorders, among others. Although providing integrated services to PLH who use drugs (PLHWUD)
      has been proven to produce positive outcomes, multilevel challenges must be addressed,
      including barriers at the policy, structural, and provider levels. Many countries, including
      Vietnam, face challenges in the pursuit of multilevel integration of combination treatment
      services and care. In Vietnam, injecting drug use accounts for nearly two-thirds of HIV
      infection, and methadone maintenance therapy (MMT) services have rapidly expanded to 135
      clinics with over 25,000 clients since 2008. There is a timely call as well as an opportunity
      to identify, implement and evaluate new strategies to provide MMT and HIV treatment as an
      integrated service system for PLHWUD. The study will take advantage of this window of
      opportunity to explore and pilot integration strategies to address the multilevel challenges
      associated with service integration in Vietnam.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: PLHWUD's service utilization
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
description: 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.
measure: CHW interaction with providers of other treatment agencies
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
description: This will be measured by a multi-item scale on interaction with other treatment providers
measure: PLHWUD's service satisfaction
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
description: 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.
measure: CHW's patient-provider interaction with PLHWUD
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
description: CHW's communication and interaction with PLHWUD will be measured by a self-reported scale and the provider-patient communication logs.
measure: CHW's service provision
time frame: Changes from baseline to 3-, 6-, 9- and 12- month follow-ups
description: 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.
arm group label: Control
arm group type: No Intervention
description: Standard of care
arm group label: Intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: VPN
description: 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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Li Li, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
facility: 
facility: 
facility: 
country: Vietnam
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Li Li
investigator title: Professor in Residence