<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/NCT04479475</url>
  </required_header>
  <id_info>
    <org_study_id>K01DA047142</org_study_id>
    <nct_id>NCT04479475</nct_id>
  </id_info>
  <brief_title>Social Networks and Methadone Maintenance Treatment Retention and Antiretroviral Therapy Retention in Tanzania</brief_title>
  <official_title>Understanding the Role of Social Networks in Methadone Maintenance Treatment Retention and Antiretroviral Therapy Adherence Among People Who Inject Drugs in Tanzania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Muhimbili University of Health and Allied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</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>
      Investigators will adapt the Brief Social Behaviour and Network Therapy (B-SBNT) intervention&#xD;
      developed to facilitate recovery among people receiving medication-assisted treatment for&#xD;
      opioid use disorder in the United Kingdom. The B-SBNT involves families and the wider social&#xD;
      networks of people receiving medications for opioid use disorder to support recovery. Key&#xD;
      components of the intervention include: mapping the social networks of clients; inviting&#xD;
      others identified through the mapping to participate in the intervention; building&#xD;
      communication strategies with network members; and developing joint activities with network&#xD;
      members. In the original B-SBNT, the intervention is delivered by therapists/clinicians who&#xD;
      undergo training. Investigators will pilot test the adapted version of this intervention with&#xD;
      a maximum of 80 people: 20 current clients receiving methadone maintenance treatment (MMT) at&#xD;
      the Muhimbili National Hospital (MNH) Medically-Assisted Treatment (MAT) Clinic and up to 60&#xD;
      social support persons identified by recruited MMT clients. The pilot will assess the social&#xD;
      network intervention's acceptability and feasibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will conduct a small pilot of the adapted social network intervention to assess&#xD;
      its acceptability and feasibility. The study team will pilot test the adapted version of this&#xD;
      intervention with a maximum of 80 people: 20 current clients receiving methadone maintenance&#xD;
      treatment (MMT) at the Muhimbili National Hospital (MNH) Medically-Assisted Treatment (MAT)&#xD;
      Clinic and up to 60 social support persons identified by recruited MMT clients.&#xD;
&#xD;
      MNH MAT clinic staff will compile a list of clients who have tested positive for heroin,&#xD;
      cannabis, and alcohol based on monthly urine screen in the past 3 months or random alcohol&#xD;
      breathalyzer test in the past 3 months. The list will be stratified by HIV status to obtain&#xD;
      equal number of MMT clients with and without HIV. From the list, the research team will&#xD;
      randomly select 10 clients with HIV and 10 clients without HIV. MNH MAT clinic staff will&#xD;
      introduce the study to the selected MAT clients who meet study eligibility and refer those&#xD;
      interested in participating to the study team.&#xD;
&#xD;
      During the social mapping session of the intervention, MMT client participants will be asked&#xD;
      to identify up to three people who provide the participant with support an invitation to&#xD;
      participate in the intervention. MMT clients will be provided a letter to give to each of the&#xD;
      social support persons identified and will provide the study team with the phone numbers of&#xD;
      the social support persons, if available. The recruitment letter will include the contact&#xD;
      information for the local co-PI. If a phone number for a social support person is provided,&#xD;
      the study team will attempt to contact the identified social support person up to three&#xD;
      times. The study team will only contact social support persons identified by participating&#xD;
      MMT clients after the MMT client has informed the social support person of the study and the&#xD;
      social support person is expecting to hear from study staff. The study team will confirm with&#xD;
      the MMT client that social support persons have been informed of the study through the&#xD;
      recruitment letter and/or vocally. Once contact with the identified social support person is&#xD;
      made, a member of the study team will introduce the study to the social support person and&#xD;
      invite the social support person to participate in the study.&#xD;
&#xD;
      After obtaining informed consent, MMT clients and the identified social support person(s)&#xD;
      will complete a pre-intervention survey. The survey with MMT clients will include questions&#xD;
      on socio-demographics, substance use behaviors, methadone treatment, stigma experiences,&#xD;
      coping skills, and social support. For questions on social network members, MMT clients will&#xD;
      be asked not to specify names of family, friends, other MMT clients, or other important&#xD;
      people in the participants lives. Rather, the participants will be asked to use nicknames,&#xD;
      initials, or relationships (e.g., &quot;mother,&quot; &quot;sister,&quot; &quot;uncle,&quot; etc.) to identify important&#xD;
      people. The survey with social support persons will include socio-demographic questions as&#xD;
      well as questions on interactions with the MMT client who was identified as a social support&#xD;
      person, substance use behaviors, methadone treatment, and knowledge and attitudes towards&#xD;
      substance use disorders and people with a substance use disorder. The pre-intervention survey&#xD;
      is expected to last approximately 15 minutes (for social support persons) and 20 minutes (for&#xD;
      MMT clients). MMT client participants will then attend seven sessions over the course of six&#xD;
      weeks. Social support persons will attend up to five sessions over the course of six weeks.&#xD;
&#xD;
      Participant attendance will be recorded for each session. Members of the study team will&#xD;
      observe sessions and take notes on intervention fidelity and delivery using a semi-structured&#xD;
      form. After each session, participants will be asked to complete a brief exit survey to&#xD;
      assess satisfaction with the session. The exit survey will be administered by the&#xD;
      intervention counselor. At the end of the pilot, the study team will conduct a&#xD;
      post-intervention survey with MMT client participants and the participating social support&#xD;
      persons. The post-intervention survey will include similar questions to the baseline survey&#xD;
      but will also include questions to gauge acceptability and satisfaction with the&#xD;
      intervention, experiences with social and income-generating activities, and suggestions for&#xD;
      changes to the intervention. The post-intervention survey is expected to last between 15&#xD;
      minutes (for social support persons) and 20 minutes (for MMT clients).&#xD;
&#xD;
      The investigators will also conduct 25 follow-up qualitative, in-depth interviews with 10 MMT&#xD;
      client participants, 10 social support person participants, and all 5 intervention&#xD;
      counselors, about one month after the trial. The investigators will purposively sample&#xD;
      participants based on attendance in sessions and based on responses to survey questions, so&#xD;
      that the investigators can obtain a sample of individuals with various experiences with the&#xD;
      program. Study interviewers will use a semi-structured interview guide to facilitate the&#xD;
      discussion. The guide will include questions on experiences with the program (what worked and&#xD;
      what could be improved), how well counselors followed the intervention manual, what clients&#xD;
      learned, how clients incorporated lessons learned in the clients daily lives, and changes in&#xD;
      the quality of relationships with social support persons and other people in the client's&#xD;
      lives. Interviews are expected to last about 45 minutes and will be audio-recorded with&#xD;
      participant permission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2023</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Eligible MMT clients identify up to three social support persons to attend intervention sessions. The adapted B-SBNT involves families and the wider social networks of people receiving MMT to support recovery. Key components of the intervention include: mapping the social networks of clients; inviting others identified through the mapping to participate in the intervention; building communication strategies with network members; and developing joint activities with network members, e.g., income-generating activities. MMT client participants attend seven sessions over the course of six weeks. Social support persons attend up to five sessions over the course of six weeks.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who attend week 1 intervention session</measure>
    <time_frame>Week 1 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who attend week 2 intervention session</measure>
    <time_frame>Week 2 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who attend week 3 intervention session</measure>
    <time_frame>Week 3 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who attend week 4 intervention session</measure>
    <time_frame>Week 4 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who attend week 5 intervention session</measure>
    <time_frame>Week 5 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who attend week 6 intervention session</measure>
    <time_frame>Week 6 of intervention</time_frame>
    <description>Intervention session attended by participants (MMT clients and identified social support persons)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of sessions with &gt; 80% fidelity</measure>
    <time_frame>Post-intervention up to 1 month</time_frame>
    <description>An Integrity of Intervention checklist will be created for the study to assess intervention delivery fidelity, including facilitator adherence to manual instructions, specifically information and content that is intended to be covered for each session. An intervention fidelity score that ranges from 0 to 100%, with 100% indicating 100% fidelity or 100% adherence to intervention manual, will be created.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceptions of intervention fidelity</measure>
    <time_frame>Post-intervention up to 1 month</time_frame>
    <description>Perceptions of intervention fidelity will be assessed through qualitative interviews with facilitators and participants. Perceptions of intervention fidelity, including facilitators and barriers to intervention fidelity will be summarized thematically.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 1)</measure>
    <time_frame>Week 1 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 2)</measure>
    <time_frame>Week 2 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 3)</measure>
    <time_frame>Week 3 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 4)</measure>
    <time_frame>Week 4 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 5)</measure>
    <time_frame>Week 5 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention session acceptability score (week 6)</measure>
    <time_frame>Week 6 of intervention</time_frame>
    <description>Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention feasibility assessed by qualitative interviews</measure>
    <time_frame>Post-intervention up to 1 month</time_frame>
    <description>Intervention feasibility will be assessed through qualitative interviews with intervention facilitators and participants. Questions will include experiences delivery or participating in the intervention, barriers and facilitators to delivering the intervention or participating in the intervention session, and recommendations for improvements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in missed methadone doses</measure>
    <time_frame>Pre- and post-intervention up to 1 month</time_frame>
    <description>Number of missed methadone doses in the past 30 days as assessed by MMT client clinical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in antiretroviral therapy (ART) adherence</measure>
    <time_frame>Pre- and post-intervention up to 1 month</time_frame>
    <description>ART pharmacy refills in the past 3 months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Adherence, Medication</condition>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Supportive care through social support persons</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MMT participants will attend seven sessions over the course of six weeks to build social support systems and make progress toward drinking and drug use goals. Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive care through community support persons</intervention_name>
    <description>The adapted B-SBNT involves families and the wider social networks of people receiving MMT to support recovery. Key components of the intervention include: mapping the social networks of clients; inviting others identified through the mapping to participate in the intervention; building communication strategies with network members; and developing joint activities with network members, e.g., income-generating activities. MMT client participants attend seven sessions over the course of six weeks: (1) Introduction, (2) Working in a social network-based setting, (3) Setting drinking and drug use goals, (4) Coping skills 1, (5), Coping Skills 2, (6) Making lifestyle changes, (7) Generating income. Social support persons attend up to five sessions over the course of six weeks.</description>
    <arm_group_label>Supportive care through social support persons</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for MMT client participants in the intervention pilot:&#xD;
&#xD;
          -  18 years old or older,&#xD;
&#xD;
          -  currently enrolled in the MAT program at the Muhimbili MAT clinic,&#xD;
&#xD;
          -  prescribed methadone for the past 3 months,&#xD;
&#xD;
          -  received a positive test result for heroin, cannabis or alcohol use in the past 3&#xD;
             months,&#xD;
&#xD;
          -  provide consent for trial participation.&#xD;
&#xD;
        Inclusion criteria for social support persons in the intervention pilot:&#xD;
&#xD;
          -  18 years old or older,&#xD;
&#xD;
          -  identified as a social support person of a MMT client participating in the pilot trial&#xD;
&#xD;
          -  lives in Dar es Salaam,&#xD;
&#xD;
          -  provide consent for trial participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haneefa T Saleem, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Iddi Haruna Nkya, MD, MMeD</last_name>
    <phone>+255713775884</phone>
    <email>idd222@yahoo.co.uk</email>
  </overall_contact>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is pilot trial is intended for assessment of feasibility and acceptability. Study investigators will make aggregate data from the intervention trial available to other researchers. Aggregate data are unlikely to present an opportunity for secondary analysis or subsequent publication, though they can provide more detail than may be available in a peer-reviewed publication.</ipd_description>
  </patient_data>
  <!-- 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/NCT04479475
org study id: K01DA047142
nct id: NCT04479475
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators will adapt the Brief Social Behaviour and Network Therapy (B-SBNT) intervention
      developed to facilitate recovery among people receiving medication-assisted treatment for
      opioid use disorder in the United Kingdom. The B-SBNT involves families and the wider social
      networks of people receiving medications for opioid use disorder to support recovery. Key
      components of the intervention include: mapping the social networks of clients; inviting
      others identified through the mapping to participate in the intervention; building
      communication strategies with network members; and developing joint activities with network
      members. In the original B-SBNT, the intervention is delivered by therapists/clinicians who
      undergo training. Investigators will pilot test the adapted version of this intervention with
      a maximum of 80 people: 20 current clients receiving methadone maintenance treatment (MMT) at
      the Muhimbili National Hospital (MNH) Medically-Assisted Treatment (MAT) Clinic and up to 60
      social support persons identified by recruited MMT clients. The pilot will assess the social
      network intervention's acceptability and feasibility.
Investigators will conduct a small pilot of the adapted social network intervention to assess
      its acceptability and feasibility. The study team will pilot test the adapted version of this
      intervention with a maximum of 80 people: 20 current clients receiving methadone maintenance
      treatment (MMT) at the Muhimbili National Hospital (MNH) Medically-Assisted Treatment (MAT)
      Clinic and up to 60 social support persons identified by recruited MMT clients.

      MNH MAT clinic staff will compile a list of clients who have tested positive for heroin,
      cannabis, and alcohol based on monthly urine screen in the past 3 months or random alcohol
      breathalyzer test in the past 3 months. The list will be stratified by HIV status to obtain
      equal number of MMT clients with and without HIV. From the list, the research team will
      randomly select 10 clients with HIV and 10 clients without HIV. MNH MAT clinic staff will
      introduce the study to the selected MAT clients who meet study eligibility and refer those
      interested in participating to the study team.

      During the social mapping session of the intervention, MMT client participants will be asked
      to identify up to three people who provide the participant with support an invitation to
      participate in the intervention. MMT clients will be provided a letter to give to each of the
      social support persons identified and will provide the study team with the phone numbers of
      the social support persons, if available. The recruitment letter will include the contact
      information for the local co-PI. If a phone number for a social support person is provided,
      the study team will attempt to contact the identified social support person up to three
      times. The study team will only contact social support persons identified by participating
      MMT clients after the MMT client has informed the social support person of the study and the
      social support person is expecting to hear from study staff. The study team will confirm with
      the MMT client that social support persons have been informed of the study through the
      recruitment letter and/or vocally. Once contact with the identified social support person is
      made, a member of the study team will introduce the study to the social support person and
      invite the social support person to participate in the study.

      After obtaining informed consent, MMT clients and the identified social support person(s)
      will complete a pre-intervention survey. The survey with MMT clients will include questions
      on socio-demographics, substance use behaviors, methadone treatment, stigma experiences,
      coping skills, and social support. For questions on social network members, MMT clients will
      be asked not to specify names of family, friends, other MMT clients, or other important
      people in the participants lives. Rather, the participants will be asked to use nicknames,
      initials, or relationships (e.g., "mother," "sister," "uncle," etc.) to identify important
      people. The survey with social support persons will include socio-demographic questions as
      well as questions on interactions with the MMT client who was identified as a social support
      person, substance use behaviors, methadone treatment, and knowledge and attitudes towards
      substance use disorders and people with a substance use disorder. The pre-intervention survey
      is expected to last approximately 15 minutes (for social support persons) and 20 minutes (for
      MMT clients). MMT client participants will then attend seven sessions over the course of six
      weeks. Social support persons will attend up to five sessions over the course of six weeks.

      Participant attendance will be recorded for each session. Members of the study team will
      observe sessions and take notes on intervention fidelity and delivery using a semi-structured
      form. After each session, participants will be asked to complete a brief exit survey to
      assess satisfaction with the session. The exit survey will be administered by the
      intervention counselor. At the end of the pilot, the study team will conduct a
      post-intervention survey with MMT client participants and the participating social support
      persons. The post-intervention survey will include similar questions to the baseline survey
      but will also include questions to gauge acceptability and satisfaction with the
      intervention, experiences with social and income-generating activities, and suggestions for
      changes to the intervention. The post-intervention survey is expected to last between 15
      minutes (for social support persons) and 20 minutes (for MMT clients).

      The investigators will also conduct 25 follow-up qualitative, in-depth interviews with 10 MMT
      client participants, 10 social support person participants, and all 5 intervention
      counselors, about one month after the trial. The investigators will purposively sample
      participants based on attendance in sessions and based on responses to survey questions, so
      that the investigators can obtain a sample of individuals with various experiences with the
      program. Study interviewers will use a semi-structured interview guide to facilitate the
      discussion. The guide will include questions on experiences with the program (what worked and
      what could be improved), how well counselors followed the intervention manual, what clients
      learned, how clients incorporated lessons learned in the clients daily lives, and changes in
      the quality of relationships with social support persons and other people in the client's
      lives. Interviews are expected to last about 45 minutes and will be audio-recorded with
      participant permission.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Eligible MMT clients identify up to three social support persons to attend intervention sessions. The adapted B-SBNT involves families and the wider social networks of people receiving MMT to support recovery. Key components of the intervention include: mapping the social networks of clients; inviting others identified through the mapping to participate in the intervention; building communication strategies with network members; and developing joint activities with network members, e.g., income-generating activities. MMT client participants attend seven sessions over the course of six weeks. Social support persons attend up to five sessions over the course of six weeks.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Proportion of participants who attend week 1 intervention session
time frame: Week 1 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of participants who attend week 2 intervention session
time frame: Week 2 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of participants who attend week 3 intervention session
time frame: Week 3 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of participants who attend week 4 intervention session
time frame: Week 4 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of participants who attend week 5 intervention session
time frame: Week 5 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of participants who attend week 6 intervention session
time frame: Week 6 of intervention
description: Intervention session attended by participants (MMT clients and identified social support persons)
measure: Proportion of sessions with > 80% fidelity
time frame: Post-intervention up to 1 month
description: An Integrity of Intervention checklist will be created for the study to assess intervention delivery fidelity, including facilitator adherence to manual instructions, specifically information and content that is intended to be covered for each session. An intervention fidelity score that ranges from 0 to 100%, with 100% indicating 100% fidelity or 100% adherence to intervention manual, will be created.
measure: Perceptions of intervention fidelity
time frame: Post-intervention up to 1 month
description: Perceptions of intervention fidelity will be assessed through qualitative interviews with facilitators and participants. Perceptions of intervention fidelity, including facilitators and barriers to intervention fidelity will be summarized thematically.
measure: Intervention session acceptability score (week 1)
time frame: Week 1 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention session acceptability score (week 2)
time frame: Week 2 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention session acceptability score (week 3)
time frame: Week 3 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention session acceptability score (week 4)
time frame: Week 4 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention session acceptability score (week 5)
time frame: Week 5 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention session acceptability score (week 6)
time frame: Week 6 of intervention
description: Acceptability of interventions sessions, specifically content, activities, and delivery (i.e., group or individual format, social support persons involvement), will be measured through the exit surveys developed by the study team. Each of the four exit survey items will be assessed as 0 for not acceptable and 1 for acceptable. Scores will be created for each participant and averaged over all intervention sessions.
measure: Intervention feasibility assessed by qualitative interviews
time frame: Post-intervention up to 1 month
description: Intervention feasibility will be assessed through qualitative interviews with intervention facilitators and participants. Questions will include experiences delivery or participating in the intervention, barriers and facilitators to delivering the intervention or participating in the intervention session, and recommendations for improvements.
measure: Changes in missed methadone doses
time frame: Pre- and post-intervention up to 1 month
description: Number of missed methadone doses in the past 30 days as assessed by MMT client clinical records
measure: Changes in antiretroviral therapy (ART) adherence
time frame: Pre- and post-intervention up to 1 month
description: ART pharmacy refills in the past 3 months
arm group label: Supportive care through social support persons
arm group type: Experimental
description: MMT participants will attend seven sessions over the course of six weeks to build social support systems and make progress toward drinking and drug use goals. Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weeks.
intervention type: Behavioral
intervention name: Supportive care through community support persons
description: The adapted B-SBNT involves families and the wider social networks of people receiving MMT to support recovery. Key components of the intervention include: mapping the social networks of clients; inviting others identified through the mapping to participate in the intervention; building communication strategies with network members; and developing joint activities with network members, e.g., income-generating activities. MMT client participants attend seven sessions over the course of six weeks: (1) Introduction, (2) Working in a social network-based setting, (3) Setting drinking and drug use goals, (4) Coping skills 1, (5), Coping Skills 2, (6) Making lifestyle changes, (7) Generating income. Social support persons attend up to five sessions over the course of six weeks.
arm group label: Supportive care through social support persons
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Haneefa T Saleem, PhD, MPH
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
last name: Iddi Haruna Nkya, MD, MMeD
phone: +255713775884
email: idd222@yahoo.co.uk
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: No
ipd description: This is pilot trial is intended for assessment of feasibility and acceptability. Study investigators will make aggregate data from the intervention trial available to other researchers. Aggregate data are unlikely to present an opportunity for secondary analysis or subsequent publication, though they can provide more detail than may be available in a peer-reviewed publication.