Social Networks and Methadone Maintenance Treatment Retention and Antiretroviral Therapy Retention in Tanzania

HIV Infections Clinical Trial

Official title:

Understanding the Role of Social Networks in Methadone Maintenance Treatment Retention and Antiretroviral Therapy Adherence Among People Who Inject Drugs in Tanzania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479475
• Other study ID #: IRB00019420
• Secondary ID: K01DA047142
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Iddi Haruna Nkya, MD, MMeD
• Phone: +255713775884
• Email: idd222[@]yahoo.co.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria for MMT client participants in the intervention pilot:

• 18 years old or older,

• currently enrolled in the MAT program at the Muhimbili MAT clinic,

• prescribed methadone for the past 3 months,

• received a positive test result for heroin, cannabis or alcohol use in the past 3 months,

• provide consent for trial participation.

Inclusion criteria for social support persons in the intervention pilot:

• 18 years old or older,

• identified as a social support person of a MMT client participating in the pilot trial

• lives in Dar es Salaam,

• provide consent for trial participation.

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• Adherence, Medication
• HIV Infections
• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• Supportive care through community support persons
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.

Locations

Country	Name	City	State
Tanzania	Muhimbili National Hospital	Dar Es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Muhimbili University of Health and Allied Sciences, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who attend week 1 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 1 of intervention
Primary	Proportion of participants who attend week 2 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 2 of intervention
Primary	Proportion of participants who attend week 3 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 3 of intervention
Primary	Proportion of participants who attend week 4 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 4 of intervention
Primary	Proportion of participants who attend week 5 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 5 of intervention
Primary	Proportion of participants who attend week 6 intervention session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 6 of intervention
Primary	Proportion of sessions with > 80% fidelity	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.	Post-intervention up to 1 month
Primary	Perceptions of intervention fidelity	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.	Post-intervention up to 1 month
Primary	Intervention session acceptability score (week 1)	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.	Week 1 of intervention
Primary	Intervention session acceptability score (week 2)	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.	Week 2 of intervention
Primary	Intervention session acceptability score (week 3)	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.	Week 3 of intervention
Primary	Intervention session acceptability score (week 4)	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.	Week 4 of intervention
Primary	Intervention session acceptability score (week 5)	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.	Week 5 of intervention
Primary	Intervention session acceptability score (week 6)	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.	Week 6 of intervention
Primary	Intervention feasibility assessed by qualitative interviews	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.	Post-intervention up to 1 month
Secondary	Changes in missed methadone doses	Number of missed methadone doses in the past 30 days as assessed by MMT client clinical records	Pre- and post-intervention up to 1 month
Secondary	Changes in antiretroviral therapy (ART) adherence	ART pharmacy refills in the past 3 months	Pre- and post-intervention up to 1 month