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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Adherence, Medication; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Supportive care through community support persons

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care through social support persons; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Attend Week 1 Intervention Session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 1 of intervention
MMT Participants Who Attend Week 2 Intervention Session	Intervention session attended by participants (MMT clients)	Week 2 of intervention
Participants Who Attend Week 3 Intervention Session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 3 of intervention
MMT Participants Who Attend Week 4 Intervention Session	Intervention session attended by participants (MMT clients)	Week 4 of intervention
Participants Who Attend Week 5 Intervention Session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 5 of intervention
Participants Who Attend Week 6 Intervention Session	Intervention session attended by participants (MMT clients and identified social support persons)	Week 6 of intervention
Number of Intervention Counselors Who Adhered to the Intervention Manual	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.	On average, 1 month post-intervention
Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility Interview	Intervention acceptability will be assessed through qualitative interviews with intervention counselors and participants. Questions will include experiences of delivering or participating in the intervention, barriers and facilitators to delivering the intervention or participating in the intervention session, and recommendations for improvements.	On average, 1 month post-intervention
Intervention Acceptability Score	Intervention acceptability was assessed through follow-up surveys conducted with participants after they completed the intervention. Acceptability was measured through five survey items developed by the study team that assessed acceptability of the intervention overall, the intervention counselor, the content of sessions, and the delivery modality (peer sessions and having social support persons present for select sessions). Mean scores are presented that range from 0 (not acceptable) to 3 (very acceptable). Higher score better.	On average, 1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Missed Methadone Doses	Number of missed methadone doses in the past 30 days among MMT clients only as assessed by MMT client clinical records	Baseline to six months post-intervention
Participants Who Obtained All Prescribed ART Refills in Past 6 Months	Clinic pharmacy log data were used to assess participants who received all prescribed antiretroviral therapy (ART) refills in the past 6 months.	Baseline and 6 months post-intervention

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: National Institute on Drug Abuse (NIDA); Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: Haneefa T Saleem, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Narcotic-Related Disorders; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; HIV Infections; Opioid-Related Disorders; Medication Adherence
• Other Study ID Numbers: IRB00019420; K01DA047142 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No