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

NCT04479475 | Completed Results

• 2 other identifiers: IRB00019420K01DA047142
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder; Adherence, Medication; HIV Infections

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Number of Missed Methadone Doses

  Baseline to six months post-intervention

• Participants Who Obtained All Prescribed ART Refills in Past 6 Months

  Baseline and 6 months post-intervention

Study Arms (1)

Supportive care through social support persons

EXPERIMENTAL

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

Interventions

Supportive care through community support persons BEHAVIORAL

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.

Supportive care through social support persons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Muhimbili University of Health and Allied Sciences: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Muhimbili National Hospital

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Medication Adherence; HIV Infections

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Haneefa Saleem, PhD, MPH
• Organization: Johns Hopkins University

haneefa.saleem@jhu.edu

443-287-5130

Study Officials

• Haneefa T Saleem, PhD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 21, 2020
• Study Start: March 1, 2024
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)