Trial Outcomes & Findings for Social Networks and Methadone Maintenance Treatment Retention and Antiretroviral Therapy Retention in Tanzania (NCT NCT04479475)

NCT ID: NCT04479475

Last Updated: 2025-10-08

Results Overview

Intervention session attended by participants (MMT clients and identified social support persons)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

Week 1 of intervention

Results posted on

2025-10-08

Participant Flow

Twenty Methadone maintenance treatment (MMT) clients were recruited from Muhimbili National Hospital (MNH) Medically Assisted Therapy (MAT) clinic in Dar es Salaam, Tanzania. Participating MMT clients identified and referred to the study social support persons to enroll and participate in the intervention.

Participant milestones

Participant milestones
Measure
Supportive Care Through Social Support Persons
MMT participants attended seven weekly sessions to build social support systems and make progress toward drinking and drug use goals. Social support persons identified by participating MMT clients jointly attended up to five sessions over the course of six weekly sessions.
Overall Study
STARTED
58
Overall Study
MMT Clients Participants
20
Overall Study
Social Support Persons
33
Overall Study
Intervention Counselors
5
Overall Study
Clients With HIV
5
Overall Study
Clients Without HIV
15
Overall Study
COMPLETED
51
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Supportive Care Through Social Support Persons
MMT participants attended seven weekly sessions to build social support systems and make progress toward drinking and drug use goals. Social support persons identified by participating MMT clients jointly attended up to five sessions over the course of six weekly sessions.
Overall Study
Withdrawal by Subject
7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=33 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Total
n=53 Participants
Total of all reporting groups
Age, Continuous
35.65 Years
STANDARD_DEVIATION 7.51 • n=5 Participants
39.13 Years
STANDARD_DEVIATION 10.85 • n=7 Participants
37.37 Years
STANDARD_DEVIATION 9.57 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
18 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
15 Participants
n=7 Participants
31 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
20 Participants
n=5 Participants
33 Participants
n=7 Participants
53 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
Tanzania
20 Participants
n=5 Participants
33 Participants
n=7 Participants
53 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Week 1 of intervention

Intervention session attended by participants (MMT clients and identified social support persons)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=33 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Participants Who Attend Week 1 Intervention Session
20 Participants
28 Participants

PRIMARY outcome

Timeframe: Week 2 of intervention

Population: MMT participants only

Intervention session attended by participants (MMT clients)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
MMT Participants Who Attend Week 2 Intervention Session
20 Participants

PRIMARY outcome

Timeframe: Week 3 of intervention

Intervention session attended by participants (MMT clients and identified social support persons)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=33 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Participants Who Attend Week 3 Intervention Session
20 Participants
25 Participants

PRIMARY outcome

Timeframe: Week 4 of intervention

Population: Week 4 intervention session was for MMT client participants only

Intervention session attended by participants (MMT clients)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
MMT Participants Who Attend Week 4 Intervention Session
20 Participants

PRIMARY outcome

Timeframe: Week 5 of intervention

Intervention session attended by participants (MMT clients and identified social support persons)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=33 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Participants Who Attend Week 5 Intervention Session
20 Participants
25 Participants

PRIMARY outcome

Timeframe: Week 6 of intervention

Intervention session attended by participants (MMT clients and identified social support persons)

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=33 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Participants Who Attend Week 6 Intervention Session
20 Participants
25 Participants

PRIMARY outcome

Timeframe: On average, 1 month post-intervention

Population: Intervention counselors only

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.

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=5 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Number of Intervention Counselors Who Adhered to the Intervention Manual
5 Participants

PRIMARY outcome

Timeframe: On average, 1 month post-intervention

Population: Qualitative, in-depth interviews with MMT client participants, social support person participants, and intervention counselors with data collected.

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.

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=10 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=10 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
n=5 Participants
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility Interview
10 Participants
10 Participants
5 Participants

PRIMARY outcome

Timeframe: On average, 1 month post-intervention

Population: MMT and social support persons with data collected

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.

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=19 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
n=27 Participants
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Intervention Acceptability Score
2.77 score on a scale
Standard Deviation 0.43
2.81 score on a scale
Standard Deviation 0.37

SECONDARY outcome

Timeframe: Baseline to six months post-intervention

Population: Enrolled MMT clients only

Number of missed methadone doses in the past 30 days among MMT clients only as assessed by MMT client clinical records

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=20 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Number of Missed Methadone Doses
7.9 doses
Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline and 6 months post-intervention

Population: MMT clients with confirmed HIV positive status

Clinic pharmacy log data were used to assess participants who received all prescribed antiretroviral therapy (ART) refills in the past 6 months.

Outcome measures

Outcome measures
Measure
Supportive Care Through Social Support Persons (MMT Clients)
n=5 Participants
MMT participants will attend seven sessions over the course of six weekly sessions to build social support systems and make progress toward drinking and drug use goals.
Supportive Care Through Social Support Persons (Social Support Persons)
Social support persons identified by participating MMT clients will jointly attend up to five sessions over the course of six weekly sessions.
Supportive Care Through Social Support Persons (Intervention Counselors)
MMT participants attended six 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 four sessions over the course of six weeks. 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.
Participants Who Obtained All Prescribed ART Refills in Past 6 Months
Baseline
5 Participants
Participants Who Obtained All Prescribed ART Refills in Past 6 Months
6-month follow-up
5 Participants

Adverse Events

Supportive Care Through Social Support Persons (MMT Clients)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Supportive Care Through Social Support Persons (Social Support Persons)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Haneefa Saleem, PhD, MPH

Johns Hopkins University

Phone: 443-287-5130

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place