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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04479475
Enrollment
58
Registered
2020-07-21
Start date
2024-03-01
Completion date
2024-09-05
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Medication, HIV Infections, Opioid-use Disorder

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.

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.

Interventions

BEHAVIORALSupportive 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.

Sponsors

Muhimbili University of Health and Allied Sciences
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention Acceptability ScoreOn average, 1 month post-interventionIntervention 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.
Number of Intervention Counselors Who Adhered to the Intervention ManualOn average, 1 month post-interventionPerceptions 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.
Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility InterviewOn average, 1 month post-interventionIntervention 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.
Participants Who Attend Week 1 Intervention SessionWeek 1 of interventionIntervention session attended by participants (MMT clients and identified social support persons)
MMT Participants Who Attend Week 2 Intervention SessionWeek 2 of interventionIntervention session attended by participants (MMT clients)
Participants Who Attend Week 3 Intervention SessionWeek 3 of interventionIntervention session attended by participants (MMT clients and identified social support persons)
MMT Participants Who Attend Week 4 Intervention SessionWeek 4 of interventionIntervention session attended by participants (MMT clients)
Participants Who Attend Week 5 Intervention SessionWeek 5 of interventionIntervention session attended by participants (MMT clients and identified social support persons)
Participants Who Attend Week 6 Intervention SessionWeek 6 of interventionIntervention session attended by participants (MMT clients and identified social support persons)

Secondary

MeasureTime frameDescription
Participants Who Obtained All Prescribed ART Refills in Past 6 MonthsBaseline and 6 months post-interventionClinic pharmacy log data were used to assess participants who received all prescribed antiretroviral therapy (ART) refills in the past 6 months.
Number of Missed Methadone DosesBaseline to six months post-interventionNumber of missed methadone doses in the past 30 days among MMT clients only as assessed by MMT client clinical records

Countries

Tanzania

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Supportive Care Through Social Support Persons (MMT Clients)
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.
20
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.
33
Total53

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject7

Baseline characteristics

CharacteristicSupportive Care Through Social Support Persons (MMT Clients)TotalSupportive Care Through Social Support Persons (Social Support Persons)
Age, Continuous35.65 Years
STANDARD_DEVIATION 7.51
37.37 Years
STANDARD_DEVIATION 9.57
39.13 Years
STANDARD_DEVIATION 10.85
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
20 Participants53 Participants33 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Tanzania
20 Participants53 Participants33 Participants
Sex: Female, Male
Female
4 Participants22 Participants18 Participants
Sex: Female, Male
Male
16 Participants31 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 33
other
Total, other adverse events
0 / 200 / 33
serious
Total, serious adverse events
0 / 200 / 33

Outcome results

Primary

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.

Time frame: On average, 1 month post-intervention

Population: MMT and social support persons with data collected

ArmMeasureValue (MEAN)Dispersion
Supportive Care Through Social Support Persons (MMT Clients)Intervention Acceptability Score2.77 score on a scaleStandard Deviation 0.43
Supportive Care Through Social Support Persons (Social Support Persons)Intervention Acceptability Score2.81 score on a scaleStandard Deviation 0.37
Primary

MMT Participants Who Attend Week 2 Intervention Session

Intervention session attended by participants (MMT clients)

Time frame: Week 2 of intervention

Population: MMT participants only

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)MMT Participants Who Attend Week 2 Intervention Session20 Participants
Primary

MMT Participants Who Attend Week 4 Intervention Session

Intervention session attended by participants (MMT clients)

Time frame: Week 4 of intervention

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)MMT Participants Who Attend Week 4 Intervention Session20 Participants
Primary

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.

Time frame: On average, 1 month post-intervention

Population: Intervention counselors only

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Number of Intervention Counselors Who Adhered to the Intervention Manual5 Participants
Primary

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility Interview10 Participants
Supportive Care Through Social Support Persons (Social Support Persons)Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility Interview10 Participants
Supportive Care Through Social Support Persons (Intervention Counselors)Number of Participants Who Find the Intervention Acceptable as Assessed by the Intervention Feasibility Interview5 Participants
Primary

Participants Who Attend Week 1 Intervention Session

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

Time frame: Week 1 of intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Attend Week 1 Intervention Session20 Participants
Supportive Care Through Social Support Persons (Social Support Persons)Participants Who Attend Week 1 Intervention Session28 Participants
Primary

Participants Who Attend Week 3 Intervention Session

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

Time frame: Week 3 of intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Attend Week 3 Intervention Session20 Participants
Supportive Care Through Social Support Persons (Social Support Persons)Participants Who Attend Week 3 Intervention Session25 Participants
Primary

Participants Who Attend Week 5 Intervention Session

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

Time frame: Week 5 of intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Attend Week 5 Intervention Session20 Participants
Supportive Care Through Social Support Persons (Social Support Persons)Participants Who Attend Week 5 Intervention Session25 Participants
Primary

Participants Who Attend Week 6 Intervention Session

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

Time frame: Week 6 of intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Attend Week 6 Intervention Session20 Participants
Supportive Care Through Social Support Persons (Social Support Persons)Participants Who Attend Week 6 Intervention Session25 Participants
Secondary

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

Time frame: Baseline to six months post-intervention

Population: Enrolled MMT clients only

ArmMeasureValue (MEAN)Dispersion
Supportive Care Through Social Support Persons (MMT Clients)Number of Missed Methadone Doses7.9 dosesStandard Deviation 10.8
p-value: 0.0094Wilcoxon signed-rank test
Secondary

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.

Time frame: Baseline and 6 months post-intervention

Population: MMT clients with confirmed HIV positive status

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Obtained All Prescribed ART Refills in Past 6 MonthsBaseline5 Participants
Supportive Care Through Social Support Persons (MMT Clients)Participants Who Obtained All Prescribed ART Refills in Past 6 Months6-month follow-up5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026