Understanding the Role of Social Networks in Methadone Maintenance Treatment Retention and Antiretroviral Therapy Adherence Among People Who Inject Drugs in Tanzania
Phase: NA
Conditions: Opioid-use Disorder, Adherence, Medication, HIV Infections
Sponsor: Johns Hopkins Bloomberg School of Public Health

Study Title: Social Networks and Methadone Maintenance Treatment Retention 
and Antiretroviral Therapy Retention in Tanzania 
Document: Study Protocol (ID: IRB00019420) 
NCT number: NCT04479475 
Document date: 4/4/2023 
 

Page 1 of 32 
 
 
JHSPH IRB Research Plan for New Data Collection 
21Sep2021 
 
For new data collection, new data collection plus secondary data analysis, 
biospecimen repositories, and data coordinating center protocols. 
 
 
 
 
 
PI Name:  Haneefa Saleem  
Study Title:  Adaptation and Pilot of a Social Network Intervention to Improve Retention in Medication-
Assisted Treatment for Opioid Use Disorder in Tanzania 
IRB No.:   
IRB00019420  
PI Version No. / Date:  Version 3.0/04.4.2023 
 
I. 
Aims of the Study:  Describe the aims/objectives of the research and/or the project’s research questions 
or hypotheses.  
 
The primary aim of this study is to adapt, pilot, and assess the acceptability and feasibility of a social 
network intervention intended to improve retention in medication-assisted treatment for opioid use disorder. 
A secondary aim is to assess the potential effect of the intervention on antiretroviral adherence among 
individuals enrolled in medications for opioid use disorder who are also living with HIV. 
 
 
II. Background and Rationale: Explain why this study is being done.  Summarize briefly what is already 
known about the issue and reference previously published research, if relevant. 
People who inject (PWID) drugs in Tanzania have high rates of HIV. The elevated HIV risks associated with 
injection drug use have been well documented (41). Globally, PWID have 28 times higher HIV prevalence than 
the general adult population (42). In Tanzania, estimates of HIV prevalence among PWID, have ranged from 
35% to 50% (9-11) compared to 5.1% in the general population (12). HIV rates are even higher among women, 
with prevalence estimates among women who use drugs reaching upwards of 66% (10, 13). 
Medication-assisted treatment (MAT) for opioid use disorder is recommended as part of a comprehensive 
package of interventions for the prevention, treatment, and care of HIV infection among PWID (14). People 
retained in MAT have lower HIV risk (15, 16), reduced rates of overdose and mortality (17), greater access to 
other services (18), and greater likelihood of positive treatment outcomes (43-46). Among HIV-positive (HIV+) 
PWID, retention in MAT is associated with antiretroviral (ART) adherence and HIV viral suppression (8).  
Tanzania delivers a good quality MAT program, but retention in treatment continues to be a challenge. To date, 
over 1,150 men and women have been enrolled in the MAT program at the Muhimbili National Hospital, with 
about 600 currently active—that is, they attend the clinic on a daily basis for methadone dosing. MMT retention 
at the Muhimbili MAT clinic is comparable to estimates reported in North America (47, 48), Europe (49, 50), 
and Asia (51, 52). However, there is ample room for improvement–only 57% of people who enroll in the MAT 
program at the clinic are retained at 12 months (19). Leaving MAT against medical advice is associated with 
increase drug use, including injection drug use, and risk behaviors, legal problems, community harms, 
overdose risk and mortality, and disengagement from other treatment, such as HIV and mental health 
treatment (8, 17). To date, research on MAT retention in Tanzania has focused mainly on individual factors, 
identifying treatment dose, age, gender, and history of sexual abuse as predictors of attrition (19), with less 
attention to social or structure factors. 

Page 2 of 32 
 
 
Social network interventions can potentially harness the power of social ties to improve MAT retention and 
ART adherence for PWID. Social network interventions have been used in various models to improve health. 
Peer-based interventions, such as peer navigators living with HIV, treatment supporters, and adherence clubs, 
focused on improving retention in HIV care, have been implemented with positive results (57). There is also a 
growing body of evidence of sustained positive influence of social networks and social network interventions on 
HIV prevention and treatment, including among PWID (58). However, there have been few studies of social 
network interventions to support people receiving MAT or people receiving MAT who are also living with HIV 
(59-61). In preliminary qualitative research that we conducted in Tanzania, we found that the social 
environment, particularly family and peer support, are essential for MAT retention and recovery. Our findings 
indicate that restoring social ties outside of other people who use drugs may aid in MAT retention and ART 
adherence. 
One social network intervention that can support MAT retention is 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. 
 
III. Study Design: 
A. Provide a BRIEF overview of your study design and methods.  The study design must relate to your 
stated aims/objectives.  DETAILS WILL BE REQUESTED LATER.  If your study also involves analysis 
of existing data, please complete Section XI, “Secondary Data Analysis of Existing Data” in the last part 
of this research plan.  If your study ONLY involves analysis of existing data, please use the research 
plan template for secondary data analysis (JHSPH IRB Research Plan for Secondary Data Analysis of 
Existing Data/Specimens).   
We will carry out this research study in two stages. In stage 1, we will adapt the B-SBNT intervention to 
the Tanzania context. We will apply the ADAPT-ITT framework (34), which provides a guide for 
systematically adapting interventions to new target audiences and new settings in seven phases: 1) 
Assessment, 2) Decision, 3) Administration, 4) Production, 5) Topical experts, 6) Integration, and 7) 
Training. Table 1 outlines the methodology, including data collection methods, that we will adopt for 
each phase of the ADAPT-ITT framework. For Phase 1, we will conduct key informant interviews with 
providers at the Muhimbili MAT clinic and community outreach workers and other staff of community-
based organizations operating in Dar es Salaam that provide outreach and/or services to people who 
use drugs. For Phase 2, we will use findings from Phase 1 to decide on which components of the 
original B-SBNT intervention should be selected for adaptation. For Phase 3, we will conduct focus 
groups with current clients enrolled in the Muhimbili MAT clinic, individuals identified by current 
Muhimbili MAT clients as providing them social support, and community outreach workers. The focus 
groups will allow us to obtain feedback from intended audiences on the components, content, and 
delivery approach for the intervention to help inform adaptation. For Phase 4, we will use findings from 
Phase 3 to revise and development any new intervention materials and procedures.  Phase 5, we will 
hold key stakeholder workshops with topical experts, MAT clinic providers, key government officials 
involved in decision-making on opioid use disorder treatment programs, and other key stakeholders 
from civil society focused on outreach and other programming for people who use drugs to present and 

Page 3 of 32 
 
 
solicit feedback on the adapted intervention. For Phase 6, we will integrate feedback from Phase 5 into 
intervention materials. For phase 7 , we will train intervention facilitators in the adapted intervention 
manual, and other materials and procedures. Only Phases 1, 3, and 5 of Stage 1 involve human 
subjects research, so the plan outlined throughout this research plan will focus on these three phases 
for Stage 1. 
 
Table 1. Phases of adaptation and associated methodology based on the ADAPT-ITT framework. 
 
Description 
Methodology 
Phase 1: 
Assessment 
Assess capacity of 
CBOs/clinics to adapt and 
implement the social network 
intervention 
Key informant interviews with MAT clinic 
providers (n=6) and CBO staff (n=4) 
Phase 2: 
Decision 
Decide which components of 
the original B-SBNT 
intervention should be selected 
for adaptation 
Literature review; Analysis of Assessment data 
from Phase 1; Selection of intervention 
components 
Phase 3: 
Administration 
Pre-test intervention content/ 
implementation strategies using 
theater tests 
Theater tests of intervention through focus 
groups with current MAT clients (n=2), social 
supporters identified by current MAT clients 
(n=1), and community outreach workers (n=1) 
Phase 4: 
Production  
Revise and develop any new 
intervention materials and 
procedures 
Develop adaptation plan based on findings from 
Phases 1-3; Adapt existing and develop any 
new intervention materials and procedures 
Phase 5: 
Topical experts 
Solicit feedback from topical 
experts on revised/new 
materials and procedures 
Identification of experts; Key stakeholder 
workshops with topical experts and government 
officials 
Phase 6: 
Integration 
Integrate feedback from Phase 
5 into an adapted social 
network intervention 
Revise intervention materials and procedures 
based on findings from Phase 5 
Phase 7: 
Training 
Train intervention facilitators 
Train intervention facilitators to administer the 
intervention using adapted intervention 
materials resulting from Phase 6 
 
In Stage 2, we will conduct a small pilot of the adapted B-SBNT intervention to assess its acceptability 
and feasibility. Facilitators will be trained on the content and implementation of the adapted intervention 
and will deliver the intervention to a small sample of current MAT clients at the Muhimbili MAT Clinic 
and their identified social support persons.  
  
B. Provide a sample size and a justification as to how you arrived at that number.  If you use screening 
procedures to arrive at a final sample, distinguish the screening sample size from the enrolled sample 
size; a table may be helpful.   For electronic survey studies involving online recruitment and survey 
completion: consider how you will set controls on how many people will join your study. 

Page 4 of 32 
 
 
Stage 1: 
Phase 1: 6 MAT clinic providers based on number and roles of providers at the Muhimbili MAT clinic 
and 4 CBO staff based on interviewing one person from each of the four CBOs currently referring 
potential clients to the Muhimbili MAT clinic. 
Phase 3: To obtain diverse perspectives on the proposed intervention components and strategies, we 
will hold 2 focus groups with MAT clients with 8-10 people per focus group for a total of up to 20 MAT 
clients; 1 focus group with 8-10 community outreach workers. This will allow us to reach data 
saturation and get essential feedback on the intervention to incorporate in the intervention manual 
and protocol. 
Phase 5: We will hold key stakeholder workshops with up to 20 representatives from the Ministry of 
Health, Drug Control and Enforcement Agency, and select community-based organizations that provide 
services to people who use drugs. 
 
Stage 2: We will pilot the intervention adapted in Stage 1 with up to 80 people: 20 current MAT clients 
at the Muhimbili MAT Clinic and 20-60 social support persons identified by recruited MAT clients (MAT 
clients will be able to invite up to 3 social support persons to participate in the intervention). The main 
purpose of this pilot is to assess the feasibility and acceptability of conducting a social network 
intervention among MAT clients and individuals identified by them as social support persons. The pilot 
study is not powered to assess statistical significance. With a sample size of 20 current MAT clients 
and up to 60 social support persons, we will be able to estimate the proportion of people who will attend 
at least 80% of the intervention sessions with some precision.  
 
C.  Does your study meet the NIH definition of “clinical trial”: ““A research study in which one or more 
human subjects are prospectively assigned to one or more interventions (which may include 
placebo or other control) to evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes”?  If yes, the study must be listed on clinicaltrials.gov, study personnel must 
complete GCP training, and federally funded studies must post consent forms on approved sites, like 
clinicaltrials.gov. 
Yes. 
 
IV. Participants: 
Describe the study participants and the population from which they will be drawn.  Specify the inclusion and 
exclusion criteria.  If you plan to include children, note their ages and whether you will include children in 
foster care or who are wards of the State. Note if the participants are particularly vulnerable in terms of 
cognitive limitations, education, legal migration status, incarceration, poverty, or some combination of 
factors.  
 
A. Inclusion Criteria:  
 
Stage 1: Inclusion criteria for key informant interviews will be: 1) at least 18 years old, 2) current 
provider or staff person at the Muhimbili MAT clinic OR current community outreach workers/staff 
person at a Dar es Salaam-operating CBO providing outreach to people who use drugs. 
 
Inclusion criteria for focus group discussions will be: 1) at least 18 years old, 2) a current Muhimbili 
MAT client OR a person identified by a current Muhimbili MAT clients as a social support person OR 

Page 5 of 32 
 
 
current community outreach workers/staff person at a Dar es Salaam-operating CBO providing 
outreach to people who use drugs. 
 
Inclusion criteria for the key stakeholder meeting will be: 1) at least 18 years old, 2) a government 
representative involved in decision-making on opioid use disorder treatment programs in Tanzania OR  
a key stakeholder from civil society organizations focused on outreach and other programming for 
people who use drugs OR a MAT clinic provider OR a topical expert relevant to the adapted 
intervention (e.g., social support interventions or economic strengthening interventions). 
 
Stage 2: Inclusion criteria for MAT client participants in the intervention pilot will be: 1) 18 years old or 
older, 2) currently enrolled in the MAT program at the Muhimbili MAT clinic, 3) prescribed methadone 
for the past 3 months, 4) received a positive test result for heroin, cannabis or alcohol use in the past 3 
months, 5) provide consent for trial participation.  
 
Inclusion criteria for social support persons in the intervention pilot will be: 1) 18 years old or older, 2) 
identified as a social support person of a MAT client participating in the pilot trial, 3) lives in Dar es 
Salaam, 4) provide consent for trial participation. 
 
 
B. Exclusion Criteria:  
 
Stage 1: none. 
 
Stage 2: none. 
NOTE: If you are recruiting participants or receiving, accessing, or using data from a U.S. health care 
provider, HIPAA review is likely to be required.  If you plan to bring identifiable health information 
from a foreign country to a U.S. covered entity (e.g., lab at the Hopkins SOM), HIPAA may be 
triggered. Check “yes” to the HIPAA question in the PHIRST application. 
 
V. Study Procedures:  
      In this section, provide details of your procedures, particularly as they relate to human subjects. If this is a  
      multi-center study, make the role of JHSPH clear. If you will collaborate with other institutions or     
      organizations, or plan to subcontract JHSPH responsibilities to others, make clear their responsibilities in 
      the Study Oversight section of this document. Be aware that all recipients of federal funding for non-exempt  
      human subjects research must have a Federal Wide Assurance (FWA) , which is a promise to comply with  
     human subjects research regulations.   
 
If the JHSPH will serve as data coordinating center, indicate in the sections below which procedures 
JHSPH will not be performing.  Additional information regarding data coordinating centers is requested in a 
later section.   
If your study will develop in phases, address each item below by phase. 
A. Recruitment Process: 
1. Describe how you will identify, approach, and inform potential participants about your study.  
Include details about who will perform these activities and their qualifications. 
Stage 1: For Phase 1, we will recruit key informants through the Muhimbili MAT clinic, CBOs, and 
snowball sampling. MAT clinic providers and CBO staff will be approached directly by the study 
team and purposively sampled based on job function (e.g., clinicians, social workers, occupational 
therapist).  

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For Phase 3, clinic staff will announce to MAT clients that focus groups will be held at certain dates 
and times and to reach out to the study team if interested. MAT clients will be given the opportunity 
to sign up to attend a focus group. We will hold two focus groups with 8-10 MAT clients in each. 
One focus group will be with clients who have been enrolled in MAT for more than 5 years. The 
other focus group will be with clients who have been enrolled in MAT for less than 5 years. We will 
attempt to have equal numbers of male and female clients in each focus group. At the end of each 
focus group, the study team will provide each person with a recruitment card with study team 
information to give to a person who they consider a positive support person (i.e., family member, 
partner, or friend) and who is not a current MAT client so that they can reach out directly to the 
study team if they are interested in participating in a focus group. One focus group will be held with 
8-10 identified social supporters. For focus group with community outreach workers (8-10 
community outreach workers), the study team will reach out directly to the directors of CBOs 
involved in outreach work for people who use drugs in Dar es Salaam and the MAT clinic and 
provide information on the study. The study team will ask CBO and MAT directors to refer any 
community outreach workers to the study team if they are interested in learning more about 
participating in a focus group. A study team member will provide all potential participants with an 
overview of the purpose of focus groups and assess his/her interest in participating. If the person is 
interested in participating, we will provide them with the date, time, and location of the focus group.  
 
For Phase 5, we will identify and recruit topical experts based on recommendations from the local 
study team. The local co-PI will reach out directly to potential topical experts and other key 
stakeholders to invite them to a key stakeholder workshop.  
 
Stage 2: We will pilot the intervention with a maximum of 80 people: 20 current MAT clients at the 
Muhimbili MAT Clinic and up to 60 social support persons identified by recruited MAT clients.  
Muhimbili 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 MAT 
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, MAT client participants will be asked to 
identify up to three people who provide them with support to invite them to participate in the 
intervention. MAT 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 MAT clients after the MAT 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 MAT 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 them to 
participate in the study.  
 
2. Address any privacy issues associated with recruitment.  If recruitment itself may put potential 
participants at risk (if study topic is sensitive, or study population may be stigmatized), explain how 
you will minimize these risks. 
To protect privacy and minimize the risk of a breach of confidentiality, all recruitment conversations 
between the study team and potential participants will take place in a quiet and private location.  
 

Page 7 of 32 
 
 
 
 
 
B. Consent Process:   
1. Describe the following details about obtaining informed consent from study participants.  If a 
screening process precedes study enrollment, also describe the consent for screening. 
a. Who will obtain informed consent, and their qualifications: 
Local interviewers trained in the responsible conduct of research, including ethical conduct of 
research, informed consent, and confidentiality, and sensitivities in working with vulnerable 
women and men, will obtain informed consent from study participants. 
b. How, where, and when the consent discussion(s) will occur: 
Consent discussions will occur verbally between the local study team member and the 
participant prior to their participation, preferably immediately preceding the interview or focus 
group, in a quiet and private location. The study team member will read through the consent 
form and will use probes to assess whether the participant understands what is being asked of 
him/her. The study team member will give the participant the opportunity to ask questions about 
the study before asking for her/his consent to participate. The study team member will offer a 
copy of the consent script which will include information on how to contact the study staff and 
IRBs to ask for further information or to report adverse events associated with his or 
participation in the research. 
c. The process for determining whether a potential participant meets eligibility criteria.  If you will 
collect personally identifiable information for screening purposes, collect only data needed for 
this purpose and explain what will happen to the data for individuals who are not eligible: 
We will recruit clients and providers directly from the MAT clinic, so any client enrolled in the 
clinic will be eligible. CBO staff will be recruited directly from CBOs, so any staff will be eligible. 
Social support persons will undergo screening to determine their eligibility for pilot trial 
participation. 
d. Whether you will obtain a signature from the participant or will use an oral consent process: 
For Stage 1 activities: We will use an oral consent process since this study present no more 
than minimal risk to participants. A written, signed consent form would be the only document 
linking the participants’ names to the study and would increase the potential risk of breach of 
confidentiality. 
For Stage 2 pilot intervention: We will obtain a signature from participants. 
e. Whether you will obtain a legally authorized representative’s signature for adults lacking 
capacity: 
N/A 
f. If children are included in the study, if and how you will obtain assent from them: 
N/A  
 
g. If children are included in the study, how you will obtain permission for them to participate from 
their parent, legal guardian, or other legal authority (if child is in foster care or under government 
supervision).  If any of the children are “wards of the state”, additional regulatory requirements 
will apply: 
N/A 
h. If you are seeking a waiver of informed consent or assent, the justification for this request: 

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We request a waiver of informed consent for participants of the key stakeholder workshop as 
we will only disseminate findings and get their feedback on the intervention in their official job 
capacities. These workshops will not include any personal questions. 
i. 
Whether you will include a witness to the consent process and why: 
We will not include a witness to the consent process to better protect participant privacy. 
j. 
If the language is unwritten, explain how you will communicate accurate information to potential 
participants and whether you will use props or audio materials: 
N/A 
 
 
 
 
 
 
 
 
 
 
2. Identify the countries where the research will take place, and the languages that will be used for the 
consent process.   
Country 
Consent Document(s) 
(Adult Consent, Parental 
Permission, Youth Assent, etc.) 
Languages 
Tanzania 
Adult Consent 
Swahili 
      
      
      
      
      
      
 
 
C. Study Implementation:  
1. Describe the procedures that participants will undergo.  If complex, insert a table below to help the 
reviewer navigate.   
Stage 1: For Phase 1 of the ADAPT-ITT approach that we are adopting for this study, we will conduct 
key informant interviews with providers at the Muhimbili MAT clinic and community outreach workers 
and other staff at community-based organizations operating in Dar es Salaam that provide outreach to 
people who use drugs. Local Interviewers, who will be fluent in English and Swahili and have previous 
experience conducting qualitative interviews and/or focus groups, will be trained in ethics and the 
specific interview data collection approach that will be used in the study. After obtaining informed 
consent, the Interviewers will conduct interviews with key informants in a private location using semi-
structured interview guides. Interview guides will include questions on intervention content/components, 
implementation approaches, duration, and training needs. Key informant interviews are expected to last 
between 45m and 1h and will audio recorded with participant permission. Interviews will be transcribed 
in Swahili and translated to English. 
 

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For Phase 3, we will conduct focus groups with current clients enrolled in the Muhimbili MAT clinic, 
individuals identified by current Muhimbili MAT clients as providing them social support, and community 
outreach workers. Focus groups will be moderated by a member of research team and a notetaker from 
the research team will also be present. The moderator will use a semi-structured focus group 
discussion guide. The guide will include questions on content/components, implementation 
approaches, duration, potential economic strengthening activities. Focus groups are expected to last 
between 1.5 and 2h. Discussions will be audio recorded with participants’ permission and audio 
recordings transcribed in Swahili and translated to English.  
 
For Phase 5, we will hold up to two half-day, key stakeholder workshops with topical experts, including 
MAT clinic providers, key government officials involved in decision-making on opioid use disorder 
treatment programs, and other key stakeholders from civil society focused on outreach and other 
programming for people who use drugs. Workshops will be structured around presenting key findings 
and materials produced from phases 1-4 and eliciting feedback on intervention content and 
implementation strategies. Members of the research team will facilitate the workshops. Each workshop 
will last 4-5 hours and notes will be taken throughout the workshop to document discussions. 
 
Stage 2: After obtaining informed consent, MAT clients and their identified social support person(s) will 
complete a pre-intervention survey. The survey with MAT 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, MAT clients will be asked not to specify 
names of family, friends, other MAT clients, or other important people in their lives. Rather, they 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 MAT client who identified them 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 MAT clients). MAT 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. The sessions are outlined in the following table:  
 
Table 2. Description of intervention sessions 
Session 
# 
Session name 
Session description 
Social support 
person 
invited to 
session? 
1 
Introduction 
• Aim: Present information on the intervention program (duration, 
content, expectations) 
• Separate, 50-min group sessions will be held with participating MAT 
clients and social support persons identified. The social support 
person introduction session will be held two weeks after the MAT 
client session. 
Yes 
2 
Working in a 
social network-
based context 
• Aim: Identify, recruit, and maintain a network supportive of positive 
change 
• In this 50-min session, the counselor will explain the importance of 
social support in achieving positive outcomes, identify the primary 
goals for which the client will focus on in the program, identify 
people who can provide the client with positive support using social 
network mapping, plan and rehearse contacting potential social 
No 

Page 10 of 32 
 
 
support persons, plan for activities with social support persons and 
maintenance of social network support. 
3 
Setting drinking 
and drug use 
goals 
• Aim: Understand the client’s current substance use, establish 
substance use harms, and agree on where the client would like to 
be in relation to their substance use 
• In this 50-min session, the counselor will get an account of recent 
substance use behavior, elicit concerns about the behavior and its 
consequences (change talk), explore motivation to change and self-
efficacy for achieving a change plan, agree on a change plan 
(commitment talk) 
Yes 
4 
Coping skills 1 
• Aim: Identify high-risk situation for drinking and drug use and agree 
on a coping strategy for each situation 
• In this 50-min group session with other MAT clients, the counselor 
will provide information on the nature of high-risk situations, help 
the clients to brainstorm potential coping strategies, and 
interactively practice coping in high-risk situations 
No 
5 
Coping skills 2 
• Aim: Identify high-risk situation for drinking and drug use and agree 
on a coping strategy for each situation 
• In this second 50-min session on coping skills, the counselor will 
work with clients and their social support persons to discuss to 
create an individualized network-based coping strategy 
Yes 
6 
Making lifestyle 
changes 
• Aim: Establish a lifestyle, free of alcohol and drug problems, with 
network support 
• In this 50-min session, the counselor will establish an understanding 
of an alcohol/drug problem-free lifestyle based on the vision of the 
MAT client and their social support persons, identify roles in 
achieving new routines and activities, create an action plan (with 
weekly schedule for routine activities, including income generation), 
and use problem-solving to address challenges to the plan 
Yes 
7 
Generating 
income 
• Aim: Build income-generating skills 
• In this 3-hour group session with other MAT clients and social 
support persons, the facilitator(s) will lead hands-on training on 
income-generating skills, including construction, carpentry, cooking, 
and jewelry-making.  
Yes 
 
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 MAT client participants and their 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 MAT clients).  
 
We will also conduct 25 follow-up qualitative, in-depth interviews with 10 MAT client participants, 10 
social support person participants, and all 5 intervention counselors, about one month after the trial. We 
will purposively sample participant based on their attendance in sessions and based on responses to 
survey questions, so that we 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 

Page 11 of 32 
 
 
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 their daily lives, and changes in the quality of relationships with social 
support persons and other people in their lives. Interviews are expected to last about 45 minutes and 
will be audio-recorded with participant permission. 
 
2. Describe the number and type of study visits and/or contacts between the study team and the 
participant, how long they will last, and where/how they will take place. 
Stage 1:  All participants will be in contact with the study team for recruitment purposes. For Phase 
1, key informant interviews are expected to last between 45m and 1h. Phase 1 participants will 
participate in a single key informant interview. It is possible that health providers or CBO staff who 
are interviewed for Phase 1 will be invited to the key stakeholder workshop for Phase 5. For Phase 
3, focus groups are expected to last 1.5 to 2h. Each focus group participant will participate in just 
one focus group discussion.  The informed consent process for key informant interviews and focus 
groups will take place before the interview or the focus group and is expected to last no more than 
10m. Key stakeholder workshops will last 4 to 5h. 
 
Key informant interviews will take place in a private and quiet location, either at the study office, 
the CBO office, or the provider office at the MAT clinic. Focus groups will take place in the 
conference room of the building that houses the study office located near the Muhimbili MAT clinic 
on the grounds of the Muhimbili National Hospital. The key stakeholder workshops will take place 
in rented venues (conference rooms) in either Dodoma (where many government offices are 
located, including the Ministry of Health) or Dar es Salaam.  
 
Stage 2: All pilot participants will be in contact with the study team for recruitment purposes, for 
pre- and post-intervention surveys, and through the pilot intervention. Upon enrollment, the pre-
intervention survey is expected to take 20m to complete for enrolled MAT clients and 15m for 
enrolled social support persons. MAT clients will participate in six 50-min sessions and one 3h 
session over the course of six weeks. Social support persons will participate in four 50-min sessions 
and one 3h session over the course of six weeks. After each intervention session, participants will 
complete a 5m exit survey. The post-intervention survey is expected to take 20 minutes and 15 
minutes for MAT clients and social support persons to complete, respectively, and will be 
conducted a week after the intervention ends. A select number of pilot participants will also be in 
contact with the study team for an approximately 45m follow-up, in-depth interview one month 
after their last intervention session. 
 
3. Describe the expected duration of the study from the perspective of the individual participant and 
duration overall. 
Stage 1: 
Phase 1: Key informant interviews are expected to last 45m to 1h. 
Phase 3: Focus group discussions are expected to last 1.5 to 2h. 
Phase 5: Key stakeholder meetings are expected to last 4 to 5h.  
 
Stage 2:  
MAT client participants: Six weeks, as well as a 45-minute, follow-up interview for select 
participants  
• Pre-intervention survey: Approximately 20m 

Page 12 of 32 
 
 
• Intervention: 50-min intervention session weekly for six weeks plus a 3h interactive, 
income-generating skills-building session 
• 
Post-intervention survey: Approximately 20m 
• 
Post-intervention interview: Approximately 45m (select participants) 
 
Social support person participants: 6 weeks, as well as a follow-up interview for select participants 
Pre-intervention survey: Approximately 15m 
• Pre-intervention survey: Approximately 15m 
• Intervention: 50m intervention session weekly for five weeks plus a 3h interactive, income-
generating skills-building session  
• Post-intervention survey: Approximately 20m 
• 
Post-intervention interview: Approximately 45m (select participants) 
 
The overall duration of the study (Stages 1 and 2) will be two years. 
 
4.   Provide a brief data analysis plan and a description of variables to be derived.  
Stage 1: We will analyze interview, focus group, and stakeholder meeting transcripts using framework 
analysis. Transcript data will be coded in NVivo and broadly categorized into participant feedback 
on the different intervention components with more detailed subcategories of codes and topics 
(such as content, feasibility and acceptability, and delivery) developed within these broader 
categories based on the data. Each interview will be placed into a framework developed from the 
broad and more detailed categories of responses, using a template developed in Microsoft Excel. 
Two independent coders will enter each interview/focus group into the framework and any 
discrepancies will be discussed and resolved. The final framework will be shared with data 
collectors and other study team members for discussion and to inform decisions on adaptations to 
the B-SBNT intervention. The study team will adapt the existing intervention manual and materials 
based on findings from Phases 1-4. Topical experts and other key stakeholders will provide 
feedback on drafts of the adapted manual and materials, which the study team will integrate in 
Phase 6. We will then pilot the resulting adapted intervention in Stage 2. 
Stage 2: We will use descriptive statistical methods and qualitative data analysis to examine 
intervention acceptability and fidelity of the intervention. Enrollment data will be used to describe the 
characteristics of the MAT clients and their social support persons. We will calculate the proportion 
of sessions attended. We will explore the reasons for missed sessions. These data will provide 
important information on the characteristics of study participants, the dose of the intervention, 
retention, reasons for missed sessions, and the acceptability of session content and approach. We 
will examine key outcomes such as changes in knowledge and attitudes, and changes in network 
and social engagement.  
 
5.  Answer the following if they are relevant to your study design: 
 
A. If the study has different arms, explain the process for assigning participants 
(intervention/control, case/control), including the sequence and timing of the assignment. 
 
N/A 
 
B. If human biospecimens (blood, urine, saliva, etc.) will be collected, provide details about who 
will collect the specimen, the volume (ml) and frequency of collection, how the specimen will be 
used, stored, identified, and disposed of when the study is over.  If specimens will be collected 

Page 13 of 32 
 
 
for use in future research (beyond this study), complete the “Biospecimen Repository” section 
below. 
 
N/A 
 
C. If genetic/genomic analyses are planned, address whether the data will be contributed to a 
GWAS or other large dataset.  Address returning unanticipated incidental genetic findings to 
study participants. 
 
 N/A 
 
D. If clinical or laboratory work will be performed at JHU/JHH, provide the JH Biosafety 
Registration Number. 
 
N/A 
 
 
 
E. If you will perform investigational or standard diagnostic laboratory tests using human samples 
or data, clarify whether the tests are validated and/or the lab is certified (for example is CLIA 
certified in the U.S.).  For clinical tests of human biospecimens, no results may be 
returned unless completed in a certified lab. Explain the failure rate and under what  
circumstances you will repeat a test.  For all human testing (biomedical, psychological, 
educational, etc.), clarify your plans for reporting test results to participants and/or to their 
families or clinicians.  Address returning unanticipated incidental findings to study participants. 
 
N/A 
 
F. If your study involves medical, pharmaceutical or other therapeutic intervention, provide the 
following information: 
 
a. Will the study staff be blind to participant intervention status?   
N/A 
b. Will participants receive standard care or have current therapy stopped? 
N/A 
c. Will you use a placebo or non-treatment group, and is that justifiable? 
N/A 
d. Explain when you may remove a participant from the study. 
N/A 
e. What happens to participants on a study in which there is a medical intervention when the 
study ends?  Will participants continue to have access to the study intervention?  What 
happens if they leave the study early? 
N/A 
f. Describe the process for referring participants to care outside the study, if needed. 
N/A 

Page 14 of 32 
 
 
VI.  Data Custody, Management, Security, and Confidentiality Protections:  Data security and management 
plans must meet institutional standards.  If you need assistance, contact jhsph_cybersecurity@jhu.edu. 
Investigators are responsible for ensuring the security of data from the time of collection, through any transfers from 
one system to another, analysis, sharing, storage, and ultimate archiving and disposal.  The questions below seek to 
elicit your plans for these protections.  Feel free to add information. 
1. Data Sources: Identify the source(s) of data. 
 
     ☒ Participant/Parent-Guardian/Legally Authorized Representative                                                       
     ☐ JHM medical records (from Epic)   
 
Note: Please complete the Data Trust Risk Tiers Calculator available on the Applications and Forms page on the JHSPH IRB website:  
https://www.jhsph.edu/offices-and-services/institutional-review-board/applications-and-forms/, and upload a copy of the those documents 
to the “Miscellaneous” section of your PHIRST application.  In addition, review the Data Protection Attestation for Research and/or 
Healthcare Operations at the link below and certify your attestation of compliance to those requirements: 
(https://intranet.insidehopkinsmedicine.org/privacy_office/_docs/additional_information/Data%20Protection%20Attestation.pdf. 
 
☐ I certify my attestation of compliance to JHM Data Protection Requirements 
 
☐ non-JHM medical records  
☐ Outside data provider (CMS, National Death Index, Insurance Co., etc.)                                                            
☐ Other existing records           
            
2. Data Content: Will you collect, use, and/or record personal identifiers about study participants for any 
purpose?  Please look at the list of identifiers in Question 3 to help answer this question. Note:  Limited Data 
Sets (including dates, ages, and zip codes) are considered to be “identifiable”. 
☒  Yes  Continue with Question 3 
☐  No  Skip to Question 9 
 
3. Data Identification: Identify the Personally Identifiable Information (PII)/Protected Health Information (PHI) you 
will access/collect by checking the boxes below for “Recruitment” and “Study Data” needs: 

Page 15 of 32 
 
 
 
Recruitment 
Study Data 
PII/PHI to be accessed/collected 
☒ 
☐ 
Name, signature, initials or other identifiable code 
☐ 
☐ 
Geographic identifier (address, GPS location, etc.)  
☐ 
☐ 
Dates (birth, death, clinical service, discharge, etc.) 
☒ 
☐ 
Contact information (phone number, email address, etc.) 
☐ 
☐ 
Identification Numbers (SSN, driver’s license, passport, etc.) 
☐ 
☐ 
Health Records Identifiers (medical record #, insurance plan, etc.) 
☐ 
☐ 
Text of clinical record notes 
☐ 
☐ 
Device identifiers (implants, etc.) 
☐ 
☐ 
Internet identifiers (IP address, social media accounts, etc.) 
☐ 
☐ 
Biometric identifiers (fingerprints, retinal scan, voice print, etc.) 
☐ 
☒ 
Audio Recordings 
☐ 
☐ 
Video or full-face photographic images 
☐ 
☐ 
Genomic / Genetic data 
☐ 
☐ 
Other identifiers: (list here)       
 
 
4. Identifiers:  If you have checked any of the boxes above, how will you protect personal identifiers? 
☒   Will delete all identifiers (explain when you will delete identifiers):   
                   We will delete all identifiers (collected for recruitment and retention purposes) when the 
follow-up assessment for the pilot intervention trial is completed.  
     ☒   Will separate identifiers from analytic data and will store the link/code.  Please explain where you will store      
link/code:    We will maintain a separate database with contact information for pilot intervention trial 
participants for the purpose of follow-up/retention during the trial and for the post-intervention follow-
up assessment. We will not link this contact information to any analytic data collected from participants. 
☐   Will use a method to make it harder to connect the data with the study participant (jiggering date, use other 
methods to obfuscate, etc.).  Please explain:        
 
5. Will you obtain consent (or Authorization if governed by HIPAA) from participants for this study?  

Page 16 of 32 
 
 
☒  Yes   
☐  No 
  
6.  Data Transit Plans and Protections: Identifiable data may transfer, sometimes with multiple steps, from 
mechanisms for collection to storage.  For example, participants may complete a web-based survey, which is 
then downloaded to a storage platform.  Briefly identify these steps and the protections for each step 
(including encryption used at each step). 
☐   Will delete all identifiers prior to transfer 
      ☒   Will separate identifiers from analytic data and will store the link/code prior to transfer.  Please explain where 
you will store link/code:   Identifiers will only be collected for the purpose of recruitment and retention 
during the pilot trial. We will not link identified to any analytic data collected from participants. 
☐   Other:        
 
7.   Device(s) used for data collection:  Identify the computing device(s) being used for identifiable data 
receipt/collection.  Check all that apply. 
     ☐ Provided or managed by JHSPH IT 
     ☒ Study-provided, and not managed by JHSPH IT. These must include the following protective controls: 
• 
Data  encrypted while “at rest” (on a storage device) 
• 
Security patches and updates are routinely or automatically applied 
• 
Devices have access controls so that: 
o    Each person accessing the device is uniquely identified (username) 
o    Passwords are sufficiently strong to prevent compromise 
o    All access is logged and recorded 
o    Unauthorized access is prevented 
• 
Approved access list is reviewed periodically for correctness 
• 
☐ Other.  Specify:        
 
 
8. Data Collection: Describe the format of data received/collected.  Check all that apply. 
☒   Paper/Hard Copy (must be secured in transit and placed in a secure cabinet/room)                                    

Page 17 of 32 
 
 
☒   Audio recording   
☐   Video recording                                               
☐   Received directly by research team member and entered into file/database 
☐   Mobile or Web App (custom developed).  Review guidance and provide attestation of compliance 
☒   Mobile or Web App (purchased). Specify product and version: Network Canvas version 6.1.2 
☐   Online survey.  Specify mechanism/platform:       
☐   3rd party collector.  Specify:       
☐  Existing data shared with JHSPH by data provider via electronic access/transfer 
☐   Duplicate and backup copies will be secured with same rigor as original data            
☐   Other.  Specify:         
 
            
9.   Devices/Platforms used for Analysis, Storage, Processing: Identify where the identifiable or de-identified data 
will be analyzed/stored.  Check all that apply. 
☒   Pre-approved storage and analysis platforms managed by JH/JHSPH for which security and risk mitigation 
measures are known. 
 
 
Identify preapproved storage platform(s) being used: 
 
JHM Preferred:           
Other Approved: 
             ☐ JH SAFE Desktop     
☒ JH OneDrive/JHSPH OneDrive       ☐ JHSPH HPCC 
               ☐ JH PMAP                      ☐ JHSPH Shares                                   ☐ JHM/JHSPH Qualtrics 
                                                          ☐ JHSPH Sharepoint                            ☐ MARCC Secure Environment 
                                  ☐ JHU RedCap                                     ☐ JH IT-managed Network Storage          
                                                                                                                           
 
 
                                                          __________________ 

Page 18 of 32 
 
 
 
☐   Platform(s) not managed by JH/JHSPH, not pre-approved, and require a risk assessment review from JHSPH 
Data Security.  Describe:         
      Describe risk mitigation measures in place:        
 
Note:  The following are examples of platforms/storage solutions that are not pre-approved to store 
identifiable information and require a risk assessment from JHSPH Data Security. 
• 
Other solutions not managed by IT@JH, e.g., commercial cloud storage (Box, Dropbox, iCloud, personal 
OneDrive, Google Drive, Amazon storage, etc.) 
• 
JHU Independent Departmental Servers 
• 
Local Computer owned by JH 
• 
Other computers or devices owned/managed by study team members and used for other than secure 
web access 
• 
USB/Portable data storage device 
 
10.  Access to Data and Access Controls: How will you ensure that only authorized individuals can access the data?  
What access controls will you put into place to ensure that only authorized individuals may access and use the 
data.  (For example, OneDrive guidance illustrates how to share files with “people you specify”.  JHSPH-Shares 
addresses providing permissions to individual people.)  Check all that apply.  Note:  If you need assistance 
implementing secure access controls, contact jhsph_cybersecurity@jhu.edu. 
 
☒   Will provide access to data in accordance with OneDrive/JHSPH-Shares guidance posted on JHU IT websites 
☐   Will use secure access controls to limit access to individual-level data  
☐   Will use secure access controls to provide other researchers controlled access only to aggregated study data 
 
11. Data Sharing:  Clarify if data are to be shared externally with third parties, including sponsors and other 
investigators, and whether only aggregated data will be shared, or if you will share individual-level data.  
Describe sharing and protection plans for that sharing, including the proposed use of data agreements.   
 
Consider the following: 
• 
Information about your data sharing in the consent forms 
• 
Information about data sharing laws in the country where data will be collected, and if they limit sharing, 
how you will comply with those limitations? 

Page 19 of 32 
 
 
• 
Whether data will be shared in aggregate only, or individual level data 
• 
Whether you plan to make the data publicly available, and in what form. 
 
☐  Will not share data with outside investigators 
☒  Will share aggregated data only 
☐  Will share individual-level data without identifiers 
☐  Will deposit data into an existing data repository for future research (explain): 
☐  Other sharing information:       
 
 
 
12. Duration and Destruction:  Explain how long data will be retained and the plan for eventual return, 
deidentification or destruction of data, including moving data to an archive. 
 
Data will be deidentified and retained for future analyses. 
A. Certificate of Confidentiality: 
All NIH studies include Certificate of Confidentiality  (C of C) protections with the grant; the consent 
form must include the C of C language provided in our template.  Other funders may obtain C of C 
protections through NIH.  (https://grants.nih.gov/policy/humansubjects/coc.htm  )  
Does the study have Certificate of Confidentiality protections?  Yes ☒   No ☐ 
 
VII.  Risks of the Study: 
A. Describe the risks, discomforts, and inconveniences associated with the study and its procedures, 
including physical, psychological, emotional, social, legal, or economic risks, and the risk of a breach of 
confidentiality.  Include risks beyond individuals to include the study population as a group and 
community risks. Ensure that the risks described in the consent documents are consistent with the risks 
outlined in the research plan. 
Stage 1: There is a risk that some questions asked during interviews or focus groups may make 
participants feel uncomfortable or experience negative emotions. The main risk for participants in the 
study is breach of confidentiality. 
 
Stage 2: There is a risk that some topics discussed during intervention group sessions may make 
participants feel uncomfortable or experience negative emotions. The main risk for participants in the 
pilot trial is breach of confidentiality. There is a risk that if confidentiality is breached then others 

Page 20 of 32 
 
 
outside of the study may learn of any reported illicit drug use reported by participants during 
intervention sessions. Participants may also experience emotional distress when discussing drug and 
alcohol use or other topics covered in intervention sessions.  
 
B. Describe steps you will take to mitigate or minimize each of the risks described above.  Include a 
description of your efforts to arrange for care or referral for participants who may need it. 
 
The following steps will be taken to minimize the risks describe above: 
 
Staff training. All study investigators have completed human subjects research ethical training through 
the Collaborative Institutional Training Initiative (CITI Program) or comparable training courses. Local 
data collectors will be trained in: ethical conduct of research, including informed consent and 
confidentiality; sensitivity training in working with high-risk men and women, particularly people who 
use drugs; and data collection procedures. Intervention facilitators will also be trained in the 
intervention manual. 
 
Recruitment. The study team will ensure confidentiality during recruitment. All recruitment discussions 
will take place in private. 
 
Informed consent. Oral informed consent will be obtained from Stage 1 participants and written 
consent from Stage 2 (pilot trial) participants prior to their participation. All consent forms will be 
translated into the local language (Swahili) and certified by a translator to ensure correct use of the 
language. Oral instead of written consent will be used for Stage 1 since this study presents no more 
than minimal risk to participants. The participant will be offered a copy of the consent form, which will 
include information on how to contact the study staff and IRBs to ask for further information or report 
adverse events associated with his or her participation in the research. 
 
Data collection procedures. For Stage 1, key informant interviews and focus groups will take place in a 
private, quiet location, either at the study office, CBO office, or private office in the MAT clinic. 
Interviews and focus groups will be audio-recorded with participant permission. Audio recordings will 
be deleted from the digital recorder once the audio files have been successfully transferred to a 
password-protected study computer and backed up. All participants will be informed that they can skip 
any questions during the interview/focus group or withdraw from the study at any time without 
penalty. For Stage 2 (pilot trial), intervention sessions will take place in a private, quiet location, either 
at the study office or CBO office. All participants will be informed that they do not have to answer any 
questions or share any information that they are uncomfortable with sharing (such as substance use, 
particularly in group session), and that they can withdraw from the trial at any time without penalty. 
 
Data management and storage. Hard copies of interview, focus group, and observations notes and 
intervention assessment forms will be stored in locked file cabinets in the study office. Any 
handwritten notes will be shredded at the end of the study period once all quality control and quality 
assurance procedures have been completed and verified, and converted to electronic versions. All de-
identified, transcripts, notes, and intervention data will be stored and backed up on a secure, 
password-protected cloud server, JH OneDrive. Electronic survey data (pre- and post-intervention 
survey data) will also be stored and backed up on JH OneDrive. 
 

Page 21 of 32 
 
 
Referrals to care. Participants who experience emotional distress during an interview, focus group, or 
intervention session will be referred to mental health care or social services offered through the 
Muhimbili National Hospital. Participants who report behaviors that may place themselves or others at 
risk of HIV, will be referred to the MAT clinic, local HIV clinics, or a community-based organization that 
could link them to HIV or other services. The Muhimbili MAT clinic has social workers and substance 
use disorder specialists, as well as community-based organizations that provide support and outreach 
services for people who use drugs in Dar es Salaam, and can refer participants to these services, as 
needed. Participants requesting support to deal with a violent situation will be referred to a mental 
health specialist or social worker at the Muhimbili MAT clinic. 
  
 
C. Describe the anticipated frequency and severity of the harms associated with the risks identified above; 
for example, if you are performing “x” test/assessment, or dispensing “y” drug, how often do you expect 
an “anticipated” adverse reaction to occur in a study participant, and how severe do you expect that 
reaction to be?   
 
Stage 1:  The potential risks described above may occur during recruitment or data collection (key 
informant interview or focus group) and will likely be minimal to the participant.  
 
Stage 2: The potential risks described above may occurring during recruitment, pre-/post-intervention 
survey data collection, or during the intervention pilot sessions and will likely be minimum to the 
participant. 
 
 
D. Describe the research burden for participants, including time, inconvenience, invasion of privacy in the 
home, out of pocket costs, etc.  
 
Participants may have to travel to the designated interview, focus group or intervention locations, 
which may require out-of-pocket transportation costs. Study participation will also cost participants 
their time. For Stage 1, the burden is expected to be limited to one data collection encounter (key 
informant interview, focus group, or key stakeholder workshop) and will not exceed 4 hours. We will 
attempt to mitigate the burden on participants enrolled in MAT by coordinating activities with existing 
clinic visits. For Stage 2, the burden is expected to be greater with the multiple components of the trial 
(baseline and follow-up assessments and participation in the intervention sessions). 
 
 
 
E. Describe how participant privacy, and if relevant – family privacy - will be protected during data 
collection if sensitive questions are included in interviews, or if study visits occur in the home setting.  
 
All in-depth interviews and focus groups will be conducted in a private, quiet, and safe location to 
protect participant privacy. Study documents, including transcripts and notes, and consent forms will 
not include participants’ names or any other identifying information. 
 
VIII. Direct Personal and Social Benefits: 
A. Describe any potential direct benefits the study offers to participants (“payment” for participation is not a 
direct personal benefit). 
 
There is no direct benefit from the study for participants. Participants may welcome the opportunity to 
share their experience with being on MAT or knowing someone enrolled in MAT if approached in a non-
judgmental manner. They may view the interview or focus group, especially, as an opportunity to 
reshape processes of MAT and ART delivery and support. 

Page 22 of 32 
 
 
 
B. Describe potential societal benefits likely to derive from the research, including value of knowledge 
learned. 
Findings from the study will be used to develop a social network intervention to help build the social 
support network of patients to remain on MAT and adhere to ART. Retention in MAT is important in 
facilitating and improving access of people who inject drugs to HIV prevention and treatment services, 
and facilitating ART adherence. 
 
IX.  Payment or Token of Appreciation:   
A. Do you plan to provide a non-monetary token of appreciation (food, soap, tea, chlorine tablets, etc.) to 
study participants?  If no payment is provided, the JHSPH IRB strongly encourages providing such 
tokens. If yes, please describe below. 
 
Stage 1: Tea and snacks will be provided for Phase 3 focus group participants during the focus group. 
Tea and snacks will be provided for the key stakeholder workshop of Phase 5. 
 
Stage 2: Tea and snacks will be provided during each of the group intervention sessions. 
B. If you plan to provide a monetary payment, describe the form, amount, and schedule of payment to 
participants. Reimbursement for travel or other expenses is not “payment,” and if the study will 
reimburse, explain. 
 
Stage 1: Phase 1: Key informants will be provided a one-time, monetary payment of 20,000 Tanzanian 
shillings ($8.68 USD equivalent) for their participation. Phase 3: Focus group participants will be 
provided a monetary payment of 10,000 Tanzanian shillings ($4.34 USD equivalent) at the end of the 
focus group to reimburse for costs of study participation, including transportation. Phase 5: Topical 
experts and other key stakeholders participating in the key stakeholder workshop will receive a sitting 
fee of 120,000 Tanzanian shillings ($52.06 USD equivalent) per standard practice. 
 
Stage 2: Trial participants will receive 10,000 Tanzanian shillings per intervention session (7 intervention 
sessions for MAT clients and 5 sessions for social support persons), 10,000 Tanzanian shillings for 
completing each of the pre-intervention and post-intervention survey, and 10,000 Tanzanian shillings 
for completing a follow-up, qualitative interview.   
 
C. Include the possible total remuneration and any consequences for not completing all phases of the 
research. 
Stage 1: The total possible renumeration for Stage 1 key informant will be 20,000 Tanzanian shillings, 
10,000 Tanzanian shillings for focus group participants, and 120,000 Tanzanian shillings for participants 
in the key stakeholder workshop. 
Stage 2: The total possible renumeration for Stage 2 participants will be 100,000 Tanzanian shillings 
(approx. 43 USD equivalent) for MAT client participants and 80,000 Tanzanian shillings (approx. 34 USD 
equivalent) for social support person participants.  
 
X. Study Management: 
A. Oversight Plan: 
 
1. Describe how the study will be implemented.  List all parties, including collaborators and 
subcontractors, who will be “engaged” in the human subjects research project and their roles . 
 
The PI will provide scientific oversight over all aspects of the study. The Tanzania-based Co-
Investigator, will manage day-to-day study operations at the field site, including supervising the 

Page 23 of 32 
 
 
local study team and managing study recruitment and data collection. The PI will have at least 
weekly calls with the Tanzania-based Co-Investigator in addition to weekly debriefing meetings with 
the entire study team. The PI will manage all data analysis along with study Co-Investigators. 
 
 
 
2. What are the qualifications of study personnel implementing the project? 
The PI, Dr. Haneefa Saleem, is an Assistant Professor in the Department of International Health at 
JHSPH. She has conducted research focused on the intersections of substance use and HIV, 
including mitigating the risks and harms associated with injection drug use. She served as Co-
investigator and oversaw data collection and analysis on research grants sponsored by the National 
Institute on Drug Abuse (NIDA) and the CDC in Tanzania. These research studies aimed to develop 
and evaluate a pilot take-away methadone treatment delivery model (CDC) and an integrated HIV 
and MMT service delivery model at the first publicly-funded MAT program in sub-Saharan Africa, 
located at the Muhimbili National Hospital in Dar es Salaam, Tanzania.  
The main Tanzanian collaborators/Co-Investigators for this project are Dr. Iddi Haruna Nkya and Dr. 
Jessie Mbwambo. Dr. Haruna Nkya is a Psychiatrist and Lecturer in the Department of Psychiatry 
and Mental Health at Muhimbili University of Health and Allied Sciences (MUHAS) and clinician at 
the Muhimbili MAT clinic. He has previously worked with Dr. Saleem on mixed methods research 
examining the integration of HIV care and treatment at the Muhimbili MAT clinic. Dr. Jessie 
Mbwambo is a Consultant Psychiatrist at the Muhimbili National Hospital and Senior Researcher 
also in the Department of Psychiatry and Mental Health at MUHAS. She has over 25 years of 
experience conducting HIV prevention and treatment research and leads the Tanzania AIDS 
Prevention Program, which overseas several community-based organizations that provide outreach 
to people who use/inject drugs in Dar es Salaam. She was instrumental in starting the first 
methadone maintenance treatment program in Tanzania. The PI has worked extensively with Dr. 
Mbwambo on HIV research projects in Tanzania. Dr. Haruna Nkya and Dr. Mbwambo will oversee 
field data collection and will assist in analysis, interpretation, and dissemination of findings.  
All study investigators have completed training in the responsible conduct of research, human 
subjects research protections, and additional training in research ethics. 
3. How will non-professional personnel (data collectors) involved with the data collection and analysis 
be trained in human subjects research ethical protections?  (Use the JHSPH Ethics Field Training 
Guide available on the JHSPH IRB website. If the study is a clinical trial, consider using the JHSPH 
Good Clinical Practice (GCP) For Social and Behavioral Research Field Guide).  
 
The PI and Co-Investigators will train study personnel involved with the data collection and 
preliminary analysis in human subjects research protections using the JHSPH Ethics Field Training 
Guide and supplemented by additional ethics training that the PIs have conducted in Tanzania for 
studies involving vulnerable populations, specifically people who use drugs and people in recovery 
for addiction. The ethics training will be included as a one-day module as part of the initial one-week 
training for the data collection team. Though all study members will be fluent in English and the 
training will be conducted in English, they will be provided copies of both the English and Swahili 
versions of the JHSPH Ethics Field Training Guide. 
 
4. If the JHSPH PI is responsible for data collection and will not personally be on-site throughout the 
data collection process, provide details about PI site visits, the supervision over consent and data 
collection, and the communication plan between the PI and study team. 
 
The PI, Dr. Saleem, will visit the study site for the one-week training with the study team on 
research ethics, data collection, and reporting procedures, and to supervise initial recruitment, 
consent and data collection for Stage 1 (depending on travel advisories and the global COVID-19 
situation). The PI will visit the site during planning for the pilot trial and possibly during the 

Page 24 of 32 
 
 
administration of the pilot intervention (again depending on travel advisories due to COVID-19 
pandemic). The study team will participate in weekly meetings to debrief on issues related to 
recruitment, consent, data collection, and emergent findings. The PI will call into these weekly 
meetings, when not at the site, and co-lead these meetings with the Tanzanian Co-Investigators. In 
addition to the weekly debriefing meeting, the PI will have bi-weekly calls with the study 
investigators to discuss any study issues, including issues concerning members of the study team. 
Outside of scheduled study team and investigators’ meetings, the PI will communicate to study 
investigators, as needed, through email or phone/Zoom call. 
 
 
 
B. Protocol Compliance and Recordkeeping:   
Describe how you plan to ensure that the study team follows the protocol and properly records and 
stores study data collection forms, IRB regulatory correspondence, and other study documentation.  
(For assistance, contact:  housecalls@jhu.edu   Please provide information about study oversight to 
ensure compliance with IRB approval and regulatory and institutional requirements.  If the study team 
does not follow study procedure, what is your plan for reporting protocol non-compliance?   
The PI and Tanzanian Co-Investigators will oversee and monitor that the study team is following the 
protocol and properly recording and storing study data collection forms. When the PI is not on-site, the 
Tanzanian Co-Investigators will provide weekly updates on the recording and storage of data collection 
forms. If any deviations from the protocol are found, the study team will be provided a refresher training 
session by Study Investigators on recording and storing data collection forms. The PI will provide 
oversight on IRB regulatory correspondence and other off-site study documentation. 
 
C.  Safety Monitoring: 
1. Describe how participant safety will be monitored as the study progresses, by whom, and how 
often.  Will there be a medical monitor on site?  If yes, who will serve in that role and what is that 
person’s specific charge? 
 
Given the nature of the study, there will not be a medical monitor on site. Investigators will ensure 
that informed consent is obtained prior to performing any data collection procedures, that all 
participants meet eligibility criteria, and that the study is conducted according to the IRB-approved 
research plan. The Tanzanian-based Co-PI, Dr. Iddi Haruna Nkya, is a clinical psychiatrist at the 
MNH MAT clinic. He will train and supervise all intervention counselors, conducting weekly 
supervision meetings with intervention counselors. 
 
 
The the full investigator team will review study conduct (recruitment, protocol deviations) on a bi-
weekly basis. Investigators will review adverse events, including serious adverse events, 
individually in real-time and in aggregate on a monthly basis. The PI, Dr. Saleem, will ensure all 
protocol deviations and adverse events are reported to the JHSPH and MUHAS IRBs according to 
the applicable regulatory requirements. 
 
 
2. If a Data Safety Monitoring Board (DSMB), or equivalent will be established, describe the following: 
 
a.   The DSMB membership, affiliation and expertise. 
 
      
 
b. The charge or charter to the DSMB. 
 
      
 

Page 25 of 32 
 
 
c.   Plans for providing DSMB reports to the IRB. 
 
      
 
3. Describe plans for interim analysis and stopping rules, if any. 
 
The anticipated risk for participants is low. However, if excess harm (e.g. severe physical or 
emotional distress during interviews or focus groups) is observed, the study will be suspended until 
the PI is able to consult with the JHSPH and MUHAS IRB to make the final determination for 
stopping the study. If the study is stopped early for any reason, participants will be informed of the 
results. 
 
 
D. Reporting Unanticipated Problems/Adverse Events (AEs) to the IRB (all studies must complete 
this section):   
NOTE: The IRB does not require PROMPT reporting of all AEs, only those that are unanticipated, 
pose risk of harm to participants or others, and are related to the study.   
Anticipated AEs may be reported with the Continuing Review/Progress Report. 
 
Describe your plan for reporting to the JHSPH IRB, local IRBs, and (if applicable) to the sponsor.  
Include your plan for government-mandated reporting of child abuse or illegal activity.  
Given the nature of the study, we do not anticipate any adverse events or serious adverse events. 
However, the PI will evaluate the event and promptly submit written reports of all events that meet the 
definition of “unanticipated problems involving risks to participants and other,” in accordance with the 
Johns Hopkins Bloomberg School of Public Health (JHSPH) IRB Policy No. 103.06 – “Reports of 
unanticipated problems involving risks to participants or to others (Problem/event reporting)” to the 
JHSPH IRB and the MUHAS IRB, using designated reporting forms, as soon as possible after she 
learns of the event, but in all cases within 10 working days. If the unanticipated adverse event is 
deemed alarming by the Project PI, she will immediately report the event to the respective IRB offices. 
 
E.  Other IRBs/Ethics Review Boards:   
If other IRBs will review the research, provide the name of each IRB/ethics review board and its Federal 
Wide Assurance number, if it has one (available on OHRP’s website at 
http://www.hhs.gov/ohrp/assurances).  For federally funded studies, subrecipients  MUST have a 
Federal Wide Assurance (FWA) number from the OHRP.  The IRB overseeing the subrecipient 
should be registered with the OHRP.  The JHSPH IRB will not have oversight responsibility for 
international subrecipients, and generally will not oversee data collection at external U.S. 
institutions  Please contact jhsph.irboffice@jhu.edu with questions. 
 
Non-JHSPH  IRB/REC 
FWA Number 
Research Ethics Committee 
Directorate of Research and Publications, 
Muhimbili University of Health and Allied 
Sciences (MUHAS) 
 
FWA00004301 
      
      

Page 26 of 32 
 
 
      
      
 
F. “Engaged” in Human Subjects Research:  
For studies that involve collaboration with non-JHSPH institutions, complete the chart below by 
describing the collaboration and the roles and responsibilities of each partner, including the JHSPH 
investigator.  This information helps us determine what IRB oversight is required for each party. 
Complete the chart for all multi-collaborator studies. 
 
Insert collaborator names and FWA numbers, if available.  Note who will be “engaged” in human 
subjects research by filling in the following table: 
 
JHSPH 
MUHAS 
      
For federally funded studies, 
collaborators’ FWA 
00000287 
00004301 
      
Primary Grant/Contract 
Recipient 
X 
      
      
Grant/Contract Subrecipient 
      
X 
      
Hiring Data Collectors 
      
X 
      
Training Data Collectors 
X 
X 
      
Obtaining Informed Consent 
and/or Identifiable Data 
      
X 
      
Accessing/Analyzing 
Identifiable Data 
X 
X 
      
Overseeing storage, access 
and use of biospecimens 
N/A 
N/A 
      
 
COMPLETE THE FOLLOWING SECTIONS WHEN RELEVANT TO YOUR STUDY:  
 
XI. Secondary Data Analysis of Existing Data: 
 
 
A. Study Design: 
1. Describe your study design and methods.  The study design must relate to your stated 
aims/objectives.   
We will use a limited, longitudinal study design to detect changes in preliminary outcomes of MAT 
clients participating in the Stage 2 pilot trial. We will extract data from the MAT clinic records of the 20 
participating MAT clients:  
• 
Time enrolled in MAT 
• 
Time since HIV diagnosis (if relevant) 
• 
Methadone dose 
• 
Drug use (heroin, cocaine, cannabis or benzodiazepines) 

Page 27 of 32 
 
 
• 
Alcohol use 
• 
Methadone adherence 
• 
Antiretroviral therapy (ART) adherence (pharmacy refills) 
We will assess changes in substance use (via drug test results), alcohol use (via breathalyzer tests), 
methadone adherence, and HIV treatment adherence (for clients living with HIV). Data will be extracted 
for the six-month period prior to the intervention and the six-month period following the end of the 
intervention. 
 
2.  Provide an estimated sample size and an explanation for that number. 
 
 
We will include 20 current MAT clients at the Muhimbili MAT Clinic in our sample. This includes all 
MAT clients who will participate in the pilot trial. 
 
3. Provide a brief data analysis plan and a description of variables to be derived. 
 
We will use descriptive statistics to characterize MAT clients participating in the pilot trial. We 
compare trends in methadone and ART adherence for the 6-month period prior to the intervention 
and 6-month period after the intervention. 
 
 
B. Participants: 
1. Describe the subjects who provided the original data and the population from which they were 
drawn.   
 
 
Participants will be current MAT clients at the Muhimbili MAT Clinic who participate in the pilot 
trial. 
 
Note: If you are receiving, accessing, or using data from a U.S. health care provider, the need for 
HIPAA review is likely.  If you plan to bring identifiable health information from a foreign country to a 
U.S. covered entity (e.g., lab at the Hopkins SOM), HIPAA may be triggered.  If either of these 
conditions is met, check “yes” to the HIPAA question in the PHIRST application.   
 
 
2. If you plan to analyze human specimens or genetic/genomic data, provide details about the source 
of those specimens and whether they were collected using an informed consent document.  If yes, 
explain whether your proposed use is “consistent with” the scope of the original consent, if it 
potentially introduces new analyses beyond the scope of the original consent, and/or if it introduces 
new sensitive topics (HIV/STDs, mental health, addiction) or cultural/community issues that may be 
controversial. 
N/A 
 
3. Explain whether (and how) you plan to return results to the participants either individually or as a 
group. 
We will not return the results of these analyses to participants as the data collected will come from 
clinical records and all participants will be clients who receive standard of care and undergo 
standard procedures for detection of drug and alcohol use or low adherence to methadone or ART. 
 
XII. Oversight Plan for Student-Initiated Studies:   
 
 
 
 
 
 
 
A. For student-initiated studies, explain how the PI will monitor the student’s adherence to the IRB-
approved research plan, such as communication frequency and form, training, reporting requirements, 

Page 28 of 32 
 
 
and anticipated time frame for the research.  Describe who will have direct oversight of the student for 
international studies if the PI will not personally be located at the study site, and their qualifications. 
 
      
 
B. What is the data custody plan for student-initiated research?  (Note:  Students may not take identifiable 
information with them when they leave the institution.)   
      
 
XIII. Creation of a Biospecimen Repository:  
 
 
 
 
 
 
Explain the source of the biospecimens, if not described above, and what kinds of specimens will be 
retained over time.  Clarify whether the specimens will be obtained specifically for repository purposes, or 
will be obtained as part of the core study and then retained in a repository. 
 
A. Describe where the biospecimens will be stored and who will be responsible for them. 
      
 
B. Describe how long the biospecimens will be stored, and what will happen at the end of that period. 
      
 
C. Explain whether the biospecimens will be shared with other investigators, inside and outside of JHU, 
how the decision to share will be made, and by whom.  Include your plans, if any, for commercial use.  
Also explain how downstream use of the specimen will be managed, and what will happen to left-over 
specimens.   
      
 
D. Describe whether future research using the biospecimens will include specimen derivation and 
processing (cell lines, DNA/RNA, etc.), genomic analyses, or any other work which could increase risk 
to participants. Explain what additional protections will be provided to participants. 
      
 
E. If future research could yield unanticipated incidental findings (e.g., an unexpected finding with potential 
health importance that is not one of the aims of the study) for a participant, do you intend to disclose 
those findings to the study participant?  Please explain your position. 
      
 
F. Explain whether the specimens will be identifiable, and if so, how they will be coded, who will have 
access to the code, and whether the biospecimens will be shared in linked (identifiable) form. 
      
 
G. Explain whether the repository will have Certificate of Confidentiality protections.  
      
 
H. Explain whether a participant will be able to withdraw consent to use a biospecimen, and how the 
repository will handle a consent withdrawal request. 
      

Page 29 of 32 
 
 
 
 
 
I. Describe data and/or specimen use agreements that will be required of users.  Provide a copy of any 
usage agreement that you plan to execute with investigators who obtain biospecimens from you. 
      
 
 
XIV. Data Coordinating Center:   
 
 
 
 
 
 
 
 
Complete if JHSPH serves as the Data Coordinating Center. 
    
A. How will the study procedures be developed?   
      
 
 
B. How will the study documents that require IRB approval at each local site be developed?  Will there be 
some sort of steering or equivalent committee that will provide central review and approval of study 
documents, or will template consent forms, recruitment materials, data collection forms, etc. be 
developed by and provided to the local sites by the coordinating center without external review?  
      
 
 
C. Will each local clinical site be overseen by its own IRB with an FWA, or will a Single IRB review the 
study?  State whether the coordinating center will collect IRB approvals and renewals from the clinical 
centers; if not, explain why. 
      
 
D. How will the coordinating center provide each local site with the most recent version of the protocol and 
other study documents?  What will be the process for requesting that these updates be approved by 
local clinical center IRBs? 
      
 
E. What is the plan for collecting data, managing the data, and protecting the data at the coordinating 
center?  
      
 
F. What is the process for reporting and evaluating protocol events and deviations from the local sites? 
Who has overall responsibility for overseeing subject safety: the investigators at the recruitment site, 
the Coordinating Center, the Steering Committee, or a Data and Safety Monitoring Board (DSMB)? Is 
there a DSMB that will evaluate these reports and provide summaries of safety information to all the 
reviewing IRBs, including the coordinating center IRB?  Please note that if there is a DSMB for the 
overall study, then the coordinating center PI does not have to report to the coordinating center IRB 
each individual adverse event/problem event that is submitted by the local site PIs. 
      
 
G. Some FDA regulated studies have different AE reporting criteria than that required by the IRB (IRB 
Policy No. 103.06).  How will you reconcile the different requirements, and who is responsible for this 
reconciliation?  

Page 30 of 32 
 
 
 
       
 
H. Who is responsible for compliance with the study protocol and procedures and how will the compliance 
of the local sites be monitored and reviewed?  How will issues with compliance be remedied? 
      
 
XV. Drug Products, Vitamins, Food and Dietary Supplements: 
Complete this section if your study involves a drug, botanical, food, dietary supplement or other product 
that will be applied, inhaled, ingested or otherwise absorbed by the study participants.  If you will be 
administering drugs, please upload the product information. 
 
A. List the name(s) of the study product(s), and the manufacturer/source of each product. 
Name of Study Product 
Manufacturer/Source 
      
      
      
      
      
      
 
B. List each study product by name and indicate its approved/not approved status. 
Approved by the FDA and 
Commercially Available 
Approved by Another 
Gov’t Entity (provide 
name) 
Cleared for Use at Local 
Study Site 
      
      
      
      
      
      
      
      
      
 
C. If your study product has an Investigational New Drug (IND) application through the U.S. Food and 
Drug Administration, provide the IND number, and the Investigators Brochure.  
 
a. Who will hold the IND? 
 
      
 
D. If your study product is a marketed drug, provide the package inserts or other product information.  If 
the study product WILL NOT be used for its approved indication, dose, population, and route of 
administration, provide a detailed rationale justifying the off-label use of the study product.  
 
      
 
E. If the study product does not require FDA approval (e.g., dietary supplements, botanicals, products not 
subject to the U.S. FDA, etc.), provide safety information (as applicable) and a certificate of analysis. 

Page 31 of 32 
 
 
            
 
 
 
 
 
F. Explain who will be responsible for drug management and supply, labeling, dispensing, documentation 
and recordkeeping.  Complete and upload into PHIRST the Drug Data Sheet available on the JHSPH 
IRB website at www.jhsph.edu/irb. 
 
       
 
 
G. What drug monitoring and/or regulatory oversight will be provided as part of the study? Please 
describe.   
 
      
XVI. Medical Devices: 
Complete this section if your study will involve an approved or investigational medical device (diagnostic, 
non-significant risk, significant risk).   
 
      
 
A. List the name(s) of the study product(s), the manufacturer/source of each product, and whether or not it 
is powered (electric, battery).  Provide product information.  If it is electric, upload documentation of 
clinical engineering approval or its equivalent from a local authority, to ensure that the device is in good 
working order. 
 
Name of Study Product 
Manufacturer/Source 
Powered? 
      
      
      
      
      
      
      
      
      
 
B. List each study product by name and indicate its status as approved by a government authority or not 
approved. 
 
Approved by the FDA and 
Commercially Available 
Approved by Another Gov’t 
Entity (provide name and 
approval information) 
Not Approved  
 
      
      
      
      
      
      
      
      
      
 

Page 32 of 32 
 
 
C. If your investigational device is Exempt from the FDA IDE regulations, explain which section of the code 
applies to your device and why it meets the criteria provided.  If it is a diagnostic device, provide pre-
clinical information about the sensitivity and specificity of the test and the anticipated failure rate.  If you 
plan to provide the results to participants or their physicians, justify doing so, and explain how those 
results will validated (or not) against the current “gold standard”.   
 
      
 
D. If you believe the investigational device is not IDE exempt under 21CFR 812.2(c), but is a “Non-
Significant Risk” device considered to have an approved IDE application, provide information from the 
manufacturer supporting that position. 
 
      
 
 
 
E. If you are using an investigational device that is a Significant Risk Device, provide the IDE number 
given by the FDA, or if not under FDA jurisdiction, explain why it is appropriate to use this device in this 
study.  Provide a description of the device, and upload a picture or manufacturing schematics into 
PHIRST.  Provide any other information relevant to a determination of its safety to be used for the 
purposes outlined in this research plan.