Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe
Sponsor: Duke University

8 April 2019 
Approved 1 version date: 30 May 2019 
Approved 1.1 amended version of January 31st 2020 
 
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Study Protocol 
 
 
Submitted to Muhimbili University of Health and Allied Sciences 
(MUHAS) and National Institute of Medical Research – Tanzania (NIMR) 
IRBs (aligns with approved Duke IRB protocol) 
 
Study Title: Family Psychoeducation for adults with psychotic disorders 
in Tanzania (NIMH R34, Baumgartner, PI, NCT04013932) 
 
 
Document Date: Jan 31, 2020 
 
 
 

8 April 2019 
Approved 1 version date: 30 May 2019 
Approved 1.1 amended version of January 31st 2020 
 
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Protocol Title:  
Family Psychoeducation for Adults with Psychotic Disorders in 
Tanzania (Phase Two--Pilot Clinical Trial of the KUPAA intervention) 
 
Study Team: 
 
Tanzanian MUHAS/MNH/MZRH Investigators (Key personnel only) 
 
Name (PI/Co-I) 
Affiliation 
Sylvia Kaaya (site PI & sub-
contracted) 
MUHAS, School of Medicine, Psychiatry & Mental 
Health, Dar es Salaam Tanzania 
Praxeda Swai (Co-I) 
MNH, Psychiatry & Mental Health; Adjunct Lecturer 
MUHAS, Dar es Salaam, Tanzania 
Paul Lawala (Co-I) 
MZRH, Psychiatry and Mental Health, Mbeya, Tanzania 
Carina Maboja 
MNH, Mental Health Nurse Specialist, Dar es salaam, 
Tanzania. 
Liness Ndelwa 
MZRH, Psychiatry and Mental Health, Mbeya, Tanzania 
 
United States, Duke and Columbia Universities Investigators (Key personnel only) 
 
Name (PI/Co-I) 
Affiliation 
Joy-Noel Baumgartner (PI & 
Prime) 
Duke University, Duke Global Health Institute (DGHI) 
Joseph Egger (Co-I) 
Duke University, DGHI 
Ezra Susser (Co-I) 
Columbia University, Department of Epidemiology 
Ellen Lukens (Co-I)  
Columbia University, School of Social Work 
Lisa Dixon (Co-I) 
Columbia University, Medical Center, Division of 
Mental Health Services and Policy Research and Center 
for Practice Innovations 
 
Study Sponsor: 
 
NIMH R34MH106663 mechanism from National Institutes for Mental Health, NIH, US 
Approved Protocol version 1.0 of May 30 2019 revised  
Protocol version 1.1 amended and submitted on January 31 2020 

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Approved 1 version date: 30 May 2019 
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Research Abstract  
 
A major obstacle to care for those living with psychotic disorders such as schizophrenia globally 
is an absence of evidence-based practices appropriate for cultural contexts where resources are 
scarce, families are fundamental for treatment, and where many affected individuals and their 
families hold traditional (i.e. non-biomedical) ideas about the cause of psychosis and seek 
treatment from traditional practitioners. Family psychoeducation (FPE) is an evidence-based 
practice used in high-income countries to help individuals with psychotic disorders and their 
relatives to cope more effectively with the illness; however, FPE has never been tested in a low-
resource country nor have the mechanisms of action for this psychosocial intervention been fully 
identified in any context. KUPAA is a culturally tailored version of FPE. The goal of this study is 
to pilot test KUPAA for adults with psychotic disorders and their relatives. KUPAA, being a 
culturally tailored version of FPE, is appropriate for cultural settings inclusive of both traditional 
and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the 
intervention. Formative research [~80 qualitative interviews] has already been conducted in Phase 
One. This current Phase Two is a small randomized controlled trial (RCT) with 72 patient/relative 
dyads that will test the KUPAA intervention to a) assess the feasibility and acceptability of an 
adapted family psychoeducation intervention for 12 weeks, and b) explore its impact on patient 
relapse, quality of life and disability. This pilot effectiveness trial will adequately prepare us for a 
subsequent NIH R01 submission for a fully powered RCT of KUPAA against the standard of care 
in Tanzania.  
 
Purpose of the Study 
 
While the burden of mental illness in in low- and middle-income countries (LMICs) is now well 
established, there remains a significant treatment gap for mental disorders, particularly for 
psychotic disorders in sub-Saharan Africa1,2,3. However, a major obstacle to care for those living 
with psychotic disorders such as schizophrenia in Africa is an absence of evidence-based practices 
(EBP) appropriate for populations where resources are scarce, families are fundamental for 
treatment, and where many affected individuals and their families hold traditional (i.e. non-
biomedical) ideas about causes of psychosis and seek treatment from traditional healers4-7. Given 
this cultural context, utilizing an EBP developed in a high-income country requires careful 
adaptation and tailoring and a clear understanding of the change mechanisms of the intervention. 
In addition, the implementation of a newly tailored psychosocial intervention must complement a 
country’s existing mental health platform and it must have the potential to reach more individuals 
with psychotic disorders with more effective care and treatment. This study posits that a new 
culturally tailored model of family psychoeducation—KUPAA—has great potential for improving 
the reach, quality, and effectiveness of mental health services for those with psychotic disorders 
in Tanzania and in similar global contexts with some new key features—namely, by using family 
members as co-facilitators for the FamPE group sessions and addressing the traditional beliefs and 
practices of affected individuals and their caregivers within the program.  
 
The study is being conducted in two phases and we are seeking ethical approval for Phase 
Two at this time. [Phase One has Duke eIRB Continuing Review ID CR001_Pro00080044 
and the protocol title is “Family psychoeducation for adults with psychotic disorders in 

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Tanzania (Phase One-­Formative Research)”.  The formative phase addressed Objectives 1 
and 2 from the original NIMH grant.  
 
Phase Two –A pilot clinical trial of the KUPAA intervention addresses Objectives 3 and 4 
from the original NIMH grant.  
 
Primary study objectives 
1)  
To pretest the quantitative patient and caregiver surveys and KUPAA groups to finalize all 
study materials and procedures 
2)  
To pilot test the KUPAA intervention to assess its feasibility and acceptability among both 
patients and caregivers 
3)  
To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life 
and disability 
 
Secondary study objectives 
4)  
To elucidate the mechanisms of action for KUPAA (e.g. hopefulness, self-efficacy) and 
refine the mediation and study outcome measures for a future R01/fully powered clinical 
trial 
 
Background & Significance 
 
Mental Health Services in Tanzania The United Republic of Tanzania has over 45 million people 
and only 0.04 psychiatrists per 100,000 persons in the country8.  With limited human resources, 
outpatient psychiatric services largely focus on medication management while psychosocial 
services are rare. The Tanzanian Ministry of Health, Community Development, Gender, Elderly, 
and Children (MoHCDGEC) endorses mental health services through primary care and it 
recognizes that familial care and support are crucial. Family involvement in psychiatric care is the 
norm in Tanzania and family members’ perception of illness causality greatly influences treatment 
choices including antipsychotic medication adherence9,10.  Likewise, relapse and recidivism (i.e. 
the “revolving door phenomenon”) are unacceptably high among clients of psychiatric services at 
Muhimbili National Hospital (MNH) in Dar es Salaam, Tanzania’s commercial capital. MNH 
offers general mental health education classes on a drop-in basis for outpatients and their families 
waiting to be seen but there are no formal group services for patients. Likewise, at Mbeya Referral 
Hospital, one of four higher level referral hospitals in the country, there are no formal psychosocial 
services beyond ad hoc individual family conferences held for individuals with frequent relapses. 
These health facilities (our study sites) are two of the best public health facilities in the country 
and yet they offer no evidence-based psychosocial services for patients with psychotic disorders. 
KUPAA would complement the existing mental health strategy of the MoHCDGEC and 
potentially reduce relapse and disability and improve social functioning for affected individuals as 
well as reduce familial burden and stigma.  
 

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Family psychoeducation (FPE) is an evidence-based practice developed in high-income countries 
that, among other things, educates affected individuals and their families about mental illness so 
that they may better understand and manage it 11,12.  FPE is a specific type of psychoeducation that 
includes both affected individuals and their family members together and that can be offered in a 
group format with multiple families.  Research shows that critical ingredients for FPE include 
education about the illness, information resources, skills training and ongoing guidance about 
illness management, problem-solving, and social and emotional support13.  FPE is provided in 
three phases: 1) joining sessions; 2) an educational workshop with a standardized curriculum; and 
3) ongoing sessions.  Literature reviews of controlled and comparative clinical trials have shown 
that FPE reduces relapse and re-hospitalization compared to standard services and recent studies 
have found positive effects on the functional aspects of recovery such as employment, and social 
functioning12,13.  Due to the level of evidence, the Schizophrenia Patient Outcomes Research Team 
(PORT) includes FPE in its treatment recommendations14. The multiple family group FPE format 
in particular, could be highly appropriate for cultural contexts such as Tanzania where the vast 
majority of affected individuals live with families, independent living is rare, and problem-solving 
often involves the larger community (i.e. other affected families, clan support/councils).  
Multifamily groups are a specific format that can help address social isolation, stigmatization, and 
psychological burden by strengthening the social support network, providing a forum for mutual 
aid and problem-solving, and increasing hope through mutual example and experience15,16. 
 
The KUPAA study would fill an important research gap given that FPE is being promoted as a 
global best practice without the associated regional evidence or sufficient evidence of the 
underlying mechanisms of action.  Researchers and providers across Africa have discussed the 
need to integrate biomedical and traditional approaches to more effectively treat mental health 
problems, but there is little evidence for how to accomplish this integration17-20. FPE has the unique 
potential to be a culturally relevant and flexible intervention given the program’s design which 
could allow for incorporating multiple perspectives on health and healing.  There is ample evidence 
that culturally centered interventions improve patient outcomes21,22.  We posit that a culturally 
tailored FPE model that explicitly addresses biomedical and traditional perspectives will have a 
positive impact on service engagement and the recovery process for adults with psychotic disorders 
in cultural settings where populations hold traditional beliefs. This research could contribute 
valuable information for U.S. populations who similarly hold traditional beliefs and utilize 
alternative, non-biomedical mental health treatments.  
 
Family Members as Co-Facilitators of KUPAA.   In addition to adapting the educational content 
of the original FPE model, the proposed KUPAA study would be testing a model of FPE whereby 
family members of individuals with psychotic disorders are trained to be co-facilitators of the 
KUPAA groups.  Two facilitators are needed to run groups which can be resource intensive for 
many health facilities in Tanzania. Therefore, using trained and motivated relatives as co-
facilitators would address human resource concerns, but more importantly, there is significant 
evidence of the positive impact of familial peer-support on family outcomes and peer support more 
broadly for affected individuals23-25.  Relative co-facilitators have not been specifically tested for 
the FPE model anywhere globally including the U.S.; however, a recent study in China found that 
family-led peer support groups with psychoeducation content resulted in positive outcomes for 
both patients and families26. In countries where mental health providers are scarce, this model has 
important implications for sustainability. Likewise, in the U.S. where FPE is underutilized and 

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treatment plans for individuals with severe mental illnesses often struggle to engage supportive 
family members, this model of family co-led FPE groups could provide evidence of a new strategy 
for engaging families in care23,27.  
 
Building the Evidence Base for FPE & Mechanisms of Action This project will pilot test a 
culturally tailored FPE model for individuals with psychotic disorders and their relatives in 
Tanzania—KUPAA (which means ‘to soar’ in Swahili). KUPAA will be developed based upon 
the U.S. Department of Health and Human Services Substance Abuse and Mental Health Services 
Administration (SAMHSA) Family Psychoeducation Evidence Based Practice KIT28. The 
educational content delivered in standardized curricula focuses on a biopsychosocial perspective 
for cause, course and management of illness with a few examples of programs that address cultural 
aspects 13,29,30. An adapted FPE model that explicitly incorporates biomedical and traditional 
perspectives could influence the therapeutic efficacy of FPE and lead to better patient outcomes 
compared to usual care31-33. In addition, while some U.S. studies have shown that (biomedical) 
insight into one’s illness is correlated with treatment adherence and illness outcome, there is 
limited and mixed evidence about how helpful insight is for individuals in settings with strong 
traditional ideas about mental illness 34-40. Given the considerable diversity of traditional healing 
practices in Tanzania and globally 9,41, KUPAA would not focus on a particular traditional belief 
or practice, but rather how to address multiple health and healing perspectives into the educational 
component of an evidence-based practice. 
 
There is currently no scientific evidence on the mechanisms of action for FPE in the U.S. This 
pilot study will explore two hypothesized primary mechanisms of action: adherence to 
medication/care plan (treatment engagement enhanced when patients can confide in their dual 
treatment practices) and hopefulness for recovery (resulting in patient resolve to improve 
functional outcomes and familial support). Additional secondary mediators will also be explored.  
 
Design & Procedures   
 
This pilot RCT will determine the feasibility, acceptability, and preliminary efficacy and 
mechanisms of change of our adapted KUPAA intervention. KUPAA has not been previously 
tested in Tanzania, and thus we believe a control group is necessary to determine whether KUPAA 
is a feasible and efficacious alternative to usual care among this patient population. The RCT 
design allows for more formal statistical exploration of hypothesized mechanisms of change. Data 
will be collected at three time points (baseline, 3 months, 6 months), allowing us to assess patient 
and relative outcomes over time and also assess the feasibility of recruiting, enrolling, and 
retaining study participants. The pilot study will inform the R01 by allowing us to implement and 
evaluate our assessment measures, assess the fidelity of KUPAA to core Family Psychoeducation 
elements, assess acceptability among participants and providers, and assess the hypothesized 
direction and strength of potential mediators/moderators of the KUPAA treatment-outcome 
association. 
 

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KUPAA Intervention 
 
The formative research of Phase One (Duke IRB Pro00080044) resulted in a draft manual of the 
KUPAA intervention ready for testing in Phase Two via a randomized pilot clinical trial. KUPAA 
is based on the SAMSHA evidence-based Family Psychoeducation model, culturally adapted and 
tailored for a low-resource setting.  Each KUPAA group will have 6 patients and 6 matched 
relatives plus two co-facilitators (one professional and one trained family caregiver). Professional 
or practitioner facilitators shall include psychiatrists, clinical psychologists, mental 
health/psychiatry nurses and medical social workers with experience in mental health care 
employed at the study facilities.  Trained family caregivers will be co-facilitators and shall a 
task-shifted volunteer who is a primary care giver identified by a client with a psychotic 
disorder who is accessing out-patient care at either the Muhimbili National Hospital in Dar 
es Salaam or the Mbeya Zonal Referral Hospital in Mbeya.  
 
KUPAA is composed of three key services: 
 
1-2 Joining sessions [~30 to 45 minutes each] involve eligible patients and the family member 
or other individual who the patient has selected.  The professional facilitator will meet with the 
patient for the first joining session and then with the selected family member and the patient 
together during the second sessions.  The joining sessions are important because they give the 
facilitator and participant a chance to get to know each other before the KUPAA groups begin.  
They also allow time for the participant and family member to ask questions. The joining sessions 
will focus on the following. 
• A brief review and explanation of the KUPAA model 
• Precipitant of current and/or past acute episodes of illness. 
• Prodromal signs and symptoms. 
• Coping strategies and strengths 
• Family and social support 
• Assess assets and strengths 
• Grief and mourning in relation to the illness 
• Treatment goals and planning 
• Time for the person to ask questions 
 
Educational Workshop [1 day] will involve family members and eligible patients as determined 
by practitioners after the joining sessions. The interactive, one day long, workshop will offer 
information about biological, psychological and social aspects of mental illness; the nature, effects 
and side effects of psychiatric treatments; what families can do to help recovery and prevent 
relapse; and guidelines for managing mental illnesses.  
 
12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-
family groups.  These sessions follow an empirically tested format and focus on solving problems 
that interfere with treatment, illness, and symptoms management and that support coping skills 
and personal care.  Case management may also be provided during the sessions and information 
regarding other mental health resources may also be provided as required by participants. 
 
Study Sites & Standard of Care  

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The study sites will be Dar es Salaam and Mbeya regions in Tanzania and the collaborating 
organization is Muhimbili University of Health and Allied Sciences (MUHAS).   
 
MUHAS is co-located with our first study site, Muhimbili National Hospital (MNH), the national 
referral hospital, in Dar es Salaam with a catchment area of ~4 million people. The Department of 
Psychiatry at MNH provides inpatient and outpatient care, has a bed capacity of 70, and admits 
~3-10 inpatients per day. Staff includes psychiatrists, psychiatric nurses, social workers, 
psychologists and occupational therapists. Clinical staff from MNH and academic staff from 
MUHAS work together per an MOU between these two institutions. All staff participate in 
teaching and clinical activities and almost all participate in research activities. General ad hoc 
drop-in psychoeducation sessions for patients and relatives are conducted before commencement 
of daily clinics and as the need arises. The MNH Department of Psychiatry offers medication 
management to outpatients with psychotic disorders and psychoeducation by nurses/social workers 
who discuss one main topic per month with outpatient attendees. On average, 30 participants 
(mostly patients but also relatives) typically attend these public 30-45-minute sessions and there 
is a question/ answer period for attendees. Educational emphasis is often focused on involving 
patients in activities of daily living with social integration being a key indicator of recovery. Clients 
are also reminded of the importance of follow-up clinics, actions to be taken for missed 
appointments, signs of relapse, and medication side effects and measures to be taken if 
encountered. The sessions are not personalized.  
 
Our second study site is Mbeya Zonal Referral Hospital (MZRH), situated in Mbeya city, 900 km 
from Dar es Salaam and 100 kilometers from the Tanzania- Zambia border. It is the only referral 
facility in the southern part of the country with 8 districts with a total population of ~2 million. It 
is also a referral facility for the neighboring regions. The Psychiatry and Mental Health unit has a 
24-bed capacity with an occupancy rate rarely less than 100%. There are male and female wards 
with 16 and 8 beds, respectively. Major ward rounds are held twice a week and outpatient clinics 
are held three times a week. Department staff include one psychiatrist, general practitioners, 
psychiatric nurses, and social workers. Currently, staff conduct individual family conferences only 
for patients with frequent relapses and more than three admissions in a year. The number of 
conferences ranges from 3-4 per week. There are no regularly offered psychosocial services for 
clients with psychotic disorders. There are 50-60 inpatient admissions per month. 
 
[Note: Records from MNH reveal ~1000 adults hospitalized per year in the Department of 
Psychiatry (~ 1/3 for non-organic psychotic disorders). For MZRH, they admit ~55 new inpatients 
per month (roughly 1/3 for psychotic disorders as well). Outpatient client numbers are much higher 
for both sites.  We anticipate no problems reaching our target sample sizes using these high-volume 
clinic sites.] 
 
At each of the clinical study sites, outpatients attending the psychiatric clinics who have a 
diagnosed non-organic psychotic disorder (each with a matched relative to form a dyad) will be 
recruited into the Pilot RCT.  Outpatient participants will be excluded from consideration if they 
are younger than 18, older than 50, or have a comorbid developmental disorder with cognitive 
impairment that would render them unable to give informed consent.  Individual randomization 
will occur at the site level.  For Dar es Salaam (MNH site), a target of 24 outpatient/relative pairs 

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will be assigned to assigned to KUPAA and 24 outpatient/relative pairs will be assigned the 
standard of care (control group).  For Mbeya (MZRH site), a target of 12 outpatient/relative pairs 
will be assigned to assigned to KUPAA and 12 outpatient/relative pairs will be assigned the 
standard of care (control group).  During recruitment and enrollment, potential study participants 
must agree to be randomized in order to participate in the study.     
 
Pre-testing recruitment and sample size 
 
The site-specific study coordinators and research assistants (RA) will purposely recruit the pre-
testing participants to represent a range of characteristics by age, sex, type of relative/caregiver, 
length of illness as much as feasible. The team will also allow those who self-identify as being 
inter7sted (e.g. patient advocates).  
 
Pre-testing surveys with 40 patient and relative participants  
• 
10 patients + 10 relatives-Dar 
• 
10 patients + 10 relatives-Mbeya 
Pre-pilot KUPAA groups/training & final revision of training tools 
• 
1 group-Dar (~1x/week for 4 weeks) 
o 4-6 patient/relative pairs  
• 
1 group-Mbeya (~1x/week for 4 weeks) 
o 4-6 patient/relative pairs  
 
In order to finalize the KUPAA manual, the team needs real-time feedback on a few KUPAA 
sessions with patients and relatives. Each site will conduct an abbreviated KUPAA intervention 
with up to 4 sessions. KUPAA facilitators and participants will share feedback on the process of 
joining, reception of the educational content, structure of the groups, and other elements of the 
group process with the team as they finalize the logistical details in the manual. Pretesting the 
surveys entails being administered all or parts of the survey and sharing with the interviewer their 
understanding of particular questions as needed.  Pretesting also allows the interviewers to test 
skip patterns, and other logistical issues of administering the survey (flow of sections could be 
revised based on interviewer feedback from pretesting). 
 
The pretesting of the surveys, but not the pre-pilot groups, will be recorded with the permission of 
the participants. Recordings will be transcribed by either study staff at the Tanzania sites fluent in 
Swahili who will transcribe and translate transcripts into English, and/or by a translation service 
hired by the Tanzanian sites. Transcripts will be shared through the project's sensitive Duke Box 
folder. 
 
Pilot Clinical Trial recruitment and sample size 
 
For the pilot randomized clinical trial (RCT), we have a study brochure (attached) that explains 
the study including what it means to be randomized. These brochures will be posted at both study 
sites around the psychiatry departments and pharmacies where patients pick up their medications. 
RAs give also general announcements about the study in the outpatient waiting areas.  During 
enrollment, RAs will be situated onsite at the clinics during busy outpatient clinic hours to identify 
potential participants.  This method has worked for previous research projects between 

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Baumgartner and Kaaya. We estimate that recruitment will take 1-2 months for each site 
concurrently.  
 
To improve the external validity of our pilot RCT findings, we will seek to enroll outpatient 
participants with roughly equal distributions across sex, age group and length of illness. Our RAs 
will keep a roster of the participant IDs with basic demographic data as they recruit so they can 
purposefully recruit a diverse sample representing women/men, younger/older ages, and 
recent/chronic illness.  The KUPAA treatment groups can start with slightly staggered timing as 
the target numbers per group are reached.  (See attached CONSORT flow diagram). 
 
To enhance retention in the pilot RCT, which is critical, we will call and reach out to participants 
on a monthly basis to touch base because the data collection time points are three months apart (0, 
3, 6 months).  “Touching base” would be a very brief phone call to ask the participant if this phone 
number is still valid (it is common in Tanzania to share phones and they may want to designate a 
new primary contact number), if any other contact information (secondary phone numbers, home 
address) has changed, and if they have any questions about the study.  If we are unable to reach a 
person via phone, we may plan a brief home-based outreach visit.  During the informed consent 
process, we ask permission for these additional points of contact to help keep participants engaged 
in the study, particularly the control group who will not be seen as often at the clinics.  In a recent 
NIMH HIV-related randomized trial conducted by Kaaya and Baumgartner in Tanzania, we used 
this monthly reach out method and found it extremely useful for keeping participants engaged in 
the research.   
 
Pilot study participants will be assessed three times: baseline (pre-intervention), at 3 months (end 
of the intervention), and at 6 months (3 months after the intervention). After recruitment but 
prior to the first KUPAA joining session, separate baseline interviews will be conducted with 
outpatients and their matched relatives (N=144; 72 outpatients and 72 relatives). Follow-up 
interviews with participants will be conducted 3 and 6 months later. The 3-month assessment at 
the conclusion of the intervention will include additional focused feedback related to KUPAA 
participation for the treatment group. A research assistant will administer all the patient 
assessments in one session except for the clinician-rated PANSS71 which will be scheduled for a 
separate interview within the same week by a co-investigator (Swai or Lawala) who will have 
received training on its use.  Relative interviews are brief and separately administered. In addition 
to the assessments, facilitators will document KUPAA group attendance and capture qualitative 
notes on participation (ex. whether patients/relatives are speaking/sharing in the group) and group 
dynamics. This information may be useful in assessing qualitative differences in FamPE groups 
and potential for effect measure modification of KUPAA group characteristics on the treatment-
outcome associations, which will be more formally estimated in a future R01 (e.g. potential 
differences by sex in how women and men participate in and benefit from KUPAA). 
 
Selection of Subjects for the Pilot Clinical Trial 
 
We will implement a pilot RCT to determine the feasibility, acceptability, and preliminary efficacy 
and mechanisms of change of our adapted KUPAA intervention. KUPAA has not been previously 
tested in Tanzania, and thus we believe a control group is necessary to determine whether KUPAA 
is a feasible and efficacious alternative to usual care among this patient population. The RCT 

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design allows for more formal statistical exploration of hypothesized mechanisms of change. Data 
will be collected at three time points (baseline, 3 months, 6 months), allowing us to assess patient 
and relative outcomes over time and also assess the feasibility of recruiting, enrolling, and 
retaining study participants.  
 
For the KUPAA pre-testing groups, participants can be more purposefully selected as noted in the 
section “Design & Procedures”.  Criteria for the pilot clinical trial are noted below.  
 
For patients, inclusion criteria are: 
• Attending outpatient psychiatric services at Muhimbili National Hospital or Mbeya 
Referral Hospital.  
• ICD-10 Diagnosis of a non-organic psychotic disorder: 
o F20 Schizophrenia 
o F21 Schizotypal disorder 
o F22 Delusional disorders 
o F25 Schizoaffective disorders 
o Comorbid diagnoses are acceptable for inclusion such as F12.15 ‘Cannabis abuse 
with psychotic disorder’ as long as they have a primary of F20, F21, F22 and F25 
o Because patient record keeping at Tanzanian psychiatric clinics is variable, 
diagnostic eligibility will be confirmed by the core study team (PI-Kaaya; Co-I 
Swai and Co-I Lawala) who are all psychiatrists 
• Age 18-50 at the time of informed consent 
• Hospitalization or relapse (confirmed by attending psychiatrist or medical officer) within 
the past 12 months. Because patient record keeping at Tanzanian psychiatric clinics is 
variable, diagnostic eligibility will be confirmed by the core study team (PI-Dr. Kaaya; Co-
I Dr. Swai and/or Co-I Dr. Lawala) who are all psychiatrists.   
 
For patients, exclusion criteria are: 
• Younger than 18 or older than 50 at time of consenting process 
• F23 Brief psychotic disorder 
• F28 Other psychotic disorder not due to a substance or known physiological condition 
• F29 Unspecified psychosis not due to a substance or known physiological condition 
• Epileptic psychoses 
• Bipolar disorder and mania 
• If initial diagnosis is substance-precipitated psychosis such as “cannabis induced 
psychosis”, patient would have to be reassessed and given a new primary diagnosis if they 
are to be included in the study 
• Co-morbid developmental disorder, dementia, or other severe cognitive deficit that renders 
the individual unable to provided informed consent.  
Eligibility criteria for caregiver/relatives: 
• Age 18 or older at time of consenting process 
• Patient agrees that this person can be their paired partner for KUPAA if the pair is 
randomized to the intervention group 

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• Typically, the caregiver is a relative as these persons usually accompany patients to clinic 
and they represent a range of relationships (parents, siblings, spouses); however, a non-
relative caregiver is also possible (e.g. guardian, close friend with whom outpatient lives)  
 
Randomization will be the responsibility of the Duke team (Baumgartner, Egger and 
Headley).  After a patient participant is enrolled, consented and administered the baseline survey, 
the Tanzania team will communicate the participant's study ID, sex, age, and length of mental 
illness.  Once all patients are enrolled (1-2 months), the Duke team will randomize all patients to 
one of two study arms in equal allocation. Randomization will be stratified by study site and 
patient-level covariates will be used in a minimization randomization procedure to improve 
exchangeability across study arm.  Results of the randomization will then be communicated with 
the patient and their paired relative after randomization and before the start of the KUPAA 
intervention via phone or in person. 
 
 
Subject Recruitment & Compensation 
 
For both study sites (Muhimbili National Hospital and Mbeya Zonal Referral Hospital), study 
brochures will be posted and distributed at their respective Departments of Psychiatry. Site PIs and 
study coordinators are available daily in order to field questions from potential participants.  In 
addition to passive recruitment, the study teams will have the brochures available for outpatient 
services.  If the site PIs (Kaaya, Swai, or Lawala) or site study coordinators (Maboja and Ndelwa) 
identify a potentially eligible participant during the course of their regular clinical duties which 
include outpatient service delivery, they also will share the study information. The local teams will 
review their weekly enrollment logs with the PI during weekly conference calls to assess diversity 
in recruitment.  We will aim for diverse representation focused primarily on patient characteristics 
(age, sex, length of illness) and to a lesser extent type of matched caregiver (parent, sibling, 
spouse/partner).  
 
For the Pilot RCT: At each interview (baseline, 3 months, 6 months), patient and caregiver 
participants will each receive 7,500 Tsh (~USD 3.50). Patient and caregiver participants who are 
randomized to the KUPAA group, will each receive 2,500 Tsh (~USD 1.15) to cover transportation 
each time they participate in a KUPAA session (up to 12 sessions) which will be held at study sites 
(MNH and MZRH). 
 
For the pre-testing activities: For each individual activity (pre-testing or a practice group feedback 
session), participants will be compensated 7,500Tsh (~USD $3.50), as compensation for their time 
and transportation. 
• 
If s/he is only participating in pretesting, s/he will be given 7,500 Tsh. 
• 
If s/he is only participating in the practice group, s/he will be given 7,500 Tsh for each 
session s/he participates in (up to 30,000Tsh total). Refreshments will also be provided. 
• 
If s/he participates in both pretesting the survey and the practice group, s/he will be given 
7,500Tsh for each meeting (up to a total of 37,500Tsh) and be provided refreshments 
during practice group sessions. 

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The payment amounts are established per Tanzania’s National Institute of Medical Research 
(NIMR) guidelines. Each person who provides an informed consent will be given a copy of the 
informed consent form and signed copies will be place in the research file. 
No DUHS subjects will be recruited. 
 
Consent Process 
 
Written informed consent will be obtained from all participants.  
 
Subject’s Capacity to Give Legally Effective Consent 
 
We will necessarily include individuals with psychotic disorders because this project will 
eventually pilot an intervention meant to improve their clinical and social functioning.  We are 
only recruiting adult outpatient participants age 18 or older. All participants with psychotic 
disorders must be stable at the time of the informed consent process as well as later during the 
interviews.  The core clinical members of the study team (three psychiatrists and the psychiatric 
nurse/study coordinator: Kaaya, Swai, Lawala, and Maboja) will be primarily responsible for 
determining whether the participants are stable and have the competence and capacity to consent 
to research participation (i.e. clinically and cognitively able to consent).   
 
As an additional safeguard to ensure that the participants living with psychotic disorders are able 
to give adequate informed consent, our research team will re-read and go over the informed consent 
prior to each follow-up interview (3 and 6 months).   
 
Patients can have a few days to decide whether they want to participate as long as they come back 
to the health facilities and talk to the study coordinator. Most patients typically attend outpatients 
clinics with their relatives about once a month to pick up their medications at the outpatient clinic 
but we will alllow them to come back another time (within two weeks of initial recruitment 
discussion with study coordinator) if they need time to think or to bring in a different relative for 
potential study participation. 
 
The informed consent process is expected to take approximately 20 minutes per person. However, 
a potential patient participant and relative participant pair may prefer to ask questions and discuss 
together since we enrolling pairs, hence, the process could take up to 1 hour. Individual participants 
will be still be given individual time to ask questions and must sign without their respective patient 
and/or relative present in order to avoid undue influence from the other.  Before requesting 
participants' signature on the consent form, the data collectors will make every effort to ensure that 
the participants questions have been answered. 
 
Risk/Benefit Assessment 
 
Potential Risks: There are no physical risks for this psychosocial intervention, but there may be 
some psychological or social risks for participants.  The participants with psychotic disorders may 
feel embarrassed or disturbed by some of the questions regarding their clinical or social 
functioning during the research interviews.  These risks are minimal; however, if a participant at 

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any time feels upset and our specially trained interviewers cannot reassure them, the best available 
psychiatric care and counseling is available through our research sites at any time.   
 
Protections Against Risk: The interviewers will receive special training from the investigators 
regarding special considerations in interviewing about sensitive topics and all interviewers will be 
trained regarding confidentiality issues. For the further protection of participants, highly trained 
supervisors (all of whom currently work in psychiatric services) will supervise a representative 
portion of interviews. Therefore, specially selected, experienced, and highly trained interviewers 
will conduct the interviews. The risk that an interview might be overheard should be minimized 
by the study procedure that specifically requires interviewers to conduct the interview in a room 
or space where there are no other family members present, unless necessary. Likewise, the 
caregiver/relative interviews will be held away from the matched patient participants. For the 
purposes of confidentiality, records of all data will be stored in locked files or rooms. Regular 
training of research personnel about issues of confidentiality helps prevent staff from violating 
confidentiality.  
 
In terms of psychiatric assessment, there is a slight risk that participants might be disturbed by 
questions. Mental health professionals will be available to talk with any individual who expresses 
such concerns. Furthermore, in case there is a danger of harm to self of others, the local PI and the 
two local co-investigators, who are all psychiatrists, will be available to assess and treat as needed. 
 
Potential Benefits of the Proposed Research to Human Subjects and Others: The potential 
benefits to the subjects (particularly for individuals with mental illness as well as their relatives) 
include the opportunity to talk and share their experience with other persons and learn more about 
psychotic illness. The risks to respondents are minimal and the measures to be taken reduce them 
even further. Consequently, we believe that the risk-to-benefit ratio is acceptable. 
 
Importance of the Knowledge to be Gained : The findings will be of great value to Tanzania and 
other settings globally that need evidence-based practices appropriate for populations where 
resources are scarce, families are fundamental for treatment, and where many affected individuals 
and their families hold traditional (i.e. non-biomedical) ideas about causes of psychosis and seek 
treatment from traditional healers. Evidence-based psychoeducation interventions for individuals 
with psychotic disorders and their families are currently missing from the standard of care in 
Tanzania.  
 
Costs to the Subject 
 
There is no cost to the subjects for participation in the study 
 
Data Analysis & Statistical Considerations 
 
The outpatient sample size (N=72: KUPAA intervention, N=36; Control Group N=36) is based on 
the diversity of participants from whom we want information (ex. rural participants from Mbeya 
region; want to recruit both recent and earlier psychosis onset). Data from the patient’s relatives 
(N=72) will be used primarily as covariates or mediators/moderators in statistical analyses and, as 
such, will not contribute to overall statistical power. Per NIMH guidance (PAR-11-278), this pilot 

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study is not powered to estimate precise treatment effects; however, our sample will allow us to 
rigorously assess issues of recruitment, retention, measurement, and working with families. 
Furthermore, we believe that we should, in fact, have reasonably high power to estimate 
preliminary treatment efficacy, as well as to explore the direction and magnitude of potential 
mediators and moderators of the treatment’s effect on study outcomes. For example, assuming we 
have 61 participants for analysis, representing 15% loss to follow-up, we expect 80% power to be 
able to detect a mean difference of 1.8 or larger in a primary outcome (WHODAS), with a two-
sided alpha level of 0.05 and a standard deviation of the mean difference of 2.5 or smaller. In 
assessing the difference in mediating factors, such as medication adherence, we will have 80% 
power to detect a difference in proportions between the treatment and control groups of about 25% 
in medication adherence, with a two-sided alpha level of 0.05 and a control group adherence rate 
of 60%. Power calculations performed using PASS v.1342.  
 
Data Analysis 
Refining measures and evaluating the pilot effectiveness study. The pilot study is a patient-
randomized equal allocation, two-arm parallel group, longitudinal trial. [Note: The analysis plan 
is designed with rigor and with an eye towards transparency for a future R01 RCT trial]. Prior to 
any assessment of change over time in the targeted outcomes, we will investigate the reliability of 
our primary outcome measures. In particular, 1) the internal consistency of multi-item scales, 2) 
measurement invariance across important sub-populations and over time, and 3) stability of 
constructs over the pre-/post-treatment assessment timepoints. These issues will be addressed 
using exploratory and (when appropriate) confirmatory factor analyses for data collected by survey 
instruments over the pre-/post-assessments. We will also provide a quantitative description of 
attrition over the pre-/post-treatment assessments with the aim of identifying the reasons for 
attrition and evaluating possible threats to internal validity of the intervention effect due to 
systematic loss of follow up data. 
 
The primary statistical analysis will be based on intention-to-treat principles; however, we will 
also consider analyses that focus on more restrictive cohorts (e.g., per protocol analysis).43 
Descriptive statistics will be generated to understand the distributional forms of all variables. 
Tabular and crude analysis of the difference in continuous outcomes between treatment and control 
groups at 3 and 6 months will be performed using an independent T-test or Mann Whitney U test. 
Tabular and crude analysis of the difference in 3- and 6-month binary outcomes between 
treatment and control groups will be performed using a Chi-square or Fisher’s exact test. All 
analyses will be performed using SAS Version 9.3 software (SAS Institute, Cary, NC).  
 
Linear and generalized linear mixed modeling will be used to test for differences in Gaussian and 
Bernoulli-distributed mediator and outcome variables, respectively44. This approach has several 
advantages: 1) all available data are modeled, allowing an unequal number of observations for 
different participants; 2) as a consequence, the model provides reliable estimates of the 
intervention effect in the presence of missing data (see below), and 3) it is possible to model and 
estimate variability and correlation structures over time. Models will include parameters to 
estimate the overall FamPE treatment effect, as well as to estimate the partial mediating and 
moderating effects of select covariates.  
 

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Regression-based mediation analysis will be used to estimate the mediating effects of select 
variables on the FamPE-outcome relationship45. This will include separate regression models to 
estimate the associations between FamPE treatment and each outcome, the association between 
FamPE treatment and the mediator, and the additive effect of FamPE treatment and the mediator 
on the outcome.  We anticipate that mechanisms through exposure to the intervention impacts the 
outcome will differ across outcomes measured from patients versus relatives and will explore this 
possibility in our data. Structural equation modeling (SEM) will be used to model more complex 
and dynamic relationships between FamPE treatment, intermediate variables and study 
outcomes46. However, SEM, as well as regression-based mediation and moderation analyses, 
generally have low power to detect these intermediate effects, compared with estimation of direct 
treatment effects. As such, these analyses will be performed, where possible, to estimate the 
general direction and strength of potential mediators and moderators, and results will be used to 
inform analyses in a future R01. Crude analyses and regression models will be performed using 
SAS software. Regression-based mediation analysis and SEM models will be fitted using SAS 
(Proc MIXED/NLMIXED) and M-Plus software (v7.4), respectively. Due to the relatively low 
power for some of the analyses much of what we will learn from this pilot study is not directly 
related to the efficacy of the intervention, but rather is meant to inform a scaled-up impact 
evaluation based on a larger, randomly allocated sample of patients. For example, although the 
purposive, non-probability, sampling of patients might limit generalizability, by insuring that all 
salient dimensions of the population of interest are represented in our small patient sample 
(women/men, Dar/Mbeya, ages 18-34 and 35-50), we will identify critical issues in the recruitment 
and retention of subjects as well as in the measurement of the primary outcomes and hypothesized 
mediators across a potentially heterogeneous population. 
 
Data & Safety Monitoring 
 
NIMH required and has approved a Data Safety and Monitoring Plan (attached/uploaded) to which 
we will adhere. It is inclusive of all study phases—Phase One (formative) and Phase Two (pilot 
clinical trial).  Given that this is a pilot study and for a relatively short time period, NIMH did not 
request a data monitoring committee. 
 
The risks from participation in the study are considered minimal and there are NIH-approved 
procedures in place for communicating and handling any potential adverse events (Data Safety 
and Monitoring Plan). The core study team (PI-Baumgartner, local PIs-Kaaya, Swai and Lawala, 
and study coordinator-Headley, as well as additional team members) have weekly project 
management conference calls where we can discuss and respond to participant concerns or safety 
issues. All study-related communication on unanticipated problems involving risks to subjects or 
others, interim results, protocol modifications and other information that may be relevant to the 
protection of subjects will be discussed on a phone or Skype/Zoom call with the local PI: Dr. 
Sylvia Kaaya. Urgent email communications will be sent out with a read receipt. Any changes to 
study procedures or amendments will be done across all three IRBs (Duke, MUHAS in Dar es 
Salaam, MZRH in Mbeya). 
 
The investigators will make all study related documents, including consent forms, readily available 
for inspection by the study’s IRBs and its authorized site monitors, and the Office for Human 
Research Protection (OHRP). On-site study monitoring will be performed by the study and local 

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PIs or their designees, to verify compliance with human subjects and other research regulations 
and guidelines, assess adherence to the study protocol, and confirm the quality and accuracy of 
information collected and entered into the study database. The study will be conducted in full 
compliance with the protocol. With the exception of modifications required to eliminate immediate 
participant safety concerns, the protocol will not be amended without approval from the study PI. 
 
Role of external (to Duke) personnel 
Duke will partner with investigators from the Muhimbili University of Health and Allied Sciences 
(MUHAS) in Tanzania. The study team at MUHAS is led by Dr. Sylvia Kaaya (site PI) and Dr. 
Praxeda Swai (co-investigator). Dr. Paul Lawala (co-investigator) is based at Mbeya Zonal 
Referral Hospital (MZRH) which has a subcontract with MUHAS as the second site for the 
research. Other personnel at MUHAS include Ms. Carina Maboja (senior community nurse and 
KUPAA facilitator), Joseph Temu (research assistant) and Anna Minja (study coordinator).  Other 
personnel at MZRH include Liness Ndelwa (social worker and KUPAA facilitator) and Eliasa 
Swata (clinical officer and research assistant).  Additional research study staff (TBD) will be hired 
by MUHAS and MZRH to conduct data collection activities as needed. All study staff based at 
MUHAS and MZRH will be trained on the protocol submitted to MUHAS for ethical approval. 
MUHAS (with MZRH) will lead all data collection activities and collaborate with Duke on the 
activities related to intervention implementation, data collection, and data analysis. Additional co-
investigator based at Columbia University (Drs. Ezra Susser, Ellen Lukens and Lisa Dixon) 
contribute technical expertise. 
 
Recruitment and Informed Consent  
All participants (patients, relatives) will provide written informed consent. We will follow local 
regulatory guidelines regarding age of consent for treatment and research which is 18 years old.  
We will seek ethical approvals from MUHAS, MZRH and the NIMR.  
 
For patients and relatives, we will screen individuals who are receiving outpatient services at one 
of two government psychiatric clinics for their interest in participating in the study.  We will also 
approach family members that accompany individuals who are receiving treatment for 
management of psychotic disorders.  
 
All participants will be informed that participation in the study is voluntary.  They will also be 
informed that their current treatment will not be affected if they decide not to participate in the 
study. Only after a patient has agreed to participate and has consented, will their caregiver/relative 
be approached for participation and consented.   
 
Cultural adaptation: The language spoken in Tanzania is Kiswahili. All of our study team is fluent 
in Kiswahili and all interviews and assessments will be conducted in Kiswahili unless a participant 
requests to be interviewed in English.  
 
Voluntary participation: All subjects will be specifically told that their participation is voluntary 
at each step in the protocol. Based on previous research experience in Tanzania, we are aware that 
this needs to be explained carefully and in a way that is culturally sensitive.  
 

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Subjects’ compensation: All subjects will be paid a modest amount (7500Tsh; ~$5) for travel and 
subsistence costs related to their attendance during the study interview only (not for attending 
KUPAA groups).  The payment amount is established per Tanzania’s National Institute of Medical 
Research (NIMR) guidelines. Each person who provides an informed consent will be given a copy 
of the informed consent form and signed copies will be place in the research file. 
 
 
Privacy, Data Storage & Confidentiality   
 
Confidentiality of information collected is of fundamental importance. The research team will be 
trained to adhere to strict confidentiality guidelines. Access to individually identifiable private 
information about human subjects will only be available to the research investigators at the study 
site. Management of data will take place at Muhumbili University of Health and Allied Sciences 
(MUHAS), but de-identified data will be transferred to Duke University. Confidentiality measures 
and protection of data are described below: 
• All interviewers will receive strict instructions about the importance of confidentiality.   
• Unique participant IDs will be used for participants and no names will be used on transcripts.  
• All interviews will be conducted in a private setting that is convenient for the participant; 
sufficient time will be allowed to reschedule interviews. 
• Any digital tape recordings will be stored in a locked cabinet. Recordings will be destroyed 
after being transcribed. 
• Study data will be backed up onto the local PI’s computer on a regular basis. Note that all 
computer terminals used in this project are housed in secure offices, with password protection 
and daily antivirus updates provided by MUHAS. 
• Written notes and transcripts from the Key Informant Interviews will be maintained on a Duke 
password-protected secured Box server and will only be shared with research staff. Audio-
recordings will not be transferred to Duke Box.  Duke Box is a secured version of Drop Box 
software and has multi-factor enabled authentication for added security. 
 
The risks from participation in the study are considered minimal and there are NIH-approved 
procedures in place for communicating and handling any potential adverse events (Data Safety 
and Monitoring Plan). The core study team (PI-Baumgartner, local PIs-Kaaya, Swai and Lawala, 
and study coordinator-Headley) have monitoring calls where we can discuss and respond 
to participant concerns or safety issues. All study-related communication on unanticipated 
problems involving risks to subjects or others, interim results, protocol modifications and other 
information that may be relevant to the protection of subjects will be discussed on a 
phone or Skype call with the local PI: Dr. Sylvia Kaaya. Urgent email communications will be 
send out with a read receipt. Any changes to study procedures or amendments will be done across 
all three IRBs (Duke, MUHAS in Dar es Salaam, MZRH in Mbeya).  
 
 
 
 
 
 
 

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19 
 
 
Illustrative KUPAA Timetable for Education Workshop 
Date 
Time 
Major Activity 
Sub Activities 
Responsible 
person/people 
02/May/2019 
09.00-
09.05 
AM 
 
Introduction and 
getting to know 
one another 
Facilitators introducing themselves  to 
the KUPAA group 
 
Facilitators 
09.05-
09.50 
AM 
KUPAA group Introduction 
- NAMWEZA naming activity 
Participants and 
Facilitators 
Strategy: NAMWEZA 
3.7.5 
09.50-
10.05 
AM 
TEA BREAK 
INSTITUTIONAL 
CATERER 
10.05-
10.35 
AM 
Norms of the 
Group Sessions 
-Facilitators to mind map words respect, 
trust, confidentiality to facilitate and 
guide participants thinking of group 
norms. 
-Facilitators to write the agreed norms on 
a flip chart and keep on board in the 
KUPAA space 
Participants and 
Facilitators 
10.35-
10.50 
AM 
 
Introduction of 
KUPAA 
-Explain the meaning of KUPAA 
-Explain why do we want to introduce 
KUPAA in Tanzania 
Facilitators 
-Mention topics that will be learnt in 
KUPAA sessions 
Facilitators 
10.50-
12.00 
AM 
Psycho 
education on 
Mental Illness 
with Psychosis 
See manual for 
topics to be 
covered  
 
• Definition and causes of mental illness 
• Signs and symptoms of mental illness 
– include residual and prodromal 
symptoms 
• Treatment of mental illness/treatment 
options and anticipated duration for 
symptom control 
• Acknowledging and overcoming the 
implications of grieving associated 
with illness and loss of functioning 
• Acknowledging and overcoming 
stigma towards mental illness 
• Role of alternative healing practices in 
generating hope and healthy 
alternative treatment options. 
• Preventing relapse: Stressors, stress 
prevention and stress management 
• Problem solving  
• Recovery 
 
Facilitators and 
participants Strategies: 
Open discussion 
together, allowing 
participants to share 
experiences associated 
with each topic and 
facilitator to conclude 
after each topic.  

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Date 
Time 
Major Activity 
Sub Activities 
Responsible 
person/people 
12.00-
12.30 
PM 
Any concern 
from the 
participants 
Allow participants: 
-to ask questions; give comments, and 
suggestions 
-Answer questions accordingly 
Facilitators and 
participants 
12.30-
1.30 
PM 
LUNCH BREAK 
INSTITUTIONAL 
CATERER 
1.30 -
2.30 
PM 
Building 
empathy and 
empowering 
group dynamics 
through looking 
at stories in our 
lives that reveal 
our strength and 
competence  
Demonstrate Ability Spotting Exercise (6-
7 minutes) and facilitate participants to 
do “ability spotting” in groups of 3 (6-7 
minutes each x 3 = 20-30 minutes). Finish 
on a positive with every friend wearing a 
chain of abilities, and conclude on 
importance of thinking positively.  
Facilitators and 
participants 
 
Strategy: NAMWEZA 
3.7.1 
2.30 -
3.00 
PM 
Closing and next 
steps 
Break into groups for the next KUPAA 
session and reach agreement on day and 
time for the next and future group 
meetings 
 
Retention strategies: Agree on reminder 
text messages prior to meeting and 
review and confirm correct contact 
mobile phone numbers; Assign “guardian 
angels” during a closing cycle.  
Facilitators and 
participants 
Review session: What went well and what went not so well – List issues for future improvements.  
Preparation for next session: Summarize in one working sheet issues from joining session 1 &2 for the 
six-patient/care-giver dyads (pages 45 - 49 in Manual Version_02_13_03_2019, keeping in mind issues 
agreed NOT to be discussed in MF sessions) in preparation for the first problem solving group session.  
 
 
 
 
 

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