Clinical trial NCT04327843
Conditions: Schizophrenia Medication Nonadherence Schizo Affective Disorder
Keywords: nonadherence Schizophrenia Africa Schizoaffective
Sponsor: Case Western Reserve University
Start date: 2019-11-05; Completion date: 2020-07-30
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The proposed, three phase project will refine and test a first-ever care approach in SSA that combines LAI with a behavioral program specifically intended to promote medication adherence in chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a manualized curriculum that targets specific barriers and facilitators to medication adherence in Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that are available in low-resource settings.

Detailed description:
In this Phase 3 portion, the study team will select appropriate measures, train staff and build capacity in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have had recent medication adherence problems). Taken together, the proposed project has substantial public health importance. It will provide the prerequisite materials, training and infrastructure needed for a prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in Sub-Saharan Africa.

The focus of this project is on feasibility, patient acceptability, and research capacity-building. Therefore a specific hypothesis is not being tested. The investigators will assess descriptive statistics and change from baseline in the primary and secondary measures using standard pre-post techniques.

Arms: arm 1: Customized Adherence Enhancement (CAE) + Long-Acting Injectable Antipsychotic (LAI)
Interventions: intervention 1: Customized Adherence Enhancement intervention 2: Haloperidol Decanoate
Intervention descriptions: intervention 1: Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L. intervention 2: Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study.

Protocol documents:
ICF_002.pdf: 
UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Qualitative 
Interview
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 1 of 4
Introduction/Purpose
You are invited to participate in a research study. You were chosen as a possible participant for 
this study because you have been diagnosed with a chronic psychotic disorder (CPD) and you 
have missed some of your psychiatric medication doses in the past month.  
Doctors at University Hospitals Cleveland Medical Center (UHCMC) and Case Western Reserve 
University (CWRU) Department of Psychiatry in the US and The Muhimbili University of Health 
and Allied Sciences (MUHAS) in Tanzania want to find out reasons that people do or do not take 
all of their medications for CPD (schizophrenia or schizoaffective disorder).  
This study is funded by the National Institute of Health in the United States. You will be one of 
15 participants enrolled in this research. 
Study Procedures
If you agree to be in the study you will be asked to participate in a one-on-one interview with 
study staff about reasons you do or do not always take your CPD medication.  The interviews 
will be audio recorded, transcribed word for word, and then, if needed, translated into English. 
All information that could identify you will be removed.
Risks
The risks to you from participating in this research study include possible discomfort from 
thinking about your mental and physical health during the survey.  You will be allowed to skip 
any questions that you do not want to answer.  
The greatest risk is to your privacy. However, your results will be recorded and kept in a 
confidential manner and will only be available to study staff.
Benefits
There are no direct benefits to you by your participation in this study. Your participation in this 
study may aid in our understanding of the best treatments for those with CPD disorder that have 
difficulty sticking with treatment.
Alternatives to Study Participation
You may choose to not take part in this study.
Financial Information
You will receive TSh. 23,000 for completing the interview.  
There is no cost to you or your insurance for participation in this research study.
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Qualitative 
Interview
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 2 of 4
Confidentiality
We will do everything we can to keep your personal information confidential. Your name or any 
other information that could directly identify you is replaced with a “code.” A list linking your code 
to your name is kept by the original researchers. This coding makes it harder for other people to 
find out who you are. 
Your personal information may be disclosed if required by law. No publication of this study will 
use your name or identify you personally.
People who may review your records include: The Muhimbili University of Health and Allied 
Sciences (MUHAS) and/or University Hospitals Cleveland Medical Center Institutional Review 
Board, Ethics Committee, other local regulatory agencies, National Institutes of Health, Office 
for Human Research Protections, study staff, study monitors, and their designees. 
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  
If injury occurs as a result of your involvement in this research, medical treatment is available 
from the Muhimbili National Hospital or another medical facility but you/your medical insurance 
will be responsible for the cost of this treatment.  A research injury is an injury that happens as 
a result of taking part in this research study.  If you are injured by a medical treatment or 
procedure that you would have received even if you were not in the study, that is not considered 
a “research injury”.  There are no plans for payment of medical expenses or other payments, 
including lost wages, for any research related injury.  To help avoid injury, it is very important to 
follow all study directions.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA 
might inspect your records. In addition, for treatment studies, the study sponsor and possibly 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Qualitative 
Interview
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 3 of 4
foreign regulatory agencies may also review your records. If your records are reviewed your 
identity could become known.
Contact information
________________________________________ has described to you what is going to be 
done, the risks, hazards, and benefits involved. The Principal Investigator Dr. Jessie Mbwambo 
can also be contacted at +255 754 339 747. If you have any questions, concerns or complaints 
about the study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- 
related injury; or other human subject issues, please call the Directorate of Research and 
Publications, at 2152489 or write to: Directorate of Research and Publications, P.O. Box 65001, 
Dar es Salaam.
Signature
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you.
x
Signature of Participant                                                                                           Date
x
Printed Name of Participant
If participant does not have the capacity to consent and protocol is approved for inclusion
x
Signature of Legally Authorized Representative (LAR) or Next of Kin                  Date
x
Printed name of Legally Authorized Representative (LAR) or Next of Kin                  
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Qualitative 
Interview
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 4 of 4
If Next of Kin, please mark ONE relationship from list below (in descending order of priority): 
Spouse
Adult 
Child
Custodial 
Parent
Adult 
Sibling
Adult relative (related by 
blood or adoption)
Study personnel (only individuals designated on the checklist may obtain consent)
x
Signature of person obtaining informed consent                                                    Date
x
Printed name of person obtaining informed consent 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021

Prot_SAP_000.pdf: 
 
Project Title: Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY) 
 
Principal Investigators: Jessie Mbwambo MD and Martha Sajatovic MD 
Co-Investigators: Carol Blixen PhD, Sylvia Kaaya MD, Catherine Kahabuka PhD, and Jennifer 
Levin PhD 
Protocol Version Date:  January 7, 2019 
 
Overview: Antipsychotic medication is a critical component of treatment for individuals with chronic 
psychotic disorders (CPDs) in conjunction with psychosocial approaches that support patients and 
families. Unfortunately, poor medication adherence is common, impedes recovery and increases burden. 
In Sub-Saharan Africa (SSA), poor adherence is seen in approximately half of individuals with CPD and 
is a major driver of relapse (6-10). Care approaches that promote adherence, take advantage of existing 
resources and which can be readily scaled and implemented in SSA settings, have the potential to greatly 
advance care and reduce the burden of CPD. 
The burden of CPD in Africa: In SSA, brain disorders are the most disabling conditions among 
people ages 10–44 (11-12). CPD causes symptoms such as hallucinations, delusions, disorganized 
communication, poor planning, and reduced motivation. Quality of life is impaired and personal and 
occupational goal attainment is sub-optimal. Care for CPD includes both psychosocial and pharmacologic 
interventions (i.e. antipsychotic drugs) along with ongoing monitoring of health status (13). This may be 
challenging in resource-limited settings where staff are sparse and/or undertrained. Importantly, forecasts 
of mental health human resource demands predict continued deficits compounded by increasing disease 
burden (14).  
CPD relapse results in hospitalization, treatment resistance, and cognitive impairment due to 
progressive structural brain damage (15). The limited number of CPD relapse studies done in Africa 
suggest that co-morbid depression, poor medication adherence, and side-effects are the factors most 
likely to increase relapse (16). A Tanzanian study found that people with CPD and their caregiver’s 
perceived non adherence to antipsychotic medication as a leading risk factor of relapse (10).   
Medication adherence is sub-optimal; use of long-acting injectable antipsychotic (LAI) 
medication may help maintain adherence: The link between poor adherence and relapse is well known 
(17-21). Even gaps in medication treatment as short as 1-10 days can double the risk of relapse (22). 
Additionally, poor adherence imposes a large economic burden both on patients’ families (23) and society 
in general (17, 24-25). Poor adherence risk factors include younger age, poor insight, negative attitude 
towards medications, shorter duration of illness, poor therapeutic alliance and poor social support (6, 26-
29). In SSA, poor adherence in CPD is a substantial problem. A Nigerian study found non-adherence rates 
in the order of 35% - 56% (7-9,30).  
Because a major obstacle to medication adherence in CPD is difficulty with consistent medication 
routines (2,31), LAI can be an attractive treatment option for some individuals. LAI can be administered 
monthly or even less frequently (newer drug formulations can even be given every 3 months), eliminating 
the daily need to take medications, which in itself can be a stigmatizing behavior (32).  But, medication in 
itself is unlikely to modify long-term attitudes and behaviors.  LAI is not a stand-alone care approach for 
CPD  (5,33).  
Health workers in mental health and primary care settings can promote adherence, support 
patients and families: Nurses and social workers play a key role in monitoring patient progress and 
facilitating long-term treatment adherence in CPD. A cross-sectional survey of 4120 nurses from Europe, 
the Middle East and Africa (34) found that nurses perceived 54% of patients to be at least partially non-
adherent. Most nurses (90%) reported experience with administration of LAI, with 24% administering >10 
injections per month. The majority (85%) of nurses believed that improving adherence would improve 
patient outcomes. Nearly half (49%) reported that most of their patients depend on a family member 
caregiver to remind them to take their medication. Most nurses (92%) felt that ensuring continuous LAI 
would yield long-term benefits for patients.  
In spite of the fact that both LAI and health workers who can promote CPD recovery are available 
in resource-poor settings, there are few widely used care approaches that combine LAI with a 
complementary psychosocial approach (35).  In SSA, the need for effective adherence promotion 
approaches is even greater considering the common oral medication “stock-outs,” high-levels of stigma 


 
and limited resources to quickly intervene when individuals with CPD skip medication and begin to 
experience signs of relapse.  
In summary, given the extensive burden of CPD in Sub-Saharan Africa, and serious 
consequences of poor adherence, care approaches that are brief, practical and customized for 
the care setting have potential to be a game-changer for individuals with CPD. With adherence 
appropriately addressed, care focus can shift to long-term recovery and social integration.  
 
Purpose: 
Overview: The proposed, three phase project will refine and test a first-ever care approach in SSA that 
combines LAI with a behavioral program specifically intended to promote medication adherence in 
chronic psychotic disorders (CPDs). In addition to the novel focus, innovative elements include: 1.) a 
manualized curriculum that targets specific barriers and facilitators to medication adherence in 
Tanzanians with CPD, 2.) targeting known, high-risk individuals with CPD (those who miss ≥20% of 
prescribed antipsychotic medication, and 3.) using existing injection clinic health workers to deliver the 
adherence promotion program. Strengths include the highly generalizable methods and use of LAIs that 
are available in low-resource settings.  
 
Aim 1: To conduct a mixed-method (quantitative + qualitative) analysis in 100 individuals with CPD to 
better understand antipsychotic use, adherence barriers and adherence attitudes in Tanzania. Phase 1 
methods will include quantitative evaluation of adherence barriers and reasons for non-adherence among 
individuals with CPD who have been recently hospitalized with relapse related to sub-optimal adherence. 
The quantitative adherence evaluation will build upon a standardized adherence vulnerabilities screen 
developed at CWRU for use in homeless people with schizophrenia/schizoaffective disorder. Qualitative 
assessment (individual interviews with patients, focus groups with families/support persons) will elicit 
information from stakeholders (persons with CPD, family, support persons) on preferred approaches to 
deliver adherence promotion interventions 
Aim 2: After completion of the Aim 1 assessments, the study team will adapt a successful CPD 
adherence enhancement approach (Phase 2) based upon findings from Phase 1. Like the original CAE-
L program, the intervention will be described in a detailed manual /curriculum that will facilitate future 
broad-scale dissemination. 
Aim 3: In Phase 3/Aim 3, the study team will select appropriate measures, train staff and build capacity 
in measure implementation, and finalize the intervention for delivery by healthcare workers. Finally, in a 
training/proof-of-concept exercise, the healthcare workers will implement the adapted CAE-L in a high-
risk sample of Tanzanians with CPD (individuals with schizophrenia or schizoaffective disorder who have 
had recent medication adherence problems). Taken together, the proposed project has substantial public 
health importance. It will provide the prerequisite materials, training and infrastructure needed for a 
prospective trial in reducing CPD burden and improving brain health in Tanzania and other countries in 
Sub-Saharan Africa. 
 
Study Design:   
Phase 1 
In Phase 1/Aim 1 the investigators will implement a mixed-methods (quantitative + qualitative) adherence 
assessment battery that will identify salient barriers to treatment adherence in people with CPD. Data 
collection and procedures will follow those previously successfully used by this team. Qualitative 
assessment will be conducted using a combination of individual and group-format methodologies. A 
“deliverable” of Phase 1 will be a summary report that describes barriers and facilitators to treatment for 
CPD from the perspective of patients, families and care providers. 
 
Quantitative assessment: Drawn from iterative pilot work (32,36 40-41), CAE is flexibly delivered as a 
series of up to 4 treatment modules whose use is determined based upon an individual’s reasons for 
non-adherence (adherence barriers) identified at baseline. The modules are Psychoeducation focused 
on medication and consequences of missing medication, Modified Motivational Enhancement Therapy 
(MET) to address non-adherence related to substance use, Communication with Providers to facilitate 
appropriate treatment expectations and optimize management of feared or experienced side effects, and 
Medication Routines intended to incorporate medication-taking into lifestyle. Prior to delivering CAE, 


 
adherence barriers are evaluated with two standardized measures, the Rating of Medication Influences 
(ROMI) (42) and the Attitudes toward Mood Stabilizers Questionnaire (AMQ)(43-44). To better 
understand adherence barriers in the proposed setting, the ROMI and AMQ will be administered to 100 
individuals with schizophrenia or schizoaffective disorder who self-report missing 20% or more of 
antipsychotic medication within the last month, an established benchmark for poor adherence (35). 
Patients will be ≥ age 18 with schizophrenia or schizoaffective disorder. 
Patients will be recruited from Muhimbili National Hospital and its associated ambulatory clinics. 
Additional information will include demographic and clinical characteristics relevant to CPD relapse. 
Adherence assessments will include the Tablets Routines Questionnaire (TRQ) (46-47) and the Drug 
Attitude Inventory (DAI) (48). CPD symptoms will be assessed with The Brief Psychiatric Rating Scale 
(BPRS) (50). Global psychopathology will be measured with the Clinical Global Impressions (CGI) (51). 
Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale 
(SOFAS) (52), Substance use will be measured with the Alcohol Use Disorders Identification Test 
(AUDIT) (53) and Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (54). 
 
Qualitative assessment: The study team will conduct individual interviews of patients with CPD and focus 
groups with family members and with healthcare workers. The qualitative sample will be derived from 
Phase 1 quantitative survey participants and target a representative sample with respect to age and 
gender. Family members will be those of enrolled Phase 1 patients with CPD. Focus groups and 
interviews will use an adapted semi-structured guide used in NIH-funded trials conducted by Drs. 
Sajatovic & Blixen. Consistent with the focus on broad generalizability to CPD in SSA, only individuals 
who are unable to provide informed consent will be excluded. Qualitative methods and thematic analysis 
will follow procedures outlined in previous work conducted by this team (55-57). 
Focus group format: Up to 16 adult (≥ age 18) family members of individuals with CPD will be invited to 
participate in 2 focus groups conducted by Dr. Kahabuka and trainees at the Tanzania site. Family 
members will all have regular contact with patients (contact a minimum of 3 days/week). Family member 
focus groups will comprise 6-10 individuals each, and will last up to approximately 90 minutes. Focus 
groups will be audio-recorded and transcribed verbatim and supplemented with the addition of copious 
field-notes. Up to 16 health workers will be invited to participate in 2 additional focus groups, using similar 
format as the family focus groups. Health workers (nurses, doctors, social workers, pharmacists) will be 
recruited from clinic and hospital-based settings and have experience interacting with patients with CPD. 
Individual interview format: Up to 15 patients with CPD will be interviewed regarding barriers and 
facilitators to medication adherence. Data recording will be the same as with focus groups. 
 
Phase 2 
In Phase 2/Aim 2, informed by the mixed-methods data from Phase 1, the study team will adapt the CAE-
L intervention to be culturally and linguistically appropriate for the Tanzanian setting. The “deliverable” of 
Phase 2 will include a manualized intervention that combines a psychosocial intervention to promote 
adherence + use of LAI. 
 
Phase 3 
In Phase 3/Aim 3, the study team will select appropriate measures, train staff in measure implementation, 
and finalize CAE-L for delivery. Social worker interventionists will be trained to deliver CAE-L. Finally, the 
study will roll-out and evaluate CAE-L in 20 individuals with CPD in a 6-month (25-week) prospective 
training/proof-of-concept exercise. CAE-L will be further refined based upon input from interventionists 
and study participants. The “deliverable” of Phase 3 will include building capacity of a clinical trials 
infrastructure that includes identification of relevant tools/ measures and appropriately trained staff who 
are capable and available to conduct research to improve health outcomes for people with CPD in 
Tanzania. 
 
Phase 3 Study Population:  
The study will enroll 20 adult patients with the following criteria: 
Inclusion Criteria: 
1. Individuals age 18 and older with schizophrenia or schizoaffective disorder.  


 
2. Known to have medication treatment adherence problems as identified by the TRQ (20% or more 
missed medications in past week or past month)  
3. Ability to be rated on psychiatric rating scales.  
4. Willingness to take long-acting injectable medication  
5. Able to provide written, informed consent to study participation.  
 
Exclusion Criteria: 
1. History of allergy or intolerance to haloperidol or haloperidol decanoate. 
2. Individuals on long-acting injectable antipsychotic medication immediately prior to study enrollment.  
3. Medical condition or illness, which in the opinion of the research psychiatrist, would interfere with the 
patient’s ability to participate in the trial.  
4. Physical dependence on substances (alcohol or illicit drugs) likely to lead to withdrawal reaction 
during the course of the study in the clinical opinion of the treated research psychiatrist.  
5. Immediate risk of harm to self or others.  
6. Female who is currently pregnant or breastfeeding. 
 
A Screening Form for each patient will be completed regardless of whether the patient is ultimately 
enrolled. The form will detail reasons for exclusion, allowing an estimate of sample generalizability. All 
study procedures will be conducted at Muhimbili Hospital and its associated ambulatory clinics. 
LAI: Patients on oral haloperidol will be switched to haloperidol decanoate as per manufacturer’s package 
insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a 
different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of 
oral haloperidol 2-5 mg twice daily. If the OTT suggests good tolerability, the participant will then receive 
LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will 
be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the 
CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 
mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although 
dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 
injections during the study.  
Concomitant treatments: Stable dose psychotropic drugs (> 30 days of previous use) other than 
antipsychotics will be continued. New psychotropic medications will be strongly discouraged. Medications 
for side effects may be given at the discretion of the treating psychiatrist and their use will be recorded. 
CAE: CAE targets key areas relevant to adherence in CPD: 1.) inadequate understanding of mental 
disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers 
and 4.) substance use which interferes with adherence and recovery. CAE delivered components are 
selected based upon findings from the ROMI and AMQ. Additional adherence barriers relevant to 
Tanzanians with CPD and the intervention and assessment tools will be adapted accordingly. CAE will 
be delivered in approximately 8 sessions by a social worker interventionist, ideally at the same time that 
LAI is administered. 
Study Measures: Baseline information will include previous illness history including duration of psychiatric 
illness, past hospitalizations, suicide attempts, medication treatment history and cumulative medical 
burden as evaluated by the self-reported Charlson Index. Table 1 illustrates Phase 3 schedule of 
procedures. Primary outcomes will be change on TRQ and mean LAI injection frequency. Secondary 
outcomes will include additional information on adherence attitudes (DAI), CPD symptoms (BPRS, CGI), 
and Social functioning (SOFAS). The Alcohol, Smoking and Substance Involvement Screening Test 
(ASSIST) and Alcohol Use Disorders Identification Test (AUDIT) (53) will assess substance use. All 
outcome assessments will be conducted at study baseline, Week 13, and at Week 25 follow-up. 
Safety/Laboratory Evaluations: Safety evaluations will include basic laboratory evaluations (serum 
comprehensive metabolic panel, lipid profile, CBC with differential, and HIV as well as urine pregnancy 
testing for women) and EKG. Patient vital signs and weight will be collected at each study visit. 
Standardized measures of extrapyramidal symptoms will be assessed with the Extrapyramidal Symptoms 
Scale-Abbreviated version (ESRS-A). Finally, reported side effects will also be evaluated at each study 
visit using a standardized form developed in the CAE-L studies conducted at CWRU 
 
Study Procedures:  Procedure timing is outlined in “Table 1: Phase 3 Schedule of procedures.” 


 
 
Phase 3 Study Measures: 
Baseline information will include previous illness history including duration of psychiatric illness, past 
hospitalizations, suicide attempts, medication treatment history and cumulative medical burden as 
evaluated by the self-reported Charlson Index. Table 1 illustrates Phase 3 schedule of procedures. 
Primary outcomes will be change on TRQ and mean LAI injection frequency. Secondary outcomes will 
include additional information on adherence attitudes (DAI), CPD symptoms (BPRS, CGI), and Social 
functioning (SOFAS). The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and 
Alcohol Use Disorders Identification Test (AUDIT) (53) will assess substance use. All outcome 
assessments will be conducted at study baseline, Week 13, and at Week 25 follow-up. 
 
Primary Outcome: 
 
Treatment adherence behavior will be evaluated with the self-reported Tablets Routine Questionnaire 
(TRQ) and adherence with regular LAI injections.  The literature on measurement of treatment 
adherence, including the PI’s work in this area (Sajatovic 2004, Sajatovic in Press-a, Colom 2005) 
recommends multiple-method assessments to fully characterize treatment adherence. A total combined 
adherence score (proportion of medications taken out of total medications prescribed) will be calculated 
as an average of the TRQ values of all orally-prescribed medications.  LAI injection frequency will also 
be assessed.   
 
The Tablets Routine Questionnaire:  (TRQ) (Scott 2002, Peet 1991) has been noted by other 
investigators to be reliable and appropriate for use in seriously mentally ill populations (Peet 1991, 
Scott 2002). The TRQ determines proportion of prescribed medication taken and is not dependent upon 
timing of medication provided that medication is consumed within the required day/24 hour period. This 
rating has demonstrated statistically significant association with past non-adherence, repeated past 
non-adherence, any non-adherence in the past month, and non-adherence in the past week (X2=7.2, 
df=6, p=.03).  Compared with non-adherence in the past two years, missing 30% or more of prescribed 
mood stabilizers in the past week has a specificity of 100% and a sensitivity of 65%.  Compared with 
non-adherence in the past week, it has specificity of 87% and a sensitivity of 84% (Scott 2002). The 
TRQ format will be modified slightly to document all adherence values (an exact proportion) for each 
item. 
 
LAI Injection Adherence: LAI injection adherence will be determined as a proportion of LAI 
(paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 
days of scheduled time). 
 
Secondary Outcome: 
 
Adherence Attitudes:  The Drug Attitude Inventory (DAI), is used to measure attitudes towards 
medication among individuals with serious mental illness (Awad 1993), and is known to be relatively 
unaffected by psychiatric symptom severity (Sajatovic 2002). The DAI was originally developed to 
assess the attitudes and subjective experience of patients with schizophrenia being treated with 
antipsychotic medications and has also been widely utilized with other seriously mentally ill populations 
receiving psychotropic medication (Sajatovic 2003). The 10-item version of the scale will be utilized 
(Awad 1993). The DAI is a simple, true-false format questionnaire that assesses domains of patient’s 
attitudes including positive and negative experience, locus of control, and attitudes towards health. 
Responses are scored on a euphoric-dysphoric continuum (alpha= 0.93). 
 
Symptoms: Symptoms of schizophrenia and schizoaffective disorder will be addressed using the Brief 
Psychiatric Rating Scale (BPRS) developed by Overall and colleagues (1962).    
 
The BPRS, developed by Overall and Gorham (1962), is a widely used, relatively brief scale that 
measures major psychotic and non-psychotic symptoms in individuals with SMI.   The 18-item BPRS is 


 
well-validated and is perhaps the most researched instrument in psychiatry.  Reliability coefficients are 
reported to be in the range of 0.56-0.87. 
 
Global psychopathology: Global psychopathology will be measured with the Clinical Global 
Impressions (CGI) (Guy, 1976) a widely used scale which evaluates illness severity on a 1 to 7 point 
continuum. Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66 
(Guy, 1976). 
 
Social Functioning: Life and Work Functional status will be evaluated using the Social and 
Occupational Functioning Scale (SOFAS), which is derived from the GAF. The GAF is a 100-point 
single-item scale which measures global functioning of psychiatric patients and is widely utilized in 
clinical studies involving Seriously Mentally Ill patients (Jones, 1995).  The reliability of the GAF ranges 
from 0.62-0.82.  
 
Alcohol and Substance Use: The 10-item version of the Alcohol Use Disorders Identification Test 
(AUDIT) will be used to asses alcohol use (Saunders et al, 1993).  The Alcohol, Smoking and 
Substance Involvement Screening Test (ASSIST) will be used to measure drug use (World Health 
Organisation ASSIST Working Group, 2002). 
 
Health Resource Use: Resources that are typically utilized by the most severely ill individuals with 
schizophrenia include emergency care and hospitalization.  Resource use in the 6-month period prior to 
study enrollment and in the 6-month study period will be evaluated. 
 
Safety/Laboratory Evaluations:  Safety evaluations will include basic laboratory evaluations (serum 
comprehensive metabolic panel, lipid profile, CBC with differential, and HIV as well as urine pregnancy 
testing for women) and EKG.  Patient vital signs and weight will be collected at each study visit. 
Standardized measures of extrapyramidal symptoms will be assessed with the Extrapyramidal Symptoms 
Scale-Abbreviated version (ESRS-A). Finally, reported side effects will also be evaluated at each study 
visit using a standardized form developed in the CAE-L studies conducted at CWRU (Appendix 4) 
 
Other Outcomes of Interest: 
Attitude toward Medication Questionnaire (AMQ): A modification of the Lithium Attitudes Questionnaire, 
the AMQ evaluates an individual’s attitudes towards psychiatric medication.  The AMQ comprises 19 
items grouped into 7 subscales: general opposition to prophylaxis (4 items), denial of therapeutic 
effectiveness (2 items), fear of side effects (2 items), difficulty with medication routines (4 items),  denial 
of illness severity (3 items), negative attitudes toward drugs in general (3 items), and lack of information 
about psychiatric medication (1 item).  Higher scores on each subscale represent more negative 
attitudes toward mood stabilizers.    
 
Rating of Medication Influences (ROMI), is a measure of attitudes towards medication treatment that 
was originally developed for populations with schizophrenia.  For this project we will be using Part II of 
the ROMI, which contains 10 items that directly inquire about influences leading to non-adherence. The 
ROMI has been found to be reliable, clinically sound and valid compared with other independent 
measures of attitudes toward medications and compliance. 
 
Vulnerable populations:  
Pregnant Women 
If a woman becomes pregnant while in the study, the PI will make a clinical decision as to whether the 
study drug will be discontinued based on the risk/benefit ratio for use of that specific drug in pregnant 
women. As with all subjects who discontinue medication early but wish to continue in the study, these 
women will be permitted to complete the CAE sessions and the remaining study visits.  
 
Major psychiatric illness 
Because this is a study evaluating the effectiveness of CAE and long-acting injectable antipsychotic 
medication on people with schizophrenia or schizoaffective disorder, subjects must have been diagnosed 


 
with one of these major psychiatric illnesses to be able to participate. The capacity to which an individual 
within this subpopulation is able to give consent may vary from individual to individual. To acknowledge 
this issue, procedures have been put in place to ensure that each individual is capable of giving signed 
written consent. A witness who is not part of the study team will sign the consent form to ensure that the 
study was thoroughly explained to the participant and that they comprehend the study procedures and 
the associated risks and benefits of participating. Within this subpopulation are also individuals who may 
have a Legally Authorized Representative (LAR). For these individuals, the signed written consent of the 
LAR is required in addition to the individual's signed written consent. If an individual is deemed unable to 
provide signed written consent, they will not be permitted to participate, regardless of the presence of 
signed written consent from the LAR. 
 
Illiterate individuals 
Some participants may be unable to read. In that case the ICF will be read to them in the presence of a 
witness who will co-sign the consent form. 
 
Non-English speaking individuals 
Participants will be residents of Tanzania. All study documents presented to the participants (ICF, 
surveys, flyers, if applicable) will be translated to Swahili; the research personnel at the study site will be 
fluent in the local language. 
 
Plan for Obtaining Informed Consent:   
Once potential participants have been identified, the purpose of the project will be explained to them, and 
consent will be obtained. The languages spoken in Tanzania are predominantly English and Swahili. The 
study team in Tanzania will be fluent in those two languages. The consent forms will be available in both 
English and Swahili, and the study staff will ask the participant about their preference. Potential 
participants will be provided with the written copy of the consent form, and the research staff will ask 
whether the participant has any questions. Individuals with limited literacy may have the consent form 
read aloud to them. Given the known importance of community and family support in this setting, family 
members will be encouraged to participate in the information-sharing and consent process in order to 
allow for patient and family consensus and allow ample opportunity to ask questions and completely 
understand the research project. If the participant agrees to participate, the researcher and participant 
sign the consent form. A copy of the signed consent form will be given to each participant. The research 
assistant will then record that the consent was obtained. 
 
Risks 
Phase 1: Patients will not be compelled to participate in any way in the activities of the project. 
Participants will be free to withdraw from the project at any time without penalty. This study involves 
participating in focus groups, and completing a set of self-report instruments, along with qualitative 
interviews. All instruments have been utilized in outpatient research settings and are not associated 
with risks to patients. The risks to the participants will be primarily those of talking about some matters 
that they may find uncomfortable. Because of the nature of group interaction, patient confidentiality 
cannot be guaranteed however, the importance of respecting other group members’ privacy will be 
stressed to all participants. 
 
Phase 3: 
Risks to taking haloperidol and injectable haloperidol decanoate may include common side effects such 
as drowsiness, reduced motivation or reduced interest in daily activities. Other side effects may include 
dizziness, blurred vision, upset stomach, loss of appetite, headache, drooling, dry mouth, sweating, and 
sleep disturbances. Most of these are transient and subside over time or with dosage adjustment. 
Acute extrapyramidal effects such as muscle rigidity or tremor or shaking may occur in some 
individuals. Other involuntary movements such as tardive dyskinesia can occur with haloperidol or 
haloperidol decanoate, but are generally associated with longer-term use. Since haloperidol is already 
the most commonly used antipsychotic medication at the Tanzania site, it is expected that most staff 
will be familiar with potential adverse effects. Potential risk of medication-related side effects will be 
minimized in several ways, including: 1.) use of OTT to ensure that participants do not have allergy or 


 
intolerance to haloperidol. Individuals who fail OTT will not receive LAI 2.) use of lowest effective 
dosage, 3.) regular monitoring for side effects using a standardized tool and assessment at all clinical 
visits, and 4.) use of agents to manage side effects as appropriate. Blood draw: Risks from taking blood 
samples and/or receiving the medication injection include fainting, discomfort, bruising, or infection at 
the blood sample puncture site. Use of staff with expertise in phlebotomy, infection control and 
intramuscular injection will minimize adverse effects of blood draws. 
Changing from one antipsychotic to another: Stopping an antipsychotic medication may cause a return 
of some symptoms that were under control. For example, stopping antipsychotics may cause insomnia 
(difficulty sleeping), or the appearance of abnormal muscle movements. 
The study doctor may be able to give participants medicine to help control these symptoms. 
CAE: The behavioral intervention intended to enhance adherence is not generally known to increase 
risk to individuals. 
 
Benefits 
There may be several potential benefits to the participants. Participants being interviewed may find it 
helpful to discuss their experience. Some participants may benefit from participation in the sessions 
and from receiving LAI. There is no guarantee of benefits to any participants. However, haloperidol is 
an evidence-based treatment for CPD and it is expected that at least some patients may experience 
symptom reduction. It is the goal of this project to contribute knowledge, which can be useful in 
improving treatment adherence in participants with CPD. It will be explained to participants that their 
participation in the study may not benefit them in any way but may be of benefit to other patients in the 
future. 
 
Data and Safety Monitoring Plan 
Tanzanian investigators and research staff will be responsible for all on-site stages of the project: 
recruiting and consenting participants, conducting the surveys, focus groups and interviews during 
Phase 1, and conducting all study assessments during Phase 3. They will be responsible for all data 
collection. Management of data will take place at the Muhimbili Hospital site, but de-identified data will 
be transferred to CWRU. CWRU will conduct quantitative data analysis. 
The data and safety monitoring plan for this project consists of two components, as outlined below. The 
contact PI (Dr. Martha Sajatovic) in coordination with the Tanzanian site PI (Dr. Jessie Mbwambo) will 
be responsible for ensuring that this plan is followed during the course of this study. 
Component 1: Approval from the UHCMC Institutional Review Board (IRB) and from the Muhimbili 
University IRB will be obtained prior to performing any research related to this study and approval will 
be maintained throughout the study period via continuing review. 
Component 2: Dr. Sajatovic & Dr. Mbwambo will co-lead regular research staff meetings to closely 
monitor study start-up and progress, including oversight of staff training and research capacity building. 
These meetings (held via SKYPE conference will be held approximately every other week for the first 3 
months of the project and then at least once a month by web teleconference thereafter. Meeting 
minutes will be sent to all research staff participants. Regularly scheduled conference calls will be 
supplemented by more frequent local meetings and ad-hoc meetings that may be called in the event 
that problems or concerns arise. In addition, there will be 1-2 in-person visits to the sites annually. 
Any adverse or unexpected events will be reported in accordance with local IRB requirements. 
 
Statistical Analysis:   
Phase 1: First, the qualitative team will first independently review each transcript and highlight 
significant statements, sentences, or quotes.  Based on review of the independently derived 
statements, the team will develop consensus-based “clusters of meaning” (58) or relevant “themes and 
categories” (58). Researchers will further read/code each document independently and iteratively until 
no new insights emerge. 
These entries will be elaborated as coding progresses. The qualitative researchers will then construct a 
consensus-based coding dictionary that includes mutually exclusive definitions for each code. This 
coding structure will be reviewed after a preliminary analysis of a sub sample 
of transcripts, and the dictionary will be refined through comparison, categorization, and discussion (59-
60). Then, using data and codes, the qualitative team will create code-based files across all 


 
respondents. The team will further elaborate, refine, and differentiate the codes and identify similarities 
and differences through comparison of respondents. 
 
Phase 3: Quantitative analysis will be limited as the focus is on feasibility, patient acceptability and 
research capacity-building. However, we will assess descriptive statistics and change from baseline in 
the primary and secondary measures using standard pre-post techniques. 


 
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59. Crabtree BF, Miller WL. Doing qualitative research. 2nd edition. ed. Thousand Oaks, Calif.: SAGE; 
1999. xvii, 406p. p. 
60. Moustakas C. Phenomenological Research Methods. Thousand Oaks, CA: Sage Publications Inc.; 
1994. 
61. Green LW, Kreuter MW. Health Program Planning: An Educational and Ecological Approach. 4th 
ed. New York, NY: McGraw-Hill; 2005. 
 


 
Table 1: Phase 3 Schedule of procedures:  
 
Procedure 
Screen* 
V1/ 
Baseline* 
V2/ 
Week 1 
V3/ 
Week 5 
V4/ 
Week 9 
V5/ 
Week 13 
V6/ 
Week 17 
V7/ 
Week 21 
V8/ 
Week 25 
Informed consent/inclusion & exclusion assessment 
X 
 
 
 
 
 
 
 
 
DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder  
X 
 
 
 
 
 
 
 
 
TRQ 
X 
X 
X 
X 
X 
X 
X 
X 
X 
LAI injection frequency 
 
X 
 
 
 
X 
 
 
X 
Demographics 
X 
 
 
 
 
 
 
 
 
Adherence vulnerabilities: ROMI, AMQ 
X 
 
 
 
 
 
 
 
X 
Laboratory testing 
X 
 
 
 
 
 
 
 
X 
EKG 
X 
 
X 
 
 
 
 
 
X 
Physician Exam 
X 
 
 
 
 
 
 
 
X 
Oral Medication Dispensing (if applicable) 
X 
 
 
 
 
 
 
 
 
Adherence attitudes : DAI 
 
X 
 
 
 
X 
 
 
X 
CPD Symptoms: CGI, BPRS 
 
X 
 
 
 
X 
 
 
X 
Health Resource Use 
 
X 
 
 
 
X 
 
 
X 
Social functioning: SOFAS 
 
X 
 
 
 
X 
 
 
X 
Standardized side effects: ESRS-A 
X 
X 
 
 
 
X 
 
 
X 
Alcohol and Drugs: AUDIT, ASSIST 
 
X 
 
 
 
X 
 
 
X 
Height (Screen only), Weight, and blood pressure  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Comorbidity:  Charlson 
X 
 
 
 
 
 
 
 
 
Pt Acceptability & Satisfaction 
 
 
 
 
 
 
 
 
X 
CAE intervention 
 
X 
X 
X 
X 
X 
X 
X 
X 
Injection  
 
X 
X** 
X 
X 
X 
X 
X 
X 
Clinician visit – medication assessment, reported side effects 
 
X 
X 
X 
X 
X 
X 
X 
X 
* Screening and baseline assessments may be completed in a single visit if it is more convenient for the participant 
** May require additional baseline booster injection depending on dosage 

ICF_001.pdf: 
UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Survey
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 1 of 4
Introduction/Purpose
You are invited to participate in a research study. You were chosen as a possible participant for 
this study because you have been diagnosed with a chronic psychotic disorder (CPD) and you 
have missed some of your psychiatric medication doses in the past month.  
Doctors at University Hospitals Cleveland Medical Center (UHCMC) and Case Western Reserve 
University (CWRU) Department of Psychiatry in the US and The Muhimbili University of Health 
and Allied Sciences (MUHAS) in Tanzania want to find out reasons that people are non-adherent 
(do not take all of their medications) for CPD (schizophrenia or schizoaffective disorder).  
This study is funded by the National Institute of Health in the United States. You will be one of 
100 participants enrolled in this research. 
Study Procedures
If you agree to be in the study you will be asked to complete a questionnaire about reasons you 
do not always take your CPD medication.  
Risks
The risks to you from participating in this research study include possible discomfort from 
thinking about your mental and physical health during the survey.  You will be allowed to skip 
any questions that you do not want to answer.  
The greatest risk is to your privacy. However, your results will be recorded and kept in a 
confidential manner and will only be available to study staff.
Benefits
There are no direct benefits to you by your participation in this study. Your participation in this 
study may aid in our understanding of the best treatments for those with CPD disorder that have 
difficulty sticking with treatment.
Alternatives to Study Participation
You may choose to not take part in this study.
Financial Information
You will receive TSh. 23,000  for completing the questionnaire.  
There is no cost to you or your insurance for participation in this research study.
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Survey
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 2 of 4
Confidentiality
We will do everything we can to keep your personal information confidential. Your name or any 
other information that could directly identify you is replaced with a “code.” A list linking your code 
to your name is kept by the original researchers. This coding makes it harder for other people to 
find out who you are. 
Your personal information may be disclosed if required by law. No publication of this study will 
use your name or identify you personally.
People who may review your records include: The Muhimbili University of Health and Allied 
Sciences (MUHAS) and/or University Hospitals Cleveland Medical Center Institutional Review 
Board, Ethics Committee, other local regulatory agencies, National Institutes of Health, Office 
for Human Research Protections, study staff, study monitors, and their designees. 
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  
If injury occurs as a result of your involvement in this research, medical treatment is available 
from the Muhimbili National Hospital or another medical facility but you/your medical insurance 
will be responsible for the cost of this treatment.  A research injury is an injury that happens as 
a result of taking part in this research study.  If you are injured by a medical treatment or 
procedure that you would have received even if you were not in the study, that is not considered 
a “research injury”.  There are no plans for payment of medical expenses or other payments, 
including lost wages, for any research related injury.  To help avoid injury, it is very important to 
follow all study directions.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA 
might inspect your records. In addition, for treatment studies, the study sponsor and possibly 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Survey
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 3 of 4
foreign regulatory agencies may also review your records. If your records are reviewed your 
identity could become known.
Contact information
________________________________________ has described to you what is going to be 
done, the risks, hazards, and benefits involved. The Principal Investigator Dr. Jessie Mbwambo 
can also be contacted at +255 754 339 747. If you have any questions, concerns or complaints 
about the study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- 
related injury; or other human subject issues, please call the Directorate of Research and 
Publications, at 2152489 or write to: Directorate of Research and Publications, P.O. Box 65001, 
Dar es Salaam.
Signature
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you.
x
Signature of Participant                                                                                           Date
x
Printed Name of Participant
If participant does not have the capacity to consent and protocol is approved for inclusion
x
Signature of Legally Authorized Representative (LAR) or Next of Kin                  Date
x
Printed name of Legally Authorized Representative (LAR) or Next of Kin                  
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Survey
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 4 of 4
If Next of Kin, please mark ONE relationship from list below (in descending order of priority): 
Spouse
Adult 
Child
Custodial 
Parent
Adult 
Sibling
Adult relative (related by 
blood or adoption)
Study personnel (only individuals designated on the checklist may obtain consent)
x
Signature of person obtaining informed consent                                                    Date
x
Printed name of person obtaining informed consent 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021

ICF_003.pdf: 
UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Focus Groups
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 1 of 4
Introduction/Purpose
You are invited to participate in a research study. You were chosen as a possible participant for 
this study because you have a family member who has been diagnosed with a chronic psychotic 
disorder (CPD) or because you are a healthcare worker who has experience working with people 
who are diagnosed with CPD.  
Doctors at University Hospitals Cleveland Medical Center (UHCMC) and Case Western Reserve 
University (CWRU) Department of Psychiatry in the US and The Muhimbili University of Health 
and Allied Sciences (MUHAS) in Tanzania want to find out reasons that people do or do not take 
all of their medications for CPD (schizophrenia or schizoaffective disorder).  
This study is funded by the National Institute of Health in the United States. You will be one of 
32 participants enrolled in this research. 
Study Procedures
If you agree to be in the study you will be asked to participate in a focus group lead by study 
staff.  The focus group will have up to 10 participants who are also family members of people 
with CPD or healthcare workers. The focus group will be about identifying reasons people with 
CPD do or do not take their CPD medication.  The group will be audio recorded, transcribed 
word for word, and then, if needed, translated into English. All information that could identify you 
will be removed.
Risks
The greatest risk of participating in this study is to your privacy. However, the recordings will be 
kept in a confidential manner and will only be available to study staff.
Benefits
There are no direct benefits to you by your participation in this study. Your participation in this 
study may aid in our understanding of the best treatments for those with CPD disorder that have 
difficulty sticking with treatment.
Alternatives to Study Participation
You may choose to not take part in this study.
Financial Information
You will receive TSh. 23,000 for attending the group.  
There is no cost to you or your insurance for participation in this research study.
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Focus Groups
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 2 of 4
Confidentiality
We will do everything we can to keep your personal information confidential. Your name or any 
other information that could directly identify you is replaced with a “code.” A list linking your code 
to your name is kept by the original researchers. This coding makes it harder for other people to 
find out who you are. 
We cannot guarantee absolute confidentiality. If you participate in the focus groups, your identity 
will be known by the other participants. Everybody will be asked to respect confidentiality and to 
not share information from the other participants with people outside of the study.
Your personal information may be disclosed if required by law. No publication of this study will 
use your name or identify you personally.
People who may review your records include: The Muhimbili University of Health and Allied 
Sciences (MUHAS) and/or University Hospitals Cleveland Medical Center Institutional Review 
Board, Ethics Committee, other local regulatory agencies, National Institutes of Health, Office 
for Human Research Protections, study staff, study monitors, and their designees. 
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  
If injury occurs as a result of your involvement in this research, medical treatment is available 
from the Muhimbili National Hospital or another medical facility but you/your medical insurance 
will be responsible for the cost of this treatment.  A research injury is an injury that happens as 
a result of taking part in this research study.  If you are injured by a medical treatment or 
procedure that you would have received even if you were not in the study, that is not considered 
a “research injury”.  There are no plans for payment of medical expenses or other payments, 
including lost wages, for any research related injury.  To help avoid injury, it is very important to 
follow all study directions.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Focus Groups
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 3 of 4
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA 
might inspect your records. In addition, for treatment studies, the study sponsor and possibly 
foreign regulatory agencies may also review your records. If your records are reviewed your 
identity could become known.
Contact information
________________________________________ has described to you what is going to be 
done, the risks, hazards, and benefits involved. The Principal Investigator Dr. Jessie Mbwambo 
can also be contacted at +255 754 339 747. If you have any questions, concerns or complaints 
about the study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- 
related injury; or other human subject issues, please call the Directorate of Research and 
Publications, at 2152489 or write to: Directorate of Research and Publications, P.O. Box 65001, 
Dar es Salaam.
Signature
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you.
x
Signature of Participant                                                                                           Date
x
Printed Name of Participant
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Focus Groups
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 4 of 4
Study personnel (only individuals designated on the checklist may obtain consent)
x
Signature of person obtaining informed consent                                                    Date
x
Printed name of person obtaining informed consent 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021

ICF_004.pdf: 
UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 1 of 7
Introduction/Purpose
You are invited to participate in a research study that may help treat your mental illness. You 
were chosen as a possible participant for this study because you have been diagnosed with a 
chronic psychotic disorder (CPD) and you have missed some of your psychiatric medication 
doses in the past month.  If you decide to be a part of this research study, you are giving up 
having your antipsychotic medication selected and having doses adjusted by your own treating 
psychiatrist during the 25-weeks (6 months) of the study.  Your regular clinical provider will 
continue to make decisions about your other medications such as mood stabilizers, 
antidepressants, or other medications intended to treat mental illness.
Doctors at University Hospitals Cleveland Medical Center (UHCMC) and Case Western Reserve 
University (CWRU) Department of Psychiatry in the US and The Muhimbili University of Health 
and Allied Sciences (MUHAS) in Tanzania want to find out how the injectable medication, 
haloperidol 
decanoate 
(Haldol 
Decanoate), 
combined 
with 
Customized 
Adherence 
Enhancement (CAE) psychosocial sessions, affect mental illness relapse and adherence to 
treatment for people with CPD (schizophrenia or schizoaffective disorder).  Haloperidol 
decanoate is a long-acting injectable (LAI) medication and has been approved by the FDA for 
the treatment of CPD.
You will be one of 20 participants enrolled in this research. 
There is a possibility that the research study team may become aware of new findings that may 
affect your willingness to continue participation.  You will be informed of these new findings so 
that you may choose to continue or discontinue your voluntary participation.  
Study Procedures
This study is funded by the National Institute of Health in the United States. The study will include 
answering interview questions, going to CAE sessions, and receiving injections of the psychiatric 
drug haloperidol decanoate for 25 weeks (about 6 months).  
CAE sessions are designed to help you take your medications as prescribed and follow your 
treatment.  CAE topics that may be assigned to you include: understanding your mental disorder, 
medication-taking routines, communication with your doctors and other care providers, and how 
using drugs or alcohol interferes with your treatment and recovery.  During a CAE session, a 
mental health professional will use a treatment manual/guide and ask you questions addressing 
the CAE topic assigned to that particular session.  All CAE sessions will be completed in a series 
of 8 face-to-face sessions with the study counselor over a 25 week (about 6 month) period.  
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 2 of 7
During the study, the Research study counselor will be contacting your current mental health 
providers or will assist in connecting you with a mental health provider if you do not already have 
one, to make sure you can continue your treatment once you have completed the study.
The study also includes an injection (shot) of the LAI haloperidol decanoate at the beginning of 
the study, again one week later (if needed), and then about every 3-5 weeks for 24 weeks for a 
possible total of 8 injections.  The injections and CAE sessions will typically take place during 
the same visits depending on how often you receive your medication shots.
Screening 
If you decide to participate, you will begin the screening period, during which members of the 
research team will interview you using a standard set of interview questions to help decide if you 
qualify for the study.  You will also have your blood drawn (approximately 2-4 teaspoons) for 
routine laboratory tests and will have an electrocardiogram (EKG), which is a painless test that 
measures your heart’s electrical activity.  These tests will be done to make sure you do not have 
any medical problems that could be affected by the study medicine.  If you are not already taking 
oral (swallowing a pill by mouth) haloperidol (Haldol), you will first be started on oral haloperidol 
during the screening period.  The screening visit is expected to last about 120 minutes (2 hours).  
The screening period can last from 1 day up to 3 weeks depending on your situation. You may 
be on oral medication from 3 days up to about 3 weeks depending on your situation.
Assessment Visits and Study Intervention
After the screening period, you will have Visit 1.  Members of the research team will interview 
you again about your symptoms, behavior, treatment, and other parts of your life.  You will be 
assigned to receive one or more CAE categories.  The doctor will perform a physical and 
neurological examination and will review your medical history.  During Visit 1, you will receive 
your first session of CAE and injection of the LAI.  Visit 1 is expected to last about 210 minutes 
(3-1/2 hours).
You will return for CAE sessions, LAI injections, and interviews at Visit 2, Visit 3, Visit 4, Visit 5, 
Visit 6, Visit 7, and Visit 8.  Visits 2, 3, 4, 6, and 7 will last about 90 minutes (1-1/2 hours).  Visit 
5 will last about 130 minutes (about 2 hours) and Visit 8 will last about 210 minutes (3-1/2 hours) 
due to additional tests that are given at both visits and a physical exam, EKG, and blood draw 
at Week 25.
If at any time you decide to drop out or quit from the CAE sessions or the LAI medication 
treatment, we ask that you still complete the rest of the interviews if possible.
Risks
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 3 of 7
The risks to you from participating in this research study include possible discomfort from talking 
about your mental and physical health during the interviews and CAE sessions.  You will be 
allowed to skip any questions that you do not want to answer.  Getting stuck by a needle to draw 
blood is painful; however, this discomfort lasts for only a very short time.  For most people, a 
needle stick to get blood samples do not cause any serious problems; however, rarely they may 
cause bleeding, bruising, discomfort, infections, dizziness, or fainting.
The possible side effects of the medication used in the study are listed below.  We will ask you 
questions about side effects at each visit and you should call the study staff or your regular 
mental health provider if you experience troublesome side effects between visits.  If you appear 
to be having trouble with side effects, the study doctor may adjust the dose of your study 
medication, may give you another prescription to treat the side effects, or in some cases, may 
stop your participation in the injection (shot) part of the study.  You are also free to quit the study 
at any time without penalty.
Risks to taking study medication 
To take the study drug haloperidol decanoate, some of the medicines you now take may have 
to be stopped.  Stopping these medicines may cause a return of some symptoms that were 
under control.  For example, stopping antipsychotics may cause insomnia (difficulty sleeping), 
or the appearance of abnormal muscle movements.  Your study doctor may be able to give you 
medicine to help control these symptoms.
Risks of haloperidol and haloperidol decanoate
Risks to taking haloperidol and injectable haloperidol decanoate may include common side 
effects such as drowsiness, reduced drive or reduced interest in daily activities, reduced interest 
in things around you, and a decrease in your expressed emotions.  Other side effects may 
include dizziness, blurred vision, upset stomach, loss of appetite, headache, drooling, dry mouth, 
sweating, and sleep problems.  Most of these problems go away as your body adjusts to the 
medication.  Serious side effects could include chest pain, aching muscles and joints, unusual 
bleeding or bruising, tremors, and involuntary (without your control) movements.  
A particular type of involuntary movement, known as tardive dyskinesia, usually occurring to the 
face, tongue, or mouth could result from taking certain medicines such as haloperidol or 
haloperidol decanoate.  This serious side effect can result from such medications at a rate of 3% 
to 5% per year for the first five years of treatment and 2% to 3% per year after that.  Tardive 
dyskinesia may go away after stopping haloperidol or haloperidol decanoate, or may become 
permanent even after stopping the medication.  
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 4 of 7
Rare, but very serious side effects from taking haloperidol and haloperidol decanoate could 
include fainting or fast/uneven heartbeat.    
If you experience certain side effects (e.g. tremors, uncontrollable movement) from haloperidol 
or haloperidol decanoate, benztropine may be provided to you by the study doctor.  Side effects 
from benztropine that are common include drowsiness, dry mouth, difficulty passing urine, and 
constipation.  More serious side effects include skin rash, fast or irregular heartbeat, fever, 
confusion, depression, delusions or hallucinations, and eye pain.  If you experience any of these 
serious side effects you should let the study doctor know immediately.
The study drug must be taken only by you.  It must be kept in a safe place out of reach of children 
and other people who cannot read well or understand that they should not take it.
Participation in this study may involve risks that are currently unforeseeable due to the nature of 
this research.  However, if any new risks become known in the future, you will be informed of 
them.  
Reproductive Health/Sexual Activity 
The effects of haloperidol and injectable haloperidol during pregnancy are unknown and there 
is no recommendation by the FDA for use during pregnancy.  If you are a woman and are of 
child bearing age and have not gone through menopause or had a hysterectomy, you will be 
given a pregnancy test at screening and again at week 25 of the study.  If the screening test 
indicates that you are pregnant, you will not be able to be part of the study. If the screening test 
indicates that you are not pregnant, you must agree to use a reliable form of birth control while 
you are in this study.  The research assistant or doctor can give you more information about this 
if you need it.  If you become pregnant during the study, you should report this to the research 
staff as soon as possible.  If you become pregnant or the test at week 25 indicates that you are 
pregnant, you will stop receiving the study injections and your regular mental health provider will 
determine the best medication treatment for you.  You may continue to participate in the 
interviews and CAE sessions if you so choose.   
Benefits
There may be no direct benefit to you by your participation in this study as it is not possible to 
predict that you will have improvement in your symptoms with study medication or CAE sessions.  
Your participation in this study may aid in our understanding of the best treatments for those with 
CPD disorder that have difficulty sticking with treatment.
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 5 of 7
Alternatives to Study Participation
You do not have to take part in this study to be treated for your illness or condition.  The 
medication treatments used in this study are available in the community.  If you decide to be a 
part of this research study, you are giving up the opportunity of having your antipsychotic 
medication selected and having doses adjusted by your own treating psychiatrist during the 25-
week active phase of the study.  Your regular clinical provider will continue to make decisions 
about your other medications such as mood stabilizers, antidepressants, or other medications 
intended to treat mental illness.  If you do not wish to participate in this study your mental health 
provider may decide to treat you with injectable haloperidol decanoate (Haldol Decanoate) or an 
alternative medication such as oral haloperidol (Haldol), aripiprazole (Abilify), paliperidone 
(Invega, Invega Sustenna), molindone (Moban), olanzapine (Zyprexa, Zyprexa Zydis) or others.
Financial Information
You will receive TSh. 23,000 for participating in the Screening and assessment visits.  Therefore, 
you could receive a possible total of TSh. 207,000.  If the doctor decides you need to come in 
between visits, you may receive additional compensation for your time.  
There is no cost to you or your insurance for participation in this research study.
Confidentiality
We will do everything we can to keep your personal information confidential. Your name or any 
other information that could directly identify you is replaced with a “code.” A list linking your code 
to your name is kept by the original researchers. This coding makes it harder for other people to 
find out who you are. 
Your personal information may be disclosed if required by law. No publication of this study will 
use your name or identify you personally.
People who may review your records include: The Muhimbili University of Health and Allied 
Sciences (MUHAS) and/or University Hospitals Cleveland Medical Center Institutional Review 
Board, Ethics Committee, other local regulatory agencies, National Institutes of Health, Office 
for Human Research Protections, study staff, study monitors, and their designees. 
Summary of your rights as a participant in a research study
Your participation in this research study is voluntary.  Refusing to participate will not alter your 
usual health care or involve any penalty or loss of benefits to which you are otherwise entitled.  
If you decide to join the study, you may withdraw at any time and for any reason without penalty 
or loss of benefits.  If information generated from this study is published or presented, your 
identity will not be revealed.  In the event new information becomes available that may affect the 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 6 of 7
risks or benefits associated with this study or your willingness to participate in it, you will be 
notified so that you can decide whether or not to continue participating.  
If injury occurs as a result of your involvement in this research, medical treatment is available 
from the Muhimbili National Hospital or another medical facility but you/your medical insurance 
will be responsible for the cost of this treatment.  A research injury is an injury that happens as 
a result of taking part in this research study.  If you are injured by a medical treatment or 
procedure that you would have received even if you were not in the study, that is not considered 
a “research injury”.  There are no plans for payment of medical expenses or other payments, 
including lost wages, for any research related injury.  To help avoid injury, it is very important to 
follow all study directions.
Disclosure of your study records
Efforts will be made to keep the personal information in your research record private and 
confidential, but absolute confidentiality cannot be guaranteed.  The University Hospitals 
Cleveland Medical Center Institutional Review Board may review your study records.  If this 
study is regulated by the Food and Drug Administration (FDA), there is a possibility that the FDA 
might inspect your records. In addition, for treatment studies, the study sponsor and possibly 
foreign regulatory agencies may also review your records. If your records are reviewed your 
identity could become known.
Contact information
________________________________________ has described to you what is going to be 
done, the risks, hazards, and benefits involved. The Principal Investigator Dr. Jessie Mbwambo 
can also be contacted at +255 754 339 747. If you have any questions, concerns or complaints 
about the study in the future, you may also contact them later.
If the researchers cannot be reached, or if you would like to talk to someone other than the 
researcher(s) about; concerns regarding the study; research participant’s rights; research- 
related injury; or other human subject issues, please call the Directorate of Research and 
Publications, at 2152489 or write to: Directorate of Research and Publications, P.O. Box 65001, 
Dar es Salaam.
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021


UNIVERSITY HOSPITALS 
CLEVELAND MEDICAL CENTER
CONSENT FOR INVESTIGATIONAL STUDIES
(v.09.2016)
Project Title:  Reducing the Burden of Chronic Psychotic Disorders in Tanzania – Phase 3
Principal Investigator:  Dr. Jessie Mbwambo (Tanzania) and Dr. Martha Sajatovic (USA)
                   
Version date 6/1/2017
Page 7 of 7
Signature
Signing below indicates that you have been informed about the research study in which you 
voluntarily agree to participate; that you have asked any questions about the study that you may 
have; and that the information given to you has permitted you to make a fully informed and free 
decision about your participation in the study.  By signing this consent form, you do not waive 
any legal rights, and the investigator(s) or sponsor(s) are not relieved of any liability they may 
have.  A copy of this consent form will be provided to you.
x
Signature of Participant                                                                                           Date
x
Printed Name of Participant
If participant does not have the capacity to consent and protocol is approved for inclusion
x
Signature of Legally Authorized Representative (LAR) or Next of Kin                  Date
x
Printed name of Legally Authorized Representative (LAR) or Next of Kin                  
If Next of Kin, please mark ONE relationship from list below (in descending order of 
priority): 
Spous
e
Adult 
Child
Custodial 
Parent
Adult 
Sibling
Adult 
relative 
(related by blood or 
adoption)
Study personnel (only individuals designated on the checklist may obtain consent)
x
Signature of person obtaining informed consent                                                    Date
x
Printed name of person obtaining informed consent 
    
        IRB NUMBER: 05-17-16.
        IRB APPROVAL DATE: 4/7/2020
        IRB EFFECTIVE DATE: 4/8/2020
        IRB EXPIRATION DATE: 4/6/2021