Feasibility and Acceptability of Critical Time Intervention to Support People With Severe Mental Illness Following Post-acute Hospital Discharge in South Africa
Phase: NA
Conditions: Mental Disorders, Severe
Sponsor: University of KwaZulu

1 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Abbreviated Title: Feasibility of the MhINT Recovery program 
IRB #: BREC/00007597/2024 
Title: Feasibility trial of a health systems strengthening intervention (MhINT Recovery) 
to reduce hospital re-admission following acute psychiatric hospitalization among people 
living with severe mental illness in uMgungundlovu, KwaZulu-Natal 

2 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
TABLE OF CONTENTS 
Table of Contents 
People living with severe mental illness and their caregivers ........................................................... 21 
Health care providers ..................................................................................................................... 22 
Information sheet General- Health Care Workers ............................................................................. 55 
Consent form for service users ......................................................................................................... 58 
Consent form for Healthcare workers ............................................................................................... 69 
Information sheet for Care Givers- Control ....................................................................................... 77 
Information sheet for Care Givers-Intervention ................................................................................. 81 
SCREENING .......................................................................................... Error! Bookmark not defined. 
CONSENT FORM ................................................................................... Error! Bookmark not defined. 
CHART REVIEW - PSYCHOTIC............................................................... Error! Bookmark not defined. 
CHART REVIEW - COMORBIDITIES ........................................................ Error! Bookmark not defined. 
SOCIO-DEMOGRAPHICS ..................................................................... Error! Bookmark not defined. 
ECONOMIC STATUS ............................................................................. Error! Bookmark not defined. 
INTERNALISED STIGMA ........................................................................ Error! Bookmark not defined. 
SUBSTANCE USE ................................................................................. Error! Bookmark not defined. 
HEALTH SERVICE USE .......................................................................... Error! Bookmark not defined. 
HOSPITALISATION HISTORY ............................................................... Error! Bookmark not defined. 
MEDICATION ADHERENCE .................................................................. Error! Bookmark not defined. 
RECOVERY ........................................................................................... Error! Bookmark not defined. 
SOCIO-DEMOGRAPHIC ......................................................................... Error! Bookmark not defined. 
ECONOMIC STATUS ............................................................................. Error! Bookmark not defined. 
OTHER HEALTH CONDITIONS ............................................................... Error! Bookmark not defined. 
HOUSEHOLD CARE COMPETENCY ....................................................... Error! Bookmark not defined. 
HOUSEHOLD FUNCTIONING .................................................................. Error! Bookmark not defined. 
STIGMA BY ASSOCIATION ..................................................................... Error! Bookmark not defined. 

3 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
SOCIAL SUPPORT ................................................................................ Error! Bookmark not defined. 
MEDICATION ADHERENCE .................................................................. Error! Bookmark not defined. 
CAREGIVING BURDEN ......................................................................... Error! Bookmark not defined. 
 

4 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Council for Harmonisation 
Good Clinical Practice (ICH GCP) and the following: 
• United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 
812) 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who 
are responsible for the conduct, management, or oversight of NIH-funded clinical trials 
have completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the Institutional Review Board (IRB) for review and 
approval. Approval of both the protocol and the consent form must be obtained before 
any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. In addition, all 
changes to the consent form will be IRB-approved; an IRB determination will be made 
regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form. 

5 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
1 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS 
 
Title: 
Feasibility 
trial 
of 
a 
health 
systems 
strengthening
intervention (MhINT Recovery) to reduce hospital re-admission
following acute psychiatric hospitalization among people living
with severe mental illness in uMgungundlovu, KwaZulu-Natal. 
Study Description: 
A multilevel health system strengthening intervention, the 
Mental Health Integration program for Psychosis care (MhINT 
Recovery), was co-developed between partners from the 
University of KwaZulu-Natal, the South African Medical 
Research Council, and the Department of Health. The purpose 
of this intervention is to develop mechanisms along the 
cascade of care that can provide psychosocial support to 
people living with severe mental illness following discharge 
from acute psychiatric hospitalization in order to reduce re-
admission rates. The intervention will be tested for feasibility 
using a cluster randomized control trial in the uMgungundlovu 
District, KwaZulu-Natal. 

6 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Objectives: 
The overall aim of this research is to determine the feasibility 
of real-world implementation of a co-produced health system 
strengthening intervention in reducing hospital re-admission 
rates related outcomes among people living with severe 
mental illness following acute psychiatric hospitalization. The 
specific study objectives are as follows: 
Primary outcomes: To test the limited-efficacy of the 
intervention on the following: 
i. 
Re-admission of people living with severe mental 
illness following acute psychiatric hospitalisation 
(primary outcome) 
ii. 
Recovery of people living with severe mental illness 
(secondary outcome) 
iii. 
Internalised stigma of people living with severe mental 
illness (secondary outcome) 
iv. 
Treatment adherence of people living with severe 
mental illness (secondary outcome) 
Secondary outcomes: To assess the feasibility of the 
intervention in terms of its 
i. 
Acceptability to stakeholders; 
ii. 
Demand in the health system; 
iii. Implementation processes; 
iv. Practicality; 
v. 
Adaptation following testing; 
vi. Integration into the health system; and 
vii. Expansion potential of the intervention. 
Endpoints: 
Primary Endpoint: 4 months 
Secondary Endpoints: 4 months 

7 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Study Population: 
86 people living with severe mental illness, as determined 
by the ICD-10 codes in their clinical records (43 
participants in the intervention and 43 participants in the 
control groups); the primary caregivers of participants (86); 
nursing staff at PHC clinics and community health centres; 
nursing staff and mental health professionals in district, 
regional and specialist hospitals. 
Phase or Stage: 
Pilot feasibility trial. 
Description 
Sites/Facilities 
Hospitals: 1 Specialist psychiatric hospital, 1 regional 
hospital, 1 district hospital 
Enrolling Participants: 
PHC facilities: 3 Community Health Centres, 48 Primary 
Healthcare Clinics Describe the study intervention (a.k.a, 
experimental manipulation; hereafter referred to as “study 
intervention”). Include intervention dose (length and 
frequency) and how it will be administered. Include method 
of delivery (e.g., group vs. individual, web-based, etc.). 
Description of Study 
Intervention: 
The intervention consists of training and mentorship of 
healthcare workers on tertiary, secondary, and primary 
levels of care, as well as training and mentorship of 
caregivers of people living with severe mental illness. 
People living with severe mental illness, who have been 
hospitalized following an acute psychotic event, will be 
recruited following stabilization in the medical and 
psychiatric wards of hospitals. Both intervention and 
control groups will be exposed to a hospital-based 
psychosocial rehabilitation program administered by 
hospital nursing and allied staff (depending on hospital 
resources). Once discharged, enhanced linkage to a PHC 
facility will occur, after which PHC nursing staff will monitor 
outpatient care following refresher training in psychiatric 
management. A trained, dedicated community health 
worker (CHW) will use vignette-based psychosocial 
support and psychoeducation materials to provide home 

8 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
support to caregivers and care recipients. The caregiver 
will further be empowered through training, mentorship, 
and a self-directed manual for psychosocial support and 
care of someone living with a severe 
mental illness. 
Study Duration: 
16 months 
Participant Duration: 
4 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

9
Abbreviated Title: MhINT Recovery 
Version Date: August 2025
1.2
SCHEMA
Flow Diagram
Enrollment
<Day 1 – Day 60>
Baseline 
assessment
<Day 1 – Day 60 >
Intervention PHC
<Discharge + 7 
days>
Intervention Household
<Monthly>
Process assessments <Monthly>
Monthly process evaluation interview and observations
Administer study intervention Session 2
Administer study intervention Session 1
Perform baseline assessments
Total N: 86
Pre-screen and enroll potential participants by
inclusion and exclusion criteria
Randomize
Arm 1
N = 43
Arm 2
N = 43

10
Abbreviated Title: MhINT Recovery 
Version Date: August 2025
Final assessments
<Enrolment +4 months>
Final 
Assessments 
Primary Outcome
Secondary
outcomes

11 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
2 
INTRODUCTION 
2.1 
BACKGROUND 
 
People living with serious mental illness (SMI) – “a mental, behavioral, or emotional 
disorder resulting in serious functional impairment, which substantially interferes with or 
limits one or more major life activities” 1 – have, globally, been repeatedly shown to have 
higher rates of excess mortality and reduced life expectancy (estimated at 10-20 years 
less) than the general population 2-4. Individuals with SMI are more likely to die from 
cardiovascular disease 5 6; hospitalized or die from pneumonia, influenza and sepsis 7; 
be diagnosed with infectious diseases such as COVID-19 8 9, tuberculosis 10, and blood-
borne viral infections such as hepatitis B and C 11; and die from unnatural causes such 
as suicide and violent homicide 12. While reasons for these disparities remain empirically 
ambiguous, inequities in healthcare access and delivery – often due to persistent 
program verticalization, pervasive stigma associated with mental illness, the 
consequences and complexities involved in the treatment of mental illness – have been 
pointed out to be major contributing causes 13. While the bulk of evidence of these 
inequities emerged from high-income countries (HICs), limited evidence from low-and-
middle income countries (LMICs) has substantiated these trends, with an Ethiopian 
study suggesting that people with SMI died approximately three decades earlier than the 
general population, mainly due to infectious diseases, suicide, accidents and homicide 
14. In both HIC and LMIC settings, homelessness among individuals with SMI are also 
pervasive, which carries with it a range of aggravating factors 15. In LMIC settings, the 
burden faced by people with SMIs is no doubt compounded by systems that are under-
resourced, hospicentric and crisis-oriented; services with low population coverage; and 
the principal responsibility for care being shared between families and informal, non-profit 
caregivers, with traditional and spiritual health practitioners involved and varying degrees 
16. These are typical features of South Africa’s mental health system where critical gaps 
remain in community-based care for people with SMI despite commendable policy 
reforms 17-19. 
As demonstrated by the deinstitutionalization experiences of the 1980s and 1990s, the 
inadequate contexts of care beyond inpatient facilities often result in the generation of a 
subpopulation of individuals with SMI that are frequently readmitted to hospital settings 
following discharge into community settings 20. Selected studies from South Africa 

12 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
suggest one-year readmission rates of 46% 21 and 66% 22, while a national survey 
suggested an average rate of 24.5% after three months discharged, translating into an 
annual figure of USD112.6 million, accounting for 18% of the country’s total mental 
healthcare expenditure 23. This “revolving door” phenomenon has been an obstinate 
challenge to mental health systems, due a range of multilevel, complex factors. Research 
has suggested that substance use; a history of and high frequency of past acute 
hospitalizations; type of residence; quality of life after being discharged; violence and 
suicidality; familial conflict; family stigma towards mental illness; unmet needs during the 
post-discharge period; social isolation; a sense of community belonging; lapses in post-
discharge consultations; poor support networks; challenging social environments; and 
medication non-adherence could all contribute to frequent acute psychiatric 
rehospitalization 20 24-29. Significantly, in South Africa, pressure to free up psychiatric 
beds in hospitals for acute care has resulted in “crisis discharge”, whereby service users 
are discharged earlier than intended significantly increasing the risk of early re-admission 
30. 
Several critical bottlenecks have been identified that impede recovery post-discharge 
generally viewed in terms of common service user pathways which have been described 
in several descriptive studies 30-39. Individuals who suffer from an acute psychiatric event 
in the community, either at home or in a public space, can be transported to a public 
hospital emergency ward. The mode of transport can depend on the severity and nature 
of the event, as well as on the availability of public resources 19 40. Family and friends may 
bring in less severe cases, while individuals with particularly severe and violent 
psychosis may require policy and/or ambulance assistance. Once the individual arrives 
at the emergency department, an attending physician and nursing staff will proceed to 
stabilize and call for a psychiatric consult (if available). Depending on these 
assessments, the individual will be admitted for a period of 72 hours to be stabilized and 
observed before further actions are taken. Here, a particular bottleneck emerges, 
namely, a chronic lack of beds in public hospitals, no doubt aggravated by COVID-19, 
means that many people with severe mental disorders wait in emergency or general 
medical wards for beds to be vacated before they can be admitted as psychiatric service 
users. Further, a lack of mental health professionals means that in many areas, 
individuals admitted for psychiatric reasons often wait for extended periods before they 
can be assessed, treated, and discharged. A lack of available social workers also means 

13 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
that little to no contact is made with caregivers prior to discharge and a void exists 
between hospital settings and contexts at home, where poor treatment adherence, 
substance abuse, lack of psychosocial support and socioeconomic determinants 
increases the possibility of relapse following discharge. The discharge procedure itself 
involves referring the service user to a clinic near their place of residence (often 
unaccompanied, with no feedback information) from where they will be able to access 
medication and six-monthly assessment for script renewals. While there are non-
governmental organizations (NGOs) that provide limited support in community settings, 
these services are extremely limited and contingent on donor funding. There is 
particularly weak coordination between government departments and NGOs resulting in 
a highly fragmented, inefficient service package for people with severe mental disorders. 
In terms of residential settings, some service users may be accommodated in community 
care centers run by NGOs, though these are mostly in urban locations, poorly regulated 
and poorly funded. Most service users in South Africa contexts receive their basic care 
from family and friends, who often depend on a monthly government disability grant to 
help cover household expenses with little to no support provided to either service users 
or their caregivers. Low levels of mental health literacy remain a crucial barrier to 
treatment adherence in addressing complex needs and recognizing early signs of 
relapse. These issues are illustrated in Figure 1 below: 
 
 
 

14 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Figure 1: Pathway for people with SMIs in South Africa to illustrate rehospitalization cycle 30-39 
The numerous factors that may predict psychiatric rehospitalization following discharge 
can be grouped according to individual vulnerability factors, aftercare-related factors, 
community care and service responsiveness, and contextual factors and social support 
41. Several intervention strategies have been applied to address these factors and 
improve readmission rates, specifically, interventions that focus on 1) the pre-discharge 
period, 2) the post-discharge period, and interventions that attempt to bridge these 
periods 42. In South Africa, transitional interventions of this nature are limited, with 
examples mostly from the Western Cape province. Here, the New Beginnings program 
has shown promise as a model to promote post-acute discharge outcomes 43. Attached 
to Stikland Hospital, New Beginnings is an intermediary, step-down facility focusing on 
psychosocial rehabilitation and can care for 40 patients in step-down or step-up settings. 
Stikland Hospital is tied to several community-based treatment and care programs, 
which includes an Assertive Community Treatment (ACT) team that has shown 
significant reductions in psychiatric readmission rates 44. Despite these promising 
developments, questions remain regarding the feasibility of broader scale-up of 
programs that rely heavily on close participation of mental health specialists. Given South 
Africa’s lack and unequal distribution of mental health specialists 45, the establishment 
of non-specialized community mental health teams (within the Balanced Care Model)46 
based on task-sharing principles, has a potentially good fit with the country’s resources 
and health system structure 17 47-49. In this vein, co-developed, health system 
strengthening along the cascade of care – from hospital to household level – is required 
for optimal reduction of re-admission rates. To date, there has been no significant 
evidence produced for a program that promotes wellbeing, create care capacity and 
prevents hospital readmission, integrated into the health system across secondary, 
primary and community levels. Following a co-creation approach, a comprehensive 
health system strengthening intervention has been developed between the research 
team, and stakeholders from the Department of Health, caregivers and people living with 
severe mental illness. Before embarking on large-scale efficacy testing, it is important to 
first determine the feasibility (which includes limited effectiveness) of this co-created 
intervention. 
 

15 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
 
3 
OBJECTIVES AND ENDPOINTS 
The overall aim of this research is to determine the feasibility of real-world 
implementation of a co-produced health system strengthening intervention in reducing 
hospital re-admission rates related outcomes among people living with severe mental 
illness following acute psychiatric hospitalization. Following Bowen et al.’s feasibility 
framework 50, the study will assess feasibility through measurements of Limited 
Efficiency, Acceptability, Demand, Implementation, Practicality, Adaptation, Integration, 
and Expansion. The specific study objectives are as follows: 
1. To test the limited-efficacy of the intervention on the following: 
v. 
Re-admission of people living with severe mental illness following acute 
psychiatric hospitalization (primary outcome) 
vi. 
Recovery of people living with severe mental illness (secondary outcome) 
vii. 
Internalized stigma of people living with severe mental illness (secondary outcome) 
viii. 
Treatment adherence of people living with severe mental illness (secondary outcome) 
2. To assess the feasibility of the intervention in terms of its 
viii. Acceptability to stakeholders; 
ix. 
Demand in the health system; 
x. 
Implementation processes; 
xi. 
Practicality; 
xii. 
Adaptation following testing; 
xiii. Integration into the health system; and 
xiv. Expansion potential of the intervention. 
 
 
 
 

16 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Change in rate of hospital psychiatric re-
admission among people living with severe 
mental illness, as assessed by medical record, 
at 4 months. 
The proportion of intervention arm 
participants who have not relapsed 
and re-hospitalised for an acute 
psychiatric event within a period of 4 
months since enrolment, compared to 
control 
arm participants, as measured by trial 
monitoring data. 
Main outcome 
Secondary 
Change in recovery score among people 
living with severe mental illness, as assessed 
by the total score on the Recovery 
Assessment Scale – Domains and Stages 
(RAS-DS), at 4 months 
The proportion of intervention arm 
participants who have shown changes 
in recovery scores, as measured by 
the Recovery Assessment Scale – 
Domains and Stages (RAS-DS), 
following an acute psychiatric event 
within a period of 4 months since 
enrolment, compared to control arm 
participants. 
Mediator of main 
outcome 
Change in internalized stigma score among 
people living with severe mental illness, as 
assessed by the total score on the Brief 
version of the Internalized Stigma of Mental 
Illness (ISMI) scale, at 4 months 
The proportion of intervention arm 
participants who have shown changes 
in internalized stigma as measured by 
the Brief version of the Internalized 
Stigma of Mental Illness (ISMI) scale, 
following an acute psychiatric event 
within a period of 4 months since 
enrolment, compared to control arm 
participants. 
Mediator of main 
outcome 

17 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Change in treatment adherence score among 
people living with severe mental illness, as 
assessed by the total score on a tailored 
scale, at 4 months 
The proportion of intervention arm 
participants who have shown changes in 
treatment adherence scores as measures 
by a tailored measure, following an acute 
psychiatric event within a period of 4 
months since enrolment, compared to 
control arm 
participants. 
Mediator of main 
outcome 
Description of stakeholder views regarding 
the acceptability of the MhINT Recovery 
intervention after 4 months of 
implementation 
A qualitative measure of the degree to 
which the MhINT Recovery intervention is 
deemed acceptable to people receiving 
the intervention, their caregivers, 
healthcare workers, managers, and 
policymakers. 
Moderator of 
main outcome 
Description of perceptions of stakeholders 
regarding the demand of the MhINT 
Recovery intervention after 4 months of 
implementation 
A qualitative measure of the degree to 
which the MhINT Recovery intervention 
meets the demands of people receiving 
the intervention, their caregivers, 
healthcare workers, managers, and 
policymakers. 
Moderator of 
main outcome 
Description of perceptions of stakeholders 
regarding the barriers and facilitators of the 
implementation of the MhINT Recovery 
intervention, in terms of the Consolidated 
Framework for Implementation Research 
(CFIR) domains, after 4 months of 
implementation 
A qualitative measure describing barriers 
and facilitators in implementation of the 
MhINT Recovery intervention, in terms of 
the Consolidated Framework for 
Implementation Research (CFIR) domains 
(Inner, Outer, Implementation, 
Innovation, Individual 
and 
Implementation), after 4 months of 
implementation. 
Moderator of 
main outcome 
Description of perceptions of stakeholders 
regarding the practicality of the MhINT 
Recovery intervention, after 4 months of 
implementation 
A qualitative measure of the degree to 
which the MhINT Recovery intervention is 
deemed to be practical by people 
receiving the intervention, their 
caregivers, healthcare workers, 
managers, and policymakers. 
Moderator of 
main outcome 
Description of perceptions of stakeholders 
regarding the degree to which the MhINT 
Recovery intervention can be adapted for 
specific subgroups after 4 months of 
implementation 
A qualitative measure of the degree to 
which the MhINT Recovery intervention 
can be adapted to the needs of different 
subgroups of people receiving 
the intervention. 
Moderator of 
main outcome 

18 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Description of perceptions of stakeholders 
regarding the degree to which the MhINT 
Recovery intervention can be integrated into 
the local health system after 4 months 
of implementation 
A qualitative measure of the degree to 
which the MhINT Recovery intervention is 
perceived to be integrated with the local 
health system. 
Moderator of 
main outcome 
Description of perceptions of stakeholders 
regarding the potential of scaling the MhINT 
Recovery intervention in future, after 4 
months of implementation 
A qualitative measure of the perceived 
potential of the MhINT Recovery 
intervention to be scaled from trial to 
routine and sustained service changes for 
people living with severe mental 
illness. 
Moderator of 
main outcome 
 
4 
STUDY DESIGN 
4.1 
OVERALL DESIGN 
This feasibility study is a multisite randomized control trial with a parallel mixed methods 
process evaluation. Simple randomization will be undertaken by trained research 
assistants with a 1:1 ratio of allocation to intervention (n=43) and control (n=43) groups. 
The following hypothesis applies: 
Re-admission among discharged people living with severe mental illness following acute 
psychiatric hospitalization is statistically significantly lower among participants being 
exposed to an integrated psychosocial support intervention for nine months compared 
to those in a control group. 
 
4.2 
JUSTIFICATION FOR INTERVENTION 
The MhINT Recovery intervention is a multilevel health system intervention, that has 
been co-designed through a human-centered design approach with people living with 
severe mental illness, their caretakers, healthcare workers on community, primary, 
secondary and tertiary levels, managers, and subject experts. The intervention has been 
designed to expose people living with severe mental illness who have been hospitalized 
due to an acute psychiatric event to psychosocial support at critical times of transition, 
from hospital to PHC clinic level, as well in their home environment with their caregivers 
and family. MhINT Recovery has been designed with sustainability and scalability in 
mind, meaning that the focus is largely on using existing service 

19 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
platforms and resources. On hospital level, the psychosocial rehabilitation will be 
delivered by hospital staff, including nurses, allied workers, and medical officers. On PHC 
clinic level, nurses and medical officers will deliver enhanced outpatient services. On 
community level, CHWs will deliver a vignette-based psychoeducation, support and 
monitoring program, while caregivers will be empowered through a self-directed 
household champion program. All intervention implementers will receive face-to-face 
training by a specialist training team in coordination with the DoH Training Unit, with 
additional mentorship and continuous quality improvement (CQI) being provided by a 
field manager. This strategy has been workshopped with the DoH, and has been 
previously successfully been implemented in previous collaborations between UKZN 
and DoH team members. This will result in minimized disruption of daily clinical routines, 
while providing psychosocial support structures at critical levels from discharge 
downward to household level. 
 
4.3 
END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the 
baseline assessment, one post-discharge clinic appointment, monthly clinic and CHW 
outreach visits, process evaluation assessments, and 4-month follow-up assessments. 
 
5 
STUDY POPULATION 
5.1 
INCLUSION CRITERIA 
The inclusion criteria for participation in the study will be as follows: 
Service user inclusion criteria: 
- 
Adults (aged 18 years and above); 
- 
Being admitted to the psychiatric ward of a hospital for observation and treatment due to 
an acute psychiatric event, based on ICD diagnosis on patient charts according to the 
following criteria: 
o F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute 
polymorph psychotic disorders, schizoaffective disorders 

20 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
o F30-39 Mood [affective] disorders with psychoses 
o F30.2 Mania with psychotic symptoms 
o F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms 
o F31.5 Bipolar affective disorder, current episode severe depression with psychotic 
symptoms 
o F32.3 Severe depressive episode with psychotic symptoms 
o F33.3 Recurrent depressive disorder, current episode severe with psychotic 
symptoms 
- 
Determined by the attending psychiatrist to be discharged into community settings 
following appropriate recovery from the psychiatric event; 
- 
Willing and able to participate in the intervention program 
- 
Resides with a caregiver (which could be a family member or member of the household). 
- 
Resides within the geographic boundaries of uMgungundlovu  
Caregiver inclusion criteria: 
- 
Adults (aged 18 years and above) 
- 
Willing and able to participate in the intervention program 
- 
Resides with a caregiver (which could be a family member or member of the household). 
- 
Resides within the geographic boundaries of uMgungundlovu  
 
5.2 
EXCLUSION CRITERIA 
Service user exclusion criteria: 
- 
Under 18 years of age 
- 
Are indicated by their chart history to have the following conditions: 

21 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
o Active suicidal ideation 
o Substance abuse or dependence as primary diagnosed psychiatric condition 
o Personality disorders 
o Serious cognitive or other sensorial impairment likely to preclude informed consent 
and reliable assessment 
- 
Does not reside with a caregiver 
- 
Does not reside within the geographic boundaries of uMgungundlovu 
 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
People living with severe mental illness and their caregivers 
The study aims to reduce re-admission and associated outcomes by improving 
transitional care through health system strengthening. Therefore, the care pathway of 
service users played a role in conceptualizing the recruitment strategy. Recruitment will 
occur at hospital level. Fieldworkers will be stationed in Harry Gwala and Northdale 
Hospitals, where an agreement with hospital management would alert fieldworkers when 
a potential participant has been admitted for an acute psychiatric episode. Once 
informed consent of a service user has been confirmed, the clinical team and service 
user will assist the fieldworker to contact the primary caregiver of the service user in 
order to obtain their consent as well. The fieldworker will request an appointment with 
the caregiver, and will then take them through the information sheet, allow for questions, 
and request informed, written consent for participation. Following successful informed 
consent from both the service user and caregiver, the two parties will receive a number 
in sequence with a pre-randomized worksheet. On an Excel worksheet, cells will be 
numbered from 1 to 86, and will be randomized into two groups, intervention and control. 
The fieldworker will not know prior to assignment which group a participant will be 
allocated to, as the fieldwork manager will check the number assigned to a participant 
pair in the randomization sheet, and will then communicate to the fieldworker which 
group the pair has been assigned to, who in turn will communicate the assignment result 
to the service user and caregiver. Once a service user and their caregiver have been 

22 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
assigned to the intervention group, the intervention will be initiated prior to discharge. 
Health care providers 
Healthcare workers will be invited to participate in a cross-sectional survey, semi-
structured interviews, focus group discussions and participatory workshops. Healthcare 
workers will be identified in consultation with facility management. Healthcare workers 
will be invited to participate in a cross-sectional survey, where, on the hospital level, 
doctors, nurses, social workers, and psychologists routinely working with people living 
with severe mental illness will be invited to participate. On the PHC clinic level, nursing 
staff (including professional and enrolled nurses), Outreach Team Leaders, and CHWs 
in the WBPHCOT working in the specific PHC clinics where the participants have been 
referred to, as well as a similar number of corresponding clinics in the control group, will 
be invited to participate. Eligible health care professionals will be approached by the 
research staff, have the study introduced to them and receive the information sheet. They 
will be given an opportunity to ask questions and to decide whether they choose to take 
part in the research. They will be assured that taking part in the study is voluntary and 
that they can choose to not to take part or to withdraw from the study at any time without 
affecting their work in anyway. If they choose to participate in the study, they will be asked 
to sign voluntarily a consent form. They will be informed that deciding not to participate 
will not affect their performance reviews or prejudice them in any way. Following informed 
and written consent, they will receive a copy of the consent form and a fieldworker will 
administer a questionnaire electronically using a digital capturing device. 
For the qualitative activities, HCWs will be purposively selected from different cadres 
and wards in the hospitals. Semi-structured interviews will be conducted with hospital 
staff and PHC nursing staff, while focus group discussions will be conducted with CHWs. 
Participatory workshops will also be conducted, where invitations will be extended to 
intervention facilities for HCW representatives to attend. Eligible health care 
professionals will be approached by the research staff, have the study introduced to 
them and receive the information sheet. They will be given an opportunity to ask 
questions and to decide whether they choose to take part in the research. They will be 
assured that taking part in the study is voluntary and that they can choose to not to take 
part or to withdraw from the study at any time without affecting their work in anyway. If 
they choose to participate in the study, they will be asked to sign voluntarily a consent 

23 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
form. They will be informed that deciding not to participate will not affect their performance 
reviews or prejudice them in any way. Following informed consent, all activities will be 
audio recorded and transcribed verbatim, translated and back-translated to ensure 
accuracy. 
5.3.1 Costs 
Due to the intervention being embedded in routine health system operations, it is not 
anticipated that participation in the study will lead to any personal financial costs beyond 
what is spent for routine health service visits that would have already been happening. 
Service users in the intervention arm will receive enhanced primary mental health 
services during their monthly clinic visits for their medication, and will additionally be 
visited at home, along with their care givers. All activities introduced as part of the 
intervention arm for healthcare workers, are within their existing scopes of practice and 
responsibilities, thereby minimizing additional workloads. 
5.3.2 Compensation 
Service users and caregivers will each receive R150-00 in grocery store vouchers for 
each data collection event, including for baseline and post-intervention assessments, 
process evaluation interviews and observations, and participatory workshops. This will 
be provided to compensate the participants’ time, inconvenience and expenses. 
Healthcare workers will not receive compensation for participation, in line with DoH 
regulations about receiving payment for research. Workshops will be conducted at 
spaces that are central and relatively reachable by participants, travel will be 
compensated with grocery store vouchers and catering will be provided. 
 
6 
STUDY INTERVENTION 
6.1 
INTERVENTION CONTENT 
The intervention is the product of a human-centered design process, involving a range 
of health system actors and focusing on the pathway of service users from hospital to 
household level following discharge. Specifically, the intervention has been designed to 
target key areas of improvement. A person suffering from a psychotic episode is taken 
to hospital (the bulk at Northdale and Harry Gwala Hospitals), usually by family or 
community members, and sometimes by SAPS. Once admitted, the clinical team 

24 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
(doctors and nurses) will assess the admitted service user, and start a process of 
stabilization. During this period, some service users might have contact with a 
rehabilitation team (made up of social workers, nurses, psychologists). There usually 
also is contact with the family to inform them of the process. Following a period of 
observation and stabilization, the service user will be discharged to a clinic in their 
community, usually into the care of a caregiver. The service user is to present a referral 
form from the hospital to the clinic in order to initiate outpatient treatment. There is little 
to no evidence of follow-up visits from CHWs, who do not have the tools or training to 
undertake home visits. There are also no standardized SOPs for discharge, referral, 
care coordination, outreach, or pharmacy support. Service users receive care in the 
community by and large in terms of monthly treatment visits to the clinic. 
The intervention of this project has been developed following an extensive period of 
formative work and co-creation with the DoH. The intervention aims to enhance service 
user support along the care cascade as follows: 
Hospital level (District, Regional, Specialist): 
• Following hospital admission, the hospital clinical team will follow an SOP to initiate early 
family readiness, by contacting the clinic to which the service user will be referred for 
outpatient care, who in turn will send a trained CHW to the hospital to visit the service user 
with the rehabilitation team. The CHW will, through the rehabilitation team, also make 
contact with the caregiver and conduct a family readiness session. 
• During stabilization, hospital multidisciplinary teams (MDT) and nursing staff will 
initiate a co-developed psychosocial rehabilitation (PSR) program, which will be 
individualized in duration and dose in terms of the intensity of need and length of stay 
(as determined by the attending psychiatrist). 
• Prior to discharge, discharge nursing staff will follow an SOP and checklist that will 
alert the clinic that the service user is about to be discharged, and will ensure that 
appropriate medication is packed and ready. 
PHC facility level: 
• After discharging the service user into the care of a caregiver, the service user will 
be requested to take their referral form to the clinic within six days, after which a 
CHW will be sent to their home to make sure that they are doing well. After receiving 

25 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
the referral form, the clinic will call the discharge team at the hospital to confirm that 
the service user has been logged in the clinic system, and this will be documented 
in a project register. 
Household level: 
• Following discharge, the service user will be visited at their home by a trained, 
project-dedicated CHW, who will provide psychoeducation to both the service user 
and the caregiver, integrated into an existing CHW tool (Community Mental Health 
Education and Detection Tool – CMED). Psychosocial support and education will be 
provided during monthly visits thereafter, and will further include treatment monitoring 
and adherence, and screening for potential early signs of distress that could lead to 
a relapse. If any potential signs of distress emerge, the service user and caregiver 
will be referred to the nurse in the Chronic Stream of the local PHC clinic, who will 
also be provided with a standardized and integrated symptom monitoring checklist. 
Should medicine stock-outs occur, the issue will be fast-tracked to the district 
pharmacist through the District Specialist Team. 
• Additionally, the primary caregiver will receive training and mentorship in a self-
directed psychosocial management manual, as part the DoH Household Champion 
program. This will ensure a supplementary level of support of monitoring of service 
users, as well as providing a degree of support to caregivers. 
• All referrals, both downwards and upwards, are integrated in the new KwaZulu-Natal 
provincial referral policy, which will be enacted through facility SOPs. 
Implementation strategies are as follows: 
Hospital level: 
• A one-day workshop at each hospital, facilitated by an adult education team, 
supported by the DoH Training Unit, aimed at medical officers, MDTs, nursing staff 
who have been nominated by hospital management to participate. Training will 
include an overview and illustrated examples of the PSR, with manuals distributed 
to all participants and wards. 
• A project-dedicated CQI specialist will provide on-going mentorship and support 
during the first three months of recruitment. 

26 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
PHC level: 
• A two-day workshop in the district, at a central venue, to which nurses and operational 
managers of clinics will be invited, facilitated by an adult education team, supported 
by the DoH Training Unit. Training will include an overview and illustrated examples 
of the enhanced APC guidelines, with manuals distributed to all participants and 
clinics. 
• A project-dedicated CQI specialist will provide on-going mentorship and support 
during the first three months of recruitment. 
Community level: 
• Three CHWs will be recruited for the project to carry out the intervention. Recruits 
would need a strong background in mental health and community health settings, 
and will undergo three-day face-to-face training using roleplay and case studies, 
sensitivity training for work involving people living with psychosis, and including how 
to orientate caregivers towards becoming Household Champions. 
• Caregivers will be trained during a one-day contact session at their homes, and be 
provided with an overview of the program and a detailed demonstration of the self-
directed manual. CHWs will continue to support caregivers in day-to-day 
management, and will be available via mobile phone for any support issues. 
• CHWs will be mentored and supported by a CQI specialist to ensure fidelity and 
optimize implementation. 
Additional implementation mechanisms will include posters about service user pathways 
in all participating healthcare facilities, and an overall orientation workshop to all 
stakeholders that will map out activities across levels. Quarterly feedback will be 
provided to facility, subdistrict and district management, as well as to the provincial PHC 
Transformation Committee (an intersectoral governance and policy-making body in 
KwaZulu-Natal). 
 
6.2 
STUDY INTERVENTION ADHERENCE 
Service user adherence and fidelity to the intervention will be monitored and determined 
by the following: 

27 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
• Attending PSR sessions in hospital, the number and duration of which determined 
during the first contact and PSR planning session (project register completed by 
HCWs). 
• Visiting the down referred clinic within 7 days (PHC visitation records) 
• Attending monthly PHC clinic visits for mental health status examinations and 
medication, during the 4-month intervention period (PHC visitation records) 
• Attending monthly CHW outreach visits at home (project register) 
Caregiver adherence and fidelity to the intervention will be monitored and determined by 
the following: 
• Caregivers using the self-directed manual (observations and fidelity checklists) 
HCW adherence and fidelity to the intervention will be monitored and determined 
by the following: 
• Relevant and nominated HCWs on all levels attend all training and engage 
during mentorship and CQI sessions (project registers) 
• Hospital staff implement the PSR program (observations, project registers, 
fidelity checklists) 
• PHC nursing staff employ enhanced APC guidelines (observations, fidelity checklists) 
• CHWs reach out to caregivers for family readiness during hospitalization, provide 
outreach to all intervention households every month over a 4-month period, orientate 
caregivers in the Household Champions program (project registers, observations, 
fidelity checklists) 
 
7 
STUDY INTERVENTION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
Service user participants will have bimonthly access with health services as part of the 
intervention, namely visiting their assigned clinic for routine medication and care, as well 
as CHW visits to their household. Both PHC clinic and household level interventions 
include a level-appropriate mental health status examination, which will be recorded on 
project registers. Should the mental health of a participant decline during these 

28 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
monitoring points, the fieldwork supervisor and PIs will be contacted for further steps. 
Two of the PIs are senior psychologists, and will, in consultation with the DoH District 
Specialist Team for mental health, refer the participant for additional assessment by a 
psychiatrist at Town Hill Hospital. Based on the assessment of the psychiatrist, and in 
consultation with the District Specialist Team, the participant and their caregivers, the 
participant can either continue with additional support and monitoring, or discontinue 
their participation. In the latter case, the participant will be referred to an appropriate 
health service provider based on the psychiatric assessment. 
When a participant discontinues from the intervention but not from the study, remaining 
study procedures will be completed as indicated by the study protocol. If a clinically 
significant finding is identified (including, but not limited to changes from baseline) after 
enrolment, the investigators will determine if any change in participant management is 
needed. Any new clinically relevant finding will be reported as an adverse event (AE). 
The data to be collected at the time of study intervention discontinuation will include the 
following: 
• The reason(s) for discontinuing the participant from the intervention, and methods 
for determining the need to discontinue 
• If the participant is due to complete assessments within 2 weeks of being 
discontinued from the study intervention, those assessments will be administered at 
the time of discontinuation; if the next scheduled assessments are more than 2 
weeks from the discontinuation date, the discontinued participant will wait for the 
next scheduled assessment. Thereafter, the participant will be included in all future 
scheduled assessments, even though not participating in the intervention. 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon 
request. A participant may be discontinued from the study for the following 
reasons: 
• Significant study intervention non-compliance, unless varying compliance is an 
aspect of the study objectives 
• Lost-to-follow up; unable to contact subject 
• Any event or medical condition or situation occurs such that continued collection of 

29 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
follow-up study data would not be in the best interest of the participant or might 
require an additional treatment that would confound the interpretation of the study 
• The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 
• Screen Failure 
• Subject has completed the study follow-up period 
The reason for participant discontinuation or withdrawal from the study will be recorded 
on a Study Case Report Form (CRF). Subjects who sign the informed consent form, and 
are randomized and receive the study intervention, and subsequently withdraw, or are 
discontinued from the study, will not be replaced. 
 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for three 
consecutive scheduled visits and is unable to be contacted by the study site staff. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site will attempt to contact the participant and reschedule the missed visit and 
counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain if the participant wishes to and/or should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee will 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls). These contact attempts should be documented in the participant’s medical 
record or study file. 
• Should the participant continue to be unreachable, he or she will be considered to 
have withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
SCREENING PROCEDURES 
Recruitment of service users will happen in hospital settings, after being admitted and in 
consultation with attending healthcare workers. Following the stabilization period, and in 

30 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
consultation with the clinical team in the medical and psychiatric wards, the eligible, 
stabilized service user be identified by a member of the clinical team based on the clinical 
history and current diagnostic status. If they are eligible according to their clinical profile, 
the service user will be asked by a member of the clinical team if they would be willing to 
meet with a fieldworker regarding a research project. If the service user is willing, a 
trained fieldworker with a BPsych degree and experience in mental health research will 
visit the service user and will be introduced to the research project. They will be provided 
an information sheet, which will be summarized by the fieldworker verbally as well. The 
questions (1) “What is the purpose of the study?” (2) “What are the risks?” and (3) “What 
are the benefits?” will help to determine consent capacity, in line with South African 
psychiatric requirements that “a mental disorder should not prevent a patient from 
understanding what s/he consents to; a mental disorder should not prevent a patient 
from choosing decisively for/against the intervention; a mental disorder should not 
prevent a patient from communicating his/her consent (presuming that at least 
reasonable steps have been taken to understand the patient's communication if present 
at all), and a mental disorder should not prevent a patient from accepting the need for 
intervention”. If consent capability has been determined, the service user will be taken 
step-by-step through the informed consent form, and will be provided with a copy. If 
there is doubt around eligibility and capacity to provide consent, the fieldworker will 
engage with the fieldwork manager and PIs, who will consult the clinical team regarding 
further steps. 
 
8.2 
STUDY EVALUATIONS & PROCEDURES 
 
Service users 
Baseline, 4-month follow-up fieldworker-administered questionnaire 
Measure 
Items Scoring 
Used in 
South 
Africa 
Source 
Demographic background: 
Age, sex, language, housing, 
employment 
5 
Categorical Open answer N/A 
N/A 

31 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Internalised Stigma of 
Mental Illness (ISMI) scale 
(brief version) 
10 
4-point Likert-type scale: 
Strongly disagree, 
Disagree, Agree, Strongly 
agree 
Yes 
Matshabane OP, Appelbaum PS, Faure MC, et 
al. Lessons learned from the translation of the 
Internalised Stigma of Mental Illness (ISMI) 
scale into isiXhosa for use with South African 
Xhosa people with schizophrenia. Transcultural 
Psychiatry. 2023;0(0). 
doi:10.1177/13634615231168461 
Alcohol, Smoking and 
Substance Involvement 
Screening Test (ASSIST) 
(Question 2) 
10 
5-point Likert-type scale: 
Never, Once or twice, 
Monthly, Weekly, Daily or 
almost daily 
Yes 
Adlard RJ, Roos T, Temmingh H. Alcohol, 
Smoking and Substance Involvement Screening 
Test validity in bipolar and psychotic disorders. 
S Afr J Psychiatr. 2023 Dec 21;29:2109. doi: 
10.4102/sajpsychiatry.v29i0.2109. 
Recovery Assessment Scale - 
Domains and Stages (RAS-
DS) 
4-point Likert-type scale: 
Untrue, A bit untrue, A bit 
true, Completely true 
Yes 
Hancock N, Scanlan JN, Honey A, Bundy AC, 
O'Shea K. Recovery Assessment Scale - 
Domains and Stages (RAS-DS): Its feasibility and 
outcome measurement capacity. Aust N Z J 
Psychiatry. 
2015 Jul;49(7):624-33. doi: 
10.1177/0004867414564084. Epub 2014 Dec 
19. 
PMID: 25526940; PMCID: PMC4941096. 
Medication adherence 
(tailored question) 
3 
Yes/No 
No 
N/A 
Health service use (tailored 
question) 
1 
Yes/No 
No 
N/A 
Hospitalisation history 
(tailored question) 
2 
Yes/No 
No 
N/A 
Monthly semi-structured interviews 
Experiences of care 
N/A 
Acceptability of intervention 
N/A 
Practicality of intervention 
N/A 
Family and household interactions 
N/A 
Caregivers 
Baseline, 4-month, 9-month follow-up fieldworker-administered questionnaire 
Demographic background: 
Age, sex, language, housing, 
employment 
5 
Categorical Open answer No 
N/A 
Health profile of household 7 
Yes/No 
No 
N/A 
Stigma by Association 
9 
5-point Likert scale 
ranging from “Never” to 
“Always”, scoring 1–5. 
No 
Goldberg JO, McKeag SA, Rose AL, Lumsden-
Ruegg H, Flett GL. Too Close for Comfort: 
Stigma by Association in Family Members Who 
Live with Relatives with Mental Illness. Int J 
Environ Res Public Health. 2023 Mar 
16;20(6):5209. doi: 
10.3390/ijerph20065209. 
Multidimensional Scale of 
Perceived Social Support 
12 
5-point Likert-type scale 
ranging from strongly 
disagree (1) to strongly 
agree (5) 
Yes 
Bruwer B, Emsley R, Kidd M, Lochner C, Seedat 
S. Psychometric properties of the 
Multidimensional Scale of Perceived Social 
Support in youth. Compr Psychiatry.  2008  
Mar-Apr;49(2):195-201.  doi: 
10.1016/j.comppsych.2007.09.002. 

32 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Medication adherence 
(tailored question) 
3 
Yes/No 
No 
N/A 
Care competent household 
measure (adapted from HIV 
care competency scale) 
5 
6-point Likert scale 
ranging from ‘completely 
disagree’ to ‘completely 
agree’ 
Yes 
Campbell LS, Masquillier C, Knight L, Delport A, 
Sematlane N, Dube LT, Wouters E. Stay-at-
Home: The Impact of the COVID-19 Lockdown 
on Household Functioning and ART Adherence 
for People Living with HIV in Three Sub-districts 
of Cape Town, South Africa. AIDS Behav. 2022 
Jun;26(6):1905-1922. doi: 10.1007/s10461-
021- 
03541-0. 
Household functioning 
16 
Agree/Disagree 
Yes 
Campbell LS, Masquillier C, Knight L, Delport A, 
Sematlane N, Dube LT, Wouters E. Stay-at-
Home: The Impact of the COVID-19 Lockdown 
on Household Functioning and ART Adherence 
for People Living with HIV in Three Sub-districts 
of Cape Town, South Africa. AIDS Behav. 2022 
Jun;26(6):1905-1922. doi: 10.1007/s10461-
021- 
03541-0. 
Monthly semi-structured interviews 
Acceptability of intervention 
N/A 
Practicality of intervention 
N/A 
Family and household interactions 
N/A 
Additional process measures 
Fidelity checklists 
(completed during each 
interaction with participant) 
and focus group discussions 
(every three months): 
Hospital staff implementing 
PSR 
PHC clinic staff 
implementing enhanced 
APC 
CHWs 
implementing CMED 
Observations: 
Interactions between CHWs 
and household members 
during visits (every three 
months) 
Weekly debriefing sessions 
between CHWs 
Measures 
Service 
users 
Caregivers Hospital 
staff 
PHC staff 
CHWs 
Managers 
Baseline survey 
X 
X 
4-month follow-up survey 
X 
X 
Process 
measures 
Monthly interviews 
X 
X 
Monthly observations 
X 
X 
Monthly FGDs 
X 

33 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Weekly Feedback sessions 
X 
Fidelity checklists 
X 
X 
X 
Feedback workshops 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 Definition of Adverse Event 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related. 
8.3.2 Definition of Serious Adverse Events (SAE) 
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the 
view of either the investigator or sponsor, it results in any of the following outcomes: 
death, a life-threatening adverse event, inpatient hospitalization, a persistent or 
significant incapacity or substantial disruption of the ability to conduct normal life 
functions. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. Examples of 
such medical events include a rapidly deteriorating mental state, suicidal ideation, and 
severe substance abuse leading to incapacity and medical or psychological harm. 
8.3.3 Classification of an Adverse Event 
8.3.3.1 Severity of Event 
For adverse events (AEs) not included in the protocol defined grading system, the 
following guidelines will be used to describe severity. 
• Mild – Events require minimal or no treatment and do not interfere with the 
participant’s daily activities. 
• Moderate – Events result in a low level of inconvenience or concern with the 
therapeutic measures. Moderate events may cause some interference with 
functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic 

34 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
drug therapy or other treatment. Severe events are usually potentially life-
threatening or incapacitating. Of note, the term “severe” does not necessarily equate 
to “serious”.] 
8.3.3.2 Relationship to Study Intervention/Experimental Manipulation 
All adverse events (AEs) will have their relationship to study procedures, including the 
intervention, assessed by an appropriately trained clinician based on temporal 
relationship and his/her clinical judgment. The degree of certainty about causality will be 
graded using the categories below. 
Related – The AE is known to occur with the study procedures, there is a reasonable 
possibility that the study procedures caused the AE, or there is a temporal relationship 
between the study procedures and the event. Reasonable possibility means that there is 
evidence to suggest a causal relationship between the study procedures and the AE. 
Not Related – There is not a reasonable possibility that the study procedures caused the 
event, there is no temporal relationship between the study procedures and event onset, 
or an alternate etiology has been established. 
OR 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event occurs in a plausible 
time relationship to study procedures administration and cannot be explained by 
concurrent disease or other drugs or chemicals. The response to withdrawal of the study 
procedures should be clinically plausible. The event must be phenomenologically 
definitive. 
Probably Related – There is evidence to suggest a causal relationship, and the influence 
of other factors is unlikely. The clinical event occurs within a reasonable time after 
administration of the study procedures, is unlikely to be attributed to concurrent disease 
or other drugs or chemicals, and follows a clinically reasonable response on withdrawal. 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after administration of study procedures). 
However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” 
soon after discovery, it can be flagged as requiring more information and later be 

35 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
upgraded to “probably related” or “definitely related”, as appropriate. 
Unlikely to be related – A clinical event whose temporal relationship to study procedures 
administration makes a causal relationship improbable (e.g., the event did not occur 
within a reasonable time after administration of the study procedures) and in which other 
drugs or chemicals or underlying disease provides plausible explanations (e.g., the 
participant’s clinical condition, other concomitant treatments). 
Not Related – The AE is completely independent of study procedures administration, 
and/or evidence exists that the event is definitely related to another etiology. There must 
be an alternative, definitive etiology documented by the clinician. 
8.3.3.3 Expectedness 
A clinician with appropriate expertise in psychiatry will be responsible for determining 
whether an adverse event (AE) is expected or unexpected. An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study procedures. 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to 
the attention of study personnel during study visits and interviews of a study participant 
presenting for medical care, or upon review by the field supervisor. 
Any medical or psychiatric condition that is present at the time that the participant is 
screened will be considered as baseline and not reported as an AE. However, if the 
study participant’s condition deteriorates at any time during the study, it will be recorded 
as an AE. 
Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity to be performed. Documentation of onset 
and duration of each episode will be maintained for AEs characterized as intermittent. 
The field manager will record events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation. At each study visit, the investigator will inquire about the 
occurrence of AE/SAEs since the last visit. Events will be followed for outcome 
information until resolution or stabilization. 

36 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
8.3.5 Adverse Event Reporting 
All AEs, not otherwise precluded per the protocol, will be captured on the appropriate 
case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study procedures (assessed 
only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study will be documented 
appropriately regardless of relationship, and will be reported to the Data Safety 
Management Board and to the Biomedical Research Ethics Committee within 30 days of 
occurrence. 
9 
STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESIS 
• Primary Endpoint: 
• We hypothesize that, compared to service users who receive care as usual (i.e. 
outpatient psychopharmaceutical support at PHC clinics), service users who receive the 
MhINT Recovery intervention for post-hospitalization support will have a reduced rate of 
acute psychiatric re-hospitalization after participating in intervention for 4 months. 
Alternatively, our null hypothesis is that there will be no difference in the effects of MhINT 
Recovery in reducing hospital re-admission after 4 months. 
• Secondary Endpoint(s): 
i. 
We hypothesize that, compared to service users who receive care as usual (i.e. 
outpatient psychopharmaceutical support at PHC clinics), service users who 
receive the MhINT Recovery intervention for post-hospitalization support will have 
higher scores in recovery after participating in intervention for 4 months. 
Alternatively, our null hypothesis is that there will be no difference in the effects 
of MhINT Recovery in increasing recovery. 
ii. 
We hypothesize that, compared to service users who receive care as usual (i.e. 
outpatient psychopharmaceutical support at PHC clinics), service users who 
receive the MhINT Recovery intervention for post-hospitalization support will have 
lower scores in internalized stigma after participating in intervention for 4 months. 
Alternatively, our null hypothesis is that there will be no difference in the effects 
of MhINT Recovery in reducing internalized stigma. 

37 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
iii. 
We hypothesize that, compared to service users who receive care as usual (i.e. 
outpatient psychopharmaceutical support at PHC clinics), service users who 
receive the MhINT Recovery intervention for post-hospitalization support will have 
higher scores in treatment adherence after participating in intervention for 4 
months. Alternatively, our null hypothesis is that there will be no difference in the 
effects of MhINT Recovery in increasing treatment adherence. 
9.2 
SAMPLE SIZE DETERMINATION 
A sample of 86 individual service users are sampled – 43 per arm, obtained by sampling 
with a 95% power to determine a decrease in hospital re-admission (our primary outcome 
most difficult to impact) from an estimated 66% (12 months re-admission rate, district 
hospital in KwaZulu-Natal, Tomita & Moodley, 2016) to 41% (effect size = 25%) post-
intervention over a period of 12 months. The proportion in the intervention arm is 
assumed to be 0.41 under the null hypothesis and 0.66 under the alternative hypothesis. 
This sample size has been calculated for a 2-sided Z-Test (Unpooled) and 0.1% 
significance level. The estimated effect size is conservative since this is a new 
intervention that has not been rigorously assessed in South Africa. We hope to 
decrease the re-admission levels by 30%, however we have powered the study on a 
lower effect size (25%) to avoid a type 2 error. One primary caregiver for each service 
user is additionally added. 
 
9.3 
STATISTICAL ANALYSES 
9.3.1 General Approach 
A descriptive and outcome analysis of quantitative measures will be undertaken using IBM 
SPSS The re-hospitalization relapse variable will be derived from routine project monitoring 
data, allowing for the inclusion of data for all participants including those who did not complete 
endpoint interviews. A sensitivity analysis will be conducted to exclude individuals who had died 
or withdrawn. To estimate the potential effect of the intervention group at 4-months, quantitative 
outcomes will be compared between treatment arms, adjusting for baseline scores and clinic, 
using linear mixed models for continuous variables and generalized linear mixed models for 
binary variables based on an intention-to-treat analysis. We will analyze the data using an 
available case analysis, that is all individuals providing data for any outcome at any timepoint 
will be included. 
10 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 

38 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Full ethics approval has been obtained from the University of KwaZulu-Natal Biomedical 
Research Ethics Committee (BREC) and the University of Antwerp Institutional 
Research Ethics Body (attached). Informed consent, participant safety and all research 
ethics procedures will be followed in line with guidance from these bodies. Further, 
regulatory approval has been obtained from the National Department of Health Research 
Database. Additionally, the trial has been registered with South African National Clinical 
Trials Register (SANCTR). The protocol will also be published in a peer-reviewed 
journal. 
Ethical Principles 
The study will adhere to the following fundamental ethical guidelines for research 
involving vulnerable populations: 
To Prevent Injury to Research Participants 
This covers any potential psychological and/or physical harm brought on by the 
research. It also refers to safeguarding the rights and interests of participants. There is 
little chance of bodily injury. The research team is knowledgeable and experienced in 
determining when procedures, observations, interviews, and focus groups can be 
conducted without causing undue inconvenience to participants. Sensitive information 
communication will be taught to research staff. Each site will have clear referral 
procedures for social work or counselor support when needed. As described, service 
users and their families will have twice-monthly interactions with healthcare services, 
where monitoring of their mental state will occur. In cases where a deteriorating mental 
state is suspected, the investigators will be alerted, who will enter into discussions with 
the field team in order to designate a visit from a healthcare worker to the participant in 
question for assessment. If an adverse even occurs, the steps outlined above will be 
followed. 
To Ensure the Safety of Research 
Participation in the study is entirely voluntary. "Voluntary participation" means that before 
any research data is collected, informed consent to participate in the study must be 
obtained. "Informed consent" refers to a participant's agreement to participate in a study 
after being made aware of and comprehending the following: the purpose, methods, and 
procedures of the study; the research topic; the use of the data; the participant's right to 

39 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
withdraw from the study at any time; and the possibility that participants who have 
withdrawn from the study may re-enter the study at any point. People will have time to 
consider whether or not to participate, and the process of gaining informed consent will 
not be rushed. 
Before gaining informed consent, the researcher will make sure people understand the 
research by asking them to repeat what they have been told. Written documentation of 
informed consent will be kept private and kept in a file in a locked cabinet at the Centre 
for Research in Health Systems. Each participant will receive a copy of the consent form. 
Mitigation of potential harms 
Information indicating that participants are immediately at risk of negative outcomes may 
be obtained during the course of the study. Regardless of the trial arm a participant is in, 
we will refer them for recall or additional clinical evaluation if this happens. This strategy 
is based on previous studies and strikes a balance between protecting patient 
participants and acknowledging that inadequate management of severe mental illness 
is a prevalent issue that is the focus of the trial and intervention. 
To Respect Cultural Traditions, Norms and Customs 
Being of South African descent, the majority of the research team is cognisant of the 
diversity of backgrounds and cultures. As sensitivity to various cultures, customs, and 
norms will be respected, this won't hinder the research. Whichever language each 
participant feels most comfortable with— isiZulu or English — will be used for the 
interviews. A large proportion of the population of KwaZulu-Natal adhere to traditional 
cultural beliefs about mental illness, which will be respected by the research team and 
within the intervention implementation process. Efforts will be made to include traditional 
health practitioners and faith-based practitioners within individuals’ care network. 
To Enhance Equality 
Every effort will be made to reduce the power imbalances that exist between participants 
and researchers. The research team will employ methodologies that are appropriate for 
working with vulnerable populations. For instance, the research team will use language 
that participants can understand rather than jargon. The research team will give enough 
time to explain the study and establish trust with participants during informed consent, 

40 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
during intervention implementation, and during data collection interactions. 
To Prevent Unrealistic Expectations 
Regarding the study and the intended use of the data collected, the research team will 
be transparent and truthful. The research team will let the participants know what to 
anticipate and that, although health workers will not be compensated for their 
involvement in the study, service user participants and caregivers will. 
To be fair 
In order to avoid interfering with participants' personal time and obligations, the focus 
groups, workshops, and interviews will be arranged at their convenience. 
To Honor Autonomy and Privacy 
Should a participant choose not to participate in any aspect of the study, their request 
will be honored. The participants will be made fully aware that their choice to participate 
or not will not have any consequences. In order to maintain confidentiality, names, 
addresses, contact information, and other personal data will all be kept private and 
confidential for the purposes of hiring or gathering data, in compliance with the General 
Data Protection Regulation (2016) and the South African Protection of Personal 
Information Act No. 4 of 2013. Every participant in the study will be given a research 
number, and all information will be encrypted and kept private without revealing the 
identity or address of the subjects. No staff identifying information or names of medical 
facilities will be used. Paper-based information will be stored in a locked filing cabinet in 
the research team office, while electronic data will be stored on a password-protected 
computer in the Centre for Research in Health Systems’ OneDrive secure database. 
Only the research team will have access to the data. Confidentiality agreements will be 
signed by transcribers. No third parties will receive participant names or information, and 
the results report will not name any specific participants. Only in the event that we 
believed there was a serious risk of harm to a research participant—typically only after 
consulting with the individual in question—would we divulge personal information to a 
third party. Participants may agree if they would like their names to appear in the printed 
materials. Data will be stored for five years following the final data collection, after which 
in will be destroyed in line with UKZN regulations. 
 

41
Abbreviated Title: MhINT Recovery 
Version Date: August 2025
11 BUDGET

42
Abbreviated Title: MhINT Recovery 
Version Date: August 2025

43 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
12 REFERENCES 
1. 
National 
Institute 
for 
Mental 
Health. 
Mental 
Illness: 
Definitions 
https://www.nimh.nih.gov/health/statistics/mental-illness: 
National 
Institutes 
for 
Health; 2021 [accessed 21 November 2021. 
2. 
Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental 
disorders: a meta-review. World psychiatry : official journal of the World Psychiatric 
Association (WPA) 2014;13(2):153–60. doi: 10.1002/wps.20128 
3. 
Walker ER, McGee RE, Druss BG. Mortality in mental disorders and global disease 
burden implications: a systematic review and meta-analysis. JAMA psychiatry 
2015;72(4):334– 
41. doi: 10.1001/jamapsychiatry.2014.2502 
4. 
Charlson FJ, Baxter AJ, Dua T, et al. Excess Mortality from Mental, Neurological, and 
Substance Use Disorders in the Global Burden of Disease Study 2010. In: Patel V, 
Chisholm D, Dua T, et al., eds. Mental, Neurological, and Substance Use Disorders: 
Disease Control Priorities, Third Edition (Volume 4). Washington (DC): The 
International Bank for Reconstruction and Development / The World Bank 
© 2016 International Bank for Reconstruction and Development / The World Bank. 2016. 
5. 
Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective 
disorder. Schizophrenia Research 
2011;131(1):101–04. 
doi: 
https://doi.org/10.1016/j.schres.2011.06.008 
6. 
Ösby U, Westman J, Hällgren J, et al. Mortality trends in cardiovascular causes in 
schizophrenia, bipolar and unipolar mood disorder in Sweden 1987-2010. Eur J 
Public Health 2016;26(5):867–71. doi: 10.1093/eurpub/ckv245 [published Online 
First: 2016/01/10] 
7. 
Nilsson NH, Bendix M, Öhlund L, et al. Increased Risks of Death and Hospitalization 
in Influenza/Pneumonia and Sepsis for Individuals Affected by Psychotic Disorders, 
Bipolar Disorders, and Single Manic Episodes: A Retrospective Cross-Sectional 
Study. Journal of clinical medicine 2021;10(19):4411. doi: 10.3390/jcm10194411 
8. 
Maripuu M, Bendix M, Öhlund L, et al. Death Associated With Coronavirus (COVID-
19) Infection in Individuals With Severe Mental Disorders in Sweden During the Early 

44 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
Months of the Outbreak-An Exploratory Cross-Sectional Analysis of a Population-
Based 
Register 
Study. 
Front 
Psychiatry 
2020;11:609579. 
doi: 
10.3389/fpsyt.2020.609579 [published Online First: 2021/01/26] 
9. 
Wang Q, Xu R, Volkow ND. Increased risk of COVID-19 infection and mortality in 
people with mental disorders: analysis from electronic health records in the United 
States. World Psychiatry 2021;20(1):124–30. doi: 10.1002/wps.20806 [published 
Online First: 2020/10/08] 
10. Qader G, Seddiq MK, Rashidi KM, et al. Prevalence of tuberculosis among mentally ill 
patients in conflict-stricken Afghanistan: A cross-sectional study. International 
Journal 
of 
Infectious 
Diseases 
2019;89:45–50. 
doi: 
https://doi.org/10.1016/j.ijid.2019.08.020 
11. Hughes E, Bassi S, Gilbody S, et al. Prevalence of HIV, hepatitis B, and hepatitis C in 
people with severe mental illness: a systematic review and meta-analysis. The 
Lancet 
Psychiatry 
2016;3(1):40–48. 
doi: 
https://doi.org/10.1016/S2215-
0366(15)00357-0 
12. Hayes JF, Miles J, Walters K, et al. A systematic review and meta-analysis of 
premature mortality in bipolar affective disorder. Acta Psychiatr Scand 
2015;131(6):417–25. doi: 10.1111/acps.12408 [published Online First: 2015/03/05] 
13. Lawrence D, Kisely S. Inequalities in healthcare provision for people with severe 
mental illness. Journal of psychopharmacology (Oxford, England) 2010;24(4 
Suppl):61–68. doi: 10.1177/1359786810382058 
14. Fekadu A, Medhin G, Kebede D, et al. Excess mortality in severe mental illness: 10-
year population-based cohort study in rural Ethiopia. British Journal of Psychiatry 
2015;206(4):289–96. doi: 10.1192/bjp.bp.114.149112 [published Online First: 
2018/01/02] 
15. Smartt C, Prince M, Frissa S, et al. Homelessness and severe mental illness in low- and 
middle-income countries: scoping review. BJPsych open 2019;5(4):e57–e57. doi: 
10.1192/bjo.2019.32 
16. Morgan C, Dazzan P, Gureje O, et al. Announcing the Lancet Psychiatry Commission 
on Psychoses in Global Context. Lancet Psychiatry 2021 doi: 10.1016/s2215-
0366(21)00234-0 [published Online First: 2021/06/21] 

45 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
17. Petersen I, Lund C. Mental health service delivery in South Africa from 2000 to 2010: 
one step forward, one step back. S Afr Med J 2011;101(10):751–57. 
18. Janse van Rensburg A. The Political Economy of Mental Illness in South Africa. 
London: Routledge 2021. 
19. Janse van Rensburg A, Wouters E, Fourie P, et al. Collaborative mental health care 
in the bureaucratic field of post-apartheid South Africa. Health Sociology Review 
2018;27(3):279–93. 
20. Garrido P, Saraiva CB. P-601 - Understanding the revolving door syndrome. European 
Psychiatry 2012;27:1. doi: https://doi.org/10.1016/S0924-9338(12)74768-5 
21. Vally Z, Cader N. The 'revolving door': a profile of acute admissions at a South African 
psychiatric hospital. International psychiatry : bulletin of the Board of International 
Affairs of the Royal College of Psychiatrists 2012;9(3):66–68. 
22. Tomita A, Moodley Y. The revolving door of mental, neurological, and substance use 
disorders re-hospitalization in rural KwaZulu-Natal Province, South Africa. African 
health sciences 2016;16(3):817–21. doi: 10.4314/ahs.v16i3.23 
23. Docrat S, Besada D, Cleary S, et al. Mental health system costs, resources and 
constraints in South Africa: a national survey. Health Policy Plan 2019;34(9):706–19. 
doi: 10.1093/heapol/czz085 
24. Lorine K, Goenjian H, Kim S, et al. Risk Factors Associated With Psychiatric 
Readmission. The Journal of Nervous and Mental Disease 2015;203(6):425–30. doi: 
10.1097/nmd.0000000000000305 
25. Shadmi E, Gelkopf M, Garber-Epstein P, et al. Routine patient reported outcomes as 
predictors of psychiatric rehospitalization. Schizophrenia Research 2018;192:119–
23. doi: https://doi.org/10.1016/j.schres.2017.04.049 
26. Di Lorenzo R, Sagona M, Landi G, et al. The Revolving Door Phenomenon in an Italian 
Acute Psychiatric Ward: A 5-Year Retrospective Analysis of the Potential Risk 
Factors. The Journal of Nervous and Mental Disease 2016;204(9):686–92. doi: 
10.1097/nmd.0000000000000540 
27. Zhao Y, Hoenig JM, Protacio A, et al. Identification of risk factors for early psychiatric 
rehospitalization. 
Psychiatry 
Research 
2020;285:112803. 
doi: 
https://doi.org/10.1016/j.psychres.2020.112803 

46 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
28. Loch AA. Stigma and higher rates of psychiatric re-hospitalization: São Paulo public 
mental health system. Brazilian Journal of Psychiatry 2012;34:185–92. 
29. Botha UA, Koen L, Joska JA, et al. The revolving door phenomenon in psychiatry: 
comparing low-frequency and high-frequency users of psychiatric inpatient services 
in a developing country. Social psychiatry and psychiatric epidemiology 
2010;45(4):461–68. 
30. Niehaus DJH, Koen L, Galal U, et al. Crisis discharges and readmission risk in acute 
psychiatric male inpatients. BMC Psychiatry 2008;8(1):44. doi: 10.1186/1471-244X-
8-44 
31. Botha UA, Koen L, Joska JA, et al. The revolving door phenomenon in psychiatry: 
comparing low-frequency and high-frequency users of psychiatric inpatient services 
in a developing country. Soc Psychiatry Psychiatr Epidemiol 2010;45(4):461–8. doi: 
10.1007/s00127-009-0085-6 [published Online First: 2009/06/19] 
32. Burns J, Kirkbride J. Social capital, pathway to care and duration of untreated 
psychosis: Findings from a low-and middle-income country context. South African 
Journal of Psychiatry 2012;18(4):163–70. 
33. Burns J, Jhazbhay K, Kidd M, et al. Causal attributions, pathway to care and clinical 
features of first-episode psychosis: a South African perspective. Int J Soc Psychiatry 
2011;57(5):538–45. doi: 10.1177/0020764010390199 [published Online First: 
2010/11/17] 
34. Lilford P, Rajapakshe OBW, Singh SP. A systematic review of care pathways for 
psychosis in low-and middle-income countries. Asian Journal of Psychiatry 
2020;54:102237. 
35. Lund C, Oosthuizen P, Flisher AJ, et al. Pathways to inpatient mental health care among 
people with schizophrenia spectrum disorders in South Africa. Psychiatr Serv 
2010;61(3):235–40. 
doi: 10.1176/ps.2010.61.3.235 [published Online First: 
2010/03/03] 
36. Tomita A, Burns JK, King H, et al. Duration of untreated psychosis and the pathway to 
care in KwaZulu-Natal, South Africa. J Nerv Ment Dis 2015;203(3):222–5. doi: 
10.1097/nmd.0000000000000268 [published Online First: 2015/02/26] 
37. Tomita A, Moodley Y. The revolving door of mental, neurological, and substance use 

47 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
disorders re-hospitalization in rural KwaZulu-Natal Province, South Africa. Afr Health 
Sci 2016;16(3):817–21. doi: 10.4314/ahs.v16i3.23 [published Online First: 
2016/12/06] 
38. Franken H, Parker J, Allen R, et al. A profile of adult acute admissions to Lentegeur 
Psychiatric Hospital, South Africa. South African Journal of Psychiatry 2019;25(1):1–
7. 
39. Vally Z, Cader N. The ‘revolving door’: a profile of acute admissions at a South African 
psychiatric hospital. International Psychiatry 2012;9(3):66–68. 
40. Janse van Rensburg A, Petersen I, Wouters E, et al. State and non-state mental health 
service collaboration in a South African district: a mixed methods study. Health Policy 
Plan 2018;33(4):516–27. doi: 10.1093/heapol/czy017 [published Online First: 
2018/02/21] 
41. Sfetcu R, Musat S, Haaramo P, et al. Overview of post-discharge predictors for 
psychiatric re-hospitalisations: a systematic review of the literature. BMC Psychiatry 
2017;17(1):227. doi: 10.1186/s12888-017-1386-z 
42. Vigod SN, Kurdyak PA, Dennis C-L, et al. Transitional interventions to reduce early 
psychiatric 
readmissions 
in 
adults: 
systematic 
review. 
Br 
J 
Psychiatry 
2013;202(3):187– 
94. doi: 10.1192/bjp.bp.112.115030 [published Online First: 2018/01/02] 
43. Botha HF, Koen L, Niehaus DJH, et al. Demographic and clinical profile of patients 
utilising a transitional care intervention in the Western Cape, South Africa. 2020 
2020;26 doi: 10.4102/sajpsychiatry.v26i0.1523 [published Online First: 2020-01-30] 
44. Botha UA, Koen L, Galal U, et al. The rise of assertive community interventions in 
South Africa: a randomized control trial assessing the impact of a modified assertive 
intervention on readmission rates; a three year follow-up. BMC Psychiatry 
2014;14(1):56. doi: 10.1186/1471-244X-14-56 
45. Docrat S, Lund C, Chisholm D. Sustainable financing options for mental health care in 
South Africa: findings from a situation analysis and key informant interviews. 
International Journal of Mental Health Systems 2019;13(1):4. doi: 10.1186/s13033-
019-0260-4 
46. Thornicroft G, Tansella M. Components of a modern mental health service: a 

48 
Abbreviated Title: MhINT Recovery 
Version Date: August 2025 
 
pragmatic balance of community and hospital care: Overview of systematic evidence. 
British Journal of Psychiatry 2004;185(4):283–90. doi: 10.1192/bjp.185.4.283 
[published Online First: 2018/01/02] 
47. Brooke-Sumner C, Lund C, Petersen I. Bridging the gap: investigating challenges and 
way forward for intersectoral provision of psychosocial rehabilitation in South Africa. 
International journal of mental health systems 2016;10(1):1–15. 
48. Petersen I, Fairall L, Zani B, et al. Effectiveness of a task-sharing collaborative care 
model for identification and management of depressive symptoms in patients with 
hypertension attending public sector primary care clinics in South Africa: pragmatic 
parallel cluster randomised controlled trial. Journal of affective disorders 
2020;282:112–21. 
doi: 
10.1016/j.jad.2020.12.123 
[published 
Online 
First: 
2021/01/08] 
49. Department of Health. National Mental Health Policy Framework and Strategic Plan 
2013-2020. Pretoria, 2012. 
50. Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J Prev 
Med 
2009;36(5):452–7. doi: 10.1016/j.amepre.2009.02.002 
51. Boyd JE, Otilingam PG, Deforge BR. Brief version of the Internalized Stigma of Mental 
Illness (ISMI) scale: psychometric properties and relationship to depression, self 
esteem, recovery orientation, empowerment, and perceived devaluation and 
discrimination. Psychiatr Rehabil J 2014;37(1):17–23. doi: 10.1037/prj0000035 

 
 
 
 
20 June 2025 
Prof Inge Petersen (3106) 
Dr Andries Petrus Janse Van Rensburg 
(63777) Dr Arvin Bhana (23304) 
School of Nursing & Public Health 
Howard College 
 
Dear PI’s 
Protocol reference number: BREC/00007597/2024 
Project title: Feasibility of a health systems strengthening intervention to reduce 
hospital re-admission following acute psychiatric hospitalization among people 
living with severe mental illness in uMgungundlovu, KwaZulu-Natal 
Non-Degree 
 
FULL COMMITTEE APPROVAL LETTER 
 
The Biomedical Research Ethics Committee (BREC) has considered the abovementioned 
application at a meeting held on 08 October 2024. 
 
I wish to advise you that your response to BREC correspondence dated 16 September 2024, 
25 October 2024 and 09 April 2025 were noted and approved by the Biomedical Research 
Ethics Committee at a meeting held on 10 June 2025. 
 
Note: Please submit SANCTR approval to BREC once received. 
 
This approval is valid for one year from 20 June 2025. To ensure uninterrupted approval of 
this study beyond the approval expiry date, an application for recertification must be submitted 
to BREC on RIG before the expiry date. 
 
Please ensure that any outstanding site permissions are obtained and forwarded to BREC 
for approval before commencing research at a new site. 
 

 
Any amendments to this study, unless urgently required to ensure safety of participants, must 
be approved by BREC prior to implementation. 
 
Your acceptance of this approval denotes your compliance with South African National 
Research Ethics Guidelines (2024), South African National Good Clinical Practice Guidelines 
(2020) (if applicable) and with UKZN BREC ethics requirements as contained in the UKZN 
BREC Terms of Reference and Standard Operating Procedures, all available at 
http://research.ukzn.ac.za/Research-Ethics/Biomedical-Research-Ethics.aspx.   Pg. 1/… 
 
Biomedical Research Ethics Committee Chair: Professor 
S Singh 
UKZN Research Ethics Office Westville Campus, Govan Mbeki Building 
Postal Address: Private Bag X54001, Durban 4000 
Email: BREC@ukzn.ac.za 
Website: http://research.ukzn.ac.za/Research-Ethics/Biomedical-Research-Ethics.aspx 

 
 
 
BREC is registered with the South African National Health Research Ethics Council (REC-
290408-009). BREC has US Office for Human Research Protections (OHRP) Federal-wide 
Assurance (FWA 678). 
 
The following Committee members were present at the meeting that took place on 08 October 
2024: 
Prof S Singh 
Dentistry (Chair) 
 
Prof R Bhimma 
Paediatrics & Child Health (Deputy Chair) 
 
Prof D Wassenaar 
Clinical Psychology and Research Ethics (Deputy Chair) 
 
Prof T Hardcastle 
Surgery (Deputy Chair) 
 
Prof N Abbai 
Microbiology and Molecular Biology 
 
Dr O B Baloyi 
Maternal and Child Health 
 
Ptr S D Chili 
Community/Lay Member (External) 
 
Prof M Gordon 
Laboratory Medicine and Medical Sciences 
 
Dr A Harrichandparsad 
Public Health 
 
Prof K Hlongwana 
Public Health 
 
Dr Z Khumalo 
KZN Health, General Medicine (External) 
 
Dr M Khan 
HIV Clinician 
 

Dr R Lessells
Infectious Diseases Specialist
Prof D Moodley
Women’s Health
Dr T Naicker
Laboratory Medicine and Medical Sciences
Dr K Naidoo
Public Health
Dr JR Ncayiyana
Nursing and Public Health
Prof S Paruk
Psychiatry
Dr P Pillay
Clinical Anatomy
Dr D Singh
Critical Care
Prof A Strode
Health Law and Research Ethics
Dr J Toohey
Law
We wish you well with this study. We would appreciate receiving copies of all publications 
arising out of this study.
This approval will be noted at the next BREC meeting to be held on 08 July 2025. 
Yours sincerely,
PROFESSOR S SINGH
Chair: Biomedical Research Ethics Committee
ROFESSO

 
 
 
Professor Wouters,Edwin 
Buffel,Veerle 
Masquillier,Caroline 
van Olmen,Josefien 
Departement Sociologie 
Faculteit Sociale 
Wetenschappen University of 
Antwerp 
Professor Charlotte De Backer 
Chair Ethics Committee for 
the Social Sciences and Humanities 
City campus 
Sint Jacobstraat 2 
2000 Antwerpen 
 
 
 
 
 
 
Date 
04 April 2023 
REFERENCE 
SHW_2023_115_1 

RE: Decision Ethics Committee for the Social Sciences and Humanities, file SHW_2023_115_1
FINAL POSITIVE CLEARANCE
Dear professor,
The independent Ethics Committee for the Social Sciences and Humanities 
(EASHW), installed by the Executive Board of the UAntwerp (03.07.2012) formulates 
a ‘final positive clearance’ with regard to your project “Het gezin in de geestelijke 
gezondheidszorg: een experimentele studie naar de rol
van het gezin in de zorg voor mensen met een ernstige mentale aandoening in
Zuid-Afrika.” (FWO Senior project & VLIR-UOS Team project (aan de UA) +
NIMH finanaciering (aan University of KwaZulu-Natal), PeopleSoft ID Antigoon: 
47877).
In its decision making process, the EASHW is guided by the Royal Decree 
implementing the Act of 30 July 2018 on the protection of privacy in relation to the
processing of personal data; the Royal Decree of May 7, 2004 regarding experiments
on the human person; the General Data Protection Regulation; the EU-“Guidance 
Note for Researchers and Evaluators of Social Sciences and Humanities Research”; 
the deontological code for the researcher (Annex ZAP-statues UAntwerp), and the
vademecum of the Belgian Privacy Commission on scientific research and privacy.
Kind regards,
Professor Charlotte De Backer
Chair Ethics Committee for
the Social Sciences and
Humanities

 
Information sheet General- Health Care Workers 
 
TITLE OF THE RESEARCH PROJECT 
Feasibility of a health systems strengthening intervention to reduce hospital re-admission 
following acute psychiatric hospitalization among people living with severe mental illness in 
uMgungundlovu, KwaZulu-Natal 
Information Sheet 
 
BREC reference number: 
KZNDoH reference number: Good 
Day 
My name is XXX. I am working on a study led by Prof Andre Van Rensburg 
(jansevanrensburga@ukzn.ac.za) and a research team based at the University of KwaZulu-
Natal. 
 
People living with mental illness face many challenges. In South Africa, people living 
with these conditions struggle to cope when living in the community, with their family or 
caregivers. We are unsure about the kind of help and support people living with mental 
illness need in the community, and would like to spend some time with you to include your 
inputs into coming up with services that can better support them and their family. 
What is this study all about? 
In this study, we have gathered information from a range of people, including people who 
live with mental illness, their families, the healthcare workers, organisations and 
government. We used that information to work with these partners to come up with a service 
plan that can better support people living with mental illness, especially after they leave the 
hospital to go stay with their families. 
Why have I been invited to take part study? 
We believe that voices like yours should be at the heart of decisions that impact the care of 
people living with severe mental illness and their caregivers. As someone involved in service 
provision for person living with mental illness, we would liketo invite you to join an exciting 
research opportunity so that we can learn from you and better understand what barriers to 
care exist in the health and social system, so that you can play a crucial role in refining the 
interventions to strengthen care for people with severe mental illness 
Who is doing the study? 

 
This study is a collaboration between the University of KwaZulu-Natal, the University of 
Antwerp, Columbia University, the University of Cape Town and the Department of Health. 
What will happen to me in this study? 
If you agree, we would like to interview you regarding the care that is provided to people with 
severe mental illness in your facility. With your permission, we would like to take notes and 
record discussions with you, in order to be able to listen to it again later and write it down. 
Your name and any personal details will be removed from the recordings, and you will not 
be named when we write up our notes. 
Can anything bad happen to me? 
We can see no reason why you should suffer any harm from taking part in this study, and your 
decision to take part or not will not affect the relationship with anybody in the mental health 
system. 
Can anything good happen to me? 
Taking part in the study may be of benefit to people living with severe mental illness and 
their caregivers, in that the intervention you contribute to will strengthen the quality of care 
that people living with mental illness receive in the community. The services that we have 
developed will be focused on their needs, and we hope that it will meet their needs and 
expectations and enhance their well-being. 
Financial Risk and benefit: If you participate in this study, you will not incur any financial 
costs. We appreciate the time that healthcare workers take to participate in the research. 
Healthcare workers will not be reimbursed. We will ensure that you are interviewed in an 
easily accessible venue in the department that you work in during work hours. 
Will anyone know I am in the study? 
All records identifying you will be kept private and only accessed by the researchers. Audio-
recordings will be stored using password protected files that can only be accessed by the 
research team. Any quotes that are used will remain anonymous and will not be linked to 
you. A participant number will be used to name the electronic files containing your data. 
Your forms, and records associated with this study will be labelled with this number. 
What if I do not want to do this? 
Participation in this study is entirely voluntary, as such you are free to stop at any point 
without the need to give a reason. This will not have any effect on your involvement in any 
other part of the study or your access to care. 

 
Who can I talk to about the study? 
If you have any questions or require more information about this study, please contact the 
investigators: 
Dr Andre Janse van Rensburg 
Dr Tasneem Kathree 
University of KwaZulu-Natal 
University of KwaZulu-Natal 
Tel: 0312601569 
0312601569 
Email: jansevanrensburga@ukzn.ac.za 
Kathree@ukzn.ac.za 
If you have questions about your rights and are not able to resolve your concerns with the study 
staff, or if you have general questions about what it means to be in a research study, contact: 
 
BIOMEDICAL RESEARCH ETHICS ADMINISTRATION 
Research Office, Westville Campus Govan Mbeki Building 
University of KwaZulu-Natal Private Bag X 54001, Durban, 4000 KwaZulu-Natal, SOUTH 
AFRICA 
Tel: 27 31 2602486 - Fax: 27 31 2604609 
Email: BREC@ukzn.ac.za 

 
Consent form for service users 
 
 
TITLE OF THE RESEARCH PROJECT 
Feasibility of a health systems strengthening intervention to reduce hospital re-
admission following acute psychiatric hospitalization among people living with 
severe mental illness in uMgungundlovu, KwaZulu-Natal 
Ifomu elivumelekile labasebenzisi bensizakalo You will be given a copy of this consent form 
Uzonikezwa ikhophi yaleli fomu lemvume 
 
BREC reference number: BREC/00005546/2023 
KZNDoH 
reference 
number: 
KZ_202307_14 
 
 
Good Day 
 
My name is XXX. I am working on a study led by Prof Andre Van Rensburg 
(Vanrensburga@ukzn.ac.za) and a research team based at the University of KwaZulu-Natal. 
Thank you for considering taking part in this study. 
Siyabonga ukuthi uvume ukuba ingxenye yalolucwaningo. 
 
If you have any questions arising from the information sheet, please ask before you decide 
whether to take part. 
Uma kunemibuzo evuswa ukufunda ulwazi osowulitholile, sicela uyibuze ngaphambi 
kokuba uvume ukubamba iqhaza kulolucwaningo 
 
People living with mental illness face many challenges. In South Africa, people living 
with these conditions struggle to cope when living in the community, with their family or 
caregivers. We are unsure about the kind of help and support people living with mental 
illness need in the community, and would like to spend some time with you to include your 
inputs into coming up with services that can better support them and their family. 
What is this study all about? 
In this study, we have gathered information from a range of people, including people who 

 
live with mental illness, their families, the healthcare workers, organisations and 
government. We used that information to work with these partners to come up with a service 
plan that can better support people living with mental illness, especially after they leave the 
hospital to go stay with their families. 
Why have I been invited to take part study? 
We believe that voices like yours should be at the heart of decisions that impact the care of 
people living with severe mental illness and their caregivers. As someone involved in service 
provision for person living with mental illness, we would like to invite you to join an exciting 
research opportunity so that we can learn from you and better understand what barriers to 
care exist in the health and social system, so that you can play a crucial role in refining the 
interventions to strengthen care for people with severe mental illness. Researchers may visit 
you a few different times over the course of the study. They will make appointments with you 
and your family so that they can interview you at a convenient time and place. 
Who is doing the study? 
This study is a collaboration between the University of KwaZulu-Natal, the University of 
Antwerp, Columbia University, the University of Cape Town and the Department of Health. 
 
Do I have to participate in this study? 
It is your choice whether you want to participate in this study or not. If you decide not to 
participate, you will not be prejudiced in any way, and your decision will not affect the 
treatment you receive at your clinic. If you decide to take part, you are still free to withdraw 
from the study at any time and without giving a reason. Should you decide not to take part, 
or if you withdraw from the study, this will in no way affect the care you receive at the clinic. 
Should you agree to participate, we will ask you to sign the attached consent form. 
 
Ngabe kufanele ngibambe iqhaza kulolu cwaningo? 
Kungukukhetha kwakho ukuthi ufuna ukubamba iqhaza kulolu cwaningo noma cha. Uma 
uthatha isinqumo sokungahlanganyeli, ngeke ubandlululwe nganoma iyiphi indlela, futhi 
isinqumo sakho ngeke sithinte ukwelashwa okutholayo emtholampilo wakho. Uma uthatha 
isinqumo sokubamba iqhaza, usekhululekile ukuhoxa ocwaningweni nganoma yisiphi 
isikhathi futhi ngaphandle kokunikeza 
isizathu. 
Uma 
ngabe 
uthatha 
isinqumo 
sokungahlanganyeli, noma uma uhoxa ocwaningweni, lokhu ngeke kuthinte ukunakekelwa 
okutholayo emtholampilo. Uma kufanele uvume ukubamba iqhaza, sizokucela ukuthi 
usayine ifomu lokuvuma elinamathiselwe. 
Will the information I provide remain confidential? 
The regulations from the Research Ethics Committee at Universities of Cape Town and 

 
KwaZulu Natal will apply to all information gathered through interviews. These will be stored 
in a password-locked computer files and locked cabinets within University of Cape Town 
and KwaZulu-Natal. We will also comply with laws around personal data including POPIA 
(Protection of Personal Information Act) in South Africa and General Data Protection 
Regulation (GDPR) in the United Kingdom. 
We will: 1) hold interviews in an area with as much privacy as is possible, 2) use experienced 
and well-trained fieldworkers to conduct interviews who have signed confidentiality 
agreements to conduct interviews, 
3) store the interview information in a secure online platform, and 4) remove your personal 
details from the information and use a participant number to name files containing your data. 
Your forms, and records associated with this study will be labelled with this number. Only 
information without your personal details will be shared with researchers from the study’s 
Universities for analysis. All study documents will be stored safely and accessible only to 
members of the research team. 
All records identifying you will be kept private and only accessed by the researchers. A 
participant number will be used to name the electronic files containing your data. Your forms, 
and records associated with this study will be labelled with this number. 
 
What are the possible drawbacks or discomforts of participating in this study? 
We can see no reason why you should suffer any harm from taking part in this study, and 
your decision to take part or not will not affect the relationship with anybody in the mental 
health system. 
If you agree to participate in this study, a fieldworker will spend time with you and your family, 
and you will be asked a number of questions about your mental health problem/s in 
interviews. If you experience any discomfort or distress during the course of this process, 
related to your condition or you are thought to need treatment, you will be referred to the 
primary health care psychologist serving the sub-district to help you with your 
condition/concerns. 
Yiziphi izingqinamba noma ukungaphatheki kahle kokubamba iqhaza kulolu cwaningo? 
Uma uvuma ukubamba iqhaza kulolu cwaningo, osebenza emkhakheni uzochitha isikhathi 
nawe nomndeni wakho, futhi uzobuzwa imibuzo eminingana ngenkinga yakho yezempilo 
yengqondo/s ezingxoxweni. Uma uhlangabezana nanoma yikuphi ukungaphatheki kahle 
noma usizi phakathi nale nqubo, okuhlobene nesimo 

 
sakho noma kucatshangwa ukuthi udinga ukwelashwa, uzodluliselwa kudokotela wokuqala 
wezokunakekelwa kwempilo okhonza isifunda esingezansi ukukusiza ngesimo / 
ngamaconcerns akho. 
 
What are the possible benefits of participating in this study? 
If you participate in this study, you will not incur any financial costs. We appreciate the time 
taken to participate in the study and you will receive a supermarket voucher valued at R150-
00 (one hundred and fifty Rands) as a gesture of thanks to acknowledge the time and 
contributions that you have given towards the study. We hope that the study results will help 
us to improve the service provision for people living with mental illness in the community. 
Yiziphi izinzuzo ezingaba khona zokubamba iqhaza kulolu cwaningo? 
Uzothola ivawusha yesuphamakethe ebiza ku-R150-00 isikhathi sakho. Siyethemba ukuthi 
imiphumela yocwaningo izosisiza ukuthi sithuthukise ukuhlinzekwa kwezidingo zabantu 
abaphila nokugula kwengqondo emphakathini. 
 
Data Handling and confidentiality 
Your identity will not be disclosed to anybody except the Ethics committee and/or regulatory 
authorities during the course and after completion of the study if required. 
 
Ingabe ulwazi engilunikezayo luzohlala luyimfihlo? 
Imithethonqubo evela kwi komidi lezimilo zocwaningo i-Research Ethics Committee 
eNyuvesi yaseKapa kanye naKwaZulu Natali ingena kulo lonke ulwazi oluqoqwe 
ngezingxoxo. Lokhu kuzogcinwa kumafayela e-computer akhiyelwe ngama-password 
namakhabethe akhiyiwe eNyuvesi yaseKapa naKwaZulu-Natal. Sizophinde futhi sithobele 
imithetho emayelana nolwazi oluqoqiwe ngomuntu siqu ehlanganisa i-POPIA (Umthetho 
Wokuvikela Ulwazi Ngomuntu Siqu) eNingizimu Afrika kanye Nomthetho Ojwayelekile 
Wokuvikelwa lolwazi oluqoqiwe (GDPR) e-United Kingdom. 
Sizokwenza: 1) ukubamba izingxoxo endaweni esesithe ukugcina izimfihlo, 2) sisebenzise 
abasebenzi abanolwazi nabaqeqeshwe kahle ukuze benze izingxoxo futhi basayine 
izivumelwano zokugcina imfihlo, 3) sigcine imininingwane yengxoxo endaweni evikelekile 
kwizinkundla zomoya we-internet, kanye no-4) sizosusa imininingwane ngawe siqu kulwazi 
oluqoqiwe bese sisebenzisa inombolo yombambi qhaza ukubhala amafayela aqukethe 
ulwazi oluqoqiwe ngawe. 
Amafomu akho, namarekhodi ahlobene nalolu cwaningo azolebulwa (labelled) ngale 
nombolo. Ulwazi olungenayo imininingwane ngawe siqu kuphela oluzokwabelwa 
abacwaningi abavela emaNyuvesi ocwaningo ukuze luhlaziywe. Yonke imibhalo 
yocwaningo izogcinwa ngokuphepha futhi amalungu ethimba locwaningo azofinyelela kuyo 
kuphela. 

 
Wonke amarekhodi analowazi oluyizinkomba ngawe azogcinwa eyimfihlo futhi kuzofinyelela 
abacwaningi kuphela kuwo. Inombolo yombambi qhaza izosetshenziswa ukubhala 
amafayela akwi-computer aqukethe ulwazi oluqoqiwe lwakho. 
Amafomu akho, namarekhodi ahlobene nalolu cwaningo azolebulwa ngale nombolo. 
Ukuphathwa kolwazi oluqoqiwe (data) nokugcinwa luyimfihlo? 
Angeke budalulwe ubuwena (imininingwane yakho) kunoma ubani ngaphandle kwekomidi 
Lezimiso Zokuziphatha (Ethics committee) kanye/noma iziphathimandla ezilawulayo 
ucwaningo phakathi nocwaningo noma nalapho seluphothuliwe uma kudingeka. 
How will we report this research? 
We intend to publish the findings so that others can also learn from the study. We will report 
our results and other aspects of the study in scholarly journals, conferences and to the 
Department of Health via policy briefs and other reporting structures. No identifying 
information will be used. In line with current requirements from peer-reviewed journals, all 
research data will be made publicly available once it has been anonymised within a specific 
period after the research has ended. The researchers will make the data from this research 
project available publicly upon the request from other researchers. 
This study has been ethically reviewed and approved by the UKZN Biomedical research 
Ethics Committee (approval number BREC reference number: BREC/ 
). 
Sizolubika kanjani lolu cwaningo? 
Sihlose ukushicilela okutholakele ukuze abanye bakwazi nokufunda ocwaningweni. 
Sizobika imiphumela yethu nezinye izici zocwaningo kumaphephabhuku ezifundo, 
izingqungquthela kanye noMnyango Wezempilo ngezithangami zenqubomgomo nezinye 
izinhlaka zokubika. Akukho mininingwane ekhomba izosetshenziswa. Ngokuhambisana 
nezidingo zamanje ezivela 

 
kumaphephabhuku abukezwe ontanga, yonke imininingwane yocwaningo izotholakala 
emphakathini uma sekungaziwa esikhathini esithile ngemuva kokuphela kocwaningo. 
Abaphenyi bazokwenza imininingwane evela kule phrojekthi yocwaningo itholakale 
esidlangalaleni ngesicelo esivela kwabanye abacwaningi. 
Lolu cwaningo lubuye lwabuyekezwa ngokuziphatha futhi lwavunywa yi-UKZN Biomedical 
Research Ethics Committee (inombolo yokugunyazwa kwenombolo ye-BREC: BREC / 
00005546/2023). 
 
In the event of any problems or concerns/questions you may contact the Principle 
Investigator, André Janse van Rensburg on 031 260 1709 or the UKZN Biomedical 
Research Ethics Committee, contact details as follows: 
Uma kwenzeka kunezinkinga noma ukukhathazeka / imibuzo ungaxhumana noMphenyi 
we-Principle, u-André Janse van Rensburg ngomhlaka 031 260 1709 noma iKomidi 
Lezokuziphatha lase-UKZN Biomedical, imininingwane yokuxhumana ngale ndlela 
elandelayo: 
 
For questions related to the 
study 
Ngemibuzo ehlobene 
nocwaningo 
For Your rights as a 
research participant 
Ngamalungelo akho 
njengomhlanganyeli 
wokucwaninga 
The Principal Investigator 
BIOMEDICAL RESEARCH 
ETHICS 
Dr André Janse van Rensburg 
COMMITTEE (BREC) 
Centre for Rural Health 
Research Office, Westville 
4th Floor George Campbell 
Building 
Campus 
Howard College 
Govan Mbeki Building 
Private Bag X 54001 
Private Bag X 54001 
Durban 
Durban 
4000 
4000 
KwaZulu-Natal, SOUTH 
AFRICA 
KwaZulu-Natal, SOUTH 
AFRICA 
Tel: 27 31 260 1709 
Tel: 27 31 2604769 - Fax: 
27 31 
Email: 
jansevanrensburga@ukzn.ac.z
a 
2604609 

 
 
Email: BREC@ukzn.ac.za 
 
You will be given a copy of the information sheet and consent form. 
Uzonikezwa ikhophi yalolulwazi nafomu ekhombisa ukuthi uyavuma 
ukusebenzisana nathi kulolucwaningo 
 
Statement 
Please 
tick 
I confirm that I have read and understood the information 
sheet for the above study. 
Ngiyavuma futhi ngiqinisekisa ukuthi ngilifundile futhi 
ngaliqonda kahle ulwazi 
olubhaliwe ngalolucwaningo 
 
I have had the opportunity to consider the information and 
ask questions which have been answered to my 
satisfaction. 
Ngibenalo ithuba lokufunda futhi ngiqonde kahle ulwazi 
engilunikiwe futhi 
ngabuza nemibuzo yaphendulwa ngokwanelisekayo 
 
I consent voluntarily to have my activities observed and 
being interviewed, and understand that if I decide at any 
time to no longer take part, I can notify the researchers and 
withdraw without having to give a reason. 
Ngivuma ngokuzithandela ukuthi imisebenzi yami 
ibhekwe futhi kuxoxwe nayo, 
futhi ngiyaqonda ukuthi uma nginquma nganoma isiphi 
isikhathi ukuthi ngingabe ngisabamba iqhaza, 
ngingakwazi ukwazisa abacwaningi futhi ngihoxe 
ngaphandle 
 

 
 
kokuthi nginikeze isizathu. 
 
I consent to my observations and interview being audio 
recorded. 
Ngiyavuma ukuthi engikubonile kanye nenhlolokhono 
irekhodwe. 
 
I consent to the processing of my personal information for the 
purposes explained to me in the Information Sheet. I 
understand that such information will be handled in 
accordance with the terms of the POPIA Act (2013) 
Ngiyavuma ukuba iminingwane yami ingacutshungulwa 
futhi 
isetshenziswe 
ngonjongo 
echazwe 
kulwazi 
engilunikeziwe. 
Ngiyaqonda 
ukuthi 
leminingwane 
izophathwa  futhi  isetshenziswe  ngokuhambisana  
nemithetho  kaHulumeni 
ikakhulukazi i-POPIA Act (2013) 
 
I understand that confidentiality and anonymity will be 
maintained, and it will not be possible to identify me in any 
research outputs. 
Ngiyaqonda ukuthi konke kuzophathwa njengemfihlo 
futhi kungaziwa ukuthi 
kushiwo ngubani 
 
I understand that recordings and the written versions of the 
recordings will only be accessed by the members of the 
research team and a professional transcriber who would have 
signed a confidentiality agreement. I give permission for the 
research team and a professional transcriber to have access 
to the recording of my consultation. 
Ngiyaqonda futhi ukuthi konke okuqoshiwe nokubhaliwe 
kuzobonwa futhi kusetshenziswe amalungu 
alolucwaningo nabaqeqeshelwe ukubhala. 
Ngiyalinikeza ithimba labacwaningi nababhali imvume 
yokuthola okuqoshwe 
ngesikhathi sixoxa 
 
 
 
 

 
 
Participant’s statement: 
Isitatimende sobambe iqhaza: 
 
I,……………………………………………………………………………………………………… 
Mina 
(Name of participant in block letters) 
(Igama lobamba iqhaza ngamagama amakhulu) 
 
 
have read the information sheet and consent form, or they have been read to me. I 
understand what the study involves and have been given the opportunity to discuss it and 
ask questions. I voluntarily agree to take part in this research study. 
Ngiyilifundile noma ngifundelwe iphepha lolwazi mayelana nocwaningo. Ngiyaqonda ukuthi 
lolucwaningo lumayelana nani futhi ludingani. Ngilitholile ithuba lokuxoxa ngalo ngibuze 
nemibuzo. Ngizivumela ngokwami ngingaphoqiwe ukuba yingxenye yalolucwaningo. 

 
…………………..……………………………… 
………… 
Signature of Participant 
Date 
 
 
Investigator’s statement: 
Isitatimende somcwaningi 
 
I……………………………………………………………………………………………………. 
Mina 
(Name of investigator or designate in block letters) (Igama lomcwaningi ngamagama 
amakhulu) 
 
confirm that I have carefully explained the nature and purpose of the study to the participant 
namedabove. Ngiyaqinisekisa ukuthi ngichaze kahle imvelo nenjongo yalolucwaningo 
kulona ovume ukubamba iqhaza 
…………………………………………………… 
………… 
Signature of investigator 
Date 
 
If I have any further questions or concerns or queries related to the study, I understand that 
I may contact the researcher at 031 260 1709 or jansevanrensburga@ukzn.ac.za. 
If I have any questions or concerns about my rights as a study participant, or if I am 
concerned about an aspect of the study or the researchers then I may contact the Biomedical 
Research Ethics Committee (details above). 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
Page 6 of 6 

 
Consent form for Healthcare workers 
 
 
 
TITLE OF THE RESEARCH PROJECT: Feasibility of a health systems strengthening 
intervention to reduce hospital re-admission following acute psychiatric 
hospitalization among people living with severe mental illness in uMgungundlovu, 
KwaZulu-Natal 
You will be given a copy of this consent form 
 
 
BREC reference number: 
KZNDoH reference number: 
 
 
Thank you for considering taking part in this study. Siyabonga ukuthi uvume ukuba 
ingxenye yalolucwaningo. 
If you have any questions arising from the information sheet, please ask before you decide 
whether to take part. 
Uma kunemibuzo evuswa ukufunda ulwazi osowulitholile, sicela uyibuze ngaphambi 
kokuba uvume ukubamba iqhaza kulolucwaningo 
 
What are the possible benefits of participating in this study? 
We hope that the study results will help us to improve the service provision for people living 
with mental illness in the community. 
What are the possible drawbacks or discomforts of participating in this study? 
If you agree to participate in this study, a fieldworker will spend time with you and your 
family, and you will be asked a number of questions about your mental health problem/s in 
interviews. If you experience any discomfort or distress during the course of this process, 
related to your condition or you are thought to need treatment, you will be referred to the 
primary health care psychologist serving the sub-district to help you with your 
condition/concerns. 
Do I have to participate in this study? 
It is your choice whether you want to participate in this study or not. If you decide not to 
participate, you will not be prejudiced in any way, and your decision will not affect the 

 
treatment you receive at your clinic. If you decide to take part, you are still free to withdraw 
from the study at any time and without giving a reason. Should you decide not to take part, 
or if you withdraw from the study, this will in no way affect the care you receive at the 
clinic. Should you agree to participate, we will ask you to sign the attached consent form. 
How will we report this research? 
We intend to publish the findings so that others can also learn from the study. We will 
report our results and other aspects of the study in scholarly journals, conferences and to 
the Department of Health via policy briefs and other reporting structures. No identifying 
information will be used. In line with current requirements from peer-reviewed journals, all 
research data will be made publicly available once it has been anonymised within a 
specific period after the research has ended. The researchers will make the data from this 
research project available publicly upon the request from other researchers. 

 
This study has been ethically reviewed and approved by the UKZN Biomedical research 
Ethics Committee (approval number 
). 
 
In the event of any problems or concerns/questions you may contact the Principle 
Investigator, André Janse van Rensburg on 031 260 1709 or the UKZN Biomedical 
Research Ethics Committee, contact details as follows: 
 
For questions related to the 
study 
For Your rights as a 
research 
participant 
The Principal Investigator 
Dr André Janse van Rensburg 
Centre for Rural Health 
4th Floor George Campbell 
Building Howard College 
Private Bag X 54001 Durban 
4000 
KwaZulu-Natal, SOUTH 
AFRICA Tel: 27 31 260 1709 
Email: 
jansevanrensburga@ukzn.ac.z
a 
BIOMEDICAL RESEARCH 
ETHICS COMMITTEE 
(BREC) 
Research Office, Westville 
Campus 
Govan Mbeki Building 
Private Bag X 54001 
Durban 
4000 
KwaZulu-Natal, SOUTH 
AFRICA Tel: 27 31 
2604769 - Fax: 27 31 
2604609 
Email: BREC@ukzn.ac.za 
 
You will be given a copy of the information sheet and consent form. 
Uzonikezwa ikhophi yalolulwazi nafomu ekhombisa ukuthi uyavuma 
ukusebenzisana nathi kulolucwaningo 
 
Statement 
Pleas
e tick 
I confirm that I have read and understood the information 
sheet for the above study. 
Ngiyavuma futhi ngiqinisekisa ukuthi ngilifundile futhi 
ngaliqonda kahle ulwazi 
olubhaliwe ngalolucwaningo 
 

 
I have had the opportunity to consider the information and ask 
questions which have been answered to my satisfaction. 
Ngibenalo ithuba lokufunda futhi ngiqonde kahle ulwazi 
engilunikiwe futhi 
ngabuza nemibuzo yaphendulwa ngokwanelisekayo 
 
I consent voluntarily to participate in an interview and 
understand that if I decide at any time to no longer take part, I 
can notify the researchers and withdraw without having to 
give a reason. 
Ngivuma ngokuzithandela ukubamba iqhaza 
kunhlolokhono futhi ngiyaqonda ukuthi uma nginquma 
noma nini ukungabambi iqhaza, ngingazisa abacwaningi 
futhi ngihoxe ngaphandle kokunikeza isizathu. 
 
I consent to my interview being audio recorded. 
Ngiyavuma ukuthi inhlolokhono yami iqoshwe umsindo. 
 
I consent to the processing of my personal information for the 
purposes explained to me in the Information Sheet. I 
understand that such information will be handled in 
accordance with the terms of the POPIA Act (2013) 
Ngiyavuma ukuba iminingwane yami ingacutshungulwa 
futhi isetshenziswe 
ngonjongo echazwe kulwazi engilunikeziwe. Ngiyaqonda 
ukuthi leminingwane izophathwa  futhi  isetshenziswe  
ngokuhambisana  nemithetho  kaHulumeni 
 

 
 
ikakhulukazi i-POPIA Act (2013) 
 
I understand that confidentiality and anonymity will be 
maintained, and it will not be possible to identify me in any 
research outputs. 
Ngiyaqonda ukuthi konke kuzophathwa njengemfihlo 
futhi kungaziwa ukuthi 
kushiwo ngubani 
 
I understand that recordings and the written versions of the 
recordings will only be accessed by the members of the 
research team and a professional transcriber who would have 
signed a confidentiality agreement. I give permission for the 
research team and a professional transcriber to have access 
to the recording of my consultation. 
Ngiyaqonda futhi ukuthi konke okuqoshiwe nokubhaliwe 
kuzobonwa futhi kusetshenziswe amalungu alolucwaningo 
nabaqeqeshelwe ukubhala. Ngiyalinikeza 
ithimba labacwaningi nababhali imvume yokuthola okuqoshwe 
ngesikhathi sixoxa 
 
 
I understand that some of the information I share that will be 
published in academic journals or presented at public and 
academic events in the future, however all data will be kept 
anonymous to maintain confidentiality. 
Ngyaqonda ukuthi ulwazi esabelene ngalo lungasiza 
ekungeneleleni ezimweni ezithize nase kwenzeni izinhlelo 
ezinye zocwaningo oluzobhalwa emabhukwini olwazi futhi 
lwethulwe kwimiphakathi noma emicimbini ehlukene kepha 
kuqikelelwe 
ukuthi luyimfihlo futhi akuveli ukuthi luvelaphi 
 
 
 
 
Participant’s statement: 
Isitatimende sobambe iqhaza: 
 
I,……………………………………………………………………………………………………… 

 
Mina 
(Name of participant in block letters) 
(Igama lobamba iqhaza ngamagama amakhulu) 
 
 
have read the information sheet and consent form, or they have been read to me. I 
understand what the study involves and have been given the opportunity to discuss it and 
ask questions. I voluntarily agree to take part in this research study. 
Ngiyilifundile noma ngifundelwe iphepha lolwazi mayelana nocwaningo. Ngiyaqonda 
ukuthi lolucwaningo lumayelana nani futhi ludingani. Ngilitholile ithuba lokuxoxa ngalo 
ngibuze nemibuzo. Ngizivumela ngokwami ngingaphoqiwe ukuba yingxenye 
yalolucwaningo. 
 
 
 
 
…………………..……………………………… 
………… 
Signature of Participant 
Date 

 
Investigator’s statement: 
Isitatimende somcwaningi 
 
I……………………………………………………………………………………………………. 
Mina 
(Name of investigator or designate in block letters) (Igama lomcwaningi ngamagama 
amakhulu) 
 
confirm that I have carefully explained the nature and purpose of the study to the 
participant named above. 
Ngiyaqinisekisa ukuthi ngichaze kahle imvelo nenjongo yalolucwaningo kulona ovume 
ukubamba iqhaza 
…………………………………………………… 
………… 
Signature of investigator 
Date 
 
If I have any further questions or concerns or queries related to the study, I understand 
that I may contact the researcher at 031 260 1709 or jansevanrensburga@ukzn.ac.za. 
If I have any questions or concerns about my rights as a study participant, or if I am 
concerned about an aspect of the study or the researchers then I may contact the Biomedical 
Research Ethics Committee (details above). 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
Page 4 of 4 

 
Information sheet for Care Givers- Control 
 
TITLE OF THE RESEARCH PROJECT: Feasibility of a health systems strengthening 
intervention to reduce hospital re-admission following acute psychiatric 
hospitalization among people living with severe mental illness in uMgungundlovu, 
KwaZulu-Natal 
Information Sheet 
 
BREC reference number: 
KZNDoH reference number: 
Good Day 
 
My name is XXX. I am working on a study led by Prof Andre Van Rensburg 
(Vanrensburga@ukzn.ac.za) and a research team based at the University of KwaZulu-
Natal. 
 
People living with mental illness face many challenges. In South Africa, people living 
with these conditions struggle to cope when living in the community, with their family or 
caregivers. We are unsure about the kind of help and support people living with mental 
illness need in the community, and would like to spend some time with you to include your 
inputs into coming up with services that can better support you and your family. 
What is this study all about? 
In this study, we have gathered information from a range of people, including people who 
live with mental illness, their families, the healthcare workers, organisations and government 
and have used that information to work with these partners to come up with a service plan 
that can better support people living with mental illness, especially after they leave the 
hospital to go stay with their families. 
Why have I been invited to take part study? 
We believe that voices like yours should be at the heart of decisions that impact your life and 
the lives of people you care about. As a caregiver of a person living with mental illness, we 
would like to invite you to join an exciting research opportunity so that we can learn from 
you and better understand what life supporting someone living with mental illness is really 
like and so that you can play a crucial role in the interventions needed to strengthen their 
care and participate in decisions that affect the research design and its outputs. 

 
Who is doing the study? 
This study is a collaboration between the University of KwaZulu-Natal, other universities, 
and the Department of Health. 
What will happen to me in this study? 
If you agree, we would like to spend some time with [INSERT SERVICE USER NAME] and 
his/her caregivers after he/she has left the hospital. We would also like to interview you 
regarding your challenges and support in the community during the care of [INSERT 
SERVICE USER NAME]. With your permission, we would like to take notes and record 
discussions with you, in order to be able to listen to it again later and write it down. Your 
name and any personal details will be removed from the recordings, and you will not be 
named when we write up our notes. 

 
What are the possible benefits of participating in this study? 
Taking part in the study may be of benefit to you, in that the intervention you contribute to 
strengthening the quality of care that people living with mental illness receive in the 
community. The services that we will develop will be focused on their needs, and we hope 
that it will meet their needs and expectations and enhance their well-being. We appreciate 
the time you have taken to participate and as a token to appreciation you will receive a 
supermarket voucher valued at R150-00 for your time. We hope that the study results will 
help us to improve the service provision for people living with mental illness in the 
community. 
What are the possible drawbacks or discomforts of participating in this study? 
We can see no reason why you should suffer any harm from taking part in this study, and 
your decision to take part or not will not affect the relationship with anybody that provides 
you with services. 
If you agree to participate in this study, a fieldworker will spend time with you and your 
family, and you will be asked a number of questions about the mental health problem/s of 
your family member/person that you care for in interviews. If you experience any 
discomfort or distress during the course of this process, related to your condition or you are 
thought to need treatment, you will be referred to the primary health care psychologist 
serving the sub-district to help you with your condition/concerns. 
Will anyone know I am in the study? 
All records identifying you will be kept private and only accessed by the researchers. Audio-
recordings will be stored using password protected files that can only be accessed by the 
research team. Any quotes that are used will remain anonymous and will not be linked to 
you. A participant number will be used to name the electronic files containing your data. 
Your forms, and records associated with this study will be labelled with this number. 
What if I do not want to do this? 
Participation in this study is entirely voluntary, as such you are free to stop at any point 
without the need to give a reason. This will not have any effect on your involvement in any 
otherpart of the study or your access to care. 
Who can I talk to about the study? 
If you have any questions or require more information about this study, please contact the 
investigators: 

 
Dr Andre Janse van Rensburg 
Dr Tasneem Kathree 
University of KwaZulu-Natal 
University of KwaZulu-Natal 
Tel: 0312601569 
0312601569 
Email: jansevanrensburga@ukzn.ac.za 
Kathree@ukzn.ac.za 
 
 
If you have questions about your rights and are not able to resolve your concerns with the 
study staff, or if you have general questions about what it means to be in a research study, 
contact: 
BIOMEDICAL RESEARCH ETHICS ADMINISTRATION 
Research Office, Westville Campus Govan Mbeki Building 
University of KwaZulu-Natal Private Bag X 54001, Durban, 4000 KwaZulu-Natal, SOUTH 
AFRICA 
Tel: 27 31 2602486 - Fax: 27 31 2604609 
Email: BREC@ukzn.ac.za 

 
Information sheet for Care Givers-Intervention 
 
TITLE OF THE RESEARCH PROJECT: Feasibility of a health systems strengthening 
intervention to reduce hospital re-admission following acute psychiatric 
hospitalization among people living with severe mental illness in uMgungundlovu, 
KwaZulu-Natal 
Information Sheet 
 
BREC reference number: 
KZNDoH reference number: 
Good Day 
 
My name is XXX. I am working on a study led by Prof Andre Van Rensburg 
(Vanrensburga@ukzn.ac.za) and a research team based at the University of KwaZulu-
Natal. 
 
People living with mental illness face many challenges. In South Africa, people living 
with these conditions struggle to cope when living in the community, with their family or 
caregivers. We are unsure about the kind of help and support people living with mental 
illness need in the community, and would like to spend some time with you to include your 
inputs into coming up with services that can better support you and your family. 
What is this study all about? 
In this study, we have gathered information from a range of people, including people who 
live with mental illness, their families, the healthcare workers, organisations and government 
and have used that information to work with these partners to come up with a service plan 
that can better support people living with mental illness, especially after they leave the 
hospital to go stay with their families. 
Why have I been invited to take part study? 
We believe that voices like yours should be at the heart of decisions that impact your life and 
the lives of people you care about. As a caregiver of a person living with mental illness, we 
would like to invite you to join an exciting research opportunity so that we can learn from 
you and better understand what life supporting someone living with mental illness is really 
like and so that you can play a crucial role in the interventions needed to strengthen their 
care and participate in decisions that affect the research design and its outputs. 

 
Who is doing the study? 
This study is a collaboration between the University of KwaZulu-Natal, other universities, 
and the Department of Health. 
What will happen to me in this study? 
If you agree, we would like to spend some time with [INSERT SERVICE USER NAME] and 
his/her caregivers after he/she has left the hospital. We would also like to interview you 
regarding your challenges and support in the community during the care of [INSERT 
SERVICE USER NAME]. We would like to introduce you to a program to help the families of 
people living with severe mental illness to so that they do not relapse and need to be admitted 
to hospital. This will involve regular visits from the study researchers during the study 
period. With your permission, we would like to take notes and 

 
record discussions with you, in order to be able to listen to it again later and write it down. 
Your name and any personal details will be removed from the recordings, and you will not 
be named when we write up our notes. 
 
What are the possible benefits of participating in this study? 
Taking part in the study may be of benefit to you, in that the intervention you contribute to 
strengthening the quality of care that people living with mental illness receive in the 
community. The services that we will develop will be focused on their needs, and we hope 
that it will meet their needs and expectations and enhance their well-being. We appreciate 
the time you have taken to participate and as a token to appreciation you will receive a 
supermarket voucher valued at R150-00 for your time. We hope that the study results will 
help us to improve the service provision for people living with mental illness in the 
community. 
What are the possible drawbacks or discomforts of participating in this study? 
We can see no reason why you should suffer any harm from taking part in this study, and 
your decision to take part or not will not affect the relationship with anybody that provides 
you with services. 
If you agree to participate in this study, a fieldworker will spend time with you and your 
family, and you will be asked a number of questions about the mental health problem/s of 
your family member/person atht you care for in interviews. If you experience any 
discomfort or distress during the course of this process, related to your condition or you are 
thought to need treatment, you will be referred to the primary health care psychologist 
serving the sub-district to help you with your condition/concerns. 

 
Will anyone know I am in the study? 
All records identifying you will be kept private and only accessed by the researchers. Audio-
recordings will be stored using password protected files that can only be accessed by the 
research team. Any quotes that are used will remain anonymous and will not be linked to 
you. A participant number will be used to name the electronic files containing your data. 
Your forms, and records associated with this study will be labelled with this number. 
What if I do not want to do this? 
Participation in this study is entirely voluntary, as such you are free to stop at any point 
without the need to give a reason. This will not have any effect on your involvement in any 
otherpart of the study or your access to care. 
Who can I talk to about the study? 
If you have any questions or require more information about this study, please contact the 
investigators: 
Dr Andre Janse van Rensburg 
Dr Tasneem Kathree 
University of KwaZulu-Natal 
University of KwaZulu-Natal 
Tel: 0312601569 
0312601569 
Email: jansevanrensburga@ukzn.ac.za 
Kathree@ukzn.ac.za 
 
 
If you have questions about your rights and are not able to resolve your concerns with the 
study staff,or if you have general questions about what it means to be in a research study, 
contact: 
BIOMEDICAL RESEARCH ETHICS ADMINISTRATION 
Research Office, Westville Campus Govan Mbeki Building 
University of KwaZulu-Natal Private Bag X 54001, Durban, 4000 KwaZulu-Natal, SOUTH 
AFRICA 
Tel: 27 31 2602486 - Fax: 27 31 2604609 
Email: BREC@ukzn.ac.za 

 
Information sheet for service users_Control 
 
TITLE OF THE RESEARCH PROJECT: Feasibility of a health systems strengthening 
intervention to reduce hospital re-admission following acute psychiatric 
hospitalization among people living with severe mental illness in uMgungundlovu, 
KwaZulu-Natal 
Information Sheet 
 
Ishidi Lolwazi 
 
BREC reference number: BREC 
KZNDoH reference number: KZ Good 
Day 
My name is XXX. I am working on a study led by Prof Andre Van Rensburg 
(jansevanrensburga@ukzn.ac.za) and a research team based at the University of 
KwaZulu-Natal. 
 
 
People living with mental illness face many challenges. In South Africa, people living 
with these conditions struggle to cope when living in the community, with their family or 
caregivers. We have developed a program of services that can better support you and your 
family. 
Abantu abaphila nokugula kwengqondo babhekana nezinselelo eziningi. ENingizimu Afrika, 
abantu abaphila nalezi zimo balwela ukubhekana nezimo lapho behlala emphakathini, 
nomndeni wabo noma abanakekeli. Asiqiniseki ngohlobo losizo nokusekelwa kwabantu 
abaphila nokugula kwengqondo okudinga umphakathi, futhi ungathanda ukuchitha isikhathi 
nawe ukufaka okokufaka kwakho ekuza nezinsizakalo ezingakusekela kangcono wena 
nomndeni wakho. 
What is this study all about? 
In this study, we have gathered information from a range of people, including people who live 
with mental illness, their families, the healthcare workers, organisations and government. 
We used that information to work with these partners to come up with a service plan that 
can better support people living with mental illness, especially after they leave the hospital 
to go stay with their families. 
Ngabe lolu cwaningo luphathelene ngani? 

 
Kulolu cwaningo, sizoqoqa imininingwane evela ezinhlobonhlobo zabantu, kubandakanya 
nabantu abaphila nokugula kwengqondo, imindeni yabo, abasebenzi bezokunakekelwa 
kwempilo, izinhlangano nohulumeni. Ngemuva kwalokho singathanda ukusebenzisa lolo 
lwazi ukusebenzisana nalaba ababambisene nabo ukuza nohlelo lwensizakalo olungaxhasa 
kangcono abantu abaphila nokugula kwengqondo, ikakhulukazi ngemuva kokuba 
sebephumile esibhedlela bayohlala nemindeni yabo. 
Why have I been invited to take part study? 
We believe that voices like yours should be at the heart of decisions that impact your life 
and the livesof people you care about. As you are a person living with mental illness, we 
would like to invite you to join an exciting research opportunity to participate in services 
that may help you and your family to help to you stay on track with your medication and 
other helpful ways to prevent you from being admitted into hospital for your mental illness. 

 
Kungani ngimenyiwe ukuthi ngibambe iqhaza esifundweni? 
Sikholwa ukuthi amazwi afana nawe kufanele abe enhliziyweni yezinqumo ezithinta impilo 
yakho kanye nezimpilo zabantu obakhathalelayo. Njengoba ungumuntu ohlala nokugula 
kwengqondo, sithanda ukukumema ukuthi ujoyine ithuba lokucwaninga elijabulisayo ukuze 
sifunde kuwe futhi siqonde kangcono ukuthi impilo ngokugula kwengqondo injani ngempela 
nokuthi ukwazi dlala indima ebalulekile ekwakheni ukungenelela okudingekayo ukuqinisa 
ukunakekelwa kwakho futhi ubambe iqhaza ezinqumweni ezithinta ukwakhiwa kocwaningo 
nemiphumela yayo. 
Who is doing the study? 
This study is a collaboration between the University of KwaZulu-Natal, other universities, 
and the Department of Health. 
Ngubani owenza isifundo? 
Lolu cwaningo ukusebenzisana phakathi kweNyuvesi yaseKwaZulu-Natali, amanye 
amanyuvesi, noMnyango Wezempilo. 
What will happen to me in this study? 
If you agree, we would like to spend some time with you after you have left the hospital, to 
get an idea of your daily routines when you stay with family. With your permission, we would 
like to look at your patient file to see what kind of challenges you have been facing. Your 
name and any personal details will be removed from the recordings, and you will not be 
named when we write up our notes. 
Kuzokwenzekani kimi kulolu cwaningo? 
Uma uvuma, singathanda ukuchitha isikhathi nawe ngemuva kokuthi ushiye isibhedlela, 
ukuthola umbono wemizila yakho yansuku zonke lapho uhlala nomndeni. Sifisa ukubona 
inqubo yakho yansuku zonke ukuthola umbono wezinselelo obhekana nazo ngezinto 
ezinjengokuthatha 
ukwelashwa, 
ukuthola 
ukwesekwa kwabanye abantu nokuya 
emtholampilo. Ngalesi sikhathi sithanda futhi ukuxoxa nawe ukuthi ulalele ukuthi yimiphi 
imibono yakho maqondana nezinselelo zakho nokusekelwa emphakathini. Ngemvume 
yakho, singathanda ukuthatha amanothi futhi siqophe imibono yethu kanye nezingxoxo 
nawe, ukuze sikwazi ukuyilalela futhi ngokuhamba kwesikhathi futhi siyibhale phansi. 
Ngemvume yakho, singathanda nokubheka ifayela lakho lesiguli ukubona ukuthi hlobo luni 
lwezinselelo obhekane nazo. Igama lakho nanoma yimiphi imininingwane yomuntu 
izosuswa kokuqoshwa, futhi ngeke uqanjwe ngegama lapho sibhala amanothi ethu. 

 
Can anything bad happen to me? 
We can see no reason why you should suffer any harm from taking part in this study, and 
your decisionto take part or not will not affect the relationship with anybody that provides 
you with services. 
Ngabe kukhona okubi okungenzeka kimi? 
Asisiboni isizathu sokuthi kungani kufanele ulimale noma yikuphi ukubamba iqhaza kulolu 
cwaningo, futhi isinqumo sakho sokubamba iqhaza noma cha ngeke sithinte ubudlelwano 
nanoma ngubani okunikeza izinsizakalo. 
Can anything good happen to me? 
Taking part in the study may be of benefit to you, in that the intervention may strengthen the 
quality of care you receive in the community. The services that we have developed will be 
focused on your needs, 

 
and we hope that it will meet your needs and expectations and enhance your well-being. 
Ngabe kukhona okuhle okungenzeka kimi? 
Ukubamba iqhaza ocwaningweni kungaba usizo kuwe, ngoba ukungenelela okufaka isandla 
kukho 
kuzoqinisa 
ikhwalithi 
yokunakekelwa 
oyithola 
emphakathini. 
Izinsizakalo 
esizothuthukisa zizogxila kuzidingo zakho, futhi sethemba ukuthi zizohlangabezana 
nezidingo zakho nokulindelwe futhi zithuthukise inhlala-kahle yakho. 
Will anyone know I am in the study? 
All records identifying you will be kept private and only accessed by the researchers. Audio-
recordingswill be stored using password protected files that can only be accessed by the 
research team. Any quotes that are used will remain anonymous and will not be linked to 
you. A participant number will be used to name the electronic files containing your data. Your 
forms, and records associated with this study will be labelled with this number. 
Ngabe ukhona owaziyo ukuthi ngisesifundweni? 
Wonke amarekhodi akhomba ukuthi uzogcinwa ngasese futhi ufinyeleleke kuphela 
ngabaphenyi. Ukuqoshwa komsindo kuzogcinwa kusetshenziswa amafayela avikelwe 
ngephasiwedi angatholwa kuphela yiqembu lokucwaninga. Noma yiziphi izingcaphuno 
ezisetshenziswayo zizohlala zingaziwa futhi ngeke zixhunyaniswe nawe. Inombolo 
yokubamba iqhaza izosetshenziselwa ukuqamba amafayela we-elekthronikhi aqukethe 
idatha yakho. Amafomu akho, namarekhodi ahambisana nalolu cwaningo azobhalwa ngale 
nombolo. 
What if I do not want to do this? 
Participation in this study is entirely voluntary, as such you are free to stop at any point 
without the need to give a reason. This will not have any effect on your involvement in any 
other part of the study or your access to care. 
Kuthiwani uma ngingafuni ukwenza lokhu? 
Ukubamba iqhaza kulolu cwaningo kungokuzithandela ngokuphelele, ngakho-ke 
ukhululekile ukuma nganoma yisiphi isikhathi ngaphandle kwesidingo sokunikeza isizathu. 
Lokhu ngeke kube nomthelela ekuzibandakanyeni kwakho kunoma iyiphi enye ingxenye 
yocwaningo noma ukufinyelela kwakho ekunakekelweni. 
Who can I talk to about the study? 
If you have any questions or require more information about this study, please contact the 
investigators: 

 
Ngubani engingakhuluma naye ngocwaningo? 
Uma unemibuzo noma udinga imininingwane eminingi ngalolu cwaningo, sicela uxhumane 
nabaphenyi: 
Dr Andre Janse van Rensburg 
Dr Tasneem Kathree 
University of KwaZulu-Natal 
University of KwaZulu-Natal 
Tel: 0312601569 
0312601569 
Email: jansevanrensburga@ukzn.ac.za 
Kathree@ukzn.ac.za 
 
If you have questions about your rights and are not able to resolve your concerns with the 
study staff, or if you have general questions about what it means to be in a research study, 
contact: 
 
Uma unemibuzo ngamalungelo akho futhi ungakwazi ukuxazulula ukukhathazeka kwakho 
nabasebenzi bocwaningo, noma uma unemibuzo ejwayelekile yokuthi kusho ukuthini 
ukuba ocwaningweni lokucwaninga, thintana: 
 
BIOMEDICAL RESEARCH ETHICS ADMINISTRATION 
Research Office, Westville Campus Govan Mbeki Building 
University of KwaZulu-Natal Private Bag X 54001, Durban, 4000 KwaZulu-Natal, SOUTH 
AFRICA 
Tel: 27 31 2602486 - Fax: 27 31 2604609 
Email: BREC@ukzn.ac.za