Comprehensive Reintegration Assistance for Women With Obstetric Fistula
Phase: NA
Conditions: Female Genital Fistula, Urinary Incontinence
Sponsor: University of California, San Francisco

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Protocol version: 1.2 Date: 15 Feb 2021 
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: 
INTERVENTION PILOTING 
 
PROTOCOL VERSION: 1.2 DATE 15 FEB 2021 
CLINICALTRIALS.GOV REGISTRATION: NCT04748653 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: 
INTERVENTION PILOTING 
 
PRIMARY INVESTIGATORS 
 
ALISON M. EL AYADI, SCD MPH 
ASSISTANT PROFESSOR 
DEPARMENT OF OBSTETRICS, GYNECOLOGY AND REPRODUCTIVE SCIENCES  
DEPARTMENT OF EPIDEMIOLOGY AND BIOSTATISTICS 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
 
JUSTUS K. BARAGEINE, MBCHB, MMED, PHD 
SENIOR LECTURER, SPECIALIST OBSTETRICIAN AND GYNAECOLOGIST 
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES 
 
CO-INVESTIGATORS 
 
JOSAPHAT BYAMUGISHA, MBCHB, MMED, PHD 
ASSOCIATE PROFESS -  
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES 
 
SUSAN OBORE, MBCHB, MMED 
OBSTETRICIAN GYNECOLOGIST AND HONORARY LECTURER 
MULAGO HOSPITAL 
 
ABNER KORN, MD 
PROFESSOR 
DEPARTMENT OF OBSTETRICS, GYNECOLOGY AND REPRODUCTIVE SCIENCES 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
 
OTHER SIGNIFICANT CONTRIBUTORS 
 
HADIJA NALUBWAMA, MPH 
PROJECT MANAGER 
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 
MAKERERE UNIVERSITY COLLEGE OF HEALTH SCIENCES 
 
 
 
PROTOCOL VERSION: 1.2 DATE 15 FEB 2021 
CLINICALTRIALS.GOV REGISTRATION: NCT04748653 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
TABLE OF CONTENTS 
List of Abbreviations ............................................................................................................................................. 4 
PROJECT SUMMARY .............................................................................................................................................. 5 
STUDY GOALS AND OBJECTIVES ........................................................................................................................... 6 
SPECIFIC AIMS ........................................................................................................................................................... 6 
BACKGROUND AND JUSTIFICATION ..................................................................................................................... 8 
CURRENT STANDARD OF CARE ................................................................................... ERROR! BOOKMARK NOT DEFINED. 
APPROACH .......................................................................................................................................................... 10 
OVERVIEW OF STUDY DESIGN ................................................................................................................................ 10 
STUDY SETTING ....................................................................................................................................................... 10 
STUDY PARTICIPANTS ............................................................................................................................................. 11 
RECRUITMENT AND ENROLLMENT ........................................................................................................................ 11 
STUDY PROCEDURES ............................................................................................................................................... 12 
STUDY MEASURES .................................................................................................................................................. 16 
SAMPLE SIZE............................................................................................................................................................ 18 
DATA ANALYSIS PLANS ........................................................................................................................................... 18 
TIMELINE ............................................................................................................................................................. 19 
SAFETY MONITORING PLAN ............................................................................................................................... 20 
POTENTIAL RISKS TO HUMAN SUBJECTS ............................................................................................................... 20 
DATA AND SAFETY MONITORING .......................................................................................................................... 20 
TRAINING, QUALITY ASSURANCE (QA) AND SUPERVISION ................................................................................... 21 
POTENTIAL BENEFITS TO HUMAN SUBJECTS ......................................................................................................... 22 
PAYMENT ................................................................................................................................................................ 22 
ETHICS REVIEW ....................................................................................................................................................... 22 
DISSEMINATION PLAN ............................................................................................................................................ 23 
BUDGET .................................................................................................................Error! Bookmark not defined. 
APPENDICES ........................................................................................................................................................ 24 
APPENDIX 1A. OVERVIEW OF REINTEGRATION INTERVENTION: HEALTH EDUCATION SESSIONS ................................................. 25 
APPENDIX 1B. OVERVIEW OF REINTEGRATION INTERVENTION: PSYCHOLOGICAL COUNSELING SESSIONS .................................... 27 
APPENDIX 1C. OVERVIEW OF REINTEGRATION INTERVENTION: PHYSICAL REHABILITATION SESSIONS ......................................... 30 
APPENDIX 1D. OVERVIEW OF REINTEGRATION INTERVENTION: ECONOMIC EMPOWERMENT .................................................... 31 
INFORMED CONSENT, STUDY PARTICIPANTS: ENGLISH ........................................................................................ 32 
INFORMED CONSENT, STUDY PARTICIPANTS: LUGANDA .......................................... ERROR! BOOKMARK NOT DEFINED. 
INFORMED CONSENT, INTERVENTION STAFF AND MODERATORS ....................................................................... 37 
QUANTITATIVE INSTRUMENT..................................................................................... ERROR! BOOKMARK NOT DEFINED. 
PHYSICAL EXAMINATION & PHYSIOTHERAPY REFERRAL ........................................... ERROR! BOOKMARK NOT DEFINED. 
REFERENCES .................................................................................................................................................. 45 
 
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
List of Abbreviations 
 
BTQ: Brief trauma questionnaire 
CEmOC: Comprehensive Emergency Obstetric Care 
DASH: UCSF Open Data Repository 
DHS: Demographic and Health Surveys 
DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition 
FIGO: International Federation of Gynecologists and Obstetricians 
HE: Health education 
ICIQ: International Consultation on Incontinence Questionnaire  
ICJME: International Committee of Medical Journal Editors 
IDI: In-depth interview 
IRB: Institutional review board 
NGO: Non-governmental organization 
NIH: National Institutes of Health  
PC: Psychosocial counseling 
POFIRT: Post-fistula repair reintegration tool 
PI: Principal Investigator 
PM: Project manager 
PT: Physiotherapy 
QA: Quality assurance 
SOMREC: Makerere University School of Medicine Research and Ethics Committee 
UCSF: University of California San Francisco 
UNCST: Uganda National Council for Science and Technology 
WHO: World Health Organization 
WHO QOL-BREF: WHO quality of life assessment - brief  
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
PROJECT SUMMARY 
 
Female genital fistula affects an estimated 2-3 million women globally. Commonly caused by prolonged 
obstructed labor, female genital fistula has broad physical and psychosocial ramifications, and affected 
women are stigmatized due to incontinence of urine and/or feces. Despite successful surgery, physical 
disabilities and poor mental health may persist, making reintegration to family and community difficult 
for women. The purpose of this project is to conduct a pilot study of a reintegration intervention within 
the context of clinical fistula care with the objective of improving women’s physical and psychosocial 
recovery. The pilot test is a preliminary phase of a broader research agenda, and the primary outcomes 
of this study are intervention feasibility and acceptability. We will recruit 30 women to participate in the 
intervention at the time of fistula repair and will follow them for 6-months. All women will receive the 
intervention; no comparison group will be included at this stage of the research. Perspectives of up to 10 
additional key stakeholders will be sought. Such an intervention has important implications for improving 
women’s health following fistula repair, and may inform service provision for women who undergo 
surgical repair at the referral hospital level. The proposed intervention pilot lays the groundwork for a 
subsequent robust trial of intervention effectiveness on women’s post-surgical reintegration, physical and 
mental disabilities, and economic status which is the next step in our research program.  
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
STUDY GOALS AND OBJECTIVES 
 
Female genital fistula is a debilitating and traumatic birth injury that affects an estimated 2 to 3 million 
women, mostly in sub-Saharan Africa.1 Primarily due to prolonged obstructed labor from cephalopelvic 
disproportion or malposition combined with delays in accessing comprehensive emergency obstetric care, 
up to 100,000 new cases occur each year globally. During the obstruction process, ischemia from 
compression of soft vaginal, bladder or rectal tissue between the fetal head and pelvic bone results in 
necrosis, and a fistula is formed upon sloughing of this tissue.2 Women with fistula experience 
uncontrollable leakage of urine and or feces, which contributes to the development of genital sores and 
infection.3,4 In addition to pain and general weakness,5 women may experience nerve damage, cervical 
injuries and pelvic bone trauma which present as secondary infertility and gait disorders 6. For most 
deliveries resulting in fistula, the baby does not survive 7. Women with fistula are often stigmatized and 
marginalized from their families and communities and live in isolation, unable to participate in social, 
economic, or religious activities,5,7 and report high psychiatric morbidity including depression, which may 
persist after surgery.8-10 
 
Access to female genital fistula surgery has improved in sub-Saharan Africa overall, including in Uganda, 
the site for the proposed research. However, despite having undergone surgical repair, women may 
continue to face myriad physical and psychological challenges to resuming their previous roles or adjusting 
to new circumstances. They may also require further medical care depending on the severity of their 
injuries and surgical outcomes, and require health care access for subsequent pregnancies and births. 
Results from a formative research in Uganda revealed that by twelve-months post-surgery, one-third of 
women continued to experience urinary incontinence (32.8%), 17.2% reported weakness, and 8.6% 
reported general pain 11. Furthermore, experience of persistent physical symptoms was associated with 
substantially lower psychosocial health. For example, at twelve months, women with persistent physical 
symptoms had mean reintegration score of 21.9 points lower (95% CI -30.2, -13.5),12 mean self-esteem of 
21.2 points lower at twelve months (95% CI -30.1, -12.4), and mean quality of life of 22.5 points lower 
(95% CI -28.9, -16.1) compared to women with no persistent symptoms. These findings highlight the need 
for post-surgical reintegration and rehabilitation services; however, there remains a stark knowledge and 
practice gap around how to best assist women to reintegrate into their families and communities after 
surgery. Research to inform the reintegration process, evaluation, and service provision is of paramount 
importance; as is meeting the future health needs of women who have experienced female genital fistula.  
 
The current proposal seeks to address the gap in evidence-based practice for reintegration following 
female genital fistula surgery through pilot testing of a multi-component intervention compiled by our 
experienced team of clinicians and researchers. Building on the existing evidence around reintegration 
programming, it will comprise four components: health education, physical rehabilitation, psychosocial 
counseling, and economic empowerment. The pilot intervention is strengthened by our prior work among 
women with fistula, including our expertise in assessment of recovery from female genital fistula 
surgery.11,13-15 Our study objective is to understand feasibility and acceptability of the intervention in 
preparation for a subsequent effectiveness trial. Using a quasi-experimental design, we will pilot the 
intervention protocol among 30 women undergoing fistula surgery at Mulago/Kawempe Hospital, 
assessing feasibility and acceptability using a convergent mixed-methods approach, capturing data from 
up to 15 intervention participants and up to 10 key stakeholders (e.g., intervention moderators, providers, 
administrators). Our specific aims are as follows:  
 
SPECIFIC AIMS 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
Aim 1. To assess the feasibility of the pilot reintegration intervention. The intervention protocol will be 
piloted with 30 women seeking fistula care at Mulago/Kawempe Hospital in order to understand feasibility 
of the intervention and intervention assessment activities. Feasibility outcomes will include process 
assessment of recruitment and retention, data collection, outcome measures, study procedures, study 
resources and study management.  
 
Aim 2. To assess the acceptability of the pilot reintegration intervention. Within the pilot intervention 
study, we will assess the acceptability of the intervention to patients, intervention implementers, 
providers, and hospital administration. Acceptability domains to be assessed include affective attitude, 
burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy.  
 
Aim 3. To explore the preliminary effectiveness of the pilot reintegration intervention. Within the pilot 
intervention study, we will explore preliminary effectiveness of the intervention on increases in our 
primary outcome of reintegration score and secondary outcomes of quality of life and depression through 
1) comparison of baseline to six-month scores among intervention participants; and 2) comparison of six-
month reintegration, quality of life, and depression scores to six-month data from a different study among 
women who participated in a longitudinal cohort study of recovery and reintegration in the year following 
fistula repair.  
 
This proposed research is a first step in moving forward robust strategies for optimizing women’s health 
and quality of life following fistula repair, providing important information on feasibility and acceptability 
of a multi-component intervention to improve women’s physical and psychosocial quality of life in 
conjunction with fistula surgery within a referral hospital context.   
 
The results from the pilot study will be used to understand and improve feasibility and acceptability of the 
intervention package, and will inform the development of a subsequent project to test the effectiveness 
of the intervention among a robust sample size. Data from this study will be an important component of 
that next proposal.   
 
CENTRAL STUDY HYPOTHESIS. Our central study hypothesis is that the provision of reintegration 
assistance to women repaired for genital fistula incorporating health education, physiotherapy training, 
psychosocial counselling and economic empowerment will be feasible and acceptable to intervention 
recipients and stakeholders.  
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
BACKGROUND AND JUSTIFICATION 
 
Women living in sub-Saharan Africa are at the highest risk of developing female genital fistula. Due to 
complex interactions between medical, social, economic and environmental factors in sub-Saharan 
countries that limit women’s access to timely high-quality obstetric care, women living in these regions 
experience the highest rates of female genital fistula worldwide.16 While measurement of female genital 
fistula is notoriously challenging,17,18 the World Health Organization estimates that 2-3 million women are 
living with female genital fistula and up to 100,000 new cases occur each year globally.1 Recent 
population-based estimates indicate that between 0.1-2.0% of women of reproductive age have 
experienced female genital fistula across the region,19 with high proportions (2.0%; regional range 0.4%-
4.0%) observed in Uganda, the focal site of the proposed research.20 About 5,000 cases occur per year in 
Uganda.21 
 
The Ugandan health care system faces many challenges to preventing female genital fistula, including 
chronic shortage of qualified physicians and nurses and poor clinical infrastructure, particularly in rural 
areas.22 Other important factors associated with female genital fistula in Uganda include early marriage, 
low prevalence of modern contraceptive use (39%), high total fertility rate of 5.4, and high maternal 
mortality at 336 maternal deaths per 100,000 live births.23 From 2011 - 2016, 25% of births in Uganda 
occurred at home, and only 6% of births were delivered by cesarean section.23 National data on service 
availability is limited; however, the latest Demographic and Health Surveys Service Provision Assessment 
survey identified limited access to comprehensive emergency obstetric care with only 9% of facilities 
offering all 7 signal functions (life-saving services) and 47% of facilities having emergency transport.24 
 
Significant efforts have been made over the past decade to improve surgical capacity for female genital 
fistula in Uganda. A Ugandan national Fistula Technical Working Group was established in 2002 with 
representatives from the Ministry of Health, international and national NGOs, medical professionals and 
media. To date, much of their focus has been on increasing availability of fistula surgery; between 2010 
and 2013 the number of women who underwent female genital fistula surgery per year in Uganda 
increased from 1377 to 2019.25 Fistula surgery is available at 6 centers of excellence in Uganda, with 26 
trained surgeons at national and regional referral hospitals. Successful fistula repair ranges 50% - 90% at 
Mulago Hospital, depending upon fistula severity; regional literature suggests an overall success rate of 
approximately 70%.26 Despite this wonderful progress in increasing surgical access, very few additional 
services are being offered to women post-surgically, despite a demonstrated need.   
 
Due to the significant physical and psychological disabilities that women experience due to the fistula 
(Figure 1), targeted rehabilitation efforts are necessary to improve recovery and quality of women’s lives. 
In addition to severe tissue damage, obstructed labor resulting in fistula can cause nerve damage, injury 
to the uterine cervix and pelvic bone trauma which present as gait disorders, secondary infertility or other 
reproductive challenges such as increased rates of spontaneous abortion and stillbirth in future 
pregnancies.6,27-29 Many women report experiencing substantial general pain and weakness that persists 
even after surgery5,30 gynatresia and dyspareunia, and high rates of psychiatric morbidity including 
depression, which may not completely resolve after surgical treatment.2,5,8-10,31,32 Our formative research 
in Uganda revealed that by twelve-months post-surgery, one-third of women continued to experience 
urinary incontinence, 17% reported weakness, and 9% reported general pain.11 Furthermore, experience 
of persistent physical symptoms to be associated with substantially lower psychosocial health. For 
example, at twelve months, women with persistent physical symptoms had mean reintegration score of 
21.9 points lower (95% CI -30.2, -13.5) 12, mean self-esteem of 21.2 points lower at twelve months (95% 
CI -30.1, -12.4), and mean quality of life of 22.5 points lower (95% CI -28.9, -16.1) compared to women 

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Protocol version: 1.2 Date: 15 Feb 2021 
with no persistent symptoms. All of these factors limit women’s ability to resume their previous roles 
despite successful surgery, particularly in the context of economic hardship.33 However, despite a clear 
need for holistic fistula treatment programming, which would combine a broad range of other services in 
addition to surgery to assist women with recovery, the majority of fistula repair services are surgically-
based with little complementary or follow-up care. Treatment facilities generally recognize reintegration 
assistance as an important adjunct to surgery, yet inadequate and inconsistent implementation is 
problematic, and most interventions to date have focused on facility-based strategies where the 
sustainability of intervention impact is not known once women return to their communities.34-37 We 
present a conceptual framework informing intervention needs of women with fistula in Figure 1.  
 
To the best of our knowledge, the evidence-base on post-surgical multi-component interventions at the 
referral hospital level with the purposes of improving women’s reintegration, including support for both 
physical and mental health, is lacking. Evidence from Nigeria, Eritrea and Tanzania supports the use of 
short-term facility-based psychological intervention to improve women’s mental health,38-41 and evidence 
from the Democratic Republic of the Congo supports implementation of health education and 
physiotherapy for improved pelvic floor strength and reducing post-repair incontinence.42-45 While the 
specific value added of economic empowerment lacks robust evidence, it is theoretically and anecdotally 
considered an important adjunct of fistula programming,46,47 and is a primary feature of social 
programming external to the health care setting. 
 
We propose concurrently targeting four specific areas to improve the lives of women that have suffered 
from fistula including health education, physical rehabilitation, psychsocial therapy, and economic 
empowerment. Informed by theoretical frameworks adopted from the interdisciplinary fields of health 
behavior, women’s empowerment, and implementation science and the developing evidence base 
previously discussed, addressing each of these areas will assist women in overcoming the mental and 
physical disabilities that they may have suffered as a result of the fistula (physical rehabilitation and 
psychological therapy), ensure they are appropriately educated about fistula and reproductive health for 
optimizing recovery and enhancing post-repair health (health education) and address their economic 
needs to improve quality of life and prevent fistula recurrence in subsequent delivery by achieving the 
status and financial standing to access timely obstetric care (economic empowerment). In addition, 
certain components of our anticipated intervention will be directly targeted to women’s partners or close 
family members, who are important sources of social support and critical links between afflicted women 
and their communities. This will be the first rigorously designed and evaluated multi-component 
intervention to address all these theoretically important supports for female genital fistula reintegration 
to our knowledge. 
 
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
Figure 1. Conceptual Framework Informing Intervention Needs of Women with Genital Fistula 
 
 
APPROACH 
 
OVERVIEW OF STUDY DESIGN 
Given the pilot nature of the current project and our primary objective to understand intervention 
feasibility and acceptability outcomes, we propose a quasi-experimental design for the current study. The 
study is being done to inform the subsequent development of a cluster-randomized controlled trial to 
estimate impact on effectiveness; however, no randomization will be undertaken at this stage of the 
research, and all women enrolled in the study will participate in the intervention. Assessment of 
preliminary effectiveness (Aim 3) in the current pilot study is exploratory, and will include change over 
time from pre-surgery as well as comparison with existing data from similar women that was collected 
within the context of a different research study.  
 
STUDY SETTING 
Our research program seeks to improve physical and psychosocial outcomes of women undergoing 
surgery for female genital fistula in Uganda. The data collection activities for the pilot test of the 
intervention will be based at two hospitals in Kampala, Uganda: Mulago Specialized Women and Neonatal 
Hospital and Kawempe National Referral Hospital, as fistula repair surgeries are conducted at both of 
these locations by the same team. These facilities were selected based on volume of fistula repair and 
prior clinical and research collaboration. They provide fistula repair as an ongoing urogynecological 
service, supplemented by several annual fistula repair camps. Surgeons are International Federation of 
Gynecologists and Obstetricians (FIGO) certified fistula surgical trainers who routinely supervise trainees 
country-wide. From 2010 through 2015, an average of 190 women per year underwent genital fistula 
surgery at Mulago Hospital.49    
 
In this setting, the current standard of care for women accessing fistula surgery includes some 
unstructured health education and counseling on post-repair behaviors, and women are instructed on 
kegel exercises for pelvic floor strengthening. Women with significant needs are referred. However, these 
adjunct services are not offered as a structured program and referral is only made for the most severe 
cases, leaving women who might benefit from some psychological and physiotherapy services without.  
 

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Protocol version: 1.2 Date: 15 Feb 2021 
 
STUDY PARTICIPANTS 
Study participants will include 30 women who receive surgical care for female genital fistula at Mulago 
and Kawempe Hospitals in Kampala, Uganda. Women are referred to these services from providers at 
Mulago/Kawempe, nearby clinics or hospitals, or learn about the services from friends, relatives, and radio 
advertisements. Women will be considered eligible for participation after undergoing fistula surgery, if 
they are above age 18 or considered emancipated minors under Ugandan law, and if they are able to 
provide consent for the study. Up to 15 of the intervention recipients will be invited for subsequent in-
depth interview for a more nuanced understanding of their experience participating in the intervention 
and its impact; they will be purposively selected with variability in the range of outcomes observed in the 
quantitative data collection: reintegration score, depression/anxiety, and economic status.  This sample 
size has been selected for feasibility.  
 
Acceptability assessment (Aim 2) will incorporate interviews with up to 10 key stakeholders including 
facility staff implementing the intervention (n=3-5), providers working in fistula care at the facility, who 
will have spoken with women receiving the intervention but who have not directly delivered the 
intervention, (n=2-4) and hospital administrators who may have important insight on implementation of 
the intervention outside of a research context and its sustainability (n=1-2). This sample size has been 
selected for feasibility.  
 
One of our exploratory comparisons for preliminary effectiveness (Aim 3) will be among the same 
participants (pre-post); however, the other comparison will be with existing data collected during a 
longitudinal cohort study we conducted among 60 women undergoing fistula care at Mulago Hospital in 
2015-2016 and followed for a 1-year period.11,14  
 
RECRUITMENT AND ENROLLMENT 
Intervention recipients: Potential intervention recipients will be recruited for participation in the study at 
the fistula ward at Mulago/Kawempe. Given current and historical rates of women’s presentation for 
fistula care, we plan to recruit all women who present for care who meet our eligibility criteria. Our 
research staff will identify which women meet the eligibility criteria of the study based on personal 
knowledge, review of surgical logbooks and through discussion with other fistula ward personnel. Women 
will be approached for recruitment when identified as eligible, potentially several days prior to surgery. 
Study staff will describe the study goals and procedures, ensuring women’s understanding of the study 
procedures and risks, and ascertain women’s interest in participating through the informed consent 
process. Women who are interested in participating will be requested to provide written confirmation of 
consent through signature or thumbprint (with witness).  
 
Key stakeholders: 10-15 key stakeholders, who are individuals known the the study investigator team, will 
be invited for in-depth interview through in-person, phone, or email.  We will purposively select 
representation from a range of stakeholders including facility staff implementing the intervention (n=3-
5), providers working in fistula care at the facility (n=2-4) and hospital administrators (n=1-2). Individuals 
who are interested will be scheduled for interview, and the qualitative interviewer will lead the individual 
through the informed consent process prior to starting the interview.  
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
STUDY PROCEDURES 
Immediately after study enrollment, women will be requested to complete an interviewer-administered 
baseline questionnaire including sociodemographic characteristics, assessment of physical and 
psychosocial health and reintegration status. Follow-up data collection will occur at hospital discharge, 
6w, 3m, and 6m following surgery. Data collection at the 6-week time point will be conducted in-person 
as women come to the facility then for their clinical follow-up visits. Data collection at the 3 and 6 month 
study visits will be captured via mobile phone, which we have previously shown to be feasible and 
acceptable among this population,50 to reduce participant burden. Data on fistula characteristics and 
procedures will be abstracted from participant medical records and collected from providers. In order to 
facilitate study communication and follow-up data collection, women who do not possess a personal 
phone will be provided with one by the study, and $6 monthly airtime will be provided for the length of 
the study.  
 
The multi-component intervention incorporates health education, psychosocial counseling, physical 
therapy, and economic empowerment across the 14-day period that women typically stay at the facility 
for fistula surgery and through their 6-week and 3-month follow-up visits. The content, rationale and 
general delivery structure of each component is described in Table 1 below, with our detailed intervention 
timeline presented in Figure 1. 
 
Table 1. Specific Components of Post-Surgical Reintegration Intervention 
Component 
Content and rationale  
General delivery structure 
Health 
education 
The health education activities have been adapted from 
materials previously developed for health education and 
reproductive health counseling for women with fistula51 and 
generally for low-literate women, including counseling 
components developed by EngenderHealth’s FistulaCare project 
which were previously implemented in Eritrea.39,51 We have 
modified these materials for relevance, understandability, and 
acceptability to our target population as well as in consideration 
of participant burden for intervention participation.  
 
This health education sessions will focus on educational and 
behavioral messages to improve women’s understanding of 
fistula and important reproductive health topics including 
comprehensive information about the development, treatment 
and rehabilitation of fistula, family planning and birth plans for 
subsequent deliveries, identification of obstetric emergencies, 
and nutrition to allow women to make informed decisions.  
 
One session will include partners and/or primary caregivers who 
are helping women on the ward as they share the burden of 
fistula with their afflicted family member, are critical sources of 
social support and may serve as links between the afflicted 
woman and other community members. 
During women’s stay at the health 
facility for fistula repair, they will 
receive daily health education and 
counseling sessions. Total health 
education content averages to ~30 
minutes per day (with the exception of 
the day of surgery and the following 
day).  
 
Educational sessions comprise a total of 
15 different relevant topics (Appendix 
1A). 
 
Health education will be delivered by 
facility nurses/midwives in a group 
setting.  

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Protocol version: 1.2 Date: 15 Feb 2021 
Psychosocial  
counseling 
Psychosocial counseling activities build on therapeutic 
strategies previously developed for women with fistula1,38,39 and 
based on treatment modalities demonstrated to be efficacious 
for the treatment of depressive, anxiety and traumatic stress 
disorders among similar populations, and which may be 
delivered both individually and within group-administered 
therapy, including delivery by trained lay persons.52-58 Short-
term facility-based psychological intervention has resulted in 
improved mental health among women with fistula. 38,39  
 
 
During the 14 days that women stay at 
the health facility post-repair, they will 
participate in a total of six hours of 
group counselling sessions and two 
individual counseling sessions. Each of 
these sessions has been prepared to 
address an important component of 
helping women accurately reframe 
their fistula experience, and to prepare 
for returning home through developing 
plans for positive coping and 
development of social support 
(Appendix 1B). 
 
Psychosocial counseling will be 
delivered by the facility 
nurses/midwives or the facility social 
worker. Most content will be delivered 
in a group setting. Two sessions will be 
individual.   
 
Physiotherapy 
Targeted physical rehabilitation can be extremely helpful for 
women with fistula.5,42,59 This intervention component is based 
on programming developed by pelvic floor physiotherapists with 
expertise in the treatment of women with fistula.60 The program 
will comprise a sequential series of exercises focused on 
recovering mobility, balance and strength and building and 
maintaining 
pelvic 
floor 
musculature. 
A 
low-literacy 
instructional manual will be developed and provided to the 
women that they can follow after their hospital discharge to 
guide them through walking, range of motion, and strength 
building exercises to stabilize the muscles of the pelvic floor and 
lower lumbar spine.  
Instruction on the exercise series will be 
delivered in a group setting at hospital 
stay for fistula care and reviewed and 
progressed as appropriate at the 6-
week follow-up visit.  Individual 
assessment and additions will be made 
to this plan.  
 
The instruction will be delivered by 
trained physical therapists supported 
by facility nurses/midwives. Referrals 
will connect women to more intensive 
care as needed (i.e. in cases of foot 
drop or more severe mobility 
concerns). 
Economic 
empowerment 
Many women with fistula lack skills or investment funds to build 
home businesses, and many have depleted savings or incurred 
debt in care-seeking for fistula. Qualitative research suggests 
small businesses, animal husbandry, or skills training are 
desired,30 and supporting women in achieving their economic 
goals is necessary for improving their recovery and lives. 
Livelihood development programs are broadly accessible in 
Uganda,61,62 and women often have prior business experience 
that they would like to develop further, thus an investment 
funding combined with a short informational session on 
financial literacy was seen to be the optimal strategy to meet 
the individual needs of women.  
We will provide $150 in investment 
funding to each woman. This will be 
provided to the woman at her 6w post-
repair visit after having received a short 
informational session covering the 
basics of financial literacy.  
 
The instruction will be provided by the 
social worker, and s/he will follow-up 
with the participants to understand 
their use of the economic incentive, 
and provide any additional support they 
may need during study follow-up.    
 
 
A detailed intervention timeline by day is provided in Table 2 below, and the composition of each 
intervention session is detailed in Appendix 1, by component. During their time at the facility, women will 
spend approximately 75 minutes per day in total participating in the intervention sessions, largely within 
a small group context. For the purposes of this intervention, a small group is defined as anywhere between 
2-15 individuals. Given varied numbers of women attending fistula camps, and the fact that women may 
seek surgical care for fistula outside of fistula camps, we will seek but cannot guarantee balanced group 

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Protocol version: 1.2 Date: 15 Feb 2021 
size. However, for a feasibility study such as ours, we anticipate this will provide important information 
regarding optimal group size. Furthermore, in the event that women are the lone fistula patients, we will 
adapt the intervention content to an individualized setting. Two individual psychological counseling 
sessions will be delivered – the initial session pre-op and the final session prior to discharge. The health 
education and psychosocial counseling component of the intervention will occur within the fistula-repair 
hospital admission; however, the physiotherapy component will extend through the 6-week post-surgical 
visit, and the economic investment and associated informational session will be provided at the 6-week 
post-surgical visit.  

15 
Protocol version: 1.2 Date: 15 Feb 2021 
Table 2. Intervention Timeline 
Component 
Pre-op 1 
Pre-op 2 
Surgery 
Post-op 2 
Post-op 3 
Post-op 4 
Post-op 5 
Post-op 6 
Post-op 7 
Session No. 
1 
2 
& Post-Op 
1 
3 
4 
5 
6 
7 
8 
HE 
Admission and 
pre-op mgmt, 
30m 
Pre-op mgmt, 25m 
Surgery + Post-op Day 1: No intervention 
sessions 
Post-op mgmt, 
30m 
Repro system 
anatomy & 
function, 30m 
Fistula causes, 
30m 
Common fistula 
myths/misconcept 
30m 
Health and 
social 
consequences 
of fistula, 20m 
Fistula 
prevention, 40m 
PC 
Intro to counseling, 40m 
individual 
Explore fistula 
experience, 60m 
Cognitive 
reframing of fistula 
experience, 30m 
Identifying 
thoughts/emotio
ns, 40m Practice 
reframing 
problematic 
thoughts, 20m 
PT 
Intro to PT, 20m 
Mobility and pelvic floor assessment, 15m 
Daily: Breathing & functional mobility 
exercises, 15m 
 
Daily: Breathing & functional mobility exercises, 15m 
Total time 
75m + 40m ind 
75m + 40m ind 
0m 
75m 
75m 
75m 
75m 
75m 
75m 
 
Component 
Post-op 8 
Post-op 9 
Post-op 10 
Post-op 11 
Post-op 12 
Post-op 13 
Post-op 14 
Other Sessions 
Session No. 
9 
10 
11 
12 
13 
14 
15 
TBD 
HE 
Sexual/RH after 
fistula, 30m 
Family planning, 
30m 
Obstetric care, 30m 
Nutrition, 30m 
Post-discharge 
management, 30m 
Recap, 30m 
Recap, 30m 
Recap, 30m 
Health education 
for 
family/caretaker, 
60m 
PC 
Coping skills, 40m 
Social support 
and relationships, 
20m 
Planning for 
future, 60m 
Pre-discharge review, 60m 
individual 
Building social 
support with 
family/caretaker, 
60m 
PT 
Daily: Breathing & functional mobility exercises, 15m 
Daily: Breathing & functional mobility 
exercises, 10m 
Individual assessment, treatment plan, 40m 
Daily: Breathing & 
functional mobility 
exercises, 15m 
Individual 
assessment, 
treatment plan, 
40m @ 6w 
Total time 
75m 
75m 
75m 
75m 
75m + 40m individual 
45m + 40m ind 
45m + 40m ind 
EE: Economic empowerment component will be distributed at the 6-week visit 
HE: Health Education, PC: Psychosocial Counseling; PT: Physiotherapy; EE: Economic Empowerment 

16 
Protocol version: 1.2 Date: 15 Feb 2021 
Data collection 
The data collection timeline is displayed in Figure 2. As previously mentioned, baseline data and 6-week 
data will be collected in person, and subsequent interviews (3 and 6 months) will be administered over 
the phone. To facilitate data collection, participants will be provided with a basic telephone (adequate for 
texting and calls) if needed which they will keep even if they choose to stop participation in the study, and 
airtime sufficient for study participation and some discretionary use. Additional airtime will be provided 
monthly.   
 
We will collect the longitudinal data via surveys on intervention feasibility and acceptability, reintegration, 
mental health (i.e., quality of life, depression, traumatic stress, anxiety), physical health (incontinence), 
social support, stigma, and income measures (i.e., food security, income) through 6 months following 
surgery. Respondents will be re-interviewed about demographic questions that may change over time 
(i.e., partnership, labor force participation) to detect reverse causation. We do not anticipate issues 
around retention given the high retention rates seen in our own50 and other fistula studies.63  
 
We will conduct in-depth interviews (3-6m after surgery) among approximately 10-15 participants using 
an open-ended semi-structured guide to understand women’s experiences with the intervention, and to 
explore acceptability and effectiveness of each of the intervention components in a more nuanced and 
subjective manner. In-depth interview participants will be purposively selected for observed variability in 
outcomes observed during data collection, including reintegration score, depression/anxiety scores, 
economic status. 
 
In-depth interviews with key stakeholders (intervention implementers, providers, and hospital 
administration) will be conducted within this same timeframe to understand their perspectives on 
intervention acceptability.  
 
Figure 2. Data Collection Timeline 
 
 
STUDY MEASURES 
 
The intervention evaluation will use quantitative and qualitative methodologies, following Proctor’s 
implementation outcome framework, 64,65 including measures of acceptability, adoption, appropriateness, 
costs, feasibility, fidelity, penetration and sustainability.  
 
Quantitative: Process data will be collected on intervention participation and engagement in intervention 
components and intervention evaluation throughout to inform adoption, cost, fidelity, and penetration. 
We will collect longitudinal data via surveys on intervention acceptability and experiences, suggestions 
for improvement, and study outcomes: reintegration, mental health (i.e., quality of life, depression, 
traumatic stress, anxiety), physical health (incontinence), social support, stigma, income measures (i.e., 

17 
Protocol version: 1.2 Date: 15 Feb 2021 
food security, income) through 6 months. Table 2 below outlines the details of the measures. Respondents 
will be re-interviewed about demographic questions that may change over time (i.e., partnership, labor 
force participation) to detect reverse causation. The longitudinal design prevents biases inherent to 
retrospective studies. We do not anticipate issues around retention given the high retention rates seen in 
other female genital fistula studies,63 including our own previous research.50 The surveys will be read to 
respondents in the local language by interviewers who will follow-up with women via phone or in person. 
Medical record abstraction will be conducted to obtain data on surgical outcomes.  
 
Qualitative: Approximately 10-15 in-depth interviews with women will be conducted among intervention 
participants using an open-ended semi-structured guide to understand women’s experiences with the 
intervention, and to explore acceptability and effectiveness of each of the intervention components in a 
more nuanced and subjective manner. Additional interviews with key stakeholders will focus on their 
perspectives and reflections on intervention acceptability, appropriateness, feasibility, penetration, and 
potential for sustainability.  
 
   Table 2. Measures for intervention assessment 
A. Intervention 
Feasibility and 
Acceptability 
Proctor’s implementation science framework is being used to inform our implementation outcomes, 
and these measures will be assessed through quantitative and qualitative inquiry.64 Primary outcomes 
for the assessment are feasibility and acceptability; however, process data will be captured to inform 
all eight implementation outcomes. Feasibility of the intervention will be assessed through 
recruitment, retention, and adherence. Acceptability of the intervention will be assessed through 
satisfaction with the intervention overall and each component. Secondary implementation outcomes 
are as follows: adoption (intention to implement the intervention), appropriateness (perspectives on 
fit and relevance of the innovation to the patient, problem, and setting), costs, fidelity (delivery per 
intent). Penetration and sustainability will be assessed as potential.  
B. Demographics 
At baseline, information on education, age, marriage, labor force participation, income and wealth, 
financial and food security, debt, household composition (including number of living children), 
partnership status and fistula-specific questions (e.g., age at fistula, length of time with fistula) will be 
captured for all participants. At each 3-month data collection a shortened version of the demographic 
survey including those indicators that might have changed over time will be collected. Other measures 
incorporated within this section of the tool will include social support and perceptions of internal and 
external stigma. Social support will be evaluated by the multi-dimensional scale of perceived social 
support, previously adapted and validated in Uganda.66,67 Stigma will be evaluated using an adaptation 
of the HIV/AIDS Stigma Instrument (HASI-P), developed and validated in East Africa.68-70 
C. Reintegration 
Reintegration success will be evaluated objectively using two different instruments. The first is our 
recently developed standardized fistula reintegration success measure, the Post-Fistula Repair 
Reintegration Tool (POFIRT).12 The tool has high internal consistency reliability (α=0.87) and face 
validity.71 It is a 19-item instrument developed through qualitative work among key informants in 
Uganda combined with literature review, and incorporates measurement of physical mobility, 
satisfaction with self-care, participation in work and meeting personal and family needs, participation 
in social and religious activities, satisfaction with roles in family and community, and comfort with 
personal relationships. Because only preliminary evidence is available on the POFIRT tool, we will also 
use the WHO QOL BREF tool to measure quality of life,72 which has been already translated and 
validated in Luganda by Martin et al.73  
D. Mental Health 
Individual mental health measures will target depression, anxiety and traumatic stress, given the 
substantial rates of these morbidities reported by women with fistula.8,74-76 We will measure 
depression and anxiety using the Hopkins Symptom Checklist, which has been used in Uganda77-80 and 
translated and validated in Luganda.81 History of traumatic experiences will be measured by the Brief 
Trauma Questionnaire (BTQ).82-86 Symptoms of trauma will be measured by the PCL-5, a 20-item self-
report measure that assesses the 20 DSM-5 symptoms of PTSD and is used to monitor symptom change 
during and after treatment. 87-91 In addition, women will subjectively rate mental health.    

18 
Protocol version: 1.2 Date: 15 Feb 2021 
E. Physical Health and 
Health Behaviors 
Physical health will be assessed using the Stanford Self-Rated Health measure for general health92, the 
International Consultation on Incontinence Questionnaire (ICIQ),93 the WHO Disability Adjustment 
Scale 2.0,94 and a list of individual fistula-specific symptoms. 
 
Health knowledge and behaviors: Understanding, retention, intent, and behaviors related to health 
education messaging content will be captured via survey.  
 
Adherence: Home implementation of physiotherapy program will be assessed through self report at 
all non-baseline surveys.    
 
SAMPLE SIZE  
 
Our sample size of 30 participants with fistula and up to 1 key stakeholders for the pilot study has been 
calculated based on feasibility.95  
 
DATA ANALYSIS PLANS 
 
Quantitative data. Data from surveys will be entered into a password-protected database. Confidentiality 
will be protected by secure data handling. Data quality practices will include range and logical checks built 
into data entry, double entry, and error checks. We will examine overall status at each time point for each 
variable, investigate patterns and types of missing data and non-response, and inspect distributions of 
mediating and outcome variables to identify outlying or unusual values and assess distributional 
characteristics. Data analysis: We will describe respondent characteristics and primary outcomes (Aims 
1&2 - acceptability and feasibility; section a in Table 2) using frequency tables and descriptive statistics 
(e.g. means, standard deviations, medians, inter-quartile ranges, and proportions). Preliminary 
effectiveness (Aim 3) will be conducted by bivariate comparisons of pre vs. post assessments (within our 
main sample) of reintegration score (primary), quality of life and depression (secondary) and comparison 
between our external control group using similar data from the same time since surgery using the 
appropriate distributional tests (paired sample t-test and Stuart-Maxwell tests for pre-post comparison, 
and two sample t-test and chi-square test for external comparison).    
 
Qualitative data will be recorded and transcribed, and translated into English (if necessary). Thematic 
analysis will involve a two-stage process 96: First, data will be  coded and classified with transcript review 
for potential conceptual categories, using the guideline questions as initial categories. Two types of codes 
will be employed. Deductive codes that represent expected influences on the outcomes will be applied to 
the data: these will be taken from from our qualitative guide informed by Proctor’s framework.64 Inductive 
codes emerging organically from the data will be applied: these codes will represent themes unexpected 
by the researchers and will be identified by recurrence rate and on similarities and differences across the 
texts. A codebook will include a detailed description of each code, inclusion and exclusion criteria, and 
examples of the code in use. Coded data will be analyzed to describe the different dimensions and 
commonalities of each theme, their distribution across participant type and the patterns and linkages 
between themes. This will allow us to build concepts grounded in the data to explain phenomena. 
Comparisons will be made with the data to detect divergent views among the participants and to contrast 
observations that relate to variables within the sample population. 
 
 
 

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Protocol version: 1.2 Date: 15 Feb 2021 
TIMELINE 
 
The planned study timeline is detailed below. We hope to begin participant recruitment in Dec 2020 and 
anticipate reaching our target sample size within four months. Baseline data collection will occur at 
recruitment, thus will span this full time period. Data collection for 6w, 3m, and 6m time points are 
detailed below. Quantitative analysis will occur throughout data collection, with analysis finalized in 
September 2021. Qualitative data collection will occur from Feb – Jul 2021, with concurrent analysis. 
Integration of quantitative and qualitative analyses will be done in Sept – Oct 2021. We plan to develop 
our research proposal for a larger trial to test effectiveness of the intervention from Aug – Oct 2021, 
submitting to the U.S. National Institutes of Health in October 2021.  
 
Table 3. Study timeline, October 2020 – October 2021 
2020 
2021 
  
Oct  
Nov 
Dec 
Jan 
Feb 
Mar 
Apr 
Mar 
Jun 
Jul 
Aug  
Sep 
Oct 
IRB review 
X 
X 
X 
X 
X 
Staff training on intervention 
protocol 
X 
X 
X 
Participant recruitment  
X 
X 
X 
Quantitative data collection 
Data collection, baseline 
X 
X 
X 
Data collection, 6w 
X 
X 
X 
Data collection, 3m 
X 
X 
X 
Data collection, 6m 
X 
X 
X 
Data analysis 
X 
X 
X 
X 
Qualitative data collection  
In-depth interviews, staff 
X 
X 
In-depth interviews, providers 
X 
X 
In-depth interviews, participants 
X 
X 
Data analysis 
X 
X 
X 
X 
X 
X 
X 
Manuscript preparation 
X 
X 
X 
Proposal development 
  
  
  
  
  
  
  
  
  
  
X 
X 
X 
 
 
 
 

20 
Protocol version: 1.2 Date: 15 Feb 2021 
SAFETY MONITORING PLAN  
 
POTENTIAL RISKS TO HUMAN SUBJECTS 
Potential risks to participants as a result of the pilot study are anticipated to be minimal. Participation is 
voluntary and participants may decide to discontinue the study at any time. As patients may be sharing 
potentially distressing experiences and emotional status, they will be provided with counseling within the 
program, and information on accessing mental health services beyond the program will be shared. Risks 
to privacy due to personal nature of some questions will be minimized by asking closed ended questions 
over the phone and conducting in-depth interviews in a private location.  
 
Potentially identifying data that will be collected from participants include names, dates, postal addresses, 
phone numbers, email addresses, and medical record numbers.  
 
The proposed pilot intervention carries a minimal level of risk; however, we will prioritize participant and 
data safety, and will implement the following plans for monitoring of our pilot study. No Data and Safety 
Monitoring Board will be implemented for the current project due to the nature of the intervention and 
the focus on feasibility and acceptability; however, the PIs and Co-Investigators will closely monitor data 
and safety related risks to human subjects. Serious adverse events will be reported promptly to the 
Makerere School of Medicine Research Ethics Committee, the UCSF IRB and the NIH project officer. Risks, 
monitoring procedures, reporting, and action plans are described below for data and safety-related risks. 
 
DATA AND SAFETY MONITORING  
 
Data-related risks. Potential data-related risks to participants include circumstances where insufficient 
data was collected for answering the research questions or high/systematic attrition in the trial or 
intervention participation affecting receipt of adequate intervention dose.  
 
Data monitoring procedures. Overall recruitment goals will be monitored monthly, as well as missing data 
and follow-up failures. Ongoing monitoring of study progress will be coordinated by Dr. Alison El Ayadi, 
ScD, Co-PI. No personal identifiers will be included within our databases or in audio recordings of our 
interviews/focus groups, but linkable identifiers exist separately and the data may be sensitive in nature 
(e.g., mental health, incontinence status, gender-based violence) such that disclosure could provide some risk 
to the individual. The codes will be stored on a computer that is password protected with a secure server.  
Transfer or storage on portable devices (e.g., laptops, flash drives) is encrypted. The devices on which this 
information is stored are accessible only to individuals who need access to these data. Data will not be 
destroyed until all analyses are complete. Identifiable data will be stored for the amount of time required 
by the ethical review board.  After that point, paper copies will be shredded and electronic copies will be 
deleted, per UCSF and Makerere policy.  A de-identified dataset with associated documentation will be 
made available to research users, hosted within the UCSF Open Data Repository (DASH).   
 
Data-related risk reporting and action plan. Research assistants will be responsible for compiling numbers 
of participants recruited, completing required assessments, maintaining databases, and identifying 
missing data and missing follow-up assessments. Research assistants will prepare recruitment and missing 
data reports for weekly review by the PIs and Co-Is. All data will be de-identified and stored on a firewall-
protected server. Upon recognition of unacceptable recruitment or follow-up rates, or of missing data, 
the Co-PIs will intervene with strategies to remedy the shortcomings. Intervention completion rates will 
be monitored.   

21 
Protocol version: 1.2 Date: 15 Feb 2021 
 
Safety-related risks. Safety-related risks may include: 1) sensitivity related to questioning about physical 
and psychological health, 2) release of confidential information about the participant, and 3) recognition 
of the need for treatment for physical or psychological health concerns.  
 
Safety monitoring procedures. All safety-related risks will be routinely monitored at assessment or 
intervention session. The security of confidential information will be monitored regularly. Research 
assistants and intervention moderators will be trained in asking questions about sensitive topics in a caring 
and non-threatening manner and will stop questioning at the first sign of discomfort or on request. Privacy 
and confidentiality will be emphasized in intervention sessions with facilitators requesting that 
participants agree to respect the privacy and confidentiality of other group member, and not to disclose 
information shared with the group in confidence to anyone outside of the group. Participants will be 
informed that confidentiality will be maintained for survey and in-depth interview responses. Research 
assistants will be trained to identify a participant who reports any physical or psychological health 
concerns, and protocols will be developed to refer participants for treatment.  
 
Safety-related risk reporting and action plan. Research assistants and intervention moderators will report 
any breaches of confidentiality risks to the Project Coordinator who will then inform the PIs. Any 
participant in need of treatment due to physical or psychological health concern will be referred for 
appropriate services per protocol, and the Project Coordinator and PIs will be informed. The PI will be 
responsible for informing the IRBs through IRB adverse reporting procedure, and the Project Officer 
through immediate email for life-threatening incidents and through annual report of other incidents per 
IRB policy. The PI will take appropriate action to stop the study, release a participant from the study, or 
modify procedures to reduce and/or eliminate the abovementioned risks if they occur at an unacceptable 
level. 
 
Adverse events. Adverse events will be tracked and referral and follow-up will occur. An adverse event 
form will be developed to record each incident, actions taken, supervisor notes, and follow-up steps. The 
form, supplemented by any notes, will be sent immediately to appropriate agencies, including the IRBs, 
and NIH, with any action recommended by IRB conveyed to the NIH.  
 
Reporting. All problems related to participant safety will be reported to the Makerere University College 
of Health Sciences School of Medicine Research and Ethics Committee and the UCSF Committee on Human 
Research and the Committee by the PI within 7 working days. Specifically, we will report in writing: 1) all 
serious adverse events associated with study procedures, and 2) any incidents or problems involving the 
conduct of the study or patient participation, including problems with recruitment or consent processes. 
The PI will provide a discussion of any side effects or problems noticed in the course of the study to the 
Committee on Human Research on an annual basis. 
 
TRAINING, QUALITY ASSURANCE (QA) AND SUPERVISION 
 
The investigators are experienced in staffing, training, and supervising clinical research studies, including 
behavioral intervention trials. Our current QA proposal is based on this experience.  
 
Data collector training. Research assistants will be selected based on their prior experience with data 
collection and familiarity with the study population. We will develop a training manual for the training 
and ongoing supervision of research staff. An initial training to be led by the PIs and Co-Is will cover: 1) 

22 
Protocol version: 1.2 Date: 15 Feb 2021 
general research interviewing skills; 2) specific training relevant to this study; 3) extensive training in 
research ethics and human subjects’ protection certification; and 4) observed practice and certification as 
research assistants. 
 
Assessment quality assurance. The PIs and PM will oversee the QA of data collection and provide feedback 
and supervision as appropriate. 
 
Intervention training. A training workshop occurs for all intervention staff, and an intervention manual 
will guide the training and ongoing supervision. This training includes detailed overviews of the 
intervention approach and procedures, the content covered, and general topics related to intervention 
research and research ethics. Techniques for adhering to a manualized intervention while allowing 
flexibility to address individual participant needs will be taught, role-played, and supplemented by 
instructional readings. Ongoing training will provide updates and troubleshooting on the content area and 
address any individual supervision or procedural issues in intervention implementation. 
 
Quality assurance of intervention procedures. Intervention fidelity is crucial to maintaining internal 
validity in intervention trials. Given the nature of the intervention and the clinical issues that arise with 
this population, facilitators are clinically trained and have knowledge in clinical trials and behavioral 
science. QA procedures of intervention delivery across facilitators and over time during the course of the 
study include: 1) development of detailed manuals for each of the sessions; 2) intensive training; 3) 
incorporation of mock sessions that enable us to ensure that moderators meet performance criteria for 
intervention delivery, leading to certification of staff based on common performance standards; and 4) 
QA feedback are incorporated into routine supervision. 
 
Supervision. Separate weekly supervision meetings will be held for data collection and intervention staff, 
covering progress of the study assessment and intervention protocol problems, providing a setting for 
staff support and development, and an atmosphere conducive to constructive discussions of dealing with 
problematic participants and situations. The investigators and project coordinator will schedule individual 
supervision meetings as appropriate. 
 
POTENTIAL BENEFITS TO HUMAN SUBJECTS 
Participants may directly benefit from participation in the intervention if the intervention activities 
improve their physical and psychosocial symptoms, and improve their quality of life. Potential benefits to 
society are the development of a model implementable within a referral facility level that can be 
implemented to improve women’s fistula-related outcomes.  
 
PAYMENT 
Participants will be provided with a phone and airtime throughout the length of the study, and 
transportation to and from all clinic visits will be provided. The phone will be kept by the participant after 
the study is completed (or the participant withdraws from participation). Intervention participants in the 
nested qualitative research will receive refreshments during the in-depth interviews, be paid the 
equivalent of $20 in cash for their participation and will have any transportation-related expenses 
reimbursed.  
 
ETHICS REVIEW 
Approval to carry out this study will be sought from the Makerere University College of Health Sciences 
School of Medicine research and Ethics Committee (SOMREC) and the Uganda National Council for Science 
and Technology (UNCST). In the US, we will submit for ethical review at the University of California, San 

23 
Protocol version: 1.2 Date: 15 Feb 2021 
Francisco Committee on Human Research.  Any modifications after initial approval will be reported to the 
ethical review board(s), trial registry, and all investigators, and approval for modifications will be sought.   
 
DISSEMINATION PLAN 
The study team plans to communicate trial results to participants where possible through community 
meetings and to healthcare professionals and researchers via presentation of findings via academic 
conferences and publication in peer-reviewed, scholarly journals. Lastly, we will maintain the engagement 
of several key stakeholders in the development and dissemination of this project, including in data 
interpretation and ongoing analyses throughout the trial.  We will use the International Committee of 
Medical Journal Editors (ICMJE) criteria for authorship.  
 
 
 

24 
Protocol version: 1.2 Date: 15 Feb 2021 
APPENDICES 
 
We include the following appendices: 
1. Detailed intervention plan 
a. Health education 
b. Psychological counseling 
c. Physiotherapy 
d. Economic empowerment 
2. Informed consent form for study participants 
3. Informed consent for key stakeholders (moderators, providers) 
4. Study instrument 
5. Physical assessment instrument  
6. In-depth interview guide  
7. Physical examination and physiotherapy referral 
 
 
 

25 
Protocol version: 1.2 Date: 15 Feb 2021 
Appendix 1A. Overview of Reintegration Intervention: Health Education Sessions 
Session 
Objective 
Length 
Timinga 
Delivery1 
1. Admission and Preoperative 
Management: Preparing for Upcoming 
Surgery and Recovery (Part 1) 
• 
Introduce patients to fistula 
• 
Introduce patients to care providers  
• 
Provide a comprehensive overview of 
procedure, risks, and outcomes 
• 
Address any patient concerns and 
questions about procedure and 
recovery 
30m 
Pre-op  
Day 1 
Group 
2. Admission and Preoperative 
Management: Preparing for Upcoming 
Surgery and Recovery (Part 2) 
• 
Familiarize patients to the patient ward 
and the surgical theatre  
• 
Discuss preoperative preparations  
• 
Discuss postoperative management 
• 
Address any patient concerns and 
questions about procedure and 
recovery 
30m 
Pre-op  
Day 2 
Group 
Surgery Day 0 
Post-op Day 1 
3. Overview of Postoperative 
Management 
• 
To discuss outcomes of surgery 
• 
To discuss postoperative care 
management at the facility 
• 
Address any patient concerns and 
questions 
30m 
Day 2 
(post-op) 
Group 
4. Reproductive system anatomy and 
function  
• 
Familiarize participants with the female 
reproductive system and female pelvis, 
anatomy and functions 
30m 
Day 2 
(post-op) 
Group 
5. Development of Fistula 
• 
Identify the causes of obstetric fistula 
30m 
Day 4 
(post-op) 
Group 
6. Common Myths and Misconceptions 
about Fistula 
• 
To dispel any common rumors and 
myths about obstetric fistula  
• 
To explaining how these may hamper 
women’s ability to prevent fistula and to 
access treatment 
30m 
Day 4 
(post-op) 
Group 
7. Health and Social Consequences of 
Fistula 
• 
To identify and discuss the health 
consequences of fistula 
• 
To identify and discuss the social 
consequences of fistula 
20m 
Day 6 
(post-op) 
Group 
8. Fistula Prevention  
• 
To discuss ways to prevent obstetric 
fistula after repair  
• 
To introduce birth spacing  
40m 
Day 6 
(post-op) 
Group 
 
1 Where group is indicated but women are in undergoing fistula repair without other fistula patients concurrently 
on the ward, they will receive a modified version of the activity appropriate for delivery to the individual.   

26 
Protocol version: 1.2 Date: 15 Feb 2021 
9. Sexual and Reproductive Health after 
Fistula 
• 
To educate patients on sexual health 
• 
To familiarize participants reproductive 
tract issues 
• 
To identify personal timelines for family 
planning and fertility preferences 
30m 
Day 8 
(post-op) 
Group 
10. Family Planning 
• 
To identify different family planning 
methods  
• 
To dispel myths and misconceptions 
regarding contraceptives 
• 
To facilitate discussion of which family 
planning method might be right for the 
participant 
30m 
Day 8 
(post-op) 
Group 
11. Future Obstetric Care 
• 
To understand the components and 
reasons for antenatal care during 
pregnancy 
• 
To recognize the danger signs during 
pregnancy 
• 
To discuss the importance of planning 
and preparation for safe delivery 
• 
Facilitate participant creation of birth 
plan 
30m 
Day 10 
(post-op) 
Group 
12. Nutrition 
• 
To understand optimizing nutrition for 
recovery 
30m 
Day 10  
(post-op) 
Group 
13. Post-discharge management  
• 
To identify ways on how to take care of 
herself at home 
• 
To discuss the importance of follow-up 
visits 
• 
To recognize surgical warning after 
discharge 
• 
Facilitate participants in creating a 
complication 
30m 
Day 12 
(post-op) 
Group 
14. Recap of Health Education Sessions 
• 
To prepare the patient for her return 
home, which maximizes the likelihood 
of a positive reintegration experience. 
• 
To review all of the materials and 
information discussed during the health 
education sessions 
• 
For participants to share their 
experiences, ask questions 
30m 
Day 12, 13, 
or 14 
(post-op) 
Group 
15. Health Education Counseling for the 
Participant’s Family &/ Caretaker 
(optional) 
• 
To communicate patient’s health 
condition and treatment (only if 
requested to be shared with family 
member(s) &/or caretaker 
• 
To communicate any risks and possible 
side effects 
• 
To address any concerns and questions 
brought up by patient’s social support 
• 
To identify warning signs  
• 
To develop plan in case of complications 
60m 
TBD  
Group 

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Protocol version: 1.2 Date: 15 Feb 2021 
• 
To provide guidance on how to support 
patient at home 
• 
To discuss sexuality after surgical repair 
• 
To discuss reproductive tract and 
sexually transmitted infections  
 
Appendix 1B. Overview of Reintegration Intervention: Psychological Counseling Sessions 
 
Session 
Objective 
Length 
Timinga 
Delivery2 
1. Introduction to Psychological 
Counseling 
• 
Introduction to counseling 
• 
Assessing the patient's needs and 
concerns 
• 
Set Initial Treatment Plan/Goals 
• 
Facility nurse will determine if patient is 
ready for group counseling session. 
 
40m 
Pre-op  
Individual 
Surgery Day 0 
Post-op Day 1 
2. Exploring the Fistula Experience  
• 
To get familiar to each other 
• 
To normalize the patient’s experience 
• 
To acknowledge the negative and 
possible positive impacts of the fistula 
experience on relationships with others 
• 
To begin exploration of how the 
patient’s experience of an obstetric 
fistula impacts her feelings and thoughts 
about herself 
 
60m 
Day 3 
(post-op) 
Group 
3. Cognitive reframing the Fistula 
Experience  
• 
To promote cognitive reframing of the 
fistula experience through medical 
education 
• 
Help the patient reframe her personal 
narrative 
 
60m 
Day 5 
(post-op) 
Group 
4. Identifying Thoughts and Emotions 
• 
To introduce the patient to the 
cognitive-behavioral model 
• 
To begin teaching patient how to 
reframe negative or unhelpful thoughts 
• 
Review key emotions 
• 
Identify negative and problematic 
thoughts 
• 
Link thoughts to resulting emotions 
60m 
Day 7 
(post-op) 
Group 
 
2 Where group is indicated but women are in undergoing fistula repair without other fistula patients concurrently 
on the ward, they will receive a modified version of the activity appropriate for delivery to the individual.   

28 
Protocol version: 1.2 Date: 15 Feb 2021 
• 
Begin practicing reframing problematic 
thoughts 
• 
To manage the emotions associated 
with their situation 
5. Develop Coping Strategies  
• 
To help the patient to recognize and 
respond to stressors in her life by 
utilizing appropriate and effective 
coping skills. 
• 
Discuss the patient’s negative vs. 
positive coping strategies 
• 
Coach patient to recognize stressors and 
respond by utilizing appropriate and 
effective coping skills. 
 
40m 
Day 9 
(post-op) 
Group 
6. Explore Social Relationships  
• 
To examine the effect of social 
relationships on the patient’s life 
• 
To generate specific strategies to 
strengthen social relationships 
• 
Discuss how one’s social network 
influences thoughts and feelings 
• 
Formulate strategies to expand and 
optimize patient’s social support 
network 
• 
Review tools to discuss her condition 
with others 
• 
To practice communication skills. 
• 
Mobilize home support by identifying 
partner &/ caregiver to participate in 
optional combined counseling session  
 
20m 
Day 10 
(post-op) 
Group 
7. Planning for the Future  
• 
To prepare the patient for her return 
home, which maximizes the likelihood of 
a positive reintegration experience. 
• 
Make practical plans for the patient’s 
return to her community 
• 
Discuss the possibility of incomplete 
cure & post-surgery medical 
recommendations 
60m 
Day 11 
(post-op) 
Group 
8. Patient Pre-discharge Assessment  
• 
Review therapy action plan and discuss 
progress in reaching goals 
• 
Patient assessment and addressing 
patient's remaining needs and concerns 
• 
Identify if patient requires additional 
psychiatric counseling/emotional 
support/medication if patient suffers 
from trauma-related fistula 
 
60 
minutes 
Day 13 or 4 
(post-op) 
Individual 

29 
Protocol version: 1.2 Date: 15 Feb 2021 
9. Building Social Support Opportunities 
(OPTIONAL) 
• 
Intended to facilitate social support for 
patient returning home after repair 
60m 
Offered 
between 
days 10-15 
(post-op) 
Group 
(with 
patient 
and 
partner &/ 
caretaker) 
 

30 
Protocol version: 1.2 Date: 15 Feb 2021 
Appendix 1C. Overview of Reintegration Intervention: Physical Rehabilitation Sessions  
 
Session 
Objective 
Length 
Timing 
Delivery3 
1. Introduction to Physical Therapy 
• 
Introduction to physical therapy 
• 
Introduction to functional pelvic 
anatomy  
• 
Goal setting and expectations 
• 
Introduce breathing exercises 
• 
Assessment of mobility and pelvic floor 
function 
35m 
Day 1 (pre-
op) 
Individual 
2. Breathing & functional mobility 
exercises 
• 
Breathing exercises 
 
15m 
Day 1 and 2 
(pre-op) 
Individual 
Surgery Day 0 
Post-op Day 1 
3-8. Breathing & functional mobility 
exercises for Acute/Inflammatory Phase 
• 
Functional mobility exercises 
• 
Diaphragmatic breathing exercises to 
load the pelvic floor without straining 
the healing tissues 
• 
Sub-maximal pelvic floor muscle 
exercises while lying in bed 
15m 
Days 2-7 
(post-op) 
Group 
9-14. Breathing & functional mobility 
exercises for Sub-Acute Phase 
• 
Functional mobility exercises 
• 
Diaphragmatic breathing exercises 
• 
Sub-maximal to maximal pelvic floor 
muscle exercises 
• 
Exercises for the abdominal, hip and low 
back muscles 
• 
Stretching areas of scar tissue and 
muscle and joint tightness (or 
contracture) 
15m 
Days 8-13 
(post-op) 
Group 
15. Physical Therapy for Sub-Acute Phase 
with Treatment Plan for Discharge 
• 
Group: Same objectives from Sessions 
9-14 
• 
Individual: Patient assessment 
(functional mobility, external and 
internal pelvic floor assessment), and 
development of home treatment plan 
15m 
40m 
Day 14 
(post-op) 
Group and 
Individual 
Follow-up 
• 
Physical assessment 
• 
Reinforcement/adjustment of exercises 
60m 
6w, 3m  
Individual 
 
 
 
 
3 Where group is indicated but women are in undergoing fistula repair without other fistula patients concurrently 
on the ward, they will receive a modified version of the activity appropriate for delivery to the individual.   

31 
Protocol version: 1.2 Date: 15 Feb 2021 
Appendix 1D. Overview of Reintegration Intervention: Economic Empowerment 
Session 
Objective 
Length 
Timing 
Delivery 
1. Livelihood assessment 
• 
Support patient skills development OR 
business investment ($150 value)  
30m 
6w visit 
(post-op) 
Individual 
 
 
 

32 
Protocol version: 1.2 Date: 15 Feb 2021 
MULAGO WOMEN & NEONATAL SPECIALISED HOSPITAL/KAWEMPE NATIONAL REFERRAL HOSPITAL 
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH OBSTETRIC FISTULA 
INFORMED CONSENT 1, INTERVENTION PARTICIPANTS: ENGLISH 
 
Study Title: Comprehensive Reintegration Assistance for Women with Obstetric Fistula 
Participant number: ……………………………………. 
 
Research Project Directors: 
Justus Barageine, MBChB, MMed, PhD, Senior lecturer/ Obstetrician, 
Gynaecologist and fistula surgeon 
Makerere University College of Health Sciences, Mulago Hill Road, 
Kampala, Uganda 
Phone: +256 702 454 869 Email: barageinej@gmail.com 
 
Alison El Ayadi, ScD, MPH, Associate Professor of Obstetrics, 
Gynecology and Reproductive Sciences 
UCSF, 550 16th Street, San Francisco, CA 94158 
Phone: 415.659.8367 Email: alison.elayadi@ucsf.edu 
 
This is a research study focused on how to help women recover and reintegrate to their families and 
communities after genital fistula surgery. The study researchers, Justus Barageine, PhD, MD, from 
Makerere University School of Medicine, Uganda, and Alison El Ayadi, ScD MPH from the University of 
California San Francisco, USA, or their representative, will explain this study to you.  
 
STUDY SUMMARY 
 
Introduction: We are asking you to consider taking part in a research study being done by Alison El Ayadi 
at UCSF and Justus Barageine at Makerere University.  
 
The first part of this consent form gives you a summary of this study. We will give you more details about 
the study later in this form. The study team will also explain the study to you and answer any questions 
you have. 
 
Purpose of the study: The purpose of this study is to pilot test a multicomponent intervention to help 
women reintegrate to their families and communities after genital fistula surgery to understand 
feasibility, acceptability, and preliminary effectiveness.  
 
You are being asked to take part in this study because you have recently undergone surgery for female 
genital fistula or are confirmed for female genital fistula surgery in the upcoming days.  
 
Study Procedures: The study participants will participate in health education, psychosocial counseling, 
and physical therapy sessions during the duration of their fistula care hospitalization and at their follow-
up care visits. In addition, facilitation of livelihood training or an economic investment will be made.  
 
If you choose to be in this study, the researchers will ask you to complete several questionnaires on your 
social and demographic characteristics, your physical and mental health, and related experiences.  
 

33 
Protocol version: 1.2 Date: 15 Feb 2021 
You will be in this study for approximately six months. The research team will help you to complete the 
first questionnaires while you are still at the hospital for surgery and when you return for your follow-up 
visits. They will call you by phone to complete the additional questionnaires, or you may come to the 
facilitiy in person if you prefer that. This means you will be asked to complete a total of five questionnaires, 
at study enrollment, hospital discharge, 6 weeks, 3, and 6 months. We expect that the questionnaires will 
take approximately 1 hour each to complete. A subset of participants will also be asked to participate in 
in-depth interview to discuss their experiences with participating. If you are selected to participate in this 
component, participation time will be approximately 1-2 hours longer.   
 
Possible risks: Risks to being in the study include discussion of emotional or sensitive experiences which 
may be emotionally upsetting to you, and risks to privacy based on the group-oriented intervention 
delivery approach. For more information about risks and side effects, ask one of the researchers.  
 
Possible benefits: Benefits of the study include the educational and counseling content that you will be 
provided with, physiotherapy, and the economic investment. Additionally, the information that you 
provide will help us to understand the impact of a pilot intervention for improving women’s recovery and 
reintegration experiences following surgery for genital fistula.  
 
Your other options: You do not have to participate in this study.  
 
Following is a more complete description of this study. Please read this description carefully. You can ask 
any questions you want to help you decide whether to join the study. If you join this study, we will give 
you a signed copy of this form to keep for future reference. 
 
DETAILED STUDY INFORMATION 
 
Research studies include only people who choose to take part. Please take your time to make your 
decision about participating, and discuss your decision with your family or friends if you wish.  If you have 
any questions, you may ask the researchers. 
 
You are being asked to take part in this study because you have recently undergone surgery for female 
genital fistula or are confirmed for female genital fistula surgery in the upcoming days.  
 
Why is this study being done?  
The purpose of this study is to pilot test a multicomponent intervention to help women reintegrate to 
their families and communities after genital fistula surgery.  
 
This study is funded by the U.S. Eunice Shriver Kennedy National Institute of Child Health and 
Development.  
 
How many people will take part in this study?  
We will pilot test the intervention with 30 women.  
 
What will happen if I take part in this research study?  
If you choose to be in this study, the following procedures will occur:  
• 
The researcher or their proxy will ask you to complete a baseline survey that describes your social 
and demographic characteristics, your physical and mental health, and related experiences.  

34 
Protocol version: 1.2 Date: 15 Feb 2021 
• 
You will attend individual sessions on health education, psychosocial counseling and 
physiotherapy during your hospitalization for fistula surgery. 
• 
You will attend physiotherapy at your 6w visit. 
• 
At hospital discharge, the researcher or their proxy will ask you to complete a survey on your 
treatment experiences and outcomes.  
• 
The researcher or their proxy will provide you with a phone if you do not have one to help you 
participate in the study, and will pay for airtime.  
• 
You will have the opportunity to participate in a livelihood training program or receive 
investments funds for a small business.  
• 
The researcher or their proxy will follow up with you at 6w, 3m and 6m to ask you to complete a 
follow-up survey to understand your current physical and mental health, and related experiences. 
This may be done in-person or on the phone, depending on your clinical care. If you prefer to 
respond to the survey in person, please tell the researcher and they will help to coordinate this.  
• 
You may be asked to participate in an in-depth interview at 6 months to discuss your experiences 
with intervention participation.  
• 
Your data may be used to respond to subsequent research questions after removing all identifying 
information.   
 
Study location  
Research-team administered interviews will take place either in-person in a private location at 
Mulago/Kawempe Hospitals, or over the phone. 
 
How long will I be in the study?  
You will be in this study for approximately six months. Each questionnaire will take approximately one 
hour to complete. In-depth interview will take between 1-2 hours to complete. 
 
Can I stop being in the study?  
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you 
wish to stop being in the study. Also, the study researcher may stop you from taking part in this study at 
any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study 
is stopped.  
 
What side effects or risks can I expect from being in the study? 
We do not anticipate any side effects or risks from being in the study; however, the research questionnaire 
does include questions about your experience with fistula, your physical and emotional status, which may 
be emotionally distressing to discuss. If you believe that discussing these topcis will be distressing for you, 
you can decide not to participate in the study. In the event you choose to participate in the study and find 
that discussing these events is too difficult for you, you may pause of stop the interview. The interviewer 
may decide to pause or stop the interview if they sense that you are very upset. Furthermore, they may 
refer you to a mental health professional if you feel that speaking with someone might help. Furthermore, 
there may be risks to privacy based on the group-oriented intervention delivery approach. For more 
information about risks and side effects, ask one of the researchers  
 
Are there benefits to taking part in the study?  
You will receive health education and direct care: counseling and physiotherapy. Additionally, you will be 
given assistance in starting up a small livelihood project. Furthermore, the information that you provide 

35 
Protocol version: 1.2 Date: 15 Feb 2021 
will help health professionals to test the impact of a reintegration program for women undergoing surgery 
for female genital fistula.  
 
What other choices do I have if I do not take part in this study?  
You are free to choose not to participate in the study. If you decide not to take part in this study, there 
will be no penalty to you. [If relevant: You will not lose any of your regular benefits, and you can still get 
your care from our institution the way you usually do.] 
 
How will my information be used?  
Researchers will use your information to understand the feasibility and acceptability of the intervention, 
and compare your physical and mental health status combined with data from other women to 
understand intervention effectiveness. Any personally-identifying information collected for this study will 
only be used for this study. Data with no personally-identifying information may be used to answer 
additional related research questions.  
 
Research results: There may be times when researchers using your information may learn new 
information. The researchers may or may not share these results with you, depending on a number of 
factors. If researchers learn new findings that may affect your decision to remain in the study, you will be 
informed about them. 
 
Will information about me be kept private? We will do our best to make sure that the personal 
information gathered for this study is kept private. However, we cannot guarantee total privacy. Your 
personal information may be given out if required by law. If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be used.  
 
Authorized representatives from the following organizations may review your research data for the 
purpose of monitoring or managing the conduct of this study:  
 
• 
Representatives of Mulago Hospital or Makerere University 
• 
Representatives of University of California  
• 
Representatives of National Institutes for Health  
 
Are there any costs to me for taking part in this study?  
There is no cost to taking part in this study.  
 
Will I be paid for taking part in this study?  
In return for your time and effort, you will be provided with a phone and monthly airtime in the amount 
of 20,000 Ugandan Shillings (UgX) to help you participate in the study and as a token of our thanks for 
having participated in this study. Additionally you will be assisted to start up a small livelihood project. 
We will also cover your transportation costs to and from the facility for fistula repair at your 6-week 
clinical follow-up, and for any participation in in-depth interview. In-depth interview participants will 
receive an additional 40,000 UgX as participation incentive    
 
What are my rights if I take part in this study?  
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. 
If you decide to take part in this study, you may leave the study at any time. No matter what decision you 
make, there will be no penalty to you in any way. [If relevant: You will not lose any of your regular benefits, 
and you can still get your care from our institution the way you usually do.]  

36 
Protocol version: 1.2 Date: 15 Feb 2021 
 
Who can answer my questions about the study?  
You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. 
Contact Dr. Justus Barageine at +256 702 454 869.  
 
 
If you wish to ask questions about the study or your rights as a research participant to someone other 
than the researchers or if you wish to voice any problems or concerns you may have about the study, 
please call the Makerere University College of Health Sciences School of Medicine research and ethics 
committee Chair, Assoc Professor Ocama Ponsiano, on Telephone +256, 0772494120 or the Secretariat at 
Uganda National Council for Science and Technology, Plot 3 Kimera Road, Ntinda on telephone 041-705-
513.  
 
STATEMENT OF CONSENT  
I have read or have been read to this consent form and I have fully understood the study purpose, 
procedures, benefits and the risks involved and I have been given a chance to ask questions and they have 
been fully answered. I also understand that my participation in this study is voluntary and I will not be 
penalised or lose any benefits to which am otherwise entitled if I decline to participate in the study. I too 
understand that am free to withdraw from the study any time if I so wish and that I will be given a copy 
of this consent form to keep.  
 
I hereby sign below as proof of my consent. 
 
 
 
 
 
Date  
 
 
 
 
Participant's name and Signature or thumbprint  
 
 
 
 
 
Date  
 
 
 
 
  Witness’s name and signature if Participant used a thumbprint 
 
 
 
 
 
Date  
 
 
 
 
 Name and signature of a Person Obtaining Consent 
 
 
 
May we contact you for participation in future studies? 
 
___Yes  
___No 
 
 
 

37 
Protocol version: 1.2 Date: 15 Feb 2021 
MULAGO WOMEN & NEONATAL SPECIALISED HOSPITAL/KAWEMPE NATIONAL REFERRAL HOSPITAL 
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH OBSTETRIC FISTULA 
INFORMED CONSENT, INTERVENTION STAFF AND MODERATORS 
 
Study Title: Comprehensive Reintegration Assistance for Women with Obstetric Fistula 
Participant number: ……………………………………. 
 
Research Project Directors: 
Justus Barageine, MBChB, MMed, PhD, Senior lecturer/ Obstetrician, 
Gynaecologist and fistula surgeon 
Makerere University College of Health Sciences, Mulago Hill Road, 
Kampala, Uganda 
Phone: +256 702 454 869 Email: barageinej@gmail.com 
 
Alison El Ayadi, ScD, MPH, Associate Professor of Obstetrics, 
Gynecology and Reproductive Sciences 
UCSF, 550 16th Street, San Francisco, CA 94158 
Phone: 415.659.8367 Email: alison.elayadi@ucsf.edu 
 
This is a research study focused on the feasibility and acceptability of an intervention to help women 
recover and reintegrate to their families and communities after genital fistula surgery. The study 
researchers, Justus Barageine, PhD, MD, from Makerere University School of Medicine, Uganda, and 
Alison El Ayadi, ScD MPH from the University of California San Francisco, USA, or their representative, will 
explain this study to you.  
 
DETAILED STUDY INFORMATION 
 
Research studies include only people who choose to take part. Please take your time to make your 
decision about participating, and discuss your decision with your family or friends if you wish.  If you have 
any questions, you may ask the researchers. 
 
You are being asked to take part in this study because you either participated in delivering the pilot 
intervention or work in the department/facility where the pilot intervention was delivered.  
 
Why is this study being done?  
The purpose of this study is to understand the feasiblility and acceptability of a multicomponent 
intervention to help women reintegrate to their families and communities after genital fistula surgery.  
 
This study is funded by the U.S. Eunice Shriver Kennedy National Institute of Child Health and 
Development.  
 
How many people will take part in this study?  
We will pilot test the intervention with 30 women, and up to 10 stakeholders (intervention moderators, 
providers) will participate in in-depth interviews.   
 
What will happen if I take part in this research study?  
If you choose to be in this study, the following procedures will occur:  

38 
Protocol version: 1.2 Date: 15 Feb 2021 
• 
The researcher or their proxy will ask you to participate in an in-depth interview regarding your 
perspectives on the pilot intervention. They will ask you a series of questions about your 
perspectives on the intervention overall, its components, and how it fits within the setting.  
 
Study location  
Research-team administered interviews will take place either in-person in a private location at 
Mulago/Kawempe Hospitals, or at another mutually agreed upon location. 
 
How long will I be in the study?  
The interview will take approximately 1 hour.  
 
Can I stop being in the study?  
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you 
wish to stop being in the study.  
 
What side effects or risks can I expect from being in the study? 
We do not anticipate any side effects or risks to you from being in the study given your role as key 
stakeholder. 
 
Are there benefits to taking part in the study?  
You will receive no individual benefits to participating in the study; however, you will be contributing to 
research which seeks to improve women’s health and well-being following fistula repair.  
 
What other choices do I have if I do not take part in this study?  
You are free to choose not to participate in the study. If you decide not to take part in this study, there 
will be no penalty to you.  
 
How will my information be used?  
Researchers will use your information to understand the feasibility and acceptability of the intervention. 
Data on your role will be used to contextualize the findings, but personally-identifying information will 
not be used.  
 
Will information about me be kept private? We will do our best to make sure that the personal 
information gathered for this study is kept private. However, we cannot guarantee total privacy. Your 
personal information may be given out if required by law. If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be used.  
 
Authorized representatives from the following organizations may review your research data for the 
purpose of monitoring or managing the conduct of this study:  
 
• 
Representatives of Mulago Hospital or Makerere University 
• 
Representatives of University of California  
• 
Representatives of National Institutes for Health  
 
Are there any costs to me for taking part in this study?  
There is no cost to taking part in this study.  
 
Will I be paid for taking part in this study?  

39 
Protocol version: 1.2 Date: 15 Feb 2021 
In return for your time and effort, you will be compensated with 40,000 UgX.    
 
What are my rights if I take part in this study?  
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. 
If you decide to take part in this study, you may leave the study at any time. No matter what decision you 
make, there will be no penalty to you in any way.  
 
Who can answer my questions about the study?  
You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. 
Contact Dr. Justus Barageine at +256 702 454 869.  
 
 
If you wish to ask questions about the study or your rights as a research participant to someone other 
than the researchers or if you wish to voice any problems or concerns you may have about the study, 
please call the Makerere University College of Health Sciences School of Medicine research and ethics 
committee Chair, Assoc Professor Ocama Ponsiano, on Telephone +256, 0772494120 or the Secretariat at 
Uganda National Council for Science and Technology, Plot 3 Kimera Road, Ntinda on telephone 041-705-
513.  
 
STATEMENT OF CONSENT  
I have read or have been read to this consent form and I have fully understood the study purpose, 
procedures, benefits and the risks involved and I have been given a chance to ask questions and they have 
been fully answered. I also understand that my participation in this study is voluntary and I will not be 
penalised or lose any benefits to which am otherwise entitled if I decline to participate in the study. I too 
understand that am free to withdraw from the study any time if I so wish and that I will be given a copy 
of this consent form to keep.  
 
I hereby sign below as proof of my consent. 
 
 
 
 
 
Date  
 
 
 
 
Participant's name and Signature  
 
 
 
 
 
Date  
 
 
 
 
 Name and signature of a Person Obtaining Consent 
 
 
 
 
 
 
 

40 
Protocol version: 1.2 Date: 15 Feb 2021 
MULAGO WOMEN & NEONATAL SPECIALISED HOSPITAL/KAWEMPE NATIONAL REFERRAL HOSPITAL 
COMPREHENSIVE REINTEGRATION ASSISTANCE FOR WOMEN WITH OBSTETRIC FISTULA 
QUALITATIVE INFORMED CONSENT 2, STUDY PARTICIPANTS: ENGLISH 
 
Study Title: Comprehensive Reintegration Assistance for Women with Obstetric Fistula 
Participant number: ……………………………………. 
 
Research Project Directors: 
Justus Barageine, MBChB, MMed, PhD, Senior lecturer/ Obstetrician, 
Gynaecologist and fistula surgeon 
Makerere University College of Health Sciences, Mulago Hill Road, 
Kampala, Uganda 
Phone: +256 702 454 869 Email: barageinej@gmail.com 
 
Alison El Ayadi, ScD, MPH, Associate Professor of Obstetrics, 
Gynecology and Reproductive Sciences 
UCSF, 550 16th Street, San Francisco, CA 94158 
Phone: 415.659.8367 Email: alison.elayadi@ucsf.edu 
 
This is a research study focused on how to help women recover and reintegrate to their families and 
communities after genital fistula surgery. The study researchers, Justus Barageine, PhD, MD, from 
Makerere University School of Medicine, Uganda, and Alison El Ayadi, ScD MPH from the University of 
California San Francisco, USA, or their representative, will explain this study to you.  
 
STUDY SUMMARY 
 
Introduction: We are asking you to consider taking part in a research study being done by Alison El Ayadi 
at UCSF and Justus Barageine at Makerere University.  
 
The first part of this consent form gives you a summary of this study. We will give you more details about 
the study later in this form. The study team will also explain the study to you and answer any questions 
you have. 
 
Purpose of the study: The purpose of this study is to explore the experiences of a multicomponent 
intervention to help women reintegrate to their families and communities after genital fistula surgery to 
understand feasibility, acceptability, and preliminary effectiveness.  
 
You are being asked to take part in this study because you have recently undergone surgery for female 
genital fistula and have participated in the initial component of the reintegration intervention.  
  
 
Study Procedures: The study participants will be asked to come to the study site to participate in indepth 
interviews where they will share their experiences with the intervention, and to explore acceptability and 
effectiveness of each of the intervention components in a detailed manner.  
 
 

41 
Protocol version: 1.2 Date: 15 Feb 2021 
You will be in this part of the study for approximately 1-2 hours. If you choose to be in this study, the 
researchers will ask you to meet at [local fistula repair facility] Hospital or at another convenient 
private location to have a conversation about your experiences with participating in the various 
intervention components The research team will facilitate the indepth interview and will be audio 
recording the entire interview so as not to miss any important information that you will be sharing during 
the interviews. However caution will be taken not to mention your name or any personal identifiers on 
the recording to ensure confidentiality.  
Possible risks: Risks to being in the study include discussion of emotional or sensitive experiences which 
may be emotionally upsetting to you, You can pause or stop participating at any time, and you may be 
referred to a mental health professional for counseling if desired.  
. For more information about risks and side effects, ask one of the researchers.  
 
Possible benefits: There may be no direct benefits in taking part in this study component but, the 
information that you provide will help us to understand the impact of a pilot intervention for improving 
women’s recovery and reintegration experiences following surgery for genital fistula.  
 
Your other options: You do not have to participate in this study.  
 
Following is a more complete description of this study. Please read this description carefully. You can ask 
any questions you want to help you decide whether to join the study. If you join this study, we will give 
you a signed copy of this form to keep for future reference. 
 
DETAILED STUDY INFORMATION 
 
Research studies include only people who choose to take part. Please take your time to make your 
decision about participating, and discuss your decision with your family or friends if you wish.  If you have 
any questions, you may ask the researchers. 
 
You are being asked to take part in this study because you have recently undergone surgery for female 
genital fistula and have participated in the initial component of the reintegration intervention.  
.  
 
Why is this study being done?  
The purpose of this study component is to understand women’s experiences participating in the multi 
component reintegration intervention after genital fistula surgery and to explore your views about the 
feasibility and acceptability of the intervention  
This study is funded by the U.S. Eunice Shriver Kennedy National Institute of Child Health and 
Development.  
 
How many people will take part in this study?  
We will invite about 15 women to participate in indepth interviews at the study site.  
 
What will happen if I take part in this research study?  
If you choose to be in this study, the following procedures will occur:  
• 
The researcher or their proxy will ask you to participate in an in-depth interview so as to discuss 
your experiences with intervention participation and to explore your views about acceptability 
and feasibility of the intervention.  

42 
Protocol version: 1.2 Date: 15 Feb 2021 
• 
Your data may be used to respond to subsequent research questions after removing all identifying 
information.   
 
Study location  
The indepth interviews will take place  in a private location at Mulago Hospitals. 
 
How long will I be in the study?  
You will be in this study for approximately 1-2 hours... 
 
Can I stop being in the study?  
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you 
wish to stop being in the study. Also, the study researcher may stop you from taking part in this study at 
any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study 
is stopped.  
 
What side effects or risks can I expect from being in the study? 
We do not anticipate any side effects or risks from being in the study; however, the questions asked during 
the indepth interviews may be emotionally distressing to discuss. If you believe that discussing these 
topics will be distressing for you, you can decide not to participate in the study. In the event you choose 
to participate in the study and find that discussing these events is too difficult for you, you may pause of 
stop the interview. The interviewer may decide to pause or stop the interview if they sense that you are 
very upset. Furthermore, they may refer you to a mental health professional if you feel that speaking with 
someone might help. For more information about risks and side effects, ask one of the researchers. 
 
Are there benefits to taking part in the study?  
There may be no direct benefits for participating in this study but the information that you provide will 
help health professionals to test the impact of a reintegration program for women undergoing surgery for 
female genital fistula.  
 
What other choices do I have if I do not take part in this study?  
You are free to choose not to participate in the study. If you decide not to take part in this study, there 
will be no penalty to you. [If relevant: You will not lose any of your regular benefits, and you can still get 
your care from our institution the way you usually do.] 
 
How will my information be used?  
Researchers will use your information to understand your experiences participating in the intervention 
and to explore your views about the feasibility and acceptability of the intervention. Any personally-
identifying information collected for this study will only be used for this study. Data with no personally-
identifying information may be used to answer additional related research questions.  
 
Research results: There may be times when researchers using your information may learn new 
information. The researchers may or may not share these results with you, depending on a number of 
factors. If researchers learn new findings that may affect your decision to remain in the study, you will be 
informed about them. 
 
Will information about me be kept private? We will do our best to make sure that the personal 
information gathered for this study is kept private. However, we cannot guarantee total privacy. Your 

43 
Protocol version: 1.2 Date: 15 Feb 2021 
personal information may be given out if required by law. If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be used.  
 
Authorized representatives from the following organizations may review your research data for the 
purpose of monitoring or managing the conduct of this study:  
 
• 
Representatives of Mulago Hospital or Makerere University 
• 
Representatives of University of California  
• 
Representatives of National Institutes for Health  
 
Are there any costs to me for taking part in this study?  
There is no cost to taking part in this study.  
 
Will I be paid for taking part in this study?  
In return for your time and effort, you will be compensated with 40,000 UgX as participation incentive 
and also be reimbursed for your transport to and from the facility for fistula repair.  
 
What are my rights if I take part in this study?  
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. 
If you decide to take part in this study, you may leave the study at any time. No matter what decision you 
make, there will be no penalty to you in any way. [If relevant: You will not lose any of your regular benefits, 
and you can still get your care from our institution the way you usually do.]  
 
Who can answer my questions about the study?  
You can talk to the researcher(s) about any questions, concerns, or complaints you have about this study. 
Contact Dr. Justus Barageine at +256 702 454 869.  
 
 
If you wish to ask questions about the study or your rights as a research participant to someone other 
than the researchers or if you wish to voice any problems or concerns you may have about the study, 
please call the Makerere University College of Health Sciences School of Medicine research and ethics 
committee Chair, Assoc Professor Ocama Ponsiano, on Telephone +256, 0772494120 or the Secretariat at 
Uganda National Council for Science and Technology, Plot 3 Kimera Road, Ntinda on telephone 041-705-
513.  
 
STATEMENT OF CONSENT  
I have read or have been read to this consent form and I have fully understood the study purpose, 
procedures, benefits and the risks involved and I have been given a chance to ask questions and they have 
been fully answered. I also understand that my participation in this study is voluntary and I will not be 
penalised or lose any benefits to which am otherwise entitled if I decline to participate in the study. I too 
understand that am free to withdraw from the study any time if I so wish and that I will be given a copy 
of this consent form to keep.  
 
I hereby sign below as proof of my consent. 
 
 
 
 
 

44 
Protocol version: 1.2 Date: 15 Feb 2021 
Date  
 
 
 
 
Participant's name and Signature or thumbprint  
 
 
 
 
 
Date  
 
 
 
 
  Witness’s name and signature if Participant used a thumbprint 
 
 
 
 
 
Date  
 
 
 
 
 Name and signature of a Person Obtaining Consent 
 
 
 
May we contact you for participation in future studies? 
 
___Yes  
___No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

45 
Protocol version: 1.2 Date: 15 Feb 2021 
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2012. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COVID 19 RISK MANAGEMENT PLAN FOR THE STUDY TITLED, “COMPREHENSIVE REINTEGRATION 
ASSISTANCE FOR WOMEN WITH FEMALE GENITAL FISTULA: INTERVENTION PILOTING 
STUDY SUMMARY 
Title of research project: Comprehensive Reintegration Assistance for Women with Female Genital Fistula: 
Intervention Piloting 
Research objectives 
Objective 1: To assess the feasibility of the pilot reintegration intervention. 
Objective 2: To assess the acceptability of the pilot reintegration intervention. 
Objective 3: To assess the preliminary effectiveness of the pilot reintegration intervention.  
Research design 
This study employs a quasi-experimental design that aims at understand intervention feasibility and 
acceptability outcomes, using both quantitative and qualitative research designs which involves conducting 
structured interviews with 30 study participants and 15 in-depth qualitative interviews with key stake 
holders and study participants 
Study population and site 
We will recruit 30 women to participate in the intervention at the time of fistula repair and will follow 
them for 6-months. All women will receive the intervention; no comparison group will be included at this 
stage of the research. 15 women will be invited to participate in the indepth interviews plus some key 
stakeholders (intervention implementers, providers, and hospital administration) in order to understand 
their perspectives on intervention acceptability.  
 
THE COVID 19 RISK MANAGEMENT PLAN FOR THE STUDY 
BACKGROUND 
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus which 
spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or 
sneezes. (WHO 2020)  
COVID 19 symptoms 
The COVID-19 disease symptoms include the following: Fever, cough, myalgia or fatigue, shortness of 
breath, sore throat and headache. Other COVID 19 symptoms may include: flu-like symptoms, diarrhoea 
and nausea, muscle ache, loss of taste, pneumonia and Acute Respiratory Distress Syndrome (ARDS), renal 
failure, pericarditis and Disseminated Intravascular Coagulation (DIC). (MOH 2020).  

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Protocol version: 1.2 Date: 15 Feb 2021 
Objectives of the risk management plan 
The risk management plan objective is to detail steps that will to be taken to reduce the risk of getting 
COVID 19 by both the study team and the study participants. 
MEASURES TO BE PUT IN PLACE AT THE STUDY SITE  
Protective Measures to be taken on arrival at the study site 
Hand washing or sanitisation 
All study staff members and study participants will have to first wash or sanitise their hands before entering 
the study room. The sanitisers, water and soap will be availed at the study site entrance.  
Measurement of the body temperature 
All study staff and study participants’ body temperatures will be measured daily by one of the available 
study using the temperature monitor availed by the study. Any person whose temperature will be above 
37.5 degrees Celsius will be isolated and referred for further investigations within the hospital.  
Use of Personal protective equipment  
The study staff and study participants will have to put on medical face masks at all times covering the nose, 
mouth and chin plus face shields to avoid direct contact with body fluids, secretions (including respiratory 
secretions) and non-intact skin. The medical face masks and face shields will be provided by the study to 
any study staff and study participants who do not have them. 
Maintaining social distancing  
At the study site waiting area plus the rooms where the consenting, interviewing, counselling, health 
education and physiotherapy training sessions will take place, chairs will be placed at least 2 meters apart 
to maintain social distancing between the study staff and the study participants. Both the study staff and 
the study participants will be required to keep on their face masks and shields with the nose, mouth and 
chin completely covered through-out the entire sessions.  
Maintaining the working environment clean 
The study rooms will be kept clean by mopping the floor on a daily basis plus sanitizing tables, chairs, door 
locks, filing cabins using water and alcohol solutions before and after working with each study participant.  
The study staff will sanitise the chairs, tables and pens to be used during the consenting and interviewing 
process before and after handling each study participant. 
Proper ventilation of the rooms will be ensured by keeping the windows and ventilators of the room wide 
open. 
Safe waste management  

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Protocol version: 1.2 Date: 15 Feb 2021 
Used disposable masks will be removed safely and disposed appropriately in infectious waste bins that will 
be provided by the study to avoid transmission of infections.  
Implementation 
The above risk management plan is going to be implemented after having a practical training session with 
the study staff and before commencement of any study recruitment activities. 
References 
Ministry of Health 2020, National guidelines for management of COVID 19 
WHO 2020, Corona virus, https://www.who.int/health-topics/coronavirus#tab=tab_1