Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Phase: NA
Conditions: Maternal Behavior, Alcohol Drinking, Fetal Conditions
Sponsor: RTI International

April 11, 2024 
 
NCT05747599 
 
Adapting and Testing a 
Behavioural Intervention to 
Prevent FASD and Adverse Infant 
Outcomes (MaRISA+) 
 

FASD Prevention Study. Version 1. 23 August 2023 
 
APPENDIX 3 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse 
infant outcomes 
 
INFORMATION AND CONSENT 
 
Introduction 
Hello. My name is____________________. I am from the South African Medical Research Council 
(SAMRC). We are asking you to take part in our study because you are either pregnant, or postpartum 
with a recent history of alcohol and tobacco/cannabis use. The information in this consent form will give 
you the necessary details about this study to help you decide whether you would like to take part or not. 
If you have any questions, which are not fully explained in this document, please do ask the study staff. 
You should not agree to take part unless you are happy about all that is involved.  
 
Why are we doing this? 
We want to adapt and test an intervention to decrease polysubstance use (i.e., alcohol and 
tobacco/cannabis) during pregnancy and breastfeeding and to prevent adverse clinical outcomes, 
including Fetal Alcohol Spectrum Disorders (FASD).  
 
What We’re Asking of You 
If you agree to participate, you will be one of 48 women (24 pregnant and 24 postpartum women) who 
have a recent history of using alcohol, tobacco, or cannabis during your current pregnancy or while you 
are breastfeeding. You will be required to complete 3 interviews as part of your participation: a screening 
interview, a baseline interview, and a 3-month follow-up interview. While enrolled in the study, you will 
be asked a series of questions during these 3 interview appointments. In addition, you will be asked to 
provide a blood sample and a urine sample at screening and once per month until the completion of your 
time in the study. You will also be asked to participate in a Post-testing qualitative interview. You will 
spend approximately one hour at each interview. Your time and inputs are very important to us since they 
will help us improve this program for future studies. 
 
Potential Risks and Discomforts.   
We don't anticipate any risks associated with taking part in this study. You might, however, feel 
uncomfortable providing biological samples or responding to certain interview questions. If you feel 
uncomfortable, please let a member of the study staff know. We want you to be aware that you will never 
be pressured to answer any questions or forced to provide biological samples. Participation is fully 
voluntary. You have the right to stop participation in the study at any time, decline to give biological 
samples, and/or decline to participate in an interview. We ensure you that if you decided to no longer 
participate in this study, your decision will not be held against you in any kind of way. 
 
Potential Benefits of Taking Part in the Study.   
There are no direct benefits to you for participating in this study , but the information you provide will 
help us gain a better understanding of how to develop an appropriate intervention.  
 
Confidentiality and Privacy. 
Any information obtained will remain confidential. It will be disclosed only as required by law in the 
following two instances: 1) If you tell us that you are about to hurt yourself or someone else 2) or if you 

FASD Prevention Study. Version 1. 23 August 2023 
 
are involved in the neglect and/or abuse of a child. In either case, we must report that information to the 
appropriate authorities. The consent and contact forms will be stored separately to transcripts in locked 
file cabinets. The South African MRC ethics committee will however have access to all data. Deidentified 
data will be shared with the funding body NIH and archived with NIH according to their policy. 
We will use the data from the interviews to write up and publish papers in academic journals, but this 
data will be anonymized (we will use a participant number instead of your name). Your name will 
therefore not appear anywhere in any published material. 
 
There is a small possibility that a person may gain access to the information you gave us without our 
permission. Every effort will be made to protect your privacy and no personal details or names will be 
used during the interview. 
 
Participation and Withdrawal. 
Participation is voluntary. You can choose not to participate.  If you decide to participate, you may choose 
to stop your participation at any time. There will be no consequences. Your decision to take part or not 
take part in this study will not affect your usual antenatal or post-partum care at your healthcare facility.  
You may also refuse to answer any questions you do not want to answer.   
 
Who is funding the study? 
The study is being conducted by the South African Medical Research Council and RTI International and 
funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of 
Health (NIH).  
 
Compensation 
While taking part in this study, you will be required to meet with study staff at the health facility once a 
month to provide a urine and dry blood sample that will be tested for alcohol, tobacco, cannabis and other 
substances. You can receive R200 for testing negative for each substance in your first month of 
participation in the research. Following that, your earnings will increase by R50 till the study is completed. 
However, if your sample tests positive for a substance, your earnings will be reduced back to R200. 
Additionally, you will be compensated R200 for completing screening and a baseline assessment and R300 
for completing the follow-up assessment at the end of the study. 
 
Who to Contact with Questions 
This study has been approved by the South African MRC Ethics Committee. The study will be conducted 
according to the ethical guidelines and principles of the International Declaration of Helsinki, and the 
South African Guidelines for Good Clinical Practice. 
 
If you have any questions or concerns about the research, please contact Dr Yukiko Washio Principal 
investigator: ywashio@rti.org or Dr Petal Petersen-Williams Site Principal Investigator: 
petal.petersen@mrc.ac.za 
 
 
Mental Health, Alcohol, Substance use and Tobacco Research Unit 
 
 
 
Medical Research Council  
 
 
 
 
P.O. Box 19070 
Tygerberg  
7505 
Tel. 021-938 0337 
 

FASD Prevention Study. Version 1. 23 August 2023 
 
 
Rights of Research Participants 
You can decide you do not want to participate at any time.    If you have any questions about your rights 
as a participant, you can contact the chairperson of the MRC ethics committee, Ms. Adri Labuschagne at 
021 938 0687 or email: adri.labuschagne@mrc.ac.za.   
 
Indicating Consent 
Please let us know if you have any questions before signing this consent form.  Please initial next to each 
item to show that you agree to what is required: 
 
Agree 
 
 
I agree to continue in the study, which has been fully described to me. This means that 
I agree to answer questions today  
 
I agree to provide my contact information 
 
I understand that my participation in this study is completely voluntary, and there will 
be no penalty if I choose not to participate. 
 
 
In accordance with the provisions of the Protection of Personal Information Act 4 of 2013 (as 
amended), I hereby consent: 
a. 
To my personal information (hereinafter 'data') being collected, processed, shared and stored in 
accordance with the research protocol as approved by the South African Medical Research Council's 
Human Research Ethics Committee (SAMRC HREC); 
b. 
To my anonymised data being shared, processed and transferred by third parties and between third 
parties, and where relevant beyond the jurisdictional borders of South Africa; 
c. 
To all findings and results flowing from my anonymised data being broadly shared and published on 
the conclusion of the research. 
 
DECLARATION BY PARTICIPANT 
By signing below, I, ____________________________ (Participant’s Full Name) agree to take part in the 
MRC Study. 
I declare that: 
• 
I have read or had read to me this information and consent form and it is written in a language 
with which I am fluent and comfortable. 
• 
I have had a chance to ask questions and all my questions have been adequately answered. 
• 
I understand that taking part in this study is voluntary and I have not been pressured to take 
part. I also understand that I do not give up any rights by signing below. 
• 
I may choose to leave the study at any time and will not be penalised or prejudiced in any 
way. 

FASD Prevention Study. Version 1. 23 August 2023 
 
• 
I have a copy of the consent form with the information about rights of research participants 
and who to contact with questions. 
 
 
Participant’s Signature  
 
Date 
(DD/MM/YYYY) 
 
Signed at (Place) 
Declaration by staff 
     I, ____________________________ (Project Staff’s Full Name) declare that: 
• I explained the information in this document to ____________________________       
                                                                                     (Participant’s Full Name) 
• I encouraged him/her to ask questions and took adequate time to answer them. 
• I am satisfied that s/he adequately understands all aspects of the research 
• I gave him/her a card with information about rights of research participants and who to 
contact with questions. 
 
 
Project staff’s Signature  
 
Date 
(DD/MM/YYYY) 
 
Signed at (Place) 
 

 
 
Adapting and testing a behavioral intervention to prevent FASD and adverse infant outcomes 
Proposal for MRC Ethics Committee 
April 2024 
 
MRC investigators: 
Site Principal Investigator (contact PI): Petal Petersen Williams, PhD 
South African Medical Research Council 
Alcohol, Tobacco and Other Drug Research Unit and 
Department of Psychiatry and Mental Health 
University of Cape Town 
Tel. 021 938 0337 
Fax. 021 938 0342  
Email: petal.petersen@mrc.ac.za 
 
Co-Investigator: Charles Parry, PhD 
South African Medical Research Council 
Alcohol, Tobacco and Other Drug Research Unit and 
Department of Psychiatry, Stellenbosch University 
Email: charles.parry@mrc.ac.za 
 
RTI International investigators: 
Principal investigator: Yukiko Washio, PhD 
Substance Use, Gender, and Applied Research 
RTI International 
3040 East Cornwallis Rd  
P.O. Box 12194 
Research Triangle Park, NC 27709-2194 
Email: ywashio@rti.org 
 
Co-Investigator: Felicia Browne, PhD 
Substance Use, Gender, and Applied Research 
RTI International 
fbrowne@rti.org 
 
Co-Investigator: Wendee Wechsberg, PhD 
Substance Use, Gender, and Applied Research 
RTI International 
wmw@rti.org 
 
Co-Investigator: Carolina Barbosa, PhD 
Substance Use, Gender, and Applied Research 
RTI International 
cbarbosa@rti.org 
 
UCT investigators: 
Site Principal Investigator: Dr. Heather Jaspan 
Department of Pediatrics 
University of Cape Town 
hbjaspan@gmail.com 
 

Co-Investigator: Dr. Anna Happel 
University of Cape Town 
anna.happel@uct.ac.za 
 
 
Key words: pregnant, post-partum, alcohol use, tobacco/cannabis, polysubstance, breastfeeding, contingency 
management, educational support. 
 
 
 
 
 
 
 
 
DECLARATION 
I, Petal Petersen Williams have read the Department of Health: Ethics in health research: principles, processes 
and structures, second edition, 2015, the Guidelines for Good Practice in the Conduct of Clinical Trials with 
Human Participants in South Africa, Second Edition, 2006, Department of Health, Pretoria, South Africa , and 
the Declaration of Helsinki (2013) and have prepared this proposal with due cognisance of its content. 
Furthermore, I will adhere to the principles expressed when conducting this proposed research project.  
 
 
 
 
 
 
 
11 April 2024 
____________________________   
 
_________________________  
Petal Petersen Williams  
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please note: The research proposal is for a National Institute of Health grant to be 
funded by NIAAA. The proposal has been selected for funding.  In keeping with the 
funding guidelines, after MRC ethics approval 

Table of Contents 
1. 
Summary ...................................................................................................................................................................................... 4 
2. 
Research Strategy ..................................................................................................................................................................... 5 
2.1 
Significance ......................................................................................................... Error! Bookmark not defined. 
2.2 
Innovation ............................................................................................................. Error! Bookmark not defined. 
2.3 
Approach ............................................................................................................................................................................... 5 
3. 
Ethical Considerations ......................................................................................................................................................... 11 
Human Subjects Population 
11 
Adequacy of Protection Against Risks ........................................................................................................................ 12 
Recruitment and Informed Consent 
12 
Protections Against Risk 
13 
Vulnerable Subjects 
18 
Potential Benefits of the Research to Research Participants and Others ........................................... 18 
Importance of the Knowledge to be Gained ............................................................................................................. 18 
4. 
BUDGET ........................................................................................................................ Error! Bookmark not defined. 
SOUTH AFRICAN MEDICAL RESEARCH COUNCIL BUDGET JUSTIFICATION ............ Error! Bookmark not 
defined. 
RTI BUDGET JUSTIFICATION ....................................................................................... Error! Bookmark not defined. 
UCT BUDGET JUSTIFICATION...................................................................................... Error! Bookmark not defined. 
REFERENCES......................................................................................................................................................................................... 19 
APPENDIX A: Investigator’s CVs ...................................................................................... Error! Bookmark not defined. 
APPENDIX 1.............................................................................................................................................................................................. 28 
APPENDIX 2.............................................................................................................................................................................................. 29 
APPENDIX 3.............................................................................................................................................................................................. 32 
APPENDIX 4 ......................................................................................................................................................................................... 35 
APPENDIX 5 ......................................................................................................................................................................................... 62 
APPENDIX 6a ........................................................................................................................................................................................... 81 
APPENDIX 6b ........................................................................................................................................................................................... 81 
APPENDIX 7.............................................................................................................................................................................................. 85 
FACILITIES & OTHER RESOURCES .............................................................................................................................................. 90 
Integration of Partnerships and Communication Plan ............................................................................................ 90 
SOUTH AFRICAN MEDICAL RESEARCH COUNCIL (SAMRC) ........................................................................... 90 
Laboratory and Other Facilities ......................................................................................................................................... 91 
Office Space, Library and Other Resources ............................................................................................................. 91 
Computing Facilities, Network, and Security ........................................................................................................... 91 
Administrative Information .................................................................................................................................................. 93 
 
 
 

 
 
1. Summary 
South Africa (SA) has a long history of social and health disparities,1–5 resulting in the world’s highest rate of 
fetal alcohol spectrum disorder (FASD; 111.1 per 1,000),6 where lifelong negative cognitive and physical effects 
result from prenatal alcohol exposure.7–10 FASD is completely preventable if women do not drink during 
pregnancy.10–12 Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and 
cannabis,13–15 and cannabis use during pregnancy may increase because of cannabis legalization in SA in 
2018.16 The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance 
alone.17 Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol 
potentiate the likelihood of alcohol-induced birth defects.18,19 Data from Cape Metropole, SA, showed that all 
women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis 
use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA.20–22 Despite tremendous health 
benefits from breastfeeding for both women and their infants,23–40 maternal alcohol use while breastfeeding 
significantly compromises infant development.20,41 Although there is strong evidence for associations between 
prenatal/postpartum alcohol use and FASD risk/compromised child development11,20 as well as evidence that 
polysubstance use (i.e., alcohol and combined use with tobacco and cannabis [tobacco/cannabis]) during 
pregnancy exacerbates birth outcomes, few effective and sustainable interventions address polysubstance use 
(i.e., alcohol and tobacco/cannabis) during pregnancy and lactation to prevent adverse effects in women and 
infants. 
Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use 
in the United States (U.S.).42 The Women’s Health CoOp (WHC) is an evidence-based brief intervention 
addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol 
use.43 These evidence-based interventions need to be combined and adapted for addressing maternal 
polysubstance use and associated health and behavioral issues during pregnancy and lactation. This R61/R33 
is based on a partnership between researchers in the U.S. and researchers and community partners in SA to 
adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol 
and tobacco/cannabis) during pregnancy and lactation and to prevent adverse clinical outcomes, 
including FASD. The R61 phase will include conducting qualitative research to adapt an evidence-based 
behavioral intervention to the key population of women in SA and testing feasibility, acceptability, and 
appropriateness among women who are pregnant or breastfeeding with a recent history of polysubstance use. 
The intervention format will include contingent incentives on abstinence. Text-based remote support based on 
WHC educational components will be provided with health promotion and referral content tailored to the key 
population of women.44,45 The Centers for Disease Control and Prevention (CDC) adaptation process of 
evidence-based interventions (i.e., ADAPT)46 with determinants for adaptation from the Consolidated Framework 
for Implementation Research (CFIR)47 will guide the adaptation process. Part of the Framework for Reporting 
Adaptations and Modifications-Expanded (FRAME) approach48 will be used to document the adaptation process. 
The R33 phase will test the effectiveness of the adapted intervention in a randomized controlled trial on maternal 

polysubstance use and gestational, birth, and infant outcomes and conduct preliminary cost-effectiveness 
analyses. The Specific Aims are as follows: 
R61 Aim 1: To conduct formative qualitative research with women who are pregnant or breastfeeding with a 
recent history of polysubstance use, clinic and community stakeholders, and an established Community 
Collaborative Board (CCB) to inform adaptation of evidence-based interventions (i.e., CM and WHC educational 
components) to maternal polysubstance use during pregnancy and lactation in Cape Metropole, SA.  
R61 Aim 2: To test feasibility, acceptability, and appropriateness of the adapted intervention with 48 women 
(24 who are pregnant and 24 who are breastfeeding) in SA, to help women abstain from polysubstance use 
during pregnancy and lactation and address disparities in polysubstance use and associated health issues. 
Milestones for assessing R61 success will include completing qualitative research for intervention adaptation 
and completing feasibility, acceptability, and appropriateness testing with 48 women for the R33 trial.  
Public Health Impact. With the effectiveness of the adapted intervention on reducing maternal polysubstance 
use during pregnancy and lactation and addressing and understanding disparities in the affected group of 
women, findings can inform providers, policymakers, and the public on the importance of targeting maternal 
polysubstance use with associated syndemic issues and resulting disparities for sustainable implementation in 
treatment settings (e.g., substance use treatment clinics, obstetric clinics, and community programs for 
mothers/children) in SA, U.S., and other countries.  
The current ethics application is for R61 Aim 2 only 
 
2. 
Research Strategy 
 
2.3 
Approach 
2.3.1 Study overview and scientific design. The CDC adaptation process of evidence-based interventions 
(i.e., ADAPT)46 will guide the adaptation process. ADAPT has 5 steps of Assess, Select, Prepare, Pilot, and 
Implement. Our study team has successfully used this rigorous CDC adaptation framework in prior adaptations 
of WHC and other evidence-based interventions.137,138 The proposed study will focus on the last 3 steps. The 
R61 phase will last 2 years and will be spent 
conducting qualitative research (Aim 1) and testing 
feasibility, acceptability, and appropriateness of the 
adapted 
intervention 
to 
reduce 
maternal 
polysubstance use during pregnancy and lactation in 
SA (Aim 2) as the Prepare and Pilot steps of ADAPT. 
The R33 phase will encompass the Implement step 
of ADAPT by testing the effectiveness of the adapted 
intervention. Determinants for adaptation used in the 
proposed study will be those from CFIR.47 We will use 
the FRAME approach48 to document the adaptation process, specifically focusing on the recipient-based reasons 
Exhibit 3. Study Framework 

for the modification during the R61 phase (Exhibit 3), such as issues specific to stigma and maternal alcohol 
and combined use with tobacco/cannabis that have not been studied.  
2.3.4 Community Collaborative Board (CCB). A Cape Town CCB was established by Dr. Wechsberg in 
2003 and remains active 18 years later. The CCB includes members from substance use treatment clinics, 
maternal/infant health providers, health department officials, nongovernmental organizations, and university 
researchers involved in NIH studies. The CCB will meet initially using a virtual platform (e.g., Zoom) to learn 
about the study design, goals, and formative plans and materials. The CCB will meet at least twice a year 
throughout the life of the project. The CCB also will review the proposed intervention materials, offer ongoing 
feedback about the study (e.g., recruitment and retention), identify relevant stakeholders, and assist with 
dissemination.  
 
2.3.5 Study timeline (R61 phase: Months 1–16). The R61 timeline is described in Exhibit 4.  
 
2.3.7 R61 Aim 2: To test feasibility, acceptability, and appropriateness of the adapted intervention with 
48 women (24 who are pregnant and 24 who are breastfeeding) in Cape Metropole, SA, to help women 
abstain from polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation. 
The R61 Aim 2 will focus on testing the 
feasibility, acceptability, and appropriateness of 
the adapted intervention with 48 women (24 
pregnant and 24 breastfeeding). This testing will 
occur for 3 months with a follow-up assessment 
and interview at the end (Exhibit 5). The R61 
Aim 2 will consist of the Pilot step of ADAPT and will collect and document information on barriers  
and facilitators from participants based on the recipient-based reasons of FRAME.48  
 Eligibility. To be eligible, women must (1) be in the second trimester of pregnancy or breastfeeding with less 
than 3 months postpartum, (2) test positive in alcohol use by urinalysis (i.e., EtG), (3) test positive in tobacco or 
cannabis use by urinalysis (i.e., cotinine and THC), (4) be over 18 years old, (5) have a negative HIV test, (6) 
not be eligible for PrEP,  (7) plan to complete antenatal care at the current clinic and remain in the area for at 
Exhibit 4. Proposed Study Process (R61 aim 2: Months 1–16) 
Aim 2: Feasibility, Acceptability, and Appropriateness Testing Phase 
Months 1-6 
Months 7-16 
 Train staff 
 Feasibility, acceptability, appropriateness testing and 
instrumentation 
 3-month follow-up assessments and interviews 
 Ongoing DSMB  
 Ongoing CCB 
 Modifications of the tested intervention 
 Complete data cleaning and analyses 
 Prepare for the R33 phase 
 Ongoing DSMB 
 Ongoing CCB  
Exhibit 5 Feasibility, Acceptability, and Appropriateness Testing 

least 3 months, and (8) own a cell phone to receive text messages. Exclusion criteria include women who report 
serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past 
month. These women will be provided necessary referrals. Women who participated in interviews during Aim 1 
will not be eligible. We will recruit 48 participants (24 pregnant and 24 breastfeeding) over 3 months, with at least 
16 participants per month. Recruitment. Research staff will deliver study posters and flyers to clinic staff so they 
can display them at each site. Research staff in the waiting area of the clinic will approach women and introduce 
the study. Additionally, clinic staff routinely ask about prenatal alcohol and substance use; therefore, clinic staff 
will also refer women who self-report prenatal alcohol and tobacco/cannabis use to research staff. We will ensure 
all COVID-19 safety protocols are followed, maintain 1.5 meters distance, and make use of personal protective 
equipment where necessary. Research staff also will provide a sign-up sheet to fill in their first name and contact 
number for making screening appointments during clinic visits. This recruitment procedure has been the standard 
for recruiting maternal populations in substance misuse and mental health studies in community clinics in 
SA.62,165 
To recruit women who are less than 1 month postpartum, research staff will approach women at an MOU clinic 
who are more than 35 gestational weeks and intend to breastfeed and will contact interested women after their 
due date to confirm their breastfeeding status and study interest and make a screening appointment at a Baby 
Clinic following their postpartum appointment. Research staff will also approach women at a Baby Clinic who 
are less than 1 month postpartum and breastfeeding and ask their interest in the study. Interested women will 
be screened in person following consenting in a private room at either an MOU or Baby Clinic. Following consent, 
we will collect detailed contact information and begin screening and baseline assessment in either English, 
Afrikaans or isiXhosa, if eligible. We will follow all COVID-19 safety protocols.  
Screening and baseline appointment. Pre-screening consent (Appendix 1) will be obtained in order to 
collect biological samples for screening. Screening (Appendix 2) will occur immediately followed by  consent 
(Appendix 3) at a clinic for those who screen positive and are interested in participation. For eligible participants 
a contact information form will be completed fr future follow up (Appendix 4). Baseline assessment (Appendix 
5) will occur immediately following screening at the clinic. Interview questions will be conducted by CASI on a 
tablet. Assessment questions will cover sociodemographic factors; social 
determinants; recent and lifetime polysubstance use; IPV/GBV exposure; 
partner drinking; stigma; coping with stress; and reproductive, sexual, physical, 
and mental health. Urine samples collected during screening will be used to test 
other substance and Mandrax use. Participants will be asked to provide a few 
drops of blood (more or less 5 drops/ 1 teaspoon) by piercing the skin of the 
finger with a small needle. The blood drops will be dropped on a dried blood 
spot (DBS) card to be tested for recent alcohol use with the Phosphatidylethanol 
(PEth) test. All pricks will be performed by staff who are fully trained in blood 
sample collection, samples will be marked with the unique participant number. 
At the end of each day, these specimens will be transported to the SAMRC site. 
The blood samples will only be identified by the unique participant number and 
Exhibit 6. Text-based support 

will not be linked to any personally identifiable information. DBS cards will be stored in a cool dry place at the 
SAMRC site until ready for transportation to the USA for testing. Each screening and baseline assessment will 
take approximately 1 hour. Participants who complete both screening and baseline assessments will be thanked 
for their participation and receive R200.  
 Proposed intervention. Findings from the formative qualitative phase highlight the need for an intervention 
programme that is innovative and tailored to the needs of women who are pregnant or postpartum. It highlights 
the importance of developing intervention programmes that move beyond education about the harms of drinking 
in pregnancy to include people’s attitudes towards drinking in pregnancy. It highlights the need to provide 
education around the harms associated with substance use in breastfeeding. There is a need to focus on the 
social norms around substance use and the normalisation of drinking, smoking and cannabis use among 
perinatal women. It also highlights the importance of including community-based support, support groups, 
counselling, partner involvement and having a committed research team offering further support in these 
interventions. Findings also suggest there is a lot of support for the provision of contingent incentives. While 
most support the provision of cash incentives, some mentioned providing food parcels. Participants will receive 
text-based support using basic language on health promotion and referral content based on WHC educational 
components (Exhibit 6). Messaging content and format details have been determined with qualitative research 
findings in Aim 1; however, the content will stay relatively generic so that study involvement is not clear to others 
who may accidentally view the messages. Aim 1 findings revealed that perinatal women would value messages 
of encouragement and reminders to eat well and drink water. Health workers throught messages should inlcude 
what danger signs to look out for that may indicate high risk and a reason to go see a healthcare provider. 
Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill 
out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if 
abstinence is verified. R200 will be provided per biochemically verified EtG abstinence for alcohol use,98 R200 
per biochemically verified cotinine abstinence105 for tobacco use, and R200 per biochemically verified THC103 for  
cannabis use (Exhibit 7). Biochemically verified abstinence in subsequent months will increase the incentive 
magnitude by R50 monthly for each substance. Total potential earning 
for 3 months will be R1,500 to R2,250  depending on whether a 
participant uses alcohol and tobacco or alcohol, tobacco, and cannabis 
together. If a participant provided a positive sample, the incentive goes 
back to R200. 
Follow-up assessment. Participants will be asked to participate in 
the 3-month follow-up assessment at a clinic at the end of the 3-month 
testing. Assessment questions (Appendix 6) will be conducted via 
CASI on a tablet covering recent self-reported alcohol and 
tobacco/cannabis use; self-reported use of other substances; recent IPV/GBV exposure; partner drinking; 
stigma, stress; and reproductive, sexual, mental, and physical health (see Measures). Consent will be obtained 
(Appendix 7a) to collect participants’ birthing facility information for those who were recruited during pregnancy 
to track birth outcomes (Appendix 7b). If a participant is already postpartum and breastfeeding, self-reported 
Exhibit 7. Contingent Incentives 
Timing 
Amount 
for 
abstinence per 
drug 
(EtG, 
cotinine, THC) 
Total 
potential 
earnings  
Month 1 
R200 each  
R400–R600 
Month 2 
R250 each 
R500–R750 
Month 3 
R300 each 
R600–R900 

incidents of breastfeeding while using alcohol and tobacco/cannabis will be collected. Infants will also be 
measured for their height, weight, and head circumference. Participants will be also asked to provide a blood 
sample. Urine samples collected at the 3rd monthly visit will be used to test other substance and Mandrax use. 
(See Appendix 8 and 9 for biological collection forms). An assessment and the subsequent interview will take 
approximately 90 minutes. Participants will be thanked for their participation and compensated R300 for their 
time. Participants who experience an adverse outcome prior to follow up such as miscarriage, stillbirth or decide 
to discontinue will not be replaced. 
 
Measures. Proposed measures are below in Exhibit 8, which includes all phases (color-coded by aims). 
 
Primary Outcomes (R61 Aim2 & R33 Aim1) 
Data Source(s) 
Visit/Time 
Urinalysis results for alcohol use: An alcohol metabolite (EtG) will be measured in urine 
samples.168 EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days 
after light drinking with ≥150 ng/mL for EtG as a cutoff value.169 The dipstick testing will have ≥300 
ng/mL as a cutoff value.170 
Dipstick 
(CONFIRM 
BIOSCIENCES); 
EtG 
ELISA 
(Microgenics 
Corp) 
Screening & 
Baseline 
(BL); 
Follow-ups 
(FUs)  
Urinalysis results for tobacco use: Biochemical verification of recent tobacco use in urine 
samples. A tobacco metabolite (cotinine) will be measured in urine samples.171 The metabolite 
can be detected up to 3–4 days after use with ≥ 80ng/mL as a cutoff value.172 The dipstick testing 
will have ≥200 ng/mL as a cutoff value.170 
Dipstick 
(CONFIRM 
BIOSCIENCES); 
Cotinine 
ELISA 
(Abnova) 
BL; FUs 
Urinalysis results for cannabis use: Biochemical verification of recent cannabis use in urine 
samples. A cannabis metabolite (THC) will be measured in urine samples.173 The metabolite can 
be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff value.174 The dipstick testing 
will have ≥50 ng/mL as a cutoff value.170 
Dipstick 
(CONFIRM 
BIOSCIENCES); THC 
ELISA (Sigma-Aldrich) 
BL; FUs 
Blood analyses for alcohol use: An alcohol metabolite (PEth) in blood samples will be 
measured as a gold standard biomarker of past 30-day alcohol consumption. The cutoff level of 
≥50 μg/L indicates heavy drinking.175  
Gas chromatography 
FUs 
Self-reported alcohol use: Self-reported daily alcohol use by the number of standard drinks 
based on the definition in South Africa (e.g., 12 g per standard drink).  
Timeline 
follow-
back/recall (TLFB) 
BL; FUs 
Self-reported tobacco/cannabis use: Self-reported use of daily cannabis by the number of 
cones/joints/pipes176 and of daily tobacco by the number of puffs (8 puffs = 1 cigarette).105,177 
TLFB 
BL; FUs 
Self-reported alcohol and tobacco/cannabis use while breastfeeding: Self-reported 
incidences of alcohol and tobacco/cannabis use while breastfeeding noted in a daily log. 
TLFB 
FUs 
Secondary Outcomes (R61 Aim2 & R33 Aim2) 
 
 
Gestational & birth outcomes: Gestational hypertension, gestational diabetes, preeclampsia, 
other gestational complications; Weight, height, head circumference, gestational age, NICU 
admission, length of stay, Apgar scores, etc.  
Medical record 
At Birth  
Infant outcomes: Infant weight, infant height, head circumference, outpatient and inpatient 
medical visits. 
medical records;  
Postpartum 
FU only 
Other Relevant Measures (R61 Aim2 & R33 Aim1) 
 
 
Urinalyses results for substance use: Urine metabolites of recent drug use 5-drug panel + 
Mandrax strip.  
Dipstick 
(CONFIRM 
BIOSCIENCES) 
BL; FUs 
Self-reported substance use: Self-reported use of illicit substance use in type, frequency, and 
severity. Alcohol, Smoking and Substance Use Involvement Scale (ASSIST). 
ASSIST178,179 
BL; FUs 
IPV/GBV: Lifetime and recent (past 3 months) main partner emotional, physical, sexual, and 
financial abuse. At baseline, family violence and past experience with abuse (e.g., age of onset). 
Revised Risk Behavior 
Assessment (RRBA)180 
BL; FUs  
Partner drinking: Partner drinking in the prior month and perceived problematic drinking.  
RRBA180 
BL; FUs 
Stigma: Everyday discrimination scale (EDS) will be used to measure perceived stigma. 
EDS181 
BL; FUs 
Coping: Brief Resilience Scale (BRS) will be used to measure coping with stressors. 
BRS182 
BL; FUs 
COVID-19−related issues: Knowledge, attitude, and impact of COVID-19 on stigma,183 mental 
health, employment, housing, family and partner relationship, and social network. 
Newly developed 
BL; FUs 
Reproductive and sexual health: Contraceptive use and sexual risk behavior (e.g., condomless 
sex, alcohol and other drug use prior to or during sex, casual and concurrent partners, and sex 
trading). 
RRBA180 
BL; FUs 
Psychological distress/depression: Patient Health Questionnaire-2 (PHQ-2); Generalized 
Anxiety Disorder (GAD-2); Edinburgh Postnatal Depression Scale (EPDS; alpha=0.91). 
PHQ-2184; GAD-2185; 
EPDS186 
BL; FUs 
Participant Characteristics (R61 Aim2 & R33 Aim1) 
 
 
Social determinants: Age, race, family structure, education, marginal housing & instability 
conditions, partner age, mobility, economic status, food insecurity. 
RRBA180 
BL 
Alcohol and substance use problems: Lifetime use, age at first use, Substance Use Risk 
Profile-Pregnancy (SURP-P), Drug Abuse Screening Test (DAST). 
RRBA180; 
SURP-P187; 
DAST188 
BL 
Nicotine use problems: Lifetime use, age at first use, Level of nicotine dependence 
(Fagerstrom) 
RRBA180; 
Fagerstrom189 
BL 
Relationship equity & Sexual control: A 10-item subscale of the Sexual Relationship Power 
Scale (SRPS) assessing decisional influence. Six items assessing influence in sexual decisions. 
SRPS190 
BL 
Implementation Related Measures (R61 Aim2) 
 
 
Feasibility: Feasibility of Intervention Measure (FIM). 
FIM191 
Interview 
Acceptability: Acceptability of Intervention Measure (AIM). 
AIM191 
Interview 
Appropriateness: Intervention Appropriateness Measure (IAM). 
IAM191 
Interview 
Intervention Satisfaction: Assesses satisfaction through questions that ask about their 
experience.  
Satisfaction Form 
Interview 

 
Data management. All data will be entered into REDCap™, which will have built-in checks for consistency 
and completeness. Electronic data entered in REDCap™ will be downloaded to the internal RTI project share 
nightly. All data, including forms with personally identifiable information (locator and consent forms), are kept on 
password-protected servers. Dr. Washio will be responsible for reviewing and cleaning the data and preparing 
weekly reports during data collection, with guidance from other investigators.  
Staff communication and quality assurance. Two female field staff members who speak the local languages 
(isiXhosa and Afrikaans) besides English will be hired by SAMRC and extensively trained and monitored by the 
PI and site PIs. Staff will recruit participants, conduct baseline assessments, and manage the database. Dr. 
Petersen Williams will communicate with research staff to supervise day-to-day operations. Dr. Washio will be 
available to communicate with Dr. Petersen Williams on a daily basis by email, Zoom, or Skype. Dr. Washio will 
also establish an effective communication plan between investigators, consultants, staff, and CCB members, 
including weekly conference calls, email distribution lists, and end-of-day reports. Quality assurance systems 
will be put in place to generate daily reports, perform data entry, undertake quality assurance checks, and ensure 
that data are cleaned and accurately transmitted, organized, and properly managed. With permission, Dr. 
Petersen Williams will observe 20% of baseline and follow-up appointments as well as monthly intervention 
sessions to monitor fidelity on intervention components and delivery manners.  
Power analysis. A sample size of 48 will achieve 80% power for 20% decreases in alcohol and 
tobacco/cannabis use from baseline to 3-month follow-up. Hypothesis. We hypothesize to detect a rate of >80% 
of the average full score per participant based on the 5-Likert scales in FIM, AIM, and IAM measures and 20% 
decreases in alcohol and tobacco/cannabis use from baseline to 3-month follow-up. Consideration of sex and 
other biological variables. Evidence shows that women are more adversely affected than men by drinking with 
susceptibility to craving and relapse.193 The proposed study is enrolling female participants; thus, no sex 
differences will be examined. However, differences by age will be examined. Data cleaning and missing 
values. All data will be reviewed for valid values/data entry errors, outliers, and the extent and pattern of missing 
data. Consistency and logic checks that constitute standard review/cleaning procedures will be applied. We will 
use the mean substitution for continuous values and mode for categorical values, last observation carried 
forward, and expectation-maximization to handle missing values, depending on the features of missingness. If 
necessary, we will use the multiple imputation procedure to treat missing values by creating multiple datasets 
with imputed values.194 Sensitivity analysis will be conducted to evaluate the robustness of the results with the 
deviations from the missing at random assumption. 
Data analysis. Descriptive statistics will be used to summarize both continuous (via means, standard 
deviations, and medians) and categorical (via proportions and total numbers) variables for the outcomes. The 
acceptability and appropriateness outcomes will be AIM and IAM scores. Two feasibility outcomes exist: FIM 
scores and polysubstance abstinence. Maternal polysubstance use measures include urinalysis dichotomous 
results and self-reported use during pregnancy and lactation. Dichotomous outcomes of 7-day point-prevalent 
abstinence of alcohol, tobacco, and cannabis will be calculated for baseline and 3-month follow-up timepoints 
Cost Related Measures (R33 Aim3) 
 
 
Healthcare utilization & patient costs: Adapted Economic Form (AEF) 90—participants’ other 
healthcare utilization, resources spent, out-of-pocket expenses.  
AEF 90192 
BL; FUs 

by combining urinalysis results and self-reported use during the past week before each assessment. If both 
urinalysis and self-reported results are negative, the dichotomous outcome will be coded as negative of use and 
otherwise coded as positive of use. We will also summarize urinalysis results and self-reported use separately 
for each substance in each month. We will also apply the same summary procedure for polysubstance 
abstinence, in which case an incident of urinalysis and self-reported results for alcohol and tobacco/cannabis 
showing negative will be coded as negative of use, and an incident of either substance showing positive in either 
measure will be coded as positive of use. Again, we will also summarize urinalysis results and self-reported use 
separately for polysubstance use in each month. Self-reported use provides continuous use outcomes; thus, we 
will calculate the average with standard deviations and median per day, week, or month and the overall number 
of days used. Secondary feasibility outcomes are gestational, birth, and infant outcomes. Gestational and birth 
outcomes among participants will be compared with the national average and also the average in a similar cohort 
of SA women (Exhibit 1). Changes in infant outcomes from baseline to 3-month follow-up will be compared to 
reduction in polysubstance and singular substance use to examine dose-dependent correlations. Participant 
characteristics, social determinants, and other relevant measures (see Measures) will be collected so that we 
can conduct the variable selection method to identify and rank the most influential covariates for moderator and 
mediation analyses in the R33 phase. Trend analyses will be conducted to statistically evaluate the features of 
changes from baseline in some of the variables to follow-up assessments. Analyses will be stratified by 
pregnnacy/lactating status. 
Milestones for assessing R61 success will include completing qualitative research for intervention adaptation 
and completing feasibility, acceptability, and appropriateness testing with 48 women for the R33 trial.  
 
 
R33 AIM 1-3 
Ethics approval will be sought following completion of R61 Aim 2 to ensure findings from R61 Aim 1 and 2 are 
incorporated into R33.  
 
3. Ethical Considerations 
 
Human Subjects Population 
The proposed study population primarily comprises women who are pregnant or breastfeeding with a 
recent history of polysubstance use and clinic and community stakeholders in SA. Furthermore, we expect that 
the sample will be individuals of African descent (i.e., Black African and Coloured, racial categories that were 
delineated during the Apartheid Era in SA). 
 For the feasibility, acceptability, and appropriateness testing, 48 eligible women (24 pregnant and 24 
breastfeeding) will be recruited. 
 
 

Potential Risks 
Although the proposed study presents no greater than minimal risk to participants, adequate provisions 
will be put in place to mitigate these risks. The potential risks to participants include (1) lack of comprehension 
and acknowledgement of informed consent, study purpose, and rights of participants; (2) exposure to 
psychological or physical coercion by clinical staff and others; (3) possible disclosure of confidential information; 
(4) the possible mental discomfort associated with some of the sensitive issues raised during assessments and 
biological specimen collection and results; and (5) social ramifications of participation in the study. These 
scenarios and the steps to mitigate the risks are detailed under 3.1.2 Adequacy of Protection Against Risks 
below. 
 
Adequacy of Protection Against Risks 
Recruitment and Informed Consent 
Recruitment. Participation in the study is voluntary. Trained research staff will ask for permission from 
facility management to post and display study posters at each MOU study site. Research staff will market the 
study and recruit women in the waiting area of the clinic and introduce the study. Clinic staff will also refer 
potential participants to the research staff if participants are interested in joining the study. Research staff will 
use established marketing methods proven successful in our previous SA studies, which include posting 
marketing flyers in study clinics. 
Consent. Before engaging in study activities, all potential participants who are interested in the study will 
undergo consenting procedures to provide informed consent. Consent forms will include details of study 
participation and activities. The form will be read to all potential participants, and they will be given the opportunity 
to ask questions and have them answered. Additionally, potential participants will be asked to both electronically 
initial and sign their written consents via REDCap. Consent forms will include the following: 
A statement describing the extent to which confidentiality will be kept and how privacy of the participants 
will be maintained, including that the only exceptions to confidentiality will be information related to 
medical emergencies, participant disclosure of current child/elder/dependent abuse or neglect, and 
imminent risk of death or serious injury to the participant or others; 
A statement that participation is voluntary; 
A statement that research data and their involvement or early termination in the study will not affect their 
access to any services, including treatment; 
An explanation of who to contact for answers to pertinent questions about the research and research 
participants’ rights; and 
Who to contact for a research-related adverse situation, such as an injury.  
Finally, potential participants will be informed of all known potential risks and benefits of participation, 
their right to refuse or revoke consent at any time, and the names and phone numbers of responsible individuals 
they may contact for additional information or to register complaints about study procedures. Consented 
participants will be given a hard or soft copy of their signed consent form for their own personal records. Women 
who decline participation in the study will not receive differential treatment at clinics, and no information collected 

during research participation will be shared with clinic staff. Individuals who do not provide written consent for 
the study will not be screened. Participants will be reminded that they have the right to discontinue participation 
in the study at any point and to refuse to answer any specific questions or let staff collect biological samples if 
they choose. They will also be told about the possibility in consenting for future studies. 
Screening. All interested individuals who provided written and verbal consent will be screened to 
determine eligibility. Screening will occur individually and privately. Ineligible women will not be told the reason 
for their ineligibility. Those who screen eligible will be enrolled in the study. Those who are ineligible because of 
reporting serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts 
in the past month will be given necessary referrals. If a participant is not eligible, she will be thanked for her 
participation in screening and receive 50 South African Rand via a mobile cash-send mechanism. 
Confidentiality. Drs. Washio and Petersen Williams will be responsible for training the staff on all 
protocols to ensure confidentiality and protocol fidelity. Each field staff member will follow prescribed guidelines 
and regulations when screening potential participants. This will be scripted in the Operations Field Manual. All 
field staff will review regulations regarding confidentiality and signed agreements will be kept on file. The 
exceptions to these regulations include threats of imminent harm (to self or others) or ongoing abuse or neglect 
of children. All proposed project staff will complete the Collaborative Institutional Training Initiative (CITI) training 
course or a comparable course on the roles and responsibilities in protecting the privacy and confidentiality of 
research participants. 
 
Protections Against Risk 
This project will adhere strictly to SA ethics and regulations for the protection of human subjects and 
follow best-practice procedures for ensuring data security.  
Protections Against Risk Associated with Informed Consent 
Before proceeding with the study procedures, individuals will be fully informed about the purpose of the 
study and study procedures. During the consenting process, a trained project staff member will describe the 
purpose and goals of the study, investigator and participant responsibilities, and the study procedures. During 
this description, all expectations of participants, the voluntary nature of participation, and rights to confidentiality 
will be emphasized. It will be made clear that participation in this study is voluntary and that individuals can refuse 
to participate, agree to participate and then withdraw their consent, or participate until completion of the study. 
Potential participants will be informed of the names and phone numbers of responsible individuals that they may 
contact for additional information or to register complaints about the study procedures. They will be given an 
accurate and fair description of the risks or discomforts and the anticipated benefits of the research study, as 
outlined in the International Conference on Harmonization–Good Clinical Practice (ICH-GCP) guidelines and the 
South African guidelines for Good Clinical Practice, so they can make an informed decision about participation. 
Potential participants will be asked to repeat in their own words what is expected of them and their rights as a 
study participant. 

Protections to Mitigate Participants’ Exposure to Psychological or Physical Coercion by Clinical Staff 
and Others 
If research staff detect psychological and physical coercion through direct and indirect observations 
during the recruitment process, they will remind women that it is their choice to be in the study and that research 
staff will not disclose their status of study participation to anyone. Research staff will be trained on how to handle 
potential coercion by clinical staff and others and will be supervised by investigators. Research staff will also 
have ongoing meetings with clinic staff to discuss the study/clinic expectations and issues related to the 
partnership. 
 
Protections Against Possible Disclosure of Confidential Information 
A breach of confidentiality could include unauthorized persons accessing information contained in their 
study files. Every effort will be made to protect the confidentiality of participant information. We will adhere to all 
applicable confidentiality regulations in SA. We have carefully considered the potential risks for each of the 
proposed research activities and have developed measures to mitigate these risks, which we have used in 
previous studies. These measures include staff training and data management procedures that separate 
identifying information from interview data. 
All participants will be informed of all anticipated risks before they can consent to participate in screening 
for the study. During the consenting process, participants will be assured that all data collected during the study 
will be kept strictly confidential to the full extent provided by law. The only exceptions to confidentiality, which will 
be clearly explained and specified in the informed consent forms, will be for information that needs to be released 
to manage medical emergencies, risk of harm to self (e.g., risk of suicide), or risk of harm to others, including 
the abuse or neglect of a minor. The consent forms will also state that individuals will be able to refuse to 
participate or withdraw consent to participate at any point in time without experiencing negative consequences. 
Potential participants will be given opportunities to ask questions about study participation, and the research 
staff seeking consent will answer these questions. Individuals who do not understand the nature of the study and 
cannot clearly provide consent will not be able to participate in the study. 
Data confidentiality will be also ensured through the study team’s rigorous standardized procedures. All 
study staff have intensive training in human subjects’ protection, GCP, and study-specific participant 
confidentiality procedures. They will be informed about the sanctions associated with breaching participant 
confidentiality and will be required to sign a staff confidentiality agreement as part of their conditions of 
employment. RTI, SAMRC, and UCT have a research integrity policy to which all staff must adhere. 
Consequences for breaching participant confidentiality include dismissal and legal sanctions. The limits to 
confidentiality, the possibility of data being seen by study monitors, and future sharing of de-identified data are 
all fully explained in the study information and informed consent forms. 
Most of the data associated with the study will be entered directly by research staff into REDCap, a 
secured web-based data entry system that is specifically geared to support online and offline data capture for 
research studies and operations. REDCap is in compliance with 21 Code of Federal Regulations (CFR) Part 11, 

FISMA, HIPAA, and the General Data Protection Regulation (GDPR). Tablets used for data collection will also 
be password protected. 
There is also a risk that participants may lose their phones or may leave them unprotected so that others 
may gain access to its contents. This risk is minimized because only generic text messages will be sent to 
participants phones with no study-specific information that reveals study participation to others.  
Furthermore, participants’ confidentiality will be ensured at recruitment, data entry, storage, retrieval, and 
analysis stages. Data and any information collected from participants during the study activities will be linked to 
participants through a unique study ID, which will ensure anonymity. Informed consent forms, which include 
personal identifying information such as full names, will be printed and then stored in double-locked cabinets in 
a locked and secured data storage room at the SAMRC site with restricted access separate from documents 
with participant data and participant IDs. Any study materials will be secured in separate double-locked file 
cabinets in a locked and secured data storage room at the SAMRC and secured on password-protected 
microcomputers with the latest Windows operating system and a secure (password-protected) file server at the 
SAMRC or UCT site. 
Biological samples, linked to participants only through unique study ID, will be transported by research 
staff from the study site to SAMRC site in locked briefcases. Results of the biological analysis will also be 
identified using the participants’ unique study ID. Anyone handling these biological specimens will sign a staff 
confidentiality agreement. 
 
Staff will follow strict protocols for ensuring participant confidentiality. For the interviews, project staff will 
confirm that each participant is in a private place. Phone interviews for clinic and community stakeholders will 
also be protected by staff conducting phone interviews in a private place.   
Finally, there is risk to client confidentiality when research staff collect these data at an MOU. Should any 
breaches of participant confidentiality occur during the study, they will be reported to Dr. Washio, SAMRC’s 
Human Research Ethics Committee (HREC), the IRB of record, the chair of the DSMB, and NIH officials. 
 
Protections Against the Possible Mental Discomfort Associated with Sensitive Issues Raised 
Because of the sensitive nature of some of the topics being addressed during the proposed project, 
participants may experience psychological or mental discomfort related to particular issues or during certain 
study activities, such as discussing certain topics in interviews and assessments. To reduce the risk of discomfort 
that may arise during study activities, participants will be informed of potential discomforts before signing the 
consent form and will be allowed to refuse to answer any question without penalty. Research staff will be trained 
on how to address discomfort among participants and how to ask research questions in a non-invasive, non-
stigmatizing manner. We will establish standard operating procedures for handling distressed respondents, 
including determining the severity of the distress, making referrals accordingly (passive or active), and mandatory 
reporting procedures, based on our previous experience in SA. All study staff will be trained on these procedures. 
Participants will be referred to counseling if necessary or if requested. 

Procedures to Address Social Ramifications of Participation in the Study 
Participants also face stigma if others in their community find out that they are participating in a health 
study or that they are using alcohol and other substances while pregnant or breastfeeding. If participants 
experience any adverse reactions to any aspects of the study, research staff will fill out an incident report 
immediately, and the team will contact Drs. Washio and Petersen Williams. Using advice from senior project 
staff, the field staff will make appropriate referrals to medical, counseling, or other health services. Dr. Washio 
will report serious adverse events, adverse events, and unanticipated events within 48 hours (24 hours for fatal 
events) to the NIAAA Program Officer, the SAMRC HREC, and the Chair of the DSMB. Serious adverse events, 
adverse events, and unintended events are further discussed in the Data and Safety Monitoring Plan. 
 
Adverse Events (AEs) and Serious Adverse Events (SAEs).  
Adverse Events (AEs) will be defined as: report of coercion to participate in the study; or significant hesitance, 
concern or emotional distress from answering research questions, such that the participant decides to stop their 
participation; and harm resulting from breach of confidentiality. Medical events for pregnancy-related and 
postpartum health, psychiatric issues including suicidal ideation, or substance abuse that do not require urgent 
medical attention, emergency care, and/or hospitalization will be also treated as AEs. We will monitor attrition 
rates for participants, but dropout from the study will not be reported as an AE unless it is related to an untoward 
event from study participation. Participants may have medical and psychiatric problems before entering the study, 
which may continue during the course of the study. As per the definition of AEs, only significant worsening of 
baseline medical or psychiatric status or new problems will be reported as AEs. The AEs listed above have been 
known to occur in prior research with the target population. However, due to the protections we have put in place 
we do not anticipate report of coercion to participate in the study; significant discomfort from answering research 
questions; or harm resulting from breach of confidentiality occurring. We do not anticipate pregnancy-related and 
postpartum health, psychiatric issues including suicidal ideation, or substance abuse occurring as a result of the 
study procedure. 
Serious Adverse Events (SAEs) will be defined as maternal or neonatal death; or any life threatening event that 
requires urgent medical attention, emergency care, and/or hospitalization including prenatal and postpartum 
health issues, psychiatric issues, and substance use or social harm for participating in the study and their 
partners knowing about it; however, No SAEs are expected as a result of the study procedures or intervention. 
If an SAE is identified, then staff members are instructed to learn the details of the AE and complete an internal 
study-specific AE form and immediately forward this form to the PI. AEs will be labeled according to severity, 
which is based on their impact on the patient. An AE will be termed “mild” if it does not have a major impact on 
the patient, “moderate” if it causes the patient some minor inconvenience, and “severe” if it causes a substantial 
disruption to the patient’s well-being. A severe AE and an SAE are distinct terms. A subject could experience a 
severe AE that does not meet the above-listed definition of an SAE; alternatively, a subject could experience a 
moderate AE that meets the SAE definition. AEs will be categorized according to the likelihood that they are 
related to the study intervention. Specifically, they will be labeled as definitely unrelated, definitely related, 
probably related, or possibly related to the study intervention. All AEs and SAEs occurring during the study are 

documented on a form, reviewed and signed by the PI, and reported to IRB of record. Determination of protocol 
relatedness is made by the PI after consultation with other investigators and research staff. This initial 
determination is reviewed, and a final determination is made by the IRB of record. All non-fatal SAEs are reported 
to the IRB of record within 48 hours of our awareness of the event (24 hours for fatal events). 
All reporting will follow the expectations and timeframes specified in the current NIH guidelines for reporting (see 
Figure 1). This includes reporting a summary of all AEs and/or SAEs that are deemed expected and/or unrelated 
to the study to the PO with the annual progress report. In the event that a participant either withdraws from the 
study, or the PI decide to discontinue a participant due to an SAE, the participant will be monitored by the 
investigator via ongoing status assessment until (1) a resolution is reached (the problem requiring hospitalization 
has resolved or stabilized with no further changes expected), (2) the SAE is determined to be clearly unrelated 
to the study intervention, or (3) the SAE results in death. Annual summaries of the SAEs that occurred during 
the previous year will be included in the yearly progress report to the IRB. This summary will be in the form of a 
table that shows each type of AE and an overall summary of the SAEs. Unexpected adverse events will be 
reported in accordance with NIH and Federal Requirements as well as requirements from the South African 
Department of Health’s Research Committee. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IRB Assurances 
Before implementing the study protocol, we will obtain human subjects’ approval of this research protocol 
from the IRB with a reliance agreement signed by other relevant institutions. Given the relatively low risk 
associated with participating in this study and the safeguards we have in place for these potential risks, we 
anticipate that we will successfully obtain IRB approval. 
Figure 1. Reporting Flow 
Field Staff 
& Project 
Manager
(immediately
)
South 
African
Site PI
(as soon 
as 
reasonably 
possible, 
but within 
24 hours 
of the 
event)
PI 
(within 
24 hours 
of the 
event)
NIH 
PO
SA MRC 
Ethics
DSMB
(As specified 
by the DSMP 
Administration 
)

Additionally, it is important to note that after providing informed consent, participants will be assigned a 
study identification number that will be affixed to all collected data. Linkage between participant identity and 
identification numbers will be stored in a locked, secure location or in a password-protected computer 
spreadsheet that will be available only to the investigators and other relevant research staff. This linking file will 
be destroyed 3 years after the end of the study. 
 
Vulnerable Subjects 
Pregnant Women, Fetuses, and Neonates or Children 
This research proposes voluntary involvement of women who are pregnant and infants, in compliance 
with Subpart A:Section 56.204 (82 FR 7259, 7273, Jan. 19, 2017) of Basic U.S. Department of Health and 
Human Services Policy for Protection of Human Research Subjects, in that (a) there is no risk to the fetus 
associated with this proposed research, (b) this study will provide data for assessing potential risks associated 
with alcohol and other substance use to women who are pregnant and fetuses and infants, (c) the research holds 
the prospect of a direct benefit both to women who are pregnant and fetuses and infants, and (d) a woman’s 
consent is obtained in accordance with the informed consent provisions of Subpart A—including that she is fully 
informed regarding the reasonably foreseeable impact of the research on the fetus or neonate; no inducements, 
monetary or otherwise, will be offered to terminate a pregnancy; individuals engaged in the research will have 
no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and individuals 
engaged in the research will have no part in determining the viability of a neonate. 
It is important to note that women who are pregnant will only participate in interview questionnaires. 
 
Potential Benefits of the Research to Research Participants and Others 
We believe that the aforementioned risks are reasonable in relation to the anticipated benefits from 
collecting information on feasibility, acceptability, appropriateness, and effectiveness of the adapted intervention 
to reduce maternal polysubstance use during pregnancy and lactation in SA. We believe the new scientific 
information to be gained in the proposed study outweighs the risks involved. 
Importance of the Knowledge to be Gained 
SA has a long history of social and health disparities, and resulting in the world’s highest rate of FASD 
(111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. 
The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. 
Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate 
the likelihood of alcohol-induced birth defects. The gap exists in that these evidence-based interventions in 
combination need to be adapted to address maternal polysubstance use during pregnancy and lactation and 
examine the effectiveness and cost-effectiveness. The proposed study will adapt evidence-based interventions 
(i.e., CM and educational components of WHC) to address maternal polysubstance use during pregnancy and 
lactation with contingent financial incentives on biochemically verified polysubstance abstinence during 
pregnancy and lactation. The text-based health promotion and referral content will also be incorporated 

according to the evidence of how lifestyle, mental health, and sexual health affect maternal alcohol and 
substance use based on WHC educational components. 
 
 
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117.  Ondersma SJ, Beatty JR, Svikis DS, et al. Computer-Delivered Screening and Brief Intervention for 
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118.  Ondersma SJ, Svikis DS, Thacker LR, Beatty JR, Lockhart N. A randomised trial of a computer-delivered 
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139.  Petersen-Williams P, Washio Y, Myers B, et al. Cannabis use and breastfeeding: Do we know enough? 
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140.  Washio Y, Collins BN, Hunt-Johnson A, et al. Individual breastfeeding support with contingent incentives 
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142.  Washio Y, Novack E, Flores D, et al. Perspectives on HIV Testing Among WIC- Enrolled Postpartum 
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143.  Teitelman AM, Calhoun J, Duncan R, Washio Y, McDougal R. Young women’s views on testing for 
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145.  Dabee S, Barnabas SL, Lennard KS, et al. Defining characteristics of genital health in South African 
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146.  Wood LF, Brown BP, Lennard K, et al. Feeding-Related Gut Microbial Composition Associates With 
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149.  Wechsberg WM, Browne FA, Poulton W, Ellerson RM, Simons-Rudolph A, Haller D. Adapting an 
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APPENDIX 1 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes. 
Pre-Screening Consent Form 
 
This pre-screening consent form is used to determine whether you are eligible to take part in a study whose goal is to 
adapt and test an intervention to reduce polysubstance use (e.g., alcohol, tobacco, and cannabis) during pregnancy and 
breastfeeding. You are being invited because you are either pregnant or postpartum and have a recent history of alcohol 
and tobacco or cannabis use. Please carefully read this information before deciding to take part in this pre-screening. If 
you have any questions, please do not hesitate to ask the study staff. Your participation in this pre-screening is 
voluntary. If you decide not to participate, your decision will not be held against you in any way. 
The purpose of this form is to obtain your consent to allow us to collect biological samples to pre-qualify your eligibility. 
If you agree, you will be asked to provide a urine sample for urinalysis. Your collected urine sample will be tested for 
alcohol, tobacco, and cannabis. 
To further your participation in this study, you must test positive for alcohol and positive for cannabis or tobacco. If you 
test negative, you will not be eligible to participate in the study and will receive R50 compensation. 
  
By signing this form, you are agreeing to the following: 
• 
That you have a recent history of alcohol, tobacco, and/or cannabis use. 
• 
You will allow staff to obtain a urine sample, which will be tested for alcohol, cannabis, and/or tobacco use. 
• 
You understand that to further your participation in the study, you must test positive for alcohol and either 
tobacco or cannabis. 
• 
You understand that your participation in pre-screening is completely voluntary, and there will be no penalty if 
you choose not to participate. 
Participant’s Signature  
 
Date 
(DD/MM/YYYY) 
 
Signed at (Place) 
 
 
  
 
 
 
 
 
 
 
 

 
 
 
APPENDIX 2 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes  
  
*PLEASE DO NOT USE FULL NAMES ANYWHERE ON THIS FORM*  
 
  
PARTICIPANT ID: .................................................................................................................... |__|__|__|__|  
STAFF ID: ................................................................................................................................ |__|__|__|__| 
DATE: ........................................................................................................... |__|__| / |__|__| / |__|__|__|__|  
  
DD  
MM  
  YYYY  
WHERE:___________________________________________________________  
 
READ:  Hello, my name is ____________________. I'm working on a study with pregnant and post-partum women at the South African 
Medical Research Council (SAMRC).   
It will take less than 5 minutes to find out if you might be eligible to take part in this study. Your answers will be kept strictly confidential 
and you do not need to give me your name at this time. Is it OK if we ask you these questions? (If no, thank them for their time and 
end the initial screener)  
SECTION 1 
1. 
What is your date of birth? ........................  |__|__|/|__|__|/|__|__|__|__|  
  
  
  
DD  
MM  
YYYY     
a. And how old are you now?...........................................__|__|  
                
           (If individual is under 18 then ineligible) – PLEASE END THE SCREENER 
  
2. 
What is your place of birth? __________________________________.  
 
 
3. 
What is your race? (select one response) 
Black African .......................................................... 1 
Response does NOT affect eligibility 
Coloured ................................................................ 2 
White South African ............................................... 3 
Asian/Indian ........................................................... 4 
OTHER ................................................................ 99 
[SPECIFY]______________________________ 
REFUSED ............................................................. -7 
  
 
4. 
Are you currently pregnant?  
  
Yes……………………………………………………....1    
 
No………………………………………………….…….0 ( If no, Skip to question 5) 
 
a. If yes, w/how many week pregnant are you now (gestational age)? Answer in weeks:      
__________________ 
 
 
If participant is less than 13 weeks or greater than 28 week- PARTICIPANT IS INELIGIBLE  

 PLEASE END THE SCREENER – 
 
5. 
Are you currently breastfeeding with less than 3 months postpartum? 
 
Yes……………………………………………………....1   
 
No………………………………………………….…….0  
If answered, NO to both question 4 and 5, PLEASE END THE SCREENER – PARTICIPANT IS 
INELIGIBLE 
 
6. 
Is your current pregnancy (or baby being breastfed) a planned pregnancy?    
  
       
Planned……………………………………………………..........1    
Unplanned………………………………………………….…….0   
 
 
7. 
Do you drink alcohol in your current pregnancy, or while you are breastfeeding? 
 
Yes……………………………………………………....1    
 
No………………………………………………….…….0 
If participant drinks alcohol and she is currently drinking during her pregnancy or breastfeeding, 
please administer an EtG test. If participant test NEGATIVE, she is INELIGIBLE. 
 
 
8. 
Do you use tobacco in your current pregnancy, or while you are breastfeeding?
 Yes……………………………………………………....1    
 
No………………………………………………….…….0( If no, skip to question 9) 
 
a. Please specify below what type of tobacco do you use (i.e. smoking, chewing)?  
 
 
 
 
 
9. 
 Do you use cannabis/dagga/marijuana in your current pregnancy or while you are breastfeeding? 
 
Yes……………………………………………………....1   
 
No………………………………………………….…….0 (If participant, answered “NO” for BOTH 
question 8 and 9, PLEASE END THE SCREENER – PARTICIPANT IS INELIGIBLE) 
 
_ Add interviewer prompt: As a reminder, your answer are  confidential. 
 
(If participant, answered “YES” for either question 8 or 9 please administer an EtG test. If tested 
NEGATIVE for BOTH THC and cotinine, PARTICIPANT IS INELIGIBLE) 
 
 
 
 
10. 
Do you plan to complete your antenatal care at this current clinic and remain to stay here for at least 3 
months after delivering your baby? 
 
 
Yes……………………………………………………....1 
No………………………………………………….…….0 
(If participant, answers “NO”, PLEASE END THE SCREENER – PARTICIPANT IS INELIGIBLE)   
11. 
Do you currently have any serious medical problems or any other reason(s) that may result in your 
pregnancy to be high risk?(If participant is currently Breastfeeding, SKIP to Question 12) 
 
 

Yes……………………………………………………....1 
No………………………………………………….…….0 
 
(If participant, answers “YES”, PLEASE END THE SCREENER – PARTICIPANT IS INELIGIBLE)   
 
12. Do you currently have suicidal thoughts or attempted suicide in the past month?  
 
 
Yes……………………………………………………....1  
No………………………………………………….…….0 
(If participant, answers “YES”, PLEASE PROVIDE  PARTICIPANT WITH LOCATE MENTAL HEALTH 
RESOURCES AND END THE SCREENER – PARTICIPANT IS INELIGIBLE) 
 
 13. Do you currently own a cell phone? 
Yes……………………………………………………....1  
No………………………………………………….…….0 
 
(If participant, answers “NO”, PLEASE END THE SCREENER – PARTICIPANT IS INELIGIBLE) 
 
14. 
Have you ever been given a positive HIV test result in your lifetime? 
 
Yes……………………………………………………....1 
 
No………………………………………………….…….0 
(If participant, answers “YES”, PLEASE END THE SCREENER – PARTICIPANT IS INELIGIBLE)   
  
  
  
END OF SCREENER   
  
  
SCRIPT A: If the person is NOT eligible, READ:   
Those are all of the questions I have for you. Thank you very much for your time and participation. All of the 
information you have provided will be kept confidential.   
  
SCRIPT B: If the person is eligible, READ:   
Based on your answers, you are eligible to take part in a study we are conducting to develop  a behavioral 
intervention to improve maternal/infant health. If you have a moment now, I would like to tell you a little more 
about the study.   
  
If yes, [READ:]   
 If you agree to participate, I would like to schedule an appointment with you to be interviewed.   
 Before you agree to participate, we will go over this study in detail so that you will know what we will be 
asking of you.   
  
Would you like to continue with the study? _____________________________  (If yes, continue 
to consent the participant).   
IF NOT INTERESTED IN STUDY, ASK AND RECORD WHY:   
  

I do not have time   
  
  
  
  
  
  
  
   
I am worried about privacy    
  
  
  
  
  
   
Not a good time (patient received results/is distressed)   
  
  
   
I am not interested in being part of a study    
  
  
  
   
I do not have alcohol use problems     
  
  
  
  
Other   
 
  
  
  
  
  
  
  
   
If other: please tell me your reason ………………………………………….. 
APPENDIX 3 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes 
 
INFORMATION AND CONSENT 
 
Introduction 
Hello. My name is____________________. I am from the South African Medical Research Council (SAMRC). We are asking 
you to take part in our study because you are either pregnant, or postpartum with a recent history of alcohol and 
tobacco/cannabis use. The information in this consent form will give you the necessary details about this study to help 
you decide whether you would like to take part or not. If you have any questions, which are not fully explained in this 
document, please do ask the study staff. You should not agree to take part unless you are happy about all that is involved.  
 
Why are we doing this? 
We want to adapt and test an intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during 
pregnancy and breastfeeding and to prevent adverse clinical outcomes, including Fetal Alcohol Spectrum Disorders (FASD).  
 
What We’re Asking of You 
If you agree to participate, you will be one of 48 women (24 pregnant and 24 postpartum women) who have a recent 
history of using alcohol, tobacco, or cannabis during your current pregnancy or while you are breastfeeding. You will be 
required to complete 3 interviews as part of your participation: a screening interview, a baseline interview, and a 3-month 
follow-up interview. While enrolled in the study, you will be asked a series of questions during these 3 interview 
appointments. In addition, you will be asked to provide a blood sample and a urine sample at screening and once per 
month until the completion of your time in the study. You will also be asked to participate in a Post-testing qualitative 
interview. You will spend approximately one hour at each interview. Your time and inputs are very important to us since 
they will help us improve this program for future studies. 
 
Potential Risks and Discomforts.   
We don't anticipate any risks associated with taking part in this study. You might, however, feel uncomfortable providing 
biological samples or responding to certain interview questions. If you feel uncomfortable, please let a member of the 
study staff know. We want you to be aware that you will never be pressured to answer any questions or forced to provide 
biological samples. Participation is fully voluntary. You have the right to stop participation in the study at any time, decline 
to give biological samples, and/or decline to participate in an interview. We ensure you that if you decided to no longer 
participate in this study, your decision will not be held against you in any kind of way. 
 
Potential Benefits of Taking Part in the Study.   
There are no direct benefits to you for participating in this study , but the information you provide will help us gain a better 
understanding of how to develop an appropriate intervention.  
 
Confidentiality and Privacy. 
Any information obtained will remain confidential. It will be disclosed only as required by law in the following two 
instances: 1) If you tell us that you are about to hurt yourself or someone else 2) or if you are involved in the neglect 
and/or abuse of a child. In either case, we must report that information to the appropriate authorities. The consent and 
contact forms will be stored separately to transcripts in locked file cabinets. The South African MRC ethics committee will 

however have access to all data. Deidentified data will be shared with the funding body NIH and archived with NIH 
according to their policy. 
We will use the data from the interviews to write up and publish papers in academic journals, but this data will be 
anonymized (we will use a participant number instead of your name). Your name will therefore not appear anywhere in 
any published material. 
 
There is a small possibility that a person may gain access to the information you gave us without our permission. Every 
effort will be made to protect your privacy and no personal details or names will be used during the interview. 
 
Participation and Withdrawal. 
Participation is voluntary. You can choose not to participate.  If you decide to participate, you may choose to stop your 
participation at any time. There will be no consequences. Your decision to take part or not take part in this study will not 
affect your usual antenatal or post-partum care at your healthcare facility.  You may also refuse to answer any questions 
you do not want to answer.   
 
Who is funding the study? 
The study is being conducted by the South African Medical Research Council and RTI International and funded by the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH).  
 
Compensation 
While taking part in this study, you will be required to meet with study staff at the health facility once a month to provide 
a urine and dry blood sample that will be tested for alcohol, tobacco, cannabis and other substances. You can receive R200 
for testing negative for each substance in your first month of participation in the research. Following that, your earnings 
will increase by R50 till the study is completed. However, if your sample tests positive for a substance, your earnings will 
be reduced back to R200. Additionally, you will be compensated R200 for completing screening and a baseline assessment 
and R300 for completing the follow-up assessment at the end of the study. 
 
Who to Contact with Questions 
This study has been approved by the South African MRC Ethics Committee. The study will be conducted according to the 
ethical guidelines and principles of the International Declaration of Helsinki, and the South African Guidelines for Good 
Clinical Practice. 
 
If you have any questions or concerns about the research, please contact Dr Yukiko Washio Principal investigator: 
ywashio@rti.org or Dr Petal Petersen-Williams Site Principal Investigator: petal.petersen@mrc.ac.za 
 
 
Mental Health, Alcohol, Substance use and Tobacco Research Unit 
 
 
 
Medical Research Council  
 
 
 
 
P.O. Box 19070 
Tygerberg  
7505 
Tel. 021-938 0337 
 
 
Rights of Research Participants 
You can decide you do not want to participate at any time.    If you have any questions about your rights as a participant, 
you can contact the chairperson of the MRC ethics committee, Ms. Adri Labuschagne at 021 938 0687 or email: 
adri.labuschagne@mrc.ac.za.   
 
Indicating Consent 
Please let us know if you have any questions before signing this consent form.  Please initial next to each item to show 
that you agree to what is required: 
Agree 
 

 
I agree to continue in the study, which has been fully described to me. This means that 
I agree to answer questions today  
 
I agree to provide my contact information 
 
I understand that my participation in this study is completely voluntary, and there will 
be no penalty if I choose not to participate. 
 
In accordance with the provisions of the Protection of Personal Information Act 4 of 2013 (as amended), I hereby 
consent: 
a. 
To my personal information (hereinafter 'data') being collected, processed, shared and stored in accordance with 
the research protocol as approved by the South African Medical Research Council's Human Research Ethics 
Committee (SAMRC HREC); 
b. 
To my anonymised data being shared, processed and transferred by third parties and between third parties, and 
where relevant beyond the jurisdictional borders of South Africa; 
c. 
To all findings and results flowing from my anonymised data being broadly shared and published on the conclusion 
of the research. 
 
DECLARATION BY PARTICIPANT 
By signing below, I, ____________________________ (Participant’s Full Name) agree to take part in the MRC Study. 
I declare that: 
• I have read or had read to me this information and consent form and it is written in a language with which I 
am fluent and comfortable. 
• I have had a chance to ask questions and all my questions have been adequately answered. 
• I understand that taking part in this study is voluntary and I have not been pressured to take part. I also 
understand that I do not give up any rights by signing below. 
• I may choose to leave the study at any time and will not be penalised or prejudiced in any way. 
• I have a copy of the consent form with the information about rights of research participants and who to 
contact with questions. 
 
Participant’s Signature  
 
Date 
(DD/MM/YYYY) 
 
Signed at (Place) 
Declaration by staff 
     I, ____________________________ (Project Staff’s Full Name) declare that: 
• I explained the information in this document to ____________________________       
                                                                                     (Participant’s Full Name) 
• I encouraged him/her to ask questions and took adequate time to answer them. 
• I am satisfied that s/he adequately understands all aspects of the research 
• I gave him/her a card with information about rights of research participants and who to contact with 
questions. 

 
Project staff’s Signature  
 
Date 
(DD/MM/YYYY) 
 
Signed at (Place) 
 
 
 
 
 
APPENDIX 4: CONTACT INFORMATION FORM 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes  
  
INTERVIEWERS INITIALS |__|__| 
DATE: 
|__|__| / |__|__| / |__|__|__|__| 
 
    DD              MM           YYYY  
PARTICIPANT ID NUMBER: |__|__| 
Instructions for Staff - Reviewing and/or Updating: This form should be reviewed and updated at each appointment.  
 
READ: As we mentioned in the consent form, we would like to collect your contact information to 
remind you of your next appointment. Please note that this information will be kept private. We will 
use the information you give us to contact you to remind you of your appointments. 
 
Please use this form to record any additional information (e.g., nicknames, hangouts, or cell phone numbers, etc.) that 
will be helpful if you need to schedule an appointment for a later time or the next day. This information should help you 
find the participant in case they forget to meet at the scheduled location. 
What is your first name, middle name and surname?  
_____________________________________________________________________________________ 
What nicknames do you use? 
_____________________________________________________________________________________ 
What is your cell phone number? 
_____________________________________________________________________________________ 
If we can’t get hold of you on this number is there anyone else we can phone who you see regularly? 
NAME AND RELATION 
CELLPHONE NUMBER 
1. 
 
1. 
2. 
 
2. 
3. 
 
3. 

4. 
 
4. 
 
 
 
 
 
 
 
Please can you supply is with your home address? 
__________________________________________________________________________________________________
__________________________________________________________________________________________________
___________________________________________________________ 
 
Please describe any relevant landmarks or any significant information we will need to locate your home address if 
applicable (this is particularly important if you reside in an informal settlement). 
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________ 
 
If we cannot get hold of you by phone, can we send a project staff member to your home?  
□YES □ NO 
 
Where do you usually hang out during the day? 
 
______________________________________________________________________ 
 
Please can you supply us with your email address if you have one? 
 
_______________________________________________________________________ 

 
 
 
 
 
 
 
 
APPENDIX 5 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes. 
Baseline Assessment 
 
Introductions: 
 
Assessor to read: We will work through the questionnaire as follows: I will ask the questions and give you the answer 
choices. You will be asked to pick the answer that is the closest to how you feel. I will then record your answer. The 
interview will take about 45 minutes to complete. There are no right or wrong answers. Please answer just what you 
think and feel. 
 
No one at the clinic will see you answers, and you will be identified with a special participant ID. 
 
A, DEMOGRAPHICS 
 
A1. How old are you? ____________(years) 
A2. What language do you speak at home? 
 1= English 
 2= Afrikaans 
 
*PLEASE DO NOT USE FULL NAMES ANYWHERE ON THIS FORM* 
 
PARTICIPANT ID: ...................................................................................................................... |__|__|__|__| 
STAFF ID: ............................................................................................................................................ |__|__| 
DATE: .............................................................................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
WHERE:___________________________________________________________ 

 3= IsiXhosa 
 4= IsiZulu 
 5= Sesotho 
 6=SeTswana 
 7= SePedi 
 8= SiSwati 
 9= Tshi Venda 
 10= Zitsonga 
 11= IsiNdebele 
 12= Other ( Please Specfiy____________________________________) 
A3. What race are you? 
 1=Coloured 
 2= Black 
 3= Indian 
 4= White 
 5=Other ( Please specify__________________________________________________) 
A4. What is your current relationship status? 
 1= Has a partner 
 2= Not married and living with a partner 
 3= Married 
 4= Divorced or separated 
 5= Widow/Widower 
 6= Single  
 7 = Other (Please specify____________________________________________________) 
A5. What education do you have? 
 1= No Formal Education 
 2= Grade 1-7 
 3= Grade 8-12 
 4= Tertiary (College, Technicon, University) 
A6. Which best describes the type of house in which you live? Please choose one answer only 
1= House or brick structure on a separate stand or yard or on farm 
2= Traditional dwelling/hut/structure made of traditional materials 
3= Flat 
4= Town/cluster/semi-detached house (simplex, duplex or triplex) 
5= Unit in retirement village 
6= Dwelling/house/flat/room in backyard 
7= Informal dwelling/shack IN the backyard of a formal house 
8= Informal dwelling/shack NOT in backyard e.g. in an informal/squatter settlement or on farm 
9= Room/flatlet not in backyard but on a shared property( e.g granny flat) 
10= Caravan/tent 
11= Worker’s hostel 
12= Other (Please specify____________________________________________________) 
A7. Which of the following best describes your current employment status? 
 1= Unemployed and looking for work 
 2= Unemployed and not looking for work 
 3= Employed part-time 
 4= Employed full-time 
 5= Self-employed 
 6= Pensioner 
 7= Student/Scholar/Learner 
A8. What is your main source of income? (Where do you get most of your money from each month?) 
 1= Formal employment 
 2= Self-employment 

 3= Odd jobs 
 4= Government grant (childhood/disability) 
 5= Income from investments 
 6= Maintenance (child support or money from ex-partner for living costs) 
 7= Scholarship/student loan 
 8= Pension 
 9= No income 
 10= Other (Please Specify ________________________________________________) 
A9. On average, what is your monthly income? 
 1= Less than R600 
 2= R600-R1000 
 3= R1001-R2000 
 4= R2001-R4000 
 5= More than R4000 
 6= Don’t know 
A10. How many people do you support with your income? ___________________________ 
A11. Are you currently pregnant? 
 1= Pregnant 
 2= Postpartum (SKIP TO A13) 
A12. How many weeks pregnant are you? _____________________________ (weeks) 
A13. How old is your baby?_____________________________(months) 
B4.  
Was your current pregnancy or baby planned?     
 
1.Yes 
 
0.No 
 
A14. What is your current weight?_________________________________(in kgs) 
A15. What is your current height___________________________________(in cms) 
 
 
B.  PREGNANCY EXPERIENCES 
 
 
PAST PREGNANCY EXPERIENCES 
 
B1. How many times have you been pregnant before now? (Excluding this pregnancy if currently pregnant or the most 
recent pregnancy if currently post-partum) :_______________________________ 
(IF CURRENT PREGNANCY IS THE FIRST PREGNANCY GO TO THE QUESTION B4) 
 
B2. Now I would like to ask you about your past pregnancies and the health of your last-born child. Please note these 
questions do not refer to your current pregnancy if currently pregnant or your new-born if currently post-partum. 
                                                                     
  
Of these pregnancies, how many are 
Outcome of Last Pregnancy 
Complications 
Nr 
Still Alive 
Still 
Birth 
Abortion Miscarriages 
Full 
Term 
Still 
Born 
Voluntary 
Abortion 
Yes 
No 
N/A 
1 
  
  
  
  
  
  
  
  
  
  
2 
  
  
  
  
  
  
  
  
  
  
3 
  
  
  
  
  
  
  
  
  
  
4 
  
  
  
  
  
  
  
  
  
  
 
B3. 
Do you have any biological children with alcohol-related disabilities from your previous pregnancies? 
 
1.Yes 

 
0.No 
 
 
 
 
B3_a. If yes, how many? ____________________ 
 
 
F. BREASTFEEDING HISTORY AND ATTITUDE 
If you are currently pregnant and have no other children, this section is NA. 
Please skip to Section G 
 
 
BFH2.1 Have you ever breastfed before in your lifetime? 
 1=Yes 
 0=No 
 
If YES to BFA2.1: 
BFH2A.1 How many children did you breastfeed and about how long? 
 
Duration of breastfeeding 
1st child 
 
2nd child 
 
3rd child 
 
4th child 
 
5th child 
 
 
BFH1Are you currently breastfeeding? 
1= Yes 
0=No 
 
 
BFH1.1 What made you decide to breastfeed? 
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________ 
 
 
BFH3.1 Has your mother ever breastfed before?  
 1=Yes 
 0=No 
 
 
 
 
If YES to BFA3.1: 
BFH3A.1 If so, how many children did she breastfeed? _______ children 
BFH3B.1 How many children did she have? 
 
_______ children 
 
BFH4.1 Has any of your relatives or friend ever breastfed before?  
 1=Yes 
 0=No 
 
C. ALCOHOL USE 
C1 Timeline follow-back 
 
Show participant the picture of the standard drinks.  Explain: Different alcohol containers have different amounts of 
alcohol.  E.g a small can of beer is 1 standard drink but a quart has 2 standard drinks.  The next few questions ask about 
the number of standard drinks you usually drink. 
 
 
 

 
Surp_p1.1 In the month before you knew you were pregnant, how many beers, how much wine, or how much liquor did 
you drink?* _______________ 
 
BFH5.1 In the past, have you every breastfed after consuming alcohol? 
1=Yes 
0=No 
  
 
C2. How old were you when you had your first drink? _______ (years) 
 
Do you currently drink alcohol? 
‘1’=Yes 
‘0’=No 
 
Alc_7dys:From 0-7, how many days in the last 7 did you drink alcohol?____ 
 
Past 7 day drinking ending on day 7 (yesterday) 
   
Please provide that number of drinks you had in a day for the last 7 days. 
 
 
 
BFH6.1 Did you breastfed your child after consuming alcohol in the past week or last 7 days? Skip is answer 0 to 
alc_7dys_bsl 
 1=Yes 
 0=No 
BFH6.2 How many days did you use alcohol and then breastfed? ___________ 
CRAVING (Scale: 0-10 with 0 not at all craving for a drink to 10 extremely craving for a drink how often do you crave a 
drink in a week? 
 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 
7(yesterday) 
 
 
 
 
 
 
 
 
 
 
Day 1: 
 
 
Day 2: 
 
 
Day 3: 
 
 
Day 4: 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
Beer 
 
 
Beer 
 
 
Beer 
 
 
Beer 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
Wine 
 
 
Wine 
 
 
Wine 
 
 
Wine 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
 
 
 
 
 
 
 
 
 
 
Day 5: 
 
 
Day 6: 
 
 
Day 7: 
 
 
 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
 
Beer 
 
 
Beer 
 
 
Beer 
 
 
 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
 
 
 
Wine 
 
 
Wine 
 
 
Wine 
 
 
 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
 
 

 
AUDIT-C 
C3. How often do you have a drink containing alcohol?  
 0=Never 
 1=Monthly or less 
 2=2-4 times a month 
 
 
 3=2-3 times a week 
 
 
 4=4 or more times a week 
C4. How many standard drinks containing alcohol do you have on a typical day?  
 0=1 or 2  
 1=3 to 4 ( flag start) 
 
 
 2=5 to 6  
 
 
 3=7 to 9  
 
 4=10 or more  
C5. How often do you have 4 or more drinks on one occasion?  
 0= Daily or almost daily    
 1=Weekly  
 
 
 2=Monthly  
 3=Less than monthly  
 4=Never 
 
Would you like a referral related to your alcohol use? If, yes please provide participant with resource 
1=Yes 
0=No 
 
 
 
D. SUBSTANCE USE 
 
The next few questions ask about your use of drugs other than alcohol and tobacco.  We know that many people use  
drugs like dagga. Don’t worry about telling us that you use drugs. We want to understand what is really happening, 
not what you think we “want to hear.” Here are a few questions about your use of drugs. 
 Drugs include substances like dagga (ganja or weed), methamphetamine or tik, ecstasy, mandrax, cocaine, heroin, 
unga 
 
 
assist_1 In your life, which of the following substances have you ever used? (NON-MEDICAL USE 
ONLY) 
0= NO 
1=YES 
assist_1aTobacco products (cigarettes, chewing tobacco, cigars, etc.) 
 
 
assist_1bAlcoholic beverages (beer, wine, spirits, etc.) 
 
 
assist_1cCannabis (marijuana, pot, grass, hash, etc.) 
 
 
assist_1dCocaine (coke, crack, etc.) 
 
 
assist_1eAmphetamine-type stimulants (speed, meth, ecstasy, etc.) 
 
 
assist_1f Inhalants (nitrous, glue, petrol, paint thinner, etc.) 
 
 
assist_1gSedatives or sleeping pills (diazepam, alprazolam, flunitrazepam, midazolam, etc.) 
 
 
assist_1hHallucinogens (LSD, acid, mushrooms, trips, ketamine, etc.) 
 
 
assist_1i Opioids (heroin, morphine, methadone, buprenorphine, codeine, etc.) 
 
 
assist_1jOther 
 
 
 
assist_2: In the past three months, how often have you used the 
substances you mentioned (FIRST DRUG, SECOND DRUG, 
ETC)?skip if the following 
0=Never 
2=Once or 
Twice 
3=Monthly 
4=Weekly 
6= Daily or 
Almost 
Daily 
assist_2aTobacco products (cigarettes, chewing tobacco, cigars, 
etc.) (branching logic, if assist_1a=”0) 
 
 
 
 
 

assist_2bAlcoholic beverages (beer, wine, spirits, etc.) 
(branching logic, if assist_1b=”0’) 
 
 
 
 
 
assist_2cCannabis (marijuana, pot, grass, hash, etc.) (branching 
logic, if assist_1c=”0’) 
 
 
 
 
 
assist_2dCocaine (coke, crack, etc.) ((branching logic, if 
assist_1d=”0’) 
 
 
 
 
 
assist_2eAmphetamine-type stimulants (speed, meth, ecstasy, 
etc.) ((branching logic, if assist_1e=”0’) 
 
 
 
 
 
assist_2f Inhalants (nitrous, glue, petrol, paint thinner, etc.) 
(branching logic, if assist_1f=”0’) 
 
 
 
 
 
assist_2gSedatives or sleeping pills (diazepam, alprazolam, 
flunitrazepam, midazolam, etc.) ((branching logic, if 
assist_1g=”0’) 
 
 
 
 
 
assist_2hHallucinogens (LSD, acid, mushrooms, trips, ketamine, 
etc.) ((branching logic, if assist_1h=”0’) 
 
 
 
 
 
assist_2iOpioids (heroin, morphine, methadone, 
buprenorphine, codeine, etc.) ((branching logic, if assist_1i=”0’) 
 
 
 
 
 
assist_2jOther(branching logic, if assist_1j=”0’) 
 
 
 
 
 
 
 
 
assist_8: Have you ever used any drug by injection? (NON-MEDICAL USE ONLY) 
0=No, 
Never 
6= Yes, in 
the past 3 
months 
3=Yes, but not in 
the past 3 months  
 
 
 
 
Surp_p2.1 Have you ever felt the need to cut down on your drug or alcohol use? 
 1= Yes 
 0= No 
 
MJ.Do you currently use cannabis? 
‘1’=YES 
‘0’=NO 
 
 
MJ.1 Which of the following statements best describes your marijuana use: Would you say: 
 1 =  I use marijuana regularly now – about the same amount as before finding out I was pregnant 
 2 = I use marijuana regularly now, but I’ve cut down since I found out I was pregnant 
 3 = I use marijuana every once in a while 
 4 = I have quit using marijuana since finding out I was pregnant 
 5 = I wasn’t using marijuana around the time I found out I was pregnant, and I don’t currently use marijuana 
 
MJ_MrngSick.1  Did you use in order to manage morning sickness during the last pregnancy?  
 1=Yes 
 0=No 
 
 
MJ_Types.1  Please specify what forms of marijuana you have used in the past:  _______________ 
 
MJ_Age.1  How old were you the first time you used marijuana? ___________________ 
 
MJ_LastUse.1  How long has it been since you last used marijuana? __________________ 
 

MJ_AvgUs.1 e On how many days in a month did you use on average? ______ 
 
 
MJ_7days From 0 to 7, how many days out of the last 7 did you use cannabis? (Even if they say 0, proceed to next 
question.)_____________________ 
 
 Please provide how many times a day you use cannabis in the last 7 days. 
 
Number of 
times: 
1x 
2x 
3x 
4x 
5x 
6 or more 
Day 1 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
Day 3 
 
 
 
 
 
 
Day 4 
 
 
 
 
 
 
Day 5 
 
 
 
 
 
 
Day 6 
 
 
 
 
 
 
Day 7 
 
 
 
 
 
 
 
 
 
 
BFMJ_7days Did you breastfed your child after smoking cannabis in the past week or the 7 days? 
 1=Yes 
 0=No 
 
BFMJ_7days How many days did you use cannabis (dagga)  and then breastfed? __________ 
 
 
 
MJ_safe.1  How safe do you think marijuana is? 
 1 = Very safe 
 2 = Somewhat safe 
 3 = Somewhat unsafe 
 4 = Very unsafe 
 5 = Don’t know 
 
MJ_harm.1  How harmful do you believe marijuana is for your health? 
 1 = Very harmful 
 2 = Somewhat harmful 
 3 = A little harmful 
 4 = Not at all harmful 
 5 = Don’t know 
 
E. NICOTINE DEPENDENCE 
E1.Do you currently smoke cigarettes? 
 1=Yes 
 0=No (IF NO, SKIP TO SECTION F.) 
 
Cigs_7dy From 0-7, how many days out of the last 7 have you smoked at least puff of a tobacco product like cigarettes?  
 
 Please provide how many times a day you used cigarettes or a tobacco product in the last 7 days. 
 
Number of 
times: 
1x 
2x 
3x 
4x 
5x 
6 or more 

Day 1 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
Day 3 
 
 
 
 
 
 
Day 4 
 
 
 
 
 
 
Day 5 
 
 
 
 
 
 
Day 6 
 
 
 
 
 
 
Day 7 
 
 
 
 
 
 
 
 
 
E2.Did you breastfed your child after using cigarettes or tobacco products in the past week or the last 7 days? 
 1=Yes 
 0=No 
 
E3.How many days after using cigarettes or tobacco did you breastfed? __________ 
 
E4. Have you used other substances other than tobacco and/or cannabis ( i.e Cocaine, Amphetamine, Opioids etc.) in the 
past week and then breastfed? 
 1=Yes 
 0=No 
 
E4.aPlease specify what substance(s) you use in the last 7 days?____________________________________ 
 
E4.b How many days did you use other substances and then breastfed? _____________________ 
 
 
 
Do you think you will need any of the following services? Only refer to things you will need yourself. 
 
 
    
 
 
 
 
 
YES 
NO  DK/Unsure     REF 
 
 
 
 
 
 
▼ 
 ▼         ▼ 
     ▼ 
   
a. 
Employment or job placement services 1 
2 
-4 
-7 
b. 
Schooling services 
  
 
1 
2 
-4 
-7 
c. 
Housing services 
 
 
1 
2 
-4 
-7 
d. 
Financial assistance services 
 
1 
2 
-4 
-7 
e. 
Food assistance services 
 
1 
2 
-4 
-7 
f. 
Legal services (e.g., lay a charge) 
1 
2 
-4 
-7 
g. 
Transportation services  
 
1 
2 
-4 
-7 
h. 
Getting medical/healthcare    
 
1 
2 
-4 
-7 
i. 
Self-help groups (for example  
 
                   Alcoholics Anonymous or Alanon) 
1 
2 
-4 
-7 
j. 
Physical and/or sexual abuse 
 
                   counseling services  
1 
2 
-4 
-7 
k. 
Mental health services  
(e.g. for depression, stress)  
 
 
1 
2 
-4 
-7 
l. 
Child care services 
 
 
1 
2 
-4 
-7 
m. 
Counseling (individual, family, couples) 1 
2 
-4 
-7 
n. 
Substance abuse rehab/treatment 
1 
2 
-4 
-7 
 
 
 
 
 

H. PSYCHOLOGICAL DISTRESS/DEPRESSION 
 
 
 
 
 
 
 
 
GENERALALISED ANXIETY DISORDER-7 (GAD-2) 
 
Over the last 2 weeks, how often have you been bothered by the following problems? 
 
Not at all (0) 
Several days (1) 
More than half the 
days (2) 
Nearly every day 
(3) 
gad2.1 Feeling nervous, anxious, or on the 
edge 
 
 
 
 
gad2.2Not being able to stop or control 
worrying 
 
 
 
 
 
 
 
EVERYDAY DISCRIMINATION SCALE(EDS) 
In your day-to-day, life how often do any of the following things happen to you? 
 
 
Never 
Less than once a 
year 
A few 
times a 
year 
A few 
times a 
month 
At least once 
a week 
Almost 
every day 
eds1.1. You are treated with less courtesy 
than other people are. 
 
 
 
 
 
 
eds2.1. You are treated with less respect than 
other people are. 
 
 
 
 
 
 
eds3.1. You receive poorer service than 
others. 
 
 
 
 
 
 
eds4.1. A doctor or nurse acts as if he or she 
thinks you are not smart. 
 
 
 
 
 
 
eds5.1. A doctor or nurse ats as if he or she is  
afraid of you. 
 
 
 
 
 
 
eds6.1 A doctor or nurse ats as if he or she is  
better than you. 
 
 
 
 
 
 
eds7.1. You feel like a doctor or nurse is not 
listening to what you were saying 
 
 
 
 
 
 
 
INTERVIEWER: Asked only of those answering “ A few times a year” or more frequently to at least one question 
Eds10.1 What do you think is the main reason for these experiences (Check all that applies) 
 
 1= Your Ancestry or National Origins 
 2.= Your Gender 
 3= Your Race 
 4= Your Age 
 5= Your Religion 
 6= Your Height 
 7= Your Weight 
 8= Some other Aspect of Your Physical Appearance 
 9= Your Sexual Orientation 
 10= Your Education or Income Level 

 11= A physical disability 
 12= Your shade of skin color (NSAL) 
 13= Your tribe (SASH) 
 14=Pregnant 
 15= Substance Use 
 16= Cannabis Use 
 17= Tobacco Use 
 18= Other (SPECIFY) _____________________________ 
 
EDINBURGH POSTNATAL DEPRESSION SCALE (EPDS) 
As you are pregnant or have recently had a baby, we would like to know how you are feeling? Please check the answer 
that comes closest to how you have felt IN THE PAST 7 DAYS, not just how you feel today. 
 
In the past 7 days…. 
 
Edps1. I have been able to see the funny side of things: 
 0= As much as I always could 
 1= Not quite so much now 
 2= Definitely not so much now 
 3= Not at all 
Edps2. I have looked forward with enjoyment to things. 
 0= As much as I ever did 
 1= Rather less that I used to 
 2= Definitely less than I used to 
 3= Hardly at all 
Edps3.I have blamed myself unnecessarily when things went wrong 
 3= Yes, most of the time 
 2= Yes, some of the time 
 1= Not very often 
 0= No, never 
Edps4. I have been anxious or worried for no good reason 
 0= No, not at all 
 1= Hardly ever 
 2= Yes, sometimes 
 3= Yes, very often 
Edps5. I have felt scared or panicky for no very good reason 
 3= Yes, quite a lot 
 2= Yes, sometimes 
 1= No, not much 
 0= No, not at all 
Edps6. Things have been getting to me. 
 3= Yes, most of the time I have not been able to cope at all 
 2= Yes, sometimes I haven’t been able to cope as well as usual 
 1= No, most of the time I have copes quite well 
 0= No, I have been coping as well as ever 
Edps.7 I have been so unhappy that I have had difficulty sleeping. 
 3= Yes, most of the time 
 2= Yes, some of the time 
 1= Not very often 
 0= No, never 
Edps8. I have felt sad or miserable. 
 3= Yes, most of time 
 2= Yes, quite often 

 1= Not very often 
 0= No, not at all 
Edps9.  I have been so unhappy that I have been crying 
 3= Yes, most of the time 
 2= Yes, quite often 
 1= Only occasionally 
 0= No, never 
Edps10. The thought of harming myself has occurred 
 3= Yes, quite often 
 2= Sometimes 
 1= Hardly ever 
 
 
I. VIOLENCE AND SEXUAL RISK EXPOSURE 
 
 
 READ: NO matter how hard people try, they sometimes have conflicts or disagreements.  People can try various ways 
to settle their differences.  I'm going to read a list of some things that you may have done when you had a 
disagreement. 
 
I1. 
In the past 90 days, have you had a disagreement in which you…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
 
 
 
 
a. Insulted or swore at someone ............................................... 1 ................ 2 ............... -4 ............. -7 
 
b. Threatened to hit or throw something 
at another person ................................................................. 1 ................ 2 ............... -4 ............. -7 
 
c. Threw something at someone ............................................... 1 ................ 2 ............... -4 ............. -7 
 
d. Pushed, grabbed, or shoved someone ................................... 1 ................ 2 ............... -4 ............. -7 
 
e. Slapped another person ......................................................... 1 ................ 2 ............... -4 ............. -7 
 
f. Kicked, bit, or hit someone ................................................... 1 ................ 2 ............... -4 ............. -7 
 
g. Hit or tried to hit anyone with something 
(an object) ........................................................................... 1 ................ 2 ............... -4 ............. -7 
 
h. Beat up someone ................................................................... 1 ................ 2 ............... -4 ............. -7 
 
i. Threatened anyone with a knife or gun ................................ 1 ................ 2 ............... -4 ............. -7 
 
j. Used a knife or gun on another person ................................. 1 ................ 2 ............... -4 ............. -7 
 
 
 
LOGIC: IF NO MAIN SEXUAL PARTNER (L9=NO, DK/UNSURE, OR REFUSED) SKIP TO I3 
 
READ: 
Now I would like to ask you about things that your main sexual partner may have done to you.  Let me 

remind you that this information will remain strictly confidential. 
I2. 
In the past 90 days, has your main sexual partner…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
a. 
Abused you emotionally, that is, did or said 
 
things to make you feel very bad about 
 
yourself or your life ............................................................ 1 ................. 2 ................ -4 ............ -7 
 
b. 
Attacked you with a gun, knife, stick, bottle, or other  
 
weapon ................................................................................ 1 ................. 2 ................ -4 ............ -7 
 
c. 
Hurt you by striking or beating you to the point  
 
that you had bruises, cuts, or broken bones, or  
 
otherwise physically abused you......................................... 1 ................. 2 ................ -4 ............ -7 
 
d. 
Pressured or forced you to participate  
 
in sexual acts against your will ........................................... 1 ................. 2 ................ -4 ............ -7 
 
 
 
 
I3. 
Has anyone ever physically hurt you (i.e., someone hurt you by striking or beating you to the point that you had 
bruises, cuts, or broken bones)? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2    
 
DK/UNSURE .............................................................................................. -4   
REFUSED ................................................................................................... -7  
 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED, SKIP TO I8. 
 
I4. 
(HAND RESPONDENT SHOWCARD O-1)  When was the last time you were physically hurt?  
 
Within the past two days ............................................................................. 1 
3-7 days ago ................................................................................................ 2 
1-4 weeks ago ............................................................................................. 3 
1-3 months ago ............................................................................................ 4 
4-12 months ago .......................................................................................... 5  
More than 12 months ago ........................................................................... 6   
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
 
I4a. 
The last time you were physically hurt did you seek medical help? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2 
 
DK/UNSURE .............................................................................................. -4 

REFUSED ................................................................................................... -7 
 
 
I4b. 
(HAND RESPONDENT SHOWCARD O-2)  The last time you were physically hurt, who hurt you?  
 
Main sexual partner ..................................................................................... 1 
Client ........................................................................................................... 2 
Male relative ............................................................................................... 3 
Female relative ............................................................................................ 4 
Friend/acquaintance/peer ............................................................................ 5 
Stranger (not a client) .................................................................................. 6 
Big mama or pimp ...................................................................................... 7 
Police .......................................................................................................... 8 
Drug dealer.................................................................................................. 9 
Security guard ............................................................................................. 10 
OTHER ....................................................................................................... 99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I5. 
How old were you when you were first physically hurt? (( ENTER "NEG4" if DK/UNSURE or "NEG7" if REFUSED) 
 
 
AGE ........................................................................ |__|__| 
 
 
DK/UNSURE ................................................................. -4  
 
REFUSED ...................................................................... -7  
 
I5a. 
(HAND RESPONDENT SHOWCARD O-2)  The first time you were physically hurt, who hurt you?  
 
Main sexual partner ..................................................................................... 1 
Client ........................................................................................................... 2 
Male relative ............................................................................................... 3 
Female relative ............................................................................................ 4 
Friend/acquaintance/peer ............................................................................ 5 
Stranger (not a client) .................................................................................. 6 
Big mama or pimp ...................................................................................... 7 
Police .......................................................................................................... 8 
Drug dealer.................................................................................................. 9 
Security guard ............................................................................................. 10 
OTHER ....................................................................................................... 99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I6. 
Have you ever gone to file a complaint to the police after you have been physically hurt? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2   
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 

LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I8 
 
I7a. 
Was there a court case following your complaint to the police? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
 
I7b. 
Was there a conviction? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
 
I8. 
Has anyone ever pressured you or forced you to participate in sexual acts against your will? 
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2   
 
DK/UNSURE .............................................................................................. -4  
REFUSED ................................................................................................... -7  
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED, SKIP TO I14 
 
I9. 
(HAND RESPONDENT SHOWCARD O-1)  When was the last time you were pressured or forced to 
participate in sexual acts against your will?  
 
Within the past two days ............................................................................. 1 
3-7 days ago ................................................................................................ 2 
1-4 weeks ago ............................................................................................. 3 
1-3 months ago ............................................................................................ 4 
4-12 months ago .......................................................................................... 5  
More than 12 months ago ........................................................................... 6   
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
 
I9a. 
(HAND RESPONDENT SHOWCARD O-2)  The last time you were pressured or forced to have sex, who 

pressured or forced you?  
 
Main sexual partner ..................................................................................... 1 
Client ........................................................................................................... 2 
Male relative ............................................................................................... 3 
Female relative ............................................................................................ 4 
Friend/acquaintance/peer ............................................................................ 5 
Stranger (not a client) .................................................................................. 6 
Big mama or pimp ...................................................................................... 7 
Police .......................................................................................................... 8 
Drug dealer.................................................................................................. 9 
Security guard ............................................................................................. 10 
OTHER ....................................................................................................... 99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I10. 
How old were you when you were first pressured or forced to have sex? 
 
 
AGE ........................................................................ |__|__| 
 
 
DK/UNSURE ................................................................. -4  
 
REFUSED ...................................................................... -7  
 

I10a. 
(HAND RESPONDENT SHOWCARD O-2)  The first time you were pressured or forced to have sex, who 
pressured or forced you? 
 
Main sexual partner ..................................................................................... 1 
Client ........................................................................................................... 2 
Male relative ............................................................................................... 3 
Female relative ............................................................................................ 4 
Friend/acquaintance/peer ............................................................................ 5 
Stranger (not a client) .................................................................................. 6 
Big mama or pimp ...................................................................................... 7 
Police .......................................................................................................... 8 
Drug dealer.................................................................................................. 9 
Security guard ............................................................................................. 10 
OTHER ....................................................................................................... 99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I11. 
Have you ever gone to file a complaint to the police after you have been pressured or forced to have sex? 
 
YES ............................................................................................................. 1   
NO ............................................................................................................... 2   
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I13a. 
 
I12a. 
Has there ever been a court case following your complaint to the police? 
 
YES ............................................................................................................. 1   
NO ............................................................................................................... 2  
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I13a. 
 

I12b. 
Has there ever been a conviction? 
 
YES ............................................................................................................. 1   
NO ............................................................................................................... 2 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I13a. 
The last time you were pressured or forced to have sex did you seek medical help? 
 
YES ............................................................................................................. 1   
NO ............................................................................................................... 2 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I13b. 
The last time you were pressured or forced to have sex did you seek rape counseling? 
 
YES ............................................................................................................. 1   
NO ............................................................................................................... 2 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
 
I14. 
Are you currently concerned that in the near future (or next 30 days) that someone might…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
a. 
Attack you with a weapon .................................................. 1 ................. 2 ............... -4 .............. -7 
 
b. 
Abuse you physically ......................................................... 1 ................. 2 ............... -4 .............. -7 
 
c. 
Make you engage in sexual acts against your will ............. 1 ................. 2 ............... -4 .............. -7 
 
d. 
Abuse you emotionally ...................................................... 1 ................. 2 ............... -4 .............. -7 
 
  
 
 

READ: Now I want to ask you what you think about men’s and women’s roles. 
 
I15. 
(HAND RESPONDENT SHOWCARD O-4)  Now I am going to ask you to respond to some statements about 
whether or not it is acceptable for a man to hit or beat a woman in a variety of circumstances.  Please tell me how 
much you AGREE or DISAGREE with the following statements: 
      
 
Strongly 
Agree 
Agree 
Neither 
agree or 
disagree 
Disagree 
Strongly 
Disagree 
DK 
REF 
 
▼ 
▼ 
▼ 
▼ 
▼ 
▼ 
▼ 
a. She does not complete  ......................... 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
her household work to his  
satisfaction. 
 
b. She disobeys him .................................. 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
 
c. She refuses to have ................................ 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
sexual relations with him. 
 
d. She asks him whether he  ...................... 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
has other girlfriends. 
 
e. He suspects that she has ........................ 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
been unfaithful. 
 
f. He learns that she has  ........................... 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
been unfaithful. 
 
g. She asks him to use a  ........................... 1 .............. 2 .............. 3 .............. 4 ................. 5 .......... -4 ......... -7 
condom. 
 
 
 

LOGIC: IF NO MAIN SEXUAL PARTNER (L9 = NO, DK/UNSURE, OR REFUSED) SKIP TO SECTION J 
 
I16. 
If you were having trouble with your main sexual partner, are any of the following “safe places” where you can 
escape…?   
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
 
 
 
 
a. Your main sexual partner’s family home. ............................ 1 ................. 2 .............. -4 .............. -7 
 
b. Your family home. ................................................................ 1 ................. 2 .............. -4 .............. -7 
 
c. House of friend/neighbor. ..................................................... 1 ................. 2 .............. -4 .............. -7 
 
d. Police. ................................................................................... 1 ................. 2 .............. -4 .............. -7 
 
e. Church/mosque (Place of worship). ..................................... 1 ................. 2 .............. -4 .............. -7 
 
f. Hospital. ............................................................................... 1 ................. 2 .............. -4 .............. -7 
 
g. Women’s shelter. .................................................................. 1 ................. 2 .............. -4 .............. -7 
 
h. Other, specify: __________________________________ 1 ................. 2 .............. -4 .............. -7 
 
 
 
READ: 
Now I am going to ask you about things that may have happened between you and your main sexual partner 
in the past month. 
 
I17. 
(HAND RESPONDENT SHOWCARD O-5)  During the past 30 days, how often have you and your main 
sexual partner argued or gotten in a verbal fight?  
 
 
Daily or almost daily ................................................................................... 1 
 
2 to 3 times a week ...................................................................................... 2 
 
1 time a week .............................................................................................. 3 
 
2 to 3 times a month .................................................................................... 4 
1 time a month ............................................................................................ 5 
 
Less than 1 time a month ............................................................................ 6 
 
Never ........................................................................................................... 7 
 
DK/UNSURE  ............................................................................................. -4 
REFUSED  .................................................................................................. -7 
 
 

I18. 
(HAND RESPONDENT SHOWCARD O-5)   During the past 30 days, how often has your drug or alcohol use 
caused problems between you and your main sexual partner?  
 
 
Daily or almost daily ................................................................................... 1 
 
2 to 3 times a week ...................................................................................... 2 
 
1 time a week .............................................................................................. 3 
 
2 to 3 times a month .................................................................................... 4 
1 time a month ............................................................................................ 5 
 
Less than 1 time a month ............................................................................ 6 
 
Never ........................................................................................................... 7 
 
DK/UNSURE  ............................................................................................. -4 
REFUSED  .................................................................................................. -7 
 
I19. 
(HAND RESPONDENT SHOWCARD O-5)  During the past 30 days, how often did your main sexual partner 
use alcohol to the point of intoxication?  
 
 
Daily or almost daily ................................................................................... 1 
 
2 to 3 times a week ...................................................................................... 2 
 
1 time a week .............................................................................................. 3 
 
2 to 3 times a month .................................................................................... 4 
1 time a month ............................................................................................ 5 
 
Less than 1 time a month ............................................................................ 6 
 
Never ........................................................................................................... 7 
 
DK/UNSURE  ............................................................................................. -4 
REFUSED  .................................................................................................. -7 
 
I20. 
(HAND RESPONDENT SHOWCARD O-5)   During the past 30 days, how often did your main sexual partner 
use drugs, including dagga or marijuana?   
  
 
 
Daily or almost daily ................................................................................... 1 
 
2 to 3 times a week ...................................................................................... 2 
 
1 time a week .............................................................................................. 3 
 
2 to 3 times a month .................................................................................... 4 
1 time a month ............................................................................................ 5 
 
Less than 1 time a month ............................................................................ 6 
 
Never ........................................................................................................... 7 
 
DK/UNSURE  ............................................................................................. -4 
REFUSED  .................................................................................................. -7 
 
 

I21. 
At any time in the last 30 days, did your main sexual partner push you, grab you, shove you, or hit you?  
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2    
 
 
DK/UNSURE .............................................................................................. -4   
REFUSED ................................................................................................... -7   
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I123 
 
I22. 
(HAND RESPONDENT SHOWCARD O-6)   In the past 30 days when your main sexual partner did any of 
these things, how often did this happen after he/she had drunk alcohol or used drugs? 
 
  
Always  ....................................................................................................... 1 
More than half the time ............................................................................... 2 
Half the time ............................................................................................... 3 
Less than half the time ................................................................................ 4 
Never ........................................................................................................... 5 
 
DK/UNSURE .............................................................................................. -4 
REFUSED ................................................................................................... -7 
 
I23. 
In the last 30 days, did you push, grab, shove, or hit your main sexual partner?  
 
YES ............................................................................................................. 1   
 NO .............................................................................................................. 2      
 
DK/UNSURE .............................................................................................. -4    
REFUSED ................................................................................................... -7    
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO SRP 
 
I24. 
(HAND RESPONDENT SHOWCARD O-6)   In the past 30 days when you pushed, grabbed, shoved, or hit 
your main sexual partner, how often did this happen after you had drunk alcohol or used drugs? 
 
  
 
Always  ....................................................................................................... 1 
More than half the time ............................................................................... 2 
Half the time ............................................................................................... 3 
Less than half the time ................................................................................ 4 
Never ........................................................................................................... 5 
 
DK/UNSURE .............................................................................................. -4 

 
Sexual Relationship Power Scale (SRP) 
 
INTERVIEWER READ OUT LOUD: Now I am going to read a list of things that might describe your current partner. Please 
tell me how closely this describes your current partner. 
 
 
During the past week…… 
Strongly Agree 
Agree 
Disagree 
Strongly Disagree 
srp1.1 If I asked my partner to use a condom, he 
would get violent 
 
 
 
 
srp2.1 If I asked my partner to use a condom, he 
would get angry 
 
 
 
 
srp3.1 Most of the time, we do what my partner 
wants to do 
 
 
 
 
srp4.1 My partner won’t let me wear certain 
things 
 
 
 
 
srp5.1When my partner and I are together, I'm 
pretty quiet 
 
 
 
 
srp6.1 My partner has more say than I do about 
important decisions that affect us. 
 
 
 
 
srp7.1 My partner tells me who I can spend time 
with 
 
 
 
 
srp8.1 If I asked my partner to use a condom, he 
would think I'm having sex with other people. 
 
 
 
 
srp9.1 I feel trapped or stuck in our relationship 
 
 
 
 
srp10.1 My partner does what he wants, even if I 
do not want him to. 
 
 
 
 
srp11.1 I am more committed to our relationship 
than my partner is 
 
 
 
 
srp12.1 My partner gets more out of our 
relationship than I do. 
 
 
 
 
srp13.1 My partner always wants to know where I 
am. 
 
 
 
 
srp14.1 My partner always wants to know where I 
am 
 
 
 
 
srp15.1My partner might be having sex with 
someone else. 
 
 
 
 
 
INTERVIEWER READ OUT LOUD: Now I am going to read a list of things that might describe your current partner. Please 
tell me how closely this describes your current partner. 
 
During the past week…… 
Your Partner 
BOTH of you Equally 
You 
srp16.1 Who usually has more say about whose 
friends to go out with? 
 
 
 
srp17.1 Who usually has more say about whether 
you have sex? 
 
 
 
srp18.1 Who usually has more say about what 
you do together? 
 
 
 
srp19.1 Who usually has more say about how 
often you seen each other? 
 
 
 
srp20.1 Who usually has more say about when 
you talk about serious things? 
 
 
 
srp21.1 In general, who do you think has more 
power in your relationship? 
 
 
 
srp22.1 Who usually has more say about whether 
you use condoms? 
 
 
 

srp23.1 Who usually has more say about what 
type of sexual acts you do? 
 
 
 
 
 
 
 
 
 
 
K.  PERSONAL SELF-CONCEPT (PSC) QUESTIONNAIRE 
 
Item 
num.  
Statement 
Totally 
Disagree 
Disagree 
Neither Agree 
nor Disagree 
Agree 
Totally 
Agree 
1  
(SF) I am satisfied with what I 
am achieving in my life. 
1 
2 
3 
4 
5 
2  
(AU)a I depend on other 
people more than the 
majority of those I know. 
1 
2 
3 
4 
5 
3  
(ESC) If I’m feeling down, I 
find it hard to snap out of it. 
1 
2 
3 
4 
5 
4  
(SF) So far, I have achieved 
every important goal I have 
set myself. 
1 
2 
3 
4 
5 
5  
(HON) I am a trustworthy 
person. 
1 
2 
3 
4 
5 
6  
(AU) In order to do anything, I 
first need other people’s 
approval. 
1 
2 
3 
4 
5 
7  
(ESC) I consider myself to be a 
very uptight and highly strung 
person. 
1 
2 
3 
4 
5 
8  
(SF) I have yet to achieve 
anything I consider to be 
important in my life. 
1 
2 
3 
4 
5 
9  
(HON) I am a man/woman of 
my word. 
1 
2 
3 
4 
5 
10  
(AU) I find it hard to embark 
on anything without other 
people’s support. 
1 
2 
3 
4 
5 
11  
(ESC) I am more sensitive 
than the majority of people. 
1 
2 
3 
4 
5 
12  
(SF) I have always overcome 
any difficulties I have 
encountered in my life. 
1 
2 
3 
4 
5 
13  
(HON)a I am a decent, honest 
person. 
1 
2 
3 
4 
5 
14  
(AU) When taking a decision, I 
depend too much on other 
people’s opinions. 
1 
2 
3 
4 
5 
15  
(SF) If I could start my life 
over again, I would not 
change very much. 
1 
2 
3 
4 
5 
16  
(HON)a I try not to do 
anything that might hurt 
others. 
1 
2 
3 
4 
5 
17  
(AU) I find it difficult to take 
decisions on my own. 
1 
2 
3 
4 
5 

18  
(ESC) I am an emotionally 
strong person. 
1 
2 
3 
4 
5 
19  
(SF) I feel proud of how I am 
managing my life. 
1 
2 
3 
4 
5 
20  
(ESC) I suffer too much when 
something goes wrong. 
1 
2 
3 
4 
5 
21  
(HON) My promises are 
sacred. 
1 
2 
3 
4 
5 
22  
(ESC)a I know how to look 
after myself so as not to 
suffer. 
1 
2 
3 
4 
5 
Note. SF: Self-fulfillment; AU: Autonomy; ESC: Emotional adjustment; HON: Honesty. ªItems eliminated from the 
definitive version of the questionnaire. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

APPENDIX 6 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes. 
FU assesssment 
 
 
 
Introduction 
 
Assessor to read: We will work through the questionnaire as follows: I will ask the questions 
and give you the answer choices. You will be asked to pick the answer that is the closest to 
how you feel. I will then record your answer. The interview will take about 45 minutes to 
complete. There are no right or wrong answers. Please answer just what you think and feel. 
 
No one at the clinic will see you answers, and you will be identified with a special participant 
ID.  
 
Are you currently pregnant? 
1= YES 
0=NO 
 
Are you currently breastfeeding? 
1=YES 
0=NO 
 
 
 
 ALCOHOL USE 
 
C1 Timeline follow-back 
Show participant the picture of the standard drinks.  Explain: Different alcohol containers have different 
amounts of alcohol.  E.g a small can of beer is 1 standard drink but a quart has 2 standard drinks.  The next few 
questions ask about the number of standard drinks you usually drink. 
 
*PLEASE DO NOT USE FULL NAMES ANYWHERE ON THIS FORM* 
 
PARTICIPANT ID: ...................................................................................................................... |__|__|__|__| 
STAFF ID: ............................................................................................................................................ |__|__| 
DATE: .............................................................................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
WHERE:___________________________________________________________ 

 
Are you currently drinking alcohol? 
 
1=YES 
0=No 
 
Alc_7dys: From 0-7, how many days in the last 7 did you drink alcohol? _____________ 
   
Please provide that number of drinks you had in a day for the last 7 days. 
 
 
 
 
BFH6.1 Did you breastfed your child after consuming alcohol in the past week or last 7 days? 
 1=Yes 
 0=No 
BFH6.2 How many days did you use alcohol and then breastfed? ___________ 
 
 
 
CRAVING (Scale: 0-10 with 0 not at all craving for a drink to 10 extremely craving for a drink) 
 
Day 1: 
 
 
Day 2: 
 
 
Day 3: 
 
 
Day 4: 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
Beer 
 
 
Beer 
 
 
Beer 
 
 
Beer 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
Wine 
 
 
Wine 
 
 
Wine 
 
 
Wine 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
 
 
 
 
 
 
 
 
 
 
Day 5: 
 
 
Day 6: 
 
 
Day 7: 
 
 
 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
Date: 
DD/MM/YYYY 
 
 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
# drinks/ 
containers 
 
 
 
Beer 
 
 
Beer 
 
 
Beer 
 
 
 
 
Liquor 
 
 
Liquor 
 
 
Liquor 
 
 
 
 
Wine 
 
 
Wine 
 
 
Wine 
 
 
 
 
Cider 
 
 
Cider 
 
 
Cider 
 
 
 
 

Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Day 6 
Day 
7(yesterday) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
AUDIT-C 
C3. How often do you have a drink containing alcohol?  
 0=Never 
 1=Monthly or less 
 2=2-4 times a month  
 
 3=2-3 times a week 
 
 
 4=4 or more times a week 
C4. How many standard drinks containing alcohol do you have on a typical day?  
 0=1 or 2  
 1=3 to 4  
 
 
 2=5 to 6  
 
 
 3=7 to 9  
 
 4=10 or more  
C5. How often do you have four or more drinks on one occasion?  
 0= Daily or almost daily  
 
 1=Weekly  
 
 
 2=Monthly  
 3=Less than monthly  
 4=Never 
 
 
 
DRUG USE ( are these questions still needed if asked at bsl) 
 
assist_1 In your life, which of the following substances have you ever used? (NON-MEDICAL USE 
ONLY) 
0= NO 
1=YES 
assist_1aTobacco products (cigarettes, chewing tobacco, cigars, etc.) 
 
 
assist_1bAlcoholic beverages (beer, wine, spirits, etc.) 
 
 
assist_1cCannabis (marijuana, pot, grass, hash, etc.) 
 
 
assist_1dCocaine (coke, crack, etc.) 
 
 
assist_1eAmphetamine-type stimulants (speed, meth, ecstasy, etc.) 
 
 
assist_1f Inhalants (nitrous, glue, petrol, paint thinner, etc.) 
 
 
assist_1gSedatives or sleeping pills (diazepam, alprazolam, flunitrazepam, midazolam, etc.) 
 
 
assist_1hHallucinogens (LSD, acid, mushrooms, trips, ketamine, etc.) 
 
 
assist_1i Opioids (heroin, morphine, methadone, buprenorphine, codeine, etc.) 
 
 
assist_1jOther 
 
 
 
assist_2: In the past three months, how often have you used the 
substances you mentioned (FIRST DRUG, SECOND DRUG, ETC)? 
0=Never 
2=Once or 
Twice 
3=Monthly 
4=Weekly 
6= Daily or 
Almost 
Daily 
assist_2aTobacco products (cigarettes, chewing tobacco, cigars, 
etc.) 
 
 
 
 
 
assist_2bAlcoholic beverages (beer, wine, spirits, etc.) 
 
 
 
 
 
assist_2cCannabis (marijuana, pot, grass, hash, etc.) 
 
 
 
 
 
assist_2dCocaine (coke, crack, etc.) 
 
 
 
 
 
assist_2eAmphetamine-type stimulants (speed, meth, ecstasy, 
etc.) 
 
 
 
 
 
assist_2f Inhalants (nitrous, glue, petrol, paint thinner, etc.) 
 
 
 
 
 

assist_2gSedatives or sleeping pills (diazepam, alprazolam, 
flunitrazepam, midazolam, etc.) 
 
 
 
 
 
assist_2hHallucinogens (LSD, acid, mushrooms, trips, ketamine, 
etc.) 
 
 
 
 
 
assist_2iOpioids (heroin, morphine, methadone, 
buprenorphine, codeine, etc.) 
 
 
 
 
 
assist_2jOther 
 
 
 
 
 
 
 
assist_8: Have you ever used any drug by injection? (NON-MEDICAL USE ONLY) 
0=No, 
Never 
6= Yes, in 
the past 3 
months 
3=Yes, but not in 
the past 3 months  
 
MJ.Do you currently use cannabis? 
‘1’=YES 
‘0’=NO 
 
MJ_7days From 0 to 7, how many days out of the last 7 did you smoke cannabis? (Even if they say 0, proceed to next 
question.)_____________________ 
 
If yes, Please provide how many times a day you use cannabis in the last 7 days.  
Number of 
times: 
1x 
2x 
3x 
4x 
5x 
6 or more 
Day 1 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
Day 3 
 
 
 
 
 
 
Day 4 
 
 
 
 
 
 
Day 5 
 
 
 
 
 
 
Day 6 
 
 
 
 
 
 
Day 7 
 
 
 
 
 
 
 
 
BFMJ_7days Did you breastfed your child after smoking cannabis in the past week or the 7 days? 
 1=Yes 
 0=No 
 
BFMJ_7days How many days did you use cannabis and then breastfed? __________ 
 
NICOTINE DEPENDENCE 
 
Are you currently smoking tobacco?  
1=Yes 
0=No 
 
Cigs_7dy From 0-7, how many days out of the last 7 have you smoked at least puff of a tobacco product like cigarettes?  
 
Please provide how many times a day you used cigarettes or a tobacco product in the last 7 days. 
 
 
Number of 
times: 
1x 
2x 
3x 
4x 
5x 
6 or more 
Day 1 
 
 
 
 
 
 
Day 2 
 
 
 
 
 
 
Day 3 
 
 
 
 
 
 
Day 4 
 
 
 
 
 
 

Day 5 
 
 
 
 
 
 
Day 6 
 
 
 
 
 
 
Day 7 
 
 
 
 
 
 
 
Did you breastfed your child after using cigarettes or tobacco products in the past week or the last 7 days? 
 1=Yes 
 0=No 
 
How many days after using cigarettes or tobacco did you breastfed? __________ 
 
Have you used other substances other than tobacco and/or cannabis ( i.e Cocaine, Amphetamine, Opioids etc.) in the 
past week and then breastfed? 
 1=Yes 
 0=No 
 
How many days did you use other substance(s) and then breastfed? _____________________ 
 
Please specify what substance(s) you use:____________________________ 
 
 
Do you think you will need any of the following services? Only refer to things you will need yourself. 
 
 
    
 
 
 
 
 
YES 
NO  DK/Unsure     REF 
 
 
 
 
 
 
▼ 
 ▼         ▼ 
     ▼ 
   
a. 
Employment or job placement services 1 
2 
-4 
-7 
b. 
Schooling services 
  
 
1 
2 
-4 
-7 
c. 
Housing services 
 
 
1 
2 
-4 
-7 
d. 
Financial assistance services 
 
1 
2 
-4 
-7 
e. 
Food assistance services 
 
1 
2 
-4 
-7 
f. 
Legal services (e.g., lay a charge) 
1 
2 
-4 
-7 
g. 
Transportation services  
 
1 
2 
-4 
-7 
h. 
Getting medical/healthcare    
 
1 
2 
-4 
-7 
i. 
Self-help groups (for example  
 
                   Alcoholics Anonymous or Alanon) 
1 
2 
-4 
-7 
j. 
Physical and/or sexual abuse 
 
                   counseling services  
1 
2 
-4 
-7 
k. 
Mental health services  
(e.g. for depression, stress)  
 
 
1 
2 
-4 
-7 
l. 
Child care services 
 
 
1 
2 
-4 
-7 
m. 
Counseling (individual, family, couples) 1 
2 
-4 
-7 
n. 
Substance abuse rehab/treatment 
1 
2 
-4 
-7 

 
Would you like a referral related to your alcohol use? If, yes please provide participants with resource. 
1=Yes 
0=No 
 
 
 
H. PSYCHOLOGICAL DISTRESS/DEPRESSION 
 
 
 
GENERALALISED ANXIETY DISORDER-7 (GAD-2) 
 
Over the last 2 weeks, how often have you been bothered by the following problems? 
 
Not at all (0) 
Several days (1) 
More than half the 
days (2) 
Nearly every day 
(3) 
gad2.1 Feeling nervous, anxious, or on the 
edge 
 
 
 
 
gad2.2Not being able to stop or control 
worrying 
 
 
 
 
 
 
 
 
EVERYDAY DISCRIMINATION SCALE(EDS) 
In your day-to-day, life how often do any of the following things happen to you? 
 
 
Never 
Less than once a 
year 
A few 
times a 
year 
A few 
times a 
month 
At least once 
a week 
Almost 
every day 
eds1.1. You are treated with less courtesy 
than other people are. 
 
 
 
 
 
 
eds2.1. You are treated with less respect than 
other people are. 
 
 
 
 
 
 
eds3.1. You receive poorer service than 
others. 
 
 
 
 
 
 
eds4.1. A doctor or nurse acts as if he or she 
thinks you are not smart. 
 
 
 
 
 
 
eds5.1. A doctor or nurse ats as if he or she is  
afraid of you. 
 
 
 
 
 
 
eds6.1 A doctor or nurse ats as if he or she is  
better than you. 
 
 
 
 
 
 
eds7.1. You feel like a doctor or nurse is not 
listening to what you were saying 
 
 
 
 
 
 
 
INTERVIEWER: Asked only of those answering “ A few times a year” or more frequently to at least one question 
Eds10.1 What do you think is the main reason for these experiences (Check all that applies) 
 
 1= Your Ancestry or National Origins 
 2.= Your Gender 
 3= Your Race 
 4= Your Age 
 5= Your Religion 
 6= Your Height 
 7= Your Weight 
 8= Some other Aspect of Your Physical Appearance 
 9= Your Sexual Orientation 
 10= Your Education or Income Level 
 11= A physical disability 
 12= Your shade of skin color (NSAL) 
 13= Your tribe (SASH) 
 14=Pregnant 
 15= Substance Use 
 16= Cannabis Use 

 17= Tobacco Use 
 18= Other (SPECIFY) _____________________________ 
 
EDINBURGH POSTNATAL DEPRESSION SCALE (EPDS) 
As you are pregnant or have recently had a baby, we would like to know how you are feeling? Please check the answer that 
comes closest to how you have felt IN THE PAST 7 DAYS, not just how you feel today. 
  
In the past 7 days…. 
 
Edps1. I have been able to see the funny side of things: 
 0= As much as I always could 
 1= Not quite so much now 
 2= Definitely not so much now 
 3= Not at all 
Edps2. I have looked forward with enjoyment to things. 
 0= As much as I ever did 
 1= Rather less that I used to 
 2= Definitely less than I used to 
 3= Hardly at all 
Edps3.I have blamed myself unnecessarily when things went wrong 
 3= Yes, most of the time 
 2= Yes, some of the time 
 1= Not very often 
 0= No, never 
Edps4. I have been anxious or worried for no good reason 
 0= No, not at all 
 1= Hardly ever 
 2= Yes, sometimes 
 3= Yes, very often 
Edps5. I have felt scared or panicky for no very good reason 
 3= Yes, quite a lot 
 2= Yes, sometimes 
 1= No, not much 
 0= No, not at all 
Edps6. Things have been getting to me. 
 3= Yes, most of the time I have not been able to cope at all 
 2= Yes, sometimes I haven’t been able to cope as well as usual 
 1= No, most of the time I have copes quite well 
 0= No, I have been coping as well as ever 
Edps.7 I have been so unhappy that I have had difficulty sleeping. 
 3= Yes, most of the time 
 2= Yes, some of the time 
 1= Not very often 
 0= No, never 
Edps8. I have felt sad or miserable. 
 .3= Yes, most of time 

 2= Yes, quite often 
 1= Not very often 
 0= No, not at all 
Edps9.  I have been so unhappy that I have been crying 
 3= Yes, most of the time 
 2= Yes, quite often 
 1= Only occasionally 
 0= No, never 
Edps10. The thought of harming myself has occurred 
 3= Yes, quite often 
 2= Sometimes 
 1= Hardly ever 
 0= Never 
 
 
VIOLENCE AND SEXUAL RISK EXPOSURE 
 
Do you currently have a main partner? 
1=YES 
0=NO 
 
 READ: 
NO matter how hard people try, they sometimes have conflicts or disagreements.  People can try 
various ways to settle their differences.  I'm going to read a list of some things that you may have done 
when you had a disagreement. 
 
I1. 
In the past 90 days, have you had a disagreement in which you…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
 
 
 
 
k. Insulted or swore at someone ....................................... 1 ............... 2 .............. -4 ............ -7 
 
l. Threatened to hit or throw something 
at another person ......................................................... 1 ............... 2 .............. -4 ............ -7 
 
m. Threw something at someone ....................................... 1 ............... 2 .............. -4 ............ -7 
 
n. Pushed, grabbed, or shoved someone ........................... 1 ............... 2 .............. -4 ............ -7 
 
o. Slapped another person ................................................ 1 ............... 2 .............. -4 ............ -7 
 
p. Kicked, bit, or hit someone .......................................... 1 ............... 2 .............. -4 ............ -7 
 
q. Hit or tried to hit anyone with something 
(an object) ................................................................... 1 ............... 2 .............. -4 ............ -7 
 
r. Beat up someone .......................................................... 1 ............... 2 .............. -4 ............ -7 
 
s. Threatened anyone with a knife or gun ........................ 1 ............... 2 .............. -4 ............ -7 
 
t. Used a knife or gun on another person ......................... 1 ............... 2 .............. -4 ............ -7 
 
 
 
LOGIC: IF NO MAIN SEXUAL PARTNER (L9=NO, DK/UNSURE, OR REFUSED) SKIP TO I3 
 

READ: 
Now I would like to ask you about things that your main sexual partner may have done to you.  Let 
me remind you that this information will remain strictly confidential. 
I2. 
In the past 90 days, has your main sexual partner…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
a. 
Abused you emotionally, that is, did or said 
 
things to make you feel very bad about 
 
yourself or your life .....................................................1................2............... -4 ........... -7 
 
b. 
Attacked you with a gun, knife, stick, bottle, or other  
 
weapon .........................................................................1................2............... -4 ........... -7 
 
c. 
Hurt you by striking or beating you to the point  
 
that you had bruises, cuts, or broken bones, or  
 
otherwise physically abused you .................................1................2............... -4 ........... -7 
 
d. 
Pressured or forced you to participate  
 
in sexual acts against your will ....................................1................2............... -4 ........... -7 
 
 
 
 
I3. 
Has anyone ever physically hurt you (i.e., someone hurt you by striking or beating you to the point that you 
had bruises, cuts, or broken bones)? 
 
YES ....................................................................................................1   
 NO .....................................................................................................2    
 
DK/UNSURE .....................................................................................-4   
REFUSED ..........................................................................................-7  
 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED, SKIP TO I8. 
 
I4. 
(HAND RESPONDENT SHOWCARD O-1)  When was the last time you were physically hurt?  
 
Within the past two days ....................................................................1 
3-7 days ago .......................................................................................2 
1-4 weeks ago ....................................................................................3 
1-3 months ago ...................................................................................4 
4-12 months ago .................................................................................5  
More than 12 months ago ..................................................................6   
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
I4a. 
The last time you were physically hurt did you seek medical help? 
 
YES ....................................................................................................1   
 NO .....................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 

 
I4b. 
(HAND RESPONDENT SHOWCARD O-2)  The last time you were physically hurt, who hurt you?  
 
Main sexual partner ............................................................................1 
Client ..................................................................................................2 
Male relative ......................................................................................3 
Female relative ...................................................................................4 
Friend/acquaintance/peer ...................................................................5 
Stranger (not a client) .........................................................................6 
Big mama or pimp .............................................................................7 
Police..................................................................................................8 
Drug dealer .........................................................................................9 
Security guard ....................................................................................10 
OTHER ..............................................................................................99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I5. 
How old were you when you were first physically hurt? 
 
 
AGE ................................................................ |__|__| 
 
 
DK/UNSURE ......................................................... -4  
 
REFUSED .............................................................. -7  
 
I5a. 
(HAND RESPONDENT SHOWCARD O-2)  The first time you were physically hurt, who hurt you?  
 
Main sexual partner ............................................................................1 
Client ..................................................................................................2 
Male relative ......................................................................................3 
Female relative ...................................................................................4 
Friend/acquaintance/peer ...................................................................5 
Stranger (not a client) .........................................................................6 
Big mama or pimp .............................................................................7 
Police..................................................................................................8 
Drug dealer .........................................................................................9 
Security guard ....................................................................................10 
OTHER ..............................................................................................99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I6. 
Have you ever gone to file a complaint to the police after you have been physically hurt? 
 
YES ....................................................................................................1   
 NO .....................................................................................................2   
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I8 
 
I7a. 
Was there a court case following your complaint to the police? 
 
YES ....................................................................................................1   

 NO .....................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
I7b. 
Was there a conviction? 
 
YES ....................................................................................................1   
 NO .....................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
I8. 
Has anyone ever pressured you or forced you to participate in sexual acts against your will? 
 
YES ....................................................................................................1   
 NO .....................................................................................................2   
 
DK/UNSURE .....................................................................................-4  
REFUSED ..........................................................................................-7  
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED, SKIP TO I14 
 
I9. 
(HAND RESPONDENT SHOWCARD O-1)  When was the last time you were pressured or forced to 
participate in sexual acts against your will?  
 
Within the past two days ....................................................................1 
3-7 days ago .......................................................................................2 
1-4 weeks ago ....................................................................................3 
1-3 months ago ...................................................................................4 
4-12 months ago .................................................................................5  
More than 12 months ago ..................................................................6   
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
I9a. 
(HAND RESPONDENT SHOWCARD O-2)  The last time you were pressured or forced to have sex, 
who pressured or forced you?  
 
Main sexual partner ............................................................................1 
Client ..................................................................................................2 
Male relative ......................................................................................3 
Female relative ...................................................................................4 
Friend/acquaintance/peer ...................................................................5 
Stranger (not a client) .........................................................................6 
Big mama or pimp .............................................................................7 
Police..................................................................................................8 
Drug dealer .........................................................................................9 
Security guard ....................................................................................10 
OTHER ..............................................................................................99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 

I10. 
How old were you when you were first pressured or forced to have sex? 
 
 
AGE ................................................................ |__|__| 
 
 
DK/UNSURE ......................................................... -4  
 
REFUSED .............................................................. -7  
 

I10a. (HAND RESPONDENT SHOWCARD O-2)  The first time you were pressured or forced to have sex, 
who pressured or forced you? 
 
Main sexual partner ............................................................................1 
Client ..................................................................................................2 
Male relative ......................................................................................3 
Female relative ...................................................................................4 
Friend/acquaintance/peer ...................................................................5 
Stranger (not a client) .........................................................................6 
Big mama or pimp .............................................................................7 
Police..................................................................................................8 
Drug dealer .........................................................................................9 
Security guard ....................................................................................10 
OTHER ..............................................................................................99 
 
Specify: _____________________________________________ 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I11. 
Have you ever gone to file a complaint to the police after you have been pressured or forced to have sex? 
 
YES ....................................................................................................1   
NO ......................................................................................................2   
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I13a. 
 
I12a. Has there ever been a court case following your complaint to the police? 
 
YES ....................................................................................................1   
NO ......................................................................................................2  
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO I13a. 
 

I12b. Has there ever been a conviction? 
 
YES ....................................................................................................1   
NO ......................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I13a. The last time you were pressured or forced to have sex did you seek medical help? 
 
YES ....................................................................................................1   
NO ......................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I13b. The last time you were pressured or forced to have sex did you seek rape counseling? 
 
YES ....................................................................................................1   
NO ......................................................................................................2 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
I14. 
Are you currently concerned that in the near future (or next 30 days) that someone might…? 
 
NOTE:  READ LIST AND MARK A RESPONSE FOR EACH ITEM 
 
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
a. 
Attack you with a weapon ........................................... 1 ............... 2 ............. -4 ............. -7 
 
b. 
Abuse you physically .................................................. 1 ............... 2 ............. -4 ............. -7 
 
c. 
Make you engage in sexual acts against your will ...... 1 ............... 2 ............. -4 ............. -7 
 
d. 
Abuse you emotionally ............................................... 1 ............... 2 ............. -4 ............. -7 
 
  
 
 

READ: 
Now I want to ask you what you think about men’s and women’s roles. 
 
I15. 
(HAND RESPONDENT SHOWCARD O-4)  Now I am going to ask you to respond to some statements 
about whether or not it is acceptable for a man to hit or beat a woman in a variety of circumstances.  Please 
tell me how much you AGREE or DISAGREE with the following statements: 
      
 
Strongly 
Agree 
Agree 
Neither 
agree or 
disagree Disagree 
Strongly 
Disagree DK 
REF 
 
▼ 
▼ 
▼ 
▼ 
▼ 
▼ 
▼ 
h. 
She does not complete  ........ 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
her household work to his  
satisfaction. 
 
i. 
She disobeys him ................. 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
 
j. 
She refuses to have............... 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
sexual relations with him. 
 
k. 
She asks him whether he  ..... 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
has other girlfriends. 
 
l. 
He suspects that she has ....... 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
been unfaithful. 
 
m. 
He learns that she has  .......... 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
been unfaithful. 
 
n. 
She asks him to use a  .......... 1 ............ 2 ............. 3 ............ 4 ................ 5 ......... -4 ........ -7 
condom. 
 
 
 

LOGIC: IF NO MAIN SEXUAL PARTNER (L9 = NO, DK/UNSURE, OR REFUSED) SKIP TO 
SECTION J 
 
I16. 
If you were having trouble with your main sexual partner, are any of the following “safe places” where you 
can escape…?   
 
YES 
NO 
DK/ 
Unsure 
REF 
 
▼ 
▼ 
▼ 
▼ 
 
 
 
 
 
i. Your main sexual partner’s family home. .....................1................2............. -4 ............ -7 
 
j. Your family home. ........................................................1................2............. -4 ............ -7 
 
k. House of friend/neighbor...............................................1................2............. -4 ............ -7 
 
l. Police. ............................................................................1................2............. -4 ............ -7 
 
m. Church/mosque (Place of worship). ..............................1................2............. -4 ............ -7 
 
n. Hospital. ........................................................................1................2............. -4 ............ -7 
 
o. Women’s shelter. ...........................................................1................2............. -4 ............ -7 
 
p. Other, specify: _______________________________1................2............. -4 ............ -7 
 
 
 
READ: Now I am going to ask you about things that may have happened between you and your main sexual 
partner in the past month. 
 
I17. 
(HAND RESPONDENT SHOWCARD O-5)  During the past 30 days, how often have you and your main 
sexual partner argued or gotten in a verbal fight?  
 
 
Daily or almost daily ..........................................................................1 
 
2 to 3 times a week.............................................................................2 
 
1 time a week .....................................................................................3 
 
2 to 3 times a month ...........................................................................4 
1 time a month ...................................................................................5 
 
Less than 1 time a month ...................................................................6 
 
Never ..................................................................................................7 
 
DK/UNSURE  ....................................................................................-4 
REFUSED  .........................................................................................-7 
 
 

I18. 
(HAND RESPONDENT SHOWCARD O-5)   During the past 30 days, how often has your drug or 
alcohol use caused problems between you and your main sexual partner?  
 
 
Daily or almost daily ..........................................................................1 
 
2 to 3 times a week.............................................................................2 
 
1 time a week .....................................................................................3 
 
2 to 3 times a month ...........................................................................4 
1 time a month ...................................................................................5 
 
Less than 1 time a month ...................................................................6 
 
Never ..................................................................................................7 
 
DK/UNSURE  ....................................................................................-4 
REFUSED  .........................................................................................-7 
 
I19. 
(HAND RESPONDENT SHOWCARD O-5)  During the past 30 days, how often did your main sexual 
partner use alcohol to the point of intoxication?  
 
 
Daily or almost daily ..........................................................................1 
 
2 to 3 times a week.............................................................................2 
 
1 time a week .....................................................................................3 
 
2 to 3 times a month ...........................................................................4 
1 time a month ...................................................................................5 
 
Less than 1 time a month ...................................................................6 
 
Never ..................................................................................................7 
 
DK/UNSURE  ....................................................................................-4 
REFUSED  .........................................................................................-7 
 
I20. 
(HAND RESPONDENT SHOWCARD O-5)   During the past 30 days, how often did your main sexual 
partner use drugs, including dagga or marijuana?     
 
 
Daily or almost daily ..........................................................................1 
 
2 to 3 times a week.............................................................................2 
 
1 time a week .....................................................................................3 
 
2 to 3 times a month ...........................................................................4 
1 time a month ...................................................................................5 
 
Less than 1 time a month ...................................................................6 
 
Never ..................................................................................................7 
 
DK/UNSURE  ....................................................................................-4 
REFUSED  .........................................................................................-7 
 
 

I21. 
At any time in the last 30 days, did your main sexual partner push you, grab you, shove you, or hit you?  
 
YES ....................................................................................................1   
 NO .....................................................................................................2    
 
 
DK/UNSURE .....................................................................................-4   
REFUSED ..........................................................................................-7   
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO O34 
 
I22. 
(HAND RESPONDENT SHOWCARD O-6)   In the past 30 days when your main sexual partner did any 
of these things, how often did this happen after he/she had drunk alcohol or used drugs? 
 
  
Always  ..............................................................................................1 
More than half the time ......................................................................2 
Half the time ......................................................................................3 
Less than half the time .......................................................................4 
Never ..................................................................................................5 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
I23. 
In the last 30 days, did you push, grab, shove, or hit your main sexual partner?  
 
YES ....................................................................................................1   
 NO .....................................................................................................2      
 
DK/UNSURE .....................................................................................-4    
REFUSED ..........................................................................................-7    
 
LOGIC: IF NO, DK/UNSURE, OR REFUSED GO TO P1 
 
I24. 
(HAND RESPONDENT SHOWCARD O-6)   In the past 30 days when you pushed, grabbed, shoved, or 
hit your main sexual partner, how often did this happen after you had drunk alcohol or used drugs? 
 
  
 
Always  ..............................................................................................1 
More than half the time ......................................................................2 
Half the time ......................................................................................3 
Less than half the time .......................................................................4 
Never ..................................................................................................5 
 
DK/UNSURE .....................................................................................-4 
REFUSED ..........................................................................................-7 
 
 
 
 
 
 
J.  TREATMENT ACCEPTABILITY   
 
 
Treatment Acceptability and 
Adherence Scale 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please respond to the 
treatment/intervention that you have 
received indicating your agreement with 
each of the below statements 
Strongly 
disagree 
 
 
Neither 
agree nor 
disagree 
 
 
Strongly 
agree 
NA 
1. If I began this treatment, I would be 
able to complete it. 
1 
2 
3 
4 
5 
6 
7 
 
2. If I participated in this treatment, I 
would be able to adhere to its 
requirements. 
1 
2 
3 
4 
5 
6 
7 
 
3. I would find this treatment 
exhausting. 
7 
6 
5 
4 
3 
2 
1 
 
4. It would be distressing to me to 
participate in this treatment. 
7 
6 
5 
4 
3 
2 
1 
 
5. Overall, I would find this treatment 
intrusive. 
7 
6 
5 
4 
3 
2 
1 
 
6. This treatment would provide 
effective ways to help me cope with 
alcohol use. 
1 
2 
3 
4 
5 
6 
7 
 
7. I would prefer to try another type of 
psychological treatment instead of this 
one 
7 
6 
5 
4 
3 
2 
1 
 
8. I would recommend this treatment to 
a friend with a similar problem i.e 
alcohol use. 
1 
2 
3 
4 
5 
6 
7 
 
9. If I began this treatment, I would 
likely drop out. 
7 
6 
5 
4 
3 
2 
1 
 

APPENDIX 7a 
RELEASE OF MEDICAL RECORDS FORM 
 
 
Staff ID: |__|__|__|__|__| 
 
 
Date |__|__| / |__|__| / |__|__|__|__| 
            DD     MM              YYYY 
 
 
Consent for the Release of Confidential Information 
 
I, _______________________________, authorise the FASD Prevention Study (MaRISA+ plus) staff 
(PIs: Dr. Yukiko Washio & Dr. Petal Petersen Williams) to disclose the following information to 
__________________________ for the purpose of referral treatment recommendation and/or other 
services. 
 
I understand that my records are protected and cannot be disclosed without my written consent unless 
otherwise provided for in the law.  I also understand that I may revoke this consent at any time except to 
the extent that action has been taken in reliance on it (e.g., obtaining medical assistance) and that in any 
event this consent expires automatically one year from the date this release was executed as indicated 
below.   
Name of Participant (Printed):  
______________________________________________ 
 
Signature of Participant: ____________________   
 
 
Date: |__|__| / |__|__| / |__|__|__|__|  
 
 
WITNESS (if client is illiterate): 
 
Name of Witness (Printed): ______________________________________ 
 
 
Signature of Witness: _______________________  Date: |__|__| / |__|__| / |__|__|__|__| 
 
The consent is valid for 365 days from the date it was signed. 
 
 
APPENDIX 7b 
 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant outcomes 
 
*PLEASE DO NOT USE FULL NAMES ANYWHERE ON THIS FORM* 
 
PARTICIPANT ID: ............................................................................................................................. |__|__|__|__| 

STAFF ID: ................................................................................................................................................... |__|__| 
DATE: .................................................................................................................... |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
WHERE:___________________________________________________________ 
           
Fetal/Birth/Neonatal Outcomes 
 
1. 
Fetal/birth weight 
 
 
3. 
Fetal/birth head circumference  
 
 
4 
Birth length (cm’s) 
 
 
5. 
Mother’s weight at delivery  
 
 
6. 
Pregnancy complications 
Yes □                         No □ 
7. 
If yes to #6, what pregnancy complications? 
 
 
8. 
Delivery method 
 
 
9. 
Gestational age 
 
10. 
Apgar score 
 
 
11. 
NICU admission 
 
Yes □      
Length of 
stay_________   
No □ 
12. 
Fetal Alcohol Syndrome diagnosis 
 
Yes □                        No □ 
13. 
Re-hospitalization incident (Mother) 
Yes □                        No □ 
14. 
If yes to #13, what was the reason for the re-hospitalization? 
 
 
15. 
Re-hospitalization incident (Infant) 
Yes □                        No □ 
16. 
If yes to #15, what was the reason for the re-hospitalization? 
 
 
17. 
Infant health complications 
Yes □                        No □ 
18. 
If yes to #17, what infant complications? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
Appendix 8 
 
The MaRISA Plus (MaRISA+) 
Biological Form - Intake 
 
Participant ID: |  | 
| 
| 
| 
| 
| 
| 
Date Seen: |  | 
|/|  | 
|/|  | 
| 
| 
| 
Staff ID: |  | 
| 
| 
DD / 
MM / 
YYYY 
 
 
1. What visit is this for this participant? 
1 
Intake 
Baseline 
1 Month 
2 Month 
3- Month 
Hard copy checked by: Staff ID         
Initials
Date
/
/

84 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
DRUG AND ALCOHOL USE 
 
 
2. Conducted urine testing for drug use? 
2A. If “No” urine drug testing, why not? 
1 
Yes go to 2B 
1 
Testing kit not available 
2 
No 
2 
Other [specify]  
 
 
 
2B. If “Yes”, what were the results? 
2C. If “Positive”, for which drugs? 
1 
AMP (Amphetamine) 
1 
Positive 
2 
MET (Methamphetamine) 
2 
Negative go to 3 
3 
COC (Cocaine) 
4 
THC (Marijuana) 
5 
OPI (Opiates) 
6 
Mandrax 
99 
Other  
 
 
3. 
Conducted alcohol urine test? 
3A. If No urine test, why not? 
1 
Yes  go to 3B 
1 
Instrument not working or not available 
2 
No 
2 
Other [specify]  
 
 
 
3B. If “yes” what were the results? 
1 
Positive 
2 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TAKE A PICTURE OF DRUG AND ALCOHOL TEST RESULTS 
Photo of drug and alcohol tests results attached? 
Yes 
No [specify reason not attached]  
 

85 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
Appendix 9 MaRISA Plus: 
BIOLOGICAL FORM FOR BLOODWORK 
 
 
PARTICIPANT ID:  ............................................................................. |__|__|__|__|__|__|__|__|__|__| 
STAFF ID: .................................................................................................................................. |__|__| 
SITE…………………………………………………………………………………|__|__|__|__|__|__| 
DATE OF SPECIMEN COLLECTION: ................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
 
TIME OF SPECIMEN COLLECTION: 
 
 
 
         |__|__| / |__|_ (HH:MM)  
 
DATE OF SPECIMEN SENT TO LAB: ................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DATE OF LAB COMPLETION: ............................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
 
                            
1. What visit is this for? (Please tick only one answer) 
 
1 
 BASELINE 
 
 
 
 
 
  
 1-MONTH CHECK-IN 
 
  
 2-MONTH CHECK-IN 
 
  
 3-MONTH CHECK-IN 
 
2. Conducted testing for alcohol metabolite (Peth)? 
1 
 Yes, blood drawn Test results: ___________________________________ 
2 
 No, not positive for PeTh    3 
 No, positive but refused testing  
4
 No, Other: Specify_________________________ 
 
 
Initials:  
 
_ _  
 

86 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
 
 
 
 
APPENDIX 10 
Adapting and testing behavioral intervention to prevent Fetal Alcohol Spectrum Disorders and adverse infant 
outcomes 
 
 
READ: Thank you for agreeing to talk with me about your experience with the MaRISA-plus 
programme. Now that you have completed the programme, we want to ask you some questions 
about your experiences about the service you received. The information you provide us with will help 
us improve the intervention. 
 
 
Acceptability of Intervention Measure (AIM) 
 
The FASD Prevention Intervention meets my approval. 
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
2) The FASD Prevention Intervention is appealing to me. 
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
3) I like the FASD Prevention Intervention 
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 
*PLEASE DO NOT USE FULL NAMES ANYWHERE ON THIS FORM* 
 
PARTICIPANT ID: ...................................................................................................................... |__|__|__|__| 
STAFF ID: ............................................................................................................................................ |__|__| 
DATE: .............................................................................................................. |__|__| / |__|__| / |__|__|__|__| 
 
DD 
MM 
  YYYY 
WHERE:___________________________________________________________ 

87 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
 4= Agree 
 5= Completely agree 
 
4) I welcome the FASD Prevention Intervention 
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
 
 Intervention Appropriateness Measure (IAM)  
 
1) The FASD Prevention Intervention seems fitting.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
2) The FASD Prevention Intervention seems suitable.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
3) The FASD Prevention Intervention seems applicable.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
4) The FASD Prevention Intervention seems like a good match.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
 
 
 Feasibility of Intervention Measure (FIM)  
1) The FASD Prevention Intervention seems implementable.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 

88 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
 
2) The FASD Prevention Intervention seems possible.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
3) The FASD Prevention Intervention seems doable.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
4) The FASD Prevention Intervention seems easy to use.  
 1=Completely disagree 
 2= Disagree 
 3= Neither agree nor disagree 
 4= Agree 
 5= Completely agree 
 
 
Study Experience 
A. What did you think about the questions that the MaRISA-Plus staff asked you before starting the programme 
(that is the screening questions about alcohol use and pregnancy?) 
Probe 
1. What about the number of questions?  
2. Were there any questions that were difficult to answer? 
 
B. From what they explained to you, how much do you think your alcohol use made it difficult for you to follow 
the programme? 
 
C. What would you like to tell us about your experience of the programme?  
 
Probe 
1. What did you like most about the programme? 
2. What did you not like about the programme?   
3. Were their parts that were difficult to understand or did not work well? 
 
D. What did you learn from the programme? 
 
Probe: 
1. 
Were there any new skills that you learned? 

89 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
2. 
What new information did you learn? 
 
E. 
Since you completed the programme, what (if any) changes have you been able to make in your life?   
Probe 
1. 
Can you describe anything that you are doing differently in your life? 
2. 
How has the programme made a difference in your life?  
 
F 
What did you think about providing urine samples for alcohol testing? 
 
Probe 
1. What was easy/difficult about it? 
2. How easy was it to attend the clinic twice weekly to provide samples? 
 
G What did you think about the financial rewards received for remaining abstinent?  
 
Probe 
1. Was it too much/too little? 
2. Was it fair to not be rewarded or positive samples? 
3. Are there alternative awards that you would have preferred? 
 
H What did you think of the weekly text messages? What did you like the most?  Is there anything you would 
have like to see changed?  
Probe 
1. Were they helpful? 
2. Did they influence your behavior? 
3. Did the messages add value to your life? 
 
 
I.  Do you have anything else to tell me about your experience of the programme? 
Probe: 
1. What, if anything would have made your experiences of this programme better?  
 
Ending Questions 
Our time is about up. You have provided us with a lot of information in this short amount of time. Thanks again 
for your time—we really appreciate all of your help. 
[Give a short oral summary of the key ideas that emerged from the discussion.] 
A. Is this an adequate summary of the things that we have discussed today?   
B. Do you have any questions for us? 
C. Do you have anything to add that we may have missed?   ____________________________  
 ____________________________________________________________________________  
 
 

90 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
 
FACILITIES & OTHER RESOURCES 
Integration of Partnerships and Communication Plan 
 
 
 
SOUTH AFRICAN MEDICAL RESEARCH COUNCIL (SAMRC) 
 
The SAMRC, is a well-established research organization with an existing infrastructure and staff who are 
highly experienced and successful on NIH funded-projects, and conducting randomized controlled trials with 
key populations, and other at-risk populations. The SAMRC has established links to the target communities 
and therefore is well suited to developing linkages and implementing this research. The SAMRC has highly 
knowledgeable staff and faculty to train staff on the study protocol, oversee the implementation of the protocol, 
provide high-quality data collection, and provide confidential and accurate data entry and storage. SAMRC 
faculty and staff have been working for many years in the local communities and with a range of health, 
substance use, and other service providers. SAMRC faculty and project staff expertise and relations with both 
local communities and service providers will facilitate participant recruitment and tracking of participants over 
the lifespan of this proposed study (see www.samrc.ac.za for more information). 
 
Response to COVID-19 Public Health Emergency. 
The SAMRC is working with stakeholders in South Africa, including the National Department of Health and 
Department of Science and Innovation, to support research and the country’s rapid response to the novel 
coronavirus (COVID-19) disease outbreak. The president of the SAMRC, Professor Glenda Gray, is the chair 
of the research committee in the newly formed Ministerial Advisory Committee on COVID-19, which consists 
of over 50 expert advisors who will provide guidance on critical health issues in attempts to prevent further 
spread of the virus (https://www.samrc.ac.za/news/samrc-president-chairs-research-committee-covid-19).  
The previous CEO of the SAMRC and director of an SAMRC extramural research unit, Professor Slim Abdool 
Karim, is the chief epidemiologist advising the south African Minister of Health and Mr Cyril Ramaphosa, the 
country’s president, on the COVID-19 response (https://www.dailymaverick.co.za/article/2020-04-07-the-
world-class-team-leading-south-africas-battle-against-covid-19/).  The SAMRC continues to monitor the 
outbreak and is actively participating and supporting initiatives for the treatment, mitigation, and management 
of coronavirus and is strongly encouraging research that addresses COVID-19.  In addition, the SAMRC has 
made funding available to focus on COVID-specific research. The SAMRC will be supporting global efforts 
against COVID-19 through surveillance of the disease. Funding of R8 million has been made available towards 
disease surveillance at five hospitals, with further funding of R5 million towards genomic sequencing at the 
National Institutes for Communicable Diseases.  It is also planning to make additional funding available 
towards drug treatment trials.  (https://www.samrc.ac.za/media-release/mobilising-resources-against-covid-
19-pandemic). 
 
The 
SAMRC’s 
COVID-19 
research 
contributions 
are 
described 
at: 
https://www.samrc.ac.za/research-for-our-people/covid-19-research 
 
Organization and Staff 
The SAMRC was established in terms of Acts of Parliament (No's 19 of 1969 and 58 of 1991). Its most 
important functions are “to promote the improvement of the health and the quality of life of the population of 
the Republic and to perform other such functions as may be assigned to the SAMRC by or under this Act.” 
Such “improvement” was to be attained “through research, development and technology transfer.” The affairs 
of the SAMRC are managed by a Board that determines the SAMRC’s policies and objectives. The Board, 
appointed by the Minister of Health, consists of a Chairperson; between 12 and 14 members who have 
distinguished themselves in medical science or a related science; two additional members; and a President. 
 
The SAMRC is a national organization with offices in Cape Town, Pretoria, Johannesburg, and Durban and 
rural offices in Hlabisa in KwaZulu-Natal province, the Eastern Cape, and Northern Cape provinces. In 
November 1997, the SAMRC was reviewed by an international panel as part of the national review of the 

91 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
country's science and technology system commissioned by the Department of Arts, Culture, Science and 
Technology. This review noted that "The Medical Research Council is a national asset.” The SAMRC supports 
a core of more than 900 scientists (with advanced degrees) plus several hundred technologists operating 
through 22 extramural units (based at universities and research centers) and 15 intramural research programs 
which are led by internationally recognized scientists and function as centers of excellence. The Alcohol 
Tobacco and Other Drug Research Unit (ATODRU) is one of these intramural programs. A total of 500 
research projects are undertaken with approximately 100 new projects submitted every year; producing more 
than 800 peer-reviewed publications and multiple policy briefs and reports annually. The SAMRC also 
supports 300 scientists engaged in 300 3-year short-term research projects (self-initiated research), which 
constitutes a substantial investment in the building of research capacity and the development of science in the 
region. 
 
 
Laboratory and Other Facilities 
The SAMRC owns large campuses in Cape Town (Medicina Campus with laboratory space at Tygerberg 
Academic Hospital and Delft), Pretoria, and Durban. The SAMRC also has research facilities in Johannesburg, 
Hlabisa (KwaZulu-Natal), Worcester (Western Cape), the Northern Cape, and the Eastern Cape. 
 
Office Space, Library and Other Resources 
Office space is available at the MRC (Cape Town) campus and within ATODRU there is access to office space 
for fieldworkers, photocopying, scanning, and facsimile machines. Key personnel have their own offices 
equipped with computers connected to Internet services and printers, and updated software in place. ATODRU 
staff members also have access to an administrator and a contracts manager, and access to a shared seminar 
room. Staff members also have ready access to statistical support and analysis services provided by the 
SAMRC’s Biostatistics division. Staff and students have library facilities with access to books, periodicals, and 
most major journals (paper and electronic) in the field. Interlibrary loan facilities are available. During office 
hours, library personnel are at hand to provide customized literature search services. There is also 24-hour 
remote Internet access to library resources. The project manager will have access to her own office and 
fieldworkers will have access to a shared office with computers and Internet connections where they will be 
able to upload data each evening. Within the ATODRU field site there is also a subzero freezer dedicated for 
the storage of biological specimens and a locked archive data storage room.  
 
Computing Facilities, Network, and Security 
The SAMRC has an Information Technology Services Division (ITSD) that provides and maintains a relevant 
corporate IT infrastructure for the SAMRC in an efficient manner. The Division supports the SAMRC’s voice, 
video, and data systems. Systems are available and monitored 24 hours a day, 7 days a week. The Division’s 
areas of responsibilities include desktop support; wide area network support; local area network support; 
Internet access (including a wireless network); application and database hosting; e-mail support; disaster 
recovery planning; and IT training. ITSD provides a windows server-based network. Microsoft exchange 
servers are used for electronic messaging and scheduling. Microsoft SQL servers are provided for database 
applications. The ITSD administrative staff is professionally trained in the supported products, with several 
holding industry and manufacturer-specific certifications (e.g., Microsoft-certified professional and Microsoft-
certified systems engineer). Further, the SAMRC has a well-resourced computer infrastructure, with high-
speed lines linking the main campus and each of the other campuses and satellite (field) offices. 
 
SAMRC Workstations: The workstation of the typical SAMRC employee is an Intel Pentium computer running 
Microsoft 2010 professional with the latest updates and patches. Workstations are connected to the SAMRC 
data network, giving the scientist access to all facilities and software described in this section. A variety of 
software is available for SAMRC scientists including the latest MS office suite of applications (Word, Excel, 
PowerPoint, Project, Access, Explorer, Outlook); statistical packages such as SPSS, STATA, and SAS and 
qualitative data analysis packages such as NVIVO and Q N*dist; and other utilities such as Adobe Acrobat, 
Zipcentral; and regularly updated antivirus software (McAfee),  ACASI, and RECAP for data capture. 
 
Security: Microsoft Windows Server operating system supports several security features including: local 
desktop security (i.e., user identification and password required for access), lockout of account upon repeated 

92 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
entry of invalid password, and Administrator-defined user groups. The SAMRC has good systems for 
password management to help maintain computer and network security: every username on all ITSD systems 
has an associated password, no records of passwords are generated, automated controls are in place to 
ensure password quality (e.g., minimum length), and there is an automatic periodic expiration of passwords. 
A complete backup of all files on every disk is written to tape weekly. Every business day, a differential backup 
is performed on all files created or modified since the last complete backup. In the event of a hardware or 
software failure, files can be restored to their status as of the time of the last differential backup. Tapes of 
complete backups are kept for about 3 months. CD-R drives and external hard drives are used for long-term 
data archiving. 
 
SAMRC Data Network: The SAMRC’s data network is a fully switched Ethernet-based network 
interconnecting all buildings on SAMRC’s main campus and our other campuses (Pretoria, Durban, Hlabisa) 
and several other remote field locations. Remote offices are connected to the network via dedicated network 
circuits or via the Internet using Virtual Private Networks (VPNs). User authentication is required for all remote 
access to the network. The core of the SAMRC network is located in a computer room at each major SAMRC 
site (Cape Town, Durban, and Pretoria). This ensures that the same level of physical security, electrical power 
conditioning, environmental conditioning and monitoring is provided to the network equipment and servers. 
The network is automatically monitored for utilization and faults. 
 
Network Security: SAMRC has excellent network security. All traffic between the SAMRC network and the 
Internet passes through an Internet firewall that is a single connection point providing protection and monitoring 
to all systems connected to or accessing the SAMRC network. The firewall is programmed to determine 
whether network access in compliance with the SAMRC’s network security policy and then allow or prevent 
access to the network. Web servers are placed behind load balancing devices which are configured to deny 
all traffic not specifically allowed according to their configuration. Only approved file types are allowed on the 
servers. Computer-based tools are used to detect and identify vulnerabilities on the SAMRC systems. If 
detected, these vulnerabilities can be corrected before they are exploited. A multilayered antivirus program is 
in place. All e- mail is scanned and anti-spam filters are in place. Security awareness articles are posted on 
the SAMRC intranet to ensure that staff members are informed about following security procedures. 
 
Security at physical facilities: SAMRC has a keyless, disk-controlled access system on all buildings. Access 
is controlled 24 hours a day, 7 days a week. Closed circuit TV cameras monitor all entrances. The system 
monitors and limits access to the buildings and to the ITSD computer room. Access is granted on an individual 
basis and reports can be generated to review access patterns. Visitors are not permitted to the computer room. 
Security officers control access to the main gates of the campus and regularly patrol the campus grounds, 
checking if doors are locked. Continuous electrical service for the computer room is ensured through using 
uninterrupted power supplies (UPS) and generators. Adequate air conditioning, ventilation, and fire detection 
systems are also available in the computer rooms. Temperature and humidity are monitored and alarmed. 
 
The Alcohol, Tobacco and Other Drug Research Unit (ATODRU).  
ATODRU is led by globally recognised researchers in the field of alcohol, other drug use and HIV. It has offices 
in Cape Town and Pretoria and clinical research sites in Delft and Worcester. Within ATODRU’s clinical 
research site, there is a subzero freezer (-70 degree Celsius) dedicated for the storage of biological 
specimens- this will facilitate long-term storage of dried blood spot samples for analysis at the end of the 
project and in future. Currently the unit’s active research projects span the causes, prevention of, response to 
and health impacts of alcohol, tobacco and other drug use. ATODRU’s environment and resources bring 
numerous strengths to this application. First, it is a well-established research unit with an existing infrastructure 
and staff who are highly experienced and successful in collaborating with NIH-funded research, in clinical trials 
methodology and rigorous study design and in the conduct of trials. For instance, Dr. Nandi Siegfried, a global 
expert in clinical trials is part of ATODRU and works across projects to ensure that studies are designed and 
conducted to the highest standard. Second, the unit has established links to the target communities and 
therefore is well suited to conducting this community-based study. Third, the unit has highly knowledgeable 
staff and faculty to train staff on the study protocol, oversee the implementation of the protocol, provide high-
quality data collection, and provide confidential and accurate data entry and storage. We have two dedicated 
data managers in the unit- one based in Cape Town and the other in Pretoria who will be able to ensure high 
quality data collection. Fourth, ATODRU has been working for many years in the local communities and with 

93 FASD Prevention. Ethics Protocol. Version 3. April 2024 
 
a range of health, substance use, and other service providers. Dr. Petersen Williams has a long-standing 
relationships with the HIV, STI and TB service director of the Western Cape Department of Health and with 
the facility managers of primary care clinics and Midwife Obstetric Unit operational managers that provide 
antenatal care for our target communities and where study activities will take place. She will leverage these 
relationships to ensure by in from healthcare facilities and staff. The unit’s excellent reputation will facilitate 
access to services and to routinely collected health service information.  
 
All managerial responsibility and oversight will occur within ATODRU managed by Dr Petersen Williams. This 
includes site reporting, financial management, procurement of equipment and research supplies, and 
management of field activities. 
 
Administrative Information 
SAMRC’s mailing address is South African Medical Research Council, PO Box 19070, Tygerberg, 7505, South 
Africa. SAMRC’s street address is 1 Duiker Street, Francie Van Zyl Drive, Parow, 7505, South Africa.  
 
 
Midwife Obstetric Units (MOUs) and Baby Clinics 
Within the Cape Town district, antenatal and postnatal care is provided at various primary care clinics, 
secondary and tertiary hospitals as well as at primary healthcare (PHC) facilities called Midwife Obstetric Units 
(MOUs). These MOUs provide primary obstetric care to women within defined areas (making them 
geographically accessible). MOUs are located within PHCs where baby clinics are co-located. There are 11 
MOUs in greater Cape Town and all fall under the Western Cape Department of Health. They include: Bishop 
Lavis, Elsies River, Gugulethu, Hanover Park, Heideveld, Khayelitsha (Site B), Kraaifontein, Macassar, 
Khayelitsha (Michael Mapongwana), Mitchell’s Plain and Retreat MOUs. All are found in areas that were 
classified as “Black African” or “Coloured” under the apartheid regime and given their location, the clientele 
visiting these clinics are mainly from these ethnic backgrounds. Furthermore, the MOUs can be considered as 
serving previously disadvantaged communities and the majority of women accessing these services continue 
to be disadvantaged. MOUs are birthing units run by midwives in the community for primary health care 
patients with doctors visiting these facilities once a week. Midwives routinely manage deliveries at these 
facilities and refer those who have high risk pregnancies to secondary or tertiary hospitals according to defined 
protocols. Post-natal care also takes place at these clinics. Referral to a hospital can occur at any stage, 
should this be necessary. The combined annual total number of women seen in the 11 MOU clinics during 
2007 and 2008 was 41715. About 3% of these pregnant women attended the smallest clinic and 17% attended 
the largest clinic in the area. Most patients start their prenatal care at the beginning of the second trimester and 
are seen by their midwives monthly up to 32 gestational weeks and weekly or biweekly for the remainder of 
pregnancy. In order to conduct research activities in any of these facilities we will need to formally apply for 
approval from the Western Cape Department of Health who will liaise with facility managers about their 
willingness and ability to accommodate a research study before informing us which facility the proposed study 
can take place in. On average 83 new patients are seen at an MOU clinic per month.