Clinical trial NCT04071470
Conditions: HIV Infections
Sponsor: Vanderbilt University Medical Center
Start date: 2021-01-01; Completion date: 2023-06-20
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV infection but requires high levels of medication adherence, particularly among women. The purpose of this proposal is to evaluate the clinical impact and mechanisms of a family-based storytelling intervention (vs. couples counseling) to improve PrEP adherence and retention among at-risk pregnant/lactating women and their HIV-infected male partners in rural Mozambique. This potentially high impact intervention provides the opportunity to test a culturally relevant approach to PrEP engagement; if proven feasible and effective, family-based storytelling for PrEP engagement could be adopted to reduce HIV incidence among pregnant/lactating women and eliminate mother-to-child transmission (MTCT).

Detailed description:
Project Summary: Pregnancy and the postpartum period are associated with an increased risk of HIV acquisition. HIV acquisition is of particular concern during pregnancy and while the mother is breastfeeding given the associated increased risk of mother-to-child transmission (MTCT). Approximately 10% of pregnant women attending antenatal care (ANC) in Mozambique are in serodiscordant relationships (HIV-negative woman/ HIV-positive man). High rates of MTCT (14%; 12,000 infants/ year) may be affected by the high rate at which pregnant women seroconvert after their first ANC visit. Beginning in 2018, pre-exposure prophylaxis (PrEP) was available to serodiscordant couples, yet only 44% of pregnant women were retained in care at 3 months.

Our current R01-funded project, Partners-based HIV Treatment for Seroconcordant Couples (R01MH113478), is testing a couple-based intervention for HIV-positive expectant parents living in extremely rural communities. Our Men for Health intervention ("Homens para Saúde+"- HoPS+) consists of (1) couple-based HIV care and treatment; (2) couple-centered education; and (3) expert-patient support. Preliminary data the HoPS+ study suggest that couple-based counseling and education is more successful at reducing maternal depression than individual care. However, couple-based sessions have not led to significantly greater improvements in HIV knowledge or social support. Given the importance of these factors on treatment adherence, this grant would allow us to revise the peer engagement strategy to increase knowledge transfer and engender partner support.

The investigators propose testing the impact of a peer-delivered oral storytelling intervention to increase retention in, and adherence to, PrEP/ART among expectant serodiscordant couples. People are 7 times more likely to remember a story compared to facts alone. Couples are also highly influenced by their immediate and extended families; \>95% of patients disclose their HIV status to members of their family. The investigators hypothesize that the use of oral storytelling will facilitate learning and encourage family support and advocacy. The investigator will compare this model to couple-based education and counseling. This innovative intervention tests a culturally relevant approach to improve ART/PrEP delivery. The investigators propose a rigorous individually randomized controlled trial at one of our current HoPS+ sites where 11% of expectant couples were serodiscordant in 2018. The investigators will randomize 70 HIV-uninfected pregnant women and 70 of their HIV-infected partners (total 140) to either the intervention or control condition.

The Specific Aims of this study are: (1) Compare the effect of a storytelling intervention (vs. couples-based counseling) on participant knowledge, motivation, and behavioral skills associated with PrEP retention and adherence; and (2) Evaluate the impact of a storytelling intervention on adherence to PrEP/ART medications. Our team of Mozambican and U.S. investigators has a proven record of international HIV research success, specific recent experience with partner-based HIV and PrEP delivery, and experience with the use of theater/storytelling to change HIV-related behaviors.

Arms: arm 1: Standard of care for pregnant women at risk of HIV seroconversion includes couples counseling and access to PrEP (women) and ART (men) arm 2: Participants in this group will receive the same services as those in the SOC but will also be provided three storytelling sessions for themselves and their families as a way to educate and de-stigmatize PrEP services.
Interventions: intervention 1: Storytelling intervention 2: PrEP
Intervention descriptions: intervention 1: Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP intervention 2: Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC

Protocol documents:
ICF_001.pdf: 
 
 
 
Partners-based HIV/PrEP services for sero-discordant 
couples attending antenatal care: A randomized trial to 
increase family-based support for PrEP adherence 
among discordant couples through storytelling  
NCT #: NCT04071470 
DOCUMENT DATE: 18 DECEMBER 2020 
Intervention Arm Consent Form 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
 
KEY ELEMENTS OF THE STUDY 
1. This consent form contains information about a new study to provide a storytelling intervention 
to serodiscordant expectant couples. 
2. Couples who are in the intervention group of this study will have the opportunity to listen to 
three stories that will educate and help support them to stay adherent to their medication and will 
complete two interview surveys.  
3. Couples in the control group will complete two interview surveys, but otherwise will enroll in 
PrEP and HIV care and treatment as they would normally. 
4. You have been selected to receive three storytelling sessions, along with any family members 
(being a confidante) you want to include. 
5. If you agree to participate in the study, a study staff person will conduct a survey now and again 
at three to four months after you start medication. 
6. If you are an eligible female and you agree to participate in the study, when you come to pick 
up your PrEP, a study staff person will do a simple urine test monthly for three (3) months from 
the first month after starting PrEP to check for the presence of the PrEP drug in your body. 
7. You can stop participating in the study at any time without penalty. 
 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the participants in the intervention arm. 
Age of participant: ____________ 
Introduction 
This consent form contains information about a new study to provide couples-based PrEP 
medication that will help prevent someone being infected with HIV and HIV care and treatment 
for discordant pregnant couples.  
You both have been selected because you both attended antenatal care visit; and one tested 
HIV-negative while the other is HIV-positive; and you are 18 years or older.  
You do not have to be in this research study. You may choose not to be in this study and get 
other treatments without changing your healthcare, services, or other rights. You can stop 
being in this study at any time. If we learn something new that may affect the risks or benefits 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
of this study, you will be told so that you can decide whether or not you still want to be in this 
study. 
This form describes your rights as a participant. It is meant to answer your questions. We will read 
this form to you. Please feel free to ask any questions you may have about this.  
If you both agree to participate in this program, I will ask you to sign the form or make your 
thumbprint mark. Even if you agree to participate, you can stop participating at any time. I will give 
you a copy of this form. This form might contain some words that you do not know. Please ask 
me to explain anything you do not understand. 
Purpose of this study  
This study is being done by staff from Vanderbilt University Medical Center (VUMC) and Friends 
in Global Health (FGH). We want to try a new way to offer PrEP and HIV care and treatment to 
couples where one person is HIV-positive and the other HIV-negative who are expecting a child. 
Right now, couples can receive PrEP and HIV care together in HIV treatment services, but their 
counseling and education is limited to short education sessions and does not engage their 
families.  
Couples who are in the intervention group of this study will have the opportunity to listen to three 
stories that will educate and help support them to stay adherent to their medication. Couples in 
the control group will complete two surveys, but otherwise will enroll in PrEP and HIV care and 
treatment as they would normally. We want to see if couples who get the additional storytelling 
sessions are better at staying on treatment compared to couples in regular care.   
Procedures to be followed and approximate duration of the study 
You have been selected to receive the storytelling sessions.  
This study will begin today and last for the next 6 months. If you and your partner agree to be part 
of this study, we will enroll you both into PrEP / HIV care and treatment. All future clinical visits, 
drugs, and tests to assess medication levels in your body will be given to you at the ANC or CCR 
clinics.  
Our study assistant will arrange a meeting with you and the storytellers in the next two weeks. 
Your storytellers will arrange three times to come to the family home (or a location of your choice) 
to tell each story to you and to any family members that you would be willing to disclose your 
treatment to and who also provide consent to participate.  
If you consent, we will record this storytelling session and the discussion that follows on an 
audiotape. The audio recording will be kept in a secure file at the FGH office in Quelimane. We 
will write out the recording into a document in the computer. The information will be analyzed to 
understand what people think about the storytelling and to improve this program. Before we use 
this data, all of your identifying information will be removed. It will not be possible for anyone to 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
know it is your words or information. These data will only be accessible by study staff and the 
principal investigator at Vanderbilt University Medical Center. After 6 years, the transcript files will 
be destroyed. 
We will access your and your baby’s medical records to see what medications you are taking, 
medical data about your health (drug levels, CD4 cell count and viral load), and the dates you 
pick up your medications.  
A study staff person will also conduct two surveys at the beginning of your treatment and at three 
to four months after you start treatment. You do not need to answer all the questions in the surveys 
if you do not want to. If a question makes you feel uncomfortable or you do not know the answer, 
it is ok to tell the interviewer that you do not want to answer the question. You can also stop the 
surveys at any time without any penalty. 
A study staff person will also do a simple urine test with all the women enrolled in the study to 
measure the presence of the PrEP drug in your body. This will be done for three (3) months, 
starting the first month after you begin PrEP, when you come to pick up your PrEP from the health 
facility. You will be asked to collect a small amount of urine in a clean container. Then the trained 
study staff person will use a testing instrument to dip into the urine to test how much PrEP drug 
is present in your body. If a PrEP pick-up appointment is missed, or if you are not able to come 
for any reason, the study staff person will do a home visit. The study staff person will complete 
the same urine test on the home visit as needed. 
This urine test has been validated for use in research but has not yet been approved for 
commercial use. This means that the results can only be used for the study. Therefore, they will 
not be part of your clinical record, and we cannot share these results with participants or health 
care providers. 
Some couples enrolled in the study will be asked to participate in an interview to describe their 
experience with the program and costs related to your and your family’s health care. This interview 
will occur at least four months after enrollment. You do not need to answer the questions if you 
do not want to. If a question makes you feel uncomfortable or you do not know the answer, it is 
ok to tell the interviewer that you do not want to answer the question. You can also stop the 
interview at any time without penalty. 
If you consent, your responses to this interview will be recorded on an audio recording. Just like 
the storytelling session recordings, the interview recording will be kept in a secure audio file at 
the FGH office in Quelimane. The recording will be transcribed to an electronic document (Word). 
We will use these transcribed data to do a data analysis at the end of this study. Before we use 
this data, all of your identifying information will be removed. It will not be possible for anyone to 
know if it is your answers or information. The transcripts will be kept and stored securely on 
servers and computers protected by a password at the FGH office in Quelimane. These data will 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
only be accessible by study staff and the principal investigator at VUMC. After 6 years, the 
transcript files will be destroyed. 
Alternative Treatments Available 
Our study is only studying the impact of our storytelling intervention on medication adherence. 
We are not providing any medication as part of our study.  
Expected Costs: 
None. 
Possible Risks  
The idea of providing stories to education and motivate discordant couples (and their families) 
expecting a baby is new and untested.  While we will provide support, there is a chance that you 
and your partner will not agree on ways to take medication or talk together. This could make more 
problems in your relationship.  If you feel any discomfort or have relationship problems, please 
contact us as soon as possible so we can work to resolve it together.  
We know that talking about your personal experiences with HIV with your partner or health care 
workers can be uncomfortable. We will try to have a comfortable, honest, and relaxed discussion. 
Still we know that some of the questions we ask might make you feel uncomfortable. We will try 
to limit embarrassment as much as possible. No study staff will tell anyone else your responses 
to the survey questions.   
Possible Benefits  
The information you share may help us to offer better services for serodiscordant couples who 
come for ANC services. This could benefit Mozambican society by improving health programs for 
people living with HIV. If the project is successful, you may have better communication and trust 
with your partner after our counseling sessions.  
Unforeseeable Risks 
In any research study there are the possibility of unforeseeable risks. We try to minimize these 
by employing trained personnel to conduct our interviews to make you comfortable and to identify 
any potential problems. We are also partnering with a Ministry of Health supported health facility 
to ensure everyone has access to the free health services they need.  
What happens if you choose to withdraw from study participation? 
Nothing. You are free to stop participating at any point without problem.  You only need to say 
that you would like to stop being in the study.  You can tell this to us at any time.   
Confidentiality 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
We will make every effort to keep your personal information confidential. However, it is not 
possible to guarantee total confidentiality. The clinical information obtained during this study will 
be kept with your medical record and stored securely at the health facility in locked areas and on 
a protected database. Only trained medical and study staff will have to access this clinical 
information.  
The information related to the study activities will be kept at the health facility and at FGH offices 
in locked secure areas. Only trained study staff will have access to this study information.  
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required to 
do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB board, U.S. Federal 
Government Office for Human Research Protections, or the Mozambican Ministry of Health.   
Study Results 
We will gather former participants and community members within one year of the study ending 
to tell you the results. You are welcome to attend this meeting to learn if storytelling was a useful 
strategy.  
Clinical Trials Registry 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. 
Law.  This website will not include information that can identify you. At most, the website will 
include a summary of the results. You can search this Web site at any time. 
Contact Information for Questions 
If you should have any questions about study or wish to have additional counseling related to your 
care, please feel free to contact the study manager, Almiro Emilio, at the FGH office in Quelimane 
at +258 24217593, or the local co-investigator, Caroline De Schacht, at the FGH office in Maputo 
by calling +258 21328310, or Principal Investigator, Carolyn Audet, at the Vanderbilt University 
Medical Center, by calling +1-615-343-2418.   
For more information about giving consent or your rights, please feel free to contact the Secretary 
of the National Committee for Bioethics of Health (CNBS) in Mozambique at +258 824066350. 
You may also contact the Vanderbilt University Medical Center Institutional Review Board (IRB) 
office in the U.S. at +001-615-322-2918 or toll free at +001-866-224-8273. 
Do you have any questions? 
This form has been read and explained to me.  I have been given an opportunity to ask questions 
I have about the study. I understand that I may decide at any time that I do not want to continue 
participating in the study. I understand that I will receive a copy of this consent form. By saying 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
yes, you agree to participate in the study for 6 months. If you are a female and saying yes, you 
are agreeing to participate in the monthly PrEP urine tests. You are agreeing to participate in our 
interviewer-administered surveys and that we can look at your medical records, and that of your 
unborn child. You are agreeing for the storytelling sessions and interview to be recorded. By 
saying no, you decline to participate in all parts of the study.  
Moderator: Answer the participant’s questions before proceeding to the next question. 
 
I give my consent to participate in the study.                 Female partner                Male Partner 
 
I agree to participate in the storytelling/discussion session    
 
 
             [     ]  YES                            [     ]   NO 
 
I agree that the storytelling/discussion session can be recorded 
 
  
 [     ]  YES                            [     ]   NO 
 
I agree to participate in the interview    
 
 [     ]  YES                            [     ]   NO 
 
I agree that the interview can be recorded 
 
 [     ]  YES                            [     ]   NO 
 
_________________________________              _______________ 
Printed Name of Participant  
 
         Date  
 
 
 
_________________________________              _______________ 
Signature of Participant 
 
 
         Date 
 
 
 
Thumbprint of Participant 


Intervention Arm Participants 
PI: Audet  
Title: Partners-based HIV/PrEP services for sero-discordant couples attending antenatal care: A 
randomized trial to increase family-based support for PrEP adherence among discordant couples 
through storytelling 
Institution: Vanderbilt University Medical Center 
Date: 18 December 2020 (Version 1.5) 
_________________________________              _______________ 
Signature of Witness (if thumbprint used) 
         Date 
 
 
 
_________________________________            
   _______________ 
Signature of Person Who Explained This Form      
 Date 
 
I have explained to the participant the study purpose and procedures and we have discussed all 
the risks that are involved.  I have answered questions to the best of my ability. 

Prot_SAP_002.pdf: 
Version 1, PI: Audet 
 
1 
 
STUDY PROTOCOL 
 
PROJECT TITLE: Partners-based HIV/PrEP services for sero-discordant couples attending 
antenatal care: A randomized trial to increase family-based support for PrEP adherence among 
discordant couples through storytelling 
 
 
Date 
8 November 2019 
Version  
1.1 
Principal Investigators 
Dr. Carolyn M. Audet, PhD, Institute for Global Health 
Vanderbilt University, USA 
Funding Agency 
National Institute of Mental Health (NIMH) 
(Dr. Carolyn M. Audet, PI) 
Location 
Zambézia Province - Mozambique 
Expected Start Date 
1 January 2020 
Expected End Date 
31 December 2010 
Type of Study 
Randomized controlled pilot 
Main objective 
The overall goal of this project is to develop and assess 
the impact of a storytelling intervention on PrEP uptake 
and adherence among pregnant women. 
Key words 
Elimination of Mother-to-Child Transmission  
Male-engagement 
PrEP 
Antenatal care 
Storytelling 
NCT Title and Number  
Storytelling to Increase Family Support for Pre Exposure 
Prophylaxis Use. NCT04071470 
 


Version 1, PI: Audet 
 
2 
 
 Table of Contents 
Table of Contents 
Acronyms ...................................................................................................................................................... 3 
1. Principal Investigator ................................................................................................................................ 4 
2. Funding...................................................................................................................................................... 4 
3. Collaborators ............................................................................................................................................. 4 
4. Introduction and Justification ................................................................................................................... 5 
5. Objectives .................................................................................................................................................. 9 
6. Design and Study Questions ..................................................................................................................... 9 
7. Study Population ....................................................................................................................................... 9 
8. Methods .................................................................................................................................................. 12 
9. Locations of Study ................................................................................................................................... 14 
10. Data Management and Analysis ........................................................................................................... 14 
11. Ethical Considerations ........................................................................................................................... 18 
12. Limitations ............................................................................................................................................. 19 
13. Dissemination Plan ................................................................................................................................ 20 
14. Budget ................................................................................................................................................... 20 
15. Timeline ................................................................................................................................................. 21 
16. Statement of Conflict of Interest .......................................................................................................... 22 
17. Bibliography .......................................................................................................................................... 23 
18. Appendices ............................................................................................................................................ 29 
Appendix 1: List of Indicators/Data to Be Collected ............................................................................... 29 
Appendix 2: Storytelling Intervention ..................................................................................................... 33 
Appendix 3: Measures used in study ...................................................................................................... 33 
Appendix 4: Semi-structured interview guide for intervention couples and their families ................... 37 
Appendix 5: Informed Consent Form for participant (intervention arm) ............................................... 38 
Appendix 6: Informed Consent Form for participant (control arm) ....................................................... 43 
Appendix 7: Informed Consent Form for Family Member Interview ..................................................... 47 
  
 
 


Version 1, PI: Audet 
 
3 
 
Acronyms  
 
AIDS 
ANC 
Acquired Immune Deficiency Syndrome 
Antenatal Care 
ART 
Antiretroviral Therapy 
APSS 
CCR 
Psychosocial Support (Apoio Psicossocial para a Saúde) 
Child at risk Clinic 
DPS 
EID 
Provincial Directorate of Health 
Early infant diagnosis 
EPTS 
EMTCT 
Electronic patient tracking system 
Elimination of Mother to Child Transmission 
FGH 
Friends in Global Health 
GoM 
Government of Mozambique 
HCW 
Health care worker 
HIV 
HoPS+ 
Human Immuno-deficiency Virus 
Homens para Saúde Mais (Men for Health Plus) 
MOH 
Ministry of Health 
MTCT 
Mother-to-child transmission 
PLHIV 
People Living with HIV 
PMTCT 
PrEP 
RCT 
SOC 
Prevention of Mother to Child Transmission 
Pre-Exposure Prophylaxis  
Randomized controlled trial 
Standard of care 
VUMC 
Vanderbilt University Medical Center 
WHO 
World Health Organization 
 
 
 
 
 
 


Version 1, PI: Audet 
 
4 
 
1. Principal Investigator 
 
The principal investigator (PI) for this evaluation will be Carolyn Marie Audet at Vanderbilt 
University Medical Center (VUMC). The PI will be responsible for all aspects of evaluation 
coordination, including design, implementation, and analysis.  
 
Contact information for PI:  
 
Carolyn Audet, PhD.    
Vanderbilt University Medical Center 
Department of Health Policy  
2525 West End Ave 
Suite 750 
Nashville, TN 37203 
carolyn.m.audet@vanderbilt.edu 
Phone: 1-615-343-2418 
2. Funding 
 
This project will be funded by a National Institute for Mental Health (NIMH) supplement to a 
parent R01 award (PI. Audet). 
3. Collaborators 
 
Various project staff from the Ministry of Health (MoH) and Friends in Global Health 
(FGH)/Vanderbilt University Medical Center will be involved in this activity. From the MoH, this 
includes Arifo Aboobacar, an assigned member of the Operational Investigation Committee of 
Zambézia (NIOZ). From FGH, this includes Caroline De Schacht, M.D., MSc, Ph.D.; and 
Fernanda Alvim, M.P.H. From VUMC, this includes Carolyn Audet, Ph.D. and Erin Graves, BSN, 
M.P.H. 
 
Table 1. Other participants in the study. 
 
Name  
Organization 
Role 
Role in the Evaluation 
Arifo Aboobacar 
DPS-Z 
Operational 
Investigation 
Committee of Zambézia 
(NIOZ) 
Collaborator; NIOZ Focal Point; 
Technical oversight 


Version 1, PI: Audet 
 
5 
 
Caroline De Schacht 
FGH 
Director of Evaluations 
Co-Investigator; Technical 
oversight; support of HoPS+ 
Study Manager 
Fernanda Alvim 
FGH 
Director, Monitoring and 
Evaluation 
Collaborator; Data Quality 
Monitoring 
Almiro Emílio 
FGH 
HoPS+ Study Manager 
Study Manager; Coordination 
and supervision of study 
Erin Graves 
VUMC 
Senior Program 
Manager 
Study Manager; Technical and 
administrative oversight 
Carolyn Audet 
VUMC 
Principal Investigator 
Principal Investigator; Technical 
oversight and mentoring 
  
4. Introduction and Justification 
 
One of the world’s poorest and most medically underserved regions, Zambézia province is located 
in north-central Mozambique. Zambézia province is home to 4.5 million people in one of the 
poorest regions in the world; its people live on subsistence agriculture, the educational system is 
weak, and few social support services exist.[1] In 2015, adult HIV prevalence was estimated at 
15.1%.[2] The Vanderbilt University Medical Center (VUMC)-affiliated non-governmental 
organization Friends in Global Health (FGH) supports more than 200 health facilities that provided 
antenatal care (ANC)-based HIV counseling and testing to 155,000 women in 2016-2017. Of 
those, 65% received couples-based testing. Approximately 7-10% of couples identified in ANC 
are composed of an HIV-uninfected person with a partner living with HIV. High rates of 
serodiscordant couples led the Ministry of Health (MoH) to initiate pre-exposure prophylaxis 
(PrEP) distribution free of charge to all serodiscordant couples in Mozambique.  
 
B.1.1. Acquisition of HIV during pregnancy increases mother-to-child-transmission (MTCT) 
risk.[3, 4] The risk of HIV transmission among pregnant and post-partum women is significantly 
higher when compared to non-pregnant female counterparts; with adjusted risk ratios of 2.82 and 
3.97, respectively.[5, 6] Pregnant women in Mozambique seroconvert at a rate of 4.28/100 
women-years,[7] which is similar to published incidence data from Swaziland,[8] Uganda,[9] and 
South Africa.[4, 10] Among pregnant women in known discordant relationships, HIV incidence is 
12.5 per 100 women years.[11, 12] In African cohorts, women with incident vs. chronic infection 
during the pregnancy/postpartum periods had a higher risk of mother to child transmission (OR 
2.3, CI 1.2 - 4.4)[12] thus PrEP is essential to preventing incident mother and infant HIV infections.   
 


Version 1, PI: Audet 
 
6 
 
PrEP offers a bridge to partner ART initiation[13] and viral suppression.[14] Among discordant 
couples, the risk of HIV transmission continues up to 6 months post antiretroviral treatment (ART)-
initiation.[11, 15] The World Health Organization (WHO) recommends combining ART with PrEP 
for HIV-1 prevention.[16] Integration of PrEP delivery and ART initiation, decreased HIV incidence 
in the negative partner to <0.5% per year.[14] Recent studies of PrEP in pregnant/lactating women 
revealed no safety-related concerns during implementation[17-19] and PrEP is now 
recommended by the WHO and the U.S. Centers for Disease Control and Prevention (CDC) for 
use among HIV-uninfected pregnant women if their partner is a person living with HIV 
(PLHIV).[20] Randomized controlled trials have demonstrated that women on PrEP must maintain 
very high levels of adherence for the drug to be effective.[21, 22]  
 
Family support can improve uptake of, retention in, and 
adherence to PrEP among pregnant/lactating women.[14, 23, 
24] Women have identified a lack of support from husbands or 
male partners as a principal barrier to engagement in ANC and 
HIV services during pregnancy.[25-28] Qualitative[24, 26, 29-31] 
and clinical trial data[32] across sub-Saharan Africa (SSA) 
reveal that women are reluctant to accept HIV testing, HIV 
treatment, or PrEP services if their partners or families are 
unsupportive, highlighting the importance of programmatic 
adjustment to prevailing gender norms. In rural Mozambique we 
found that family beliefs affect a woman’s health decisions.[33] 
Mozambique is not unique; acceptable engagement of partners 
in HIV counseling during ANC has resulted in increased 
acceptability of testing and treatment uptake across SSA.[34-42] 
We anticipate maternal uptake of PrEP services will face similar 
challenges.[43, 44] Thus, we propose a culturally-grounded, 
family-based approach.  
Family-based support systems are essential to changing health-
related behaviors. Families, including couples, are a proven, 
effective unit of intervention in the African HIV prevention and 
care context. [29, 34, 36, 37, 39, 44-52] Our successful “Men for 
Health” program was designed to increase male participation in ANC services, including couple-
based HIV testing. We trained “male champions” to counsel husbands about the importance of 
ANC uptake, HIV counseling and testing, and the need for men to provide physical and emotional 
support to their partners during pregnancy. Male partners were encouraged to accompany their 
wives to the health facility for ANC services. Traditional Birth Attendants (TBAs) were trained to 
provide similar education to pregnant women. We increased couples testing from 2% to 60% in 
less than three years.[44] While couple-centered behavioral interventions have been effective in 
reducing sexual and drug-risk behaviors, increasing access to HIV testing, and improving uptake 
of PrEP services,[29, 34, 36, 37, 39, 44-56]  no studies have assessed the effect of family-
centered interventions on adherence to maternal PrEP/paternal ART during pregnancy and 
lactation.[14]  
Will treatment adherence by 
one partner result in 
decreased adherence by 
the other?  
Will serodiscordant partners 
receive differing levels of 
family support (i.e. more 
support for negative woman 
or positive man)? 
Do people learn more about 
PrEP via storytelling vs. 
counseling sessions? 
Can family support for PrEP 
use overcome partner 
neglect or rejection? Or Can 
partner support for PrEP 
use overcome extended 
family neglect/rejection?  
Table 2: Unique social 
challenges faced by 
serodiscordant couples 


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7 
 
 
Discordant couples face unique challenges to adherence and retention in care (Table 2). Couples 
in concordant relationships are more likely to stay together than those who find themselves HIV 
discordant. PrEP is so new to Mozambique that few people have heard of it before it is offered at 
the health facility. This lack of information can be exploited; stigma towards those who use PrEP 
is non-existent. However, the lack of information about the medication can make it difficult for 
families to understand the importance of adherence, the value of the medication, or the potential 
role they have in supporting women taking medication. As with people taking ART, family 
engagement can address multiple patient-reported barriers to retention in care in rural 
Mozambique, notably lack of partner support, challenges with transportation and security while 
traveling to and from the health facility, and disbelief or denial of the existence of HIV by family 
members.[57, 58] More so than with ART, including partners in the education, counselling and 
treatment process can improve male partner retention by creating accountability and support: a 
woman cannot stop PrEP until her male partner is virally suppressed. If both partners (and their 
families) understand this, commitment to treatment is enhanced.  
Families cannot provide substantive support to discordant couples unless they have adequate 
knowledge and skills to do so. Among participants in the HoPS+ study, the average level of 
education is only two years. More than 50% (primarily women) have no formal education; many 
of these individuals do not have the ability to even sign their own name. Our R01 is situated in an 
extremely rural portion of Zambézia Province with little exposure to larger towns or cities. There 
has been a long-standing struggle to develop educational strategies to explain what HIV is, what 
HIV is doing in their bodies, and how medication works to improve the health of people living with 
HIV. Currently, counselors in our clinical sites describe HIV as a tiny bug that lives in patients’ 
blood. The medication puts the bug to sleep, but the bug never really goes away and will wake 
up if the patient stops taking medication. The level of detailed understanding about the disease is 
not as important as the creation of a relevant construct that allows people to contextualize their 
illness and the interaction between their medication and disease progression. Explaining how 
PrEP works and developing motivational messages that are effective in this population remains 
a challenge. Our interviews among discordant couples revealed a complete lack of information 
about PrEP; they are offered it at the time of a discordant test. Development of a couple-based 
education and messaging is essential to improving knowledge. 
People are seven times more likely to remember a story vs. facts alone.[59] Mozambique has a 
rich history of oral storytelling, a cultural tradition we will integrate into this intervention. Couples 
live with, and are influenced by, their immediate and extended families and >95% of patients 
disclose their HIV status to at least one of their family members (ongoing study, Audet personal 
communication, 2019). The strength of family support provided to the discordant couple is 
correlated with adherence to medication and retention in care.[60] Developing and delivering 
engaging stories has proved essential via numerous RCTs for several reasons:  (1) Stories act 
as mnemonic devices for facts;[61, 62] (2) Stories engage our emotions, which results in 
increased empathy and adoption of messages;[63] and (3) Stories that engage participants lead 
to story-consistent beliefs.[64] Narratives have been used to persuade patients to accurately 
assess their risk of a particular condition (lung cancer, cervical cancer, etc.), in efforts to change 
behavior (smoking, condom use) or uptake specific medical services (HPV vaccination, lung 


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8 
 
cancer screening).[65-69] Given the history of oral storytelling as education in Mozambique, there 
is evidence that this culturally-informed tradition can be used to reduce HIV stigma[70] and 
increase understanding of complex topics[71, 72] like PrEP and ART use.  
The 
use 
of 
entertainment-
education 
fosters 
interest 
among listeners in the events 
and characters described in the 
story. This engagement, also 
described as transportation, 
immersion, and absorption[69] 
differentiates 
overtly 
educational messaging from 
entertainment-education.  
Successful narratives engender 
participant 
involvement 
with 
characters. This involvement 
occurs 
through 
five 
mechanisms: (1) Identification 
with a character or characters; 
(2) Wishful identification with a 
character (i.e. wants to be like a 
character but does not see themselves like that person currently); (3) Similarity with a character 
(e.g. physical attributes, race, values, personality); (4) Parasocial interaction[73] between the 
audience and narrator (i.e. the illusionary experience of friendship with the narrator); and (5) Liking 
the main characters of a narrative (e.g. I would like to be friends with this character). While the 
listener is enjoying the story, they are (ideally) identifying with a character that they deem likeable 
and similar to themselves; the behavior and experiences of the character becomes acceptable 
and appropriate to the listener.  
The experiences of the character serve to motivate the listener to change their own behavior or 
beliefs, without generating counterarguing based on previously conceived opinions or 
expectations. Storytelling can influence outcome expectations among the listener (e.g. “PrEP 
does work to keep me from contracting HIV!”), shift a listener’s notions about their own 
vulnerability to HIV infection and self-efficacy to change their behavior (e.g. “If they can do it, so 
can I!”). The interaction between characters can change perceived social norms in relation to 
protective behavior and/or treatment uptake (Figure 1). 
Accurately assessing adherence to medication is essential to understanding if an intervention is 
successful. People frequently overestimate their adherence to medication or have difficulty 
quantifying how much medication they took, and individuals without sufficient PrEP in their system 
are more likely to seroconvert than those with detectable levels of tenofovir in their urine.[74] Thus 
we propose to conduct a urine assay to monitor adherence in real time using disposable, point of 
care, qualitative tests at each clinical visit.[75]   
Figure 1: Impact of Storytelling 


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9 
 
5. Objectives 
 
The overall goal of this project is to develop and assess the impact of a partner-based ART 
delivery intervention among HIV-positive expectant couples.  
 
Our specific objectives are as follows: 
 
Objective 1:  Compare the effect of a storytelling intervention (vs. couple-based counseling) on 
participant knowledge, motivation, and behavioral skills associated with PrEP retention and 
adherence.   
Objective 2: Evaluate the impact of a storytelling intervention on adherence to PrEP/ART 
medications.   
Objective 3: Assess the experiences of participants and family members in the storytelling 
intervention.  
6. Design and Study Questions 
 
The proposed study is a two sample, couple-randomized pilot to test the impact of an oral 
storytelling intervention (versus standard of care PrEP/ART delivery) to increase retention in, and 
adherence to, PrEP and ART among HIV-discordant expectant couples. 
There are seven specific study questions:  
Question 1: Is our intervention idea acceptable to discordant expectant couples and their 
families? 
Question 2: Does our intervention positively impact partner support for PrEP/ART medication 
adherence and retention in care?  
Question 3:  Does the intervention increase empathy among partners enrolled?  
Question 4:   Does the intervention increase knowledge about HIV?  
Question 5: Does the intervention reduce depression among couples enrolled into the 
intervention? 
Question 6: Does our intervention improve the proportion of exposed infants who are tested for 
HIV (early infant diagnosis [EID])?  
Question 7:  Does it decrease the number of infants who are HIV-positive at 12 months? 
7. Study Population 
 
a. Population:  


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10 
 
1. Couples consisting of two adults 18 years or older (one HIV-uninfected pregnant woman 
and her HIV-infected male partner) presenting for ANC services together in Zambézia 
province, and their infants.  
2. Family members of couples in the intervention group who participate in the storytelling 
events. 
 
b. Inclusion Criteria:  
1. Couples, one pregnant woman and her male partner, will be eligible to participate if: i) the 
male partner is identified as HIV-positive at any ANC appointment, either through ANC-
based HIV testing or having a known history of HIV-positive (from clinical records or 
medication pick-up documents, or any other mechanism by which ANC staff identify him 
as HIV-positive); ii) both persons agree to take PrEP (pregnant woman)/ART (male 
partner) together and receive standard care in pre- and postnatal period, including care of 
the HIV-exposed infant (“CCR – Consulta de Criança em Risco”; iii) the woman’s due date 
is >4 weeks from study enrollment; iv) both persons are 18 years or older; v) both persons 
are able to give informed consent; vi) both persons (parents) are willing to consent to an 
infant record search, and v) both persons consent to be in the study.  
2. Family members (as defined by relatives living in the participants’ household or relatives 
the participants identify as living in the study community) will be eligible to participate if: i) 
they participated in at least one of the storytelling sessions; ii) are 18 years of age or older; 
iii) are able to give informed consent; and iv) are willing to participate in the interview.  
   
c. Exclusion Criteria: 
1. Couples will not be eligible to participate in the study if the woman is not pregnant, if she 
is HIV-positive or if her partner is not HIV-positive, if either person is younger than 18 
years, if one member of the couple is unwilling to enroll in PrEP/ART or consent to the 
infant record search, or if one member of the couple is unable or unwilling to give informed 
consent for any reason. 
2. Family members will not be eligible to participate in the study if they do not participate in 
at least one storytelling session, if they are younger than 18 years old, if they are unable 
or unwilling to give informed consent for any reason (e.g. have been drinking or show 
other signs of mental limitations), or if they are not willing to participate in the interview.  
 
d. Calculations of Sample Size:  
Objectives 1 & 2: Our pilot will involve 70 couples (70 HIV-negative pregnant women and their 
HIV-positive male partners; 35 couples in each arm) from a single clinic. Limited data on PrEP in 
Mozambique suggest 55% of pregnant women were not retained at 3 months after PrEP initiation. 
Given our sample size of 70 women and a 5% type I error, we will have 82% power to detect a 
RR of 0.40 for not being retained. Should there be evidence the intervention effect is similar for 
men and women with regards to retention, the two groups can be analyzed together to further 
improve power to detect RRs closer to 0.50. We do not have estimates of Tenofovir levels among 
PrEP users, but other studies indicate as many as 70% may have no active drug detected.[76] 


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11 
 
Given our sample of 70 women and a 5% type I error, we will have 85% power to detect a RR of 
0.50 for no detectable drug level.  
Objective 3: Interviews will be conducted with 25-40 family members and 15-20 couples who 
participate in at least one storytelling session four months after enrollment. We will recruit family 
members of at least 10 different couples to ensure we have enough variability. We will complete 
interviews until we reach data saturation[77]. In this population, data saturation has been reached 
after an average of 30 interviews; thus, we hope to reach saturation with this sample.    
e. Sampling 
1. [Objectives 1-2] Participants: Eligible discordant couples will be enrolled at the study site 
on a first come, first enrolled (consented) basis until 70 couples have been enrolled. 
Randomization will be done using Stata with the results printed into numbered envelopes 
opened by the study assistant at the time of participant enrollment.   
2. [Objectives 3] Participants: For qualitative in-depth interviews with family members, we 
will use convenience sampling to identify family members of couples who were successful 
and those who were unsuccessful at adhering to PrEP/ART.  
 
f. 
Recruitment procedures 
Serodiscordant couples identified in ANC will be informed about their eligibility for a study by the 
maternal and child health nurse.  If the couple is interested in discussing further, they will be 
referred to a study assistant based at the health facility. This study assistant will sit with both 
members of the couple to describe the study. The specific points they will address include (but 
are not limited to), (1) that if the participants are randomized to the intervention group we will 
include them and their nominated family members in three storytelling sessions to increase 
understanding and support for use of PrEP and ART medications; (2) that some people are 
randomized to the control group, which means that they will receive the normal PrEP and HIV 
care and treatment at the health facility; (3) that we will measure the female’s PrEP adherence 
using a point of care urine test at each medication pick up for the first three months on the PrEP 
regimen. The couples will be offered to ask any questions and will be explained that their 
participation is voluntary. If the both members of the couple consent to participate, they will be 
randomized to the control or intervention group using a pre-determined allotment recorded within 
a sealed envelope at the health facility site.  
Family members of intervention participants who are nominated for participation by the discordant 
couple will be recruited by the study assistant at the home of the discordant couple (already 
consented and enrolled in the study). The discordant couple will ask their family member(s) to 
stay home or invite their family member(s) over during a pre-arranged time slot, and the study 
assistant will meet them there to explain their potential participation in the trial and to obtain the 
family members’ consent (if applicable).   
g. Patient participant retention and withdrawal: 
Participant retention and withdrawal from clinical care: As per standard clinic procedure, peer 
educators will track all patients who miss appointments at the health facility selected as study site. 
The peers will document patients as terminating clinical care services if they: (1) discontinued 


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12 
 
services due to death; (2) transferred their care to another clinic; (3) are lost to follow-up (defined 
as being >60 days late for a clinic appointment); or (4) discontinue for any other reason, including 
patient choice.  
Participant retention and withdrawal from pilot: Study participants can choose to discontinue 
participation in the study and decide that their medical data and/or study data cannot be used in 
the analysis at any time by formally communicating their decision to the study manager. 
8. Methods 
a. Study Procedures for patients  
 
Standard of care (SOC): The participants randomized to the control arm will receive SOC 
services that include: (1) standard male engagement (male invitation to ANC services and couples 
HIV testing), (2) opt-out rapid HIV testing of all pregnant women attending ANC, including two 
HIV tests before PrEP initiation to ensure patient status [Determine HIV-1/HIV-2®, (Abbott 
Laboratories, Abbott Park, Illinois, USA)] followed by [Unigold HIV-1/HIV-2® (Trinity Biotech Plc, 
Bray, Co. Wicklow, Ireland)], (3) Confirm estimated creatinine clearance (CrCl) ≥ 60 mL/min per 
1.73m2 prior to ART initiation and periodically during treatment,  (4) Counseling for the HIV-
positive partner as per national guidelines; (5) PrEP medications, condoms and psychosocial 
support (PrEP package) free of 
charge, and (6) follow-up HIV 
testing at time of medication 
pick-up (1 month and every 
three months thereafter). The 
partner will be referred to one of 
the differentiated models of 
care if viral load (VL) is 
suppressed at month 6 (at 
which point the PrEP regimen 
may also be suspended with 
clinician’s approval). If the male 
partner abandons HIV care and 
treatment, 
the 
woman 
will 
continue to be eligible for PrEP. 
Postpartum women on PrEP 
receive follow-up at the adult 
clinic for PrEP services; her 
infant is followed at the Health 
Child Clinic for clinical follow-up 
and vaccination; if the woman 
seroconverts, 
infants 
have 
access to HIV testing by dried 
blood spot (DBS) PCR as early 
Figure 2: Procedures in SOC vs. Intervention Arm 


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13 
 
as six weeks after birth. If the infant seroconverts, s/he is provided ART for life. Follow-up at 
respective clinic points for mother and infant continues for 18 months or until the mother ceases 
breastfeeding. Relevant medications are also offered free of charge in the adult HIV clinic to male 
partners (Figure 2). If the woman seroconverts at any point during the study, HIV-specific 
counseling and support, provision of cotrimoxazole prophylaxis, Isoniazid Preventive Therapy, 
and universal ART are provided free of charge (currently all adults are offered ART, regardless of 
CD4 cell count).[78] Viral load testing is routinely available for all ART-treated children and adults. 
The only other procedure that is not considered SOC, but will be conducted with all consenting 
study participants, including in the control arm, is the monthly measuring of PrEP (tenofovir) drug 
level via urine assay testing, which will be explained to all participants prior to consenting to study 
enrollment.     Storytelling Intervention: The participants randomized to the intervention arm will 
receive all of the SOC services and PrEP drug level testing (for female) as described above (i.e., 
will receive the same SOC clinical services as those couples randomized to the control arm). In 
addition, the individuals randomized to intervention arm will be invited to participate in three 
storytelling sessions with their partner and family members (of their choosing). The stories will be 
told by theater-trained community members who will deliver the narratives in the first person, each 
person playing/voicing an assigned character at the couple’s home (or in a preferred location 
chosen by the participants). Each narrative will last 12-15 minutes. At the conclusion of the 
narrative, the facilitators will open up a discussion with those listening to the story. They will 
engage the family in a discussion, asking them about the storyline they just heard. They will ask 
questions to specifically probe for reactions to events and difficult characters/interactions. They 
will lead the discussion about ways the main characteristic (discordant couple) overcome 
challenges in adherence to medication; seeking to see if there are ways the messages can be 
related to their own lives (Appendix 2).  We will conduct the first two stories in the first month of 
enrollment to try and influence participants’ behavior/thinking prior to their first follow-up visit for 
medication pickup (in an effort to assess storytelling’s impact on attendance at visit).  
 
Procedures for drug level measurement.  
Every time the couple returns for a medication pick up the woman on PrEP will be asked to provide 
a small sample (1ml is sufficient) of urine for the tenofovir assay. If a participant misses a 
medication pick-up, or if their male partner picks up their medication, the study assistant will bring 
the urine assay to the participant’s home to complete the test. The test is simple to use: like a 
pregnancy test, the patient only has to urinate on a testing stick to identify the presence of the 
medication.  
    
Study procedures for the qualitative interviews  
Qualitative interviews will be conducted at least 4 months after the couple and their indicated 
family members have been enrolled in the study. We will purposely select roughly equal numbers 
of participants (including couples and their family members) who were adherent to PrEP/ART and 
those who have not been adherent to medication (measured via ART pick-ups and PrEP drug 
level assays). Interviews will be arranged by the study assistant and can be completed either at 
the health facility or at the home of the participant (depending on the preference of the participant). 
The qualitative interviews will only be completed one time, with no additional follow-up for the 


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14 
 
participant.   
 
Measurement of Results 
Objective 1: Using interviewer assisted surveys, we will collect male and female partner (1) 
depression;[79] (2) partner and family support;[60, 80] (3) empathy;[81]  (4) relationship 
satisfaction;[82] (5) PrEP adherence knowledge; and (6) motivation/perceived ability to adhere to 
medication[83] at baseline and three months. 
Objective 2: Routinely collected demographic, community-based social support, and PrEP/HIV 
care and treatment data will be used in the analysis. Select demographic, clinic, and laboratory 
data (see Appendix 1) from these forms are entered routinely into OpenMRS (an electronic 
medical record “EMR” system) at FGH-supported sites. We will collect data about participant 
eligibility among those who attend ANC services including reasons for refusal among eligible 
participants. Lastly, we will assess PrEP drug levels using urine analysis (not considered standard 
of care) among participants in both groups (control and intervention).   
Objective 3: Qualitative interviews will be measured using open-ended interview questions to 
understand their perspectives and experiences with the study activities, strategies, benefits, 
disadvantages, and suggestions for program implementation and improvement. These qualitative 
interviews will not necessarily provide objective measurement, but rather in-depth information 
regarding program implementation issues and strategies for improvement.   
b. Instruments used in the study 
We will use the following instruments in the study: (1) depression;[79] (2) partner and family 
support;[60, 80] (3) empathy;[81]  (4) relationship satisfaction;[82] (5) PrEP adherence 
knowledge; and (6) motivation/perceived ability to adhere to medication[83] at baseline and three 
months (Appendix 3). These instruments are quantitative scales with closed ended response 
options. During qualitative interviews with our smaller samples we will follow semi-structured 
interview guides (Appendix 4). 
 
c. Anticipated end date of study: 
 
This study is expected to be concluded in September 2020. 
9. Locations of Study 
This pilot will be conducted at Namacurra Sede health facility.  
10. Data Management and Analysis 
Data Management and Security 
The data collected will be kept in a database housed in Mozambique. Data will be stored in a 
restricted access folder that sits on the FGH server. In addition, data will be password-protected 
to limit access to staff involved in the study and to ensure confidentiality. Data will be encrypted, 


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15 
 
backed up on FGH servers, and uploaded to the VUMC servers as needed for PI access. FGH 
servers have daily backups scheduled; therefore, all data will be backed up on a day-to-day basis. 
 
Data from the surveys will be coded and transferred into a REDCap database by field staff trained 
in data entry. The original surveys will be locked in a file cabinet in the FGH office in Quelimane 
for five years. The interview data will be recorded; field workers will transcribe the data within a 
month of the interview into a password-protected Word document. After transcription and 
translation, the original recording will be deleted. Only the PI, investigators who will complete the 
analysis, and the Study Manager at the FGH Quelimane office will have access to the coded data. 
The data files will be password-protected to ensure confidentiality. All routine monitoring data will 
be documented by health facility staff into patient clinical records. Data are extracted from patient 
clinical records into electronic patient tracking systems already established and functioning as 
part of routine monitoring by FGH data entry specialists. The staff has specific training on data 
confidentiality; all FGH staff sign confidentiality agreements as they come into contact with patient 
clinical files. 
 
As the HIV care program has grown, FGH and other PEPFAR partner organizations within the 
province have implemented electronic databases using either ACCESS® or OpenMRS, 
depending on the district, to collect patient information facilitating the maintenance of these 
records for the Ministry of Health’s program.  At the end of each patient encounter, data entry 
personnel based at the health facility enter information collected on the paper forms into the 
electronic database. This database does not have the capacity to collect information from the 
various different services and connect them to a specific patient. As a result, only information from 
the HIV care is currently collected in the electronic database.   
 
The OpenMRS databases are password protected and can only be accessed by FGH monitoring 
and evaluation staff. Data quality assurance for the OpenMRS is ensured through semi-annual 
audits as well as automatic data validation steps. All data are reviewed by FGH regional data 
supervisors at the district level and by data analysis officers based in the FGH provincial offices 
in Quelimane. Corrective measures are taken as necessary as a result of data quality audits and 
regular reviews of data.  
 
For this project, de-identified data will be extracted into a restricted dataset by FGH employees 
from the existing OpenMRS databases and sent to a VUMC Biostatistician for analysis. All routine 
programmatic data are owned by the MOH.  All routine programmatic data are part of the clinical 
record and as such will not be destroyed. 
 
Data from interviews will be transcribed (and if necessary translated from local language into 
Portuguese) at FGH Quelimane office. Transcription data will be typed up into Word documents, 
and subsequently translated into English. The English transcriptions will be imported into 
MAXQDA 12® software to be coded by Dr. Audet and a study assistant. The electronic database 
will be coded. The data will be password-protected to ensure confidentiality. Data will be stored 
in a restricted access folder (protected by an additional password) that sits on the VUMC server. 


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VUMC servers have daily backups scheduled; therefore, all data will be backed up on a day-to-
day basis. 
The original audio recordings of the interviews, which will not include participant names or other 
identifiable information, will be locked in a file cabinet in the FGH office in Quelimane until 
transcripts of the interviews have been entered into the database and the data has been checked 
for errors. After this point they will be erased to ensure voices cannot be linked back to the 
transcripts. All paper copies of transcripts will be destroyed once they have been typed up, 
verified, and the electronic versions have been sent to VUMC. All electronic copies of transcripts 
will be kept in a password-protected folder on a secure server at VUMC for a period of 7 years, 
after which time they will be destroyed by the PI (Dr. Audet).  
Data Analysis 
Objective 1: Statistical analysis plan for Objective 1.  
Qualitative Analyses 
Audio files will be transcribed verbatim by a research assistant and two researchers will code and 
analyze the interviews using MAXQDA® software. We will employ a thematic approach to identify 
and analyze themes in the data.[84]  We will focus on two key reactions to the storytelling: (1) the 
experience of listening to the stories, with a focus on the effectiveness of the narrators ability to 
transport the listener, the level of identification and perceived similarity with characters; and (2) 
the impact of the storytelling intervention on information related to PrEP/ART adherence, 
motivation to adhere to medication due to self-efficacy, family support and feelings of 
depression/hopelessness, and behavioral skills learned. We will use a combination of deductive 
codes based on findings from previous adherence research and inductive codes to categorize 
newly-identified factors associated with uptake, adherence, and retention in PrEP/ART services 
(e.g. self-efficacy, partner support, information etc.). Two researchers will read through the 
transcripts several times and highlight relevant examples of storytelling impact on information, 
behavioral skills and motivation. Researchers will generate codes and highlight themes by 
collating codes across the data set and the review themes to develop a thematic map (e.g. the 
influence of a character’s successful use of a strategy on a listener’s self-efficacy to employ the 
same tactic). The final coding framework will have at least 85% agreement between the two 
coders.  This exercise will allow us to modify our behavioral model if necessary.   
Quantitative Analyses  
AIM 1 Endpoints: (1) partner/family support;[60, 80] (2) empathy;[81] (3) relationship 
satisfaction;[82] (4) PrEP adherence knowledge; (5) depression[85]; and (6) motivation/perceived 
ability to adhere to medication[83] 
Analyses will follow an intent-to-treat protocol. We will estimate the intervention effect on mean 
outcome scores using separate linear regression models for each outcome. If any outcome 
demonstrates a skewed distribution, we will consider score transformation. Generalized 
estimating equations (GEE) with an exchangeable working correlation structure will be used to 
account for clustering within couples. Each model will also include an interaction term between 
treatment arm and gender to identify gender-specific effects. Given the small sample size and low 
power of homogeneity tests, if the p-value for the interaction term is ≥0.20, we will also report the 


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intervention effect for men and women combined (no interaction term). We will not be powered to 
detect other intervention effect modifiers unless gender is not a modifier, in which case we will 
explore modification by baseline values of the outcome being analyzed (e.g., is the intervention 
more effective at improving partner/family support among participants with low partner/family 
support at baseline), again using an interaction p-value  <0.20 as our criteria for evidence of 
modification of the intervention effect. Finally, given the small sample size of this RCT, it is 
possible potential confounders remain imbalanced between treatment arms. We will repeat the 
above analyses (which already include gender), further including age and the baseline value of 
the outcome being analyzed, to adjust for residual confounding. The small sample, however, 
precludes from including additional covariates beyond these.  
Objective 2: Primary analyses will follow an intent-to-treat protocol. We operationalize the 
outcomes in the negative (e.g., not retained, no active drug levels, no virologic suppression) such 
that the risk ratios (RR) for the intervention effect will be <1.0 if effective. We will estimate the 
intervention effect on dichotomous endpoints using separate modified Poisson regression models 
for each outcome to estimate risk ratios and 95% confidence intervals. Modified Poisson models 
use a robust standard error to estimate the RR with unbiased confidence intervals to avoid 
convergence problems with log linear models and to improve interpretation over logistic 
regression since the outcome is relatively common (>30%). If we still encounter problems with 
model convergence due to the small sample size, we will utilize logistic regression models 
instead. We will use GEE models with an interaction term between intervention arm and gender 
as described in Aim 1. We will also explore intervention effect modification and adjustment for 
other covariates as described in Aim 1.   
Secondary analyses will also follow intent-to-treat protocol, again operationalizing the outcomes 
in the negative (monthly count of missed doses; monthly nonadherence) such that the rate or risk 
ratios will be <1.0 if the intervention is effective. We will estimate the intervention effect on the 
count of monthly missed doses using a negative binomial regression model to account for 
overdispersion due to an excessive amount of zero missed doses (perfect adherence). In addition 
to clustering of couples, each participant will have up to three observations (one for each month 
of follow-up). Participants LTFU will only contribute an observation for each completed month of 
follow-up for which there is a pill count, otherwise they are censored. Similarly, self-reported 
monthly nonadherence is likely to be heavily skewed with a large proportion of 0% nonadherence. 
As this is inherently a continuous measure (rather than a count), we will dichotomize as 0% 
nonadherence vs. >0% nonadherence and each participant will contribute an observation for each 
completed month of follow-up. A sensitivity analysis will be performed with dichotomization at 
≤10% nonadherence vs. >10% nonadherence. As for the prior analyses, we will utilize GEE 
models (accounting for clustering of couples and repeated measures on individuals) with an 
interaction term between intervention arm and gender and will explore modification and 
adjustment for other covariates as described in Aim 1. 
Objective 3: Following completed interviews, audio files will be transcribed by the interviewer, 
and the PI will code and analyze the interviews using MAXQDA 12® software. Framework 
Analysis will be used to identify responses to questions about the drivers, core facilitators, and 
barriers to intervention acceptability and success using grounded theory.[86] Two code maps will 
be developed to categorize data: (1) to understand the social, structural, and informational drivers, 
facilitators, barriers to recruiting, providing services for, and supporting discordant couples in 


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couple-based ANC and post-natal care; and (2) to understand concepts of “best-practice” for 
scaling up and implementing these services, particularly in regards to family engagement and 
using stories for educational purposes.   
11. Ethical Considerations 
The sites that participate in this proposal meet the requirements for the conduct of research using 
funds from the US Government.  The protocol and consent forms will be reviewed and approved 
by the Vanderbilt University IRB (FWA00005756, IRB00000475-7, IRB00002125) and the 
Ministry of Health in Mozambique (FWA00003139 IRB# IRB00002657). The proposed project is 
Non-Exempt Human Subjects Research. 
Recruitment and Consent of Serodiscordant Couples: Discordant couples who are identified 
during an ANC visit at one of the study sites will be asked a whether they would be willing to 
participate in a research study. If the couple is interested, they will be provided a consultation with 
the study assistant, at which point they will be asked to give informed consent through our consent 
form. This consent will include their willingness for us to access medical records and participate 
in survey sessions.  
 
Recruitment and Consent of family members: Family members who agree to participate in the 
storytelling narrative sessions will be asked if they would be willing to participate in a research 
study. That study team member will describe the nature of the storytelling sessions and the 
possibility of their participation in a follow-up qualitative interview and ask if the person is 
interested in participating. If they are selected to participate in the interview, the study team 
member will organize a specific time/day for the interview. When the interviewer arrives, they will 
work with the provider to find a private room/space either at the home or within the community 
(whatever the preference of the participant).  
 
Participant confidentiality 
All participants who are consented in the study will be assigned a study ID number. Only study 
members will have the codebook that links the identifiers. Identifying information associated with 
these ID codes, such as names, will be kept in a data file separate from the survey data and clinic 
records. All data will be managed in a way that meets Vanderbilt IRB and Mozambique Bioethics 
standards for the protection of human subjects and to ensure confidentiality and the protection of 
sensitive health information. 
 
A participant’s study information will not be released without the written permission of the 
participant. All study-related information will be stored securely at the study site. All participant 
information will be stored in locked file cabinets in locked rooms, i.e., access is limited to study 
staff. All study data collection, process, and administrative forms and other reports will be 
identified by a coded number to maintain participant confidentiality. All records that contain names 
or other personal identifiers, such as locator or informed consent forms, will be stored separately 
from study records identified by a code number. All databases will be secured with password-
protected access systems. Forms, lists, logbooks, appointment books, and any other listings that 


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link participant ID numbers to other identifying information will be stored in a separate, locked file 
in an area with limited access.   
 
Consent Procedures  
 
The consent procedures are detailed above and the consent forms can be found in the Appendix 
(Appendices 5, 6, and 7). The signed consent forms will be kept in a lock box at the FGH office 
in Quelimane, separate from the transcripts of the interviews. The consent forms will be kept for 
seven years, at which point they will be burned to ensure that no one will be able to link any 
consents to participants.   
 
Evaluation of benefits and risks 
 
Adverse events  
 
Risks to the subjects (both intervention and control group and family members): The level of risk 
associated with this research is expected to be minimal for all participants. Potential psychological 
discomfort may occur when administering the survey for participating couples, as many of the 
questions are personal and have to do with a stigmatized infectious disease. All participants are 
able to decline to answer any question that they deem uncomfortable.  
 
Adverse Experience: We do not anticipate any adverse events as a result of this study, however 
study participants will be provided with a telephone number and instructed to contact study 
clinicians to report any serious AEs they experience.    
 
Protection against risks: The study protocol and training manuals will include strict guidelines for 
conducting the survey and recording the data in a confidential manner. All study staff will receive 
formal responsible conduct of research training per NIH, VUMC, and Mozambican Ministry of 
Health guidelines. Participants may withdraw from the study for any reason at any time. 
 
Benefits 
For serodiscordant infected couples there is a possibility that storytelling engagement with family 
members will result in them gaining additional psychosocial support and education for their 
treatment.  For these patients, they could experience improved health outcomes. The results of 
this evaluation may help us to offer better services for discordant couples who access services at 
the study clinics and throughout Mozambique. There could be a benefit to Mozambican society 
through improved health programs for people living with HIV. 
12. Limitations  
 
Our sample size of 35 couples in each arm is small, which limits our ability to detect a small 
change in behavior among couples. However, we believe this pilot will allow us to detect signals 
of an interventions success, which we can subsequently use to fund a larger trial.  


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13. Dissemination Plan  
Results from this study will be collected into a report and will be shared with MISAU and the DPS.  
The results will also be disseminated to government officials and physicians working in these 
communities.  If results are deemed by the authors to be potentially of interest to a wider scientific 
audience, we would plan on sharing these data in manuscript form, after obtaining appropriate 
clearances. 
14. Budget 
 
Description 
TOTAL 
USD         MZM 
Study Details 
 
USD 
MZ 
Price per 
unit/ 
person 
(USD) 
Number 
of 
people/ 
units  
Human Resources 
11,150 
669,000 
 
 
Project Officer   
3,000 
180,000 
3,000 
1 (20% 
effort) 
Study Counselor  
3,000 
180,000 
3,000 
1 
Interviewers for in-depth qualitative 
interviews 
3,150 
189,000 
35 
2(p)*45(d) 
Storytelling implementer  
2,000 
120,000 
2,000 
1 
TRAVEL & TRANSPORT 
1,130 
 67,800 
  
  
maintenance for car/gas  
900 
 54,000 
45 
20 
bicycle repair kit 
90 
 5,400 
45 
2 
bicycle for storyteller 
140 
 8,400 
140 
2 
TRAINING/PROJECT ACTIVITIES 
9,045 
 542,700 
  
  
Training for protocol implementation 
 
 
 
 
     Per diem (food) 
1,625 
97,500 
65 
5(p)*5(d) 
     Venue hire (day) 
500 
30,000 
100 
5(d) 
     Training materials 
1,000 
60,000 
1,000 
1 
Training for Storytellers supporters  
 
  
  
  
     per diem (food) 
1,300 
78,000 
65 
10 
     Venue hire (day) 
400 
24,000 
100 
4 
     Training Materials 
1,000 
60,000  
1,000 
1 
Supervision Activities 
 
 
 
 
     Per diem (food) 
1,820 
109,200 
65 
4(d)*7(m) 
     Hiring of transport to/from site 
1,400 
84,000 
100 
14(d) 
OTHER 
1,745 
104,700 
  
  


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21 
 
Photocopies of consent forms and 
questionnaire  
500 
30,000 
0.25 
2,000 
basic nokia phone & credit for study 
counselor 
195 
 11,700 
15 
13 
Urine assay tests 
1,050 
63,000 
5 
210 
Total of all costs 
23,070 
1,384,200 
  
  
Contingency 10% 
2,307 
138,420 
  
  
TOTAL  
25,377 
1,522,620 
  
  
15. Timeline 
 
 
 
Month 
Activities/Description 
Month 1 
Hire personnel & train them in PrEP specific protocols and delivery of Storytelling 
intervention 
Month 2-7 
Recruit of discordant couples in ANC 
Months 2-9 
Delivery of storytelling intervention to couples  
Months 2-9  
Collect quantitative survey data at baseline and 3 months 
Months 5-9 
Collect qualitative data from intervention couples  
Month 7 
Coding and data analysis of qualitative data  
Month 9-10 
Conduct quantitative data analysis of survey data and adherence measures 
Month 11-12 
Write up R01 grant to conduct a larger healer-initiated counseling and testing 
project. 
Months 11-12 
Disseminate findings via community meetings in Zambézia, to the Ministry of 
Health in Maputo, and PEPFAR partners.   


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16. Statement of Conflict of Interest 
 
As the Principal Investigator, I will be responsible for the relevance and quality of the project 
research, and for the confidentiality and anonymity of the participants. 
 
Statement of conflict of interests 
 
I, Carolyn M. Audet, as Principal Investigator of the Project entitled “Partners-based HIV 
Treatment for Sero-concordant Couples attending Antenatal Care: Increasing family-based 
support for PrEP adherence among discordant couples through storytelling”, declare that I am an 
employee of the Vanderbilt University Medical Center in Nashville, Tennessee, USA, working 
closely with Friends in Global Health (FGH) in Mozambique.   
 
I am engaged in the interview and survey design process, the evaluation design approach, as 
well as in the production of the pilot intervention and evaluation protocol. I will also contribute in 
the analysis and presentation of the results of the above-mentioned evaluation, in collaboration 
with: 
 
• 
VUMC’s Institute of Global Health: non-profit entity committed to building capacity in low-
resource settings through interdisciplinary global health educational and training 
programs, technical assistance to government and civil sector organizations, and 
implementation science and research in order to improve health and equity.  
• 
FGH: wholly-owned subsidiary of VUMC, which supports HIV/ AIDS care and treatment 
programs (HIV adult and pediatric care and treatment, Prevention of Mother to Child 
Transmission (PMTCT), Counseling and Testing (CT) services, Tuberculosis (TB) 
program services and exposed child services (CCR) in 9 rural districts and the urban 
capital district within Zambézia Province. 
• 
Provincial Health Directorate of Zambézia Province. 
 
Finally, I would like to mention that the present pilot intervention and evaluation does not involve 
any personal financial benefits, nor is it a for-profit evaluation. 
 
I declare that there are no conflicts of interest in the aforementioned Project: 
 
 
_______________________ 
Carolyn M. Audet 
 
 
 


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Qualitative Tool to Promote Health Among Vulnerable Populations. Journal of Transcultural 
Nursing 2014, 26:346-353. 
73. 
parasocial interaction. 
74. 
Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, 
Defechereux P, Buchbinder SP, et al: Low tenofovir level in urine by a novel immunoassay is 
associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS 
2019, 33:867-872. 
75. 
Koenig HC, Mounzer K, Daughtridge GW, Sloan CE, Lalley-Chareczko L, Moorthy GS, Conyngham 
SC, Zuppa AF, Montaner LJ, Tebas P: Urine assay for tenofovir to monitor adherence in real 
time to tenofovir disoproxil fumarate/emtricitabine as pre-exposure prophylaxis. HIV Med 
2017, 18:412-418. 
76. 
Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van 
der Straten A, Noguchi L, et al: Tenofovir-Based Preexposure Prophylaxis for HIV Infection 
among African Women. New England Journal of Medicine 2015, 372:509-518. 
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Guest G, Bunce A, Johnson L: How many interviews are enough? An experiment with data 
saturation and variability. Field Methods 2006, 18:59-82. 
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Toolkit, expanding and simplifying treatment foe pregnant women living with HIV: Managing 
the transition to Option B/B+ [http://www.who.int/hiv/pub/mtct/iatt_optionBplus_toolkit/en/] 


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79. 
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH: The PHQ-8 as a measure of 
current depression in the general population. J Affect Disord 2009, 114:163-173. 
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Schmidt CD, Gelhert NC: Couples Therapy and Empathy. The Family Journal 2016, 25:23-30. 
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Hendrick SS: A Generic Measure of Relationship Satisfaction. Journal of Marriage and Family 
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Erlen JA, Cha E, Kim KH, Caruthers D, Sereika SM: The HIV Medication Taking Self-Efficacy Scale: 
Psychometric Evaluation. Journal of advanced nursing 2010, 66:2560-2572. 
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Braun V, Clarke V: Using thematic analysis in psychology. Qualitative Research in Psychology 
2006, 3:77-101. 
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Kroenke K, Spitzer RL, Williams JB: The PHQ-9: validity of a brief depression severity measure. J 
Gen Intern Med 2001, 16:606-613. 
86. 
Pope C, Ziebland S, Mays N: Qualitative research in health care. Analysing qualitative data. 
BMJ 2000, 320:114-116. 
 
 
 
 


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18. Appendices 
 
Appendix 1: List of Indicators/Data to Be Collected 
 
Demographics data (to be obtained from study registry documents and OpenMRS database) 
  
1. Number of couples attending ANC 
2. Number of couples eligible for study (female HIV-negative/ male HIV-positive) 
3. Reasons for couples refusing entry into the study 
 
 
4. District;  
5. Health facility;  
6. Urban (yes/no);  
7. Main (sede) health facility (yes/no);  
8. NID;  
9. Sex;  
10. Date of birth; 
11. Age (years), at current enrollment; 
12. Employment status at the time of enrollment; 
13. Marital status of the patient at time of enrollment; 
14. Sexual preference/orientation at time of enrollment; 
15. Village, town, or city of residence at PrEP/ART initiation;  
16. Previous ART enrollment (yes/no) (Male partner);  
17. Previous ARV regimen before patient was LTFU (if applicable);  
18. ART regimen at re-initiation/initiation (current medication regimen);  
19. Enrollment date (current);  
20. PrEP/ART initiation date (current);  
21. WHO clinical stage at ART initiation, and date of documentation (male partner); 
22. CD4+ cell count (cells/mm3) ‘at enrollment’, taken between enrollment and 1 month after 
enrollment, and date of sample collection (male partner); 
23. All CD4+ cell counts (cells/mm3) and dates of sample collections (male partner);  
24. Viral load, first result obtained at or after enrollment, and results of any other VL tests, 
and date of sample collection (male partner);  


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25. All previous TB investigation results (positive/negative), and date of investigation (male 
partner);  
26. Previous date of enrollment in TB services (if applicable) (male partner);  
27. Previous TB treatment completed (yes/no) (if applicable) (male partner);  
28. Previous date TB treatment completed (if applicable) (male partner);  
29. Current enrollment in TB services, at (ART) enrollment, and date of documentation 
(male partner);  
30. Weight (kg), at enrollment, and at all other clinic visits, and date of documentation;  
31. Height (m2), at enrollment, and date of documentation;  
32. Body mass index (kg/m2) at enrollment, and at all other clinic visits, and date of 
documentation;  
33. Hemoglobin, at enrollment, and at all other clinic visits, and date of documentation; 
34. Blood pressure, at enrollment, and at all other clinic visits, and date of documentation;  
35. Alanine Transferase (ALT) at enrollment, at PrEP/ART initiation, and date of 
documentation; 
36. Creatinine at enrollment, at ART initiation, and date of documentation; 
37. Patient status (active, default, LTFU, transfer, or death) every month after enrollment; 
38. Dates of all PrEP/ART pick-ups 
39. Dates of all next scheduled PrEP/ART pick-ups;  
40. Dates of all clinic visits 
41. Dates of all next scheduled clinic visits; 
42. Date cotrimoxazole (CTX) prescribed; 
43. Patient reported use of intravenous (IV) drugs; 
44. Patient reported use of tobacco; 
45. Patient reported use of alcohol; 
46. Estimated due date of pregnant female patient; 
47. Initiation of any family planning method (Depo, pill, intrauterine device (IUD), implant, 
condoms, lactational amenorrhea [LAM], tubal ligation, vasectomy [male partner]), and 
date of initiation; 
48. Continuation of any family planning method (Depo, pill, IUD, implant, condoms, LAM, 
tubal ligation), and date of continuation;  
49. Final patient outcome status and date of final status: 
a. Transfer out of care at that facility, and date of transfer out; 
b. Death, date of death recorded, cause of death where available; 
c. LTFU, date of most recent visit (LTFU defined as not returning for >60 days past 
last scheduled appointment / pick-up date); 


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50. Number of babies with this pregnancy; 
51. Concentration of PrEP in patient urine; 
52. Monthly patient self-report of adherence using this scale:  
 
 
 
 
 
 
 
 
 
 
(for each baby, if multiple live births this pregnancy) 
53. Date of birth of infant(s); 
54. Infant status at birth (alive, dead); 
55. Sex of infant(s); 
56. Weight of infant(s) at birth, and at all other clinic visits, and date of documentation; 
57. Whether infant(s) received ART prophylaxis after birth, date of start, and type of ARV; 
58. Data on infant feeding practices where available; 
59. Date of any PCR testing for infant(s), and test results; 
60. Date of any HIV rapid testing for infant(s), and test results; 
61. Data on discharge from CCR services (transfers, referrals, abandoned, died), and date; 
62. Health status of child(ren) at 18 months (alive, dead); 
63. HIV health status of child(ren) at 18 months (HIV-positive, HIV-negative) 
 
ANC-specific indicators (aggregated data, from OpenMRS and DHIS databases) 
64. Number of pregnant women who arrived for first ANC appointment; 
65. Number of pregnant women who know their serostatus, known positive; 
66. Number of pregnant women who know their serostatus, recently tested; 
67. Number of pregnant women who received HIV test results in ANC, first test (positive, 
negative, and indeterminate results); 
68. Number of pregnant women who received HIV test results in ANC, repeat test, positive, 
negative, and indeterminate results);  
69. Number of HIV-positive pregnant women enrolled in ANC; 


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70. Number of HIV-positive pregnant women who received ARVs to reduce risk of MTCT 
(NVP, AZT+NVP, initiated ART, and already on ART); 
71. Number of pregnant women receiving CTZ upon entrance to ANC; 
72. Number of HIV-positive pregnant women that initiate prophylaxis with CTZ; 
73. Number of HIV-positive pregnant women who are clinically malnourished (DAM, DAG); 
74. Number of HIV-positive pregnant women who receive nutritional support (supplemental 
and therapeutic); 
75. Number of HIV-negative pregnant women who receive nutritional support (supplemental 
and therapeutic); 
76. Number of pregnant women in ANC with HIV-negative results; 
77. Number of partners of pregnant women present in ANC; 
78. Number of partners of pregnant women who tested for HIV in ANC; 
79. Number of partners of pregnant women who tested for HIV in ANC and received results, 
by test result (positive, negative, or indeterminate); 
80. Number of HIV-positive partners of pregnant women who initiated ART in ANC.  


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Appendix 2: Storytelling Intervention  
The three motivational stories include the following themes: 
(1)  A couple who has to overcome the difficulties associated with having a different HIV status 
compared to their partner. Specifically, how they address accusations of infidelity, how they 
manage to take different medications, interpret different messages (lifelong ART vs. short term 
PrEP), and a woman’s concerns with seroconversion. How their family provides emotional and 
physical support via assistance in food preparation, completing chores around the house, and 
counseling both partners not to give up on the medication.  
(2)  A woman who overcomes the difficulties of an unsupportive husband and extended family. 
The story of a woman who wants to take PrEP but must take medication and attend clinical 
visits without detection. The challenges she encounters while hiding her treatment, the moment 
of discovery, and how she successfully changes the beliefs and attitudes of her husband and 
extended family.  
(3)  An encouraging couple who overcomes the difficulties of an unsupportive extended family. 
The story of a couple who support each other in medication adherence but face the scorn and 
derision of their extended family. The extended family blames the man for exposing the pregnant 
woman and her unborn child to HIV. The strategies this couple uses to change the attitudes and 
options of their family, to remain adherent to medication, and to have an HIV-uninfected baby.  
 
Appendix 3: Measures used in study 
 
1. Social Support (Berlin Social Support Scales) 
Perceived Emotional Support 
1. There are some people who truly like me. 
2. Whenever I am not feeling well, other people show me that they are fond of me. 
3. Whenever I am sad, there are people who cheer me up. 
4. There is always someone there for me when I need comforting. 
Perceived Instrumental Support 
1. I know some people upon whom I can always rely. 
2. When I am worried, there is someone who helps me. 
3. There are people who offer me help when I need it. 
4. When everything becomes too much for me to handle, others are there to help me. 
Need for Support 
1. When I am down, I need someone who boosts my spirits. 


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2. It is important for me always to have someone who listens to me. 
3. Before making any important decisions, I absolutely need a second opinion. 
4. I get along best without any outside help. (-) 
 
Support Seeking 
1. In critical situations, I prefer to ask others for their advice. 
2. Whenever I am down, I look for someone to cheer me up again. 
3. When I am worried, I reach out to someone to talk to. 
4. If I do not know how to handle a situation, I ask others what they would do. 
5. Whenever I need help, I ask for it. 
 
2. Relationship Empathy (Davis; Interpersonal Reactivity Index [IRI]) 
1. I daydream and fantasize, with some regularity, about things that might happen to me.   
2. I often have tender, concerned feelings for people less fortunate than me.  
3. I sometimes find it difficult to see things from the "other guy's" point of view.  
4. Sometimes I don't feel very sorry for other people when they are having problems.  
5. I really get involved with the feelings of the characters in a novel.  
6. In emergency situations, I feel apprehensive and ill-at-ease.  
7. I am usually objective when I watch a movie or play, and I don't often get completely caught 
up in it.  
8. I try to look at everybody's side of a disagreement before I make a decision.  
9. When I see someone being taken advantage of, I feel kind of protective towards them. 
10. I sometimes feel helpless when I am in the middle of a very emotional situation.  
11. I sometimes try to understand my friends better by imagining how things look from their 
perspective.  
12. Becoming extremely involved in a good book or movie is somewhat rare for me.  
13. When I see someone get hurt, I tend to remain calm.  
14. Other people's misfortunes do not usually disturb me a great deal.  
15. If I'm sure I'm right about something, I don't waste much time listening to other people's 
arguments.  


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16. After seeing a play or movie, I have felt as though I were one of the characters.  
17. Being in a tense emotional situation scares me.  
18. When I see someone being treated unfairly, I sometimes don't feel very much pity for them.  
19. I am usually pretty effective in dealing with emergencies.  
20. I am often quite touched by things that I see happen.  
21. I believe that there are two sides to every question and try to look at them both.  
22. I would describe myself as a pretty soft-hearted person.  
23. When I watch a good movie, I can very easily put myself in the place of a leading character.  
24. I tend to lose control during emergencies.  
25. When I'm upset at someone, I usually try to "put myself in his shoes" for a while.  
26. When I am reading an interesting story or novel, I imagine how I would feel if the events in 
the story were happening to me.  
27. When I see someone who badly needs help in an emergency, I go to pieces.  
28. Before criticizing somebody, I try to imagine how I would feel if I were in their place.   
 
3. Patient Health Questionnaire - 9 (PHQ-9 Depression Screening tool) 
Over the last 2 weeks, how often have you been bothered by any of the following problems? 
1. Little interest or pleasure in doing things.  
2. Feeling down, depressed, or hopeless.  
3. Trouble falling or staying asleep or sleeping too much.  
4. Feeling tired or having little energy.  
5. Poor appetite or overeating.  
6. Feeling bad about yourself - or that you are a failure or have let yourself or your family down.  
7. Trouble concentrating on things, such as reading the newspaper or watching television.  
8. Moving or speaking so slowly that other people could have noticed? Or the opposite – being 
so fidgety or restless that you have been moving around a lot more than usual.  
9. Thoughts that you would be better off dead or of hurting yourself in some way.  
 
4. Relationship Satisfaction: 


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1. How well does your partner meet your needs?  
2. In general, how satisfied are you with your relationship?  
3. How good is your relationship compared to most?  
4. How often do you wish you hadn’t gotten into this relationship?  
5. To what extent has your relationship met your original expectations?  
6. How much do you love your partner?  
7. How many problems are there in your relationship?  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. Self-Efficacy Beliefs  
“I believe that I can …. 
1. Keep a clinic appointment 
  
2. Follow overall treatment regimen 
  
3. Follow a plan for taking PrEP medication 
  
4. Take my PrEP Medication with correct intervals 
  
5. Take correct dose of my medications 
  
6. take my medications while I am at the farm 
  
7. Take my medications on a weekday 
  
8. Take my medications on a weekend 
  
9. Take my medications if I am travelling  
  
10. Take my medications even if I feel well 
  
11. Take my medications even if I feel ill 
  
12. Take my medications even if I am having medication side 
effects 
  
13. Take my medications even if I am having a personal crisis 
  
 
6. Outcome Expectancy 
If I take my PrEP medication regularly I will….  
  
1. be healthy 
  
2. have a good quality of life 
  
3. have a long life 
  
4. lead a normal life 
  
5. avoid getting HIV 
  
 
  
 
 
 
 
 
 


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Appendix 4: Semi-structured interview guide for intervention couples and their 
families  
 
Note: For use in completing in-depth interviews with couples and with their families.  
Intervention Couple questions 
1. Tell me what were the common messages your heard in the PrEP stories? Did they sound 
like issues that might be common here in Zambézia?  
2. Did you think the stories addressed the major concerns people have with PrEP during 
pregnancy here in Mozambique? What did they miss?  
3. What were your favorite parts of the stories? What parts did you like the least?  
4. How have the stories impacted your motivation to take your medication? (what is the most 
important reason you take your medications? If you don’t take them, why are you not 
motivated?)  
5. How did the story impact your belief in your ability to take the medication every day? (what 
strategies did you learn that help you remember to take your medications?) 
6. If you take your medications regularly, do you believe you can remain HIV-uninfected?  
7. Did the stories change your partners view about taking medications? 
8. Did the stories change your family’s attitudes towards discordant couples staying 
together? Did the stories change your family’s view of PrEP/ART use?  
 
Intervention Family questions 
1. Tell me what were the messages your heard in the PrEP stories? Did they sound like 
issues that might be common here in Zambézia?  
2. Did you think the stories addressed the major concerns people have with PrEP during 
pregnancy here in Mozambique? What did they miss?  
3. What were your favorite parts of the stories? What parts did you like the least?  
4. Do you think that an HIV-negative pregnant woman should stay with an HIV-positive 
man? Should she continue to have sex with him?  
5. Did the stories change your view of PrEP?  
6. Did the stories change your view of discordant couples?  
7. How did hearing the stories help you provide support to your family? (things to say, ways 
to help?) 
8. Do you believe that PrEP can prevent a pregnant woman from contracting HIV? What 
are some reasons it might not work?  
9. If you were making up your own stories to help discordant couples and their families, 
what are other topics you would add? What else would be helpful to know?  
 
 
 


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Appendix 5: Informed Consent Form for participant (intervention arm) 
 
KEY ELEMENTS OF THE STUDY 
1. This consent form contains information about a new study to provide a storytelling intervention 
to serodiscordant expectant couples. 
2. Couples who are in the intervention group of this study will have the opportunity to listen to 
three stories that will educate and help support them to stay adherent to their medication, and will 
complete two interview surveys.  
3. Couples in the control group will complete two interview surveys, but otherwise will enroll in 
PrEP and HIV care and treatment as they would normally. 
4. You have been selected to receive three storytelling sessions, along with any family members 
you want to include. 
5. If you agree to participate in the study, a study staff person will conduct a survey now and again 
at six months after you start medication. 
6. You can stop participating in the study at any time without penalty. 
 
 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the participants in the intervention arm. 
Age of participant: ____________ 
Introduction 
This consent form contains information about a new study to provide couples-based PrEP 
medication that will help prevent someone being infected with HIV and HIV care and treatment 
for discordant pregnant couples.  
You have been selected because you attended antenatal care visit and tested HIV-negative 
while your partner is HIV-positive (serodiscordant couples) and you are 18 years or older. 
This form describes your rights as a participant. It is meant to answer your questions. We will read 
this form to you. Please feel free to ask any questions you may have about this.  
If you and your partner agree to participate in this program I will ask you to sign the form or make 
your thumbprint mark. Even if you agree to participate, you can stop participating at any time. I 
will give you a copy of this form. This form might contain some words that are unfamiliar to you. 
Please ask me to explain anything you do not understand. 
Purpose of this study  


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This study is being done by staff from Vanderbilt University Medical Center (VUMC) and Friends 
in Global Health (FGH). We want to try a new way to offer PrEP and HIV care and treatment to 
couples where one person is HIV-positive and the other HIV-negative who are expecting a child. 
Right now, couples can receive PrEP and HIV care together in HIV treatment services, but their 
counseling and education is limited to short education sessions and does not engage their 
families.  
Couples who are in the intervention group of this study will  have the opportunity to listen to three 
stories that will educate and help support them to stay adherent to their medication. Couples in 
the control group will complete two surveys, but otherwise will enroll in PrEP and HIV care and 
treatment as they would normally. We want to see if couples who get the additional storytelling 
sessions are better at staying on treatment compared to couples in regular care.   
 
Procedures to be followed and approximate duration of the study 
You have been selected to receive the storytelling sessions.  
This study will begin today and last for the next 6 months. If you and your partner agree to be part 
of this study, we will enroll you both into PrEP / HIV care and treatment. All future clinical visits,  
drugs, and tests to assess medication levels in your body will be given to you at the ANC or CCR 
clinics.  
Our study assistant will arrange a meeting with you and the storytellers in the next two weeks. 
Your storyteller will arrange three times to come to the family home (or a location of your choice) 
to tell each story to you and to any family members that you would be willing to disclose your 
treatment to. We will access your and your baby’s medical records to see what medications you 
are taking, medical data about your health (drug levels, CD4 cell count and viral load), and the 
dates you pick up your medications.  
A study staff person will also conduct two surveys at the beginning of your treatment and at six 
months after you start treatment. You do not need to answer all the questions in the surveys if 
you do not want to. If a question makes you feel uncomfortable or you do not know the answer, it 
is ok to tell the interviewer that you do not want to answer the question. You can also stop the 
surveys at any time without any penalty. 
Some couples enrolled in the study will be asked to participate in an interview to describe their 
experience with the program and costs related to your and your family’s health care. This interview 
will occur at least 6 months after enrollment. You do not need to answer the questions if you do 
not want to. If a question makes you feel uncomfortable or you do not know the answer, it is ok to 
tell the interviewer that you do not want to answer the question. You can also stop the interview 
at any time without penalty. 
Expected Costs: 
None. 
Possible Risks  


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The idea of providing stories to education and motivate discordant couples (and their families) 
expecting a baby is new and untested.  While we will provide support, there is a chance that you 
and your partner will not agree on ways to take medication or talk together. This could make more 
problems in your relationship.  If you feel any discomfort or have relationship problems, please 
contact us as soon as possible so we can work to resolve it together.  
We know that talking about your personal experiences with HIV with your partner or health care 
workers can be uncomfortable. We will try to have a comfortable, honest, and relaxed discussion. 
Still we know that some of the questions we ask might make you feel uncomfortable. We will try 
to limit embarrassment as much as possible. No study staff will tell anyone else your responses 
to the survey questions.   
Possible Benefits  
The information you share may help us to offer better services for serodiscordant couples who 
come for ANC services. This could benefit Mozambican society by improving health programs 
for people living with HIV. If the project is successful, you may have better communication and 
trust with your partner after our counseling sessions.  
What happens if you choose to withdraw from study participation? 
Nothing. You are free to stop participating at any point without problem.  You only need to say 
that you would like to stop being in the study.  You can tell this to us at any time.   
Confidentiality 
We will make every effort to keep your personal information confidential. However, it is not 
possible to guarantee total confidentiality. The clinical information obtained during this study will 
be kept with your medical record and stored securely at the health facility in locked areas and on 
a protected database. Only trained medical and study staff will have to access this clinical 
information.  
The information related to the study activities will be kept at the health facility and at FGH offices 
in locked secure areas. Only trained study staff will have access to this study information.  
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required to 
do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB, U.S. Federal Government 
Office for Human Research Protections, or the Mozambican Ministry of Health.   
Contact Information for Questions 
If you should have any questions about study or wish to have additional counseling related to your 
care, please feel free to contact the HoPS+ study manager, Almiro Emilio, at the FGH office in 
Quelimane at +258 24217593.   
For more information about giving consent or your rights, please feel free to contact the National 
Committee for Bioethics of Health in Mozambique at +258 824066350. You may also contact the 


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VUMC Institutional Review Board (IRB) office in the U.S. at +001-615-322-2918 or toll free at 
+001-866-224-8273. 
Do you have any questions? 
This form has been read and explained to me.  I have been given an opportunity to ask questions 
I have about the study. I understand that I may decide at any time that I do not want to continue 
participating in the study. I understand that I will receive a copy of this consent form. By saying 
yes, you agree to participate in the study for 6 months. You are agreeing to participate in our 
interviewer-administered surveys and that we can look at your medical records, and that of your 
unborn child. By saying no, you decline to participate in all parts of the study.  
Moderator: Answer the participant’s questions before proceeding to the next question. 
 
I give my consent to participate in the study.                 Female partner                Male Partner 
 
 
_________________________________              _______________ 
Printed Name of Participant  
 
         Date  
 
 
 
_________________________________              _______________ 
Signature of Participant 
 
 
         Date 
 
 
_________________________________              _______________ 
Signature of Witness (if thumbprint used) 
         Date 
 
 
 
_________________________________            
   _______________ 
Signature of Person Who Explained This Form      
 Date 
 
 
Thumbprint of Participant 


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I have explained to the participant the study purpose and procedures and we have discussed all 
the risks that are involved.  I have answered questions to the best of my ability. 
 
 


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Appendix 6: Informed Consent Form for participant (control arm) 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the participants in the control arm. 
 
KEY ELEMENTS 
1. This consent form contains information about a new study to provide a storytelling intervention 
to serodiscordant expectant couples. 
2. Couples who are in the intervention group of this study will have the opportunity to listen to 
three stories that will educate and help support them to stay adherent to their medication, and will 
complete two interview surveys.  
3. Couples in the control group will complete two interview surveys, but otherwise will enroll in 
PrEP and HIV care and treatment as they would normally. 
4. You have been selected for the control group. This means you will get all the clinical care that 
you usually would get at this health facility. 
5. If you agree to participate in the study, a study staff person will conduct a survey now and again 
at six months after you start medication. 
6. You can stop participating in the study at any time without penalty. 
 
Age of participant: ____________ 
Introduction 
This consent form contains information about a new study to provide a storytelling intervention to 
serodiscordant pregnant couples. This form describes your rights as a participant. It is meant to 
answer your questions. We will read this form to you. Please feel free to ask any questions you 
may have about this.  
You have been selected because you attended antenatal care visit and tested HIV-negative 
while your partner is HIV-positive (serodiscordant couples) and you are 18 years or older. 
If you and your partner agree to participate in this program, I will ask you to sign the form or make 
your thumbprint mark. Even if you agree to participate, you can stop participating at any time. I 
will give you a copy of this form. This form might contain some words that are unfamiliar to you. 
Please ask me to explain anything you do not understand. 
Purpose of this study  
This study is being done by staff from Vanderbilt University Medical Center (VUMC) and Friends 
in Global Health (FGH). We want to try a new way to offer PrEP and HIV care and treatment to 


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44 
 
couples where one person is HIV-positive and the other HIV-negative who are expecting a child. 
Right now, couples can receive PrEP and HIV care together in HIV treatment services, but their 
counseling and education is limited to short education sessions and does not engage their 
families.  
Couples who are in the intervention group of this study will  have the opportunity to listen to three 
stories that will educate and help support them to stay adherent to their medication. Couples in 
the control group will complete two surveys, but otherwise will enroll in PrEP and HIV care and 
treatment as they would normally. We want to see if couples who get the additional storytelling 
sessions are better at staying on treatment compared to couples in regular care.   
Procedures to be followed and approximate duration of the study 
You have been selected for the control group. This means you will get all the clinical care that you 
usually would get at this health facility.  
This study will begin today and last for the next year. If you and your partner agree to be part of 
this study, you will enroll into PrEP and HIV care and treatment today. All future clinical visits, 
drug pick-ups, and tests to assess medication levels in your body will be given to you at the ANC 
or CCR clinics. After you are enrolled on medication, you and your partner will be brought to meet 
with the study assistant who will ask you and your partner to complete a survey.  
A study staff person will also conduct the same survey at six months after you start treatment. If 
you give us permission, we can complete this survey at the health facility or at your home 
(depending on your preference). You do not need to answer all the questions in the surveys if you 
do not want to. If a question makes you feel uncomfortable or you do not know the answer, it is 
ok to tell the Interviewer that you do not want to answer the question. You can also stop the 
surveys at any time without any penalty. 
Expected Costs: 
None 
Possible Risks  
We know that talking about your personal experiences with HIV with your partner or health care 
workers can be uncomfortable. We will try to have a comfortable, honest, and relaxed discussion. 
Still we know that some of the questions we ask might make you feel uncomfortable. We will try 
to limit embarrassment as much as possible. No study staff will tell anyone else your responses 
to the survey questions.   
Possible Benefits  
The information you share may help us to offer better services for serodiscordant couples who 
come for ANC services. This could benefit Mozambican society by improving health programs 
for discordant people expecting a child. If the project is successful, you may have better 
communication and trust with your partner after our storytelling sessions.  
What happens if you choose to withdraw from study participation? 


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Nothing. You are free to stop participating at any point without problem.  You only need to say 
that you would like to stop being in the study.  You can tell this to us at any time.   
Confidentiality 
We will make every effort to keep your personal information confidential. However, it is not 
possible to guarantee total confidentiality. The clinical information obtained during this study will 
be kept with your medical record and stored securely at the health facility in locked areas and on 
a protected database. Only trained medical and study staff will have access to this clinical 
information. 
The information related to the study activities will be kept at the health facility and at FGH offices 
in locked secure areas. Only trained study staff will have access to this study information. 
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required to 
do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB, U.S. Federal Government 
Office for Human Research Protections, or the Mozambican Ministry of Health.   
Contact Information for Questions 
If you should have any questions about this study or wish to have additional counseling related to 
your care, please feel free to contact the HoPS+ study manager, Almiro Emilio, at the FGH office 
in Quelimane at +258 24217593 or toll free at +001-866-224-8273.   
For more information about giving consent or your rights, please feel free to contact the National 
Committee for Bioethics of Health in Mozambique at +258 824066350. You may also contact the 
VUMC Institutional Review Board (IRB) office in the U.S. at +001-615-322-2918. 
Do you have any questions? 
This form has been read and explained to you.  You have been given an opportunity to ask 
questions about the study. You know that you may decide at any time to not continue participating 
in the study. You understand that you will receive a copy of this consent form. By saying yes, you 
agree to participate in two surveys: one now and another in six months. You are agreeing that we 
can look at your medical records, and that of your unborn child. If you say no, you decline to 
participate in all parts of the study.  
Moderator: Answer the participant’s questions before proceeding to the next question. 
 
I give my consent to participate in the study.                Female partner                Male Partner 
 
_________________________________              _______________ 
Printed Name of Participant 
 
         Date  


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46 
 
 
 
_________________________________              _______________ 
Signature of Participant 
 
         Date 
 
 
_________________________________              _______________ 
Signature of Witness (if thumbprint used) 
         Date 
 
 
 
_________________________________              _______________ 
Signature of Person Who Explained This Form      Date 
 
 
I have explained to the participant the study purpose and procedures and we have discussed all 
the risks that are involved.  I have answered questions to the best of my ability. 
 
 
 
 
Thumbprint of Participant 


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47 
 
Appendix 7: Informed Consent Form for Family Member Interview 
 
This informed consent document applies to adults 18 years or older. This document is to 
be read aloud to the participants. 
 
KEY ELEMENTS 
1. This consent form contains information about a new study to provide a storytelling intervention 
to serodiscordant expectant couples. 
2. Couples who are in the intervention group of this study will have the opportunity to listen to 
three stories that will educate and help support them to stay adherent to their medication, and will 
complete two interview surveys.  
3. Family members of those in the intervention group are also invited to listen to the stories. 
4. You are invited to listen to three storytelling sessions to help you learn more about PrEP and 
about ways you can support your family. 
5. If you agree to participate in the study, a study staff person may request to conduct a single 
interview with you 4-6 months from now. 
6. You can stop participating in the study at any time without penalty. 
 
 
Age of participant: ____________ 
Introduction 
This consent form contains information for family members who participate in a storytelling 
intervention with discordant couples expecting a child.  
You have been selected because you were nominated by a family member to participate in 
the story-telling study.  
This form describes your rights as a participant. It is meant to answer your questions. We will 
read this form to you. Please feel free to ask any questions you may have about this.  
If you agree to participate in this project I will ask you to sign the form. Even if you agree to 
participate, you can stop participating at any time. I will give you a copy of this form if you 
would like one. This form might contain some words that are unfamiliar to you. Please ask 
me to explain anything you do not understand. 
Purpose of this study  


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This study is being done by staff from Vanderbilt University Medical Center (VUMC) and 
Friends in Global Health (FGH), in collaboration with the Provincial health authorities, as a 
part of the PrEP storytelling study. In the storytelling study we want to try a new way to 
educate and motivate discordant couples who are expecting a child to adhere to their 
medication. In conducting this project, we want to include you in this study and investigate 
your perspectives and experiences listening to the stories, supporting your discordant family 
member in taking their medications, and any suggestions you may have for program 
implementation and improvement.  
Procedures to be followed and approximate duration of the interview 
Participants who are nominated to listen to stories with their families will have the opportunity 
to listen to 3 stories about the importance of PrEP, some challenges to taking PrEP, and ways 
we can help friends and family members take their medication. The stories will be delivered 
at the home, or in the preferred location, of the couple who nominated you. You can come to 
listen to any of the stories that you wish.  
Some family members will be asked to complete an interview. If you are selected, the 
interview will last an estimated 30-45 minutes. If you agree to participate in this interview, a 
study staff person will conduct the interview with you now, or at a scheduled time in the near 
future of your choosing.  
You do not need to answer all the questions in the interview if you do not want to. If a question 
makes you feel uncomfortable or you do not know the answer, it is ok to tell the interviewer 
that you do not want to answer the question. You can also stop the interview at any time 
without any penalty. 
Your responses to this interview will be recorded in an audio recording. The recording will be 
kept on a secure audio file at the FGH office in Quelimane. The recording will be transcribed 
(copied) into a written document. We will use this transcribed data to do data analysis at the 
end of this study. Before we use this data all of your identifying information will be taken out. 
It will not be possible for anyone to know it is your responses or information. The transcriptions 
will be kept and securely stored on password-protected servers and computers of study 
personnel at the FGH office in Quelimane, and principal investigator at VUMC. After 6 years 
the transcript files will be destroyed (as suggested by VUMC IRB). 
Expected Costs: 
None. 
Possible Risks  
Listening to stories about discordant couples may be challenging, given that you are close 
with the couple who nominated you. It may make you feel sad when you think of the 
challenges they face. If you are selected to participate in the interview, we do not anticipate 
any possible risks with participating in this interview. We will try to have a comfortable, honest, 
and relaxed discussion. We will try to limit any discomfort as much as possible. If you feel any 


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discomfort, please contact us as soon as possible so we can work to resolve it together. No 
study staff will tell anyone else your responses to the interview questions.   
Possible Benefits  
You may learn a great deal about PrEP and how people can keep themselves from 
contracting HIV if you attend the storytelling sessions. If you are selected to participate in an 
interview, the information you share may help us to offer better services for serodiscordant 
couples who seek ANC services, and for families affected by HIV. This could benefit 
Mozambican society by improving health programs for people at risk of HIV acquisition.  
What happens if you choose to withdraw from interview participation? 
Nothing. You are free to stop participating at any point without problem. If you want to stop 
attending the stories, you can simple stop attending. If we are conducting the interview and 
you want to stop, you only need to say that you would like to stop being in the interview. You 
can tell this to us at any time.   
Confidentiality 
If you are selected to participate in the interview we will make every effort to keep your 
responses confidential. However, it’s not possible to guarantee total confidentiality. The 
information obtained during this interview will be kept with the trained study team, stored 
securely in the FGH office in Quelimane and with the principal investigator at VUMC. 
Privacy Information 
Your information may only be shared if you or someone else is in danger, or if we are required 
to do so by law. If this occurs, your information may be shared with VUMC, or the U.S. and/or 
Mozambican government. This includes, for example, the VUMC IRB, U.S. Federal 
Government Office for Human Research Protections, or the Mozambican Ministry of Health.   
Contact Information for Questions 
If you should have any questions about this study, please feel free to contact the HoPS+ 
study manager, Almiro Emilio, at the FGH office in Quelimane at +258 24217593.   
For more information about giving consent or your rights, please feel free to contact the 
National Committee for Bioethics of Health in Mozambique at +258 824066350. You may 
also contact the VUMC Institutional Review Board (IRB) office in the U.S. at +001-615-322-
2918 or toll free at +001-866-224-8273. 
 
Do you have any questions? 
This form has been read and explained to you. You have been given an opportunity to ask 
questions you have about the interview. You understand that you may decide at any time that 
you do not want to continue participating in the interview. You understand that you can receive 


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50 
 
a copy of this consent form. By saying yes, you agree to participate in this study. By saying 
no, you decline to participate in the study.  
Moderator: Answer the participant’s questions before proceeding to the next question. 
I give my consent to participate in the interview. 
 
Relationship with Couple ___________________________________________ 
 
 
__________________________________________              _______________ 
Printed Name of Participant 
 
          
 
Date 
 
 
 
 
 
__________________________________________          
Signature of Participant 
 
          
 
Date 
 
 
 
__________________________________________              _______________ 
Signature of Person Who Explained This Form      
 
Date 
 
I have explained to the participant the purpose of the study and procedures and we have 
discussed all the risks that are involved.  I have answered questions to the best of my 
ability. 
 
 
Thumbprint of Participant