Understanding the Role of Food Insecurity and Depression in Non-adherence to Option B+ Among Perinatal Kenyan Women Living With HIV: A Syndemics Approach
Phase: NA
Conditions: Mental Health Issue, Hiv, Breastfeeding, Exclusive
Sponsor: University of California, San Francisco

Healthy Mothers Project 
Protocol Version 2.0 
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Study Protocol  
 
Official study title: Understanding the Role of Food Insecurity and Depression in Non-adherence to Option B+ 
Among Perinatal Kenyan Women Living With HIV: A Syndemics Approach   
 
NCT#: NCT05219552 
 
Unique Protocol ID: K23MH116807 
 
Date: The study protocol is dated July 25, 2022 and was approved by Kenya Medical Research Institute Scientific 
Ethics Review Unit on September 14, 2022.  
 
Note: This study protocol describes 2 phases of the study.  The Intervention Pilot registered with ClinicTrials.gov, 
with the brief title “Healthy Mothers: an Intervention to Support Perinatal Women Living With HIV in Kenya”, is part 
of Phase 2—described beginning on line 327.  
 
 

Healthy Mothers Project 
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1. Title: Understanding the role of food insecurity and depression in non-adherence to Option B+ among perinatal 
1 
Kenyan women living with HIV: a Syndemics approach. 
2 
 
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2. Investigators and Institutional Affiliations  
4 
Name 
Organization 
Role on Project 
Emily L. Tuthill, RN, 
PhD 
Department of Community Health 
Systems, University of California, San 
Francisco, School of Nursing 
Principal Investigator  
(Trainee)  
Sheri D. Weiser, MD, MPH 
Division of HIV/AIDS, San Francisco General 
Hospital, University of California, San 
Francisco, Department of Medicine 
Co-Investigator 
( mentor)   
Elizabeth Bukusi, MD, MPH, 
PhD 
Center for Microbiology Research, 
Kenya Medical Research Institute 
KEMRI Principal 
Investigator 
( mentor)   
Craig R. Cohen, MD, MPH 
Department of Obstetrics, Gynecology, and 
Reproductive Sciences, Bixby Center for 
Global Reproductive Health, University of 
California, San Francisco 
Co- Investigator 
( mentor)   
Eliud Akama, BSN, MPH 
Kenya Medical Research Institute  
Site Co-Investigator 
Mallory Johnson, PhD 
Center for AIDS Prevention Studies, University 
of California San Francisco 
Mentor 
Monica Gandhi, PhD 
 Center for AIDS Prevention Studies, 
University of California San Francisco 
Mentor 
Tor Neilands, PhD 
Center for AIDS Prevention Studies, University 
of California San Francisco 
Statistician  
Sera Young, PhD 
Northwestern University, Evanston IL 
Mentor 
 
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Collaborating institutions moved as appendix 
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7 
List of Abbreviations 
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ART: Antiretroviral Therapy 
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HIV: Human Immunosuppression Virus 
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FI: Food Insecurity 
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PMTCT: prevention of mother to child transmission of HIV 
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EBF: exclusive breastfeeding 
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3. ABSTRACT 
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Strategies to prevent mother-to-child transmission (PMTCT) of HIV can reduce the risk of vertical transmission to less 
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than 2%, but difficulties in adhering to the three pillars of PMTCT (maternal ART; exclusive breastfeeding; provision 
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of ART prophylaxis to infant) has led to high rates of MTCT in sub-Saharan Africa and suboptimal maternal and infant 
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health. The goals of the proposed research are to: 1) gain an understanding of the influences and mechanisms by 
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which food insecurity (FI) and perinatal depression- two modifiable determinants of non-adherence to HIV 
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treatment and exclusive breastfeeding- interact to impact adherence through a qualitative approach, and 2) Develop 
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and pilot test a theory-based intervention that bolsters adherence to the PMTCT guidelines. 
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 Methods: To better understand the relationship of food insecurity and depression among pregnant and postpartum 
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women living with HIV we will use a longitudinal qualitative design. Thirty pregnant women will be recruited in their 
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third trimester to participate in an in-depth interview. Each participant will be followed up to 12 months postpartum 
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and asked to participate in three additional interviews in order to understand how depression changes over time 
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(each participant will participate in a total of 4 interviews over this timeframe). Drawing upon findings from the in-
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depth interviews, in conjunction with key informant interviews (n= 5-up to 12) and focus group discussions with our 
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target population (1-2 discussions with n=8-12 participants), we will apply the theoretical model of transitions 
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theory to develop a multi-level intervention that improves adherence to PMTCT guidelines. We will test intervention 
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acceptability and feasibility among 40 pregnant women (20 intervention and 20 current standard of care) and 
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conduct follow-up to evaluate results at 6-months postpartum. Candidate and Mentoring: This project is being 
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supported by an NIH K23 Career Development Award. I am a nurse-scientist with a background in health behavior 
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change theory and infant feeding in the context of HIV. My mentor team is composed of exceptional research 
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scientists from multiple disciplines with extensive experience in HIV treatment and prevention research in Kenya. 
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4. INTRODUCTION/BACKGROUND 
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In 2016, 160,000 children acquired HIV from mother to child transmission of HIV; 90% of these occurred in sub-
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Saharan Africa (SSA), including Kenya 1. PMTCT is now entirely possible through the efficacious strategies in Option 
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B+ which include: 2-6 1) women with HIV be placed on lifelong antiretroviral therapy (ART), 2) women are advised to 
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exclusively breastfeed (EBF) their infant for the first 6 months of life, and 3) provision of prophylactic HIV treatment 
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to the HIV-exposed infant throughout the breastfeeding period. However, suboptimal engagement in care and 
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inadequate ART adherence during pregnancy and, especially postpartum remain major concerns and compromise 
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the ability for women to remain adherent to lifelong ART5,7-9. On average, 50%, with some studies finding as high as 
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81% of HIV+ mothers 10,11 are disengaged in care by 6 months postpartum, suggesting non-adherence to Option 
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B+12,13. As such, although adhering to PMTCT Option B+ reduces the risk of MTCT of HIV from 45% to less than 2%14, 
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HIV incidence among children born to mothers living with HIV remains unacceptably high11.  For instance, in Kenya, 
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MTCT rates are approximately 14%15. Furthermore, non-adherence to Option B+ increases morbidity and mortality 
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for mothers16 and their infants17 and prevents both mothers and infants from the health and nutritional benefits of 
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EBF18-20. In effect, we have solved PMTCT efficacy.  We have not solved Option B+ implementation effectiveness 
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and furthering maternal and child health for HIV+ mothers. In order to fully realize the benefits of Option B+ and fill 
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a crucial knowledge gap, it is necessary to identify and address drivers of Option B+ non-adherence21. 
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Two potential drivers of non-adherence to Option B+, that are also substantial health issues in SSA, 
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including in Kenya, are food insecurity (FI) and perinatal (pregnancy and postpartum) depression. In SSA, over half 
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of people living with HIV are moderately or severely food insecure 22and rates of depression among all pregnant and 
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postpartum women range from 10-47% 23. FI is inextricably linked with poor health outcomes among people living 
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with HIV, including increased disease progression, lower ART adherence 24,25, and higher mortality 26. Perinatal 
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women are uniquely vulnerable to FI due to nutrient demands being higher, the effort required to prepare food, and 
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financial constraints related to being obliged to leave the workforce27. FI during pregnancy is associated with poor 
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pregnancy outcomes, including low birth weight and gestational diabetes 28,29, and increased risk of MTCT25. 
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Postpartum FI can impact breastfeeding outcomes30, child cognitive development 31 and increase the risk of MTCT of 
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HIV 32.  
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In separate studies among women living with HIV, depression has been associated with poor adherence to 
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ART 17,33-37 and EBF practice 38-40, as well as the risk of MTCT of HIV41,42. FI is an important driver of depression27,43. A 
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cross-sectional study found that FI was associated with maternal depression among all women across four ethnic 
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groups in Tanzania 44. The authors proposed several explanations; FI can lead to poor diet exacerbating anxiety and 
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depression; FI can lead to feelings of disempowerment increasing depression; and both FI and depression share 
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roots in larger inequalities preventing women from economic opportunities 44.These data show FI and depression are 
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interrelated and burden perinatal women45.  
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Interventions to improve Option B+ adherence by targeting FI and perinatal depression simultaneously 
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have the potential for greater success, but are lacking4,13,46-49. Existing interventions to improve PMTCT have 
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focused almost exclusively on supporting adherence to one of the three pillars. In Kenya, Drake et al., applied a novel 
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mHealth strategy to improve postpartum adherence to ART46. Fayorsey et al., utilized a combination of support 
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strategies including, phone and messaging, counseling and follow up support in the case of missed-appointments 50 
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to increase retention in care and adherence. Other interventions have focused on the EBF pillar of the PMTCT 
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cascade 51,52 through peer counselors 53 or clinic-based counseling sessions 54. Interventions to improve PMTCT must 
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account for the multiple levels of influence that facilitate or inhibit HIV treatment and EBF success throughout 
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pregnancy and postpartum, yet few do. 
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5. JUSTIFICATION FOR THE STUDY 
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Current Research Gaps: Although existing literature provides evidence linking FI and perinatal depression 
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among HIV+ women, there is a crucial gap in understanding the detrimental synergy in the interplay between these 
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two factors and their combined impact on Option B+ adherence27,55,61,62. In addition, understanding maternal 
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retention to Option B+ adherence beyond 6-weeks postpartum is extremely limited49. A sharp drop-off in 
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engagement of mothers and their infants occurs after 6 weeks, yet the reasons for this are unclear. This 
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compromises Option B+ adherence and long-term health as women fail to return for ART refills, infant HIV testing, or 
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infant feeding follow-up. Longitudinal data are needed to help understand this trend. Moreover, theory-based 
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approaches to mitigate non-adherence among postpartum HIV+ women are lacking66 and none have focused on 
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addressing FI and depression together. 
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Findings from phase one of our study demonstrated that financial insecurity during the perinatal period was 
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detrimental to the mental health and food security of mothers living with HIV,82 and cash transfers have been shown 
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to improve outcomes for low-income families in Kenya.83,84 Yet, little is known about the specific benefits of cash 
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transfers to perinatal women living with HIV (WLWH) and their infants in this setting. In addition, participants from 
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phase one also reported challenges, including significant stress, related to safe infant feeding, a key component of 
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the prevention of mother to child transmission strategy. Barriers to current infant feeding guidelines (specifically EBF 
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for the first 6-months postpartum) are now well documented,85-90 however, more research is needed to develop and 
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test interventions that support women to overcome these barriers.   
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6. HYPOTHESIS 
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Hypothesis 1: We hypothesize that higher levels of food insecurity and depression lead to lower adherence to 
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prevention of mother to child transmission of HIV strategies. These strategies include HIV treatment for the mother, 
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treatment for her infant and to exclusively breastfeed for 6 months.  
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Hypothesis 2: We hypothesize that targeted support provided to women living with HIV during the transition period 
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from pregnancy to postpartum can improved adherence to the prevention of mother to child transmission of HIV 
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guidelines. 
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     6b. Theoretical framework Under the mentorship of Dr. Weiser, we developed a conceptual framework to serve as 
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a basis for the research proposed here. This framework draws from Weiser et al.’s framework illustrating the 
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relationship between FI and HIV/AIDS outcomes. The original framework posits that FI and HIV/AIDS are linked in a 
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harmful cycle through nutritional, mental health and behavioral pathways among people living with HIV63. In this 
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proposal, we apply these underpinnings to the complex relationship between FI and depression during the perinatal 
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period and its impact on both PMTCT outcomes and maternal and infant health (Figure 1). Our framework draws on 
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Syndemic Theory64, the co-occurring conditions of poverty, depression and HIV resulting in a synergistic response 
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worsening the effects of each state. As can be seen in Figure 1, I hypothesize that FI operates at the household level 
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to impact perinatal depression. In turn, perinatal depression acts through several mechanisms, including perinatal 
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stress, lack of self-efficacy and lack of social support to influence adherence to PMTCT strategies and maternal and 
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infant health. Moreover, our model stresses that both FI and perinatal depression operate independently and jointly 
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to impact maternal health. Previous work has demonstrated the link between stress, self-efficacy and social support 
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and poor maternal outcomes postpartum65-67, however the role and the interplay of FI and perinatal depression 
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among HIV+ women over time remains a knowledge gap we hope this proposal will start to fill. 
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In addition to the conceptual framework we have developed, Transitions Theory provides an innovative framework 
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to explore HIV treatment adherence among pregnant and postpartum women.75 The theory was developed by Dr. 
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Afaf Meleis who recognized healthy and unhealthy patterns in the way people experience and respond to different 
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life transitions.76 According to the theory, transitions occur over a period of time, they are characterized by change 
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and adaptation and, once complete, result in a state of greater stability relative to the period of transition during 
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which established support systems and resources may have been disrupted.77 We will apply transitions theory35 
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(making this the first study to apply a targeted theory to understand the experiences of postpartum women living 
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with HIV) with the aim of improving PMTCT adherence. Our intervention development will adapt the Transition’s 
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Theory framework to target the specific personal, community, and societal issues identified by participants in the in-
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depth interviews. 
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7a. GENERAL OBJECTIVES 
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The proposed study will investigate the role of food insecurity and depression among women living with HIV and its 
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impact on adherence to HIV treatment and prevention strategies as well as develop and test the acceptability and 
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feasibility of a multi-level FI and depression intervention for perinatal HIV+ women in Kenya.  
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7b. SPECIFIC OBJECTIVES 
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1. Phase One: Identify factors that increase risk for or protect against FI and perinatal depression among HIV+ 
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women in the Nyanza Region of Kenya We will use qualitative techniques to clarify the protective factors, 
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perceived causes, cultural understandings and individual perspectives of FI and perinatal depression by 
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conducting a longitudinal design with in-depth interviews at 4 consequential time-points (i.e., prenatal, 1, 4 
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and after 6-months postpartum) with 30 HIV+ women who screen positive for depressive symptoms during 
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routine care visits in Kisumu, Kenya. Our sample size is based on previous qualitative work where data 
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saturation was reached with less than 30 participants. Applying grounded theory analysis techniques, I will 
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describe how the above factors and perspectives of FI and depression are manifested in the perinatal period.  
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2. Phase Two: Apply findings from Phase One, using the theoretical framework of Transitions Theory to 
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develop and test the acceptability and feasibility of a multi-level intervention to promote adherence to 
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PMTCT strategies for perinatal HIV+ women in Kenya. Drawing upon findings from Phase One of our study, 
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in conjunction with consultation with key informant interviews with FACES clinic staff (n=5-12) and focus 
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group discussions with our target population (1-2 discussion with n=8-12 participants per group), we will 
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apply the theoretical model of transitions theory to develop a multi-level intervention that improves 
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adherence to PMTCT guidelines. The intervention will be tested among 40 pregnant women (20 intervention 
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and 20 current standard of care) and follow-up to evaluate results will occur at 6-months postpartum. The 
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intervention will likely include individual mental health and nutrition counseling, and food support with or 
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without some livelihood training. 
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In Phase One of our study, we identified perceived or actual milk insufficiency, as primary barrier to exclusive 
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breastfeeding not addressed through the current education and support being provided at the clinic. 
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Furthermore, we identified financial insecurity as a deeply-rooted threat to the health and well-being of 
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perinatal WLWH and their infants across time. Based on our findings from our longitudinal qualitative study, 
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our key informant interviews, focus groups with our target population and a review of the literature, we 
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developed an intervention which we will pilot test to determine the potential impact of providing 
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individualized support from a local lactation specialist along with monthly unconditional cash transfers (UCTs) 
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to WLWH from 20-35 weeks pregnancy to 6-months postpartum.  
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The pilot test will be carried out among 40 pregnant women divided into 2 groups (n=20 intervention group, 
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n=20 control group). The intervention group will receive personalized lactation support and monthly UCTs 
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from approximately 30 weeks pregnancy to approximately 6-months postpartum. Personalized lactation 
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support will be provided by a local, experienced lactation consultant. Her support will be aimed at providing 
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person centered care to assess for and address barriers to optimal, safe infant feeding with a focus on 
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exclusive breastfeeding for the first 6-months postpartum. The cash transfer will be 10,000 Kenyan shillings 
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per month. This amount is slightly less than the median amount women in our preliminary study reported 
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needing to meet their basic needs (13,500KES) and is in line with other cash transfers completed in the area.83 
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It is equivalent to approximately 3.33USD per day, or about 40% more than the World Bank’s most recent 
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poverty line estimated of 1.90 USD per person per day. This amount is lower than the estimated median 
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monthly income for those informally employed in sectors such as retail trade or food service in Kenya 
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(estimated at 15,000 and 30,000KES monthly in rural and urban areas respectively).91 We expect this amount 
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will allow women to meet many of their household’s basic needs during late pregnancy and throughout the 
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period of EBF when women are largely unable to maintain gainful employment.  
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The control group will receive the current standard care.  
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We will recruit women during their 20th-35th week of pregnancy and follow them until 6-months postpartum. 
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We will collect survey and clinical data at baseline (20-35 weeks pregnancy, 2-weeks, 4-weeks, 6-weeks, 3-
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months and 6-months). We will conduct qualitative interviews at the end of the intervention period with all 20 
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participants in the intervention group to evaluate the acceptability of the pilot intervention as well as to 
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better understand how UCTs were used and the perceived impact on financial security, food security, mental 
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health, relationships with primary partners and the ability to adhere to PMTCT strategies.  
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8. DESIGN AND METHODOLOGY 
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Phase One (In-depth Interviews): 
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  (a) Study site (geographical): The proposed study will be conducted in Kisumu county in the former Nyanza Region 
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in western Kenya.  
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Table 1: Characteristics of study population 
 
Aim 1: Longitudinal Interview 
Sample Size 
N= 30 women to complete 4 interviews 
each (Number of interviews=120) 
Age 
18+ 
Inclusion 
Criteria 
32-38 weeks pregnant at enrollment 
 
Depressive Symptoms: two-thirds of the 
sample- Screen positive for depressive 
symptoms on PHQ-9 scale and one-third 
who screen negative for depressive 
symptoms 
 
HIV positive 
 
Currently prescribed ART 
 
Exclusion 
Criteria 
High-risk pregnancy for reasons other than 
HIV status (e.g., pregnancy complications, 
preeclampia, gestational diabetes, preterm 
labor) 
Self-reported participation in another ART 
adherence-related study 
Unable to understand consent process 
Planning on relocating out of Nyanza 
province over the next 12 months 
 
 
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(b) Study populations: Pregnant and postpartum women over 18 years of age.  
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     (i)Inclusion criteria: 1) 32-38 weeks pregnant at enrollment, 2) Depressive Symptoms: two-thirds of the sample- 
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Screen positive for depressive symptoms on PHQ-9 scale and one-third who screen negative for depressive 
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symptoms, 3) HIV positive and 4) Currently prescribed ART. 
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     (ii)Exclusion criteria: 1) High-risk pregnancy for reasons other than HIV status (e.g., pregnancy complications, 
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preeclampia, gestational diabetes, preterm labor), 2) Self-reported participation in another ART adherence-related 
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study, 3) Unable to understand consent process, and 4) Planning on relocating out of Nyanza province over the next 
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12 months. 
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(c) Sampling   
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     (i) Sample size determination: For Qualitative Interviews (Aim 1), we will recruit a sample of N=30 HIV positive 
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pregnant women to complete four in-depth interviews over the course of approximately one year. We anticipate 
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this sample size will reach saturation, which will be assessed on an on-going basis based on previous qualitative 
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work. The sample size has been increased from the original protocol to account for attrition which may occur during 
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the time between follow up interviews such that we can ensure saturation is reached despite some anticipated loss 
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to follow up. We will recruit through designated FACES clinics in-person with a FACES staff member positioned in the 
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clinic waiting room. Interested women will be assessed for eligibility using a brief screening assessment administered 
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by a female study staff member.  
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     (ii) Sampling procedures: See above 
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(d) Procedures 
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     (i) Description of the type of data to be collected and collection procedures: We will enroll 30 HIV+ pregnant 
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women recruited from FACES to complete 120 in-depth interviews (4 per participant). We anticipate this sample size 
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will reach saturation, which will be assessed on an on-going basis. Each interview will last 1-1.5 hours, will be held in 
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a private room at the FACES clinic, and will be recorded with a digital voice recorder.  
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The interviews will follow a semi-structured format, with probing for key components reflected in our conceptual 
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framework. For example, the first interview will probe for engagement in preparations for newborn care, infant 
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feeding intentions, how a newborn will impact engagement in HIV treatment, anticipated family support, access to 
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and quality of food, factors causing anxiety, perceptions of mental health and its impact on engagement in care. 
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Subsequent interviews will focus on key mental health and FI issues associated with each time point and tailored to 
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assessing our framework. Based on the iterative nature of longitudinal qualitative interviews, the content of the 2nd, 
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3rd, and 4th interviews will be based on findings from the first interview. When possible, one interviewer will 
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complete all interviews to build rapport and to aid in retention 
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For a number of reasons, there is no feasible remote option to carry out our in-depth interviews.  We need face to 
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face interactions to elicit in depth responses to our interview questions by ensuring participant privacy and comfort. 
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We also need to capture non-verbal cues and body language as they are important components which guide our use 
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of interview probes.  Given our participants do not have access to good reliable internet/phone we would not be 
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able to effectively and securely capture audio or video interviews remotely. Therefore, taking into consideration 
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current public health guidelines to reduce COVID-19 exposure (as outlined in the KEMRI SERU Guidelines for the 
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Conduct of Research During the COVID-19 Pandemic in Kenya), we will minimize the risk of exposure for research 
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staff and participants by instituting the following procedures for our 4th and final in-depth interviews:  
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1) We will remotely screen participants for respiratory illness. Anyone who screens positive for exposure or 
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suggestive symptoms will not be invited to the interview until COVID-19 has been ruled out and they will be 
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referred to the Ministry of Health (MOH) for follow-up. 
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2) We will screen our staff daily for COVID-19 exposure and symptoms. Only staff without exposure or 
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suggestive symptoms will conduct interviews with participants.  Staff will also be encouraged to undergo 
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free testing provided by the MOH. 
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3) At the interview site, we will implement all infection control measures as outline in the KEMRI SERU 
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Guidelines for the Conduct of Research During the COVID-19 Pandemic in Kenya including: temperature 
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checks, hand washing/ hand sanitizers for all to use, providing 3-ply faces masks to participants and staff and 
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maintaining the recommended 1.5 meter distancing in a well ventilated spacious room.  
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4) We will train all staff on appropriate infection prevention measures to mitigate COVID-19 spread. 
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.   
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     (ii) Provisions for data verification and validation in the field and laboratory: All interviews will be transcribed 
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and then translated into English. Audio files will promptly be deleted after the transcription is complete. Translations 
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of the interviews and observational field notes will be analyzed using dedoose, a qualitative management program.  
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Phase Two (Intervention Development and Testing): 
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Intervention Development:  
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1. Key Informant Interviews 
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(a) Study site (geographical): The proposed study will be conducted in Kisumu county in the former Nyanza Region 
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in western Kenya.  
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(b) Study populations: Self-described stakeholders in the health of perinatal women living with HIV such as those 
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involved in providing healthcare and other resources to the women as well as those involved in creating policies and 
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procedures that impact this population. For example, FACES clinic staff and mentor mothers who work directly with 
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pregnant and postpartum women living with HIV. 
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     (i)Inclusion criteria: Self-described key stakeholder in the health of perinatal women living with HIV and or 
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experience working with pregnant and postpartum women living with HIV. 
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     (ii)Exclusion criteria: Unwillingness or inability to participate. 
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(c) Sampling   
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     (i) Sample size determination: Sample size determinations are based on standardized feasibility procedures 
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outlined in the literature.78-80 
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     (ii) Sampling procedures: 5-12 Key informants will be identified and selected by the PI an and Site Co-I. The 
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sample will include a purposeful sample of key stakeholders identified by the PI and her mentors to ensure a variety 
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of perspectives. Potential participants will be called by the site PI. They will be asked to participate in the evaluation 
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of the conceptual model and/or intervention. If they are interested, and available, the PI will set up a time for the 
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interview to take place virtually through video/phone call and verbal consent will be obtained remotely. 
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(d) Procedures:  
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     (i) Description of the type of data to be collected and collection procedures: Once a candidate intervention has 
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been identified, preliminary research on its acceptability will be conducted. Key stakeholders will be individually 
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presented with the intervention and asked questions about the intervention. The interview will last around 1.5 hours 
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for each key informant and they will be asked to find a secure and private location with good network as the sessions 
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will take place virtually through a video or phone call as convenient to the key informant. The purpose of the 
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interview will be to gain insight as to the stakeholder’s evaluation of the acceptability of the intervention. An 
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interview guide for Key Informant interviews will be submitted with future amendments. Notes will be taken during 
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the key informant interviews.  
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     (ii) Provisions for data verification and validation in the field and laboratory: Most Key Informant 
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interviews will be conducted in English. However, if necessary, the interviews will be recorded, transcribed 
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and translated into English. If audio files are created, they will be promptly deleted after the audio is 
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transcribed. Given our aim is to get feedback on the intervention, there is no need to record or transcribe 
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interviews conducted in English for the purpose of analysis or publication. 
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2. Focus Group Discussions 
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(a) Study site (geographical): The proposed study will be conducted in Kisumu County in the former Nyanza Region 
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in western Kenya.  
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(b) Study populations: (1-2 discussions with N=8-12 participants each) Postpartum women over 18 years of age.  
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     (i)Inclusion criteria: a) 18 years or older, b) postpartum within 6 months of delivery c) HIV positive status based 
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on clinic records, d) currently prescribed ART. 
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     (ii)Exclusion criteria: a) self-reported participation in another ART adherence related study, or b) unable to 
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understand consent process.  
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(c) Sampling   
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     (i) Sample size determination: Sample size determinations are based on standardized feasibility procedures 
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outlined in the literature.78-80 
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     (ii) Sampling procedures: We will recruit 8-12 women for each discussion (up to 2 discussions) through 
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designated FACES clinics in-person with a FACES staff member positioned in the clinic waiting room. Interested 
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women will be assessed for eligibility using a brief screening assessment administered by a female study staff 
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member. We will use purposeful sampling to ensure a diverse sample across ages, parity (1st pregnancy or 
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subsequent pregnancies), and employment (employed vs. unemployed) Screening will be done  
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(d) Procedures 
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     (i) Description of the type of data to be collected and collection procedures: The focus group discussion will be 
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held in a private room at the FACES clinic and last approximately 1-2 hours. Participants will be asked maintain the 
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confidentiality of their fellow participants and not to disclose any information discussed within the group. The group 
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will be presented with an overview of the intervention and asked for feedback. The moderator will probe for 
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feedback on acceptability of content, delivery of content and design. Provided all participants consent to being 
316 
recorded, focus groups discussions will be audio recorded for qualitative analysis purposes. If any participants do not 
317 
wish to be recorded, the discussions will not be recorded and detailed notes will be taken. Recordings will be 
318 
transcribed and audio files promptly deleted after the transcription is complete. No identifying information will be 
319 
revealed in the transcripts (transcribers will be instructed to remove any identifying information, and replace first 
320 
names with generic terms, such as female 1, female 2, etc.).  Participants’ names will not be linked to this data in any 
321 
way. 
322 
     (ii) Provisions for data verification and validation in the field and laboratory: All focus group transcriptions will 
323 
be transcribed and translated into English. The translations and observational field notes will be analyzed using 
324 
dedoose, a qualitative management program.  
325 
 
326 
Intervention Pilot Test 
327 
(a) Study site (geographical): The proposed study will be conducted in Kisumu County in the former Nyanza Region 
328 
in western Kenya.  
329 
(b) Study populations: Pregnant and postpartum women over 18 years of age. 
330 
     (i)Inclusion criteria: a) 20-35 weeks pregnant, b) Living with HIV, c) currently prescribed ART.  
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     (ii)Exclusion criteria: a) High-risk pregnancy for reasons other than HIV status (e.g., pregnancy complications, 
332 
preeclampia, gestational diabetes, preterm labor), b) Self-reported participation in another ART adherence-related 
333 
intervention study, c) Unable to understand consent process, and d) Planning on relocating out of Nyanza province in 
334 
the following 12 months. 
335 
(c) Sampling   
336 
     (i) Sample size determination: Sample size determinations are based on standardized feasibility procedures 
337 
outlined in the literature.78-80 
338 
     (ii) Sampling procedures: We will recruit 40 pregnant women from 2 designated clinics. 20 women will be 
339 
recruited from Lumumba sub-County Hospital to participate in our intervention. During the same period, 20 women 
340 
will be recruited from Kisumu County Hospital to participate as our control group. We have opted to use an alternate 
341 
clinic site for the control group not receiving cash transfers to avoid interactions between women receiving cash 
342 
transfers and women not receiving cash.  We will recruit in-person, with a clinic staff member positioned in the clinic 
343 
waiting room.  Interested women will be assessed for eligibility using a brief screening assessment administered by a 
344 
female study staff member.  For women who are eligible, the staff member will privately give a more complete 
345 
description of the study, and if the individual is interested, the consent process will begin. 
346 
 
347 
(d) Procedures 
348 
     (i) Description of the intervention pilot test: To test feasibility, we will recruit and enroll N= 40 women, 20-35 
349 
weeks pregnant, 18-years and above, living with HIV (n=20 for the intervention group and n=20 for the control 
350 
group).  
351 
 
Intervention group (n=20): Women in the intervention group will receive personalized support for 
352 
breastfeeding provided by a local skilled lactation specialist and a monthly UCT of 10,000KES.  
353 
 
Women in this arm of the study will meet with a lactation consultant at 5 timepoints throughout the 
354 
intervention: once during pregnancy and at 2-weeks, 4-weeks, 6-weeks and 3-months postpartum. During 
355 
pregnancy, the lactation specialist will assess women’s knowledge and experience with regards to breastfeeding and 
356 
provide them information and support for optimal infant feeding after birth while emphasizing exclusive 
357 
breastfeeding. Each post-partum visit with the lactation specialist will be individualized and continue to focus on 
358 
optimizing infant feeding with a focus on exclusive breastfeeding for up to 6-months postpartum. During the 
359 
postpartum sessions, the lactation specialist will assess for milk sufficiency or any other barriers to optimal infant 
360 
feeding. The assessment will include the infant’s weight and a physical assessment of women’s breasts and 
361 
breastfeeding practice. The lactation specialist will counsel women on how to address both perceived and actual 
362 
milk insufficiency as well as address any of the other barriers to infant feeding as appropriate. Counseling topics will 
363 
include women’s breastfeeding timing and technique, diet, hydration and infant hunger and satiety cues to optimize 
364 
safe infant feeding. Other treatments may include warm or cold compresses or the use of a breast pump to treat 
365 
engorged breasts. The lactation specialist will not prescribe women any medications. Any medications the lactations 
366 
specialist would recommend (for example an antibiotic to treat mastitis) will be recommended to the participant’s 
367 
primary perinatal care provider for further consideration and prescribing as appropriate.  At the last visit (3-months 
368 
postpartum) the lactation specialist will provide women with support and information about when and how to 
369 
introduce affordable nutritious supplemental foods to their infants while at the same time promoting continued 
370 
breastfeeding for 24-months or beyond.  
371 
 
Women in the intervention group will also receive monthly UCT of 10,000KES sent directly to an MPESA 
372 
accounts associated with their personal cell phone. Cash transfers using MPESA accounts have an electronic trail for 
373 
auditing purposes and such transactions have already been successfully used in healthcare research in Kenya.92 If any 
374 
interested and eligible participant does not have their own cellular phone with MPESA account, they will be provided 
375 
with a low-cost phone for use during the study period. As a University of California San Francisco affiliated study, our 
376 
research team will work together with the finance team at Global Programs Kenya to administer the UCT to 
377 
participants.  
378 
 
  
379 
 
Control Group (n=20): The women enrolled in the control arm will receive standard care. After the last data 
380 
collection for the control group is complete (at around 6-months postpartum), control group participants will be 
381 
offered a one-on-one informational session, designed by a lactation specialist, and provided by the same RA who 
382 
administered the electronic surveys throughout the study period.  The session will provide women with support and 
383 
information about how to introduce affordable, nutritious supplemental foods to their infants while at the same 
384 
time promoting continued breastfeeding for 24-months or beyond. The session will last 20-40 minutes, depending 
385 
on the number of questions participants have. 
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387 
    (ii) Description of the type of data to be collected and collection procedures: Participants in both the intervention 
388 
and control groups will be asked to complete electronic surveys via tablet at baseline (20-35 weeks pregnant), 2-
389 
weeks, 4-weeks, 6-weeks, 3-months and 6-months. The electronic surveys will collect information on a variety of 
390 
outcomes including socio-demographics, FI, financial stability, mental health, infant health, relationships, stigma, 
391 
empowerment, breastfeeding practices and adherence to HIV medications for participants and their infants (see 
392 
Table 3 for all topics and specific tools to be included in the survey). At each research encounter where the surveys 
393 
will be completed, infants will also be weighed by a trained member of our research team and clinic records will be 
394 
used to collect participant’s viral loads, infants’ HIV test results and information on health status and engagement in 
395 
care for the participant and her infant (see also Table 3). At each research encounter, participants in both the 
396 
intervention and control groups will be reimbursed for their transportation costs and provided with refreshments.   
397 
 
For participants in the intervention group, the lactation specialist will coordinate to meet women, whenever 
398 
possible, on the same day of their research encounters with our Research Associate who will collect survey data and 
399 
infant weights. To the extent possible, we will also arrange the research encounters to coincide with participants 
400 
regular clinic visits. Following each session with participants, the lactation specialist will write or dictate a summary 
401 
note to include her professional assessment with regards to the adequacy of the participants milk supply, her 
402 
assessment of the woman’s breastfeeding practices (i.e. to what extent women are exclusively breastfeeding and/or 
403 
any successes or challenges women experience), and a summary of the counseling or treatment she provided.   
404 
 
Women from the intervention group will also be asked to participate in exit interviews, conducted at around 
405 
6-months postpartum, to assess the acceptability of all intervention components and to seek suggestions for 
406 
improvement. An interview guide for the follow up interviews has been submitted for IRB approval along with this 
407 
updated protocol.  
408 
 
409 
Table 3 
410 

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Baseline: recruitment  
Birth: no face-to-face 
encounter  
2-weeks 
4-weeks  
6-weeks 
3-months 
6-months 
Demographic and Individual item Questions 
Baseline questionnaire  
x 
 
 
 
 
 
 
Breastfeeding focused follow-up questionnaire 
 
 
 
x 
x 
 
x 
 
 6-week follow-up questionnaire  
 
 
 
 
 
x 
 
 
6-month follow-up questionnaire V 1.1 
 
 
 
 
 
 
 
x 
SCALES 
Mental Health:  
PHQ-9;  
Perceived stress scale 
 
x 
 
 
 
x 
 
x 
Food Insecurity:  
Household food insecurity access scale 
 
x 
 
 
 
x 
 
x 
Financial status:  
Wealth Index  
 
x 
 
 
 
x 
 
x 
Relationships:   
Couples Satisfaction Index 
 
x 
 
 
 
x 
 
x 
Breastfeeding:  
Prenatal BF Self-Efficacy (pre) 
Postpartum Breastfeeding Self Efficacy (PP) 
 
X(pre) 
 
X (PP) 
X (PP) 
X (PP) 
X (PP) 
X (PP) 
Social support:  
The Duke-UNC Functional Social Support (DUFSSQ) 
 
x 
 
 
 
x 
 
x 
Empowerment:  
Demographic Health Survey 
Household decision making and IPV 
 
x 
 
 
 
x 
 
x 
HIV related stigma:   
12-item HIV stigma scale 
 
x 
 
 
 
x 
 
x 
411 
     
412 
 
Infant weight measured by RAs  
 
 
 
x 
x 
x 
x 
x 
From participant’s clinical record: hemoglobin, Viral Load  
 
x 
 
 
 
 
x 
x 
From infant’s clinical record: # weeks gestation at birth, 
weight, length, HIV test results, vaccinations status 
 
 
x 
x 
 
x 
x 
x 
Qualitative Exit Interview Intervention Group Only 
 
 
 
 
 
 
 
x 
413 
 
414 
(ii) Provisions for data verification and validation in the field and laboratory: Our female RAs on site will ensure 
415 
participants are able to read and understand survey questions. They will read the questions out loud to participants 
416 
as needed and clarify the intended meaning of the questions without leading participants in any way and (to the 
417 
extent possible) without viewing participants responses. The RAs will ensure all questions are answered unless 
418 
intentionally skipped by participants. The RAs will then download and quality check the survey data to REDCap after 
419 
each research encounter. The interviews conducted at the endpoint of the intervention will be transcribed and 
420 
translated into English and quality checked by our experienced RAs. All recordings will be promptly deleted after 
421 
transcription. Translated interviews and clinical notes from the lactation specialist will be analyzed using dedoose, a 
422 
qualitative management program.  
423 
 
424 
9. DATA MANAGEMENT 
425 
a) Data Storage 
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i. Provision for database management: Data from the tablets will be uploaded after each research encounter to a 
427 
UCSF-based server. All records will be kept on password protected tablet computers. All participant record forms will 
428 
be kept in individual files in a secured filing cabinet in an access-limited room at the health facility. Participant names 
429 
and addresses will be stripped from the database prior to analysis. Audio files will not be downloaded from our 
430 
secure server. They will be accessed directly from the server and once the transcription of the interview has been 
431 
completed and verified, the audio files will be deleted. The responsible financial administrators at Global Program 
432 
Kenya who will administer the UCTs will be properly trained on how to securely handle participants personal 
433 
identifiable information (names and associated phone numbers). They will also receive CITI training. Such 
434 
information will be maintained and communicated to only those with a need to know through UCSFs secure 
435 
database.     
436 
 
437 
ii. Description of devices to be used for storage: Data collected for this study will be entered into handheld 
438 
computer tablets operating the Redcap system used by UCSF. The database will be protected by a separate 
439 
password on password-protected tablets.  Qualitative data and any electronic research documents will be stored in 
440 
UCSF’s secure database, “BOX.” 
441 
 
442 
(b) Data Management 
443 
i. Data analysis:  
444 
Phase One: The focus of this analysis is to connect themes both between participants, to gain an understanding of 
445 
common experiences, and within participants across time, to better understand how FI and perinatal depression 
446 
conditions change over time and those impacts on adherence to PMTCT outcomes. We will use grounded theory 69 
447 
and ‘sensitizing concepts’70 to guide analysis. Sensitizing concepts starts with a general reference point to guide 
448 
interpretation of emerging themes while maintaining use of inductive analysis, a key principle of a grounded theory 
449 
approach. Thus, we’re able to guide our analysis from our conceptual framework while allowing for codes/themes to 
450 
emerge from the data to yield a comprehensive picture of women’s experiences. Constant comparative method will 
451 
be used where each line, phrase, sentence and paragraph from interviews are reviewed to find concepts and code 
452 
the data 69,71. Reliability will be measured as the amount of inter-rater agreement using Cohen’s Kappa, which 
453 
measures agreement corrected for change. Discrepancies between coders will be discussed and resolved until >80% 
454 
agreement in codes.  
455 
Phase Two: The key informant interviews and focus group discussions will provide us with feedback on a proposed 
456 
intervention. Thus, data collected from these activities will be qualitatively reviewed and used to make modifications 
457 
to the intervention before pilot testing. Content analysis81 for the focus group discussions will be applied to coding 
458 
and analysis using dedoose software. The focus of the analysis for the data collected during pilot testing will be to 
459 
assess the impact of the intervention on measures such as depression, financial security, relationships, stress, 
460 
empowerment, social support and adherence to PMTCT guidelines as well as to gather feedback from the women 
461 
who participated in the intervention. Published scales will be scored according to the scales’ guidelines. Although our 
462 
sample size may be too small to detect statistically significant differences, we will use statistical analysis to look for 
463 
difference/trends in scores across time within each group (intervention and control), as well as differences between 
464 
the intervention and control group scores at each timepoint.  After the pilot is complete, we will conduct exit 
465 
interviews with participants in the intervention group to assess the acceptability of all intervention components and 
466 
suggestions for improvement. Transcripts from these interviews will be coded and content analysis81 will be used to 
467 
group and summarize women’s feedback regarding the intervention. Documentation from the lactation specialist 
468 
will be analyzed using a longitudinal qualitative approach to determine the specific barriers or successes women 
469 
experienced with regards to optimal infant feeding across time. The analysis will also identify what information, 
470 
support or treatments were offered and to what extent women were able to overcome these barriers given the 
471 
personalized care provided.  
472 
 
473 
 
474 
 
475 
 
476 
 
477 
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10.  TIME FRAME/DURATION OF THE PROJECT: 
479 
 
480 
 
Year1 
Year 2 
Year 3 
Year 4  
Year 5 
Months 
1-6 
6-12 
1-6 
6-12 
1-6 
6-12  
1-6 
6-12 
1-6 
6-12 
Operationalize study procedures 
 
 
 
 
 
 
 
 
 
 
Hire & train researchers 
 
 
 
 
 
 
 
 
 
 
Recruit participants and data collection 
Phase 1 
 
 
 
 
 
 
 
 
 
 
Process data from Phase 1 
 
 
 
 
 
 
 
 
 
 
Intervention development 
 
 
 
 
 
 
 
 
 
 
Recruit key informants/ focus group 
participants and initial data collection 
for Phase 2 
 
 
 
 
 
 
 
 
 
 
Revise and finalize intervention  
 
 
 
 
 
 
 
 
 
 
 Phase 2 Pilot test of the intervention 
 
 
 
 
 
 
 
 
 
 
Process data from Phase 2 
 
 
 
 
 
 
 
 
 
 
 
481 
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11. ETHICAL CONSIDERATIONS 
483 
The study protocol and forms will be submitted to the UCSF Committee on Human Research, as well as the Scientific 
484 
and Ethical Review Unit (SERU) of the Kenya Medical Research Institute (KEMRI).  No aspect of the study will be 
485 
conducted without explicit study approval from both UCSF CHR And KEMRI SERU.  
486 
(a) Human Subjects 
487 
 
488 
     (a1) “First, do no harm.” 
489 
The primary risks associated with the study are loss of confidentiality and risks to reputation. Participation in this 
490 
research and research results will be kept as confidential as possible. No individual identities will be used in any 
491 
reports or publications resulting from the study.  
492 
There is also the risk of fatigue from interviewing or participation in the group discussion. In addition, participants 
493 
will be asked some sensitive questions regarding mental health, which may lead to personal discomfort or 
494 
embarrassment. Participants are free to decline to answer any questions and can stop the interview or leave the 
495 
discussion at any time. Field staff will be trained in non-judgmental interactions, how to recognize and respond to 
496 
any distress and strategies designed to minimize these risks and their potential impact on study participants. To 
497 
avoid fatigue, interviews and discussions will be kept to no more than 2 hours, with breaks available as needed. 
498 
All serious and unexpected adverse events will be reported to the Study PIs and to the relevant IRBs per local 
499 
regulation. We have preemptively come up with a number of procedures to protect study participants against any 
500 
potential risks that may result from study participation, including: 
501 
Planned procedures for protecting against fatigue: Interviews as well as focus group discussions will last 1-2 hours. 
502 
Participants will be informed that they can take a break or stop at any time. Staff will be well-trained and supervised 
503 
under the direction of experienced clinical researchers. 
504 
Planned procedure for protection of risks due to sensitive questions: Efforts will be made to minimize discomfort by 
505 
assuring that interviewers and discussion moderators are well trained and that they will inform participants 
506 
beforehand about the nature of the questions and assure participants of privacy. 
507 
For the In-Depth Interviews: The interviewer will be available after the interview to debrief the participant if s/he is 
508 
in any way concerned by the nature of the questions. Routine demographic questions will be asked first, followed by 
509 
more personal questions. Participants will be informed that they have the right to decline participation in the study, 
510 
to refuse to answer any questions, or to withdraw at any time without adverse consequences. Sensitive questions 
511 
such as sexual risk may be asked using ACASI. Since the Ministry of Health with additional support from 
512 
implementing partners such as the FACES program provides comprehensive AIDS education, counseling, and 
513 
services, it will be possible for the interviewers to provide immediate referrals for research participants who are in 
514 
emotional distress or exhibit any concerning physical signs or symptoms. As we will screen for depression, for 
515 
participants who have suicidal thoughts, we will ask participants to speak with one of our study health providers who 
516 
can further screen them for suicidal ideation and make appropriate referrals if they are suicidal. This may lead to 
517 
some discomfort, but we hope will provide benefits for the participants if they are able to get access to appropriate 
518 
mental health care. 
519 
For the Focus Group Discussions: Disclosure of HIV status to other focus group participants by virtue of 
520 
participating in the group.  Potential negative effects associated with this risk are minimized through our IRB-
521 
approved recruitment procedures and informed consent that clearly conveys to individuals that they will be 
522 
identified as being HIV positive through participation in the focus group. Participants are informed of this risk, 
523 
however cannot be fully protected from it.  However, women attending PMTCT care are already unofficially 
524 
disclosing their status by virtue of PMTCT counseling addressing HIV positive women. This does not lessen the 
525 
impact of the potential risk, however, it speaks to women attending PMTCT are in essence self-disclosing to their 
526 
peers already. 
527 
Potential for others in focus group to fail in maintaining participant’s privacy. We cannot guarantee everyone will 
528 
honor the pledge of confidentiality and therefore this is a risk that participants will be fully informed of during the 
529 
IRB-approved recruitment procedures. To mitigate this risk, focus group facilitators will reinforce to participants to 
530 
refrain from sharing something they feel uncomfortable with others hearing.  Participants will also be reminded that 
531 
part of participating in focus groups is the agreement that information shared within the group is confidential and 
532 
not to be spoken of outside the group.  If a participant does not feel she can maintain that agreement she will be 
533 
asked not to participate. 
534 
 
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For the Intervention Pilot Test: The lactation specialist who will be providing personalized lactation support will be 
536 
trained on the protection of human subjects including maintaining privacy and handling personally identifiable 
537 
information. The financial administrators facilitating the UCTs will also be trained and they will only be given the 
538 
information about participants necessary for administering the monthly UCTs. A potential risk of the cash transfer is 
539 
women could experience negative feelings including stress, anxiety or sadness if they are asked to or forced to share 
540 
some or all of the money with their partners or others in their household/ community. We will assure women that 
541 
no information about the monthly UCTs will be disclosed to anyone outside our study team. In addition, if women do 
542 
not have access to a telephone of their own, we will provide them with a telephone for use to ensure to the extent 
543 
possible the money will be privately and directly available to them. We will also monitor closely including via 
544 
monthly follow-up phone calls with participants to promptly identify and address any adverse events experienced by 
545 
women related to the monthly UCTs. Cash transfers have been used widely in a variety of settings to include similar 
546 
sums of money without negative consequences to recipients. We will also discuss the progress of our study regularly 
547 
with clinic staff at our research sites to identify any real or potential negative impact related to the intervention. To 
548 
reduce risk of any negative interaction between our intervention and control arms we will be using two separate, 
549 
but matched, clinics. In this way we attempt to avoid a potential situation where women in the control group discuss 
550 
their participation in the study with women in the intervention group and vice versa leading to the control group to 
551 
feel negatively about the study or members of the intervention group as they are not receiving the same supportive 
552 
intervention. 
553 
 
554 
Planned procedure for reporting of adverse events: All serious adverse events associated with the procedures of 
555 
this study will be reported within 10 days to the appropriate IRBs. Current guidance on adverse event reporting has 
556 
focused on clinical trials of drugs or devices and has not provided clear guidance on behavioral prevention trials. The 
557 
primary risk to subjects in this study is loss of confidentiality. If serious or unexpected adverse events occur, these 
558 
will be filed with the appropriate IRBs within ten working days. We will ask study participants to return to the 
559 
research field site in the case of ongoing adverse events. We will also provide participants with a palm card 
560 
containing information on how to contact the local field staff to report such incidents as HIV-related disruption of 
561 
families, acts of discrimination, physical harm, adverse events following phlebotomy, or personal distress. Field staff 
562 
will be trained to complete descriptions of adverse events that will then be sent electronically to the study PIs.  
563 
     (a2) Potential benefits of the proposed research to the subjects and others 
564 
Participants in the study will be able to access the results of the study.  The research findings have the potential to 
565 
ultimately benefit other perinatal women in Kenya and elsewhere is sub-Saharan Africa who are struggling with the 
566 
overlapping epidemics of food insecurity, mental health and HIV. In view of the minimal risks to subjects, and the 
567 
many actual and anticipated potential benefits to research subjects and others in their community, we believe that 
568 
the benefits strongly outweigh the risks. The receipt of unconditional cash transfers may provide considerable 
569 
benefit to participants in meeting basic needs for themselves and their dependents during a period of time while 
570 
perinatal women are typically out of the workforce. In addition, the lactation support may have direct and 
571 
immediate benefit to breastfeeding women who are also confronting food insecurity, breast health concerns and 
572 
other complexities that may challenge their ability to exclusively breastfeed.  
573 
The research will not provide any direct benefits to the participants, other than possible psychological benefits 
574 
associated with sharing their insights and stories. As a token of appreciation, participants in the in-depth interviews 
575 
and focus group discussions will be compensated for their time with up to 800 Kenyan Shillings (equivalent to ~$8) 
576 
per interview or group discussion. 
577 
 
578 
     (a3) Informed Consent 
579 
Research will be conducted according to Good Clinical Practice guidelines, the U.S. Code of Federal Regulations (CFR) 
580 
Title 21 CFR (Part 50 – Protection of Human Subjects and Part 56 – Institutional Review Boards), and the Declaration 
581 
of Helsinki. This protocol has been approved by UCSF‘s Committee on Human Research (letter attached). The 
582 
informed consent of each participant will be obtained before protocol-specified procedures are carried out.  
583 
The consent process will be conducted with a staff member fluent in English, Swahili and Dholou who has been 
584 
trained in research ethics and the specific consenting protocol for this study. The consent process will be conducted 
585 
in the language of the participants choosing. The informed consent process will highlight the specific risks associated 
586 
with the study, including discomfort from in-depth discussions of HIV infection, perinatal depression and mother-to-
587 

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child transmission of HIV and risks for breaches to confidentiality. The participants will be informed about the 
588 
precautions put in place to minimize the risk of breaches in confidentiality. The participants will be informed about 
589 
all procedures put in place to reduce the risk of breaches in confidentiality including: the use of a unique participant 
590 
ID number on all research data and that her name will not be used in relation to her data and that all data will be 
591 
kept in a safe, locked filing cabinet or password-protected computer in a locked office. It will also be noted that 
592 
study staff are not practicing doctors, nurses or any type of healthcare provider and, thus, cannot diagnose, treat or 
593 
prescribe medications of any kind. The participant will be allowed to ask questions and the staff member will probe 
594 
for complete understanding during key points of the consent form. The participant can take as much time as they 
595 
need to make a decision and she will be reminded that she can de-enroll in the study at any time and that 
596 
participation is completely voluntary and will not impact her regular clinic visits. All participants will be provided the 
597 
contact numbers of the PI Dr. Tuthill, Dr. Bukusi and the KEMRI IRB chairs to answer any questions that the 
598 
participant might have about the study or one’s rights as a human subject. Completed, signed consent forms will be 
599 
kept in a locked filing cabinet in our secured research office. The participant will be allowed to take a copy of the 
600 
consent form home to have a reference, but will be reminded that someone finding the form may result in a breach 
601 
of confidentiality. 
602 
We have developed a separate informed consent for intervention and control participants based on previously 
603 
established protocols for conducting research when an intervention involves cash transfers. This will ensure the 
604 
participants in each arm are not influenced by the other. Given cash transfers need to be handled with care because 
605 
they provide financial assistance to a vulnerable population these additional steps are critical for protecting human 
606 
subjects.  
607 
     (a4) Method of maintaining confidentiality of information obtained during the study: 
608 
To ensure confidentiality of participation, all data will be coded by a unique participant identifier number. Data will 
609 
be kept in locked cabinets and will only be provided to a subject’s clinician upon the written request of the subject. 
610 
Research records will be kept confidential to the level allowed by law. For interview data, survey data and any 
611 
participant data recorded by our lactation specialist collected as part of the study, subjects will be assigned a unique 
612 
study identification number. Interviewers and support staff including the lactation specialist and financial 
613 
administrator assisting with cash transfers will be trained on procedures for maintaining privacy and will sign a 
614 
pledge of confidentiality. Additionally, discussion group participants will be asked to pledge that they will not share 
615 
the personal information of others, disclosed in the session, with anyone outside of the group. All transcripts and 
616 
computer records will be password-protected to prohibit illicit access.  All personal identifiers will be removed from 
617 
any paper or electronic study forms, which will be coded only by numerical identifiers. When these procedures are 
618 
followed, it is highly unlikely that any information revealed by participants during the course of the interviews or 
619 
clinic visits will be disclosed to anyone outside the research team. 
620 
Primary responsibility for data and safety monitoring will fall on the PIs (Drs. Tuthill and Bukusi). In this research, the 
621 
primary risk to subjects is loss of confidentiality. Risks to participants will be minimized through informed consent 
622 
and strict confidentiality. In the case of any serious adverse events, we will ask subjects to return to the research 
623 
field site. We will also provide subjects with an informed consent translated into the local language of their choice, 
624 
so that they have the opportunity to contact the local field staff or one of the study investigators at any time. Study 
625 
staff will be trained to complete descriptions of adverse events that will be sent electronically to the principal 
626 
investigators (Drs. Tuthill and Bukusi).  Serious or unexpected AEs will be reported to the appropriate IRBs within 10 
627 
working days of awareness of the incident.   
628 
 
629 
     (a5) Not applicable.  
630 
 
631 
(b) Animal subjects 
632 
Not applicable.  
633 
 
 
634 

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July 25, 2022 
 
12.  EXPECTED APPLICATION OF RESULTS 
635 
 
This study will fill key gaps about the interplay of FI and perinatal depression and its impact on adherence to 
636 
PMTCT strategies among women living with HIV, specifically during the transition period from pregnancy to 
637 
postpartum. Background literature suggests there is causal, additive impact between FI and perinatal depression on 
638 
ART adherence and exclusive breastfeeding, however, how impactful this relationship may be and at what point 
639 
during the perinatal period these factors are most detrimental is not known. Furthermore, both FI and perinatal 
640 
depression are substantial maternal and infant health issues in their own right. Addressing them together through a 
641 
multi-level intervention designed to promote adherence to PMTCT strategies will have the added benefit of 
642 
improving overall health.  
 
643 
 
These efforts are aimed to help impact Sustainable Development Goals: 1) improve maternal and infant health 
644 
and 2) further several top Sustainable Development Goals (SDG) including SDG 1 (zero poverty), SDG 2 (zero hunger), 
645 
SDG 3 (good health and wellbeing), and SDG 5 (gender equality). 
646 
 
 
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Amendment_8  
 
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