Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)
Phase: NA
Conditions: Human Immunodeficiency Virus, Perinatal Depression
Sponsor: University of North Carolina, Chapel Hill

STUDY PROTOCOL 
 
 
Adaptation of the Friendship Bench Mental Health Intervention for 
HIV-infected Perinatal Women in Lilongwe (Periscope) 
 
 
NCT number NCT04143009 
Document Date 12/16/2022 
 

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Version 4.1 dated – 16 December 2022 
Full Research Protocol: UNCPM 21910 - Phase 2 - Adaptation of the Friendship Bench mental health 
intervention for HIV-infected perinatal women in Lilongwe. 
 
Protocol Date: December 16, 2022 
  
Protocol Version: 4.1 
  
Principal Investigators: Brian Pence1, PhD Co-investigators: Samantha Meltzer-Brody2 MD; Angela 
Bengtson3 PhD; Vivian Go4 PhD; Dixon Chibanda5, PhD; Kazione Kulisewa6, MBBS, M.Med; Michael Udedi7 
MPhil, MBA; Bradley Gaynes2 MD; Mina Hosseinipour8 MD 
 
 
 
Institutions and Addresses of Affiliation:   
 
1. Department of Epidemiology University of North Carolina-Chapel Hill, 135 Dauer Drive, Chapel Hill, NC 
27599, USA 
 
2. Department of Psychiatry, University of North Carolina-Chapel Hill, 101 Manning Dr # 1, Chapel Hill, NC 
27514, USA 
 
3. Department of Epidemiology, Brown University, 21 South Main Street, Providence, Rhode Island 02903, 
USA   
 
4. Department of Health Behavior, University of North Carolina-Chapel Hill, 135 Dauer Drive, Chapel Hill, NC 
27599, USA 
 
5. Department of Psychiatry, University of Zimbabwe, Harare, Zimbabwe 
 
6. University of Malawi, College of Medicine, Private Bag 360, Chichirie, Blantyre 3, Malawi 
 
7. Malawi Ministry of Health, PO Box 30377, Lilongwe Area 3, Malawi  
 
8. UNC Project Malawi Tidziwe Centre Private Bag A-104 Lilongwe, Malawi   
 
 
 
 
 

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Appendices 
 
Appendix 1 – English and Chichewa Informed consent forms (version 3.1, dated 09 September 2020) 
 
Appendix 2 – English and Chichewa data collection instrument (version 1.0, dated 7 June 2019) 
 
 

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Abstract  
The scale up of antiretroviral treatment (ART) to all pregnant and breastfeeding women, known as Option B+, 
has the potential to dramatically improve maternal health and end mother-to-child HIV transmission. However, 
lack of engagement in HIV care among peripartum women threatens to limit the positive impact of Option B+ 
on HIV care outcomes. Engagement in HIV care is likely to be adversely influenced by perinatal depression 
(PND), particularly in settings like Malawi where disengagement from HIV care and PND are common. 
Interventions that improve PND and address engagement in HIV care are urgently needed. Our long-term 
goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve 
engagement in HIV care among women taking ART under Option B+ in Malawi. Our central hypothesis is 
that the adaptation and further enhancement of the Friendship Bench intervention will reduce PND symptoms 
and increase HIV care engagement in this population. The objective of this proposal is to assess the 
feasibility, fidelity of delivery, and acceptability of an enhanced version of the Friendship Bench intervention in 
addressing PND and HIV care engagement among perinatal HIV-infected women. This proposal draws on our 
formative work on the experiences of PND and feasibility and acceptability of PND screening and treatment 
among HIV-infected perinatal women in Malawi. Our specific aim is to assess the feasibility, fidelity, and 
acceptability of the Enhanced Friendship Bench intervention to improve PND and engagement in HIV care 
among women taking ART under Option B+. Our multi-disciplinary team is uniquely positioned to address 
these aims given our expertise in PND, mental health, perinatal HIV and our extensive research experience in 
Malawi. The proposed work is significant because PND among HIV-infected women is common and likely to 
adversely affect perinatal engagement in HIV care. Mental health interventions exist, but their impact on PND 
and engagement in perinatal HIV care has not been explored. The proposed work is innovative because it is 
the first to assess how PND affects engagement in HIV care and gathers formative research needed to 
develop scalable treatment options. Completion of the proposed aims will directly lead to an adapted 
counseling intervention protocol to improve PND and perinatal engagement in HIV care among perinatal HIV-
infected pregnant women in a subsequent R01 (large scale randomized controlled trial) application.   
 
 

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A. BACKGROUND AND JUSTIFICATION  
The scale up of antiretroviral treatment (ART) to all pregnant and breastfeeding women, known as Option B+, 
has the potential to dramatically improve maternal health and end mother-to-child HIV transmission.1 However, 
lack of engagement in HIV care among peripartum women threatens to limit the positive impact of Option B+ 
on HIV care outcomes. In Malawi, women who initiate ART during pregnancy under Option B+ are 5 times as 
likely to not return to HIV care after their initial visit, compared to non-pregnant women initiating ART.2 For 
Option B+ to improve HIV care outcomes at a population level, women must remain engaged in HIV care.  
 
Engagement in HIV care is likely to be influenced by perinatal depression (PND). Worldwide, PND (onset of 
depression during pregnancy or the first 3-6 months postpartum3,4) affects 10-15% of women during pregnancy 
and up to 20% of women postpartum, with higher rates seen in lower income countries.5-7 PND causes 
potentially devastating consequences to women, their infants and families.8-11 Depression also 
disproportionately affects people living with HIV,12,13 leading to poor ART adherence, reduced retention in care, 
and ultimately worse clinical outcomes – all important aspects of engagement in HIV care.14-20 Despite the high 
burden of PND and negative effects of depression on HIV outcomes in non-pregnant populations, the impact of 
PND on engagement in perinatal HIV care has received little attention. 
 
Consequently, understanding how PND affects women’s health and engagement in HIV care is a high 
priority.21-23 Women in Malawi are not currently screened for PND and treatment is rare. Growing literature 
shows that counseling interventions delivered by non-specialists in resource-limited settings can improve 
depression outcomes.24-31 Yet, the feasibility and acceptability of expanding such interventions to HIV-infected 
perinatal women has received limited attention,32 and the possibility of enhancing mental health interventions 
to simultaneously address perinatal engagement in HIV care has not been explored.  
 
Our long-term goal is to adapt a culturally and resource-appropriate intervention for HIV-infected women with 
PND.  
 
B. HYPOTHESES 
Our central hypothesis for this pilot study is that our enhanced Friendship Bench intervention will prove 
feasible and acceptable to providers and women, and will be delivered with fidelity by study staff.  This will lay 
the groundwork for a future study that will test whether the intervention reduces PND symptoms and increases 
HIV care engagement among HIV-infected women with PND. 
 
C. OBJECTIVES 
The objective of this proposal is to adapt and enhance the Friendship Bench and assess its feasibility, fidelity 
of delivery, and acceptability in addressing PND and HIV care engagement among perinatal HIV-infected 
women. This proposal draws on our formative research on the experiences of PND and feasibility and 
acceptability of PND screening and treatment among HIV-infected perinatal women in Malawi. To address our 
main objective, our specific objectives are:  
 
 
1. To assess the feasibility of the Enhanced Friendship Bench intervention to improve PND and 
engagement in HIV care; 
2. To assess the fidelity of the Enhanced Friendship Bench intervention to improve PND and 
engagement in HIV care, and; 
3. To assess the acceptability of the Enhanced Friendship Bench intervention to improve PND and 
engagement in HIV care.  
 
 
D. LITERATURE REVIEW 
PND is common among women worldwide, and is a leading cause of maternal morbidity.6 PND is defined 
as onset of depression during pregnancy and/or within the first 3-6 months postpartum.3,4 About 10-15% of 
women experience depression prenatally and ~20% of women become depressed postnatally, with higher 
rates seen in lower income countries.5-7,33 PND, like depression generally, may be very common among HIV-
infected women: our group’s recent meta-analysis of PND among HIV-infected women in sub-Saharan Africa 
found a pooled prevalence of 42.5% for prenatal and 30.7% for postnatal depression.34  

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PND adversely affects the health of women, their infants and families. In the general population, PND has 
been associated with an increased risk for low birth weight and prematurity, impaired mother-infant attachment, 
and infant malnutrition during the first year of life.5,10,11,35 Women living with HIV are already at an increased 
risk of adverse pregnancy and infant health outcomes,36,37 and may be at particularly high risk of PND.9,38 
Consequently, addressing PND in HIV-infected women may have several maternal-child health benefits.21,22  
 
PND may be a barrier to the success of Option B+, the rapidly expanding effort to initiate all HIV-infected 
pregnant women on lifelong ART.39,40 Option B+ is expected to have major benefits by preventing vertical HIV 
transmission, improving maternal health, and reducing onward sexual transmission. However, the realization of 
these benefits requires engagement in HIV care, which has emerged as a major challenge and priority area of 
research for the National Institute of Mental Health (NIMH). In Malawi, up to 30% of women are lost to HIV care 
within 6 months of starting ART2,41 and globally just 28% of HIV-exposed infants are tested for HIV within 2 
months of birth.42,43 Given the strong and consistent associations between depression and HIV outcomes in 
general (non-pregnant) HIV-infected populations14-20, women with the dual burden of HIV and PND may be at 
particularly high risk for disengagement from HIV care.44  
 
Evidence-based PND interventions exist, but they have not been adapted to the unique needs of HIV-
infected women. We proposed to adapt The Friendship Bench, an evidence and theory-based counseling 
intervention that improves depression in the general population.24,45 Friendship Bench uses problem-solving 
therapy46,47 to help participants identify a problem they can address, such as barriers to attending their HIV 
visits, during counseling sessions with trained, supervised lay healthcare workers. The Friendship Bench has 
been adapted to address PND among postpartum women32, but has not been adapted to the specific needs of 
HIV-infected women. HIV-infected women with PND face unique issues surrounding disclosure to their partner, 
stigma related to HIV and PND, concerns over perinatal HIV transmission, and barriers to ART adherence and 
retention in HIV care. For these reasons, PND among HIV-infected women may lead to suboptimal 
engagement in HIV care. Addressing these issues through evidence-based interventions is essential to 
address NIMH’s research priorities of supporting engagement in HIV care and improving HIV care outcomes. 
 
The goal of the proposed developmental award is to gather formative research for a R34 application to 
develop a scalable, culturally sensitive intervention to address PND among HIV-infected women. After 
the completion of our specific aims we will have gathered information on: 1) women’s experiences pre and 
postnatally with PND, how PND affects perinatal engagement in HIV care, and preferences on counseling and 
pharmacological treatment; 2) the feasibility of provider screening for PND in high-volume antenatal/ART 
clinics; and 3) and adapted the Friendship Bench intervention to address PND and its possible impact on 
engagement in HIV care. Information gathered in this proposal will lead to a R34 application to pilot test our 
adapted intervention, and a subsequent R01 application to test our intervention in a randomized controlled trial.  
 
E. INNOVATION 
The proposed project is innovative in two important ways: 
1) This will be the first project to evaluate how PND affects engagement in HIV care during the 
peripartum period. By gathering rich, qualitative data among HIV-infected women with PND in the 
prenatal and postnatal periods, we will explore women’s experiences of PND and how those experiences 
influence ART adherence, retention in HIV care, and behaviors around infant HIV testing.  
2) We will gather the in-depth information needed to adapt a scalable perinatal counseling 
intervention for HIV-infected women, with the goal of improving PND and engagement in HIV care.  
 
F. METHEDOLOGY   
F1. Environment and Team  
Dr. Brian Pence, PI, is an Associate Professor of Epidemiology who has led research for 15 years on the 
identification and treatment of mental health disorders among people living with HIV in the US and Africa. He is 
supported in the US by Dr. Samantha Meltzer-Brody, a Professor of Psychiatry with particular expertise in 
perinatal mood disorders who recently launched an initiative to integrate depression screening into maternal 
waiting homes in Malawi, Dr. Go, Professor of Health Behavior, an expert in qualitative and mixed methods 
research, Dr. Angela Bengtson, epidemiologist and postdoctoral trainee at Brown University whose recently 
funded NIMH K99 award focuses on retention in HIV care among perinatal HIV-infected women, and Dr. 

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Bradley Gaynes, psychiatrist who has collaborated on several studies of mental health integration in Malawi. 
The team further includes Dr. Mina Hosseinipour, Scientific Director at UNC Project-Malawi, Dr. Dixon 
Chibanda, psychiatrist at the University of Zimbabwe, developer of the Friendship Bench and a leader in 
developing task-shifting models for treating mental health disorders in low-income countries; Dr. Kazione 
Kulisewa, Malawian psychiatrist leading mental health reform efforts in Lilongwe; and Mr. Michael Udedi, 
Assistant Director of Clinical Mental Health Services at the Malawi Ministry of Health.  These team members 
have all collaborated together previously on mental health research and service initiatives in Malawi.  Overall 
this impressive and experienced team is well positioned to successfully implement this high-impact project.  
 
F2. Study Design: We will conduct a clinic-level pilot study among five clinics. Three of the five clinics initially 
served as primary study sites and were assigned to one of 3 conditions: 1) Adapted Friendship Bench (AFB; 
n=1 clinic/35 women), 2) Enhanced Friendship Bench (EFB; n=1 clinic/35 women) or 3) Enhanced Usual Care 
(n=1 clinic/35 women).   
 
In June 2020, it was clear that due to both low patient volume and COVID-19 delays, recruitment targets would 
not be met at these three sites.  Therefore recruitment is on hold at these sites and resources will be focused 
on launching activities at two new larger sites: Bwaila and Area 18.  These sites will employ individual-level 
randomization of the study intervention. Participants will be enrolled at an ANC visit prior to or including 34 
weeks gestation and followed through 6 months postpartum. 
 
F3. Study Setting and Site: The proposed study will be at conducted at five public antenatal clinics in 
Lilongwe District, Malawi: Lumbadzi, Mitundu Nathenje, Area 18, and Bwaila health centers. Each of the five 
health centers provides ART services to HIV-infected women through the antenatal clinic during pregnancy, 
and also has separate ART clinics serving non-pregnant HIV-infected adults on the health center grounds. In 
Malawi, HIV-infected pregnant women typically initiate ART at an antenatal care clinic, and transition to an HIV 
clinic for care after delivery. Thus, the co-location of antenatal and ART services makes these health centers 
the ideal locations to serve HIV-infected women as they transition from receiving HIV care prenatally in an 
antenatal clinic, to postnatally in an ART clinic.   
 
In Malawi, all pregnant women presenting for care receive opt-out HIV testing at their first antenatal care visit. 
Women who test HIV+ undergo adherence counseling and start ART the same day. PND screening and 
assessment are rare to nonexistent at antenatal/ART clinics in Lilongwe, as in most clinical settings in Malawi.  
 
UNC Project in Lilongwe will serve as the administrative home for the study and has longstanding relationships 
with Bwaila FHU, antenatal/ART clinics in Lilongwe, and the Ministry of Health.  
 
 
F4. Study Population:  
 
Women (92 total): As of this protocol v3.2, we have recruited a total of 12 women from our original 3 clinics.  
As we launch activities at our two new clinics and reduce to 2 arms, we will seek to recruit 40 new participants 
per arm or 80 new participants total, for a total enrollment of 92 participants.  All 92 women will contribute to 
analyses of feasibility and acceptability, but only the new 80 women will contribute to between-arm 
comparisons due to the differences in sites.   
 
We will include 92 HIV-infected, depressed women initiating, re-initiating, or continuing ART who engage in 
ANC and are identified with antenatal depression at ≤34 weeks gestation to allow sufficient time for 
approximately 4 prenatal counseling sessions and approximately 2 postnatal counseling sessions. Women with 
a score >10 on the EPDS48,49 and/or > 8 on the SRQ-20 will be considered to be depressed and will be invited 
to participate.  
 
Inclusion criteria: 
- 
HIV-infected, pregnant women initiating, re-initiating, or continuing ART during antenatal care 
(ANC)  
- 
≤34 weeks gestation to allow sufficient time for approximately 4 prenatal counseling sessions and 
approximately 2 postnatal counseling sessions.  

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- 
Screened positive for depression with a score  >  8 on the SRQ-20  
- 
At least 18 years of age  
 
Feasibility of recruitment – Approximately 30 HIV-infected women initiate or re-initiate ART monthly at each 
of the study sites, or 150 women over 6 months, with ~90% presenting at ≤30 weeks. Based on our group’s 
systematic review34, we conservatively estimate 30% of HIV-infected women will have antenatal 
depression, suggesting that enrolling ~6 women per site per month  is feasible.  Utilization of two additional 
clinics will aid in timely participant recruitment should enrollment at the three primary sites lag behind 
expected targets. 
 
Psychosocial counselors (n=4 total): Trained psychosocial counselors will be identified to administer 
counseling sessions for both the AFB and EFB arm. We will recruit 2 female counselors for each primary 
intervention arm clinic to complete up to 4 individual prenatal counseling sessions and up to 2 postnatal 
group sessions (approximately 100 counseling sessions per counselor total over 4-6 months, and ~ 20 
counseling sessions per counselor per month). Group counseling will be offered on multiple days; each 
group will have 5-8 women attending 2 sessions.  
 
Research Assistants (n=3): Trained research assistants will be hired to conduct participant screening and 
to complete baseline and 6-month data collection with all participants at each of the five study clinics.  
Research assistants will spend the majority of their time in each of the three primary study sites and rotate 
between the remaining two clinics as needed.   
 
Supervisors (n=2): Supervision for counselor will be provided by the study mental health professionals 
(n=2).  
 
F6. Pilot Trial Arms 
We have adapted the Friendship Bench intervention to meet the particular needs of HIV-infected women with 
PND and enhanced it to additionally support engagement in perinatal HIV care. We will conduct a pilot trial, 
comparing Enhanced Friendship Bench (EFB), to enhanced standard care (ESC).  
 
1. Arm 1: Adapted Friendship Bench (AFB - DROPPED) – [Note: This arm is no longer included in the trial 
as of protocol v3.1, but this text is retained to aid with understanding Arm 2.] The existing Friendship Bench 
intervention protocol has been adapted to address the unique needs of HIV-infected women. AFB will include 4 
individual prenatal counseling session (in-person or by phone) and 2 group postnatal counseling sessions. No 
specific retention support will be provided, but participants may identify barriers to engagement in HIV care to 
address during their pre- or postnatal counseling sessions.   
 
Prenatal counseling sessions (n=4) will be facilitated by psychosocial counselors and are designed to align 
with the WHO’s recommended 4 antenatal care visits. However, since many women in sub-Saharan Africa do 
not attend all 4 antenatal sessions, prenatal counseling sessions can occur outside antenatal visits, including 
by phone. The first session includes three components called Opening the Mind, Uplifting, and Strengthening, 
with subsequent sessions building on the first. Opening the Mind refers to the therapeutic process by which, 
through asking questions, clients are encouraged to open their minds to identify their problems, choose one to 
work on, identify a feasible solution, and agree on an action plan through an iterative process guided by the 
counselor. Each structured session lasts 30-45 minutes and will be conducted in a private clinic room, or by 
phone, in participant’s local language (Chichewa). Participants will receive up to 4 text messages, phone calls, 
or both during their treatment course to reinforce the PST approach and encourage them to follow their action 
plan. After 4 sessions of individual prenatal therapy, the counselor can refer participants not improving or with 
suicidal ideation to a supervisor trained in mental health to reassess and manage the case. Case management 
may include additional counseling or pharmacotherapy, at the discretion of the managing clinician.  
 
Postnatal counseling sessions (n=2) will be facilitated by a psychosocial counselor. In Malawi, HIV-infected 
women transition from receiving HIV care at an antenatal clinic to an ART clinic, typically by 6 weeks 
postpartum. Postnatal group counseling session will occur after a woman has transitioned to receiving care at 
an HIV clinic. In the Adapted Friendship Bench arm, women will be invited to attend 2 postnatal group-
counseling sessions. Postnatal group counselling sessions will be scheduled to coincide with a woman’s 

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regularly scheduled ART visits. All sessions will include 5-8 women and will take place on a variety of days to 
accommodate women’s varying ART clinic appointment schedules. Group counseling sessions will last ~60 
minutes and will be conducted in a semi-private clinic location in Chichewa.  
 
2. Arm 2: Enhanced Friendship Bench (EFB) -  EFB will include all elements of AFB, but will additionally 
integrate retention strategies. Retention Strategy 1. Strengthening social support: To provide additional social 
support for participants, we will add one (optional, recommended) “person important to me” session to the 
AFB. At this session, the participant will be invited to bring with her to one session a person of her choice who 
can be a support to her in managing both her HIV and/or depression, such as a partner, friend, or companion.   
To reduce the risk of inadvertent disclosure of one’s HIV or depression status, prior to this social support 
session, we will ask all participants beforehand whether the person that she identified knows her HIV and 
depression status. If they do not, we will discuss risks with her before proceeding as she wishes.  The social 
support session may be conducted in person, in a private clinic room, or by phone. Retention Strategy 2. Home 
visits:  In our formative research, perinatal women discussed their barriers to attend clinic visits to pick up their 
meds, especially during late stages of pregnancy and immediately following birth. One common suggestion the 
women discussed to support HIV care engagement was home visits when they were unable to attend clinic. To 
assist women with receiving their medication during late pregnancy and postpartum, we will conduct up to six 
home visits in the EFB arm. To preserve patient confidentiality, prior to initiating home visits the participant and 
her counselor will agree on a “cover story” for the counselor’s identity when she comes to visit (“This is my aunt 
from…”). The counselor will be able to deliver her medications. The counselor will also conduct a counseling 
session, if they have enough privacy to do so.  Home visits may begin monthly starting in the third trimester 
and continuing through up to 6 months postpartum.  The participant may decline home visits, if for example 
she is concerned that the home visit would pose a risk for her with her community or family.   
 
3. Enhanced Standard Care (ESC).  Standard care for mental health in public facilities in Malawi includes 
options for basic supportive counseling by the primary provider or nurse, medication management by the 
primary provider, referral to the clinic psychiatric nurse or mental health clinic (most clinics have either an 
assigned psychiatric nurse or a mental health clinic that visits on a rotating basis), or in more severe cases 
referral to the psychiatric units at tertiary care hospitals (in the Lilongwe region, this is Bwaila Hospital). For this 
study, standard care will be enhanced by a trained study research assistant who will provide mental health 
screening; basic psychoeducation education on common mental disorders; and (if indicated) facilitation of 
referral to the clinic’s psychiatric nurse or mental health clinic or to Bwaila Hospital.  The RA will also ensure 
that the patient sees a nurse or clinical officer that day to evaluate whether the referral plan is appropriate and 
to ensure that the participant is safe to go home. The research assistant will have up to 3 follow-up contacts 
with the participant to assess whether she has followed up on recommended referrals or treatment plans and 
to assess whether any further outreach is indicated.24  
 
F7. Intervention delivery and supervision – Our adapted and enhanced counseling interventions will be 
delivered by trained psychosocial counselors. Prior to study enrollment, counselors will be trained to deliver the 
Adapted Friendship Bench and Enhanced Friendship Bench interventions. During the pilot, counselors will be 
supervised by District Health Promotion Officers and the study psychiatrist.    
• 
Setting: During the prenatal period, individual counseling sessions will be facilitated by counselors in a 
private location within the antenatal clinic, or via phone. Due to issues around stigma and disclosure for 
both HIV-infected and depressed women, individual, rather than group, counseling sessions will be 
preferable to ensure patient privacy in the antenatal clinic which serves the general pregnant population. 
During the postnatal period, group counseling sessions will be facilitated by counselors at a semi-private 
location on the grounds of ART clinics. The group counseling sessions will be described as “friendship 
groups”, with no mention of PND, to reduce possible stigma associated with depression. ART clinics serve 
only HIV-infected women, reducing concerns about HIV-related stigma or disclosure.  
• 
Training: counselors serving as counselors from both antenatal and ART clinics will attend a 2-week 
training. Topics included in the training will be PND, counseling skills, problem solving therapy, and self-
care. Dr. Chibanda and members of his team will deliver the training. All training sessions will be audio-
recorded for fidelity and assessed using a checklist to ensure the counselors had covered all the critical 
components. 

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• 
Supervision: counselors will be supervised and supported by the study’s two mental health professionals 
(Dr. Kulisewa and Mr. Udedi) who will be contacted in the event that a client presents with very high scores 
on the EPDS or suicidality.  A Friendship Bench trainer will provide weekly group supervision for 
counselors.  
 
 
F8. Intervention Delivery and Data Collection. Prior to launch, each of the three primary clinics will be 
randomly assigned to  Adapted Friendship Bench (AFB), Enhanced Friendship Bench (EFB) or enhanced 
standard care (ESC), with the exception of the fourth and fifth clinics which will individually randomize eligible 
participants to one of the two remaining study arms. 
 
Screening and Enrollment HIV-infected women who are initiating, re-initiating, or continuing ART during 
pregnancy under the Option B+ will be informed about the study by their provider and invited to participate. 
Screening and enrollment procedures will take place on the same day as a woman’s ANC visit. Women who 
consent to participate (Appendix 1) will be given an initial screening for perinatal depression or anxiety using 
the Patient Health Questionnaire (PHQ)-2 and/or the Generalized Anxiety Disorder (GAD)-2 as a part of 
routine antenatal care. Women who show symptoms perinatal depression or anxiety will be asked to complete 
the Edinburgh Postnatal Depression Scale (EPDS) and/or the Self-Reporting Questionnaire (SRQ)-20 with a 
trained psycho-social counselor to confirm symptoms (Appendix 2). Women who screen positively on either the 
PHQ-2/GAD-2, the EPDS (>10) or SRQ-20 (>8) will be invited to participate. Women screening positive for 
depression who choose not to participate will be referred to a mental health provider for care.  
 
Study Visits (n=2 for participants in all arms) 
 
 Baseline Visit: At the baseline visit, women will be asked to fill out a questionnaire about their mental health, 
HIV, and reproductive health history. In addition to assessing depression with the EPDS, we will assess the 
prevalence of common mental disorders using the Self-Reporting Questionnaire (SRQ-20). The SRQ-20 was 
designed by the World Health Organization as a screening tool for common mental health disorders (CMD). 
The SRQ-20 has 20 questions exploring symptoms of depression, anxiety and somatic complaints, rather than 
a specific diagnosis of depression or anxiety. The SRQ-20 was validated in Malawi and is available in 
Chichewa. 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 48-51 A cut-point of 8 or above has been previously used 
in Malawi to identify probable CMD. The baseline interview will also assess socio-demographics, self-reported 
health, and key structural and psychosocial factors including trauma history, intimate partner violence (IPV), 
other violence in the home, socioeconomic measures, coping, social support, self-efficacy, and experiences of 
stigma related to HIV and mental health (Appendix 2). Measures of trauma, IPV, and other violence will be 
important for understanding participants’ experience of depression in their broader socioecological context.  
We have used these measures previously in similar settings.  
 
6-month Postpartum Visit: At 6 months postpartum, HIV-infected women will be asked to complete the EPDS 
and SRQ-20 either in-person of by phone. Viral load measures for all HIV-infected women will be collected by 
study personnel at 6 months postpartum. Information on HIV appointment attendance and infant HIV testing 
during the first 6 months postpartum will be collected from a participant’s medical record, as we are doing in 
our ongoing USAID project. Information on infant anthropometry (length, weight, head circumference), infant 
physical health (presence of respiratory illness, diarrhea, and immunization records) and infant development, 
assessed using the Observation of Mother-Child Interaction (OMCI) guide, the  PAMANED Study  
Family Care Indicators Questionnaire in Chichewa, and the WHO Indicators of Infant and Young Child 
Development (IYCD) Item guide, which have been validated for use in children as young as 4 months of age, 
will also be collected (Appendix 2).The OCMI portion of the 6 month postpartum visit will be video-recorded to 
review the fidelity rating after the visit has occurred. HIV-infected women, counselors and supervisors will be 
asked to complete a brief exit interview either in-person or by phone to assess the feasibility and acceptability 
of the intervention. 
 
Counseling Sessions (EFB n= up to 7; ESC, n=0):  
Women will be followed from study enrollment at their ANC visit through 6 months postpartum. Women in the 

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AFB and EFB arms will receive approximately 4 prenatal individual counseling sessions and approximately 2 
optional, but recommended postnatal group counseling sessions (n=up to 6 counseling session). Women in 
the EFB arm will receive up to the same number of counseling sessions (4 prenatal and 2 postnatal) as women 
in the AFB arm, with an additional social support session described in section F6 (n=up to 7 counseling 
sessions). Women in the ESC arm will not receive counseling sessions, but will receive psychoeducation from 
a trained research assistant, referrals as needed, and follow-up calls to assess whether referrals were acted on 
and whether any further unmet mental health needs remain (n=0 counseling sessions). Counseling sessions 
will take place every 1-2 weeks at the antenatal care clinic, or via phone, during the prenatal period and 
approximately monthly during the postnatal period to coincide with routine ART refill visits.  
 
Data Collection: At each counseling session (prenatal and postnatal) women will be asked to complete the 
EPDS and SRQ-20 to assess their mental health status.  
 
F9. Outcomes – The primary goal of this R34 application is to evaluate the feasibility, acceptability, and fidelity 
of a counseling intervention to improve PND and engagement in HIV care among HIV-infected women. 
Recognizing the small sample size, indicators of preliminary effectiveness of the intervention for mental health 
and engagement in care outcomes will be reported as secondary outcomes. Primary and secondary outcomes 
will be assessed at 6 months postpartum and compared across the study arms.  
 
F9.a. Primary Outcomes: 
Feasibility will be defined as the ability to successfully enroll and retain HIV-infected, depressed women in the 
pilot intervention. Feasibility will be assessed as the number of women enrolled, a comparison of planned to 
actual enrollment and reasons for non-enrollment, and the proportion of women retained in each arm at 6 
months postpartum.  
 
Acceptability will be defined as the ability to deliver a culturally and resource-appropriate intervention. 
Acceptability will be assessed through brief exit interviews among a subset of HIV-infected women. Exit 
interviews will include both closed and open-ended questions and will assess how easy the intervention was to 
participate in or deliver, the perceived usefulness of the intervention, and suggestions for improvement.  
 
Fidelity will be defined as adherence to the intervention protocol. Fidelity to session content for both individual 
and group counseling sessions will be assessed by members of the Friendship Bench team (DHO or study 
psychiatrist), by using a checklist of intervention characteristics either during direct monitoring or using audio 
recording of up to 3 randomly chosen sessions per counselors. Scoring either ‘meeting expectations’ or 
‘exceeding’ expectations’ on at least 80% of applicable checklist items during each session will be considered 
fidelity to the intervention protocol.  
  
F9.b. Secondary Outcomes: Secondary outcomes will be used to provide preliminary information about 
effectiveness at 6 months postpartum, taking into consideration the limited sample size for the pilot project. 
Composite outcome: Retained in HIV care, with improved depression: We will assess a combined outcome at 
6 months of whether a woman attended an HIV visit within the last 30 days and achieved remission (defined as  
≥50% improvement in SRQ-20 score from baseline and an SRQ score <8). We will compare the following 
additional outcomes at 6 months postpartum: Self-Reporting Questionnaire (SRQ-20): The proportion of 
women reporting a score >8; Retention in HIV Care: (a) The proportion of women who attended an HIV care 
visit in the last 30 days; (b) considering the increase in visit spacing during the COVID-19 pandemic, we will 
consider a second definition of retention in HIV care of at least 2 visits at least 30 days apart in the first 6 
months postpartum; Viral Load Suppression: The proportion of women with a HIV RNA level <1000 copies/mL; 
Infant health: the proportion of women whose infants received an HIV RNA test .  
 
F10. Statistical Analysis – Baseline mental health, HIV, and reproductive health characteristics of women will 
be compared across 2 study arms using t-tests for continuous variables and chi-square tests for categorical 
variables to assess balance across study arms. Primary Outcomes – Quantitative measures of feasibility, 
acceptability, and fidelity will be summarized using means and standard deviations or proportions and 
compared across arms using statistical models for continuous or binary outcomes, as appropriate. Specifically, 

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we will compare the mean number of women enrolled and the proportion of women retained in EFB or ESC 
through 6 months postpartum (feasibility); the proportion of participants who found the intervention easy to 
administer and helpful (acceptability), and the proportion of counseling sessions scoring either ‘meeting 
expectations’ or ‘exceeding’ expectations’ on at least 80% of applicable checklist items (fidelity) across study 
arms. Secondary Outcomes will be analyzed as above at 6 months postpartum across 2 study arms. In 
addition, statistical models examining differences in SRQ-20 scores at 6 months will be generalized linear 
models.  
 
F11. Sample Size. The primary goal of this R34 proposal is to evaluate the feasibility, acceptability, and fidelity 
of the adapted and enhanced Friendship Bench intervention to improve PND and engagement in HIV care 
among HIV-infected women. In Aim 3, we will enroll 92 HIV-infected women with PND in a 2-arm pilot (n=12 
total in the clinic-randomized phase, n=40 women per arm in the individually randomized phase) to compare 
enhanced standard care with the enhanced Friendship Bench intervention. Information on preliminary 
effectiveness of the intervention across a range of mental health and engagement in HIV care outcomes will be 
assessed, but interpreted cautiously as effectiveness is not the primary aim of this pilot study. Intervention 
effectiveness will subsequently be assessed in a large-scale clinic-randomized controlled trial. Given that the 
objective of this analysis is to estimate feasibility, acceptability, and fidelity of the described interventions, 
feasible sample sizes (n=40/arm; 92 including both the clinic-randomized and individually randomized phases) 
were determined according to clinic patient volumes and estimated perinatal depression among women living 
with HIV in the study setting.  Precision estimates for the given sample size are based on two-tailed statistical 
significance tests and a Type 1 error probability (α) of 0.05.  The sample of 92 women (40 per arm) will be 
sufficient to estimate quantitative measures of feasibility and acceptability with reasonable precision (e.g., 
confidence intervals around proportions of ±5-9 percentage points across all arms, and ±9-17 percentage 
points within a given arm).  This margin of error was estimated using a desired sample size of 92 and 
population feasibility and acceptability proportions ranging from 10 to 50%. 
 
E. Potential Challenges and Solutions 
What if women are lost to follow-up (LTFU) between pre and postnatal care? Our proposal directly 
addresses the high rate of LTFU in the postnatal period2,52 for women on Option B+ by providing linkage to 
care coordination from the antenatal to ART clinic and measuring engagement in care through 6 months 
postpartum. The information gathered at the pilot stage will help to inform the design of a large-scale 
randomized controlled trial to improve PND and engagement in HIV care during the peripartum period.  
Will group counseling sessions be difficult to coordinate among multiple women? Our team has 
successfully coordinated group counseling sessions as a part of the original Friendship Bench intervention,24 
and among postnatal women.32  Uptake of group counseling sessions has been very high and it has been 
feasible to integrate the group counseling sessions into routine clinical care.  
What other retention support is available to HIV-infected women and how will this influence this study? 
During this pilot phase, we will carefully record what other retention support is available to HIV-infected women 
at the study sites and other area clinics, and how frequently women access these services. Currently at our 
five sites these services consist of tracing patients who have defaulted for >2 months.  Tracing is done either 
by clinic personnel, depending on available MoH funding for transportation, or by staff of the local NGO 
Lighthouse Trust through PEPFAR and CDC funding.  A time-updated understanding of available retention 
support services will be critical in order to design the subsequent RCT to test the effectiveness of the 
Friendship Bench in improving PND and engagement in HIV care.   
 
G. Timeline for Work Plan 
Timeline 
2019 
2020 
2021 
  
Aug 
Sep 
Oct 
Nov 
Dec 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Continued planning and development 
  
  
  
  
  
  
  
  
  
  
  
Post job openings and hire staff 
  
  
  
  
  
  
  
  
  
  
  
Staff training 
  
  
  
  
  
  
  
  
  
  
  
Launch 3-arm pilot trial 
  
  
  
  
  
  
  
  
  
  
  
Pilot accrual and follow-up; Fidelity monitoring 
  
  
  
  
  
  
  
  
  
  
  

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Exit Interviews 
  
  
  
  
  
  
  
  
  
  
  
Data analysis, manuscript preparation, RCT planning 
  
  
  
  
  
  
  
  
  
  
  
 
 
H. Dissemination of Results 
Results from this study will be shared with the Community Advisory Board at UNC-Project and other key 
stakeholders, including HIV-infected women, community members, HIV and mental health providers, the 
National Health Sciences Research Committee, and Ministry of Health officials in Malawi. We will also 
disseminate our results through presentation at international scientific conferences focused on HIV, mental 
health, or women’s health and through publication in peer-reviewed journals.  
 
 
I. Impact and Future Directions: PND is extremely common in sub-Saharan Africa and negatively affects 
women, infants, and communities. For HIV-infected women, PND may also adversely affect perinatal 
engagement in HIV care, putting them at an even greater risk of poor HIV outcomes. Resource-appropriate 
interventions to address PND, and its possible impact on engagement in HIV care, are urgently needed. The 
information gathered in this proposal will lead to an R01 application to test our intervention in a randomized 
controlled trial.  
 
J. Protection of Human Subjects 
This Human Subjects Research meets the definition of clinical research. The data collection and analyses 
outlined in this proposal will be reviewed by the University of North Carolina Institutional Review Board, in the 
U.S., and the Malawi National Health Sciences Research Committee (HSRC) before any data collection or 
analysis occurs. 
The study will also be reviewed and informed by the existing community advisory board (CAB) of UNC Project 
in Malawi.  The CAB will review the study protocol prior to implementation and provide feedback. The CAB 
meets monthly. 
1. Risks to Human Subjects 
 
a. Human Subjects Involvement and Characteristics 
In our pilot study, we will recruit 92 prenatal HIV-infected women who consent to participate and screen 
positive for mental health disorders during pregnancy on the EPDS or SRQ-20 questionnaires, indicating 
perinatal depression (PND) or common mental health disorders. Psychosocial counselors (n=4), research 
assistants (n=3), and supervisors (n=2) will be considered a secondary population. The goal of or study is to 
evaluate the feasibility, acceptability, and fidelity of the enhanced Friendship Bench intervention to improve 
PND and engagement in HIV care among HIV-infected women. Women will be recruited from the Lumbadzi, 
Mitundu, Nathenje, Area 18, and Bwaila healthcare centers in Lilongwe, Malawi when they present for prenatal 
care initiation and are HIV-positive. All women who screen positive for depression will be referred for mental 
health treatment to the nearest provider.  
 
Rational for including pregnant women: Option B+ is a program of the Malawi Ministry of Health to provide 
lifelong ART to all HIV-infected women who are pregnant. A critical component to the success of Option B+ is 
keeping women engaged in HIV care – something that has emerged as a challenge since Option B+’s 
inception in Malawi. Women with PND may be at an increased risk of disengaging from HIV care. Our project 
includes pregnant women in an effort to improve treatment options for PND among this population, with the 
goal of also improving engagement in HIV care and ultimately the effectiveness of Option B+.  
 
The study characteristics of the study population are expected to be similar to those of all HIV-infected, 
peripartum women with PND in public healthcare centers in Lilongwe, Malawi.  
 
Participants who live outside of the Lilongwe District or are less than 18 years old will be excluded.  
 
b. Sources of Materials 

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All data will be gathered specifically for the purpose of the study. For Aim 1, women will undergo a screening 
and enrollment visit (baseline), up to six counseling sessions, and will have outcomes assessed at 6 months.  
 
Screening and Enrollment HIV-infected women who are initiating, re-initiating, or continuing ART during 
pregnancy under the Option B+ will be informed about the study by their provider and invited to participate. 
Screening and enrollment procedures will take place on the same day as a woman’s ANC visit. Women who 
consent to participate (Appendix 1) will be given an initial screening for perinatal depression or anxiety using 
the Patient Health Questionnaire (PHQ)-2 and/or the Generalized Anxiety Disorder (GAD)-2 as a part of 
routine antenatal care. Women who show symptoms perinatal depression or anxiety will be asked to complete 
the Edinburgh Postnatal Depression Scale (EPDS) and/or the Self-Reporting Questionnaire (SRQ)-20 with a 
trained psycho-social counselor to confirm symptoms (Appendix 2). Women who screen positively on either the 
PHQ-2/GAD-2, the EPDS (>10), or SRQ-20 (>8) will be invited to participate. Women screening positive for 
depression who choose not to participate will be referred to a mental health provider for care.  
 
Study Visits (n=2 for participants in all arms) 
 
 Baseline Visit: At the baseline visit, women will be asked to fill out a questionnaire about their mental health, 
HIV, and reproductive health history. In addition to assessing depression with the EPDS, we will assess the 
prevalence of common mental disorders using the Self-Reporting Questionnaire (SRQ-20). The SRQ-20 was 
designed by the World Health Organization as a screening tool for common mental health disorders (CMD). 
The SRQ-20 has 20 questions exploring symptoms of depression, anxiety and somatic complaints, rather than 
a specific diagnosis of depression or anxiety. The SRQ-20 was validated in Malawi and is available in 
Chichewa. 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 50,51 48-51 A cut-point of 8 or above has been previously used 
in Malawi to identify probable CMD. The baseline interview will also assess socio-demographics, self-reported 
health, and key structural and psychosocial factors including trauma history, intimate partner violence (IPV), 
other violence in the home, socioeconomic measures, coping, social support, self-efficacy, and experiences of 
stigma related to HIV and mental health (Appendix 2). Measures of trauma, IPV, and other violence will be 
important for understanding participants’ experience of depression in their broader socioecological context.  
We have used these measures previously in similar settings.  
 
6-month Postpartum Visit: At 6 months postpartum, HIV-infected women will be asked to complete the EPDS 
and SRQ-20, either in person or by phone. Viral load measures for all HIV-infected women will be collected by 
study personnel at 6 months postpartum. Information on HIV appointment attendance, infant birthweight, and 
infant HIV testing during the first 6 months postpartum will be collected from a participant’s medical record, as 
we are doing in our ongoing USAID project. Information on infant anthropometry (length, weight, head 
circumference), infant physical health (presence of respiratory illness, diarrhea, and immunization records) and 
infant development, assessed using the Observation of Mother-Child Interaction guide, the PAMANED Study 
Family Care Indicators Questionnaire in Chichewa, and the WHO Indicators of Infant and Young Child 
Development (IYCD) Item guide, which have been validated for use in children as young as 4 months of age, 
will also be collected (Appendix 2). HIV-infected women, counselors and supervisors will be asked to complete 
a brief exit interview, either in person or by phone, to assess the feasibility and acceptability of the intervention. 
 
Counseling Sessions (EFB n= up to 7; ESC, n=0):  
Women will be followed from ART initiation through 6 months postpartum. Women in the EFB arm will receive 
approximately 4 prenatal individual counseling sessions and approximately 2 optional, but recommended 
postnatal group counseling sessions (n=up to 6 counseling session). Women in the EFB arm will receive an 
additional social support session described in section F6 (n=up to 7 counseling sessions). Women in the ESC 
arm will not receive counseling sessions, but will receive psychoeducation from a trained research assistant, 
referrals as needed, and follow-up calls to assess whether referrals were acted on and whether any further 
unmet mental health needs remain (n=0 counseling sessions). Counseling sessions will take place every 1-2 
weeks at the antenatal care clinic, or via phone, during the prenatal period and approximately monthly during 
the postnatal period to coincide with routine ART refill visits.  
 
Data Collection: At each counseling session (prenatal and postnatal) women will be asked to complete the 

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EPDS and SRQ-20 to assess their mental health status 50,51 
 
All data will be collected by trained research assistants and stored in a database on the secure UNC Project 
Server, which only the PI will have access to. For each aim, participants will be assigned a study identification 
number. This study identification number will be linked to their name and clinic site through a separate log 
book. The log book will be kept at UNC Project’s offices in a locked cabinet. At the conclusion of the study the 
link between the participant’s name and study number will be destroyed.  The principal investigator will be the 
only person with access to the subject identities.   
 
c. Potential Risks – Including for Pregnant Women 
Potential risks to the study population include loss of confidentiality and social harms to participants. Loss of 
confidentiality could include disclosure of HIV status. Social harms include emotional harm, economic or 
financial harm to the participant related to a woman’s HIV or PND status being disclosed. While study 
participants will be pregnant at baseline, we do not anticipate any additional risks to women or their fetuses by 
being involved in the study. Procedures to protect against these risks are described below. 
2. Adequacy of Protection against Risks 
 
a. Recruitment and Informed Consent 
 
The research study will be described briefly to all women initiating, reinitiating, or continuing ART at Lumbadzi, 
Mitundu, Nathenje, Area 18, and Bwaila healthcare centers in Lilongwe while they wait in the reception area. 
Once a participant is determined to be eligible for the study and following the standard post-test counseling, a 
trained interviewer will complete an informed consent process with each participant in their native language, 
Chichewa. During the informed consent process, the counselor will describe the procedures to be followed, the 
risks and benefits of participation, the duration of participation, and the steps taken to protect participant’s 
confidentiality, particularly with respect to keeping all personal and private information (such as HIV and PND 
status) private. Illiterate participants may sign the consent form via thumbprint, in the presence of an impartial 
witness (Appendix 1). Any questions or concerns about privacy will be answered by the counselor or referred 
to the PI, who will address them. HIV-infected women initiating, reinitiating, or continuing ART prenatally who 
screen positive for perinatal depression or anxiety on the PHQ-2, GA-2, EPDS (>10) or SRQ-20 (>8) measure, 
and who consent to participate will be enrolled. All women who screen positive for PND will be referred to 
outpatient psychiatry services that are currently available and staffed by master’s level nursing staff that can 
prescribe antidepressant medications.  
Written informed consent will be obtained from each participant and participants will be provided with a copy of 
their informed consent forms if they are willing to receive it (Appendix 1).  Study staff will document the 
informed consent process. 
b. Protection against Risk  
Risks of loss of confidentiality or social harms to participants will be minimized by: 1) training of study staff in 
the ethical conduct of research; 2) strict protection of confidentiality and personal information; 3) close 
monitoring of social harms with appropriate IRB reporting.  
Discussing personal information – Data collection will include asking women about their mental health, social 
support, alcohol use and intimate partnerships. All data associates will be trained to keep all information 
confidential. Research assistants will be trained, and participants informed, that they can pause or discontinue 
a research interview at any time if they find the topic upsetting.   
Data security - All study data, including interview guides, audio recordings of interviews, interview transcribes, 
and logbooks will be kept in a locked cabinet at the UNC Project data center, where they will be maintained in 
a locked office at UNC Project accessible only to the principal investigator. Interviews that are transcribed and 
computerized will be stored on the secure central server at UNC Project. For analysis purposes, data will be 
de-identified before coding and analysis. Only the principal investigator, data entry personnel, and assigned 
data analysts will have access to the de-identified electronic study database. Video recordings will be 

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transferred onto the OneDrive secure server with access restricted to study personnel, where they will be 
reviewed to verify the accuracy of the interviewer rating.   
Home visits for women - For women who receive home visits as part of the EFB, information on the 
participant’s HIV status or the nature of the home visitor’s interest in visiting the participant will not be 
disclosed. All women presenting to HIV clinic sites and accepting the services are considered fully protected by 
the policies and guidelines outlined in the Government of Malawi’s ‘National HIV/AIDS Policy, October 2003’, 
‘HIV/AIDS Counseling and Testing, Guidelines for Malawi, Second Edition, 2004’. No participants will be 
identified in any report or publication about this study. 
3. Potential Benefits of the Proposed Research to the Subjects and Others 
This study has some minimal risks associated with participation and we anticipate that few participants will 
experience negative events as a result of taking part in the study. This research will improve our understanding 
of how an adapted and enhanced counseling intervention may improve PND and engagement in HIV care. 
Long-term, supporting HIV-infected women with PND through a counseling intervention carried out by 
counselors is expected to reduce PND, improve engagement in HIV-care, and ultimately improve women’s 
health and HIV outcomes. Therefore, the risk to individual participants in the study is small and the potential 
benefit to society is substantial. 
 
Individuals participating in study research interview visits will receive a transport reimbursement of 7,000 
Malawian kwacha (about US$10) at the completion of the baseline and 6-month interviews. Individuals 
participating in counseling sessions will receive a transport reimbursement of 3,500 Malawian kwacha (about 
US$5) at the completion of each counseling session. 
 
4. Importance of the Knowledge to be Gained 
This project will provide important information about whether an adapted and enhanced counseling intervention 
is a feasible and acceptable strategy to improve PND and engagement in HIV care among HIV-infected 
women. Disengagement from HIV care is a critical issue among women taking ART under the Option B+ 
program. In the general HIV-infected population, depression has been identified as an important detriment to 
retention in HIV care. Rates of PND are high among HIV-infected women in Malawi. However, the importance 
of addressing PND in the context of retention in care support has received little attention. The proposed project 
builds on formative research on women and healthcare providers’ experiences with and preferences for 
treating PND among HIV-infected women through qualitative interviews, and uses that information to launch a 
pilot study testing culturally-adapted and enhanced forms of an existing, evidence-based counseling 
intervention to treat PND and support engagement in HIV care among HIV-infected women.  
 
5. Data Safety and Monitoring Plan 
This project involves a pilot randomized controlled trial compared the Adapted Friendship Bench and 
Enhanced Friendship Bench interventions, to enhanced standard care, to address PND and engagement in 
HIV care in HIV-infected women. Participation in the study involves sharing possibly personal or sensitive 
information, such as HIV-status and experiences related to PND. In order to keep participant’s private 
information and identity safe, we will store all data on a secure server at UNC Project in Malawi, which only the 
PI will have access to. In addition, to prevent any unforeseen risk we will also provide all participants with study 
contact information and ask that they contact us immediately if they experience any social harm or other 
adverse event, such as disruption of families, acts of discrimination or physical harm. If a social harm is 
reported, a short questionnaire will be administered to characterize the social harm and describe its impact.  All 
reported social harms will be documented and communicated to the Malawi Health Science Research 
Committee (HSRC) and the UNC Institutional Review Board within 7 days.  
 
 

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H.  Budget 
Line Item 
Cost per unit 
(USD) 
# and type units 
Total Cost 
1. Study Staff 
  
  
  
Counselors 
$200  
4 x 12 months  
$ 9,600  
Research assistants* 
__$200 
3 x 12 months 
$7,200 
Sub-total 
  
  
$ 16,800  
  
  
  
  
2. Compensation for study 
participants 
  
  
  
Study visit travel reimbursement 
$10  
105 participants x 2 
study visits (baseline 
and 6-month follow-
up visit 
$2,100  
Counseling session travel 
reimbursement 
$5 
35 AFB participants 
x 6 counseling 
sessions;  
35 EFB participants 
x 7 counseling 
sessions 
$2,275 
Sub-total 
  
  
$4,375 
  
  
  
  
3. Other Research Costs 
  
  
  
Paper, toner, and printing costs 
 
 
$1,000 
Fuel for study activities 
 
 
$500 
Airtime for study staff 
 
 
$525 
Tablets for data collection 
 
 
$500 
Translation Fees 
  
  
$200  
Malawi IRB Fee 
  
  
$150  
Sub-total 
  
  
$2,875  
  
  
  
  
Total 
  
  
$24,050  
10% NHSRC fee 
  
  
$2,405  
*Research assistants will float between clinics as needed to meet project needs. 
   
   
I. BUDGET JUSTIFICATION  
 
PERSONNEL 
Counselors in Malawi ($9,600 - 100% effort for 12.0 months) – Four counselors (2 per intervention clinic) 
will be hired to conduct pre- and post-natal counseling sessions and home visits for HIV-infected women over a 
12 month period. $200 salary/month x 4 counselors x 12 months = $9,600.  
 
Research Assistants in Malawi ($7,200 -100% effort for 12.0 months)- Three research assistants will be hired 
to conduct  mental health screening with the Edinburgh Postnatal Depression Scale and Self-Report 
Questionnaire-20 and to complete data collection for study visits over a 12 month period. $200 salary/month x 
3 RAs x 12 months = $7,200.  
 
Total Personnel Costs $16,800 
 

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COMPENSATION FOR STUDY PARTICIPANTS 
Study Interview Travel Reimbursement ($2,100) – A total of 105 participants will be included in our 
proposed aim. Each participant will receive 7,000 Malawi Kwacha (~$10/person) as an incentive to participate 
in the study for each study visit. $10 x 105 participants x 2 visits (baseline and 6 months) = $2,100.   
 
Counseling Session Travel Reimbursement ($2,275) - Participants in the EFB arm (n=up to 6 counseling 
sessions) and the AFB (n=up to 7 counseling sessions)  will also receive travel reimbursement as an incentive 
to attend intervention counseling sessions. 35 x 5 x 6 = $1050 + 35 x 5 x7 = $1,225, for a total of $2,275. 
 
Total Compensation for Study Participants Costs $4,375 
 
OTHER RESEARCH COSTS 
Paper, toner and printing costs ($1,000) – We have budged $1000 to cover the costs of paper, toner, and 
printing costs for all study material, including informed consent forms, screening and enrollment logs, and logs 
for counselling sessions.  
 
Fuel for study activities ($500) – We have budged $500 to cover the costs of fuel for study-related activities, 
including getting staff to and from study sites and for home visits.  
 
Airtime for study staff ($525) – We have budged $500 to cover the costs of airtime for study staff so they can 
be in contact with one another as needed and with the project coordinator. 
 
Tablets for data collection ($500) – We have budged $500 to purchase 3 tablets ($167 x 3 tablets) to support 
data collection activities.  
 
Translation and Transcription Fees ($200) – All study materials including informed consent forms, in-depth 
interview guides, and the Edinburgh Postnatal Depression Scale will be translated into Chichewa, the local 
language in Lilongwe, Malawi. Translation fees $200.  
 
Malawi IRB Fee ($150) – All research in Malawi must receive ethical approval from the National Health 
Science Research Committee, which charges a $150 fee to review all applications for ethical approval.  
 
Total Other Research Costs $2,875 
 
TOTAL COSTS: $24,050 
10% NHSRC Fee: $2,405 
 
 
 

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