Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression
Phase: NA
Conditions: Human Immunodeficiency Virus, Depression
Sponsor: Massachusetts General Hospital

ClinicalTrials.Gov PRS Cover Page 
 
 
 
 
 
 
 
 
Title: 
Project INSPireD: Integrating Nuanced Support for Perinatal 
Adherence and Depression  
  
 
 
NCT Number: 
NCT03069417  
 
 
Version Date: 
25 July 2016 
  
 
 
 

PROTOCOL 
 
 
Principal Investigator:  
Dr. Christina Psaros 
 
Site Principal Investigator:  Professor Jennifer Smit 
 
Project Title: 
INSPireD: Integrating Nuanced Support for Perinatal adherence 
and Depression 
 
Agency:   
Massachusetts General Hospital (MGH), Boston, Massachusetts, 
U.S.A. 
Maternal, Adolescent & Child Health Research (MatCH 
Research), University of the Witwatersrand, Durban, South Africa 
 
Funding:  
 
 
U.S. National Institutes of Health 
 
Version Date: 
 
25 July 2016 
 
 
 
TABLE OF CONTENTS 
 
1. Specific Aims …………………………………………………………………….2 
 
2. Background and Significance……………………………………....................2 
 
3. Research Strategy…………………………………………………...................4 
 
4. Tables and Figures  
 
i. 
Figure 1: The PMTCT “Cascade”…………………………………….11 
 
ii. 
Figure 2: Conceptual Model…………………………………………..12 
 
iii. 
Figure 3: Intervention Feasibility.....................................................13 
 
iv. 
Figure 4: Participant Flow Chart.....................................................14 
 
 
v. 
Table 1: List of proposed measures and assessments……………15 
 
5. References………………………………………………………………………17   
 
 

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1. SPECIFIC AIMS 
 
Specific Aims. Following standards for developing and initially testing a behavioural 
intervention, this study will involve an iterative process of intervention development.  The main 
aim is to conduct a pilot field test of a group based counselling intervention with HIV positive 
women in the perinatal period (N=40) as delivered by a lay counsellor (an individual who has 
completed the requirements to serve as an HIV counsellor, but who is not a clinical psychologist 
or social worker). The primary goal of the intervention is to improve the detection of perinatal 
depression and facilitate treatment, and increase adherence to antiretroviral therapy among HIV 
infected women during pregnancy and continued adherence during the postpartum period living 
in a resource limited setting; secondary outcomes will include reductions in stigma, increased 
social support, and improved adherence to other aspects of the postpartum PMTCT cascade, 
namely, contraception uptake. We have two hypotheses: Hypothesis 1a: Women who 
participate in the intervention will have lower levels of depression and stigma, and increased 
levels of adherence to antiretroviral therapy, and other aspects of the postpartum PMTCT 
cascade (e.g., contraception uptake), and social support at the end of the intervention. 
Hypothesis 1b: The intervention will be both acceptable and feasible.  
 
Please note that this is a follow up (Phase II) study of a previous submission approved and 
completed under the same investigators (Clearance Certificate M110963). 
 
2. BACKGROUND AND SIGNIFICANCE 
 
“There can be no health without mental health.” The United Nations Millennium 
Development Goals (MDGs) initiative illustrates eight key areas in which the lives of women 
worldwide are in need of vast improvement, including reductions in child mortality, improvement 
of maternal health, and the need to address issues related to HIV/AIDS. Researchers have 
argued that targeting maternal mental health is critical to the success of this global call to 
action1-3. Depression is approximately twice as common in women versus men worldwide, with 
rates highest during the childbearing years1. Sub-Saharan Africa (SSA) is one of the areas 
specifically targeted by the MDGs, where a recent review suggests depression rates of 4-17% 
during pregnancy and 3-48% in the postpartum period, with the highest rates reported in South 
Africa 2. 
 
Women of childbearing age in South Africa bear a substantial degree of HIV disease 
burden. Sub-Saharan Africa remains the epicenter of the HIV pandemic, with well over 24 
million people living with HIV in the region at the end of 2013.3 With respect to concentration of 
cases, South Africa is currently home to the largest number of HIV infected individuals in the 
world.3 Rates of new infections are consistently higher in women than in men, particularly 
women of reproductive age 3,4. In South Africa, data obtained from antenatal clinics suggest 
elevated rates of infection among pregnant women, documenting rates as high as 37% among 
women presenting for antenatal care5 . 
 
The synergy between HIV infection and reproductive events may leave women 
particularly vulnerable to depression. Documented rates of major depressive disorder among 
HIV infected individuals in South Africa range from 11%-35%6–8, and one study found elevated 
depressive symptomatology among 41% of women presenting for an HIV test in the context of 
antenatal care9. HIV related stigma remains present in SSA, and represents yet another factor 
influencing depression in this setting 10,11. Thus, the complexities of managing both pregnancy 
(many of which are unplanned) and a highly stigmatized chronic illness in a resource limited 
setting may predispose women to additional vulnerability for mood disturbance.  

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Maternal mental health is critically linked to the health of infants.  Reducing childhood 
mortality is another MDG, and is indisputably tied to maternal behaviour. The consequences of 
untreated depression alone during pregnancy and the postpartum for mothers and children are 
well documented and include poor attendance at antenatal care visits, low birth weight, early 
gestational age, inadequate nutrition, worse overall infant health, maternal disability, and 
disordered maternal-infant interactions (e.g., 12–16). Poor maternal mental health has also been 
associated with subsequent behavioural and mental health disorders in children (e.g., 17). Patel 
and colleagues14 describe the importance of effective maternal care during the first year of life 
particularly in resource limited settings given the increased environmental challenges that 
infants in these settings need to negotiate, such as inadequate shelter and sanitation. In these 
settings in particular, maternal depression may compromise mothers’ abilities to provide the 
best care possible to their infant.  
 
Depression impacts adherence to healthcare behaviours. Preventing mother to child 
transmission protocols (PMTCT) involve a “cascade” of interventions across several stages (see 
Figure 1). Utilization of PMTCT is considered suboptimal18–23 and a WHO report suggests that 
only 58% of pregnant women in SSA who needed antiretrovirals (ARVs) received them 24. Few 
studies to date have examined depression as a risk factor for non-adherence to various stages 
of PMTCT, though at least one report has documented an association between depression 
scores and infant HIV testing 11, while depression in general has been associated with poorer 
adherence to ARVs in resource limited settings 25–27. Pregnancy has been identified as a risk 
factor for falling out of HIV care 28,29, though to what extent this is due to depression remains 
unknown. Depression has also been associated with negative views about the health care 
system and fear of stigmatization among a sample of women receiving an HIV test during 
antenatal care; as the authors suggest, this could result in a failure to establish health care, 
which makes the delivery of interventions meant to optimize maternal and foetal health, such as 
PMTCT, nearly impossible 9. 
 
HIV-infected women in resource limited settings are required to negotiate complex 
barriers in order to maintain their health and the health of their infants. Structural barriers 
to healthcare, such as limited financial resources, distance from healthcare facilities, and 
availability of ARVs are commonplace in SSA 29,30. Social support is the term used to describe 
resources that are the result of social ties 31,32, and is emerging as a critical component of 
adherence to health behaviours in resource limited settings, and among individuals living with 
HIV 29. HIV related stigma may jeopardize one’s ability to leverage social support, and may thus 
impact adherence to health care behaviours such as attending clinic and taking ARVs. 
Pregnancy and postpartum health care behaviours may be especially vulnerable to stigma, as 
many interventions designed to help protect the infant from acquiring HIV (e.g., delivering in a 
hospital, modifications to breastfeeding behaviour) may lead to inadvertent disclosure of 
serostatus. Symptoms of depression, including social isolation, hopelessness, or decreased 
problem solving may represent yet another barrier to the utilization of social support.  
 
Better understanding of the role of modifiable, behavioural factors associated with non-
adherence to PMTCT may improve uptake of these cost-effective interventions. In South 
Africa overall, 29.5% (37.4% in KwaZulu-Natal) of antenatal women are HIV positive, and 
approximately 21,000 children become infected with HIV in South Africa alone every year5. 
According to the PMTCT Country Report for South Africa, only 51.7% of HIV infected women 
received treatment 33. Modelling studies have proposed that without increasing rates of 
adherence to PMTCT protocols, we will not see significant reductions in vertical transmission 34. 
It is important to maintain the health of HIV positive mothers in its own right, but mothers are 

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also the gateway to care for HIV exposed infants, and the eradication of vertical transmission 
cannot be achieved without them. Resource limited settings are different from resource rich 
settings such that individuals with HIV have to overcome a myriad of social and structural 
barriers to care. Alone, depression is a significant barrier to adherence, but adherence is likely 
compromised further by high levels of stigma and inability to effectively use social support. 
There is no “one-size-fits-all” approach to HIV care or prevention, thus understanding the way in 
which modifiable psychosocial factors contribute to PMTCT non-adherence is essential.  
 
2. Innovation  
The proposed study seeks to develop a scalable depression and adherence intervention that 
can be delivered by healthcare workers. While effective psychosocial treatments for depression 
exist, few studies to date have attempted to investigate the acceptability or feasibility of 
delivering these treatments to HIV infected women during the perinatal period in resource 
limited settings35,36, and none have attempted to treat diagnostic levels of depression. In a 
setting where there is a dearth of mental health providers or antidepressant medication, 
identification of such an intervention is critical. Maternal mental health has a direct impact on the 
well-being of children, including vertical transmission of HIV, and the current study seeks to 
identify modifiable barriers to PMTCT adherence in a resource limited setting. The proposed 
work will allow for the development of a targeted mental health intervention, which is based on 
empirical evidence. 
 
3. RESEARCH STRATEGY 
3.1 Conceptual framework. Our preliminary conceptual framework (see Figure 2) which was 
examined in phase 1 of this project (Clearance Certificate M110963) is based on a model of 
ART adherence developed by Bangsberg and Deeks 30, who propose that HIV-infected 
individuals living in Sub-Saharan Africa have to manage both “standard” barriers to HIV 
adherence (such as side effects and forgetting), and unique economic and structural barriers 
such as high transportation costs and “opportunity costs,” or loss of income that may result from 
time spent obtaining HIV related care. Their work suggests that individuals in resource limited 
settings need to rely on their community resources (or social support) in order to overcome 
structural barriers to ART adherence. Bangsberg and Deeks propose that high levels of HIV-
related stigma disrupt this system by making it difficult for individuals to access their community 
as a potential source of help (e.g., financial support, help with transportation to appointments). 
Stigma, inadequate social support, and mental health issues have all been cited as reasons for 
nonadherence to antiretroviral therapy 25–27. High levels of stigma have been described in 
postpartum women with HIV in South Africa 37, and may be  especially salient during the 
perinatal period, due to fears of disclosure amid the demands that managing a pregnancy and 
HIV infection place on women, including regular PMTCT appointments, delivering in healthcare 
facilities, and breastfeeding behaviour 22,38. Inability to get to a healthcare facility due to a lack of 
transport or inability to pay for the cost of transport have been identified as barriers to adhering 
to PMTCT 19,21,37, barriers that could possibly be circumvented by being able to make use of 
one’s social support. We have expanded the Bangsberg and Deeks original model to include 
depression as an additional determinant of whether an individual will access their community or 
individual support network. We have also expanded the definition of adherence to include not 
only ART adherence, but adherence to other behaviours that are part of preventing mother to 
child transmission (PMTCT) in South Africa.  
 
While data analysis from phase I (approved by HREC, Clearance Certificate M110963) is still 
underway, some preliminary analyses have been conducted. Specifically, we have explored the 
data collected during pregnancy examining depression, stigma, social support and structural 
barriers to PMTCT. An adherence score was created using principal components analysis on 

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the response to four questions assessing adherence over the past 30 days. Depression was 
defined as a Hopkins score > 1.75 and was examined as a predictor of the adherence score in a 
linear regression model.  Separate linear regression models also examined relationships 
between (1) social support and structural barriers (income and time spent traveling to clinic) and 
(2) depression and stigma as predictors of social support. We found that depression predicted 
adherence: participants with elevated depressive symptoms had significantly lower adherence 
scores (p<0.01). Neither income (p=0.10) nor time spent traveling to clinic (p=0.28) predicted 
adherence; thus, moderation with social support was not examined. Depression significantly 
predicted social support (est=-0.46 p<0.01): those with elevated depressive symptoms had a 
lower social support score. Similarly, a higher stigma score was significantly associated with a 
lower social support score (est=-0.09, p<0.01). We therefore conclude thus far that while 
PMTCT programs are effective, adherence to these services is suboptimal. Depression may 
play an important role in adherence to these behaviours. HIV infected pregnant women with 
elevated depressive symptoms may also suffer from low social support and high stigma; 
interventions targeting these factors may support maternal and foetal health. 
 
Anticipated enrolment.  
Study setting. Prince Mshiyeni Memorial Hospital (PMMH) is a 1200-bed government hospital, 
situated 10 miles (16KM) southwest of Durban city centre which serves the population of 
Umlazi, the second largest township in South Africa. Umlazi District has one of the highest 
seroprevalence of HIV in South Africa, with 39% seroprevalence in antenatal clinic attendees in 
of 20125. The antenatal clinic serves approximately 150-200 clients per day. 
 
Inclusion and exclusion criteria. We will obtain consent prior to screening participants for the 
current study. Inclusion criteria include (1) female sex; (2) age 18-45; (3) currently pregnant; (4) 
HIV positive and diagnosed with HIV during the index pregnancy; (5) meet criteria for a current 
major depressive episode; (6) currently on antiretroviral therapy and eligible for lifetime therapy; 
(7) receiving antenatal care at PMMH Gateway clinic; (8) primary language English or isiZulu; 
(9) access to a phone and willing to give researchers permission to reach them via phone; (10) 
resident of Umlazi; and (11) able and willing to give informed consent. Participants will be 
screened for eligibility (after consent is obtained) using a screening script. The screening script 
contains a screener (the Patient Health Questionnaire; PHQ-2) to assess for the presence of 
depressive symptoms; participants who meet all other criteria, endorse depressive symptoms, 
and would like to participate will sign an informed consent document and complete a full 
baseline assessment to determine presence of a major depressive episode. Participants who do 
not meet criteria for a major depressive episode after completion of the baseline evaluation will 
be informed that they do not meet full study criteria, and will be referred to a health care 
provider. Participants who do meet criteria for a major depressive episode will be randomized to 
study condition (see Figure 4 for Flow Chart) and also provided with a referral to counselling 
services at PMMH. Women with active or untreated major mental illness that would interfere 
with participation (e.g., untreated psychosis, bipolar disorder, dementia, or active suicidality), will 
also be excluded and referred for mental health treatment via counsellors at PMMH. Acutely 
distressed or suicidal participants will be escorted to on-site mental health services immediately. 
A potential participant may also be excluded if, in the opinion of the Principal Investigator, 
participation in the study would be unsafe, would complicate interpretation of study findings, or 
otherwise interfere with achieving study objectives. 
 
Recruitment procedures. We are requesting approval to enrol/randomize up to 40 (20 
treatment and 20 control) HIV infected women meeting the aforementioned inclusion criteria 
from PMMH Gateway clinic. Potential participants will be approached about study participation 
by a trained research assistant (experienced in sexual and reproductive health fieldwork) as 

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they wait in the clinic queue. Those who express interest will be invited to speak with the study 
research assistant to learn more about study participation and be screened for eligibility; written 
signed consent to screening will be obtained. Those who volunteer to participate will complete 
the informed consent process. These procedures will be completed in a private setting, and 
procedures will be undertaken to ensure women do not lose their place in line. This strategy has 
successfully been used for other studies at PMMH antenatal clinic. Phase I of this protocol was 
approved by HREC (Clearance Certificate M110963), which utilized the same procedures. The 
research assistant will use an eligibility screening script to track all screened potential 
participants. These data will be recorded for study data reports. Review of the 
inclusion/exclusion checklists will be part of regular supervisory meetings between the local site 
PI, project manager and the research assistant. 
 
Intervention development. The preliminary intervention content is based on two established 
cognitive-behavioural interventions: problem-solving therapy (PST; 39) and Cognitive 
Behavioural Therapy for Adherence and Depression (CBT-AD; 40). PST was selected as it is an 
effective depression treatment in its own right,41 but because many of the challenges that HIV 
infected women in the perinatal period face  (e.g., managing stigma, overcoming barriers to 
PMTCT adherence) are strong targets for a problem-solving intervention, and the group setting 
may contribute to a rich range of potential solutions to these problems. Furthermore, PST is 
straightforward to deliver, increasing the likelihood of successful delivery by a wider variety of 
individuals with varied training in psychosocial interventions. CBT-AD combines traditional 
cognitive-behavioural skills (including problem-solving) for depression with adherence 
counselling skills. The “Lifesteps” module of CBT-AD has been modified to reflect the 
adherence needs of HIV-infected women during the perinatal period. The intervention manual is 
included as an Appendix.  
 
The intervention has been conceptualized as a group intervention as it has been proposed that 
interventions that make use of and foster social support may be helpful in decreasing social 
isolation and stigma among individuals living with HIV 10. In addition, interventions that target 
social networks and strengthen group ties have also been used to empower marginalized 
groups, and to effect health related behaviour change related to HIV prevention (e.g., 42–44). 
Lastly, group mental health interventions are cost-effective, which is of particular benefit in 
resource-limited settings 44,45. The ideal number of participants per group will be approximately 
2-10. In the event that enough participants cannot be recruited to participate in group-based 
sessions (i.e. due to scheduling concerns), individual sessions will be conducted. This data will 
be recorded and analysed as part of the feasibility and acceptability data.  
 
Study procedures. After the informed consent document has been reviewed and signed, 
participants will be scheduled to complete a study intake assessment with the Project Manager 
or a Research Assistant. Once eligibility is determined, participants will be randomized to study 
condition. To allow an estimate of effect size for a larger trial, we will use a “treatment as usual” 
control group, and participants will be randomly assigned to a group. The treatment as usual 
group will consist of a referral to counselling services at PMMH, with the option of participating 
in the group sessions later (i.e. the next time the group is offered). Participants who will be 
postpartum by that time will be offered the option of attending a series of open problem-solving 
groups. With permission of the participants, we will send a referral letter documenting that 
criteria for depression have been met to a public health facility of the participants’ choosing to 
facilitate treatment for all participants who complete the baseline evaluation. Participants who do 
not wish to have a letter of this nature sent to a facility will be provided with a letter directly, if 
desired. We will also refer ALL participants who meet study inclusion criteria (or, those who do 
not meet criteria but could benefit from, or wish to be referred) to counselling services at PMMH, 

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where there is a social worker, psychiatrist, and trauma specialist on site. To facilitate referral, 
we developed a referral letter in collaboration with staff at PMMH (included with this application) 
that has been used in other studies with similar populations. Acutely distressed or suicidal 
participants will be escorted directly to counselling services by study staff. The screening that 
occurs as part of this study goes beyond the standard of care for depression screening and 
thus, women may actually benefit from the screening process. The specific referral path is 
described below.  
 
The study staff will be trained to identify participants with symptoms of depression during data 
collection through self-reporting or using the assessment measures.  Study staff will complete a 
referral letter and refer the participant to the project manager/coordinator.  The project 
manager/coordinator will then discuss the depression symptoms identified with the participant, 
as outlined on the referral letter. She will explain to the participant the purpose of referral to the 
clinic healthcare provider for assessment, counselling and further management.  Each 
participant will be escorted by the study staff to the service point healthcare provider. The 
healthcare provider will assess the patient, counsel, treat or refer to the hospital Social Worker 
or Psychologist or Crisis Centre for further appropriate management.       
 
The initial intervention will consist of 5 to 8, 90-minute, weekly sessions. Each session will begin 
with a brief “open” check-in among group members to foster relationships and social support 
among group members. The remaining session time will consist of teaching problem-solving 
skills for managing depression and adherence. While participants will be encouraged to attend 
group sessions at a regularly scheduled time to facilitate group cohesion, a total of three group 
sessions will be offered each week to facilitate group attendance.  
 
Baseline assessments will occur until it is deemed that enough participants are available for 
randomization and to run a group. For example, baseline assessments may occur until a 
minimum of four participants are identified (two intervention participants, and two control 
participants). In the event that recruitment is difficult, the investigators may run sessions with as 
few as two participants (one intervention participant, and one control participant). Participants 
will complete assessments with an interviewer (constructs described below in Table 1) at the 
following time points: once before the intervention begins, once after all intervention sessions 
are completed, and once at approximately three months postpartum. Control participants will be 
assessed at times mirroring that of the intervention participants.  
 
As noted above, we will use an iterative process of intervention development. Interventions will 
be held in waves whereby an intervention group will be conducted, feedback collected from 
participants on the intervention, and another intervention group conducted. This process will be 
completed up to three times. In order to collect feedback from participants, the opportunity to 
participate in a brief qualitative interview will be offered to a random sample of intervention 
participants at the conclusion of each wave of intervention sessions. This qualitative interview is 
optional, and would be in addition to the aforementioned assessments. Approximately 3-5 
participants per wave of intervention sessions will be randomly selected (a total of 10-15 
interviews, maximum) to provide feedback on the intervention. If data from the qualitative 
interviews suggests that changes be made to the intervention (e.g., changing the number of 
sessions, changing the length of sessions, etc.), the investigators will propose changes and 
submit them to the ethics committee for consideration prior to starting the next wave of group 
sessions.  
 
Sources of Materials: In order to maximize the integrity of the data, a racially and ethnically 
concordant female interviewer, fluent in both English and isiZulu, and who is different from the 

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study interventionist, will complete assessments with each participant. After eligibility is 
determined, assessments will occur immediately pre and post intervention; a third and final 
assessment will occur at approximately three months postpartum (see Table 1 for constructs 
and measures). In addition to a self-report measure of adherence, each participant will also be 
provided with a Medication Event Monitoring System (MEMS) to monitor their adherence to 
ARVs. Data from the MEMS caps will be uploaded at the beginning of each intervention 
session, and at all assessment visits. Feasibility will be documented as depicted in Figure 3. 
Qualitative interviews will be conducted with a sub-sample of participants at the end of the 
group in order to describe the acceptability and perceived usefulness of the intervention. 
Interviews will follow a structured interview guide, with flexibility to explore probes and content 
that may not specifically be in the guide to begin with. Questions will be open-ended to most 
effectively elicit information without biasing participants’ responses.  
 
Minimization of risks. All research study staff will be thoroughly trained in assessment 
procedures. In the event that a subject is determined to be in distress or actively suicidal and at 
risk for self-harm during any study procedure, study staff will refer to the local site Principal 
Investigator (Professor Smit) and the Project Manager so that appropriate clinical intervention is 
executed. Participants who are in distress or seemingly depressed will be assessed by the 
study staff and the Project Manager. The study staff will complete a referral letter, and the 
participant will then be referred via an in-charge at the antenatal clinic to either a psychologist, 
social worker, or other relevant person in at PMMH for further evaluation and treatment. All 
participating study institutions have been involved with numerous local, national, and 
international studies of persons living with HIV and each have considerable experience in 
implementing measures to protect confidentiality. Some of these steps include in-service 
trainings on confidentiality and the assignment of study ID numbers. Staff at all sites who 
conduct participant recruitment, screening, enrolment, and assessments will have been trained 
in ethical human subjects research and screening and interviewing techniques, to minimize 
participant risk as much as possible. Each research assistant employed by MatCH Research is 
required to sign a confidentiality agreement as part of their employment contract; oversight is 
managed carefully by Human Resources. In addition, all research assistants are required to 
have a valid Good Clinical Practice certificate and undergo training in the ethical conduct of 
studies. All data will be kept confidential, under lock-and-key, accessible only to trained study 
staff.  Participants’ data will be identified by an ID number only, and a link between names and 
ID numbers will be kept separately under lock and key.   
Foreseeable risks and discomforts. It is unlikely that participants will be at any risk for 
physical harm as a result of study participation. However, subjects may find some of the 
questions asked during the interviews to be emotionally upsetting. If this occurs, or if 
participants endorse active suicidality or exposure to intimate partner violence, they will be given 
the opportunity to cease study participation, and will be referred for counselling services as 
described above. As with any study, there is always the risk of inadvertent breach of 
confidentiality. This is of particular importance here because participants are infected with HIV, 
which may be stigmatizing. An additional discussion of how we minimize these risks is 
described above under “Minimization of risks”. 
 
Expected benefits. Participants in an intervention group may experience a reduction in 
depressive symptoms and an increase in adherence to the PMTCT cascade, including 
antiretroviral therapy. Study staff will refer participants to appropriate social services as needed 
or upon request. The data collected as part of this study may ultimately help researchers and 

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clinicians better care for HIV infected women and their children. 
 
Equitable selection of participants. All women presenting for care at antenatal clinic at PMMH 
and meeting inclusion criteria will be invited to participate in the current study. We have 
budgeted time for research assistants to be physically located at the antenatal clinic to 
encourage and insure adequate recruitment. Men have been excluded from study participation 
because the aims of the study relate specifically to women. Children under the age of 18 are 
excluded as we are interested in studying the phenomenon of adherence to PMTCT among 
adult women; women under the age of 18 likely face additional and different barriers to PMTCT 
adherence than women 18 years or more. 
 
Remuneration. Refreshments will be served at all assessment and intervention visits. There 
are three main interviews in this study. Participants will be reimbursed R100.00 for each 
interview where we collect data from participants (at the beginning of the study, after the group 
counselling intervention / 8-10 weeks after participant first interview, approximately three 
months postpartum). There is also an optional qualitative interview; participants who are 
selected to participate and complete this interview will be reimbursed R100.00. In order to 
support transport costs to sessions, participants in the intervention group will also be 
reimbursed R50.00 at each intervention session.  
 
Consent procedures. Two informed consent procedures will occur; the first will occur before 
the eligibility screening, and the second will occur before study enrolment.  
 
A detailed pre-screening informed consent form will be signed by each participant willing to 
participate in the eligibility screening questions. The consent form will include information about 
the study procedures, and the nature of the screening questions. It will also state that 
participants do not have to answer any questions they do not want to answer, and that they may 
stop the screening at any time. Participants will be informed that they do not have to answer any 
question they do not want to answer, they may stop the screening at any time, and that their 
answers will remain anonymous and confidential.  
 
A detailed study consent form will be signed by each participant willing to participate in the 
study, following the explanations of the study procedures by the research project staff. The 
study consent form will include all of the study procedures, information about potential risks and 
benefits of participation, and information regarding who they can contact for further questions. It 
also will state that participation is voluntary, that participants can refuse to answer any question, 
that they can withdraw from the study at any time, and that study participation is in no way 
related to their care. Participants will also be reminded to take care when storing the consent 
document to avoid inadvertent disclosure of HIV status. Participants will also be informed that 
depression treatment is available via a referral for mental health treatment at PMMH, and thus 
they do not need to participate in the study in order to receive depression treatment. 
Participants will have as much time as they require to decide if they want to participate, even if 
this requires re-scheduling other portions of the visit to allow the participant more time to review 
the informed consent document. All procedures and protocols will have been approved by the 
Massachusetts General Hospital (MGH) institutional review board (IRBs) and the Wits 
University Human Research Ethics Committee and by PMMH and local and KwaZulu-Natal 
provincial health authorities before the inception of any study procedures. 
 
Data analytic plan. All analyses conducted as part of this field test intervention are meant to lay 
the groundwork for future work, and it is not necessarily powered to detect statistically 
significant changes in depression, adherence, stigma, or social support. Because this is an 

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exploratory study, we will first examine the outcome variables continuously. We may determine 
cut-off scores that are appropriate to the sample and make clinical sense, and examine 
dichotomous outcomes (e.g., a reduction of 30-50% in depressive symptoms and/or the 
percentage of the sample scoring lower than >/= 9 on the Edinburgh Postnatal Depression 
Scale (EPDS) and achieving ≥90% adherence) when assessing the effect of the intervention. 
Descriptive measures (such as mean, standard deviation, median, and range) will be used to 
summarize continuous patient characteristics (such as age, income) and categorical patient 
characteristics (such as ethnicity, employment status) will be summarized using frequencies and 
percent’s. Descriptive data on the feasibility outcomes depicted in Figure 3 will be presented. 
With respect to qualitative exit interviews, data will be analysed using standard qualitative 
methodologies described by Miles and Huberman46. After transcripts are translated to English, 
they will be reviewed for errors and omissions. NVivo software (version 9) will be used to 
organize data and to facilitate analyses. Two investigators, one of whom will be a South African 
study staff member (to ensure accurate interpretation), will independently review the transcripts 
in order to generate an overarching thematic framework for data interpretation, in which major 
and minor themes are identified.  
 
Data and safety monitoring.  Data collection occurs in the form of a series of quantitative 
assessment interviews. The principal investigator (Dr. Psaros) and her primary mentor (Dr. 
Safren) will work closely with the South African site PI (Professor Smit), to oversee all data 
management and analysis issues. The proposed study team has extensive experience 
collecting data on reproductive health among women in Durban, South Africa, and a quality 
management plan will be developed to specify daily quality control and monthly quality 
assurance measures. The research assistant will review all assessments prior to the end of all 
interviews to minimize missing data. Data will be entered in an on-going fashion (into REDCap 
data management system), and will be analysed using the Statistical Package for the Social 
Sciences (SPSS), version 18, and QSR NVivo qualitative software, version 9, after being 
thoroughly checked and cleaned as appropriate. Data files will be sent to Dr. Psaros from the 
site using secure (password protected) file transfer. The MGH IRBs will review the data-
monitoring plan along with the full study protocol at least annually.  
 
Data will be obtained from participants recruited specifically for this protocol and will include 
sociodemographic information (e.g., age, level in school, race and ethnicity, etc.), depression, 
stigma, social capital utilization, and adherence to PMTCT (see Table 1). A research assistant 
will collect data from the participants’ record on CD4 cell count, viral load, and antiretroviral 
regimen during the last trimester of pregnancy and immediately postpartum, the stage of HIV as 
determined by World Health Organization’s staging criteria, and the gestational age, date of 
birth, and weight of each participant’s infant at birth. No other information will be abstracted from 
the medical record. Only trained study staff will have access to these data. Participants’ data will 
be identified by an ID number only, and a link between names and ID numbers will be kept 
separately under lock and key.   
 
The data files from the interviews will be sent by a secure file transfer system between South 
Africa and Boston without names and other personal identifiers. These files will be sent with a 
password lock known only to the key study staff.  These files without any personal identifiers will 
be kept in Boston for 10 years, and then destroyed. Study results will be reported only in summary 
form so that no individual participant can be identified.  
 
Adverse events reporting. As a result of participation in the interview, study staff may become 
aware of an adverse event, including participant distress or disclosure of current or past 
physical or sexual abuse. Study staff will be trained to make appropriate referrals for clinical or 

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psychological care in consultation with the PIs and/or antenatal clinic staff and in accordance 
with South African law regarding the reporting of sexual or physical abuse. Adverse events will 
be reported according to the local South African ethics committee procedures and these will be 
discussed on calls between the overall PI (Psaros) and the site PI (Smit). 

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4. TABLES AND FIGURES 
 
Figure 1: The PMTCT “cascade” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Postpartum PMTCT 
• 
Nevirapine to infants for first 6 weeks of life or duration of breastfeeding 
• 
Safe infant feeding practices 
• 
Infant PCR testing 
• 
Continuation of maternal ARVs 
• 
Family planning  
PMTCT during labour and delivery (for women not on therapy) 
• 
Nevirapine ≥ 2 hours prior to delivery, 3 hourly AZT, and single dose of 
tenofovir/emtracitabine at delivery 
Primary Prevention of HIV 
• 
Preventing infection among HIV-negative women of reproductive age via counselling 
and testing 
 
Antenatal PMTCT 
• 
CD4 cell testing and HIV staging  
• 
Initiation of lifelong ARVs for all HIV positive pregnant women 

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Figure 2: Conceptual model 
 
 
 
 
Depression 
Stigma 
Social Support 
  Structural & 
economic 
barriers 
 
PMTCT health 
behaviours 

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Figure 3: Intervention feasibility 
 
 
 
 

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Figure 4: Participant Flow Chart 
 
 
 
Interested in being screened for study 
Screened using the Screening Script (must 
meet criteria to move on, including endorsement 
of depressive symptoms as measured by Patient 
Health Questionnaire (PHQ) 
 
Baseline Assessment 
(must meet criteria for depression based on Mini 
International Neuropsychiatric Interview (MINI) 
If participant does not 
meet criteria depression 
as measured by the MINI, 
refer to health care 
provider for depression 
management if needed / 
desired 
Randomized to condition 
Refer to health care provider for depression 
management  
Informed Consent Form for study enrolment 
Informed Consent Form for eligibility 
screening 

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Table 1: List of proposed measures and assessments 
Construct 
Measurement tool and schedule 
Sociodemographic and 
structural barriers 
Age; ethnicity; educational level; employment status; 
occupation; income; distance to clinic; time spent travelling to 
clinic; mode of transportation to clinic. 
Clinical information 
Approximate due date, number of pregnancies, number of 
children, date of HIV diagnosis, number of children who are HIV 
positive 
Partnership characteristics 
Marital/partnership status; partner’s HIV status; length of 
relationship with partner; if live with partner; disclosure to 
partner; partner involvement in pregnancy (yes/no).  
HIV characteristics 
CD4, viral load, year of diagnosis; disclosure status.  World 
Health Organization staging classification for HIV stage, as 
available. Antiretroviral therapy regimen.  
Pregnancy characteristics 
Attitudes towards pregnancy and pregnancy intention as 
measured by the CDC PRAMS instrument;33,47,48 parity. 
Instrument is scored using an accompanying variable 
codebook, with answers “Yes” scoring ‘1’ and “No” scoring ‘0’. 
Number of antenatal care visits.  
Depression 
Diagnosis of current and past Major Depressive Disorder will be 
made using the Mini International Neuropsychiatric Interview 
(MINI), Major Depressive Episode Module. The Edinburgh 
Postnatal Depression Scale will also be utilized to measure 
depression at baseline, post treatment, and postpartum. This 10 
item measure has been validated for broadly African and 
specifically South African populations specifically for perinatal 
and postpartum participants. 49,50 
Stigma 
HIV/AIDS Stigma Instrument-People living with AIDS (HASI-P) 
has been developed and tested broadly in five African countries 
(including South Africa). The instrument was validated with a 
sample of 1,477 persons living with HIV/AIDS in those five 
countries. This is a large measure from which we are utilizing 3 
sub-scales: negative self-perception items (n=5), social 
isolation (n=5), and verbal abuse (n=8).51 
Social support 
Modified version of the Duke-UNC Functional Social Support 
Questionnaire.52 10-item scale evaluating availability of 
emotional, informational, and tangible support. Items are rated 
on a 4-point Likert scale; number of persons providing support 
is also assessed. 
Adherence to ARVs during 
pregnancy and PP (self-
report and objective 
measure) 
(1.) Adherence with ARV medications over the past month with 
three different response formats: (1) frequency, (2) percent, and 
(3) rating response. Category scores of 0, 20, 40, 60, 80, and 
100, with 100 being the best adherence are calculated53 (2.) 30-
day visual analogue scale (VAS) for overall adherence 
assessment for one month. Adherence is calculated as the % of 
doses taken over those prescribed and categorized into full, 
partial, and non-adherence. The VAS has been used in South 
Africa.23 MEMS caps will be brought to each session and each 
assessment and read for quantifiable adherence value (i.e. 
when the pill was opened every day).  

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Adherence to labour and 
delivery practices 
Method of delivery (vaginal or Cesarean section); delivery in a 
healthcare setting (yes/no; 21)  
Infant nevirapine 
administration 
Select questions from the ACTG Paediatric International 
Adherence Questionnaire (NIAID Paediatric AIDS Clinical Trials 
Group). Assesses missed doses and reasons for missed doses. 
This measure has been used in South Africa. 
 
Initiation of family planning 
methods 
Initiation of family planning (yes/no); means of family planning 
(including intrauterine devices, oral and injectable hormonal 
contraception, implants, condoms).54,55 These questions have 
been used in South Africa and Zambia. 
Infant outcomes 
HIV testing (yes/no);11 HIV status; gestational age; birth weight; 
mortality; birth date. 
Breastfeeding 
Assesses breastfeeding practices (breast, formula, mixed); 
reasons why participants may have chosen to opt out of 
breastfeeding or why they may have chosen to supplement 
breast milk. 
 
 
 

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