A Stigma Reduction Intervention at Time of Entry Into Antenatal Care to Improve PMTCT Services in Tanzania (Maisha)
Phase: NA
Conditions: HIV Infections
Sponsor: University of Utah

 
VERSION: 23 July 2018 
1 
Study Protocol  
 
Protocol Title:  
Postpartum HIV care engagement in the context of Option B+ in Tanzania 
 
Principal Investigator at Duke:  
Melissa Watt, PhD 
 
Principal Investigator at KCMC (Tanzania):  
Blandina Mmbaga, MD, PhD 
 
Version 
 
July 23, 2018 
 
1.  Research Design  
 
Background 
 
The goal of this study is to examine the implementation of the Option B+ protocol, whereby all HIV-
infected pregnant women initiate lifelong antiretroviral therapy (ART) during pregnancy, regardless 
of CD4 count or clinical staging. The Option B+ approach of establishing lifelong ART for pregnant 
women holds great promise for improving women’s long-term health and moving towards an “AIDS 
free generation.”1 At the same time, there have been concerns about implementation challenges, 
particularly with retention and adherence in the postpartum period.2,3 Data from multiple African 
settings suggest that one-third to one-half of all women who start ART during pregnancy are lost to 
care within six months after childbirth.4-8 Retention in care and sustained adherence to ART 
following childbirth are vital to the success of the Option B+ protocol, to ensure the viral suppression 
of the woman, to prevent HIV transmission to her child during breastfeeding, and to reduce the 
probability that she might transmit HIV to her sexual partners.9 
 
This study is filling a critical void in understanding the implementation of Option B+, and will identify 
opportunities to strengthen programmatic efforts to support women’s long-term care engagement.  
Using the Consolidated Framework for Implementation Research, this study examines the Option 
B+ protocol in the sites in Tanzania, seeking multiple perspectives (facilities, providers, patients) 
and using multiple methods (observations, surveys, record reviews, qualitative interviews/ 
discussions). Taken together, these data can help to identify bottlenecks and barriers, and inform 
interventions to promote women’s care engagement and optimal medication adherence in the 
postpartum period. Preliminary findings from our cohort demonstrate the need to address stigma 
among pregnant women navigating PMTCT services. Therefore, this study will also develop and 
pilot test an intervention that addresses stigma at early entry into PMTCT. 
 
Study aims 
 
This study is addressing four specific aims: 
  
Aim #1: Examine the facility-level implementation of Option B+ in several diverse care 
delivery sites in the Kilimanjaro region, focusing on women’s HIV care engagement in the 
postpartum period. Methods: At sites within the Moshi Urban and Moshi Rural districts of the 
Kilimanjaro Region, we will document practices to support postpartum HIV care engagement 
through clinical observations; explore implementation processes and barriers through key informant 
interviews with health care providers (n=30); and examine retention in care outcomes through 
medical record reviews of all pregnant women receiving ART through the B+ protocol since the 
policy was implemented in February 2014 (n=512).  
 

 
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Aim #2: Examine patient-level factors that impede or support postpartum care engagement 
among women initiating or continuing ART during pregnancy. Methods: Over a six-month 
period, we will enroll up to 200 women who are HIV-infected and either initiating or continuing ART 
during pregnancy at sites in the same clinic sites described in Aim #1, which lie in the Moshi Rural 
and Moshi Urban districts of the Kilimanjaro Region. We will conduct baseline surveys in the second 
or third trimester of pregnancy, and follow-up surveys at 3 and 6 months postpartum. We will retain 
participants’ contact information and may contact them for additional surveys up to 24 months 
postpartum.  Surveys will measure potential predictors (intrapersonal, interpersonal and facility 
issues) that affect engagement in HIV care (ART receipt and adherence) in the postpartum period. 
For participants who have not had viral load testing as part of their standard of care, we will also test 
for viral load at 6 months postpartum as a marker of ART adherence, with drug resistant resistance 
testing if the viral load test yields a result of greater than 1000 copies/ml. We will access 
participants’ medical records during the study period to abstract clinical data and capture it in a de-
identified database. We began enrollment in our cohort on 19 July 2016, and completed our 
enrollment of 200 women on 7 August 2017. Women were enrolled across nine sites in the Moshi 
Urban and Moshi Rural areas (Majengo, Pasua, KCMC, St. Joseph’s, Bondeni, Msaranga, Himo, 
Faraja, and Cogi Health Centres). A subset of women (n=24) completed in-depth interviews during 
pregnancy and again in the postpartum period, to examine the complex interplay of individual, social 
and contextual factors that influence HIV care for women following childbirth.  
 
Aim #3: Identify opportunities to improve implementation of Option B+ so that it enhances 
and promotes continuous care in HIV services following childbirth, including the 
development of a brief, theory-based intervention and methodological protocol to address 
HIV stigma at entry into ANC. Methods: We will conduct focus group discussions (FGDs) and in-
depth interviews at the same clinic sites described in Aim #2, with the following populations: health 
care providers (n=5 IDIs or FGDs; including HIV care providers, PMTCT coordinators, and ANC 
nurses); home-based HIV care workers (n=16; 2 FGDs); HIV-infected pregnant and postpartum 
women (n=18 IDIs); and HIV-uninfected pregnant and postpartum women (n=12 IDIs). These 
discussions will identify opportunities to improve implementation of the national PMTCT policy to 
support continuous care engagement in the postpartum period and will inform the content and 
protocol of the Maisha intervention. Intervention ideas will be further discussed and refined through 
a community stakeholder meeting. We will also conduct ~40 observation hours in each of the two 
clinic sites (Majengo and Pasua) selected for the pilot trial and record detailed notes on clinic flow 
and opportunities to integrate study activities into routine care. We will conduct cognitive interviews 
with 10 HIV-infected women to revise our study surveys and assess whether our stigma measures 
capture the intended constructs. We will also conduct a trial run of the full Maisha intervention with 
HIV-infected pregnant/postpartum women (n=6) to refine and finalize the intervention curriculum 
and study protocol.  
 
Aim #4: Conduct a pilot randomized controlled trial (RCT) of Maisha to examine 1) feasibility 
and acceptability in an ANC setting, and 2) impact on early retention in PMTCT, HIV 
disclosure, and constructs of HIV stigma. Methods: We will conduct a pilot RCT with 150 
women, both HIV-infected (n=25 Maisha; 25 Standard of Care, SoC) and HIV-uninfected (n=50 
Maisha; 50 SoC. Women will be randomized to receive either the SoC HIV testing and counseling, 
or SoC plus the Maisha intervention. Participants will complete a baseline survey and a follow-up 
survey at 3 months. Surveys will include measures for health outcomes (e.g., HIV care engagement, 
adherence to ART, depression, HIV testing), stigma outcomes (e.g., anticipated stigma, enacted 
stigma, internalized stigma), and other secondary outcomes or potential covariates (e.g., partner 
support, attitudes to ART, intimate partner violence). A subset of 15 HIV-infected intervention 
patients will participate in a qualitative in-depth interview at 3 months to provide feedback on the 
intervention. Clinical data will be abstracted from the medical records of participants completing the 
3-month survey. 
 

 
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Overview and timeline 
This 5-year study (2016-2021) seeks to understand and inform the implementation of the Option 
B+ protocol for PMTCT care in the Kilimanjaro Region of Tanzania, and develop an intervention 
to support women who are newly pregnant and being tested for HIV. The work is being completed 
in diverse clinical settings, using a multi-methods approach informed by the Consolidated 
Framework for Implementation Research (Table 1). 
 
Table 1: Study timeline 
 
Setting 
The research will be conducted in diverse clinical sites in the Moshi region that provide PMTCT 
services. Those sites will be identified in consultation with the Ministry of Health, considering 
both patient load and capacity to absorb research.  
 
Study procedures by phase 
 
Phase 1: Observations and key informant interviews 
 
First, the KCMC team and the Duke graduate student will conduct semi-structured observations 
in relevant clinical areas in order to document the process of implementing the national PMTCT 
protocol to promote postpartum HIV care engagement. Observations will include a review of 
protocols, practices and record keeping procedures. Observations will focus on the services 
specifically meant to promote engagement in HIV care for women in the postpartum period (e.g., 
counseling across the perinatal continuum, monitoring of patient retention, transfer of care from 
antenatal care to reproductive & child health to HIV care & treatment). Following informed 
AIMS 
METHODS 
YEAR 1 
YEAR 2 
YEAR 3 
YEAR 4 
YEAR 5 
1 2 3 4 
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 
Aim 1: Examine 
implementation 
of B+ for 
postpartum care 
engagement 
Observations to assess services and fidelity to 
protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Key informant interviews to assess process and 
barriers 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record review to assess care engagement outcomes 
(n=512) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 2: Identify 
factors that 
impact 
postpartum care 
engagement 
Enroll pregnant women on ART at clinic sites (n=200)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up interviews at 3m and 6m postpartum with 
possible additional surveys up to 2 years post-
partum 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-depth interviews to explore care engagement 
process (n=24) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 3: Identify 
opportunities to 
promote 
postpartum care 
engagement 
under B+ 
Stakeholder feedback meeting & dissemination 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Focus group discussions and in-depth interviews with 
stakeholders at each site  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct clinic interviews & observations; refine 
measures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze data, prepare draft curriculum & record video  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Trial run; feedback from advisory board & FGDs; 
refine & revise 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aim 4: Pilot test 
Finalize the pilot study protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruit, baseline & deliver intervention vs. SoC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct 3-month follow up with participants (n=50 
HIV+ & 100 HIV-) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze data, write manuscripts & prepare R01 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
VERSION: 23 July 2018 
4 
consent specific to clinic observation, the observations will be conducted by a KCMC staff 
member and the Duke graduate student, who will spend approximately 5 weeks conducting 
observations on clinic days, using a combination of checklists and ethnographic observation 
tools.  
Second, the KCMC team and the Duke graduate student will conduct key informant interviews 
with health care providers, in order to understand the implementation process and barriers. The 
following stakeholders will be interviewed (distributed evenly across sites): attending physicians 
(n=3), ANC nurses (n=6), RCH nurses (n=6), counselors (n=6), community health workers (n=6), 
and managers (n=3). Interviews will be conducted by a KCMC staff member and the Duke 
graduate student, with semi-structured guides developed for each distinct stakeholder group. 
Interviews will focus on issues related to perceptions of policy guidelines, experience with 
implementing guidelines, work environment and burden, training and perceived capacity, and 
perceptions of bottlenecks/barriers to postpartum care engagement. Interviews will be conducted 
after the observations in order to cross-check and provide greater context for the observational 
data. Following informed consent, the KCMC research nurse and the Duke graduate student will 
conduct the interviews in Kiswahili or English (depending on participant’s preference), using a semi-
structured guide. Interviews will be audio-recorded with participants’ permission. Interviews will last 
approximately 60 minutes. 
 
Phase 2: Surveys and In-depth Interviews with female patients 
 
Procedure: Over a twelve-month period, we will enroll women (n=200) who are HIV-infected and 
either initiating or continuing ART during pregnancy at sites in the Kilimanjaro region. We will 
conduct baseline surveys in the second or third trimester of pregnancy, and follow-up surveys at 3 
and 6 months postpartum. We will also contact participants shortly after the birth of their child to 
complete a brief research form to obtain information about the birth and any changes in the 
participant’s engagement in care. Additionally, in the event of the child’s death, we will contact 
participants 4-6 weeks after the loss to complete a brief research form and obtain information about 
what occurred. Participant contact information will be retained and we may contact participants for 
additional surveys at critical time points in their care (i.e., transition of HIV care from the ANC back 
to CTC facility) for up to 2 years postpartum. Surveys will measure potential predictors 
(intrapersonal, interpersonal and facility issues, including transferring between clinics for care) that 
affect engagement in HIV care (ART receipt and adherence) in the postpartum period. De-identified 
clinical data will be abstracted from participants’ medical records during the study period, up to two 
years postpartum. A subset of women (n=24) will complete in-depth interviews during their third 
trimester and again during the postpartum period, to examine the complex interplay of individual, 
social and contextual factors that influence HIV care for women following childbirth. Participants will 
complete an interviewer-administered structured survey, conducted by a research nurse at a 
minimum of three time points, with the potential to add additional time points as resources allow. For 
participants who have not received viral load testing as part of their standard of care, blood will be 
collected at 6 months postpartum by the research nurse for viral load testing. If the participant’s viral 
load is measured at greater than 1000 copies/ml, follow-up testing will be conducted to test for drug 
resistance. 

 
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• 
Pregnancy: Complete the baseline assessment in 
the second or third trimester of pregnancy, with a 
target date of 30 weeks gestation. 
• 
Birth: Complete brief research form approximately 
1-2 weeks after delivery. 
• 
3 months postpartum: Complete the second survey 
at approximately 3 months after the birth of the 
child. 
• 
6 months postpartum: Complete the second survey 
at approximately 6 months after the birth of the 
child. Blood samples for viral load testing will also 
be collected at this time point. 
• 
Up to 2 years postpartum: As study resources 
allow, we will contact participants up to 24 months 
postpartum to repeat the survey measure. 
• 
Death of child: In the event of the death of the 
child, complete brief research form. 
Patient-level data will be collected for the purpose of 
identifying factors that should be addressed in implementation. All assessments will include 
questions about demographics and key constructs reflecting intrapersonal issues (e.g., mental 
health and self-efficacy for ART care), interpersonal issues (e.g., disclosure and social support), and 
facility-related issues (e.g., knowledge of B+ protocol, perceptions of care quality, care experiences 
at different clinics). The survey will be conducted in a private room and will take approximately 90 
minutes.  
Measured predictors will correspond to patient-level factors that reflect individual constructs, 
interpersonal relationships, and experiences with the health care facility (Figure 2) that may 
influence care engagement. These predictors were chosen based on meaningful influences that 
have been identified in prior research. The outcome of interest, postpartum HIV care engagement, 
will include receipt of ART (confirmed by clinical record review) and self-reported ART adherence 
with the ACTG adherence instrument,47 using strategies to improve recall and validity.48 We will 
implement mechanisms for retention (as Dr. Mmbaga has done for IMPAACT study). For women 
who are lost from the study, their care engagement data will be extracted from medical records. 
At the 6-month postpartum visit, patient records will be reviewed to determine whether participants 
received viral load testing in the postpartum period as part of their standard of care. Women who 
have not received testing will be asked to provide a blood sample for viral load testing. The research 
nurse will perform the phlebotomy procedures. For HIV RNA, approximately 6 ml of whole blood will 
be collected in an EDTA tube. The collected samples will be stored at room temperature for not 
more than 4 hours and then transported to the KCRI biotechnology laboratory for analysis. HIV RNA 
samples will be analyzed in real time and results reported back to clinics. The samples of 
participants with observed viral loads greater than 1000 copies/ml will also be subject to resistance 
testing to assess the extent to which high viral loads are due to drug resistance. 
Viral load and resistance test results will be shared with the patients in a timely manner. For 
participants who are still enrolled in HIV care in the study clinic, the results of their viral load and any 
resistance tests will be added to their medical record, to be discussed with the patient at their next 
clinical visit. For participants who are no longer in HIV care or who have transferred to another 
clinic, they will be called and informed that their viral load and any resistance test results are 
available and invited to come to the clinic to have them explained by the study nurse. For study 
purposes, the test results will be entered onto a clinical report form, marked only with the 
participant’s study ID, and entered as part of the patient’s study records. The results for the viral 
load and any resistance testing will be compared to self-reported adherence to inform analysis of 
viral suppression as a result of drug adherence versus drug resistance.   
 
Figure 2: Conceptual model guiding cohort measures 

 
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Eligibility: 200 female patients: Women who are > 18 years of age, diagnosed with HIV, prescribed 
ART, and pregnant at the time of enrollment are eligible to enroll. Participants may either be newly 
initiating ART during pregnancy, or continuing ART due to an established HIV diagnosis. To ensure 
the safety of participants and integrity of the data, participants will be excluded if the attending 
physician determines that the patient has impaired mental status.  
 
Recruitment: For female patients, the research nurses will work with a specific health care provider 
in the clinic to identify individuals who are eligible for the study. The heath care provider will 
approach the patient during a clinical appointment to see if she is interested in meeting with a 
research nurse to learn more about the study. If so, a research nurse will meet with the patient to 
explain the study and what participation involves, and to offer her the opportunity to participate if 
she chooses. 
 
Compensation: At each survey, participants will receive 5,000 TSh (~3 USD) for participation. 
Phase 3: Focus Group Discussions and In-Depth Interviews with Stakeholders 
 
Procedure: We will conduct focus group discussions and in-depth interviews with the following 
populations: health care providers (IDIs/FGDs with 5 HIV care providers, PMTCT coordinators, and 
ANC nurses providing HIV testing); home-based HIV care workers (2 FGDs, 16 participants); HIV-
infected pregnant and postpartum women (18 IDIs); and HIV-uninfected pregnant/postpartum 
women (12 IDIs). These discussions will identify opportunities to improve implementation of the 
national PMTCT policy to support continuous care engagement in the postpartum period and inform 
the content and protocol of the Maisha intervention. Semi-structured interview guides will be tailored 
to each group. Questions and probes related to intervention content (video and counseling) will 
focus on HIV stigma during two time points: presentation to ANC (e.g., HIV testing experience and 
current counseling, role of stigma upon HIV diagnosis, stigma for women with established 
diagnoses) and PMTCT initiation (e.g., content of PMTCT counseling, decision about care site, HIV 
disclosure). Questions and probes related to the study protocol will include: timing of recruitment, 
consent, and baseline; reactions to a video-based module; desired characteristics of intervention 
counselors; and strategies for retention. Interviews and FGDs will be audio-recorded with 
permission, and transcribed and translated into English. Intervention ideas will be further discussed 
and refined through a community stakeholder meeting. 
 
 
Phase 4: Medical Record Review 
 
A retrospective medical record review will include a review of 
the clinical records of all patients in antenatal care in the 
study clinics, who had deliveries in a two-year period, 
between Feb 1, 2014 (date of roll-out) and present. Data will 
be analyzed to first determine the proportion of pregnant 
women in ANC who had a documented HIV test result as part 
of ANC services, and of those, the number who were HIV 
infected (separately by new diagnoses and established 
diagnoses). For patients who are HIV-infected, a data 
extraction form will be used to merge information across the 
relevant clinical services (i.e., ANC, RCH, CTC). Linking 
patients across the three registries will be possible by linking 
the unique Tanzanian CTC identification number that is given 
to all patients upon initiation of ART. The data extracted from each setting are described in Table 2. 
 
Phase 5: Development of the Maisha Intervention 
 
Procedure: Intervention development will begin during the qualitative procedures described in 
Phase 3, which will allow for an iterative process where new data collection builds upon what has 
Table 2: Data extracted from the clinical 
records of HIV-infected pregnant patients 
ANC 
Socio-demographics 
HIV testing history 
Counseling exposure 
ART initiation 
Engagement in care  
RCH 
Delivery data 
Counseling exposure 
Engagement in care  
Referral to CTC 
CTC 
Linkage to CTC (ever, date, location) 
Counseling exposure 
Engagement in care  
Viral load 

 
VERSION: 23 July 2018 
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been learned, continually making progress to finalize intervention and protocol content. We will also 
conduct ~40 observation hours in each of the two clinic sites selected for the pilot trial and record 
detailed notes on clinic flow and opportunities to integrate study activities into routine care. During 
this phase, we will also use various methods to confirm and refine our measurements of HIV stigma. 
Cognitive interviews49 will assess whether our stigma measures capture the constructs of 
stigmatizing attitudes, internalized stigma, and anticipated stigma in this population, and whether 
items are appropriate, comprehensible given literacy levels, culturally salient, and translated to 
reflect the desired constructs. Per typical measure development procedures,50 we will conduct 
cognitive interviews with 10 HIV-infected pregnant or recently postpartum women identified during 
Phase 3 IDIs. Detailed notes will be taken during the cognitive interviews and discussed as a team 
in order to finalize the measures and their translations. 
 
 
 
The Phase 3 qualitative data and the theoretical framework (Figure 3) will be used to create 
intervention content for three counseling sessions. For session 1, we will write a script with 
accompanying visuals that will then be adapted to a video format. The video will be recorded in 
Tanzania, with support from a video consultant in Moshi, who will oversee the recording and final 
editing of the video. Depending on the qualitative input, video content may include actual people 
living with HIV, health care providers, and general community members – all with the goal of 
normalizing HIV and creating an environment of support and empathy for PLWH. For sessions 2 
and 3, we will develop a semi-structured curriculum that includes session descriptions, activities, 
and psychoeducation, and links back to the video content. We will get feedback on the draft 
intervention via a half-day study advisory board meeting and a trial run with 6 participants. The 
intervention facilitators will be trained and will conduct the trial run. Debriefing interviews with 
intervention counselors and trial run participants will elicit areas for modification and counselor 
training. The feedback will inform final modifications to the intervention content, and the final video 
will be revised as needed. 
 
Phase 6: Pilot RCT of the Maisha Intervention 
 
Procedure: 
For the full pilot test of Maisha, female ANC patients who are interested in enrolling in the study will 
be orally administered the informed consent by the study researcher. Participants will then complete 
an interviewer-administered, structured baseline survey. The survey will include questions about 
demographics, social support, attitudes toward HIV and people living with HIV, HIV testing history, 
and mental health. Following the baseline survey, participants will be randomized to receive either 
the control condition (standard of care) or the intervention condition (standard of care + Maisha) 
(Figure 4). 
Participants assigned to the control condition will receive the standard of care at the clinic, which 
includes all standard procedures related to HIV counseling.  
Figure 3. Intervention Theoretical Framework 

 
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Participants assigned to the intervention condition will 
receive the Maisha Session 1 counseling intervention 
(video, followed by a brief counseling session) 
immediately following the baseline survey, in the same 
private meeting space. They will then return to the waiting 
area to await the standard of care for the first ANC visit 
(which includes HIV testing). At this time, the study 
researcher will inform the clinic nurse that the participant 
is a part of the intervention condition.  
Upon completion of the standard of care HIV counseling 
and testing, participants who are HIV-positive will be 
escorted by clinic nurses back to the study researcher’s 
office to immediately complete the Maisha Session 2 
counseling session. At the conclusion of this session, the 
participant will be invited and encouraged to attend a 
Session 3 individual counseling session at the same 
location 1 week later. 
3 months after baseline, all HIV-positive participants 
(expected n=50) and a sub-set of 100 HIV-negative 
participants will complete a follow-up survey. The survey 
will explore key constructs reflecting health outcomes 
(HIV care engagement, adherence to ART, mental 
health), stigma outcomes (internalized, anticipated, and 
enacted stigma), and secondary outcomes (social support, partner support, intimate partner 
violence). This survey will be conducted in a private room and will take approximately 60 minutes.  
Immediately after the 3-month survey, a subset of 15 HIV-positive intervention participants (5 
established diagnoses, 10 new diagnoses) will be invited to participate in a qualitative in-depth 
interview (IDI) to explore their reactions to the intervention with greater nuance. Interviews will be 
conducted immediately after the survey and will take an additional 60 minutes. The IDI will be 
conducted in Kiswahili, using a semi-structured guide. Interviews will be audio recorded with 
participants’ permission.  
At the conclusion of pilot trial participation, the research nurse will review the medical records of the 
150 pilot trial participants who are selected to receive follow-up as part of the study. A structured 
data extraction form will be used to record key data on HIV care engagement.  
 
 
2.   Subject Selection  
 
Below are the eligibility and recruitment procedures that the KCMC team will use for inclusion of 
participants by study phase. 
Phase 1: Key Informant Interviews with Health Care Providers 
 
Eligibility: 30 health care providers: Individuals who are employed at one of the three study clinics 
and are involved in the care of HIV-infected women who are pregnant or postpartum. These 
individuals may include nurses, counselors, physicians, data capturers, and managers. 
 
Recruitment: For health care providers, the KCMC PI (Dr. Mmbaga), the Duke graduate student 
and KCMC research nurses will conduct a brief presentation at each of the study clinics. The 
research nurse and the Duke graduate student will then approach providers individually to invite 
them to participate in a key informant interview. 
 
 
Phase 2: Surveys and In-depth Interviews with female patients 
Figure 4. Pilot test design 

 
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Eligibility: 200 female patients: Women who are > 18 years of age, diagnosed with HIV, prescribed 
ART, and pregnant at the time of enrollment are eligible to enroll. Participants may either be newly 
initiating ART during pregnancy, or continuing ART due to an established HIV diagnosis. To ensure 
the safety of participants and integrity of the data, participants will be excluded if the attending 
physician determines that the patient has impaired mental status.  
 
Recruitment: For female patients, the KCMC research nurses will work with a specific health care 
provider in the clinic to identify individuals who are eligible for the study. The health care provider 
will approach the patient during a clinical appointment to see if she is interested in meeting with a 
KCMC research nurse to learn more about the study. If so, a research nurse will meet with the 
patient to explain the study and what participation involves, and to offer her the opportunity to 
participate if she chooses. 
 
Phase 3: Focus Group Discussions with Stakeholders 
 
Eligibility:  
• 
Health care providers, 3 FGDs or IDIs with 5 participants: Individuals who are employed 
at the study clinics and are involved in the care of HIV-infected women or women testing 
for HIV who are pregnant or postpartum. These individuals may include nurses, 
counselors, physicians, social workers, nursing assistants, data capturers, and 
managers. 
• 
Community health workers (CHWs), 2 FGD, 16 participants: CHWs are based in the 
study clinics to provide community-based care and support for people living with HIV 
(PLWH), and to encourage and coordinate HIV care engagement. 
• 
HIV-infected pregnant/postpartum women, 18 IDIs: Women who are > 18 years of age, 
diagnosed with HIV, prescribed ART, and pregnant or within 6 months postpartum at the 
time of enrollment. Participants may either be newly initiating ART during pregnancy, or 
continuing ART due to an established HIV diagnosis. To ensure the safety of participants 
and integrity of the data, participants will be excluded if an attending clinician determines 
that the patient has impaired mental status. 
• 
HIV-uninfected pregnant and postpartum women, 12 IDIs: Women who are > 18 years of 
age, pregnant or within 6 months postpartum, and received a negative HIV test result 
during pregnancy.  
 
Recruitment: For health care providers, the KCMC PI (Dr. Mmbaga), the Duke graduate student 
and KCMC research nurses will conduct a brief presentation at each of the study clinics. The 
research nurse will then approach providers individually to invite them to participate in a key 
informant interview. For female patients, the Duke graduate student and KCMC research nurses will 
work with a specific health care provider in each clinic to identify individuals who are eligible for the 
study. The heath care provider will approach the patient during a clinical appointment to see if she is 
interested in meeting with a research nurse to learn more about the study. If so, a research nurse 
will meet with the patient to explain the study and what participation involves, and to offer her the 
opportunity to participate if she chooses. 
Compensation: Patients will receive 5,000 TSh (~3 USD) for participation, and providers will receive 
an equivalently valued gift for participation. 
 
Phase 5: Development of the Maisha Intervention 
 
Eligibility: HIV-infected pregnant/postpartum women: Women who are > 18 years of age, diagnosed 
with HIV, prescribed ART, and pregnant or within 6 months postpartum at the time of enrollment. 

 
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Participants completing cognitive interviews may be the same as those completing IDIs in Phase 3. 
6 additional women will be enrolled for a trial run of the Maisha intervention. 
 
Recruitment: The research nurses will work with a specific health care provider in the clinic to 
identify individuals who are eligible for the study. The heath care provider will approach the patient 
during a clinical appointment to see if she is interested in meeting with a research nurse to learn 
more about the study. If so, a research nurse will meet with the patient to explain the study and what 
participation involves, and to offer her the opportunity to participate if she chooses. 
 
Compensation:  Trial run participants will receive 10,000 TSh (~6 USD) per visit for participation. 
Cognitive interview participants will receive 5,000 TSh (~3 USD) for their participation. 
 
Phase 6: Pilot RCT of the Maisha Intervention 
 
Eligibility: 1000 female patients: Women who are > 18 years of age, pregnant, and attending their 
first ANC appointments for the current pregnancy at one of the two pilot test study sites are eligible 
to enroll. To ensure the safety of participants and integrity of the data, participants will be excluded if 
the attending physician determines that the patient has impaired mental status. 
 
Recruitment: Research staff will work with clinic staff, including the receptionist at the Reproductive 
& Child Health (RCH) clinic and the ANC clinic nurse-in-charge, to identify women who are eligible 
for the study. When a woman arrives for her ANC appointment, she is routinely asked whether this 
is her first clinic appointment for the current pregnancy. For all women who answer “yes” to this 
question, the intake nurse will inform her that there is a research study taking place and inquire 
whether she would like to speak to the study researcher. Those who agree will meet with the study 
researcher, who will explain the study, review eligibility criteria, and offer her the opportunity to 
participate if she chooses, following the informed consent procedures. Clinic staff will be given a 
small monthly stipend to compensate for the added work of identifying and referring interested 
clients to the study staff; they will not be reimbursed based on whether or not the referral is 
successful, so that compensation does not create undue influence on a patient’s participation in the 
study. Enrollment will stop when we have enrolled 50 women who are HIV infected, which we 
estimate will require consenting and baselining approximately 1000 women over a six month period. 
 
Compensation: No compensation will be offered at baseline, but nutritious snacks will be given to all 
women taking part. Women who attend a follow-up counseling session will receive 5000 TSh (~3 
USD) to cover their transportation. Women who complete a 3-month survey will receive 5000 TSh 
for their participation, and snacks will be offered during the assessment. Women who complete an 
in-depth interview will receive an additional 5000 TSh.  
 
 
3.  Risks and Benefits 
 
The risk/benefit ratio for this study is relatively low, primarily because all of the data collection 
procedures are minimally invasive. All procedures will be performed by trained research staff at 
KCMC and the Duke graduate student, who will follow protocols to minimize risks, discomfort, and 
adverse events. As an implementation science study, we expect that the results of this study will 
inform the delivery of HIV care services for women in this setting. Women who receive the 
counseling intervention as part of the trial run or pilot test may also receive benefits associated with 
the counseling. At Duke, the primary risks will be confidentiality of the data we receive. The 
procedures to protect confidentiality of the data are described below. 
We believe that the potential risks of this study are reasonable given the potential benefits to 
inform future service implementation. The study team at KCMC has significant experience working 
with this population, and we are confident in their assessment of potential risks and their ability to 

 
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handle such risks. They are also well-equipped to supervise the Duke graduate student in her role 
with the support of the Duke co-PI. As such, we believe that the potential benefits outweigh the risks 
posed to human subjects. This research is expected to yield important new information on the 
implementation of Option B+ in Tanzania, which can inform the delivery of services in Tanzania and 
similar settings.  
 
4.  Confidentiality 
 
Confidentiality is of critical importance, and we will take many precautions to protect against the 
possibility of a breach of confidentiality at Duke. Our research team is very aware of the importance 
of maintaining strict confidentiality and has extensive experience dealing with sensitive information. 
At KCMC, the team has developed a study protocol to protect the confidential information collected 
from human subjects; this ethics protocol has been approved by KCMC and NIMR.  
 
Transfer of Digital Data from KCMC to Duke University 
The KCMC study team will collect the assessment data via paper and pencil and will enter the data 
into a RedCap software program that is programed at Duke. Duke will access the data by logging in 
to the secure RedCap server. If other data or study related information that has sensitive health 
information is shared with Duke, it will be transferred via a “sensitive data” project folder that will be 
established for this project on box.duke.edu (PROJECT_DGHI_PMTCT). Limited members of the 
study team at Duke will have access to the Duke Box folder. Within one week of data upload, 
authorized team members at Duke will move the data from the shared box.com folder to a folder on 
the protected server that will be established for the project (\\secure-nas-
fe01.oit.duke.edu\chpir\projects\PMTCT-watt). The data will be stored on Box, and relevant Duke 
study staff on the IRB protocol will access the drive through a VPN connection. De-identified data 
will remain on Duke Box when required for cross-site collaborations (e.g., data analysis). Otherwise, 
the data will be deleted on Duke Box.   
 
The study team will also host a Dropbox folder and use email to share materials that are essential to 
the study progress, but that do not contain participant data. Such materials may include study 
protocols, data collection instruments, and participant tracking logs that include participant ID and 
survey assessment dates. Materials shared through these means will not include names, contact 
information, clinic visit dates, or any participant-level data.   
 
Storage of Digital Data at Duke University 
All data kept at Duke University will be stored electronically, either on Duke Box or on the secure, 
password protected server folder that will be established for this study (\\secure-nas-
fe01.oit.duke.edu\chpir\projects\PMTCT-watt). Quantitative data will be stored as SPSS files and we 
will use SPSS to analyze the data. Qualitative data will be stored as Microsoft Word documents and 
NVivo project files, and we will use NVivo to analyze the data. The server where the data is stored 
meets all requirements for handling sensitive health data, as outlined in the Duke ITSO server 
standard security document. Only research staff who have completed IRB training and are directly 
involved in this project will have access to the data. The IT person responsible for managing the 
Duke team’s access to the server is Patrick Daniels, IT Manager – West Campus/Trent Support, 
(919) 660-2401.  
 
All study data will be kept identified by a study ID number. The file linking the participant ID number 
and identifying information of the individual (name, contact information) will be stored in a locked 
cabinet in Moshi, Tanzania. The Duke study team will not have access to that file. 
 
5.  Trainee Supervision 
 

 
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The research team at KCMC, led by the Co-PI, Dr. Blandina, will be involved with orientation, 
training and supervision of students and trainees involved in the study. This will be done with the 
support of the study team at Duke University. The KCMC team will also provide the trainees with 
resources needed to facilitate their involvement in the project(s) (e.g., workspace, equipment, 
access to data, etc.), meet regularly with them to provide support, guidance, and feedback and 
communicate with the Duke team to provide feedback on their progress. 
 
6. Compensation 
 
Below we describe the compensation procedures that KCMC will use for participants by study 
phase. Under all circumstances, participants who begin a procedure will receive compensation, 
even if they voluntarily choose not to complete the procedure. 
Phase 1: Key Informant Interviews with Health Care Providers 
 
Compensation: Participants will receive a small gift valued at 5,000 TSh (~3 USD) for participation. 
With the guidance of the Ministry of Health, it was determined that compensation in the form of a gift 
would be more appropriate than cash. 
Phase 2: Surveys and In-depth Interviews with female patients 
 
Compensation: Participants will receive 5,000 TSh (~3 USD) for participation in each survey 
assessment and in-depth interview. 
Phase 3: Focus Group Discussions and In-Depth Interviews with Stakeholders 
 
Compensation: Patients will receive 5,000 TSh (~3 USD) for participation, and providers will receive 
an equivalently valued gift for participation. 
 
Phase 4: Medical Record Review 
No human subjects to compensate. 
 
Phase 5: Development of the Maisha Intervention 
Compensation:  Trial run participants will receive 10,000 TSh (~6 USD) per visit for participation. 
Cognitive interview participants will receive 5,000 TSh (~3 USD) for their participation. 
 
Phase 6: Pilot RCT of the Maisha Intervention 
Compensation: No compensation will be offered at baseline, but nutritious snacks will be given to all 
women taking part. Women who attend a follow-up counseling session will receive 5,000 TSh (~3 
USD) to cover their transportation. Women who complete a 3-month survey will receive 5,000 TSh 
for their participation, and snacks will be offered during the assessment. Women who complete an 
in-depth interview will receive an additional 5,000 TSh.  
 
 
7.  Informed Consent 
 
Prior to participating in the study, KCMC staff and the Duke graduate student will obtain informed 
consent from participants. A KCMC research assistant and the Duke graduate student will describe 
the study in detail to the participant, allow him/her ample time to read the consent form thoroughly 
(or have it read to them) and ask questions, and ensure that he/she understands the purpose of the 
study, study procedures involved, and potential risks. Verification of comprehension of informed 
consent will be accomplished by asking participants to recall central points in the consent process. 
This procedure will also provide an opportunity to clarify any points of confusion. Participants will 
complete a separate informed consent for observations of their medical care at the clinic. 
Participants will sign one copy of the informed consent form and will be given a copy for their 

 
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personal records. If the participant is not able to write his/her name, a thumb print can be used in 
lieu of a signature. Participants will be told at enrollment that their decision to participate or not will 
in no way affect their current or future employment or health care at the facility.  
 
8.   Deception 
 
N/A.  This study does not involve deception.  
 
9.  Debriefing 
 
N/A. Because this study does not include deception, it is not necessary to conduct debriefing 
(defined by the IRB as telling the subjects about the deception). 
 
10. Statistical analysis  
 
Data analysis for Aim 3 (pilot trial) will follow guidelines of the CONSORT 2010 statement, as 
extended to pilot feasibility trials. 
 
  Feasibility and acceptability of the intervention and the associated trial will be described by: 
recruitment and retention patterns, participant satisfaction, fidelity, and implementation cost. 
Retention will be monitored to calculate the percentage of participants who attend the 1-week 
Maisha session (in intervention) and the 3-month assessment, to document barriers to attendance 
for participants, and to examine differences between those who attend and those who do not. 
Participant satisfaction data at the 3-month follow-up will be described, with >80% satisfaction used 
as a metric of acceptability. Qualitative data will be thematically coded for focus on participants’ 
perceptions of the intervention, suggestions for changes, and feasibility moving forward. The fidelity 
to the intervention will be assessed by examining the percentage of components from the 
manualized content that are covered in each session. To estimate the cost of the intervention, we 
will track the time for training and delivery, as well as actual costs incurred. Qualitative feedback and 
QA data will be used to revise and improve the curriculum for the future. 
 
  Potential efficacy will be examined by analyzing separate outcomes for HIV-infected and HIV-
uninfected women. For HIV-infected women, we are interested in differences between conditions 
in health outcomes (retention in PMTCT, medication adherence, depression) and stigma 
(anticipated stigma, internalized stigma and HIV disclosure). For HIV-uninfected women, we are 
interested in differences between conditions in stigma (attitudes to PLWH and anticipated 
stigma), as well as willingness to test for HIV in the future. For outcomes where there is a 
baseline measure, mixed-effects regressions will be used to model pre-post differences within 
and between arms, using a time by condition model specification (time, condition, and 
time*condition). Individual-level random intercepts will be used to account for correlation due to 
repeated measurement. Using a mixed-effects regression approach leaves flexibility to control for 
baseline outcome values that may not be balanced between groups due to small sample size, 
and may improve precision of treatment effect estimation. For outcomes where there is no 
baseline measure, we will examine differences in means or proportions with 95% confidence 
intervals. If we suspect, a priori, that baseline imbalance in prognostic covariates may be an 
issue, we will move into a regression framework. Results across outcomes will generate parameter 
estimates and potential ranges of values to estimate power for a future R01. This analytic approach 
is consistent with best practices for analysis of pilot feasibility trials. Data analysis will be led by the 
KCRI statistician and DGHI postdoc. To reduce bias and ensure reproducibility of results, we will 
discuss analytic approaches and review syntax as a team. All outcome analysis will be reviewed by 
an external statistician with study condition blinded (see letter from DGHI Research Design Core). 
 
 

 
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