Efficacy Testing of a Culturally Relevant Stigma Intervention With Women Living With HIV in Tanzania
Phase: NA
Conditions: HIV, Stigma, Social, Self Efficacy, Self Esteem, Hope, Depressive Symptoms
Sponsor: Duke University

Efficacy Testing of a Culturally Relevant Stigma Intervention in WLWH in Tanzania
Approval Date: 04/23/2024
NCT05033002
N

Standard Research Summary
Purpose of the Study
Objectives & hypotheses to be tested
The scientific premise of this program of research is that stigma has significant and negative effects on 
various psychosocial, behavioral, and clinical outcomes associated with prevention, care, and treatment 
among Tanzanian WLWH. 
For this specific study, we will obtain the following feasibility information:
· Recruitment metrics: length of time to complete participant recruitment; barriers to recruitment; percent
of total participants screened who meet screening criteria (median score of IHSS; intention to remain
resident in study area for duration of study) to meet sample size requirements for future RO1;
· Retention metrics: attendance and completion of the five group intervention sessions, punctuality. We
will also monitor the number of pre-session contacts for each study participant and the amount and type of
follow-up required for participants who miss one or more study visits.
· Timing and Completeness of study instruments: time (minutes) it takes to complete the questionnaires;
missing data from questionnaires.
· Fidelity: to evaluate fidelity to the study protocol and structured debriefing of each story, we will use
detailed fidelity checklists. RAs will complete a process rating form at the end of each intervention session
capturing issues of feasibility, coverage of debriefing session content, length of session, disruptions, issues
raised during the session, and level of participant engagement with the material. The training team will
maintain attendance rosters for each session, noting when participants leave the room and if/when they
return.
Hypothesis:  Although not formally articulated in the grant application, we hypothesis that the stigma 
intervention to be tested in this study (Labda Siku Moja) will reduce internalized stigma and improve 
coping self-efficacy, self-esteem, and hope among women living with HIV (WLWH) in Tanzania.
Background & Significance
Should support the scientific aims of the research
HIV-related stigma yields a number of negative outcomes1 among women living with HIV 
(WLHW) including a diminished self-efficacy for disclosing one’s HIV status to family members, friends, 
DUHS IRB Application (Version 1.7)
General Information
*Please enter the full title of your protocol:
Efficacy Testing of a Culturally Relevant Stigma Intervention in WLWH in Tanzania
*Please enter the Short Title you would like to use to reference the study:
Stigma Efficacy Trial, Tanzania
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.

and sexual partners
; postponed or refused care (non-engagement in care)
; healthcare services 
7-8
 1, 9-10
sought outside one’s community for fear of confidentiality breaches ; delayed early initiation 
6
of antiretroviral therapy (ART) ; diminished ART adherence
; diminished hope
; increased 
9
1, 9-11
12-13
psychological distress, including depression
; and a reduced quality of life
. 
14-18
18-20
This highly significant study focuses on Tanzania – a country in east Africa – where the burden of HIV, and 
its related stigma, is disproportionately prevalent among WLWH
. In support of PAR-19-326, 
17
this study 
will test the feasibility and preliminary efficacy of the internalized stigma reduction 
(Maybe Someday: Voices of 
intervention, Labda Siku Moja: Sauti za Wanawake Wanaoishi na VVU 
Women Living with HIV) supporting the program announcement’s goal “to improve health seeking 
behaviors across the HIV…care continuum and improve biologic and mental health outcomes” in Tanzanian 
WLWH. Labda Siku Moja is a theoretically based, culturally relevant, linguistically sensitive, sex 
.
specific internalized stigma reduction intervention developed for Tanzanian WLWH
In Tanzania, where 80% of the population lives in rural areas24 and HIV is the third leading 
cause of death25, an estimated 880,000 women are living with HIV26. In sub-Saharan Africa, 
including Tanzania, 
 because they are 
WLWH contract HIV at least 5 to 7 years earlier than men27
more likely to have older partners, get married earlier, and have greater challenges in negotiating safer 
sex because of gender inequality
. In 2018, according to UNAIDS, 4.6% of Tanzanian adults between the 
28
ages of 15 and 49 were living with HIV with the 
 (♀ = 6.0%: 
prevalence being higher among women
♂=3.6%)
. Although the prevalence is higher in urban areas (urban, 7.5% versus rural, 4.5%)
, this
26
29
study will also recruit rural WLWH since most of the Tanzanian population live in rural areas. Further, one
could argue that the 
 intervention may be even more useful for women in isolated, rural
Labda Siku Moja
areas, as they would have fewer opportunities to see women as portrayed in the stories
. There are 
30
dispr
 (ages 15-24) compared to
oportionate rates of new infections among young women in Tanzania
their male counterparts of the same age
. In 2012, women aged 23-24 were twice as likely to be living
26
with HIV as men of the same age
. Data from the representative 2016-2017 Tanzania Impact Survey
28
identified that women between the ages of 15 and 39 are more than twice as likely to be living 
. Additionally, 
with HIV as their male counterparts31
the highest HIV prevalence rate in Tanzania 
 (compared with 8.4% among men of this age)
. Thus, in the 
is among women aged 45-49, at 12%
31
design of this proposed study, we are focusing on WLWH since they are disproportionately impacted and 
will purposively recruit based on geography (urban and rural) and age (18-24 and 25+). 
The United Republic of Tanzania’s Fourth Health Sector HIV and AIDS Strategic Plan (HSHSP- IV) 2017-
 calls for the elimination of HIV related stigma and discrimination recognizing its negative impact on 
202229
PLWH; and achieving the 90-90-90 targets (now the 95-95-95 targets for 2030). The most recent 
Tanzanian 
 (2013; N = 2205, 57% of sample = WLWH) 
PLWH Stigma and Discrimination Survey32
documented that: 
“Being gossiped, verbally insulted, exclusion from social, family as well as religious activities were 
the leading forms of stigmatization whereby Dar es Salaam indicated high levels of stigma (49.7%) 
as compared to (39.4%) from other regions, females experienced more gossiping than male 
counterparts in both regions” 
. 
32. p. vi
Compared to men, WLWH had higher rates of feeling ashamed (29.8%) and feeling suicidal (7.0%) 
or nearly equal rates for feeling guilty (13.8%), having a low self-esteem (42.9%), and believing 
they should be punished (5.4%)
. 
32
In appraising the current literature on HIV-related stigma interventions, Pantelic et al. (2019)
 and Ma et 
33
al. (2019)
 recently shifted the focus toward systematic examination of interventions specifically aimed at 
34
reducing self-stigma or internalized stigma in PLWH. Pantelic et al.
 further differentiated their focus by 
33
only examining self-stigma or internalized stigma interventions (N=20) implemented in low- and middle-
income settings. The parent intervention to the 
 intervention – the 
 
Labda Siku Moja
Maybe Someday
intervention developed by Sandelowski and Barroso
 and tested by Barroso and Relf in the Southern US 
4, 22
(R21NR021415)
 was identified in the Ma et al systematic review
 as being one of the few to use an 
23, 35
34
RCT design with sufficient power and include a qualitative evaluation of the intervention – the two 
identified limitations of the internalized stigma reduction interventions identified in this systematic review. I
n Tanzania, despite the negative impact of stigma on psychosocial, behavioral, and clinical HIV 
outcomes, rigorously tested, efficacious interventions to mitigate the negative effects of 
internalized stigma associated with HIV among women are limited, and critically needed. 
Design & Procedures

Describe the study, providing details regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
This individually randomized, group-treatment feasibility and efficacy trial will compare the Labda Siku Moja
internalized stigma intervention to treatment as usual (TAU). Treatment as usual will consist of routine 
care offered by each site; currently, there is no specific stigma reduction intervention delivered as part of 
routine care in Tanzania. Specifically, feasibility will utilize a process evaluation approach while efficacy 
and determination of effect sizes will utilize a 2x4 repeated measures randomized controlled trial (2 
treatments x 4 time points [baseline, 30 days, 90 days, 180 days]) with a post-intervention focus group 
“to expand our understanding of how best to deliver the intervention, it is crucial to include the voices of 
the participants in the evaluation of the intervention” as advocated by Ma et al.
. By conducting a post-
34
intervention focus groups, we can “elicit the participants’ experiences with the intervention and their 
perceptions of it, and provide insights into the acceptability and feasibility of the intervention, and how to 
further improve it”
. 
34, p. 739
Intervention Procedures. Before implementing the intervention, we will work with the Community and 
Technical Advisory Board (CTAB) to finalize all study procedures. The CTAB will consist of 6 to 8 individuals 
and will be co-chaired by a social/ behavioral scientist experienced in HIV research, Dr. Lusajo Kajula, and 
a national HIV community advocate, Ms. Pfiriaeli Kiwia, Program Coordinator and Co-Founder, Kimara Peer 
Educators and Health Promoters (please see letters of support). Other CTAB members may include health 
center or dispensary staff, a representative from TACAIDS and/or the National AIDS Control Program/ 
MOH, and at least one WLWH. This CTAB will provide guidance on all study and human subjects protection 
procedures and will help identify mechanisms to recruit WLWH who may be disconnected from care. 
The intervention will be delivered via in-person groups. These groups will be held at either the dispensary 
or health center where the WLWH were recruited or at MUHAS. Regardless of site, the group/cohort 
meetings will occur in a private room. The stories of the 
 intervention will be viewed on 
Labda Siku Moja
either a health facility/dispensary TV or projected from a laptop using existing equipment. During the 5 
weekly meetings, intervention arm participants will view one story and have a structured debrief by the 
Tanzania MPI; the structured debrief will use Motivational Interviewing (MI)
, a practical, empathetic, and 
42
short-term process that recognizes the difficulty of making life changes. MI utilizes a spirit of empathy, 
acceptance, respect, honesty, and caring, which helps in building warm, trusting relationships. MI will help 
the participants in the intervention arm of this study to explore and resolve issues, feelings, and 
insecurities associated with HIV-related stigma. 
The recruited sample recruited will be comprised of both urban and rural Tanzanian WLWH,purposivel
. Eligible participants will be individually randomized in 8 waves (8 
y stratified by age (18-24/25+)
waves x 10 participants/wave x 2 sites (urban site and rural site) yielding the sample of 160 participants 
(80 intervention arm and 80 control arm).  Up to 200 may be consented to factor in for screen failures. 
Selection of Subjects
List inclusion/exclusion criteria and how subjects will be identified.
Study Sample Recruitment. 
We will recruit 160 WLWH in total for this study. The sample recruited will be comprised of both urban and 
rural Tanzanian WLWH, purposively stratified by age (18-24/25+). Eligible participants will be individually 
randomized in 8 waves (8 waves x 10 participants/wave x 2 sites (urban site and rural site) yielding the 
sample of 160 participants (up to 200 may be consented to factor for screen failures)  (80 intervention 
arm and 80 control arm). We will recruit at community-based clinics, health centers, and dispensaries in 
the Kinondoni Municipal District (part of urban Dar es Salaam) and a rural area different that the current 
R21 study (recruited rural participants from Lushoto); for this proposed study, we will recruit from one or 
more of the following rural sites – Bagamoyo, Kigamboni, Mkuranga. At both the urban and rural sites, 
staff at these organizations who are already aware of the woman’s HIV status will approach potential 
respondents to introduce the study. At health centers and dispensaries, staff will be particularly 
encouraged to refer WLWH who are not regularly engaged in care and/or not virologically suppressed to 
help facilitate reaching a population not stably engaged and retained in care. Study staff will only meet 
WLWH who, after learning about the study from the above agencies, indicate they are potentially 
interested in learning more the study. Convenience sampling will be employed, however purposively 

ensuring both young women (18-24) and older women (25+) living with HIV and urban and rural WLWH 
will be a focus. This study team has successfully recruited from these sites in previous studies.
Inclusion Criteria.
The inclusion criteria for this study are: (1) women who are living with HIV; (2) age 18 (age of adulthood 
as defined by the Tanzanian government); (3) able and willing to voluntarily consent to participate in the 
study; (4) able to travel to a data collection in their local community (as described above); (5) 
demonstrate mental competence at time of informed consent; (6) verbally indicate that they plan to reside 
in their current community for at least 6 months after enrollment (necessary to prevent attrition); and (7) 
score at the median or higher level on the Swahili Version of the Multidimensional Measure of Internalized 
HIV Stigma Scale.
Exclusion Criteria.
At the time of obtaining informed consent, eligible participants will be excluded if there is (1) any acute 
psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they 
will be excluded from this study and referred to an appropriate site for evaluation and treatment. (2) 
Transgender women living with HIV will not be eligible to participate in this study to reduce the potential 
for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and 
culturally sensitive in Tanzania. Further, it would be exceedingly difficult to recruit a sufficient sample of 
transgender women living with HIV to conduct an appropriate analysis. (3) Participants may be enrolled in 
other HIV-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, 
self-esteem, and/or disclosure
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
Recruitment.
At both the urban and rural sites, staff at these organizations who are already aware of the woman’s HIV 
status will approach potential respondents to introduce the study. At health centers and dispensaries, staff 
will be particularly encouraged to refer WLWH who are not regularly engaged in care and/or not 
virologically suppressed to help facilitate reaching a population not stably engaged and retained in care. 
Study staff will only meet WLWH who, after learning about the study from the above agencies, indicate 
they are potentially interested in learning more the study. Convenience sampling will be employed, 
however purposively ensuring both young women (18-24) and older women (25+) living with HIV and 
urban and rural WLWH will be a focus. This study team has successfully recruited from these sites in 
previous studies.
Retention. 
At the time of enrollment, the study protocol, including the number of study visits will be explained in 
detail. To help facilitate retention, study participants will be asked to provide a mobile phone number to 
facilitate outreach to remind participants of upcoming study visits. We will obtain permission to contact 
them via this mobile phone (phone, SMS, WhatsApp) as part of the informed consent process. After each 
wave of data collection, participant information will be updated, in case they have changed their phone 
number or address.
Additionally, we will ask each study participant to provide the name and contact information for two 
persons from their social network who the participant has designated as a “safe contact”. Using a “safe 
contact” locator form, the study staff will records the contact information for friends and family members 
who may be contacted in the event the participant misses a visit, with the consent of the participant.
This “safe contact” will only be contacted if we are unable to contact the individual study participant after 5 
attempts over 5 different days. If this individual is contacted, we will use a standardized script developed 
with the study participant and documented in the participant’s study protocol file with the informed 
consent document to explain the purpose of the call. In all situations, we will not discuss anything about 
HIV.
Particularly for follow-up study visits (30-60-90-180 days), we will offer flexible scheduling options. This 
may include early morning or late afternoon visits as well as visits on Saturday. During each study visit, in 
addition to the reimbursement for time and transportation reimbursement, participants will receive small 
tokens of appreciation for either themselves or a child. These small tokens of appreciation might be a pen, 
notebook, and/or personal hygiene product.

Community engagement through Community and Technical Advisory Board (CTAB) and relationship 
building with health centers/dispensaries will enable the broad support needed to better follow up with and 
retain participants.
Compensation.
UPDATED, 8 September 2022:
All women who are screened for the study, will receive an incentive as described below:
not eligible-get incentive ($2.50)
eligible-decline enrollment-get incentive ($2.50)
eligible-enroll-complete rest of questionnaire-get incentive ($5)
ORIGINAL TEXT
Participants will receive 20,000 Tanzanian Schilling (TZA; equivalent of $8.50) USD for the 
baseline study visit and the 30 day study visit.  For participants in the intervention arm, they 
will also receive $8USD for each of the 5 intervention study visits.  At the 90 and 180 day study 
visits, participants will receive 30,000 Tanzanian Schillings (equivalent to ~$13.00USD).  This 
compensation should cover transportation costs and loss of income for study participation.
Tanzania salary information for comparative purposes:  In Tanzania, the average daily wage in Tanzania 
ranges from 3077 TZS for domestic workers to 15,3835 TZS for someone working in the mining sector
/financial institution/international company.  Reference: Etyang, D. (2017). An Analysis of Wages and 
Collective Bargaining in Tanzania - 2016. May 2017 - ALREI - WageIndicator Foundation, Amsterdam.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
This study will not enroll individuals who do not have capacity to provide informed consent.  All study staff 
(PD, RAs), as a part of their orientation to the study protocol, will receive information about capacity to 
provide consent.  The PD for the study will be an individual with an MSc in Clinical Psychology.  
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.
This study will not use an investigational drug or biologic or device.
This study's intervention will include 5 ethnodramas identified to be culturally and linguistically acceptable 
through a mixed methods evaluation in a previous R21 with the same study team.  These 5 ethnodramas 
associated with the Labda Siku Moja are described in detail 
 
in Table 2 of the full grant application
which is attached.  They are also provided as an attachment/appendix
Risk/Benefit Assessment

Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant individuals, imprisoned persons or 
cognitively impaired adults), what special precautions will be used to minimize risks to these subjects? 
Also identify what available alternatives the person has if he/she chooses not to participate in the 
study. Describe the possible benefits to the subject. What is the importance of the knowledge expected 
to result from the research?
Participation in this study is completely voluntary.  Those who personally select not to participate, if 
inclusion/criteria are met, will receive usual care associated with HIV.  In this situation, there is no usual 
care condition for stigma.  
This individually randomized, group-treatment feasibility and efficacy trial will compare the Labda Siku 
Moja internalized stigma intervention to treatment as usual (TAU). Treatment as usual will consist of 
routine care offered by each site; currently, there is no specific stigma reduction intervention delivered as 
part of routine care in Tanzania. Specifically, feasibility will utilize a process evaluation approach while 
efficacy and determination of effect sizes will utilize a 2x4 repeated measures randomized controlled trial 
(2 treatments x 4 time points [baseline, 30 days, 90 days, 180 days]) with a post-intervention focus group 
“to expand our understanding of how best to deliver the intervention, it is crucial to include the voices of 
the participants in the evaluation of the intervention” as advocated by Ma et al.34. By conducting a post-
intervention focus groups, we can “elicit the participants’ experiences with the intervention and their 
perceptions of it, and provide insights into the acceptability and feasibility of the intervention, and how to 
further improve it”34, p. 739. A flow diagram of the study is illustrated in figure 3 of the full grant 
.
application which is attached
Risk:
There is minimal risk to human participants in this proposed study. Nonetheless, rigorous efforts will be 
made to protect them. We will recruit a total of 160 participants for this study. The WLWH will be recruited 
by a project team member across urban and rural areas in Tanzania. Community-based clinics and health 
centers/dispensaries providing HIV care and treatment services, and HIV/AIDS service organizations 
involving WLWH will be the primary recruitment sites. 
The study team has successfully recruited from these sites/agencies previously. IRB approval will be 
sought in accordance with all domestic and foreign regulations. As such, in the Republic of Tanzania, the 
study will be reviewed by the IRB at Muhimbili University of Health and Applied Sciences (MUHAS) and will 
be registered with the National Institute of Medical Research (NIMR). The study will also obtain IRB 
approval from Duke University since this is the coordinating site of the project. In standard operating 
procedure, once approval is obtained from MUHAS, NIMR, and Duke University, RTI will defer IRB approval 
to Duke University.
We will obtain written informed consent, or thumb print confirmation for those who are illiterate, from the 
participants prior to initiating any study activities. The Tanzanian MPI, project director or research 
assistant will screen eligible participants with regard to inclusion/exclusion criteria.
Benefits:
There are possible benefits to participants of this study. All participants will help researchers better 
understand stigma, coping self-efficacy, ART medication adherence, engaging in care, sexual risk 
behaviors and quality of life. Completion of study instruments will allow the women an opportunity to 
express past/recent experiences. Participants will receive the equivalent of $8USD to $13USD for their 
time (lost wages) and to cover travel associated costs. The risks to participants are both minimal and 
reasonable in relation to the anticipated benefits to participants and others.
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
Participants in this study will not incur any costs.
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.

 STATISTICAL DESIGN AND POWER
Power Analysis. The proposed study is designed to assess the preliminary efficacy of the intervention 
and to generate pilot data to support the conduct of a larger trial. The sample size of 160 is, therefore, 
primarily determined by whether the intervention could be feasibly implemented in a larger, multi-site 
study and to calculate a pooled effect size for the primary outcomes so as to determine the sample size 
necessary for such a large study, rather than by the power to detect specified effect sizes. Nevertheless, 
we have conducted a power analysis using the Optimal Design
 for mixed effects models on repeated 
47
measures of continuous outcomes, employing an intention-to-treatment analysis. The power analysis 
revealed that a total sample size of 160 (i.e, 80 in each treatment arm) would achieve 80% power to 
detect a standardized effect size δ of 0.51 with four repeated measurements, assuming an intra-class 
correlation of 0.70 and a two-tailed alpha of .05. The standardized effect size δ is analogous to Cohen’s  
d
for which Cohen defines 0.20 as a small effect, 0.50 as a medium effect size, and 0.80 as a large effect
. 
48
Thus, we will have sufficient power to detect a medium effect size of the longitudinal intervention effect on 
a linear trend of stigma, coping self-efficacy, and self-esteem over time. For comparing intervention effects 
at days 30, 90, and 180, cross-sectionally, the results from another power analysis with the G*Power
  on
49
independent-sample tests show that we will have 80% power to detect a close to medium effect size of 
Cohen’s  = 0.45. Additionally, we expect the dropout rate will be less than 10% based on studies we 
d
have conducted in this area, and attrition between conditions will not differ. The sample size will not 
require an attrition adjustment because mixed-effects models allow for data missing at random.
Statistical Analysis, Aim #1, Feasibility: To assess the feasibility, the following parameters will be 
collected and evaluated: 
·Recruitment:  to identify the length of time to complete participant recruitment; identify barriers to
recruitment; to assess the number of participants who meet screening criteria (median score of IHSS) to
meet sample size estimation; to determine capacity to recruit women who may not be engaged in care
·Retention:  to assess adherence to and completion of the intervention (high-intensity intervention),
attendance and punctuality for group intervention sessions
·Measurement:  to assess the time (minutes) it takes to complete the questionnaires; to evaluate missing
data from questionnaires
·Fidelity: to evaluate fidelity to study protocol and structured debriefing using Motivational Interviewing
will be done using detailed fidelity checklists. These fidelity checklists will evaluate delivery of a list of
important teaching components in each session
·Process Evaluation:  to conduct a qualitative evaluation with participants to identify barriers and
facilitators, perceptions, and overall satisfaction with the 
 intervention
Labda Siku Moja
Statistical Analysis, Aim #2: We will conduct an intention-to-treat analysis which will include all women 
randomized to determine whether women living with HIV who viewed the video experience a greater 
reduction in internalized stigma and greater improvements in coping self-efficacy and self-esteem over the 
180 days than women in the control condition. Two-tailed statistical tests will be performed using SAS 9.4. 
For this exploratory study, the significance level will not be adjusted for multiple tests. Student 
tests and 
t-
chi-square tests will be used to test whether the randomization balanced the conditions on key baseline 
characteristics and baseline scores on the main outcomes. If treatment conditions differ significantly on 
any these characteristics, which is unlikely to happen though due to the random assignment, the baseline 
measure would be controlled as a covariate in subsequent analyses. Random coefficients regression 
models (a type of hierarchical mixed effects model for repeated measures) will be used to examine 
between-condition differences in change over time (trajectories across baseline, 30 days, 90 days, and 180 
days) in the outcomes. Fixed effects will be condition, time, and condition-by-time, while random effects 
will be participant and participant-by-time. If necessary, baseline covariates will be included as fixed 
effects. We will also conduct 
contrasts to examine differences between treatment conditions at 30, 
a priori 
90, and 180 days. Observed effect sizes will be calculated for the condition-by-time effects (rate of 
change) and between-condition differences at 30, 90, and 180 days. 
Estimated Time to Target Accrual and Accrual Rate:
Study Sample Recruitment. We will recruit 160 WLWH in total for this study. The sample recruited will 
be comprised of both 
 
urban and rural Tanzanian WLWH, purposively stratified by age (18-24/25+)
. Eligible participants will be individually randomized in 8 waves (8 waves x 10 participants/wave x 2 sites 
(urban site and rural site) yielding the sample of 160 participants (80 intervention arm and 80 control 
arm). 
We will recruit at community-based clinics, health centers, and dispensaries in the Kinondoni Municipal 
District (part of urban Dar es Salaam) and a rural area different from a previous R21 study (recruited rural 
participants from Lushoto); for this proposed study, we will recruit from one or more of the following rural 
sites – Bagamoyo, Kigamboni, Mkuranga. At both the urban and rural sites, staff at these organizations 
who are already aware of the woman’s HIV status will approach potential respondents to introduce the 
study. At health centers and dispensaries, staff will be particularly encouraged to refer WLWH who are not 
regularly engaged in care and/or not virologically suppressed to help facilitate reaching a population not 
stably engaged and retained in care.

Study staff will only meet WLWH who, after learning about the study from the above agencies, indicate 
they are potentially interested in learning more the study. Convenience sampling will be employed, 
however purposively ensuring both young women (18-24) and older women (25+) living with HIV and 
urban and rural WLWH will be a focus. This study team has successfully recruited from these sites in 
previous studies.
Time/Accrual Rate.
In accordance with the study timeline, we will recruit participants beginning in Year1/Month 6 and follow 
participants through Year 2/Month 9.  Control and intervention eligible participants will be individually 
randomized in 8 waves (8 waves x 10 participants/wave x 2 sites (urban site and rural site) yielding the 
sample of 160 participants (80 intervention arm and 80 control arm).  We estimate that it will take 6 
months to complete recruitment.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
The MPIs (Relf, Nyblade, Kilonzo) will virtually meet bi-weekly with the Project Leadership Team (please 
refer to study team structure) to monitor the conduct of the study and ensure that the study protocol is 
implemented as written. All project team members will be instructed to notify either the Tanzanian MPI 
(Kilonzo) or contact MPI (Relf) if there is any adverse event. Once an adverse event is identified and/or 
reported, actual or potential, the MPI Steering Committee will virtually meet within 24 hours. The MPI 
Steering Committee will implement the appropriate course of action to remedy critical incidents and 
adverse events that may occur during the study. The MPI Steering Committee and the CRC, PD, Chief 
Statistician will conduct a data and safety review at mid-point of data collection and at any time a serious 
adverse event occurs.
During the study, if an adverse event were to be occur, the MPI Leadership Team, the CRC, and the 
Project Director will evaluate the adverse event and determine whether the event affects the risk/benefit 
ratio of the study and whether modifications to the protocol or consent form are required. A “Critical 
Incident Journal” will also be maintained during the project. This journal will contain information such as 
the nature of the critical incident, the personnel involved, the solutions considered, and the final action 
implemented to resolve the incident. When necessary, the study team will also seek the expert opinion of 
the Duke University Health System IRB, the Research Triangle International IRB, and/or the Muhimbili 
University of Health and Applied Sciences IRB. Safety concerns for participants in this protocol are 
minimal. However, non-serious adverse events will be summarized and reported to the IRB periodically. 
The summary will include the number of participants enrolled and a summary of graded adverse events to 
date. Should serious adverse events occur, they will be reported within 48 hours to the appropriate IRB as 
well as the NIH by the contact MPI (Relf). 
All members of the investigative team have completed or will complete during the orientation/on-boarding 
process, in a standard program on the ethical conduct of human research that conforms to current NIH 
guidelines or the country-specific equivalent. This program included information on the history of human 
participant protection, ethical principles governing informed consent, risk/benefit evaluation, equitable 
selection of research participants, and regulatory oversight. The study protocol will be implemented by 
project staff that will receive standardized and verified training in study protocols and procedures and will 
be monitored in continued use of those protocols/procedures over the course of the study.
A project database will be constructed using participant study numbers. A separate file, cross-referencing 
participant identification with project ID numbers, will be maintained with access limited only to staff 
working directly with the participants. Participants will be assured that they can withdraw from the study 
at any time without adverse effects. The Tanzanian MPI will be responsible for on-going quality control of 
the project database. The Tanzanian MPI, in collaboration with the other members of the MPI Leadership 
Team and Tanzanian Project Director, will ensure the confidentiality of all data and the results of 
monitoring, and will assist NIH by commenting on any problems that arise around the conduct of the 
study, participant enrollment, and data collection.
Regarding quantitative data integrity, field data collected by participants will be uploaded to a central 
database housed at TRI via an encrypted, secured network stored on servers behind RTI’s firewall. 
REDCap (Research Electronic Data Capture) is a secure, web-based application that is HIPAA compliant 
and secure designed to support data capture. Data capture in the field, via REDCap, will use a tablet 
device with instruments preloaded in the local language (Swahili) and English. 

During the quantitative data collection/analysis period, the key team members (MPIs, CRC, Project 
Director, Database Coordinator, Chief Statistician) will meet bi-weekly (every 2 weeks), and as needed, to 
discuss issues related to data elements/data analysis and results. The quantitative database used for 
storing data will be saved and backed up nightly on a secure encrypted server behind the firewall at RTI. 
The MPIs, CRC, and PD will enact several safeguards to ensure that office and other space needed for the 
conduct of the proposed research to ensure the confidentiality of participants. Safeguards include the 
following:
a) all computers will be password-protected;
b) screensavers on computers will automatically initiate after 60 seconds of non-use;
c) all computers will be located in positions and angled so that casual observers cannot read computer
screens;
d) all computers will contain the most current virus and security software and receive regular updates of
this software;
e) all data collection materials will be stored in locked file cabinets inside a locked office, and access to
these offices is limited to key study personnel (who have completed human participants’ protection
certification);
f) all data will be backed up nightly on a secure server and a flash drive will be used to store data off-site
in the event of a building catastrophe; and
g) all data documents will be shredded or destroyed by the Tanzania MPI or PD at the appropriate time.
We are confident that all research activities conducted for the study will protect the privacy and
confidentiality of the study participants and will fully meet the requirements of human participants’
protection.