In-the-kNOW (Novel Approaches to Optimizing Women's Health): A Mobile Application to Optimize HIV Prevention and Sexual/Reproductive Health Communication Among Black Women in the Southern U.S.
Phase: NA
Conditions: Mobile Phone Use, Hiv, Stigma, Social
Sponsor: Emory University

 
 
 
 
 
 
 
 
In-the-kNOW (Novel Approaches to Optimizing Women's Health): A 
Mobile Application to Optimize HIV Prevention and 
Sexual/Reproductive Health Communication Among Black Women in 
the Southern U.S.  
 
 
Date: February 19, 2024 
NCT05080972 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
PRINCIPAL INVESTIGATOR: 
, Deans Office, School of Nursing, ; 
 
 
EXTERNAL (NON-EMORY) COLLABORATORS N/A ☐:                                                                   
, Assistant Professor, Morehouse School of Medicine, and 
Department of Community Health and Preventive Medicine; 
 Georgia Tech, 
School of Interactive Computing, College of Computing  
 (This institution’s IRB will not review)  
VERSION:  Version-2- 06/23/2021. 
 
FUNDING SOURCE: NIH, NIMH funding pending 
 
 
 
REVISION HISTORY 
 
Revision # 
Version 
Date 
Summary of Changes 
1 
06/09/2021 
We have indicated the School of Nursing Department. We 
have made edits to the consenting procedures in which 
participants will provide electronic consent. In addition, 
we have made revisions to recruitment flyers and have 
uploaded additional documents per request in the study 
application. 
2 
06/23/2021  
More detail has been added to the Lay Summary. We have 
made additional revisions to the consent template, 
consent form, and device checklist. 
3 
02/28/2023 
We have included TBD Health as a study partner, and this 
revision reflects in the consent form along with data 
sharing and authorization. 
4 
03/27/2023 
We have updated to reflect that we will be collecting 
specific data points related to test study results from TBD 
Health. 
5 
02/19/2024 
We updated the recruitment section to utilize the MyChart 
Recruitment Service. 
 
 
 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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Table of Contents 
 
1.0 
Study Summary ................................................................................................................3 
2.0 
Objectives* .......................................................................................................................3 
3.0 
Background* ....................................................................................................................4 
4.0 
Study Endpoints*..............................................................................................................5 
5.0 
Study Intervention / Design ..............................................................................................5 
6.0 
Procedures Involved* .......................................................................................................5 
7.0 
Data and Specimen Banking* ...........................................................................................9 
8.0 
Sharing of Results with Participants* ................................................................................9 
9.0 
Study Timelines* ..............................................................................................................9 
10.0 Subject Population*..........................................................................................................9 
11.0 Study Partner ...................................................................................................................9 
12.0 Vulnerable Populations*.................................................................................................10 
13.0 Local Number of Participants ..........................................................................................10 
14.0 Recruitment Methods ....................................................................................................10 
15.0 Withdrawal of Participants* ...........................................................................................11 
16.0 Risks to Participants* ......................................................................................................11 
17.0 Potential Benefits to Participants*..................................................................................13 
18.0 Data Analysis, Management* and Confidentiality ...........................................................13 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants* .............................14 
20.0 Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data....................................................................................................14 
21.0 Compensation for Research-Related Injury .....................................................................16 
22.0 Economic Burden to Participants ....................................................................................16 
23.0 Consent Process .............................................................................................................17 
24.0 Process to Document Consent in Writing........................................................................17 
25.0 Setting ............................................................................................................................17 
26.0 Resources Available ........................................................................................................18 
27.0 Multi-Site Research* ......................................................................................................18 
28.0 References .....................................................................................................................19 
 
 
 
 
 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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1.0 
Study Summary 
 
Study Title 
In-the-kNOW (Novel approaches to Optimizing 
Women’s Health): A mobile application to optimize 
HIV prevention and sexual/reproductive health 
communication among Black women in the Southern 
U.S. 
Study Design 
Descriptive 
Primary Objective 
Evaluate the feasibility, acceptability, and usability of 
the refined in-the-kNOW mobile app. We will employ 
experimental (n = 30) and control (n = 30) conditions 
to determine the feasibility and acceptability 
(retention rates and satisfaction) of both the app and 
the control condition (e.g., referral to the CDC’s online 
HIV risk reduction tools). 
Secondary Objective(s) 
Determine feasibility of collecting secondary outcome 
measures (e.g. PrEP Stigma) for a R01. 
 
Research 
Intervention(s)/Interactions 
N/A 
Study Population 
Black women (18-44 y.o.) 
Sample Size 
N= 60 Black women 
Study Duration for 
individual participants 
4 months 
Study Specific 
Abbreviations/ Definitions  
CBWW:  Center for Black Women’s Wellness; AHSI: 
Atlanta Healthy Start Initiative 
Study Partner 
TBD Health 
Funding Source (if any) 
NIH, NIMH Funding pending 
 
2.0 
Objectives* 
 
 
2.1  Black women have a significantly higher risk of acquiring HIV compared to their non-Black 
counterparts. The purpose of this study is to refine and test a mobile HIV Prevention and 
Reproductive Health app develop specifically for Black women. The overall goal in 
implementing this study will be to assess the feasibility, acceptability, and usability of the app. 
The app will be refined using preliminary data obtained through prior research with Black 
women in which their perspectives towards the use of an HIV and sexual health mobile app 
were ascertained. Preliminary data obtained from our Community Advisory Board (CAB), which 
will predominately consist of Black women will guide refinement of the content and features 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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included within the mobile app, whilst ensuring that the app is tailored towards the needs and 
perspectives of Black women. We propose to: 
Aim 1: Refine the in-the-kNOW mobile app for PrEP-eligible Black women. Using a human-
centered design approach1, we will conduct a single-arm technology usability pretest to 
optimize usability, technical functionality, and performance of the app, among n = 10 PrEP-
eligible Black women. The mobile app will be refined per pretest feedback.   
Aim 2a. Evaluate the feasibility, acceptability, and usability of the refined in-the-kNOW mobile 
app. We will employ experimental (n = 30) and control (n = 30) conditions to determine the 
feasibility and acceptability (retention rates and satisfaction) of both the app and the control 
condition (e.g., referral to the CDC’s online HIV risk reduction tools). Aim 2b. Determine 
feasibility of collecting secondary outcome measures (e.g. PrEP Stigma) for a R01. 
 
The sample for this study will include young adult Black women 18-44 years of age living  in 
metro-Atlanta who are patients at the Center for Black Women’s Wellness (CBWW). 
Participants will be recruited through flyer distribution and enrollment by CBWW clinic staff 
during clinic visits, coupled with posting recruitment content on CBWW’s website and social 
media platforms. Written consent will be obtained from participants who agree to participate 
in the study. The methodology for this study will be descriptive and will employ both 
quantitative and qualitative data collection through administering online surveys along with 
semi-structured interviews through the online platform Zoom, as well as participant HIV/STI 
testing data collected from TBD Health. Survey responses will be anonymous, and interviews 
will be recorded and transcribed with transcriptions being de-identified to maintain 
confidentiality.  
 
 
3.0 
Background* 
One in 48 Black women will be diagnosed with HIV in her lifetime.2-5 Although HIV incidence in 
women has declined, Black women continue to be disproportionately affected. In 2016, Black 
women accounted for 61% of newly diagnosed HIV infections among women in the U.S.,2,3 yet 
they only comprise 13.7% of the U.S. female population.1 Eight of ten states with the highest 
rates of new HIV diagnoses are in the South.5-8  Black women account for 69% of all HIV 
diagnoses among women in the South.  
PrEP offers women an HIV prevention method that is discreet, does not require partner 
consent, and may be compatible with both contraception and conception as desired. There is 
considerable research about PrEP awareness and adoption among MSM,9-16 but far less among 
women, particularly Black women. The few studies that investigated PrEP attitudes exclusively 
in women found that most have never heard of PrEP but have generally responded positively to 
the idea of this prevention method.17-21 Black women’s willingness to consider PrEP depends 
greatly upon social understandings—whether it is seen as an effective, healthy, and socially 
acceptable HIV prevention strategy—in addition to cultural and structural factors.7,18-20,22-25 In-
the-kNOW will be a culturally relevant and competent digital health communicator for a local 
Healthy Start (AHSI) and a National Healthy Start Association to promote HIV prevention 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
Page 5 of 22                                                                                                        Version-5- 02/19/2024  
 
(including increasing PrEP knowledge) and optimal sexual health to PrEP-eligible Black women. 
That app also aims to reduce structural barriers to PrEP uptake by: 1) providing secure sensitive 
data to prevent intimate partner violence [IPV] practices such as partner monitoring, 2) 
incorporating harm reduction strategies, social support, and communication resources for 
women facing housing insecurity and other material insufficiencies.   
4.0 
Study Endpoints* 
4.1 Primary endpoint: Refine the in-the-kNOW mobile app for PrEP-eligible 
Black women. Using a human-centered design approach 1, we will conduct 
a single-arm technology usability pretest to optimize usability, technical 
functionality, and performance of the app, among n = 10 PrEP-eligible Black 
women. The mobile app will be refined per pretest feedback.   
4.2 Secondary endpoint:  Evaluate the feasibility, acceptability, and usability of 
the refined in-the-kNOW mobile app. We will employ experimental (n = 30) 
and control (n = 30) conditions to determine the feasibility and 
acceptability (retention rates and satisfaction) of both the app and the 
control condition (e.g., referral to the CDC’s online HIV risk reduction 
tools). Aim 2b. Determine feasibility of collecting secondary outcome 
measures (e.g. PrEP Stigma) for a R01. 
5.0 
Study Intervention / Design  
This is a descriptive study.   
6.0 
Procedures Involved* 
Study overview. We plan to finalize development of our mobile health app and pilot 
test it with Black women, examining acceptability, feasibility and usability of the app. Upon 
completion of this R34 (assuming findings are promising), we will have evidence to support a 
large-scale RCT examining the app’s efficacy for promoting HIV prevention and sexual health 
behaviors. 
Participants. Eligible participants will be those who meet the following inclusion criteria: 
a) 18-44 years of age; b) self-identify as Black c) assigned female at birth and identify as female; 
d) PrEP-qualified based on CDC criteria for residence in high HIV incident areas—reside in a 
Fulton, Cobb, Gwinnett, or Dekalb counties; e) sexually active within the last 6 months; f) HIV-
negative; and g) own an Android smartphone. The procedures for each specific aim are 
described below: 
Specific Aim 1: Refine in-the-kNOW with Black women. With regular input from Black women 
enrolled in AHSI, we will assemble culturally- and contextually-targeted HIV prevention and 
optimal sexual health messaging within the app. We will then finalize the app, integrating 
findings from a pilot usability study. We will also finalize control condition materials with Black 
women and refine study eligibility and outcome assessments.  
 
Data Collection Procedures:  App Usability Pretest (n = 10 Black women)  

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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We will conduct a 2-month, single-arm pilot study with 10 Black women, using the same 
eligibility and recruitment strategies described below (Section D.2.a). During an in-person or 
virtual enrollment visit (approximately 1.5 hours), participants will download the in-the-kNOW 
app and answer a web-based questionnaire on socio-demographics, time spent using mobile 
technology per day, and risk behaviors. Study staff will use an enrollment checklist to walk 
participants through procedures for downloading and using the app. Participants will then be 
encouraged to use all app components over the pilot period (2 months), including ordering and 
using the HIV/STI test kit at least once. Upon completion of the usability pretest, all participants 
will complete an exit interview with qualitatively-trained study staff to provide feedback on 
functionality, technical performance, errors and bugs encountered, overall experiences with the 
app, feasibility and acceptability, and feedback for further refinement. The exit interview 
(approximately 45-60 minutes) can be scheduled in-person or via Zoom (HIPAA-compliant video 
chat). We will assess satisfaction with the app using the System Usability Scale (SUS).26-29 Exit 
interviews will be audio-recorded and transcribed for analysis by the research team. 
Transcribed interview data will be reviewed for overall impressions of content, materials, 
activities, and delivery of the app. Descriptive statistics will be generated for SUS data. We will 
also review participant HIV/STI test results and test kit ordering history to evaluate whether 
having access to testing resources through the app impacts testing behavior. Informed by these 
data, the app will be finalized for feasibility testing. 
Data Analysis plan: Quantitative analysis will be descriptive in nature for the App usability 
pretest (N=10), focusing on feasibility and usability of the app. Summary statistics (mean/Sd, 
frequency/percent) of item scores of the SUS will highlight common issues faced by the 
participants. Participants’ testing data will also be subject to quantitative analysis to assess 
usability of the app for accessing testing services. Qualitative. Using thematic framework 
analysis, each exit interview will be digitally recorded and transcribed verbatim; content 
analysis will be used to map themes. Two members of the research team will independently 
evaluate interview transcripts to ensure congruence with extracted themes using MAXQDA 
software. Upon completion of individual analyses, the researchers will convene to discuss and 
compare their findings. Transcribed text and field note data will be reviewed for overall 
impressions and then will move to line-by-line review for extraction of significant statements. 
Meaning will be formulated from these statements and then organized into themes. 
Trustworthiness of data will be determined by: (a) debriefing after each interview, (b) providing 
an audit trail of how and why study components were executed, (c) using the same basic 
interview guide for all interviews, and (d) presentation of rich data with sample and setting 
descriptions. 
 
Specific Aim 2. Evaluate the feasibility, acceptability, and usability of the refined in-the-kNOW 
mobile app. We will employ experimental (n = 30) and control (n = 30) conditions to determine 
the feasibility and acceptability (retention rates and satisfaction) of both the app and the 
control condition (e.g., referral to the CDC’s online HIV risk reduction tools). Aim 2b. Determine 
feasibility of collecting secondary outcome measures (e.g. PrEP Stigma) for a R01. 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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After the in-the-kNOW app is refined and optimized through the findings from the technology 
usability pretest, we will evaluate the feasibility and acceptability of in-the-kNOW through a 
pilot feasibility trial. A total of 60 PrEP-eligible Black women will be randomized to the in-the-
Know intervention (n = 30) or the control condition (n = 30) and complete baseline and 4-month 
follow-up assessments. We will also determine the feasibility of the study procedures and 
collecting outcome measures for both the intervention and control conditions in preparation 
for a R01 proposal. 
Data Collection Procedures: in-the-kNOW  
After completion of the written consent process, each participant will complete baseline 
assessments using REDCap, an online survey platform and will confirm they are HIV-negative by 
taking a screening test, after which she will be granted access to all app components depending 
on the arm she is randomized into. To restrict access to the in-the-kNOW app to the 
intervention arm participants only, participants will be provided with a single-use registration 
code that will need to be entered to gain access to the app. AHSI staff will be trained to assist 
participants in downloading the app, provide instruction on its use, and assist with reminder 
set-up. Study staff will use an enrollment checklist to walk participants through procedures for 
downloading and using the app. Each participant will have 4 months to engage with the app, 
including the option to order at least one HIV/STI test through TBD Health (the results of which 
will be shared with Emory), with e-reminders in time intervals preferred by the participants (a 
minimum of 3 times per week) via push notifications. During the 4-month study period, 
participants will receive push notifications to encourage use of all app domains: My Logger, My 
Test, My Resources, and My Circle. For confidentiality purposes, reminder notifications are 
nonspecific. Reminders (e.g., “Order your goodies,” “Log your activity,” or a custom message 
option) will be dictated by the participant as a notification setting option for exact days of the 
week and times of the day. We will ask that participants schedule reminders during their peak 
times of cell phone use. Research staff will complete 2-month check-ins via phone call or video 
chat with participants in both the intervention and control conditions. Research staff will 
contact control group participants and determine if they wish to be retained in the study. At 
month 4, all participants will complete their post-assessment survey and an exit interview. 
Quantitative Data Analysis Plan. The response data will be exported from Qualtrics to IBM SPSS 
27 for processing and analysis. Because the focus of this pilot study is to establish feasibility and 
acceptability, statistical analysis will be mostly descriptive.  
For demographic characteristics, categorical variables will be described by percentages; 
continuous variables will be described by mean, standard deviation, range, and median. For all 
outcome measures (e.g., PrEP/PEP knowledge), a mean score and 95% confidence interval will 
be calculated, and distributional assumptions will be assessed. The mean change in outcome 
measure scores between pre-test (T0) and post-test (T1) will be compared (paired-samples t-
test) for trends in the expected direction or no change. The literature on effect size estimates, 
from pilot studies and NIH recommendations, confirms that attempting to obtain valid 
estimates of effect sizes cannot be statistically justified.30-41 We have identified feasibility and 
acceptability as the primary outcomes of this pilot. This approach is supported by the 
literature.30-41 We have indicated target metrics that will substantiate feasibility, and we will use 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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both a quantitative survey and qualitative interview data to determine the acceptability of both 
the mobile app and the control condition.  
 
We will use mobile app analytics (e.g., Google Analytics) to assess trends in app engagement, 
like duration and number of app/module/social media forum engagement, clicks, modules 
viewed/completed, GPS solicitation, and correct/incorrect responses to questions. These 
analytics, in turn, will allow us to explore links between usage characteristics and primary 
outcomes.  
 
In order to inform intervention testing, we will collect data on the number and yield of 
screened participants enrolled, recruiting sources that yielded the largest number of enrolled 
individuals, recruitment methods used for successful enrollment, the elapsed time from first 
contact to enrollment, the amount of app interactions, and technological challenges (or other 
connection challenges.). Feedback about the content, delivery, payment method, and 
transportation options will also be elicited through surveys and focus group sessions and 
analyzed for themes. We will collect data on participants’ ownership of smartphones and 
preferred app formats. These measures will help determine the time, resources, and workload 
involved in implementing the HIV prevention mobile app for Black women; whether users  
perceived the app as beneficial; and whether alternatives (in app content and/or delivery) can 
be determined. 
 
We will collect data on the participants’ test results from TBD Health as described in Section 11 
(Study Partner) below in order to assess usability of the app for accessing testing services (such 
as TBD Health) and whether use of the app has an impact on testing behavior.  
 
Qualitative Data Analysis: Exit interviews (e.g. What about the app did you use most? Which 
features could be revised, and how?) will be audio-recorded, and recordings will be stored 
using password-protected encryption software and only accessible to the research team. 
Codes, transcripts, and memos will not contain any identifying information. 
 will 
analyze audio-recordings using MAXQDA software, provided free to Emory faculty. Interviews 
will be first transcribed by a professional transcriptionist trained in using MAXQDA and the 
encryption software. We will then code the sessions based on emerging themes using an 
inductive approach, developing during the review of interview transcripts and comparing 
passages. We will apply the codes to text in an iterative process of reading and refining codes 
when new codes emerge.  
Stipend for Intervention and Control arm. Participants will receive compensation for 
completion of the baseline assessment ($50) and for completion of the post-assessment/exit-
interview ($80).  
Control condition. 
The control condition will be a one-time virtual women’s health counseling session with a 
healthcare provider. Content will be finalized with input from the CAB. Participants will be given 
information on: 1. STI/HIV prevention, 2. Family planning, and 3. General health promotion 
(e.g., exercise and diet). More specifically, the control condition provides access to HIV 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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prevention materials that are publicly available but that do not offer the dynamic and 
individually customized features of the health communication/new media research approach 
proposed herein. Control group participants will continue to receive the usual care associated 
with AHSI enrollment. The control group will not have access to intervention content (e.g., 
commodity ordering) until after the study has concluded. Including a control condition helps to 
inform the next stage of what the enrollment and retention rates will be for that group.  
Long Term Follow-up. There are no plans for long-term follow-up or for further data collection 
after all research-related procedures are complete. 
 
7.0 
Data and Specimen Banking* 
N/A 
8.0 
Sharing of Results with Participants* 
N/A 
9.0 
Study Timelines* 
Study enrollment and implementation is anticipated to last no longer than 6 
months.  Analysis and dissemination will likely persist for 1-1.5 year(s) 
10.0 Subject Population* 
Eligible participants will be those who meet the following inclusion criteria: a) 
18-44 years of age; b) self-identify as Black c) assigned female at birth and 
identify as female; d) PrEP-qualified based on CDC criteria for residence in high 
HIV incident areas—reside in a Fulton, Cobb, Gwinnett, or Dekalb counties; e) 
sexually active within the last 6 months; f) HIV-negative; and g) own an Android 
or IOS smartphone. We will exclude: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
• 
Cognitively impaired or Individuals with Impaired Decision-Making 
Capacity 
• 
Individuals who are not able to clearly understand English 
11.0 Study Partner 
              TBD Health is a vendor partner on the Savvy HER study that, upon request of a 
participant, may provide at-home sample collection kits for STI/HIV tests to Savvy HER study 
participants and make the results available for participants once received from their third-party 
laboratory. TBD Health’s mission is to provide best-in-class sexual healthcare services that are 
accessible, approachable, and affordable. Savvy HER study participants will use the at-home 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
Page 10 of 22                                                                                                        Version-5- 02/19/2024  
 
sample collection kits that they can ship to TBD Health’s third-party lab vendors for analysis. 
Participants will complete an online account with TBD Health and complete separate consent 
forms as part of the normal course of TBD Health’s operations and in accordance with its 
policies. Results will be shared with participants through the TBD Health platform. TBD Health 
will provide the following data points regarding participants to Emory solely for use in the Savvy 
HER study: 
• 
Unique participant ID number, 
• 
Date of birth, 
• 
The test kit(s) ordered from TBD Health and the date of sample 
collection, 
• 
Test results,  
• 
Whether any medications were prescribed based on the test results, and 
• 
The number of messages exchanged between the participant and TBD 
Health in connection with the test(s) and an aggregated summary of the 
content of the messages (NOTE: the actual content of the messages will 
not be shared) 
  
 
12.0 Vulnerable Populations* 
• 
N/A 
13.0 Local Number of Participants 
13.1 N=60 Black women 
14.0 Recruitment Methods 
Recruitment strategy: We will use passive and active recruitment approaches including flyer 
distribution and enrollment by CBWW clinic staff during clinic visits. We will also post content 
on the CBWW website and social media platforms, targeting participants enrolled in AHSI. 
 
is a family nurse practitioner who has access to women who seek care at CBWW, our 
study site. In addition, we will work with the Georgia CTSA to utilize the MyChart Recruitment 
Service to send invitations for our study to potentially eligible patients as defined by study 
inclusion/exclusion criteria which are able to be queried from the Epic Clinical Databases and by 
having not opted out of direct research contact. These invitations will be sent by the MyChart 
Recruitment Service staff with the patient-facing description below, and the study team will 
follow up with individuals who respond as interested. 
 
Study Title: SavvyHER Mobile App Study 
Description: We are looking for participants to test SavvyHER, an HIV Prevention 
and Reproductive Health app that is developed by Black women for Black 
women. This app gives you education on sexual and reproductive health topics, 
links to local doctors, and community resources including ways to access at-

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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home STI test kits. We want to understand how women feel about using the app, 
compared to standard online CDC tools.  If you participate in the study, you may 
use the app for 4 months and check in with our study staff via phone or video 
during that time. To be in the study, you must be a Black woman, ages 18 to 44, 
and own a smartphone. You must also be HIV-negative and have been sexually 
active in the last 6 months. If you are interested or would like more information, 
the study staff can discuss with you and answer any of your questions. 
 
 
Randomization Procedures 
After all baseline assessments are completed, participants will be randomized 1:1 to either 
intervention or control using a randomization schedule generated by our statistician using a 
permuted block procedure (www.randomization.com).  
Screening.  Interested individuals, upon signing the informed consent form for the study, will 
complete a web-based screening survey and read a brief description of the study. Interested 
individuals must also take an STI/HIV test and receive a negative result in order to be eligible. If 
eligible, participants will provide contact information (e.g. by calling or texting the study phone) 
for a research team member to contact them and establish an intake meeting for completion of 
the baseline assessments. Recruitment strategies will be evaluated weekly to determine if 
recruitment goals are met and to adjust goals as needed. 
Incentives. Participants will receive compensation for completion of the baseline assessment 
($50) and for completion of the post-assessment/exit-interview ($80).  
No tax information is required 
15.0 Withdrawal of Participants* 
Participants will be informed that they can withdraw from the study at any time.  If a 
participant completes any incentivized component of the study for any amount of time, 
they will be given the incentive. 
16.0 Risks to Participants* 
List of potential risks and discomforts:  Black Women 
 
The risks associated with the proposed study are minimal. There is a slight risk of loss of 
confidentiality; however, we will take appropriate precautions to minimize this risk. 
Participation in the study will not affect the care the participants receive at the Center for Black 
Women’s Wellness in any way. Although we do not expect this to occur, should study 
participants experience mental health or physical problems during a study visit, they will be 
referred to appropriate healthcare providers (e.g. behavioral health department at CBWW) or 
emergency services as needed.   
 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
Page 12 of 22                                                                                                        Version-5- 02/19/2024  
 
Loss of confidentiality is the main potential risk associated with participation in this study. We 
will take appropriate precautions to minimize loss of confidentiality. Identifying information will 
be stored separately from health and behavioral information. Health and behavioral data will 
be identified only with a subject ID. Individuals will not be identified in any reports or 
publications of the research. All data on the participants maintained for the study will be kept in 
locked file cabinets in locked office suites, or as password-protected computer files on secure 
servers, and will be accessible only to the project staff via encrypted computers.  
 
Security and privacy are our top priority; therefore, for the design and development of our 
mobile health app, we have partnered with the Wellness Technology Lab at Georgia Tech to 
maximize security. Access to the app will be restricted, utilizing aliases and user-selected 
passwords, to enhance the security of the app. Participants will be automatically logged off if 
the app has not been in use for more than 10 minutes. The Wellness Technology Lab at Georgia 
Tech will employ the known best practices for developing HIPAA-compliant apps and will 
closely work with Georgia Tech’s Institute for People and Technology (IPaT) team to review the 
in-the-KNOW architecture and conduct security testing of the app on an iterative basis, to 
ensure the highest level of security. This team is knowledgeable about current regulations 
around mobile requirements for healthcare data and applications and collaborates with 
researchers across Georgia Tech to develop and host healthcare software applications that 
achieve the highest levels of security.   
 
Confidentiality of groups during peer interaction via the app.  To address confidentiality, a 
password will be required to gain entry into the group. Upon entry, group moderator(s) will 
explain that the research team will keep conversations confidential and that participants should 
not discuss outside of the group what is shared inside the group. We will also let all participants 
know that, realistically, we cannot guarantee absolute confidentiality. Participants will be 
required to agree to a Terms of Participation document that will require maintaining 
confidentiality of group members/content and failure to do so, will result in suspension or 
revocation of access to the group. In order to facilitate a candid discussion, we will permit use 
of filters that can hide a participant’s identity and the use of aliases to hide real names. 
 
Mitigation of psychological and social distress via My Circle app feature. We will mitigate any 
psychological distress, bullying, or stigma during peer interactions via the My Circle app feature 
by requiring participants to agree to a Terms of Participation document that states that any 
displays of bullying, harassment, threatening, abusive, or otherwise harmful behavior will result 
in suspension or revocation of access to the My Circle feature of the app. We will also inform 
participants that any concerns around the conduct of others in My Circle can be reported to the 
research team. Participants who are identified as experiencing stress (through self-report or 
notification of study team staff by another participant) caused by using our app will be referred 
for psychological support to the CBWW behavioral health department for further evaluation. 
 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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Mitigation of potential harms per commodity ordering. In addition to the discreet packaging 
described in the application, when a participant selects their commodities they will be 
prompted to provide a delivery address and a preferred delivery date. The prompt will also 
provide two reminders: 1) that they do not have to have commodities shipped to their home 
address, and 2) that shippers do not have complete control of mail delivery arrival dates/times. 
They will also be provided with an option to receive a tracking number so that a delivery – 
wherever it is to be sent – can be tracked and planned for. 
 
To secure sensitive private data and prevent IPV practices such as partner monitoring, in-the-
kNOW will implement standard mobile application security features in addition to IPV-specific 
security features. Standard features include requiring system-level security, app-specific PIN 
code creation during setup, and PIN code re-authorization on app close or background events. 
IPV-specific features include a no-PIN-code reset option and a safe mode PIN. The safe mode 
PIN will show the user content that does not relate to HIV or sexual health. Dr. Drenna 
Waldrop-Valverde will advise on any mental health distress related to the study and our referral 
system to behavioral health at CBWW will be initiated. 
 
Any participant who does not feel comfortable answering any questions in the survey or 
continuing participation will be reminded that study participation is voluntary and that they 
may withdraw at any time. Prior to initiating the audio-recording of CAB sessions and exit 
interviews, participants will be asked to not use any names, and all names stated inadvertently 
will be deleted from transcripts. During these interviews and all study interactions, participants 
will be in a private Zoom account provided by Emory University. All audio-recorded files will be 
deleted upon completion of the study. All data will be collected for the purpose of this 
proposed research only and will be password-protected and viewed on the Emory University or 
partnering institutions’ (e.g., Georgia Tech) secure network. 
 will consult with the 
Emory University Institutional Review Board for guidance throughout the course of the study. 
  
17.0 Potential Benefits to Participants* 
List of potential benefits: 
Participants may potentially benefit through an improved ability to engage with 
creditable HIV prevention content (including HIV testing, initiation of PrEP, condom use, and 
improved communication with their HCP). Participants may also benefit from access to various 
resources and online social network engagement. Improving engagement in care could lead to 
improved quality of life and reduced HIV acquisition. If the study finds that the app is feasible 
and acceptable, an intervention will be implemented to determine the effectiveness and 
efficacy of in-the-Know on uptake of HIV prevention behaviors (e.g., PrEP initiation/persistence; 
HIV testing) by Black women at high risk for acquiring HIV.  
 
18.0 Data Analysis, Management* and Confidentiality 
Using thematic framework analysis, 42 each focus group/interview will be digitally recorded and 
transcribed verbatim; content analysis will be used to map themes.43,44 Two members of the 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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research team will independently evaluate focus group/interview transcripts to ensure 
congruency with extracted themes using nVIVO software. Upon completion of individual 
analyses, the researchers will convene to discuss and compare their findings. Transcribed text 
and field note data will be reviewed for overall impressions and then will move to line-by-line 
review for extraction of significant statements. Meaning will be formulated from these 
statements and then organized into themes. Trustworthiness of data will be determined by: (a) 
debriefing after each focus group/interview, (b) providing an audit trail of how and why study 
components were executed, (c) using the same basic interview guide for all groups/interviews, 
and (d) presentation of rich data with sample and setting descriptions.   
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants* 
• 
N/A 
20.0 Provisions to Protect the Privacy Interests of Participants and 
Confidentiality of Participants’ identifiable data 
The Data and Safety Monitoring Plan (DSMP) for the proposed study incorporates the 
policies on human subject data and safety monitoring specified by the Emory University 
Institutional Review Board (IRB). Additionally, all computers used for this research will be Emory 
University, Georgia Tech, or Morehouse School of Medicine computers that have active anti-
virus, host-based firewall, and encryption software. All electronic systems will be password-
protected. Devices will be configured to “lock” and require user to re-authenticate if left 
unattended for more than 10 minutes. Data from participants will be recorded in a password-
protected file, which will be kept on the Emory University server, and all study related text 
messages (e.g., notifications or reminders) will be deleted at the end of the study. All emails will 
be through the Emory University or Georgia Tech network. Each interview will be audio-
recorded stored on an encrypted volume. At the end of each interview, data will be transferred 
to an encrypted volume created using an encryption software. This encrypted volume can only 
be opened using a password and will only be accessible to the study investigators and the study 
staff. Codes, transcripts, and memos will not contain any identifying information. The project 
staff will review data for accuracy and completeness on a weekly basis and bring any illogical 
entries or issues to 
 attention. 
 
a. Risk Assessment - Minimal Risk 
This study represents minimal risk. It involves a series of interviews and questionnaires 
of persons who meet the eligibility criteria.  Although we will collect sensitive information, like 
HIV/STI results we have instituted safeguards that is standard to other electronic medical 
records. Linkage to care for any positive results will be facilitated by CBWW. 
b. Description of Adverse Event Grading and Anticipated Adverse Events 
An adverse event is here defined as any unfavorable and unintended sign (regardless of 
whether it is considered related to a study visit) that occurs during the study. In this study, we 
do not anticipate moderate, severe, life threatening, disabling, or fatal adverse events. 
Anticipated adverse events include loss of confidentiality. The PI, in consultation with the 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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research team, is responsible for evaluating each adverse event as it occurs and for notifying 
Emory University IRB and NIMH of the occurrence of an adverse event. 
c. Description of Monitoring Study Progress and Safety of Human Subject Participants 
The PI has primary responsibility for the overall conduct of the study and for the safety 
of participating human subjects. The PI will ensure that (1) the informed consent process is 
conducted appropriately and that informed consent is obtained prior to proceeding with any 
study procedures; (2) only eligible subjects, per protocol eligibility criteria, are enrolled in the 
study; (3) data are collected and analyzed per protocol requirements; (4) procedures are 
implemented to ensure that the project is consistently monitored for possible adverse events; 
(5) adverse events are reviewed promptly and reported as required to the Emory University IRB 
and NIMH; and (6) the privacy and confidentiality of study subjects is maintained. While 
implementation of aspects of the DSMP may be delegated to members of the research team, 
the PI maintains ultimate responsibility for the project and for the safety of study participants. 
The project staff will meet with the PI on a weekly basis to review the progress of the 
study and address any human subjects’ issues that occur. These discussions may involve 
adverse event prevention measures, subject accrual issues, research staff training on protection 
of human subjects, as well as occurrence of adverse events. The project director will report any 
participant complaint, or possible protocol violation or adverse event to the PI immediately 
(i.e., such information will not wait for the weekly meeting to be exchanged). 
The Emory University IRB application and consent forms all adhere to HIPAA regulations. 
IRB members have been trained to examine applications and consent forms with HIPAA 
protection requirements in mind. HIPAA training is required of all investigators at Emory 
University. The members of this application have both Human Subject Protection Training 
Certification as well as HIPAA Training Certification. 
 will work with the Wellness Technology Lab at Georgia Tech to create this 
mobile health app. The director of the Wellness Technology Lab, 
, is affiliated with 
and will work in collaboration with the Institute for People and Technology (IPaT) at Georgia 
Tech to build the proposed app within the known best practices for developing HIPAA-
compliant apps and review the app’s architecture on an iterative basis. IPaT works with 
researchers across Georgia Tech to develop HIPAA-compliant apps and has the infrastructure to 
support the risk assessment process necessary for apps of this type. To ensure the security of 
the mobile app in this project, 
 and the Wellness Technology Lab at Georgia Tech will 
build this app within the known best practices for developing HIPAA-compliant apps and will 
utilize IPaT’s Protected Health Data Infrastructure (PHDI). PHDI supports projects and datasets 
from any Georgia Tech unit with Protected Health Information/Personally-Identifiable 
Information compliance needs, including HIPAA. PHDI is a secure enclave with resources that 
will be provisioned to host the mobile app that will be built in this project. Furthermore, the 
PHDI has physical, technical, and administrative safeguards in place to ensure the security of 
applications hosted on its servers (see Facilities document for further details). 
As this is a relatively small, single-site minimal risk behavioral study, a Data and Safety 
Monitoring Board will not be assembled.   

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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d. Plans for Assuring Compliance with Requirements Regarding the Reporting of Adverse 
Events 
The PI will inform the research team about any reported adverse events and implement 
appropriate training or protocol changes, as approved by the IRB. The PI will report adverse 
events to the Emory University IRB and Nell Hodgson Woodruff School of Nursing (NHWSON) 
Office of Nursing Research Associate/Assistant Dean as soon as reasonably possible. Adverse 
events will be reported in writing within 10 working days of the occurrence. This means that the 
project staff will be trained to recognize, respond to, and record adverse events when they 
occur or immediately after they occur to ensure the safety of the human subjects, and to report 
adverse events to the PI in a timely manner to ensure compliance with institutional policies on 
human subject protection. This also means that the study staff engaged in data collection can 
contact the PI as soon as an adverse event occurs. Reports of adverse events will include (1) all 
serious adverse events associated with the study procedures, and/or (2) any incidents or 
problems involving the conduct of the study or study participation, including problems with the 
recruitment and/or consent processes.  
e. Plans for Performance of Safety Reviews, for Assuring Data Accuracy and Security, 
and Assuring Protocol Compliance  
f. Reportable Events.  The PI 
 will be responsible for notifying NIMH of any 
reportable event(s). More specifically, if we experience suspension or termination of IRB 
approval the PI will notify the NIMH PO within 3 business days of receipt.  If a death related to 
study participation occurs, the PI will notify the NIMH PO immediately (no later than within 5 
business days) of first learning of the death.  Unanticipated Serious Adverse Events (SAEs), 
unanticipated problems involving risks to subjects or others, and serious or continuing 
noncompliance notification from IRB will be reported to the NIMH PO within 10 business days 
of the PI learning of the event.  For all Adverse Events and Serious Adverse Events that are 
deemed expected and or/unrelated to the study will be submitted to the NIMH PO in the 
annual progress report.  Lastly, any protocol violations will be reported to the NIMH PO in the 
annual progress report.  Documentation for reportable events will include all information 
specified in the NIMH Reportable Events Policy (e.g. the date on which the event occurred and 
the date at which the PI became aware of the event; a detailed description of the event and 
impact on the participant(s); a detailed description of the measures taken [including clinical] in 
response to the event [if any]). 
The PI will conduct quarterly safety reviews that will include: (1) an evaluation of study 
recruitment, retention and follow-up procedures; (2) compliance with study protocols; and (3) 
assessment of adverse events, if any.  
 
21.0 Compensation for Research-Related Injury 
21.1 N/A 
22.0 Economic Burden to Participants 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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22.1 Participants may incur transportation or childcare costs, but we hope to 
offset this potential financial burden by providing an incentive for 
participation.   
23.0 Consent Process 
23.1 Consent documents will be discussed for at least 10 minutes or as long as a 
participant needs clarity about the study. Participants will be permitted to 
clarify any questions prior to the focus group/interview, participants will be 
asked to provide electronic confirmation with a statement of ‘yes’ when 
the moderator queries ‘Do you understand the terms of this study and do 
you consent to participate in this study?’  Electronic consent will be 
obtained from each participant prior to initiating the focus 
group/interview.  We will provide an electronic copy of the consent to each 
participant. 
Non-English-Speaking Participants ☐ 
• 
N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) ☐ 
• 
N/A 
Participants who are not yet adults (infants, children, teenagers) ☐ 
• 
N/A 
Cognitively Impaired Adults ☐ 
• 
N/A 
Adults Unable to Consent ☐ 
• N/A 
24.0 Process to Document Consent in Writing 
24.1 N/A 
25.0 Setting 

FIRM:58441880v2 
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Black women in the Southern U.S. 
 
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The Center for Black Women’s Wellness (CBWW) is in Fulton County, identified as one of 
48 Ending the HIV Epidemic high-burden counties. This site presents an opportunity to 
augment access to HIV prevention for women most in need. For 30 years, the CBWW 
has worked with predominantly Black women and underserved communities in Atlanta, 
GA to design, implement, and evaluate culturally appropriate healthcare interventions 
aimed at eliminating racial and ethnic disparities across a range of areas. The study will 
be conducted with women enrolled in their Atlanta Healthy Start Initiative (AHSI), a site 
of National Healthy Start (NHS). The NHS program is an ideal vehicle to deliver HIV 
prevention and sexual and reproductive health information to women at high risk for 
HIV. The integration of the in-the-kNOW app with the NHS program can increase the 
dissemination of HIV prevention services to a wider audience. NHS has tremendous 
reach, serving some of the nation’s poorest and most at-risk families in 101 
communities in 34 states, Washington, DC, and Puerto Rico.  
AHSI has been implemented at CBWW over 20 years to improve perinatal health for 
high-risk, predominantly Black families living in Atlanta, GA. AHSI communities are 
located in South Atlanta and are majority African American (88%); have an average 
household income of $23,243, a 21% unemployment rate, and a 38% poverty rate; and 
are ranked the lowest on a constellation of neighborhood health and quality of life 
factors compared to other parts of Atlanta.125,126 Key AHSI services include 
community outreach, education, and case management for 300 families annually. 
Sustainability of in-the-kNOW App  will occur through AHSI, which will implement the 
app as a service to clients. Specifically, clients will be offered the app as an extension of 
AHSI enrollment, and AHSI staff will orient and train women on use of the app 
Exit Interviews will occur online via the HIPPA compliant platform Zoom 
(https://zoom.us/docs/doc/Zoom-hipaa.pdf) afforded to Emory Faculty and Staff. 
26.0 Resources Available 
CBWW is a safety net clinic and will serve as the referral option for any adverse 
health events. 
27.0 Multi-Site Research*  
 
Emory University is the lead institution on this grant and data collection that involves human 
subjects, which will be implemented by 
 (the PI) with support from Georgia tech 
and Morehouse School of Medicine. 
  
Georgia Institute of Technology will co-lead with Emory and Morehouse School of Medicine in 
the design and creation of in-the-Know (mobile app). The app will be used to obtain 
feasibility/acceptability content to determine desired revisions to in-the-Know app. [Georgia 
Tech role:  Technology development and support for data collection] 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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Morehouse School of Medicine will collaborate/consult with the Georgia Tech and Emory 
team to ensure that the content incorporated within the app is relevant to community per 
study inclusion criteria. Morehouse will also assist in designing the interface for the app 
through undertaking a human-centered design approach. [MSM role:  Liaison to the community 
and support for data collection] 
  
Although the study will include a multidisciplinary team of scientist from different institutions, 
the human subjects management and interaction will be solely managed by Emory; therefore, 
we are only submitting the IRB request at Emory for review. 
 
28.0 References 
1. RFA-MH-21-150: Strengthening HIV Prevention Efforts for Women in the Southern U.S. (R34 Clinical  
Trial Optional). https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-21-150.html. Accessed January 8,  
2021 
2.  Hess K, Johnson S, Hu X, et al. Diagnoses of HIV Infection in the United States and Dependent Areas, 
2017.; 2017. http://www.cdc.gov/hiv/library/reports/hiv-
surveillance.html.PublishedNovember2018.Accessed[date].OntheWeb:http://www.cdc.gov/hiv/library/r
eports/hiv-surveillance.htmlhttp://wwwn.cdc.gov/dcs/ContactUs/Form. Accessed August 26, 2019. 
3.  CDC. HIV among Women [Fact Sheet]. www.cdc.gov/hiv. Accessed September 5, 2019. 
4.  HHS, CDC, NCHHSTP. African Americans continue to face the most severe burden of hiv compared to 
other racial/ethnic groups in the nation. www.cdc.gov/nchhstp/newsroom. Accessed September 5, 
2019. 
5.  CDC.  Prevention Division of HIV. HIV in the Southern United States Strengthening Prevention and 
Care in the Nation’s Most-Affected Region. https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-in-the-south-
issue-brief.pdf. Accessed September 5, 2019. 
6. Adimora AA, Schoenbach VJ, Doherty IA. HIV and African Americans in the southern United States: 
sexual networks and social context. Sex Transm Dis. 2006;33(7 Suppl):S39-45. 
doi:10.1097/01.olq.0000228298.07826.68 
7.  
Auerbach JD, Kinsky S, Brown G, Charles V. Knowledge, Attitudes, and Likelihood of Pre-
Exposure Prophylaxis (PrEP) Use Among US Women at Risk of Acquiring HIV. AIDS Patient Care STDS. 
2015;29(2):102-110. doi:10.1089/apc.2014.0142 
8. Reif S, Safley D, McAllaster C, Wilson E, Whetten K. State of HIV in the US Deep South. J Community 
Health. 2017;42(5):844-853. doi:10.1007/s10900-017-0325-8 
Friedman MR, Sang JM, Bukowski LA, et al. Prevalence and Correlates of PrEP Awareness and Use 
Among Black Men Who Have Sex with Men and Women (MSMW) in the United States. AIDS Behav. 
2019;23(10):2694-2705. doi:10.1007/s10461-019-02446-3 
9.  
Hillis A, Germain J, Hope V, Mcveigh J, Claire M, Hout V. Pre-exposure Prophylaxis (PrEP) for HIV 
Prevention Among Men Who Have Sex with Men (MSM): A Scoping Review on PrEP Service Delivery and 
Programming. AIDS Behav. 1234;24:3056-3070. doi:10.1007/s10461-020-02855-9 
10.  
Walsh JL. Applying the Information–Motivation–Behavioral Skills Model to Understand PrEP 
Intentions and Use Among Men Who Have Sex with Men. AIDS Behav. 2019;23(7):1904-1916. 
doi:10.1007/s10461-018-2371-3 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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11.  
Sullivan PS, Driggers R, Stekler JD, et al. Usability and Acceptability of a Mobile Comprehensive 
HIV Prevention App for Men Who Have Sex With Men: A Pilot Study. JMIR mHealth uHealth. 
2017;5(3):e26. doi:10.2196/mhealth.7199 
12.  
Akintobi TH, Lockamy E, Goodin L, et al. Processes and outcomes of a community-based 
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13.  
Goldenberg T, McDougal SJ, Sullivan PS, Stekler JD, Stephenson R. Building a Mobile HIV 
Prevention App for Men Who Have Sex With Men: An Iterative and Community-Driven Process. JMIR 
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Hannaford A, Lipshie-Williams M, Starrels JL, et al. The Use of Online Posts to Identify Barriers to 
and Facilitators of HIV Pre-exposure Prophylaxis (PrEP) Among Men Who Have Sex with Men: A 
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1095. doi:10.1007/s10461-017-2011-3 
15.  
Lelutiu-Weinberger C, Golub SA. Enhancing PrEP access for black and latino men who have sex 
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16.  
Leluțiu-Weinberger C, Manu M, Ionescu F, et al. An mHealth intervention to improve young gay 
and bisexual men’s sexual, behavioral, and mental health in a structurally stigmatizing national context. 
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Auerbach JD, Kinsky S, Brown G, Charles V. Knowledge, attitudes, and likelihood of pre-exposure 
prophylaxis (PrEP) use among us women at risk of acquiring HIV. AIDS Patient Care STDS. 
2015;29(2):102-110. doi:10.1089/apc.2014.0142 
17.  
Bradley ELP, Geter A, Lima AC, Sutton MY, Hubbard McCree D. Effectively Addressing Human 
Immunodeficiency Virus Disparities Affecting US Black Women. Heal Equity. 2018;2(1):329-333. 
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18.  
Flash CA, Stone VE, Mitty JA, et al. Perspectives on HIV prevention among urban black women: A 
potential role for HIV pre-exposure prophylaxis. AIDS Patient Care STDS. 2014;28(12):635-642. 
doi:10.1089/apc.2014.0003 
19.  
Patel AS, Goparaju L, Sales JM, et al. Brief Report: PrEP Eligibility among At-Risk Women in the 
Southern United States: Associated Factors, Awareness, and Acceptability. J Acquir Immune Defic Syndr. 
2019;80(5):527-532. doi:10.1097/QAI.0000000000001950 
10.  
Beyrer C, Bekker LG, Pozniak A, Barré-Sinoussi F. Pre-exposure prophylaxis works - It’s time to 
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21.  
Aaron E, Blum C, Seidman D, et al. Optimizing Delivery of HIV Preexposure Prophylaxis for 
Women in the United States. AIDS Patient Care STDS. 2018;32(1):16-23. doi:10.1089/apc.2017.0201 
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23.  
Ojikutu BO, Bogart LM, Higgins-Biddle M, et al. Facilitators and Barriers to Pre-Exposure 
Prophylaxis (PrEP) Use Among Black Individuals in the United States: Results from the National Survey 
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24.  
Ojikutu BO, Amutah-Onukagha N, Mahoney TF, et al. HIV-Related Mistrust (or HIV Conspiracy 
Theories) and Willingness to Use PrEP Among Black Women in the United States. AIDS Behav. 
2020;24(10):2927-2934. doi:10.1007/s10461-020-02843-z 

FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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25.  
Teitelman AM, Chittamuru D, Koblin BA, et al. Beliefs Associated with Intention to Use PrEP 
Among Cisgender U.S. Women at Elevated HIV Risk. Arch Sex Behav. 2020;49(6):2213-2221. 
doi:10.1007/s10508-020-01681-3 
26. Sullivan PS, Driggers R, Stekler JD, et al. Usability and Acceptability of a Mobile Comprehensive HIV 
Prevention App for Men Who Have Sex With Men: A Pilot Study. JMIR mHealth uHealth. 2017;5(3):e26. 
doi:10.2196/mhealth.7199 
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FIRM:58441880v2 
PROTOCOL TITLE:   In-the-kNOW (Novel approaches to Optimizing Women’s Health): A mobile 
application to optimize HIV prevention and sexual/reproductive health communication among 
Black women in the Southern U.S. 
 
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