Mobile HIV Prevention App for Black Women (In-the-kNOW)

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.

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 developed specifically for Black women.

Study Overview

• Status: Completed
• Conditions: Hiv; Mobile Phone Use; Stigma, Social
• Intervention / Treatment: Behavioral: in-the-kNOW mobile app; Behavioral: Control

Detailed Description

The overall goal in implementing this study will be to assess the feasibility, acceptability, and usability of the in-the-kNOW mobile 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 a Community Advisory Board (CAB), which will consist predominately of Black women will guide refinement of the content and features included within the mobile app, whilst ensuring that the app is tailored towards the needs and perspectives of Black women.

This will be a randomized study with quantitative data collected through surveys, and qualitative data collected through in-depth interviews.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30312
      • Center for Black Women's Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-44 years of age
• Self-identify as Black
• Assigned female at birth and identify as female
• Individuals who qualify for Pre-Exposure Prophylaxis (PrEP) based on the Centers for Disease Control (CDC) criteria (for residence in high HIV incidence areas-reside in Fulton, Cobb, Gwinnett, or Dekalb counties)
• Sexually active within the last 6 months
• HIV-negative
• Owner of an Android or IOS smartphone

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: in-the-kNOW mobile app.; Participants will be assigned to the in-the-kNOW mobile app for four (4) months.	Behavioral: in-the-kNOW mobile app; in-the-kNOW is a mobile app with restricted access through a single-use registration code. The app will be developed with regular input from Black women enrolled in Atlanta Healthy Start Initiative (AHSI). The app will have culturally- and contextually targeted HIV prevention and optimal sexual health messaging. Each participant will have 4 months to engage with the app, 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 the use of all app domains: My Logger, My Test, My Resources, and My Circle. Research staff will complete 2-month check-ins via phone call or video chat with participants.; Other Names: in-the-kNOW mobile health app
Active Comparator: Control condition.; Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.	Behavioral: Control; The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on; Sexual Transmitted Infections (STI)/HIV prevention,; Family planning, and; General health promotion (e.g., exercise and diet). The control condition provides access to HIV 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 Atlanta Healthy Start Initiative (AHSI) enrollment. The control group will not have access to intervention content (e.g. commodity ordering) until after the study has concluded. Research staff will complete 2-month check-ins via phone call or video chat with participants.; Other Names: Regular Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rate	Feasibility is assessed with the retention rate of participants in each study arm. Quantitative survey and qualitative interview data to determine acceptability of both the mobile app and the control condition.	4 months
App User Retention Rate	App user retention rate was calculated among participants only in the intervention group. App user retention was measured by comparing the number of first-time app opens to the number of app removals.	4 months
System Usability Scale (SUS)	The System Usability Scale (SUS) is a validated industry-standard scale used to evaluate a variety of products and services, including websites, mobile phones, computer software, and more. It is a quick, 10-item questionnaire for gauging perceived usability, resulting in a score from 0-100, where higher is better, with 68 as the average benchmark, and scores above 80 considered excellent; it's calculated by summing adjusted responses to positive/negative statements. Lower scores indicate low usability, and higher scores indicate good usability. *Only participants in the treatment group received these questions.	4 months
Impact Scale	Impact is evaluated using three items that assess how the SavvyHER app influences Black women's quality of life and their sexual and reproductive health. Items prompt participants to rate their agreement with statements such as "I think SavvyHER will be a positive addition to sexual and reproductive health resources for Black women" and "I think SavvyHER will improve the Quality of Life for Black women," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging the responses. Impact scores ranged from 1 to 5, where 1 indicates the least perceived impact, and 5 indicates the most positive perceived impact. A high impact score indicates that the users perceive the technology as having a strong, positive, real-world effect on their relevant outcomes or performance. Higher scores indicate that the mHealth app had a more positive impact on their quality of life and health.	4 months
Perceived Usefulness (PU) Scale	Perceived usefulness (PU) is defined as the extent to which a person believes that using a system or tool will help in reaching their goals. The PU of SavvyHER was determined from participants' responses to nine survey items assessing the app's impact on their quality of life and health management. Survey items used 5-point Likert scales, ranging from "strongly disagree" (1) to "strongly agree" (5). These scores are calculated by averaging the responses across PU items. PU scores ranged from 1 to 5, with higher scores indicating a more positive perception of the technology being evaluated.	4 months
Perceived Ease of Use (PEOU) Scale	Perceived ease of use (PEOU) is the extent to which a system or tool is easy to learn and use. PEOU is assessed using five survey items rated on a 5-point Likert scale that ask about people's experiences learning to operate a technological system or tool. Sample items prompt participants to rate their agreement with statements such as "Learning to operate SavvyHER is easy for me" and "It is easy for me to become skillful at using SavvyHER," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging responses across PEOU items. PEOU scores ranged from 1 to 5, with higher scores indicating that users find the system intuitive. A high PEOU score suggests that users find the system intuitive.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Home Test Kits Ordered by Participants.	The research team will measure HIV testing by counting the number of home test kits ordered by participants and receiving HIV test results from TBD Health. TBD Health partnered with the research team on at-home testing, laboratory work, and linking participants to care. Only participants in the treatment arm had access to at-home HIV testing; control participants did not.	4 months
Number of Participants Indicating Intention to Start PrEP	Participants were asked about their intention to initiate PrEP during the 4-month study period using a post-test survey. Intention was assessed through a series of statements rated on a 5-point Likert scale (from 'definitely not' to 'definitely'	4 months
Number of Participants Who Agreed With Statements About PrEP Initiation	Participants were asked to select the statement that best reflected their attitude toward initiating PrEP from a predefined list of options.	4 months
Number of Participant's Who Initiated PrEP Treatment	The research team asked participants about their PrEP initiation. Response options were yes/no if participants had started PrEP by the end of the study period.	4 months
Number of Enrolled Participants by Recruiting Source	Enrolled participants were asked how they heard about the study, allowing researchers to determine which method yielded the largest number of enrolled individuals.	4 months
Number of Participants Reporting Smartphone Ownership	Participants who owned/used their smartphones for the intervention.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of App Interactions	The research team will use mobile app analytics (e.g., Google Analytics) to assess trends in in-app engagement, defined by the number of clicks. Additionally, the number of clicks for each app component, including: Different apps such as My Circle, which provides a mental health screener; a physical activity tracker where participants log their steps and overall health; Groups and Stories, which share personal stories and goals to encourage user interaction; and My Test, which features a GPS locator for HIV testing/PrEP and allows ordering of condoms/STI testing kits; My Logger, a self-tracking tool; My Profile. Results are presented as the total number of clicks over 1-month.	1 month
The Elapsed Time From First Contact to Enrollment	The research team will use mobile app analytics (e.g., Google Analytics) to assess time elapsed in in-app engagement, from consent time to enrollment.	4 months
Technological Challenges or Other Connection Challenges.	Exit interviews will be audio-recorded and analyzed by the research team	4 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Mental Health (NIMH); Georgia Institute of Technology; Morehouse School of Medicine
• Investigators: Principal Investigator: Rasheeta Chandler, PhD, RN, Nell Hodgson School of Nursing, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Behavior; Communication; Social Behavior; Acquired Immunodeficiency Syndrome; Social Stigma; Cell Phone Use
• Other Study ID Numbers: STUDY00002857; 1R34MH128048-01 (U.S. NIH Grant/Contract); 2024P007523 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No