Mobile HIV Prevention App for Black Women

Not Applicable

Completed

• Conditions: Mobile Phone Use; Hiv; Stigma, Social
• Interventions: Behavioral: in-the-kNOW mobile app; Behavioral: Control

• Registration Number: NCT05080972
• Lead Sponsor: Emory University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-18
• Study Start: 2022-02-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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 incident 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
in-the-kNOW mobile app.	in-the-kNOW mobile app	Participants will be assigned to the in-the-kNOW mobile app for four (4) months.
Control condition.	Control	Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.

Primary Outcome Measures

Name	Time	Method
Retention Rate	4 months	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.
Participants' Satisfaction Interview	4 months	Acceptability will be assessed through an interview consisting of open-ended questions. There is not a summary score for this qualitative assessment.; Question sample: 1. Overall how would you describe your experience using the app; 2. Was the information on the app helpful in providing education on HIV prevention and safe sex?

Secondary Outcome Measures

Name	Time	Method
Participant's PrEP Intentions and Initiation	4 months	Research team will ask participants to indicate whether they initiated PrEP during the 4-month study period on the post-test survey.
Recruiting sources that yielded the largest number of enrolled individuals	4 months	Exit interviews and mobile app analytics will determine the Recruiting sources that yielded the largest number of enrolled individuals.
Recruitment methods used for successful enrollment	4 months	Exit interviews will determine the successful recruitment methods.
The elapsed time from first contact to enrollment	4 months	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.
Participants Completing HIV Testing	4 months	Participants will be asked how many times they got a HIV test in the 12-month period before the study and during the 4-month study period. Additionally, research team will quantify home test kit ordering by participants and receive HIV test results from the lab.
Technological challenges or other connection challenges.	4 months	Exit interviews will be audio-recorded and analyzed by the research team
The amount of app interactions	4 months	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.
Participants' ownership of smartphones and preferred app formats	4 months	Exit interviews will be audio-recorded and analyzed by the research team

Trial Locations

Locations (1)

Center for Black Women's Wellness; 🇺🇸 Atlanta, Georgia, United States