Mobile HIV Prevention App for Black Women

Hiv Clinical Trial

— In-the-kNOW  

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05080972
• Other study ID #: STUDY00002857
• Secondary ID: 1R34MH128048-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Mobile Phone Use
• Stigma, Social

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Black Women's Wellness	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Georgia Institute of Technology, Morehouse School of Medicine, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Participants' Satisfaction Interview	Acceptability will be assessed through an interview consisting of open-ended questions. There is not a summary score for this qualitative assessment.; Question sample: Overall how would you describe your experience using the app; Was the information on the app helpful in providing education on HIV prevention and safe sex?	4 months
Secondary	Participants Completing HIV Testing	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.	4 months
Secondary	Participant's PrEP Intentions and Initiation	Research team will ask participants to indicate whether they initiated PrEP during the 4-month study period on the post-test survey.	4 months
Secondary	Recruiting sources that yielded the largest number of enrolled individuals	Exit interviews and mobile app analytics will determine the Recruiting sources that yielded the largest number of enrolled individuals.	4 months
Secondary	Recruitment methods used for successful enrollment	Exit interviews will determine the successful recruitment methods.	4 months
Secondary	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
Secondary	The 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.	4 months
Secondary	Technological challenges or other connection challenges.	Exit interviews will be audio-recorded and analyzed by the research team	4 months
Secondary	Participants' ownership of smartphones and preferred app formats	Exit interviews will be audio-recorded and analyzed by the research team	4 months