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

• ClinicalTrials.gov Identifier: NCT05080972
• Recruitment Status: Recruiting
• First Posted: October 18, 2021
• Last Update Posted: May 6, 2023
• Sponsor: Emory University
• Collaborators: Morehouse School of Medicine; Georgia Institute of Technology; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Rasheeta Chandler, Emory University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mobile Phone Use; Hiv; Stigma, Social	Behavioral: in-the-kNOW mobile app; Behavioral: Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: February 5, 2022
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

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 Name: 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 Name: Regular Care

Outcome Measures

Primary Outcome Measures :

1. Retention Rate [ Time Frame: 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.
2. Participants' Satisfaction Interview [ Time Frame: 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 :

1. Participants Completing HIV Testing [ Time Frame: 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.
2. Participant's PrEP Intentions and Initiation [ Time Frame: 4 months ]
   Research team will ask participants to indicate whether they initiated PrEP during the 4-month study period on the post-test survey.
3. Recruiting sources that yielded the largest number of enrolled individuals [ Time Frame: 4 months ]
   Exit interviews and mobile app analytics will determine the Recruiting sources that yielded the largest number of enrolled individuals.
4. Recruitment methods used for successful enrollment [ Time Frame: 4 months ]
   Exit interviews will determine the successful recruitment methods.
5. The elapsed time from first contact to enrollment [ Time Frame: 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.
6. The amount of app interactions [ Time Frame: 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.
7. Technological challenges or other connection challenges. [ Time Frame: 4 months ]
   Exit interviews will be audio-recorded and analyzed by the research team
8. Participants' ownership of smartphones and preferred app formats [ Time Frame: 4 months ]
   Exit interviews will be audio-recorded and analyzed by the research team

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Assigned female at birth and identify as female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 18-44 years of age
• Self-identify as Black
• Assigned female at birth and identify as female;
• Individual 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 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

Contacts and Locations

Contacts

Contact: Rasheeta Chandler, PhD, RN; 404-727-8164; r.d.chandler@emory.edu

Contact: Tassia Drame, MPH; tdrame@emory.edu

Locations

United States, Georgia

Center for Black Women's Wellness; Recruiting

Atlanta, Georgia, United States, 30312

Contact: Rasheeta Chandler

Sponsors and Collaborators

Emory University

Morehouse School of Medicine

Georgia Institute of Technology

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Rasheeta Chandler, PhD, RN; Nell Hodgson School of Nursing, Emory University

More Information

• Responsible Party: Rasheeta Chandler, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT05080972
• Other Study ID Numbers: STUDY00002857; 1R34MH128048-01 ( U.S. NIH Grant/Contract )
• First Posted: October 18, 2021
• Last Update Posted: May 6, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• Supporting Materials: Study Protocol
• Time Frame: Beginning 9 months and ending 36 months following article publication
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No