Mobile HIV Prevention App for Black Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Mobile Phone Use, Hiv, Stigma, Social

Intervention / Treatment
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* Behavioral: in-the-kNOW mobile app
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: in-the-kNOW mobile app.<br>Participants will be assigned to the in-the-kNOW mobile app for four (4) months. | Behavioral: in-the-kNOW mobile app<br>* 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.<br>* Other names: in-the-kNOW mobile health app;|
| Active Comparator: Control condition.<br>Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. | Behavioral: Control<br>* 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.<br>* Other names: Regular Care;|

What is the study measuring?
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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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Recruitment methods used for successful enrollment | Exit interviews will determine the successful recruitment methods. | 4 months | 
| 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 | 
| 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 | 
| Technological challenges or other connection challenges. | Exit interviews will be audio-recorded and analyzed by the research team | 4 months | 
| Participants' ownership of smartphones and preferred app formats | Exit interviews will be audio-recorded and analyzed by the research team | 4 months |