Clinical trial NCT05080972: Mobile HIV Prevention App for Black Women
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Phone Use
Hiv
Stigma, Social
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Morehouse School of Medicine
name: Georgia Institute of Technology
name: National Institute of Mental Health (NIMH)
First posted: 2021-10-18
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention Rate
timeFrame: 4 months
measure: Participants' Satisfaction Interview
timeFrame: 4 months
Secondary outcomes:
measure: Participants Completing HIV Testing
timeFrame: 4 months
measure: Participant's PrEP Intentions and Initiation
timeFrame: 4 months
measure: Recruiting sources that yielded the largest number of enrolled individuals
timeFrame: 4 months
measure: Recruitment methods used for successful enrollment
timeFrame: 4 months
measure: The elapsed time from first contact to enrollment
timeFrame: 4 months
measure: The amount of app interactions
timeFrame: 4 months
measure: Technological challenges or other connection challenges.
timeFrame: 4 months
measure: Participants' ownership of smartphones and preferred app formats
timeFrame: 4 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Center for Black Women's Wellness
state: Georgia
Study officials:
affiliation: Nell Hodgson School of Nursing, Emory University
name: Rasheeta Chandler, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: