Skip to main content
Clinical Trials/NCT05080972
NCT05080972
Completed
Not Applicable

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.

Emory University1 site in 1 country56 target enrollmentFebruary 5, 2022

Overview

Phase
Not Applicable
Intervention
in-the-kNOW mobile app
Conditions
Mobile Phone Use
Sponsor
Emory University
Enrollment
56
Locations
1
Primary Endpoint
Retention Rate
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2022
End Date
December 31, 2024
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rasheeta Chandler

Principal Investigator

Emory University

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 incidence 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

Arms & Interventions

in-the-kNOW mobile app.

Participants will be assigned to the in-the-kNOW mobile app for four (4) months.

Intervention: in-the-kNOW mobile app

Control condition.

Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.

Intervention: Control

Outcomes

Primary Outcomes

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.

App User Retention Rate

Time Frame: 4 months

App user retention rate was calculated among participants only in the intervention group. App user retention was measured by comparing the number of first-time app opens to the number of app removals.

System Usability Scale (SUS)

Time Frame: 4 months

The System Usability Scale (SUS) is a validated industry-standard scale used to evaluate a variety of products and services, including websites, mobile phones, computer software, and more. It is a quick, 10-item questionnaire for gauging perceived usability, resulting in a score from 0-100, where higher is better, with 68 as the average benchmark, and scores above 80 considered excellent; it's calculated by summing adjusted responses to positive/negative statements. Lower scores indicate low usability, and higher scores indicate good usability. \*Only participants in the treatment group received these questions.

Impact Scale

Time Frame: 4 months

Impact is evaluated using three items that assess how the SavvyHER app influences Black women's quality of life and their sexual and reproductive health. Items prompt participants to rate their agreement with statements such as "I think SavvyHER will be a positive addition to sexual and reproductive health resources for Black women" and "I think SavvyHER will improve the Quality of Life for Black women," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging the responses. Impact scores ranged from 1 to 5, where 1 indicates the least perceived impact, and 5 indicates the most positive perceived impact. A high impact score indicates that the users perceive the technology as having a strong, positive, real-world effect on their relevant outcomes or performance. Higher scores indicate that the mHealth app had a more positive impact on their quality of life and health.

Perceived Usefulness (PU) Scale

Time Frame: 4 months

Perceived usefulness (PU) is defined as the extent to which a person believes that using a system or tool will help in reaching their goals. The PU of SavvyHER was determined from participants' responses to nine survey items assessing the app's impact on their quality of life and health management. Survey items used 5-point Likert scales, ranging from "strongly disagree" (1) to "strongly agree" (5). These scores are calculated by averaging the responses across PU items. PU scores ranged from 1 to 5, with higher scores indicating a more positive perception of the technology being evaluated.

Perceived Ease of Use (PEOU) Scale

Time Frame: 4 months

Perceived ease of use (PEOU) is the extent to which a system or tool is easy to learn and use. PEOU is assessed using five survey items rated on a 5-point Likert scale that ask about people's experiences learning to operate a technological system or tool. Sample items prompt participants to rate their agreement with statements such as "Learning to operate SavvyHER is easy for me" and "It is easy for me to become skillful at using SavvyHER," with responses on a scale from "strongly disagree" (1) to "strongly agree" (5). Scores were calculated by averaging responses across PEOU items. PEOU scores ranged from 1 to 5, with higher scores indicating that users find the system intuitive. A high PEOU score suggests that users find the system intuitive.

Secondary Outcomes

  • Number of Home Test Kits Ordered by Participants.(4 months)
  • Number of Participants Indicating Intention to Start PrEP(4 months)
  • Number of Participants Who Agreed With Statements About PrEP Initiation(4 months)
  • Number of Participant's Who Initiated PrEP Treatment(4 months)
  • Number of Enrolled Participants by Recruiting Source(4 months)
  • Number of Participants Reporting Smartphone Ownership(4 months)

Study Sites (1)

Loading locations...

Similar Trials