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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
56
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.
The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on 1. Sexual Transmitted Infections (STI)/HIV prevention, 2. Family planning, and 3. 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.
Center for Black Women's Wellness
Atlanta, Georgia, United States
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.
Time frame: 4 months
App User Retention Rate
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.
Time frame: 4 months
System Usability Scale (SUS)
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.
Time frame: 4 months
Impact Scale
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.
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Time frame: 4 months
Perceived Usefulness (PU) Scale
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.
Time frame: 4 months
Perceived Ease of Use (PEOU) Scale
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.
Time frame: 4 months
Number of Home Test Kits Ordered by Participants.
The research team will measure HIV testing by counting the number of home test kits ordered by participants and receiving HIV test results from TBD Health. TBD Health partnered with the research team on at-home testing, laboratory work, and linking participants to care. Only participants in the treatment arm had access to at-home HIV testing; control participants did not.
Time frame: 4 months
Number of Participants Indicating Intention to Start PrEP
Participants were asked about their intention to initiate PrEP during the 4-month study period using a post-test survey. Intention was assessed through a series of statements rated on a 5-point Likert scale (from 'definitely not' to 'definitely'
Time frame: 4 months
Number of Participants Who Agreed With Statements About PrEP Initiation
Participants were asked to select the statement that best reflected their attitude toward initiating PrEP from a predefined list of options.
Time frame: 4 months
Number of Participant's Who Initiated PrEP Treatment
The research team asked participants about their PrEP initiation. Response options were yes/no if participants had started PrEP by the end of the study period.
Time frame: 4 months
Number of Enrolled Participants by Recruiting Source
Enrolled participants were asked how they heard about the study, allowing researchers to determine which method yielded the largest number of enrolled individuals.
Time frame: 4 months
Number of Participants Reporting Smartphone Ownership
Participants who owned/used their smartphones for the intervention.
Time frame: 4 months