Trial Outcomes & Findings for Mobile HIV Prevention App for Black Women (NCT NCT05080972)

Participants were recruited from the Atlanta Metropolitan Area, Georgia. Participant enrollment began February 05, 2022, and all follow-up was completed by December 31, 2024

Mobile HIV Prevention App for Black Women

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 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.

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 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) 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) 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.

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.

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'

Participants were asked to select the statement that best reflected their attitude toward initiating PrEP from a predefined list of options.

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.

Enrolled participants were asked how they heard about the study, allowing researchers to determine which method yielded the largest number of enrolled individuals.

Participants who owned/used their smartphones for the intervention.

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. Additionally, the number of clicks for each app component, including: Different apps such as My Circle, which provides a mental health screener; a physical activity tracker where participants log their steps and overall health; Groups and Stories, which share personal stories and goals to encourage user interaction; and My Test, which features a GPS locator for HIV testing/PrEP and allows ordering of condoms/STI testing kits; My Logger, a self-tracking tool; My Profile. Results are presented as the total number of clicks over 1-month.

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.

Exit interviews will be audio-recorded and analyzed by the research team