Center for Black Women's Wellness
Atlanta, Georgia, 30312, United States
NCT Number: NCT05080972
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.
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Notify Me18 year–44 year
Female
Interventional
Not applicable
Atlanta, Georgia, 30312, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: in-the-kNOW mobile health app
The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on
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.
Other names: Regular Care
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.
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.
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.
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.
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.
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.
Time frame: 4 months
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
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
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
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
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
Participants who owned/used their smartphones for the intervention.
Time frame: 1 month
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.
Time frame: 4 months
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.
Time frame: 4 months
Exit interviews will be audio-recorded and analyzed by the research team
Emory University
Other
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.
Acronym: In-the-kNOW
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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