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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
in-the-kNOW mobile app.
Participants will be assigned to the in-the-kNOW mobile app for four (4) months.
干预措施: in-the-kNOW mobile app (Behavioral)
Control condition.
Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.
干预措施: Control (Behavioral)
结局指标
主要结局
Retention Rate
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Rasheeta Chandler
Principal Investigator
Emory University
