Hiv, Mobile Phone Use, Stigma, Social
Conditions
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.
Interventions
BEHAVIORALin-the-kNOW mobile app
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.
BEHAVIORALControl
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.
Sponsors
Emory University
Morehouse School of Medicine
Georgia Institute of Technology
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Ease of Use (PEOU) Scale | 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. |
| Retention Rate | 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 | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Enrolled Participants by Recruiting Source | 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. |
| Number of Home Test Kits Ordered by Participants. | 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. |
| Number of Participants Indicating Intention to Start PrEP | 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' |
| Number of Participants Who Agreed With Statements About PrEP Initiation | 4 months | Participants were asked to select the statement that best reflected their attitude toward initiating PrEP from a predefined list of options. |
| Number of Participant's Who Initiated PrEP Treatment | 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. |
| Number of Participants Reporting Smartphone Ownership | 4 months | Participants who owned/used their smartphones for the intervention. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRasheeta Chandler, PhD, RN
Nell Hodgson School of Nursing, Emory University
Participant flow
Recruitment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 29.67 years STANDARD_DEVIATION 7.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 0 Participants |
| Sexual Orientation Bisexual | 10 Participants |
| Sexual Orientation Gay | 0 Participants |
| Sexual Orientation Lesbian | 0 Participants |
| Sexual Orientation Missing | 0 Participants |
| Sexual Orientation Other | 2 Participants |
| Sexual Orientation Prefer not to answer | 1 Participants |
| Sexual Orientation Straight | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
None listed