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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH128048-01 | U.S. NIH Grant/Contract | View source | |
| 2024P007523 | Other Identifier | Emory Insight Humans IRB |
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| Name | Class |
|---|---|
| Morehouse School of Medicine | OTHER |
| Georgia Institute of Technology | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| in-the-kNOW mobile app. | Experimental | Participants will be assigned to the in-the-kNOW mobile app for four (4) months. |
|
| Control condition. | Active Comparator | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in-the-kNOW mobile app | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of App Interactions | 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. |
Inclusion Criteria:
Exclusion Criteria:
Assigned female at birth and identify as female
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| Name | Affiliation | Role |
|---|---|---|
| Rasheeta Chandler, PhD, RN | Nell Hodgson School of Nursing, Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Black Women's Wellness | Atlanta | Georgia | 30312 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata.
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | In-the-kNOW Mobile App. | Participants will be assigned to the in-the-kNOW mobile app for four (4) months. in-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. |
| FG001 | Control Condition. | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. Control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In-the-kNOW Mobile App. | Participants will be assigned to the in-the-kNOW mobile app for four (4) months. in-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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 4 months |
|
Information on adverse events was collected from the time informed consent was obtained through 4 months post-intervention, for a total follow-up period of 4 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-the-kNOW Mobile App. | Participants will be assigned to the in-the-kNOW mobile app for four (4) months. in-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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rasheeta Chandler, PhD, RN, FNP-BC, FAANP, FAAN | Emory University | 404-727-8164 | r.d.chandler@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2024 | Dec 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 8, 2023 | May 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000075782 | Cell Phone Use |
| D000163 | Acquired Immunodeficiency Syndrome |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D015658 | HIV Infections |
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|
|
| Control | Behavioral | 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. |
|
|
| 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. | 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. | 4 months |
| 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' | 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. | 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. | 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. | 4 months |
| Number of Participants Reporting Smartphone Ownership | Participants who owned/used their smartphones for the intervention. | 4 months |
| 1 month |
| The Elapsed Time From First Contact to Enrollment | 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. | 4 months |
| Technological Challenges or Other Connection Challenges. | Exit interviews will be audio-recorded and analyzed by the research team | 4 months |
| BG001 | Control Condition. | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. Control: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| OG001 | Control Condition. | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. Control: 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. |
|
|
| Primary | 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. | This outcome applies only to the intervention group | Posted | Number | % of first-time app opens retained | 4 months |
|
|
|
| Primary | 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. | Only participants in the treatment group received the satisfaction questionnaire. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Primary | 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. | Only participants in the treatment group received these survey questions to measure impact. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Primary | 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. | Only participants in the treatment group received these questions to measure the perceived usefulness of the application. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Primary | 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. | Only participants in the treatment group received these questions to measure the perceived ease of use of the application. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
|
| Secondary | 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. | Only participants in the treatment arm had access to at-home HIV testing; control participants did not. | Posted | Number | Number of at-home testing kits supplied | 4 months |
|
|
|
| Secondary | 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' | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Number of Participants Reporting Smartphone Ownership | Participants who owned/used their smartphones for the intervention. | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Other Pre-specified | Amount of App Interactions | 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. | Not Posted | 1 month | Participants |
| Other Pre-specified | The Elapsed Time From First Contact to Enrollment | 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. | Not Posted | 4 months | Participants |
| Other Pre-specified | Technological Challenges or Other Connection Challenges. | Exit interviews will be audio-recorded and analyzed by the research team | Not Posted | 4 months | Participants |
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Control Condition. | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. Control: 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. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D000086982 |
| Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Might or might not |
|
| Probably |
|
| Definitely |
|
| Missing |
|
| Do you plan on using PrEP to reduce your risk of getting HIV in the next 12 months? |
|
| Do you plan to talk with your health provider about PrEP? |
|
| I am considering taking PrEP for HIV prevention, but I'm not ready to take action |
|
| Missing |
|
| Social Media |
|
| Community Event |
|
| Center for Black Women's Wellness |
|
| Other |
|