Mobile Phone UseIn-the-kNOWNCT05080972
Mobile HIV Prevention App for Black Women
A study testing in-the-kNOW mobile app in people with Mobile Phone Use and Hiv, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mobile Phone Use, Hiv, Stigma, Social
- What is being tested?
- in-the-kNOW mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Black Women's Wellness
Atlanta, Georgia, 30312
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Mobile Phone Use, Hiv, Stigma, Social
- Being tested
- in-the-kNOW mobile app, Control
- Medical subject headings
- Cell Phone Use, Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-the-kNOW mobile appBehavioural
Also called in-the-kNOW mobile health 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.
ControlBehavioural
Also called Regular Care
The control condition will be a one-time virtual women's health counseling session with a healthcare provider. Participants will get information on
- Sexual Transmitted Infections (STI)/HIV prevention,
- Family planning, and
- 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.
| Study group | Role | What they receive |
|---|---|---|
| in-the-kNOW mobile app. | Experimental | Participants will be assigned to the in-the-kNOW mobile app for four (4) months. Receives: Behavioral: in-the-kNOW mobile app |
| Control condition. | Active comparator | Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (6)
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.
Measured: 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'
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Number of Participants Reporting Smartphone Ownership
Participants who owned/used their smartphones for the intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start5 Feb 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mobile Phone UseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Morehouse School of Medicine, Georgia Institute of Technology, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rasheeta Chandler, Emory University
- Investigators
- Rasheeta Chandler, PhD, RN, Principal investigator, Nell Hodgson School of Nursing, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080972
- Sponsor's protocol ID
- STUDY00002857
- Other IDs
- 1R34MH128048-01, 2024P007523
- Acronym
- In-the-kNOW
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2021
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05080972
- Acronym / sponsor ID
- In-the-kNOW / STUDY00002857
- Conditions
- Mobile Phone Use, Hiv, Stigma, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Morehouse School of Medicine, Georgia Institute of Technology, National Institute of Mental Health (NIMH)
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-the-kNOW mobile app. | Experimental | Behavioral: in-the-kNOW mobile appParticipants will be assigned to the in-the-kNOW mobile app for four (4) months. |
| Control condition. | Active comparator | Behavioral: ControlParticipants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-the-kNOW mobile appAlso: in-the-kNOW mobile health appin-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. | Behavioural | in-the-kNOW mobile app. |
| ControlAlso: Regular CareThe 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. | Behavioural | Control condition. |
Primary outcome
Retention Rate
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.
App User Retention Rate
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.
System Usability Scale (SUS)
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.
Impact Scale
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.
Perceived Usefulness (PU) Scale
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.
Perceived Ease of Use (PEOU) Scale
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.
6 secondary outcomes
Number of Home Test Kits Ordered by Participants.
Time frame: 4 months
Number of Participants Indicating Intention to Start PrEP
Time frame: 4 months
Number of Participants Who Agreed With Statements About PrEP Initiation
Time frame: 4 months
Number of Participant's Who Initiated PrEP Treatment
Time frame: 4 months
Number of Enrolled Participants by Recruiting Source
Time frame: 4 months
Number of Participants Reporting Smartphone Ownership
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasheeta Chandler, PhD, RN principal investigator
Nell Hodgson School of Nursing, Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in-the-kNOW mobile app in people with Mobile Phone Use and Hiv, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.