HIV Prevention App for Black Women at Risk of HIV

(In-the-kNOW Trial)

Overseen By Rasheeta Chandler

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

Must be taking: PrEP

Disqualifiers: Pregnant, Prisoners, Cognitively impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mobile app designed to help Black women reduce their risk of contracting HIV. The app, called in-the-kNOW, will be evaluated for its effectiveness in providing HIV prevention and reproductive health information. Participants will either use the app for four months or participate in a one-time virtual health counseling session. Black women who are HIV-negative, sexually active, and own a smartphone may be suitable for this study, particularly if they reside in certain high-risk areas.

As an unphased trial, this study offers participants the opportunity to contribute to important research that could lead to innovative health solutions for their community.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this app is safe for Black women at risk of HIV?

Research has shown that users generally like mobile apps for HIV prevention, such as the in-the-kNOW app. In one study, users appreciated the app's design and found features like alerts for nearby HIV testing sites helpful. Another study on a similar app demonstrated that it helped young people improve their health related to HIV. These findings suggest that this type of app is safe and well-tolerated, with no reports of harm or negative effects. While specific safety data for the in-the-kNOW app itself is lacking, similar apps have proven beneficial and easy to use without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the in-the-kNOW mobile app because it offers a unique approach to HIV prevention for Black women at risk. Unlike traditional methods such as PrEP medications or in-person counseling, this app uses a digital platform to deliver prevention education and support directly to users' smartphones. This method not only enhances accessibility and convenience but also provides tailored information and resources, empowering users to make informed health decisions. By leveraging technology, the app has the potential to reach a broader audience and provide continuous support, making it a promising tool in the fight against HIV.

What evidence suggests that the in-the-kNOW mobile app is effective for HIV prevention?

Research has shown that mobile apps like in-the-kNOW, which participants in this trial may receive, can help prevent HIV among Black women. Studies have examined how these apps assist users in tracking risky behaviors and making better sexual health choices. One study in Georgia focused on enhancing a similar app for Black women in high-risk areas, demonstrating its potential to reduce health inequalities. Feedback from college-aged Black women supports the app’s usefulness, as they find mobile health tools helpful for preventing HIV. These findings suggest that the in-the-kNOW app could be an important tool in lowering HIV risk for Black women. ^{6 7 8 9 10}

Who Is on the Research Team?

Rasheeta Chandler, PhD, RN

Principal Investigator

Nell Hodgson School of Nursing, Emory University

Are You a Good Fit for This Trial?

This trial is for Black women aged 18-44, living in specific high HIV incident areas, who are sexually active and own an Android smartphone. They must be HIV-negative, meet CDC criteria for PrEP eligibility, not pregnant, able to consent, and understand English.

Inclusion Criteria

I have been sexually active in the past 6 months.

HIV-negative

Owner of an Android smartphone

Exclusion Criteria

Prisoners

I have difficulty making decisions due to cognitive impairment.

I cannot clearly understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the in-the-kNOW mobile app or a virtual women's health counseling session for four months

4 months

1 virtual session for control group; ongoing app interaction for experimental group

Follow-up

Participants are monitored for app usability, acceptability, and HIV prevention outcomes

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Control
• in-the-kNOW mobile app

Trial Overview The study aims to refine and test a mobile app called in-the-kNOW designed for HIV Prevention and Reproductive Health education tailored specifically for Black women. Participants will either use the app (intervention group) or be part of a control group without the app.

How Is the Trial Designed?

Group I: in-the-kNOW mobile app. Experimental Treatment 1 Intervention

Participants will be assigned to the in-the-kNOW mobile app for four (4) months.

Group II: Control condition. Active Control 1 Intervention

Participants will be randomized to receive a one-time virtual women's health counseling session with a healthcare provider.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Georgia Institute of Technology

Collaborator

Trials

53

Recruited

5,600+

Morehouse School of Medicine

Collaborator

Trials

22

Recruited

16,300+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10541635/

Digital Health App to Address Disparate HIV Outcomes ... The study aims to refine SavvyHER, a mobile app for HIV prevention, with Black women residing in high HIV incidence areas of Georgia.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9999260/

Mobile Phone Apps for HIV Prevention Among College ... We aimed to quantitatively and qualitatively explore the perspectives of college-aged Black women on using a mobile health app for HIV prevention and sexual ...

3. researchprotocols.org researchprotocols.org/2025/1/e69540

Evaluating the Effectiveness of a Mobile HIV Prevention ... Brief self-assessments are provided to allow participants to monitor their sexual behaviors associated with HIV and STI acquisition and ...

4. mhealth.jmir.org mhealth.jmir.org/2020/7/e18437/

Focus Group Study to Determine Preferences via Prototype ... The purpose of this study is to understand cisgender Black women's preferences for functionality, format, and design of a mobile HIV prevention app.

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074823003773

Protocol Digital Health App to Address Disparate HIV ... Cisgender Black women in the southern United States are at heightened risk for HIV and adverse sexual and reproductive health outcomes. Mobile health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12329388/

Evaluating the Effectiveness of a Mobile HIV Prevention ... This trial will determine whether the Combine app increases HIV testing, STI testing, and PrEP uptake among rural MSM in the Southern United ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9557764/

Using the Positive Peers Mobile App to Improve Clinical ... The Positive Peers App (PPA) is a multifunctional HIV support tool designed to improve HIV-related clinical outcomes for young people with HIV.

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X23007461

Mobile Phone Apps for HIV Prevention Among College ... A cross-sectional web-based survey evaluating the willingness to use a mobile app for HIV prevention was conducted in the quantitative phase.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/42/NCT03763942/Prot_SAP_001.pdf

Theoretically based mobile App to increase PrEP uptake ... HIV prevention mobile app with basic prevention services including ... HIV Prevention Counseling course before providing any test results.

10. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887121002569

Development and Evaluation of a Mobile App Designed to ... Participants liked the look and feel of the app and believed that the ability to search for and be pinged when near an HIV testing site would be beneficial.