PrEP for Pre-Exposure Prophylaxis Uptake

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-black, Age 30+, Heterosexual

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on encouraging the use of PrEP (a medication that helps prevent HIV) among young, black men who identify as gay, bisexual, or same-gender loving. Participants will use a special mHealth app called Us*Now, and some will attend sessions led by black women from the community to discuss important topics. The trial aims to determine if these sessions increase PrEP use. Ideal participants are black men, aged 18-29, who identify as gay, bisexual, or same-gender loving and can use a smartphone app. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance community health and support.

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 the Us*Now mHealth app is safe?

Research has shown that mobile health apps, such as the Us\*Now mHealth app, are generally safe. Studies on similar apps have found that users appreciate them, and no serious side effects have been reported. These apps aim to increase HIV testing and the use of PrEP, a method to prevent HIV infection.

No major safety issues have emerged, suggesting that the Us\*Now app should be well-tolerated by participants in this trial. It functions like other health apps that focus on education and support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Us*Now mHealth app because it offers a new approach to increasing PrEP uptake for HIV prevention. Unlike traditional methods that rely on in-person counseling or educational programs, this app provides a digital, mobile-friendly way for users to access information and support. Its unique feature is its ability to engage with users through a convenient, personalized platform, potentially reaching a wider audience and encouraging consistent use. By leveraging technology, the app aims to overcome barriers to PrEP adoption, such as stigma or lack of access to healthcare providers.

What evidence suggests that the Us*Now mHealth app is effective for PrEP uptake?

Studies have shown that mobile health (mHealth) apps can increase the use of pre-exposure prophylaxis (PrEP), which is crucial for preventing HIV. Research indicates that these apps can improve adherence to PrEP medication by 60%, as they assist users in following their medication schedule. The Us*Now mHealth app is being tested in this trial to boost PrEP use among young, black men by providing social support through community connections. This approach leverages networks of relationships to promote healthier habits. Initial findings suggest that involving users with community support can significantly enhance their PrEP use. This method simplifies staying committed to health goals. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for young black men who are gay, bisexual, or same gender loving and are interested in using PrEP to prevent HIV. Participants must be comfortable with technology as they will use a mobile health app. Specific eligibility criteria were not provided.

Inclusion Criteria

I am a Black/African American woman, aged 18-80, and can lead sessions and use the app.

I am a Black/African American man, 18-29, identify as gay/bisexual/same gender loving, and can download the Us*Now app.

Exclusion Criteria

I am not eligible to be a facilitator because I am either male, identify as Black/African American, or cannot commit to the schedule.

I am 30 or older, not Black/African American, straight, and can't use the Us*Now app.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the Intervention arm interact with the Us*Now mHealth app and attend 4 weekly sessions led by a black female facilitator

4 weeks

4 visits (in-person)

Control

Participants in the Control arm interact with the Us*Now mHealth app only

4 weeks

Follow-up

Participants are monitored for changes in sexual practices, social capital, internalized homonegativity, and PrEP uptake

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Us*Now mHealth App

Trial Overview The study tests if having black female facilitators lead weekly sessions can increase PrEP uptake among participants compared to those who only use the Us*Now mHealth app without additional support.

How Is the Trial Designed?

Group I: Intervention Participants Experimental Treatment 1 Intervention

Group II: Female Facilitator Experimental Treatment 1 Intervention

Group III: Control Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

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/PMC12491899/

An mHealth App–Based Social Capital Intervention (PrEP US ... PrEP US NoW: Pre-Exposure Prophylaxis Utilization Through Increasing Social Capital Among Young, Black, sexual minority Men Networks With Women.

2. researchprotocols.org researchprotocols.org/2025/1/e66326

An mHealth App–Based Social Capital Intervention (PrEP ... An mHealth App–Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, ...

3. formative.jmir.org formative.jmir.org/2025/1/e69255

Feasibility and Acceptability of a mHealth Patient Navigation ... An important factor to end the HIV epidemic is increasing the uptake of pre-exposure prophylaxis (PrEP), a medication that can prevent the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40966683/?utm_source=SimplePie&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1zOrwYPa_1RS6jdZ9VLHcTFM_z0nKGv5xC17ijJBVjdDspZQ-I&fc=20220524062322&ff=20250918191212&v=2.18.0.post9+e462414

An mHealth App-Based Social Capital Intervention (PrEP ... Results: Phase 1 (development) of PrEP US NoW research activities lasted from November 2019 to June 2024. Data collection for the phase 2 ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1600773/pdf

Impact of mHealth on enhancing pre-exposure prophylaxis ... The results of the meta- analysis showed that mHealth interventions significantly promoted PrEP adherence (OR = 1.60, 95% CI [1.09, 2.35], p = ...

6. journals.plos.org journals.plos.org/digitalhealth/article?id=10.1371/journal.pdig.0000643

User preferences for an mHealth app to support HIV testing ... This study assessed attitudes and preferences toward the format, content, and features of a mobile app designed to increase HIV testing and PrEP uptake among ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04855773

Study Details | NCT04855773 | Comparing Mobile Health ... The purpose of this study is to compare the effectiveness of two mobile health technologies (text messaging or a mobile app) designed to help people take HIV ...