SmartPrEP App for HIV Prevention

No longer recruiting at 1 trial location

Overseen By Connor Wright, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: PrEP

Must not be taking: Hepatitis C antivirals, NRTIs

Disqualifiers: HIV-positive, Pregnancy, Renal dysfunction, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help cisgender and transgender women adhere to their PrEP (pre-exposure prophylaxis) routine, which prevents HIV infection. The app, called Making PrEP Smart, also supports HIV self-testing and partner testing, making it a comprehensive tool for HIV prevention. Participants should be HIV-negative women, either already on PrEP or ready to start, and must have a smartphone with active service. The study aims to evaluate the app's effectiveness for daily PrEP use and gather user feedback on its features. As an unphased trial, it offers participants the chance to contribute to innovative HIV prevention strategies and improve health outcomes for women.

Do I need to stop my current medications to join the trial?

You may need to stop taking certain medications if they could interact negatively with Truvada or Descovy, which are part of the trial. This includes some hepatitis C treatments, certain HIV medications, and drugs that affect kidney function. It's best to discuss your current medications with the study team to see if any changes are needed.

What prior data suggests that the SmartPrEP app is safe for use in supporting PrEP adherence?

Research has shown that the SmartPrEP app is designed to help users remember to take their PrEP medication. PrEP, or pre-exposure prophylaxis, is a medicine that helps prevent HIV. The app also assists with HIV testing for both the user and their partner.

There is no direct data yet on the safety of using the SmartPrEP app, but it is important to note that the app does not involve any drugs or medical procedures. It simply sends reminders and offers support for testing, making physical side effects unlikely.

For those already taking PrEP, the app aims to simplify remembering doses and getting tested for HIV. This could enhance the effectiveness of PrEP. The main goal is to make staying healthy simpler and more organized. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SmartPrEP App for HIV prevention because it introduces a digital approach to enhancing PrEP (pre-exposure prophylaxis) adherence, which is crucial for preventing HIV infection. Unlike traditional methods that rely solely on individual discipline to take medication consistently, this app provides tailored reminders and supports HIV self-testing and partner testing, specifically designed for cis- and transgender women. This innovative use of mobile technology aims to increase accessibility and engagement, potentially leading to higher adherence rates and better health outcomes.

What evidence suggests that the SmartPrEP app is effective for PrEP adherence in HIV prevention?

Research shows that mobile apps can help people adhere to taking PrEP, a medication that prevents HIV. Studies have found that digital tools send personalized reminders and support, making it easier for users to take PrEP regularly. For example, the UPrEPU app successfully helped men who have sex with men maintain their PrEP routine. This trial will evaluate the SmartPrEP app, which aims to help cisgender and transgender women take PrEP consistently. By encouraging regular use of PrEP and promoting HIV testing, the app aims to reduce the risk of HIV infection. ^{1 2 5 6 7}

Who Is on the Research Team?

Jessica Justman, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for HIV-negative cisgender and transgender women over 18, who are sexually active or use injection drugs, and are either starting PrEP or have been on it for less than three months. They must have a mobile phone with at least a 3G network, normal kidney function, no acute HIV symptoms, not be pregnant or breastfeeding, and plan to stay in the NYC area for the next year.

Inclusion Criteria

I am willing to start or have already started PrEP within the last three months.

I identify as a woman, whether cisgender or transgender.

documented negative HIV test result at Screening Visit

Exclusion Criteria

I am taking medication that may not mix well with Truvada or Descovy.

I am currently using HIV post-exposure prophylaxis but am willing to switch to PrEP after.

My kidney function is reduced, with a filtration rate under 60 mL/min.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SmartPrEP app and receive PrEP medication with adherence counseling and HIV testing over a 12-month period

12 months

6 visits (in-person) at enrollment, Month 1, Month 3, Month 6, Month 9, and Month 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Making PrEP Smart

Trial Overview

The 'SmartPrEP' app is being tested to see if it helps these women stick to their PrEP regimen over a year. It also looks into whether they like using the app for self-testing and partner testing for HIV.

How Is the Trial Designed?

Group I: Making PrEP Smart Experimental Treatment 1 Intervention

The Making PrEP Smart intervention is a mobile-based application which provides PrEP adherence reminders and supports HIV-self and partner testing for cis- and transgender women.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05111119

NCT05111119 | Making PrEP Smart: An HIV Testing and ...

The purpose of this study is to understand if a smartphone app, SmartPrEP, will help promote HIV self-testing and PrEP adherence among cisgender and transgender ...

2.

icap.columbia.edu

icap.columbia.edu/news-events/making-prep-smart-icap-investigates-apps-ability-to-improve-prep-usage-and-hiv-testing-among-women/

Making PrEP Smart: ICAP Investigates App's Ability to ...

The Making PrEP Smart study will assess the acceptability of the app, elicit user feedback on app features, and evaluate whether PrEP adherence ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9131382/

Usability and effectiveness of adherence monitoring of a ...

The UPrEPU mobile app is a self-monitoring system to enable men who have sex with men to optimize their pre-exposure prophylaxis adherence for HIV prevention.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12505014/

Enhancing PrEP adherence through person‐centred ...

Person‐centred mobile applications such as UPrEPU provide valuable data for tailored, just‐in‐time interventions, enhancing adherence.

5.

nature.com

nature.com/articles/s41746-025-01743-7

Real-time digital intervention on oral pre-exposure ...

We evaluated the effectiveness of real-time digital intervention in promoting oral PrEP adherence through a randomized controlled trial using electronic ...

6.

withpower.com

withpower.com/trial/phase-acquired-immunodeficiency-syndrome-10-2021-1bc7a

SmartPrEP App for HIV Prevention · Info for Participants

This N/A medical study run by Columbia University needs participants to evaluate whether Making PrEP Smart will have tolerable side effects & efficacy for ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9947765/

Development of a Mobile App to Increase the Uptake of HIV ...

A comprehensive HIV prevention mobile app aiming to increase PrEP uptake, HIV testing, and condom use by Latino SMM.