SmartPrEP App for HIV Prevention

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

53 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: To assess PrEP adherence among sexually-active and/or injection-drug using, HIV-negative cis- and transgender women who use the "SmartPrEP" phone app to support PrEP adherence during a 12-month period of observation. Secondary Objective: To assess the acceptability of using the SmartPrEP app to support HIV self-testing and partner testing among sexually active and/or injection-drug using, HIV-negative cisgender and transgender women on PrEP. Exploratory Objectives: To describe patterns of PrEP adherence and user feedback on acceptability, utility, and features of the app; To assess correlations between self-reported sexual behavior and PrEP adherence; To assess patterns of HIV testing (self and partner testing), self-reported reasons for HIV testing, and correlations with test results.

Research Team

Jessica Justman, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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