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Behavioral Intervention

SmartPrEP App for HIV Prevention

N/A

Waitlist Available

Led By Jessica Justman, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

self-identify as either a cisgender or transgender woman

no signs/symptoms of acute HIV infection

Must not have

renal function, eCrCl< 60 mL/min at Screening or Enrollment visit;

age under 18 years;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month period of observation

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to assess how well the SmartPrEP app helps people adhere to taking PrEP, a medication to prevent HIV, and how acceptable users find the app.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on an adherence support tool rather than medication itself, direct side effects from the intervention aren't expected. However, participants will continue taking PrEP medications which can have side effects such as nausea or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I identify as a woman, whether cisgender or transgender.

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I do not have any signs or symptoms of a recent HIV infection.

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My kidney function is normal.

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I am willing to follow the study's procedures and take Truvada.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month period of observation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month period of observation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month period of observation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants with optimal PrEP adherence

Secondary study objectives

Proportion of participants who perform HIV self-testing

Proportion of participants who rated app to be acceptable

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Making PrEP SmartExperimental Treatment1 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.

0 / 6Eligibility criteria met