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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

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 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

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.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,300 Total Patients Enrolled
Jessica Justman, MDPrincipal InvestigatorAssociate Professor of Medicine
7 Previous Clinical Trials
42,843 Total Patients Enrolled
~8 spots leftby Apr 2025
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