Making PrEP Smart: An HIV Testing and PrEP Electronic Support Tool ("SmartPrEP" App) for Women on PrEP

NCT05111119 | Completed

• 1 other identifier: AAAT7092
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

Pre-Exposure Prophylaxis (PrEP); HIV Prevention; Mobile App

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with optimal PrEP adherence

  This is to measure PrEP Adherence, defined as taking \>/= 6 doses per week, as recorded in the SmartPrEP app.

  12-month period of observation

Secondary Outcomes (2)

• Proportion of participants who perform HIV self-testing

  12-month period of observation

• Proportion of participants who rated app to be acceptable

  12-month period of observation

Study Arms (1)

Making PrEP Smart

EXPERIMENTAL

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.

Behavioral: Making PrEP Smart

Interventions

Making PrEP Smart BEHAVIORAL

The Making PrEP Smart intervention is a mobile-based application with the following components: * Notification-based PrEP Reminders and Adherence Self-Monitoring * HIV self-testing facilitation, interpretation of results, and testing support * HIV partner testing facilitation, interpretation of results, and testing support * Nearby HIV clinic contact information

Making PrEP Smart

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on self-representation of gender identity. Participants must identify as a cis- or transgender woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older (confirmed by ID)
• self-identify as either a cisgender or transgender woman
• eligible for and willing to initiate PrEP or already on PrEP \[having initiated PrEP within the last three months per participant self-report\]
• documented negative HIV test result at Screening Visit
• Has a mobile phone with a minimum of 3G network with an active cellular plan
• no signs/symptoms of acute HIV infection
• normal renal function (eCrCl of \>/= 60 ml/min)
• not taking contraindicated medications
• documented negative hepatitis B virus (HBVAg) status or documented evidence of seroimmunity
• if HCV Ab positive, documented evidence of previous completed treatment, resolution of active HCV infection (i.e. documented negative HCV RNA), or documented evidence of PCP/HCV care provider management/treatment progress
• meets CDC criteria for HIV risk
• willing to complete all required study procedures including the use of Truvada.

You may not qualify if:

• age under 18 years;
• HIV-positive status based on documented test results at at Screening or Enrollment Visits;
• any sign or symptom of acute HIV infection at screening or enrollment visit, until HIV status is confirmed negative via HIV RNA PCR testing;
• renal function, eCrCl\< 60 mL/min at Screening or Enrollment visit;
• inability to provide informed consent;
• pregnancy or breast-feeding;
• plans to move away from NYC area in the next 12-month period;
• Current use of HIV post-exposure prophylaxis (PEP), though participants who wish to transition from PEP to PrEP will be eligible at the completion of PEP
• Continued need for/use of medications with potential for adverse interactions with Truvada (FTC/TDF) or Descovy (TAF/FTC) on a case-by-case basis, i.e., hepatitis C antiviral agents, such as EPCLUSA (sofosbuvir/velpatasvir) or VOSEVI (sofosbuvir/velpatasvir/voxilaprevir); NRTIs, such as didanosine; medications that may decrease renal function (i.e., high-dose or multiple NSAIDS, aminoglycosides; and other medications that may result in compromising a participant's overall health if combined with Truvada, per the discretion of the IOR;
• History of self-reported low adherence to PrEP, based on study team's judgement

Sponsors & Collaborators

• Columbia University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica Justman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: February 3, 2022
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

US (1)