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

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ClinicalTrials.gov Identifier: NCT05111119
Recruitment Status : Recruiting
First Posted : November 8, 2021
Last Update Posted : July 18, 2022
Sponsor:
Information provided by (Responsible Party):
Jessica E Justman, MD, Columbia University

Study Description
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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.


Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Making PrEP Smart Not Applicable

Detailed Description:
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 women over a twelve-month period. As part of this, participants will be required to download the SmartPrEP app and participate in six study visits starting at enrollment, Month 1, Month 3, Month 6, Month 9, and Month 12. Most visits will take place at the Bronx Prevention Center and include adherence counseling, app acceptability assessments, behavioral risk assessments, and STI/HIV testing. App data will be collected which evaluates PrEP adherence, HIV self-testing, and HIV partner testing. Additionally, all participants will be invited to take part in either a focus group discussion (FGD) or an open-ended, in-depth interview (IDI) to elicit their thoughts and preferences regarding the SmartPrEP app acceptability. Interventions consist of (1) smartphone app "SmartPrEP"; (2) PrEP medication.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Making PrEP Smart: An HIV Testing and PrEP Electronic Support Tool ("SmartPrEP" App) for Women on PrEP
Actual Study Start Date : February 3, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Making PrEP Smart
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

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants with optimal PrEP adherence [ Time Frame: 12-month period of observation ]
    This is to measure PrEP Adherence, defined as taking >/= 6 doses per week, as recorded in the SmartPrEP app.


Secondary Outcome Measures :
  1. Proportion of participants who perform HIV self-testing [ Time Frame: 12-month period of observation ]
    This is to measure HIV Self-Testing, as recorded in the SmartPrEP App during the study. Participant-reported reasons for performing HIV self-testing will be included in the analyses.

  2. Proportion of participants who rated app to be acceptable [ Time Frame: 12-month period of observation ]
    This is to measure acceptability of the SmartPrEP App, per participant report, as collected in the focus group discussions and in-depth interviews.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self-representation of gender identity. Participants must identify as a cis- or transgender woman.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05111119


Contacts
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Contact: Rita Sondengam (Bronx Prevention Center), MPH (347) 590-7280 rs2227@cumc.columbia.edu
Contact: Connor Wright, MPH (212) 305-1348 cgw2121@cumc.columbia.edu

Locations
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United States, New York
CUIMC Recruiting
New York, New York, United States, 10032
Contact: Jessica Justman, MD       jj2158@cumc.columbia.edu   
Principal Investigator: Jessica Justman, MD         
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Jessica Justman, MD Associate Professor of Medicine
More Information
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Responsible Party: Jessica E Justman, MD, Senior Technical Director, ICAP, Columbia University
ClinicalTrials.gov Identifier: NCT05111119    
Other Study ID Numbers: AAAT7092
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: July 18, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica E Justman, MD, Columbia University:
Pre-Exposure Prophylaxis (PrEP)
HIV Prevention
Mobile App
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
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
Immunologic Deficiency Syndromes
Immune System Diseases