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

Primary Purpose

HIV/AIDS

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Making PrEP Smart

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Pre-Exposure Prophylaxis (PrEP), HIV Prevention, Mobile App

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CUIMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Making PrEP Smart

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of participants who perform HIV self-testing

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.

Proportion of participants who rated app to be acceptable

This is to measure acceptability of the SmartPrEP App, per participant report, as collected in the focus group discussions and in-depth interviews.

Full Information

NCT ID

NCT05111119

First Posted

October 27, 2021

Last Updated

July 14, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT05111119

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2022 (Actual)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Making PrEP Smart

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Making PrEP Smart

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants with optimal PrEP adherence

Description

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

Time Frame

12-month period of observation

Secondary Outcome Measure Information:

Title

Proportion of participants who perform HIV self-testing

Description

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.

Time Frame

12-month period of observation

Title

Proportion of participants who rated app to be acceptable

Description

This is to measure acceptability of the SmartPrEP App, per participant report, as collected in the focus group discussions and in-depth interviews.

Time Frame

12-month period of observation

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Eligibility is based on self-representation of gender identity. Participants must identify as a cis- or transgender woman.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rita Sondengam (Bronx Prevention Center), MPH

Phone

(347) 590-7280

rs2227@cumc.columbia.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Connor Wright, MPH

Phone

(212) 305-1348

cgw2121@cumc.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Justman, MD

Organizational Affiliation

Associate Professor of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

CUIMC

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Justman, MD

jj2158@cumc.columbia.edu

First Name & Middle Initial & Last Name & Degree

Jessica Justman, MD

12. IPD Sharing Statement

Learn more about this trial

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

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