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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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.
- 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
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
|Contact: Rita Sondengam (Bronx Prevention Center), MPH||(347) email@example.com|
|Contact: Connor Wright, MPH||(212) firstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Jessica Justman, MD email@example.com|
|Principal Investigator: Jessica Justman, MD|
|Principal Investigator:||Jessica Justman, MD||Associate Professor of Medicine|
|Responsible Party:||Jessica E Justman, MD, Senior Technical Director, ICAP, Columbia University|
|Other Study ID Numbers:||
|First Posted:||November 8, 2021 Key Record Dates|
|Last Update Posted:||July 18, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Pre-Exposure Prophylaxis (PrEP)
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases