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

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    50
  • sponsor
    Columbia University
Updated on 4 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition HIV/AIDS
Treatment Making PrEP Smart
Clinical Study IdentifierNCT05111119
SponsorColumbia University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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