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

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    50
  • sponsor
    Columbia University
Send
Updated on 4 October 2022
See if I qualify
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Browse trials for

Accepts healthy volunteers

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note