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

Other illness

• 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;
• 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

Age

• age under 18 years;

Other

• 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;

• 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.