CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
Condition: Patient Adherence; HIV Seronegativity
Intervention: SoC + iTab
Intervention description: Text messaging reminders to improve adherence to PrEP
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The purpose of this study is to evaluate a promising method of reinforcing PrEP adherence using text message. In this study, we will hope to learn if text message reminders increase PrEP adherence.
Masking: None (Open Label)
Masking description: Group 1: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety monitoring Group 2: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety monitoring as well as iTAB text adherence reminders
Enrollment: 398.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PrEP; Pre exposure Prophylaxis; Text Messaging; Truvada; iTab; CCTG; 595

Summary:

      CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration
      project to determine if the use of a text-message based adherence intervention (iTAB)
      improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or transgender M to F who has sex with men.

          -  Age 18 years or older.

          -  Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or
             more of the following:

               -  Has at least one HIV infected sexual partner for ≥4 weeks.

               -  No condom use during anal intercourse with ≥3 male sex partners who are
                  HIV-positive or of unknown HIV status during the last 3 months.

               -  No condom use during anal sex with ≥1 male partner and STI diagnosis during the
                  last 3 months.

          -  Negative for HIV infection by rapid HIV test and confirmed negative by NAT or other
             sensitive method such as antibody- antigen test.

          -  Acceptable laboratory values in the past 30 days:

               -  Calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault
                  formula (eCcr (male) in mL/min = [(140 - age in years) x (lean body weight in
                  kg)] / (72 x serum creatinine in mg/dL)

               -  Alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) < 3 x
                  upper limit of normal (ULN)

               -  Hemoglobin > 9 g/dL

               -  Absolute neutrophil count > 750/ mm3

               -  Platelets > 75,000/ mm3

        Exclusion Criteria:

          -  Unable to give informed consent.

          -  Active hepatitis B (positive hepatitis B surface antigen (HBSAg) or HBSAg negative/ HB
             core antibody positive/ HBV PCR positive).

          -  Has substantial medical condition, that in the opinion of the investigator would
             preclude participation, as defined by

               -  cardiovascular condition that may lead to an increased risk of complication if
                  placed on study drugs.

               -  gastrointestinal condition that would impair absorption of study drugs.

               -  neurological or psychiatric condition that would significantly impair the ability
                  to adhere to PrEP.

               -  calculated GFR < 60 mL/min.

               -  alcohol or drug abuse or dependence that would significantly impair the ability
                  to adhere to PrEP (only for those with severe impairment).

               -  other medical condition that would unacceptably increase the risk of harm from
                  study drug or significantly impair the ability to adhere to PrEP.

          -  Suspected sensitivity or allergy to the study drug or any of its components.

          -  Currently using an essential product or medication that interacts with the study drug
             such as the following:

               -  ART (including nucleoside analogs, non-nucleoside reverse transcriptase
                  inhibitors, protease inhibitors or investigational antiretroviral agents)

               -  Agents with known nephrotoxic potential:

                    -  aminoglycoside antibiotics (including gentamicin)

                    -  IV amphotericin B

                    -  cidofovir

                    -  cisplatin

                    -  foscarnet

                    -  IV pentamidine

                    -  IV vancomycin

                    -  oral or IV gancyclovir

                    -  other agents with significant nephrotoxic potential

               -  Drugs that slow renal excretion

                    -  Probenecid

               -  Immune system modulators

                    -  Systemic chemotherapeutic agents (i.e. cancer treatment medications)

                    -  Ongoing systemic corticosteroids (with the exception of short courses of
                       tapering steroid doses for asthma or other self- limited condition).

                    -  Interleukin-2 (IL-2)

                    -  Interferon (alpha, beta, or gamma)

               -  Other agent known to have a significant interaction with TDF or FTC

               -  Proteinuria 2+ or greater by urine dipstick

               -  Signs or symptoms suggestive of acute HIV infection

               -  Any other reason or condition that in the opinion of the investigator would
                  interfere with participation, complicate interpretation of study outcome data, or
                  otherwise interfere with achieving the study objectives.