CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM

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.