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

Completed · Phase 4

Conditions studied: Patient Adherence, HIV Seronegativity

In brief

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.

Key facts

Study ID

NCT01761643

Run by

University of California, San Diego

People needed

398

Starts

2012-12-19

Expected to finish

2018-07-11

Last updated by the study team

2020-06-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Long Beach Department of Health and Human Services — Long Beach, California, United States
• University Southern California — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

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