CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM (NCT01761643) | Clinical Trial Compass
CompletedPhase 4
CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
United States398 participantsStarted 2012-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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…