HIV Seronegativity Clinical Trial
Official title:
CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
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.
A total of 400 HIV-uninfected men who have sex with men (MSM)and male to female (M to F)
transgender individuals with recent high-risk transmission behavior will be enrolled into the
study. Each subject will be followed for up to 48 weeks after enrollment of the last subject.
The primary endpoint will be measured at 48 weeks.
All subjects will start PrEP with TDF + FTC fixed dose combination given once daily. Subjects
will be randomized (1:1) to either the iTAB text messaging adherence reminder intervention
with SoC or the SoC alone arm. Subjects placed into the iTAB intervention arm will receive a
personalized, automated texting system to maintain adherence and retention. Both groups will
receive access to PrEP in accordance with standardized comprehensive methods of prescribing,
risk reduction counseling, adherence counseling, and clinical assessments that include safety
monitoring, as well as HIV and STD screening.
TDF 300 mg + FTC 200 mg fixed dose combination will be given orally once daily starting at
the baseline visit (month 0) and continued throughout the study.
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