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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
Text messaging reminders to improve adherence to PrEP
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
Adherence to PrEP
Proportion of participants adherent to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations \> 719 fmol/punch at Week 12 and the last on-drug visit.
Time frame: Baseline to Week 48
Perfect Adherence to PrEP
Proportion of participants with perfect adherence to PrEP as measured by TFV-DP dried blood spot (DBS) concentrations \> 1246 fmol/punch at Week 12 and the last on-drug visit.
Time frame: Baseline to Week 48
Rate of HIV Seroconversion
Determine the rate of HIV seroconversion in PrEP users and compare the iTAB to SOC arms for number of new infections as a proportion at 48 weeks and end of study.
Time frame: Up to 2.5 years after baseline
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