NCT01761643

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

CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Patient Adherence
• HIV Seronegativity

Interventions

Type	Name	Description
DEVICE	SoC + iTab	Text messaging reminders to improve adherence to PrEP

Timeline

• Start date: 2012-12-19
• Primary completion: 2018-06-13
• Completion: 2018-07-11
• First posted: 2013-01-07
• Last updated: 2020-06-30
• Results posted: 2020-06-02

Locations

4 sites across 1 country: United States