CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
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ClinicalTrials.gov Identifier: NCT01761643 |
Recruitment Status :
Completed
First Posted : January 7, 2013
Results First Posted : June 2, 2020
Last Update Posted : June 30, 2020
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Tracking Information | |||||||
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First Submitted Date ICMJE | January 2, 2013 | ||||||
First Posted Date ICMJE | January 7, 2013 | ||||||
Results First Submitted Date ICMJE | May 13, 2020 | ||||||
Results First Posted Date ICMJE | June 2, 2020 | ||||||
Last Update Posted Date | June 30, 2020 | ||||||
Actual Study Start Date ICMJE | December 19, 2012 | ||||||
Actual Primary Completion Date | June 13, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Adherence to PrEP [ Time Frame: Baseline to Week 48 ] 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.
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Original Primary Outcome Measures ICMJE |
Adherence to PrEP [ Time Frame: Baseline to Week 48 ] CCTG 595 will compare adherence to fixed dose TDF/FTC, between subjects randomized to receive SoC plus text message reminders versus SoC, when used for pre-exposure prophylaxis among MSM at high risk for HIV acquisition.
The primary outcome is defined as a composite endpoint of remaining on PrEP and having adherence > 90% over 48 weeks of follow-up. The adherence endpoint will be derived from the 4 day ACTG adherence assessment from each of the visits from week 4, 12, 24, 36, and 48. 'Adherent' will be defined as self-reported TDF/ FTC adherence of 90% or greater (at least 18 of 20 days). If a subject misses an adherence assessment within the window of a scheduled visit or discontinues study prior to week 48, then the missed visits will be counted no adherence for the time of that visit. All randomized subjects that were dispensed PrEP at baseline will be included in the modified intent-to-treat analysis.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures |
Changes of self-reported adherence [ Time Frame: Baseline until up to 2.5 years of follow up ] Describe changes over time of self-reported adherence in real time by texting.
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Descriptive Information | |||||||
Brief Title ICMJE | CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM | ||||||
Official Title ICMJE | CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM | ||||||
Brief 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Intervention Model Description: The purpose of this study is to evaluate a promising method of reinforcing PrEP adherence using text message. In this study, we will hope to learn if text message reminders increase PrEP adherence. Masking: None (Open Label)Masking Description: Group 1: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety monitoring Group 2: PrEP daily, HIV/STI screening, adherence and risk behavior counseling, and safety monitoring as well as iTAB text adherence reminders Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Device: SoC + iTab
Text messaging reminders to improve adherence to PrEP
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
398 | ||||||
Original Estimated Enrollment ICMJE |
400 | ||||||
Actual Study Completion Date ICMJE | July 11, 2018 | ||||||
Actual Primary Completion Date | June 13, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01761643 | ||||||
Other Study ID Numbers ICMJE | CCTG 595 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Sheldon Morris, University of California, San Diego | ||||||
Original Responsible Party | University of California, San Diego | ||||||
Current Study Sponsor ICMJE | University of California, San Diego | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, San Diego | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |