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
|Condition or disease||Intervention/treatment||Phase|
|Patient Adherence HIV Seronegativity||Device: SoC + iTab||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||398 participants|
|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|
|Official Title:||CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM|
|Actual Study Start Date :||December 19, 2012|
|Actual Primary Completion Date :||June 13, 2018|
|Actual Study Completion Date :||July 11, 2018|
No Intervention: Standard of Care (SoC)
This proposal will perform a study of potential methods to improve adherence and retention by evaluating standard procedures versus the use of the iTAB platform.
All subjects will receive SoC that will include health education, clinical assessments, laboratory safety monitoring, STI and HIV screening, HIV risk reduction counseling, assessment of psycho-social barriers, adherence counseling, and completion of a computer based survey.
Active Comparator: SoC + iTab
Subjects assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
Subjects will have visits with the study coordinator to introduce the iTAB texting system.
Once the time is identified, the text reminder system is automated. Patients will confirm medication taking via text responses to the personalized reminders. If a participant does not respond on three consecutive occasions, a high alert message (chosen by the participant) will be sent. If the subject does not respond to this message, the study coordinator would initiate phone calls to contact the subject and explore barriers.
Device: SoC + iTab
Text messaging reminders to improve adherence to PrEP
- 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.
- Perfect Adherence to PrEP [ Time Frame: Baseline to Week 48 ]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.
- Rate of HIV Seroconversion [ Time Frame: Up to 2.5 years after baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761643
|United States, California|
|City of Long Beach Department of Health and Human Services|
|Long Beach, California, United States, 90815|
|University Southern California|
|Los Angeles, California, United States, 90033|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|Harbor-UCLA Medical Center|
|Torrance, California, United States, 90502|
|Principal Investigator:||Sheldon Morris, MD, MPH||CCTG, UCSD AVRC|
|Study Chair:||David Moore, PhD||CCTG, UCSD HNRP|