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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761643
Recruitment Status : Completed
First Posted : January 7, 2013
Results First Posted : June 2, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
Information provided by (Responsible Party):
Sheldon Morris, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Patient Adherence HIV Seronegativity Device: SoC + iTab Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
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
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Man or transgender M to F who has sex with men.
  • Age 18 years or older.
  • Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following:

    • Has at least one HIV infected sexual partner for ≥4 weeks.
    • No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last 3 months.
    • No condom use during anal sex with ≥1 male partner and STI diagnosis during the last 3 months.
  • Negative for HIV infection by rapid HIV test and confirmed negative by NAT or other sensitive method such as antibody- antigen test.
  • Acceptable laboratory values in the past 30 days:

    • Calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula (eCcr (male) in mL/min = [(140 - age in years) x (lean body weight in kg)] / (72 x serum creatinine in mg/dL)
    • Alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN)
    • Hemoglobin > 9 g/dL
    • Absolute neutrophil count > 750/ mm3
    • Platelets > 75,000/ mm3

Exclusion Criteria:

  • Unable to give informed consent.
  • Active hepatitis B (positive hepatitis B surface antigen (HBSAg) or HBSAg negative/ HB core antibody positive/ HBV PCR positive).
  • Has substantial medical condition, that in the opinion of the investigator would preclude participation, as defined by

    • cardiovascular condition that may lead to an increased risk of complication if placed on study drugs.
    • gastrointestinal condition that would impair absorption of study drugs.
    • neurological or psychiatric condition that would significantly impair the ability to adhere to PrEP.
    • calculated GFR < 60 mL/min.
    • alcohol or drug abuse or dependence that would significantly impair the ability to adhere to PrEP (only for those with severe impairment).
    • other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP.
  • Suspected sensitivity or allergy to the study drug or any of its components.
  • Currently using an essential product or medication that interacts with the study drug such as the following:

    • ART (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)
    • Agents with known nephrotoxic potential:

      • aminoglycoside antibiotics (including gentamicin)
      • IV amphotericin B
      • cidofovir
      • cisplatin
      • foscarnet
      • IV pentamidine
      • IV vancomycin
      • oral or IV gancyclovir
      • other agents with significant nephrotoxic potential
    • Drugs that slow renal excretion

      • Probenecid
    • Immune system modulators

      • Systemic chemotherapeutic agents (i.e. cancer treatment medications)
      • Ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
      • Interleukin-2 (IL-2)
      • Interferon (alpha, beta, or gamma)
    • Other agent known to have a significant interaction with TDF or FTC
    • Proteinuria 2+ or greater by urine dipstick
    • Signs or symptoms suggestive of acute HIV infection
    • Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of California, San Diego
University of California, Los Angeles
University of Southern California
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
Investigators
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Principal Investigator: Sheldon Morris, MD, MPH CCTG, UCSD AVRC
Study Chair: David Moore, PhD CCTG, UCSD HNRP
  Study Documents (Full-Text)

Documents provided by Sheldon Morris, University of California, San Diego:
Study Protocol  [PDF] August 10, 2015
Statistical Analysis Plan  [PDF] March 18, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheldon Morris, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01761643    
Other Study ID Numbers: CCTG 595
First Posted: January 7, 2013    Key Record Dates
Results First Posted: June 2, 2020
Last Update Posted: June 30, 2020
Last Verified: June 2020
Keywords provided by Sheldon Morris, University of California, San Diego:
PrEP
Pre exposure Prophylaxis
Text Messaging
Truvada
iTab
CCTG
595