Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
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
Information provided by (Responsible Party):
California Collaborative Treatment Group
ClinicalTrials.gov Identifier:
NCT01761643
First received: January 2, 2013
Last updated: February 10, 2015
Last verified: February 2015
History of Changes
  Purpose

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 Intervention Phase
Patient Adherence
HIV Seronegativity
 Device: SoC + iTab
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by California Collaborative Treatment Group:

Primary Outcome Measures:
  • Adherence to PrEP [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Adherence in subjects that remain on PrEP [ Time Frame: Baseline to Week 48, and up to 2.5 years follow up if subject desires to remain on study after reaching the primary endpoint ] [ Designated as safety issue: No ]
    Compare adherence to TDF/FTC in the iTAB versus SoC in the subjects that remain on PrEP (at 48 weeks and up to 2.5 years follow up) by the continuous measure of percent days adherent by the cumulative 4 day ACTG and the visual analog scale (VAS) recall in an 'as treated' analysis.

  • Adherence to PrEP for duration of study [ Time Frame: Baseline to Week 48, and up to 2.5 years follow up if subject desires to remain on study after reaching the primary endpoint ] [ Designated as safety issue: No ]
    Compare adherence to TDF/FTC in the iTab versus SoC groups for the duration of the study (up to 2.5 years). Adherence will be compared using the same outcomes as the Primary Outcome Measure (self-reported to be on drug and 90% adherent and 100% detectable FTC at each scheduled visit) as modified intent to treat analysis.

  • Factors associated with poor adherence [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Determine factors associated with poor adherence/lost to PrEP in study participants (outcomes of < 90% adherent on drug at 48 weeks by ACTG 4 day recall or discontinuation of drug). Factors associated with poor adherence to TDF/FTC will include demographics, ongoing substance use, untreated mental illness, socioeconomic status, low health/HIV and system literacy, fear of disclosure and non-English language.

  • Factors associated with discontinuation of TDF/FTC [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
    Determine the factors associated with discontinuation of TDF/FTC at any time point including change in perceived and actual risk of HIV acquisition, demographics, ongoing substance use, untreated mental illness, socioeconomic status, low health/HIV and system literacy, fear of disclosure and non-English language.

  • Rate of HIV seroconversion [ Time Frame: Baseline to Week 48, and up to 2.5 years follow up if subject desires to remain on study after reaching the primary endpoint ] [ Designated as safety issue: No ]
    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.

  • Acquisition of other sexually transmitted infections [ Time Frame: Baseline to Week 48, and up to 2.5 years follow up if subject desires to remain on study after reaching the primary endpoint ] [ Designated as safety issue: No ]
    Measure acquisition of other sexually transmitted infections (STIs); the proportion of subjects with any new STI at any site will be compared between the iTAB to SOC arms at 48 weeks and through the end of the study.

  • Changes in risk behavior [ Time Frame: Baseline until up to 2.5 years follow up ] [ Designated as safety issue: No ]
    Evaluate changes in risk behavior after initiation of PrEP (risk compensation) comparing baseline to subsequent visits for number of HIV positive/unknown status partners and any unprotected anal intercourse with an HIV positive/ unknown status partner.

  • Safety and tolerability of daily TDF/FTC [ Time Frame: Baseline until up to 2.5 years of follow up ] [ Designated as safety issue: No ]
    Evaluate the safety and tolerability of daily TDF/FTC given for PrEP including discontinuation for any adverse event, serious adverse events and adverse events (grade 2 or higher).


Other Outcome Measures:
  • Changes of self-reported adherence [ Time Frame: Baseline until up to 2.5 years of follow up ] [ Designated as safety issue: No ]
    Describe changes over time of self-reported adherence in real time by texting.
Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761643

Locations
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
California Collaborative Treatment Group
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
Study Chair: Sheldon Morris, MD, MPH CCTG, UCSD AVRC
Study Chair: David Moore, PhD CCTG, UCSD HNRP
  More Information

No publications provided

Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT01761643     History of Changes
Other Study ID Numbers: CCTG 595
Study First Received: January 2, 2013
Last Updated: February 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by California Collaborative Treatment Group:
PrEP
Pre exposure Prophylaxis
Text Messaging
Truvada
 iTab
CCTG
595

ClinicalTrials.gov processed this record on March 03, 2015