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

NCT01761643 | Completed Phase 4 Results

• 1 other identifier: CCTG 595
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 4

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.

Conditions

Patient Adherence; HIV Seronegativity

Keywords

PrEP; Pre exposure Prophylaxis; Text Messaging; Truvada; iTab; CCTG; 595

Outcome Measures

Primary Outcomes (1)

• Adherence to PrEP

  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.

  Baseline to Week 48

Secondary Outcomes (2)

• Perfect Adherence to PrEP

  Baseline to Week 48

• Rate of HIV Seroconversion

  Up to 2.5 years after baseline

Study Arms (2)

Standard of Care (SoC)

NO INTERVENTION

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.

SoC + iTab

ACTIVE COMPARATOR

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

Interventions

SoC + iTab DEVICE

Text messaging reminders to improve adherence to PrEP

SoC + iTab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, Los Angeles: collaborator
• University of Southern California: collaborator
• City of Long Beach Department of Health and Human Services: collaborator
• California HIV/AIDS Research Program: collaborator
• Gilead Sciences: collaborator

Study Sites (4)

City of Long Beach Department of Health and Human Services

Long Beach, California, 90815, United States

Location

University Southern California

Los Angeles, California, 90033, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (3)

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

• Pasipanodya EC, Jain S, Sun X, Blumenthal J, Ellorin E, Corado K, Dube MP, Daar ES, Morris SR, Moore DJ; California Collaborative Treatment Group (CCTG) TAPIR Study Team. Trajectories and Predictors of Longitudinal Preexposure Prophylaxis Adherence Among Men Who Have Sex With Men. J Infect Dis. 2018 Oct 5;218(10):1551-1559. doi: 10.1093/infdis/jiy368.

  PMID: 30295803 DERIVED

• Moore DJ, Jain S, Dube MP, Daar ES, Sun X, Young J, Corado K, Ellorin E, Milam J, Collins D, Blumenthal J, Best BM, Anderson P, Haubrich R, Morris SR. Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study. Clin Infect Dis. 2018 May 2;66(10):1566-1572. doi: 10.1093/cid/cix1055.

  PMID: 29228144 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Discontinuation of PrEP may be for valid reasons for not needing prevention of HIV due to not being sexually active

Results Point of Contact

• Title: Mike Duszynski
• Organization: UC San Diego

mduszynski@health.ucsd.edu

6195438080

Study Officials

• Sheldon Morris, MD, MPH

  CCTG, UCSD AVRC

  PRINCIPAL INVESTIGATOR

• David Moore, PhD

  CCTG, UCSD HNRP

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 7, 2013
• Study Start: December 19, 2012
• Primary Completion: June 13, 2018
• Study Completion: July 11, 2018
• Last Updated: June 30, 2020
• Results First Posted: June 2, 2020

Record last verified: 2020-06

Locations

US (4)