This trial is active, not recruiting.

Conditions patient adherence, hiv seronegativity
Treatment soc + itab
Phase phase 4
Sponsor California Collaborative Treatment Group
Collaborator University of California, San Diego
Start date January 2013
End date June 2016
Trial size 400 participants
Trial identifier NCT01761643, CCTG 595


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
(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.
(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.
soc + itab
Text messaging reminders to improve adherence to PrEP

Primary Outcomes

Adherence to PrEP
time frame: Baseline to Week 48

Secondary Outcomes

Factors associated with poor adherence
time frame: Baseline to Week 48
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
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
Changes in risk behavior
time frame: Baseline until up to 2.5 years follow up
Safety and tolerability of daily TDF/FTC
time frame: Baseline until up to 2.5 years of follow up

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by California Collaborative Treatment Group.