Patient AdherencePhase 4NCT01761643
CCTG 595: Text Messaging Intervention to Improve Adherence to PrEP in High-risk MSM
A Phase 4 study testing SoC + iTab in people with Patient Adherence and HIV Seronegativity, run by University of California, San Diego at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Adherence, HIV Seronegativity
- What is being tested?
- SoC + iTab
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Dec 2012to 11 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Long Beach Department of Health and Human Services
Long Beach, California, 90815
University Southern California
Los Angeles, California, 90033
University of California, San Diego
San Diego, California, 92103
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
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.
Read the 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.
- Conditions
- Patient Adherence, HIV Seronegativity
- Being tested
- SoC + iTab
- Keywords
- PrEP, Pre exposure Prophylaxis, Text Messaging, Truvada, iTab, CCTG, 595
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoC + iTabDevice
Text messaging reminders to improve adherence to PrEP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SoC + iTab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 48
Secondary outcomes (2)
Perfect Adherence to PrEP
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.
Measured: Baseline to Week 48
Rate of HIV Seroconversion
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.
Measured: Up to 2.5 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study start19 Dec 2012
- Primary completion13 Jun 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Sheldon Morris, University of California, San Diego
- Investigators
- Sheldon Morris, MD, MPH, Principal investigator, CCTG, UCSD AVRCDavid Moore, PhD, Study chair, CCTG, UCSD HNRP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761643
- Sponsor's protocol ID
- CCTG 595
- Status last verified
- Jun 2020
- First submitted
- 2 Jan 2013
- Last updated
- 30 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32779730Pasipanodya 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.
PubMed 30295803Moore 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.
PubMed 29228144
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
- ClinicalTrials.gov ID
- NCT01761643
- Acronym / sponsor ID
- CCTG 595
- Conditions
- Patient Adherence, HIV Seronegativity
- Keywords
- PrEP, Pre exposure Prophylaxis, Text Messaging, Truvada, iTab, CCTG, 595
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- 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
- Study start
- 19 Dec 2012 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Posted 2 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: SoC + iTabSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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:
Key exclusion criteria (33 listed)
- 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
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoC + iTabText messaging reminders to improve adherence to PrEP | Device | SoC + iTab |
Primary outcome
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.
2 secondary outcomes
Perfect Adherence to PrEP
Time frame: Baseline to Week 48
Rate of HIV Seroconversion
Time frame: Up to 2.5 years after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32779730Palmer 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.
- Derived from this study: PubMed 30295803Pasipanodya 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.
- Derived from this study: PubMed 29228144Moore 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Morris, MD, MPH principal investigator
CCTG, UCSD AVRC
David Moore, PhD study chair
CCTG, UCSD HNRP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SoC + iTab in people with Patient Adherence and HIV Seronegativity, run by University of California, San Diego at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to PrEP (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761643, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.