HIVNCT02371525
Enhancing PrEP in Community Settings (EPIC)
A study testing Prepmate in people with HIV, run by University of California, San Francisco at 1 site in United States.
Trial summary
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Prepmate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
- Interested in initiating PrEP
- Eligible to initiate PrEP
- Creatinine clearance > 60 ml/min as estimated by the Cockcroft-Gault equation within 6 weeks of enrollment
- Hepatitis B surface antigen (HBsAg) negative within 6 weeks Enrollment
- No other medical contraindications to PrEP
Show all 17Show fewer
- Age 18 years - 29 years
- Willing and able to provide written informed consent
- Report having had anal sex with a man in the previous 6 months
- Meet any of the following risk criteria for the prior 6 months:
- Any condomless anal sex
- Three or more anal sex partners
- Self-reported new STI
- Known HIV-infected sex partner
- Have regular access to a computer and/or a smart phone to access the internet and/or apps
- Have the ability to send and receive text messages
- Able to read and speak in English
Who cannot join
- PrEP use within the past year (PrEP naïve participants will be prioritized).
- Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
- Prior or current participation in the active arm of an HIV vaccine trial
- At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
- Signs or symptoms of acute HIV infection (as described in the SSP Manual)
- History of pathological bone fracture not related to trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stroger Hospital and the CORE Center
Chicago, Illinois, 60612
About this study
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
- Conditions
- HIV
- Being tested
- Prepmate
- Keywords
- adherence, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrepmateBehavioural
A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Prepmate | Experimental | Not described Receives: Behavioral: Prepmate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence among young MSM over time based on dried blood spot (DBS)
PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.
Measured: DBS measured through week 36
Secondary outcomes (8)
Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)
Change in PrEP knowledge assessed via computer-assisted self-interview (CASI) at baseline and week 36 (or early termination)
Measured: baseline and week 36
Change in risk behaviors administered via CASI
Change in self-reported sexual risk behavior administered via CASI
Measured: baseline through week 36
Change in risk perception administered by CASI
Changes in risk perception during the study administered by CASI
Measured: baseline through week 36
Acceptability of Prepmate as measured by an acceptability index collected via CASI
Acceptability of Prepmate as measured by an acceptability index collected via CASI at 9 months (or early termination).
Measured: Month 9 (or early termination)
Perceptions of Prepmate provided via individual exit interviews
Qualitative feedback provided via individual exit interviews with a subset of participants one month after Prepmate termination. Interviews will be open-ended and will cover topics such as usability, acceptability, user-experience and effectiveness of the Prepmate intervention.
Measured: Month 10
Patterns of use of Prepmate texting service over time as measured by responses to text messages.
Use patterns of Prepmate texting service over time as measured by responses to text messages.
Measured: through week 36
The incidence of sexually-transmitted infection (STI) among all participants.
Incidence of a combination endpoint of gonorrhea, chlamydia, and/or syphilis.
Measured: through week 36
The number of participants who acquire HIV
The number of HIV infections (2) The drug resistance profiles of breakthrough infections
Measured: week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Hektoen Institute for Medical Research
- Responsible party
- Sponsor
- Investigators
- Albert Liu, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371525
- Sponsor's protocol ID
- 5R01MH095628
- Status last verified
- Oct 2017
- First submitted
- 19 Feb 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
Publications
Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.
PubMed 30239620
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing PrEP in Community Settings (EPIC)
- ClinicalTrials.gov ID
- NCT02371525
- Acronym / sponsor ID
- 5R01MH095628
- Conditions
- HIV
- Keywords
- adherence, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Hektoen Institute for Medical Research
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effectiveness of Prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support among young men who have sex with men (MSM).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Prepmate | Experimental | Behavioral: Prepmate |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- HIV-uninfected as determined by a negative/non-reactive laboratory test within 7 days of Enrollment (as defined in the study-specific procedures (SSP) Manual).
- Interested in initiating PrEP
- Eligible to initiate PrEP
- Age 18 years - 29 years
- Willing and able to provide written informed consent
Key exclusion criteria (6 listed)
- PrEP use within the past year (PrEP naïve participants will be prioritized).
- Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
- Prior or current participation in the active arm of an HIV vaccine trial
- At Enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives.
- Signs or symptoms of acute HIV infection (as described in the SSP Manual)
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 |
|---|---|---|
| PrepmateA novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support . | Behavioural | Prepmate |
Primary outcome
PrEP adherence among young MSM over time based on dried blood spot (DBS)
Time frame: DBS measured through week 36
PrEP adherence during follow-up based on dried blood spot (DBS) concentrations.
8 secondary outcomes
Change in PrEP knowledge assessed via computer-assisted self-interview (CASI)
Time frame: baseline and week 36
Change in risk behaviors administered via CASI
Time frame: baseline through week 36
Change in risk perception administered by CASI
Time frame: baseline through week 36
Acceptability of Prepmate as measured by an acceptability index collected via CASI
Time frame: Month 9 (or early termination)
Perceptions of Prepmate provided via individual exit interviews
Time frame: Month 10
Patterns of use of Prepmate texting service over time as measured by responses to text messages.
Time frame: through week 36
The incidence of sexually-transmitted infection (STI) among all participants.
Time frame: through week 36
The number of participants who acquire HIV
Time frame: week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 30239620Liu AY, Vittinghoff E, von Felten P, Rivet Amico K, Anderson PL, Lester R, Andrew E, Estes I, Serrano P, Brothers J, Buchbinder S, Hosek S, Fuchs JD. Randomized Controlled Trial of a Mobile Health Intervention to Promote Retention and Adherence to Preexposure Prophylaxis Among Young People at Risk for Human Immunodeficiency Virus: The EPIC Study. Clin Infect Dis. 2019 May 30;68(12):2010-2017. doi: 10.1093/cid/ciy810.
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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.
Albert Liu, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prepmate in people with HIV, run by University of California, San Francisco at 1 site 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 17 inclusion and 6 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PrEP adherence among young MSM over time based on dried blood spot (DBS) (time frame: DBS measured through week 36). 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 NCT02371525, which also lists 1 linked publication.
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 26 Oct 2017.