Human Immunodeficiency VirusNCT02495779
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
A study testing emtricitabine/tenofovir and CBT-based counseling in people with Human Immunodeficiency Virus, run by James Egan at 2 sites in United States.
Trial summary
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). 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
- Human Immunodeficiency Virus
- What is being tested?
- emtricitabine/tenofovir and CBT-based counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Nov 2017
- Phase
- Interventional
- 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
- Self-identify as MSM: (1) born male who (2) has sex with men
- Age: 18 or older
- Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months.
- Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event.
- Able and willing to provide informed consent
Who cannot join
- HIV positive
- Glomerular filtration rate < 60 mL/min (calculated using the Cockcroft-Gault formula)
- Hepatitis B surface antigen positive
- Symptoms suggestive of acute HIV seroconversion at screening or enrollment
- Have used PrEP or PEP within the previous 3 months
- Currently enrolled in another study involving medications, investigational drug, or medical device
- Has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Fenway Institute
Boston, Massachusetts, 02215
Div of Infectious Diseases, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
Read the detailed description
This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- emtricitabine/tenofovir, CBT-based counseling
- Keywords
- PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emtricitabine/tenofovirDrug
Also called Truvada
Short-term episodic use for 2-3 weeks.
CBT-based counselingBehavioural
Brief CBT-based counseling to promote adherence
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Given emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence Receives: Drug: emtricitabine/tenofovir; Behavioral: CBT-based counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PrEP Adherence
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
Measured: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2017
- Study completionNov 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Egan
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, James Egan, University of Pittsburgh
- Investigators
- Ronald D Stall, PhD, MPH, Principal investigator, University of PittsburghKenneth Mayer, MD, Principal investigator, Fenway Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495779
- Sponsor's protocol ID
- PRO15060504
- Other IDs
- 1R34MH104083-01A1
- Status last verified
- Mar 2019
- First submitted
- 29 Jun 2015
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Egan JE, Ho K, Stall R, Drucker MT, Tappin R, Hendrix CW, Marzinke MA, Safren SA, Mimiaga MJ, Psaros C, Elsesser S, Mayer KH. Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. J Acquir Immune Defic Syndr. 2020 Aug 15;84(5):508-513. doi: 10.1097/QAI.0000000000002382.
PubMed 32692109
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV
- ClinicalTrials.gov ID
- NCT02495779
- Acronym / sponsor ID
- PRO15060504
- Conditions
- Human Immunodeficiency Virus
- Keywords
- PrEP, HIV, MSM, Men Having Sex With Men, Episodic PrEP, Adherence, Episodic HIV Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- James EganUniversity, hospital or other
- Collaborators
- Fenway Community Health, National Institute of Mental Health (NIMH)
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Posted 27 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis (PrEP) for HIV prevention among men who have sex with men (MSM). The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
Detailed description
This proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic Pre-Exposure Prophylaxis for HIV prevention among men who have sex with men (MSM). Long-term PrEP may be unnecessary for the many HIV-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. Alternative dosing strategies, such as short-term fixed-interval episodic PrEP (Epi-PrEP), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of MSM. The overall objective is to determine the feasibility of a clinic-based Epi-PrEP implementation pilot project for 50 MSM (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: emtricitabine/tenofovir, Behavioral: CBT-based counselingGiven emtricitabine/tenofovir for 2-3 weeks. Brief CBT-based counseling to promote PrEP adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identify as MSM: (1) born male who (2) has sex with men
- Age: 18 or older
- Sexual Risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months.
- Vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event.
- Able and willing to provide informed consent
Key exclusion criteria (7 listed)
- HIV positive
- Glomerular filtration rate < 60 mL/min (calculated using the Cockcroft-Gault formula)
- Hepatitis B surface antigen positive
- Symptoms suggestive of acute HIV seroconversion at screening or enrollment
- Have used PrEP or PEP within the previous 3 months
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 |
|---|---|---|
| emtricitabine/tenofovirAlso: TruvadaShort-term episodic use for 2-3 weeks. | Drug | Intervention |
| CBT-based counselingBrief CBT-based counseling to promote adherence | Behavioural | Intervention |
Primary outcome
Number of Participants With PrEP Adherence
Time frame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32692109Egan JE, Ho K, Stall R, Drucker MT, Tappin R, Hendrix CW, Marzinke MA, Safren SA, Mimiaga MJ, Psaros C, Elsesser S, Mayer KH. Feasibility of Short-Term PrEP Uptake for Men Who Have Sex With Men With Episodic Periods of Increased HIV Risk. J Acquir Immune Defic Syndr. 2020 Aug 15;84(5):508-513. doi: 10.1097/QAI.0000000000002382.
- Individual participant dataSharing planned: Undecided
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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.
Ronald D Stall, PhD, MPH principal investigator
University of Pittsburgh
Kenneth Mayer, MD principal investigator
Fenway Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emtricitabine/tenofovir and CBT-based counseling in people with Human Immunodeficiency Virus, run by James Egan at 2 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 5 inclusion and 7 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 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2019). 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?
Number of Participants With PrEP Adherence (time frame: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)). 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 NCT02495779, 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 27 Mar 2019.