Medication AdherencePhase 4PrEPareNCT01632397
Pre-exposure Prophylaxis Adherence Intervention for MSM
A Phase 4 study testing CBT-based counseling and Health education and supportive counseling in people with Medication Adherence, run by Fenway Community Health at 1 site in United States.
Trial summary
Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling. 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
- Medication Adherence
- What is being tested?
- CBT-based counseling and Health education and supportive counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2014
- Phase
- Phase 4
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male sex at birth
- being 18 years old or older
- testing HIV-negative at screening
- evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
- medically cleared to take the study drug (ambulatory performance >=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
- able to understand and speak English (for consenting and counseling).
Who cannot join
- participants who are not able to consent due to psychiatric or cognitive concerns
- those who have already been prescribed PrEP
- having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
- receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
- receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
- active alcohol or drug use that would interfere with study participation
- having 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
1 site in 1 country.
About this study
Official title: Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.
- Conditions
- Medication Adherence
- Being tested
- CBT-based counseling, Health education and supportive counseling
- Keywords
- PrEP, HIV, Adherence, MSM, Men having sex with men
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based counselingBehavioural
Cognitive Behavior Therapy for PrEP adherence
Health education and supportive counselingBehavioural
Time matched general supportive therapy of the type commonly available from community therapists.
| Study group | Role | What they receive |
|---|---|---|
| CBT-based counseling | Experimental | Cognitive behavioral based intervention to promote PrEP adherence. Receives: Behavioral: CBT-based counseling |
| Health education and supportive counseling | Active comparator | Time matched supportive counseling Receives: Behavioral: Health education and supportive counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PrEP over time
This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).
Measured: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)
Secondary outcomes (1)
Sexual Risk Compensation
This is primarily a feasiblity RCT. Sexual risk compensation is defined as a potential change in sexual risk taking behaviors (unprotected anal sex). This is measured daily with text message assessments for sexual risk as well as at each study visit with self-report measure(s).
Measured: At each of the 9 study visits spread over up to six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth H. Mayer, MD, Fenway Community Health
- Investigators
- Kenneth Mayer, MD, Principal investigator, Fenway Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632397
- Sponsor's protocol ID
- 1R34MH095584-01
- Acronym
- PrEPare
- Status last verified
- Feb 2016
- First submitted
- 8 May 2012
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
- ClinicalTrials.gov ID
- NCT01632397
- Acronym / sponsor ID
- PrEPare / 1R34MH095584-01
- Conditions
- Medication Adherence
- Keywords
- PrEP, HIV, Adherence, MSM, Men having sex with men
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Jul 2012 (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.
Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-based counseling | Experimental | Behavioral: CBT-based counselingCognitive behavioral based intervention to promote PrEP adherence. |
| Health education and supportive counseling | Active comparator | Behavioral: Health education and supportive counselingTime matched supportive counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male sex at birth
- being 18 years old or older
- testing HIV-negative at screening
- evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
- medically cleared to take the study drug (ambulatory performance >=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
Key exclusion criteria (7 listed)
- participants who are not able to consent due to psychiatric or cognitive concerns
- those who have already been prescribed PrEP
- having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
- receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
- receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
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 |
|---|---|---|
| CBT-based counselingCognitive Behavior Therapy for PrEP adherence | Behavioural | CBT-based counseling |
| Health education and supportive counselingTime matched general supportive therapy of the type commonly available from community therapists. | Behavioural | Health education and supportive counseling |
Primary outcome
Adherence to PrEP over time
Time frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)
This is primarily a feasiblity pilot RCT. However, the primary eventual endpoint is PrEP adherence measured daily via electronic medication adherence monitoring (Wisepill™).
1 secondary outcome
Sexual Risk Compensation
Time frame: At each of the 9 study visits spread over up to six months.
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 9 Feb 2016.
- Related InfoLink provided by the sponsor.
Related trials for Medication Adherence
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Not yet recruiting
Personalized Routine and Habit Integration to Support Medication Management
Medication Adherence
Not yet recruitingObservational study
Antipsychotic Safety and Adherence in Patients With Psychiatric Disorders-An Egyptian Institution-Based Cross-Sectional Study.
Psychiatric Disorder
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruiting
Team-Based Shared Decision-Making Program in Hypertension Control (Healthy Heart - BP Program)
Hypertension (HTN), Blood Pressure
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.
Kenneth Mayer, MD principal investigator
Fenway Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CBT-based counseling and Health education and supportive counseling in people with Medication Adherence, run by Fenway Community Health 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 6 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 9 Feb 2016. 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.
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?
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?
Adherence to PrEP over time (time frame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2016.