PrEP UptakeNCT03137342
Pepped on Pre-exposure Prophylaxis (PrEP): A Counseling and Problem-Solving PrEP Adherence Intervention for Stimulant Using Men Who Have Sex With Men (MSM).
A study testing Pepped on PrEP Package in people with PrEP Uptake and Stimulant Abuse, run by Brown University at 1 site in United States.
Trial summary
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PrEP Uptake, Stimulant Abuse, Adherence, Medication
- What is being tested?
- Pepped on PrEP Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Sex: assigned male sex at birth
- Self-reports having sex with another man in the past month while using stimulants
- Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
- Not currently prescribed PrEP at initial visit
- Able to speak and understand English (for consenting and counseling)
- Lives in New England
Who cannot join
- 1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02903
About this study
Official title: Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
Read the detailed description
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
- Conditions
- PrEP Uptake, Stimulant Abuse, Adherence, Medication
- Being tested
- Pepped on PrEP Package
- Keywords
- PrEP, Adherence, Risk Reduction, Stimulant Use
- Medical subject headings
- Medication Adherence, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pepped on PrEP PackageBehavioural
A counseling and problem-solving adherence intervention with a Behavioral Activation approach to re-engage participants in safe but pleasurable activities in life and addresses stimulant abuse as well as associated factors, including depression, as barriers to optimal PrEP adherence.
| Study group | Role | What they receive |
|---|---|---|
| Pepped on PrEP | Experimental | Using an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist. Some individuals may require a more intensive approach. These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors. Receives: Behavioral: Pepped on PrEP Package |
| Standard of Care | No intervention | PrEP adherence counseling from the Miriam Hospital PrEP Clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake
>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Measured: Baseline Stage 2
Improve rate of PrEP adherence
Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence .
Measured: Daily beginning at Stage 2 Baseline up to the four month assessment visit
Improve rate of PrEP adherence
Self report adherence to assess for change in adherence.
Measured: Baseline Stage 2 and four month assessment
Secondary outcomes (2)
Reduce Unsafe Sex
Self report sexual history to assess for change in sexual risk.
Measured: Baseline Stage 1,Baseline Stage 2 and four month assessment
Reduce Stimulant Use
Self report stimulant use to assess for change in drug use.
Measured: Baseline Stage 1,Baseline Stage 2 and four month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 May 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP UptakeStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Intervention Condition: Pepped-for-PrEP intervention counseling plus standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital Control Condition: only the standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Mimiaga, Brown University
- Investigators
- Matthew J Mimiaga, ScD, MPH, Principal investigator, Brown University, School of Public Health, Center for Health Equity Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137342
- Sponsor's protocol ID
- 1610001629
- Status last verified
- Jul 2018
- First submitted
- 4 Apr 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pepped on Pre-exposure Prophylaxis (PrEP): Pilot-randomized Controlled Trial (RCT) to Assess the Feasibility/Acceptability of the Pepped-for-PrEP Package (Counseling and Problem-solving PrEP Adherence Intervention With Behavioral Activation (BA) Approach) Among Stimulant Abusing MSM.
- ClinicalTrials.gov ID
- NCT03137342
- Acronym / sponsor ID
- 1610001629
- Conditions
- PrEP Uptake, Stimulant Abuse, Adherence, Medication
- Keywords
- PrEP, Adherence, Risk Reduction, Stimulant Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 2 May 2017 (actual)
- 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.
Pepped on PrEP is an innovative pilot RCT designed by an interdisciplinary team to develop a counseling and problem-solving PrEP adherence intervention with a Behavioral Activation (BA) approach that aims to re-engage participants in safe but pleasurable activities in life and addresses stimulant-abuse as well as associated factors including depression, as barriers to optimal PrEP adherence.
Detailed description
Enrolled participants will receive a referral to the Miriam Hospital for standard of care PrEP treatment. Once prescribed PrEP through the Miriam Hospital, the study participants will be randomly assigned to one of two treatment conditions. In the intervention condition, participants will receive a two-stepped intervention which could include up to 10 free BA and risk reduction (RR) counseling sessions. Participants assigned to the comparison condition will receive the standard of care for PrEP treatment at the Miriam Hospital, which includes information about PrEP and how to obtain it, assistance from medical staff in obtaining health insurance for study participants, and information regarding local community resources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Condition: Pepped-for-PrEP intervention counseling plus standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital Control Condition: only the standard of care adherence counseling as part of their PrEP related care via The Miriam Hospital.
| Arm | Type | Receives |
|---|---|---|
| Pepped on PrEP | Experimental | Behavioral: Pepped on PrEP PackageUsing an efficient stepped care ("adaptive") model, all participants will receive three sessions of PrEP-STEPS counseling for PrEP adherence delivered by a Masters-level or above therapist. Some individuals may require a more intensive approach. These participants will receive an additional seven counseling sessions of behavioral activation with integrated cognitive behavioral therapy (CBT) designed to reduce stimulant use and promote positive behaviors. |
| Standard of Care | No intervention | –PrEP adherence counseling from the Miriam Hospital PrEP Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years or older
- Sex: assigned male sex at birth
- Self-reports having sex with another man in the past month while using stimulants
- Self-reports behavioral risk for HIV infection (consistent with the Center for Disease Control guidelines) for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the preceding six months)
- Not currently prescribed PrEP at initial visit
Key exclusion criteria (1 listed)
- 1.) Potential participants unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate.
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 |
|---|---|---|
| Pepped on PrEP PackageA counseling and problem-solving adherence intervention with a Behavioral Activation approach to re-engage participants in safe but pleasurable activities in life and addresses stimulant abuse as well as associated factors, including depression, as barriers to optimal PrEP adherence. | Behavioural | Pepped on PrEP |
Primary outcome
PrEP Uptake
Time frame: Baseline Stage 2
>80% of participants who complete Stage 1 baseline and report PrEP initiation (verified by prescription) will progress to Stage 2 Baseline.
Improve rate of PrEP adherence
Time frame: Daily beginning at Stage 2 Baseline up to the four month assessment visit
Wisepill electronic pill dispenser will monitor when the pill dispenser is opened to measure medication adherence .
Improve rate of PrEP adherence
Time frame: Baseline Stage 2 and four month assessment
Self report adherence to assess for change in adherence.
2 secondary outcomes
Reduce Unsafe Sex
Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment
Reduce Stimulant Use
Time frame: Baseline Stage 1,Baseline Stage 2 and four month assessment
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 11 Jul 2018.
- Individual participant dataSharing planned: Yes
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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.
Matthew J Mimiaga, ScD, MPH principal investigator
Brown University, School of Public Health, Center for Health Equity Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pepped on PrEP Package in people with PrEP Uptake and Stimulant Abuse, run by Brown University 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 7 inclusion and 1 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 11 Jul 2018. 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 Uptake (time frame: Baseline Stage 2). The study lists 3 primary outcomes in all. 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 11 Jul 2018.