PreventionNCT03086057
Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
A study testing PrEPare for Work: Strength Based Case Management (Stage 1) and PrEPare for Work: Adherence Training and Counseling (Stage 2) in people with Prevention, run by Brown University at 2 sites in United States.
Trial summary
"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW). 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
- Prevention
- What is being tested?
- PrEPare for Work: Strength Based Case Management (Stage 1) and PrEPare for Work: Adherence Training and Counseling (Stage 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 15 Dec 2019
- 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
- 18 years of age or older
- Biological male at birth and current male gender identity
- Exchanged sex for money or drugs with another man in the past 3 months
- Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
- HIV uninfected by antibody test* Stage 2
- Able to understand and speak English (for consent and counseling)
Show all 9Show fewer
- Mental competency to provide voluntary informed consent
- Lives in the New England area
- Willing to initiate PrEP
Who cannot join
- Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
- HIV Positive at baseline
- Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate < 50) *Stage 2
- History of or current medical conditions that would preclude taking Truvada for PrEP *Stage 2
- Currently taking Truvada for PrEP
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Miriam Hospital
Providence, Rhode Island, 02906
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
Official title: Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design
"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
Read the detailed description
The "PrEPare for Work" package includes two behavioral intervention components:
- Strengths-based case management for PrEP initiation, and
- Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.
Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.
- Conditions
- Prevention
- Being tested
- PrEPare for Work: Strength Based Case Management (Stage 1), PrEPare for Work: Adherence Training and Counseling (Stage 2)
- Keywords
- PrEP, Prevention, Male Sex Workers (MSW)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPare for Work: Strength Based Case Management (Stage 1)Behavioural
Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
PrEPare for Work: Adherence Training and Counseling (Stage 2)Behavioural
Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Strength Based Case Management | Experimental | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. Receives: Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1) |
| PrEP adherence training and counseling | Experimental | Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. Receives: Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2) |
| Standard of Care:Stage 1 | No intervention | Stage 1: Referral to The Miriam Hospital PrEP Clinic. |
| Standard of Care: Stage 2 | No intervention | Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records
Measured: 2-month post Stage 1 randomization
Number of Participants Who Initiated PrEP
Initial prescription from provider filled and shown to study staff
Measured: 2-month post Stage 1 randomization
Number of Participants Reporting Optimal PrEP Adherence
Self-reporting missing 0 PrEP pills in the past week
Measured: 6-months post Stage 2 randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 May 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Model description
- In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital
- 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
- NCT03086057
- Sponsor's protocol ID
- 1R34MH110369-01
- Status last verified
- Feb 2021
- First submitted
- 8 Mar 2017
- Last updated
- 15 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design
- ClinicalTrials.gov ID
- NCT03086057
- Acronym / sponsor ID
- 1R34MH110369-01
- Conditions
- Prevention
- Keywords
- PrEP, Prevention, Male Sex Workers (MSW)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- The Miriam Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).
Detailed description
The "PrEPare for Work" package includes two behavioral intervention components:
- Strengths-based case management for PrEP initiation, and
- Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.
Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.
| Arm | Type | Receives |
|---|---|---|
| Strength Based Case Management | Experimental | Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1)Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. |
| PrEP adherence training and counseling | Experimental | Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2)Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. |
| Standard of Care:Stage 1 | No intervention | –Stage 1: Referral to The Miriam Hospital PrEP Clinic. |
| Standard of Care: Stage 2 | No intervention | –Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Biological male at birth and current male gender identity
- Exchanged sex for money or drugs with another man in the past 3 months
- Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
- HIV uninfected by antibody test* Stage 2
Key exclusion criteria (5 listed)
- Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
- HIV Positive at baseline
- Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate < 50) *Stage 2
- History of or current medical conditions that would preclude taking Truvada for PrEP *Stage 2
- Currently taking Truvada for PrEP
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 |
|---|---|---|
| PrEPare for Work: Strength Based Case Management (Stage 1)Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. | Behavioural | Strength Based Case Management |
| PrEPare for Work: Adherence Training and Counseling (Stage 2)Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. | Behavioural | PrEP adherence training and counseling |
Primary outcome
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
Time frame: 2-month post Stage 1 randomization
Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records
Number of Participants Who Initiated PrEP
Time frame: 2-month post Stage 1 randomization
Initial prescription from provider filled and shown to study staff
Number of Participants Reporting Optimal PrEP Adherence
Time frame: 6-months post Stage 2 randomization
Self-reporting missing 0 PrEP pills in the past week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
Related trials for Prevention
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEPare for Work: Strength Based Case Management (Stage 1) and PrEPare for Work: Adherence Training and Counseling (Stage 2) in people with Prevention, run by Brown University 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 9 inclusion and 5 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 15 Mar 2021. 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 15 Mar 2021). 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 Verified Attendance at Initial Appointment at PrEP Clinic (time frame: 2-month post Stage 1 randomization). 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 15 Mar 2021.