PreventionP4WNCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

A study testing Stage 1 Strength Based Case Management (SBCM) Condition and Stage 2 PrEPare for Work Intervention Condition in people with Prevention, run by Brown University at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among 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?: Stage 1 Strength Based Case Management (SBCM) Condition and Stage 2 PrEPare for Work Intervention Condition
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 5 sitesUnited States
Study dates: 3 Nov 2022to Aug 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Age: 18 years or older
Assigned male sex at birth
Identifies as male at enrollment
Report having engaged in condomless anal sex with another man in the past 3 months
Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months
Report HIV status as negative or unsure
Not currently on PrEP
Able to understand and speak English or Spanish

Who cannot join

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)
Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)
Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)
Participated in the pilot RCT and initiated PrEP during study participation

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

UCLA Fielding School of Public Health
Los Angeles, California, 90095
The Miriam Hospital
Providence, Rhode Island, 02906
Open Door Health
Providence, Rhode Island, 02907
Project Weber/RENEW
Providence, Rhode Island, 02907
Brown University School of Public Health
Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design

Read the detailed description

A theory-based, manualized intervention -called "PrEPare for Work"-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal \& structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.

Conditions: Prevention
Being tested: Stage 1 Strength Based Case Management (SBCM) Condition, Stage 2 PrEPare for Work Intervention Condition
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.

Stage 1 Strength Based Case Management (SBCM) ConditionBehavioural
Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 2 PrEPare for Work Intervention ConditionBehavioural
Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Study groups in NCT05736614
Study group	Role	What they receive
Stage 1 Standard of Care (SOC) Control Condition	No intervention	SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.
Stage 1 Strength Based Case Management (SBCM) Condition	Experimental	Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment. Receives: Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition
Stage 2 SOC Control Condition	No intervention	Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care.
Stage 2 PrEPare for Work Intervention Condition	Experimental	Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist. Receives: Behavioral: Stage 2 PrEPare for Work Intervention Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage one: PrEP initiation
Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report.
Measured: 2-month post Stage 1 randomization
Stage two: PrEP adherence
Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.
Measured: 12-month post Stage 2 randomization

Secondary outcomes (1)

PrEP persistence
PrEP persistence will be measured via medical records and self-report. We will assess PrEP persistence using medical and pharmacy records to confirm provider follow-up visits and prescription refill maintenance. As per Coy et al., PrEP persistence will be defined as having ≥16 days of PrEP medication filled per 30-day period, for at least three-quarters of the months since initiation to study completion (~9 months).
Measured: 12-month 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.

3 Nov 2022Aug 2027

First posted21 Feb 2023
Study start3 Nov 2022
Primary completionJun 2027 (estimated)
Study completionAug 2027 (estimated)

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 PreventionStudies 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: Parallel groups
Model description: Randomized Controlled Trial (RCT) Study arms: 1. Stage 1 Standard of Care (SOC) Control Condition 2. Stage 1 Strength Based Case Management (SBCM) Condition 3. Stage 2 SOC Control Condition 4. Stage 2 PrEPare for Work Intervention Condition
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05736614
Sponsor's protocol ID: 2001002627
Other IDs: R01NR020227
Acronym: P4W
Status last verified: Oct 2026
First submitted: 8 Feb 2023
Last updated: 13 Oct 2026
Results posted: No
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.

Publications

Biello KB, Chan PA, Ndoye CD, Nelson L, Nelson E, Silva V, Kwak E, Napoleon S, Cormack Orellana C, Richards OG, Davis E, Mimiaga MJ. Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S. BMC Public Health. 2024 Feb 9;24(1):424. doi: 10.1186/s12889-024-17710-y.
PubMed 38336731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
ClinicalTrials.gov ID: NCT05736614
Acronym / sponsor ID: P4W / 2001002627
Conditions: Prevention
Keywords: PrEP, Prevention, Male Sex Workers (MSW)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: The Miriam Hospital, University of California, Los Angeles, Project Weber/RENEW, Open Door Health, National Institute of Nursing Research (NINR)
Study start: 3 Nov 2022 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 21 Feb 2023 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: Randomized Controlled Trial (RCT) Study arms: 1. Stage 1 Standard of Care (SOC) Control Condition 2. Stage 1 Strength Based Case Management (SBCM) Condition 3. Stage 2 SOC Control Condition 4. Stage 2 PrEPare for Work Intervention Condition

Arm	Type	Receives
Stage 1 Standard of Care (SOC) Control Condition	No intervention	–SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.
Stage 1 Strength Based Case Management (SBCM) Condition	Experimental	Behavioral: Stage 1 Strength Based Case Management (SBCM) ConditionIntervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 2 SOC Control Condition	No intervention	–Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care.
Stage 2 PrEPare for Work Intervention Condition	Experimental	Behavioral: Stage 2 PrEPare for Work Intervention ConditionIntervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age: 18 years or older
Assigned male sex at birth
Identifies as male at enrollment
Report having engaged in condomless anal sex with another man in the past 3 months
Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months

Key exclusion criteria (4 listed)

Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)
Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)
Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)
Participated in the pilot RCT and initiated PrEP during study participation

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
Stage 1 Strength Based Case Management (SBCM) ConditionIntervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.	Behavioural	Stage 1 Strength Based Case Management (SBCM) Condition
Stage 2 PrEPare for Work Intervention ConditionIntervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.	Behavioural	Stage 2 PrEPare for Work Intervention Condition

Primary outcome

Stage one: PrEP initiation
Time frame: 2-month post Stage 1 randomization
Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report.
Stage two: PrEP adherence
Time frame: 12-month post Stage 2 randomization
Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.

1 secondary outcome

PrEP persistence
Time frame: 12-month post Stage 2 randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Derived from this study: PubMed 38336731Biello KB, Chan PA, Ndoye CD, Nelson L, Nelson E, Silva V, Kwak E, Napoleon S, Cormack Orellana C, Richards OG, Davis E, Mimiaga MJ. Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S. BMC Public Health. 2024 Feb 9;24(1):424. doi: 10.1186/s12889-024-17710-y.
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

RecruitingPhase 1
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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.

Katie Biello, PhD principal investigator

Brown University School of Public Health

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

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?

Stage one: PrEP initiation (time frame: 2-month post Stage 1 randomization). The study lists 2 primary outcomes in all. 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 NCT05736614, 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 13 Oct 2026.