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Client-Centered Care Coordination for HIV Prevention

This study is testing a new approach called Client-Centered Care Coordination (C4) to help Black men who have sex with men (MSM) stick to their PrEP (pre-exposure prophylaxis) medication. PrEP is a medicine that helps prevent HIV. The study wants to see if C4 can improve how well participants take their PrEP. You might be able to join if you are a Black, African American, Black African, Afro-Caribbean, or Black-Latino cisgender man, at least 18 years old, who is new to PrEP or stopped taking it early, and has not been diagnosed with HIV. The study will measure how well participants take their PrEP at 6, 12, and 18 months. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 350 participants. Participants will be randomly assigned to receive either the C4 intervention or standard care for PrEP.
What's involved
During initial C4 sessions, participants will be offered PrEP and receive an individualized PrEP initiation plan. Subsequent C4 sessions will review prevention plans and goals.
Compensation
Not stated in the trial record.
Follow-up
PrEP adherence will be measured at 6, 12, and 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06056544

Client-Centered Care Coordination for Black Men Who Have Sex With Men

Enrolling by Invitation
NAAges 18+InterventionalPrevention
University of Maryland, Baltimore
~350 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Client Centered Care Coordination

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PrEP Adherence
Measured over 6, 12, 18 months
+1 more outcome measured

Conditions

HIV Prevention
HIV Pre-exposure Prophylaxis

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Pre-exposure prophylaxisStroke prevention

Where it's being run

1 sites across 1 states
District of Columbia1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age of 18 years of age
Identify as Black, African American, Black African, Afro-Caribbean, or Black-Latino
Cisgender male
PrEP naïve or who prematurely stopped PrEP
No prior HIV diagnosis confirmed through HIV testing
Self-reported high risk for acquiring HIV
Currently not enrolled in another HIV prevention study

Exclusion

Black MSM who received a reactive or positive HIV test at screening or self report HIV-positive
Identifying as transgender
Current participation in any research study via self-report
Use of PrEP or post-exposure prophylaxis in the last 60 days prior to anticipated enrollment

What this trial measures

  • PrEP Adherence6, 12, 18 months

    Count of doses of PrEP missed in the last 30 days by self report

  • PrEP Adherence6, 12, 18 months

    Number of participants with the following levels of PrEP using dried blood spots analyzing peripheral blood mononuclear cells (PBMCs) and plasma concentration assay for tenofovir-diphosphate (TDF), tenofovir alafenamide(TAF), lenavapavir, and cabotegravir. The drug assays with lower limit of quantification (LLoQ) are: Oral TAF/TDF Plasma: 1.0 ng/mL DBS: 0.3 ng/mL Injectables: CAB Plasma: 25 ng/mL (standard) DBS: 10 ng/mL (sensitive); 25 ng/mL (standard) Injectables: LEN Plasma: 0.5 ng/mL DBS: 1.0 ng/mL