HIV PreventionNCT06056544
Client-Centered Care Coordination for Black Men Who Have Sex With Men
A study testing Client Centered Care Coordination in people with HIV Prevention and HIV Pre-exposure Prophylaxis, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are: 1. 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
- HIV Prevention, HIV Pre-exposure Prophylaxis
- What is being tested?
- Client Centered Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2025to Aug 2028
- 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Us Helping Us, People Into Living Inc.
Washington D.C., District of Columbia, 20009
About this study
Official title: A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men
The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are:
- Determine the efficacy of C4 for increasing PrEP adherence among Black MSM.
- Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence.
- Describe the acceptability and feasibility of C4 implementation in community settings.
Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis
- Being tested
- Client Centered Care Coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Client Centered Care CoordinationBehavioural
During the initial C4 sessions, participants will be offered PrEP. For participants who initiate PrEP, C4 staff will provide an individualized PrEP initiation plan. During subsequent C4 sessions, C4 staff will review the prevention plan and goals with participants and use autonomy supportive counseling to address the barriers that are identified by participants that impact their motivation to use PrEP and adhere to PrEP through referrals to support services (e.g, PrEP access programs, addiction medicine services, housing, and job resources). In addition, the C4 staff will ensure any medical issues related to PrEP adherence are addressed by the site medical providers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). Receives: Behavioral: Client Centered Care Coordination |
| Control Group | No intervention | Individuals in the control group will receive standard of care for PrEP use at each clinic. The standard of care is PrEP clinical care includes identifying and engaging patients in need of PrEP, conducting necessary exams and lab tests and prescribing PrEP for the patients, as well as ongoing patient monitoring with follow-up visits and prescriptions-for as long as the patient needs PrEP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Adherence
Count of doses of PrEP missed in the last 30 days by self report
Measured: 6, 12, 18 months
PrEP Adherence
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
Measured: 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start21 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Yale University, George Washington University, Us Helping Us, People Into Living, Inc.
- Responsible party
- Principal investigator, Darren L Whitfield, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056544
- Sponsor's protocol ID
- HP-00106408
- Other IDs
- 1R01MH134721
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing ensures the ability of translation of research results into knowledge, research products, and interventions to improve the health of communities. The research team commits to transparency through sharing the data generated by this project. All research data will be shared as requested in accordance with federal regulations and the Freedom of Information Act. The research team anticipates dissemination of results beginning in the 4th year of the award period. Sharing of the findings will involve a primary paper describing the effectiveness of the intervention on pre-exposure prophylaxis (PrEP) use and adherence and secondary papers reporting the qualitative findings and sub-analyses. Study findings will also be shared in the form of scientific and community presentations.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT06056544
- Acronym / sponsor ID
- HP-00106408
- Conditions
- HIV Prevention, HIV Pre-exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Yale University, George Washington University, Us Helping Us, People Into Living, Inc.
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Sep 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.
The goal of this clinical trial is to determine the efficacy of a client-center care coordination intervention (C4) in improving pre-exposure prophylaxis (PrEP) adherence in Black men who have sex with men (MSM). The main aims of the study are:
- Determine the efficacy of C4 for increasing PrEP adherence among Black MSM.
- Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence.
- Describe the acceptability and feasibility of C4 implementation in community settings.
Participants in the clinical trial will be randomized to receive the intervention or standard of care for PrEP in two sites. Researchers will compare administration of C4 to standard of care to see if C4 improves adherence to PrEP. C4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). The intervention pulls from the Centers for Disease Control and Prevention (CDC) Comprehensive Risk Counseling and Services (CRCS) and Self-Determination Theory (SDT) to support client-identified HIV prevention goals to promote, adopt, and maintain PrEP use. CRCS is a public health strategy to assist persons in developing behavioral goals to reduce HIV acquisition and transmission. In this intervention, the HIV prevention plan element of CRCS will be the foundation of the C4 intervention. After the initial prevention plan is developed, elements of SDT will be used to implement a client-centered care approach to assist in addressing issues which many arise which impede successful PrEP adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Client Centered Care CoordinationC4 is a longitudinal intervention which provides individualized client-centered HIV prevention and support services designed to address health and psychosocial needs that impact the success of PrEP use and adherence (i.e., co-morbidities, substance use, mental health, housing, etc.). |
| Control Group | No intervention | –Individuals in the control group will receive standard of care for PrEP use at each clinic. The standard of care is PrEP clinical care includes identifying and engaging patients in need of PrEP, conducting necessary exams and lab tests and prescribing PrEP for the patients, as well as ongoing patient monitoring with follow-up visits and prescriptions-for as long as the patient needs PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Client Centered Care CoordinationDuring the initial C4 sessions, participants will be offered PrEP. For participants who initiate PrEP, C4 staff will provide an individualized PrEP initiation plan. During subsequent C4 sessions, C4 staff will review the prevention plan and goals with participants and use autonomy supportive counseling to address the barriers that are identified by participants that impact their motivation to use PrEP and adhere to PrEP through referrals to support services (e.g, PrEP access programs, addiction medicine services, housing, and job resources). In addition, the C4 staff will ensure any medical issues related to PrEP adherence are addressed by the site medical providers. | Behavioural | Intervention Group |
Primary outcome
PrEP Adherence
Time frame: 6, 12, 18 months
Count of doses of PrEP missed in the last 30 days by self report
PrEP Adherence
Time frame: 6, 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
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 1 May 2026.
- Individual participant dataSharing planned: Yes. Data sharing ensures the ability of translation of research results into knowledge, research products, and interventions to improve the health of communities. The research team commits to transparency through sharing the data generated by this project. All research data will be shared as requested in accordance with federal regulations and the Freedom of Information Act. The research team anticipates dissemination of results beginning in the 4th year of the award period. Sharing of the findings will involve a primary paper describing the effectiveness of the intervention on pre-exposure prophylaxis (PrEP) use and adherence and secondary papers reporting the qualitative findings and sub-analyses. Study findings will also be shared in the form of scientific and community presentations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Client Centered Care Coordination in people with HIV Prevention and HIV Pre-exposure Prophylaxis, run by University of Maryland, Baltimore 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 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: enrolling by invitation, as of the sponsor's last update on 1 May 2026. 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?
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?
PrEP Adherence (time frame: 6, 12, 18 months). 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?
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 1 May 2026.