HIV PreventionC4+3MVNCT06661343
Pre-exposure Prophylaxis (PrEP) Adherence for Black MSM
A study testing C4 Program and C4 + 3MV Program in people with HIV Prevention, run by Yale University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time. 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
- What is being tested?
- C4 Program and C4 + 3MV Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 30 Jun 2029
- 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
- Self-identify as male.
- Self-Identify as Black people.
- Aged 18 or older.
- Self Report having sex with men in the past 6 months.
- Eligible for PrEP or currently prescribed PrEP.
- Willing to participate in behavioral intervention sessions.
Who cannot join
- Currently diagnosed with HIV.
- Unable to provide informed consent.
- Unable to fully engage with the intervention due to health issues.
- Participating in another clinical trial with conflicting outcomes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Abounding Prosperity, Inc.
Dallas, Texas, 06477
3MVCare Study Team, ysn.c4_3mvstudy@yale.edu
Bronx Health Center
New York, New York, 10035
3MVCare Team, ysn.c4_3mvstudy@yale.edu
About this study
Official title: A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time.
The main questions it aims to answer are:
Read more
- Does the C4 program help participants take PrEP more regularly?
- Does adding the 3MV intervention to C4 provide additional support for adherence?
Researchers will compare two intervention strategies to see if they result in better PrEP adherence:
- C4 Intervention: A program focused on individualized care coordination and addressing structural needs.
- C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions.
Participants will:
- Participate in PrEP education and counseling sessions.
- Have their PrEP use monitored through dried blood spot (DBS) tests.
- Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.
Read the detailed description
This clinical trial aims to evaluate two intervention strategies-C4 and C4 + 3MV-to improve adherence to PrEP (pre-exposure prophylaxis) among Black men who have sex with men (MSM) in two metropolitan areas: Dallas/Fort Worth and New York City. The study addresses structural and behavioral barriers to PrEP adherence, aiming to reduce disparities in HIV prevention efforts.
Study Design and Methodology:
- Trial Type: Multi-site, staircase stepped-wedge randomized controlled trial (RCT)
- Duration: 24 months total, with 9-month intervention periods for each group
- Participants: 500 participants (Texas n=150 and NYC n=350); Participants are recruited from community-based organizations and through network-based referrals
Randomization:
- 48 networks will be randomized into 8 sequences.
- Each network will experience a 3-month control period, followed by either the C4 intervention or the C4 + 3MV intervention.
Interventions:
- C4 Intervention: Focuses on care coordination, addressing participants' needs related to healthcare access, stigma, and mental health services. Uses individualized care plans and support systems to facilitate adherence.
- C4 + 3MV Intervention: Incorporates both care coordination and the 3MV (Many Men, Many Voices) behavioral change program. 3MV focuses on reducing stigma, promoting safe behaviors, and improving self-efficacy through group sessions.
Primary and Secondary Outcomes:
- Primary Outcome: PrEP adherence, measured through dried blood spot (DBS) assays to assess drug levels over time.
- Secondary Outcomes: Changes in HIV-related health-seeking behavior (e.g., frequency of HIV testing); Autonomy and social support, measured through validated scales; Reduction in stigma and mental health improvements
Data Collection and Monitoring:
- Data will be collected at multiple points using questionnaires, DBS tests, and counseling session evaluations.
- A Learn-as-You-Go (LAGO) adaptive analysis will be conducted every 6 months to optimize intervention delivery.
- Conditions
- HIV Prevention
- Being tested
- C4 Program, C4 + 3MV Program
- Keywords
- HIV, PrEP, Black MSM, Stigma Reduction, Client Centered Care Coordination, Many Men Many Voices, Evidence-based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C4 ProgramBehavioural
Also called Client Centered Care Coordination
The C4 intervention is a behavioral program designed to provide care coordination to address structural barriers to PrEP adherence among Black men who have sex with men (MSM). It includes personalized support services, focusing on healthcare access, mental health, and stigma reduction to promote consistent PrEP use. Participants will receive counseling sessions and follow-ups based on their individual needs.
C4 + 3MV ProgramBehavioural
Also called Many Men Many Voices and Client Centered Care Coordination Integrated Intervention
This intervention combines the C4 care coordination with the 3MV behavioral program. The 3MV program focuses on behavior change, addressing self-efficacy, stigma, and promoting healthy practices. Through this combination, participants receive both structural and behavioral support to maximize their adherence to PrEP.
| Study group | Role | What they receive |
|---|---|---|
| C4 Intervention | Experimental | Participants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests. Receives: Behavioral: C4 Program |
| C4 + 3MV Intervention | Experimental | Participants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence. Receives: Behavioral: C4 + 3MV Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP adherence- self report
PrEP adherence will be assessed through self-report. Self-reported adherence is measured by doses taken in the past 30 days, with fewer missed doses indicating higher adherence.
Measured: 0, 3, 6, 9, 12 months
PrEP adherence- biomarker validation
PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level >700 fmol/punch confirms adherence.
Measured: 0, 6, and 12 months
Secondary outcomes (1)
HIV Testing Frequency
HIV testing frequency will be assessed by the number of tests taken in the past 90 days, with more tests indicating higher engagement in testing
Measured: Every 3 months for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Jun 2029 (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.
- More trials run by Yale 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
- Sequential
- Model description
- This study uses a stepped-wedge cluster randomized trial. Participants from multiple networks are introduced to the intervention in a sequential manner, with each cluster beginning in a control phase and transitioning into one of two intervention phases over time. This design allows for comparison between groups while also ensuring all participants eventually receive the intervention.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661343
- Sponsor's protocol ID
- 2000037790
- Other IDs
- 1R01MH138225-01
- Acronym
- C4+3MV
- Status last verified
- May 2026
- First submitted
- 24 Oct 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators plan to share de-identified participant data, including information on PrEP usage, behavioral intervention participation, survey responses, and biological specimen results (e.g., dried blood spot test results). The shared data will support future research on HIV prevention and PrEP adherence, ensuring participant privacy throughout the process.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Level Integrated Strategy to Optimize PrEP Adherence for Black MSM and Accelerate Implementation at Scale
- ClinicalTrials.gov ID
- NCT06661343
- Acronym / sponsor ID
- C4+3MV / 2000037790
- Conditions
- HIV Prevention
- Keywords
- HIV, PrEP, Black MSM, Stigma Reduction, Client Centered Care Coordination, Many Men Many Voices, Evidence-based Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 28 Oct 2024 (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 learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time.
The main questions it aims to answer are:
- Does the C4 program help participants take PrEP more regularly?
- Does adding the 3MV intervention to C4 provide additional support for adherence?
Researchers will compare two intervention strategies to see if they result in better PrEP adherence:
- C4 Intervention: A program focused on individualized care coordination and addressing structural needs.
- C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions.
Participants will:
- Participate in PrEP education and counseling sessions.
- Have their PrEP use monitored through dried blood spot (DBS) tests.
- Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.
Detailed description
This clinical trial aims to evaluate two intervention strategies-C4 and C4 + 3MV-to improve adherence to PrEP (pre-exposure prophylaxis) among Black men who have sex with men (MSM) in two metropolitan areas: Dallas/Fort Worth and New York City. The study addresses structural and behavioral barriers to PrEP adherence, aiming to reduce disparities in HIV prevention efforts.
Study Design and Methodology:
- Trial Type: Multi-site, staircase stepped-wedge randomized controlled trial (RCT)
- Duration: 24 months total, with 9-month intervention periods for each group
- Participants: 500 participants (Texas n=150 and NYC n=350); Participants are recruited from community-based organizations and through network-based referrals
Randomization:
- 48 networks will be randomized into 8 sequences.
- Each network will experience a 3-month control period, followed by either the C4 intervention or the C4 + 3MV intervention.
Interventions:
- C4 Intervention: Focuses on care coordination, addressing participants' needs related to healthcare access, stigma, and mental health services. Uses individualized care plans and support systems to facilitate adherence.
- C4 + 3MV Intervention: Incorporates both care coordination and the 3MV (Many Men, Many Voices) behavioral change program. 3MV focuses on reducing stigma, promoting safe behaviors, and improving self-efficacy through group sessions.
Primary and Secondary Outcomes:
- Primary Outcome: PrEP adherence, measured through dried blood spot (DBS) assays to assess drug levels over time.
- Secondary Outcomes: Changes in HIV-related health-seeking behavior (e.g., frequency of HIV testing); Autonomy and social support, measured through validated scales; Reduction in stigma and mental health improvements
Data Collection and Monitoring:
- Data will be collected at multiple points using questionnaires, DBS tests, and counseling session evaluations.
- A Learn-as-You-Go (LAGO) adaptive analysis will be conducted every 6 months to optimize intervention delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a stepped-wedge cluster randomized trial. Participants from multiple networks are introduced to the intervention in a sequential manner, with each cluster beginning in a control phase and transitioning into one of two intervention phases over time. This design allows for comparison between groups while also ensuring all participants eventually receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| C4 Intervention | Experimental | Behavioral: C4 ProgramParticipants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests. |
| C4 + 3MV Intervention | Experimental | Behavioral: C4 + 3MV ProgramParticipants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as male.
- Self-Identify as Black people.
- Aged 18 or older.
- Self Report having sex with men in the past 6 months.
- Eligible for PrEP or currently prescribed PrEP.
Key exclusion criteria (4 listed)
- Currently diagnosed with HIV.
- Unable to provide informed consent.
- Unable to fully engage with the intervention due to health issues.
- Participating in another clinical trial with conflicting outcomes.
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 |
|---|---|---|
| C4 ProgramAlso: Client Centered Care CoordinationThe C4 intervention is a behavioral program designed to provide care coordination to address structural barriers to PrEP adherence among Black men who have sex with men (MSM). It includes personalized support services, focusing on healthcare access, mental health, and stigma reduction to promote consistent PrEP use. Participants will receive counseling sessions and follow-ups based on their individual needs. | Behavioural | C4 Intervention |
| C4 + 3MV ProgramAlso: Many Men Many Voices and Client Centered Care Coordination Integrated InterventionThis intervention combines the C4 care coordination with the 3MV behavioral program. The 3MV program focuses on behavior change, addressing self-efficacy, stigma, and promoting healthy practices. Through this combination, participants receive both structural and behavioral support to maximize their adherence to PrEP. | Behavioural | C4 + 3MV Intervention |
Primary outcome
PrEP adherence- self report
Time frame: 0, 3, 6, 9, 12 months
PrEP adherence will be assessed through self-report. Self-reported adherence is measured by doses taken in the past 30 days, with fewer missed doses indicating higher adherence.
PrEP adherence- biomarker validation
Time frame: 0, 6, and 12 months
PrEP adherence will be assessed through biomarker validation using dried blood samples. A tenofovir disoproxil fumarate (TFV-DF) level >700 fmol/punch confirms adherence.
1 secondary outcome
HIV Testing Frequency
Time frame: Every 3 months for 12 months
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 18 May 2026.
- Individual participant dataSharing planned: Yes. Investigators plan to share de-identified participant data, including information on PrEP usage, behavioral intervention participation, survey responses, and biological specimen results (e.g., dried blood spot test results). The shared data will support future research on HIV prevention and PrEP adherence, ensuring participant privacy throughout the process.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C4 Program and C4 + 3MV Program in people with HIV Prevention, run by Yale 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 6 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: opening soon, as of the sponsor's last update on 18 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 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?
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?
Contact Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA (203-737-2339, ysn.c4_3mvstudy@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP adherence- self report (time frame: 0, 3, 6, 9, 12 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 18 May 2026.