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| ID | Type | Description | Link |
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| 1R01MH138225-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute of Mental Health (NIMH) | NIH |
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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:
Researchers will compare two intervention strategies to see if they result in better PrEP adherence:
Participants will:
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:
Randomization:
Interventions:
Primary and Secondary Outcomes:
Data Collection and Monitoring:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C4 Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 0, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Every 3 months for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Competence for PrEP use | Perceived Competence for PrEP Use Scale will measure participants' confidence in their ability to follow PrEP recommendations. Scores range from 9 to 45, with higher scores reflecting greater competence. | Baseline, 6 months, and 12 months |
| PrEP Use Self-Regulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raquel Ramos, PhD, MBA, MSN, FNYAM, FAHA | Contact | 203-737-2339 | ysn.c4_3mvstudy@yale.edu | |
| LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA | Contact | 203-785-5797 | ysn.c4_3mvstudy@yale.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bronx Health Center | New York | New York | 10035 | United States |
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.
The data will be made available within six months after the publication of the primary study results and will remain accessible for at least five years. The availability period may be extended depending on research needs and ethical guidelines.
Access to the data will be granted to researchers with ethical approval from the Institutional Review Board (IRB). Researchers must submit a request outlining the purpose and intended use of the data, which will be reviewed by the study team. Approved users will be required to sign a Data Use Agreement to ensure the data is used for approved purposes only and that participant privacy is safeguarded.
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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.
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| C4 + 3MV Program | Behavioral | 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. |
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PrEP Use Self-Regulation Questionnaire will assess participants' internalization of autonomous motivation to maintain adherence to PrEP. Scores range from 9 to 45, with higher scores indicating stronger self-regulation. |
| Baseline, 6 months, and 12 months |
| Basic Needs Satisfaction Scale | The Basic Needs Satisfaction Scale (9 items) assesses participants' fulfillment of psychological needs (autonomy, competence, and relatedness) within social relationships, especially from close friends. Scores range from 9 to 45, with higher scores indicating greater satisfaction. | Every 3 months for 12 months |
| Healthcare Climate Questionnaire | The Healthcare Climate Questionnaire (15 items) will measure participants' perception of their healthcare providers' support. Scores range from 15 to 75, with higher scores reflecting a more supportive healthcare environment. | Baseline, 6, and 12 months |
| Depression (PHQ-9) | Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-27. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. | Baseline, 6 months, and 12 months |
| HIV Stigma Scale | Intersectional stigma will be measured across four subscales: Enacted Stigma (10 items) Vicarious Stigma (10 items) Perceived Stigma (10 items) Internalized Stigma (10 items) Each subscale ranges from 10 to 50, with higher scores indicating more stigma experienced. | Baseline, 3, 6, 9, and 12 months |
| Quality Client Perception of Coordination Quality | The Client Perception of Coordination Quality Questionnaire will assess participants' satisfaction with healthcare services. Scores range from 3 to 15, with higher scores indicating better care coordination. | Baseline, 6 months, and 12 months |
| Abounding Prosperity, Inc. | Dallas | Texas | 06477 | United States |
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