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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men

Conditions
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HIV Prevention, HIV Pre-exposure Prophylaxis

Intervention / Treatment
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* Behavioral: Client Centered Care Coordination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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.). | Behavioral: Client Centered Care Coordination<br>* 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.<br>|
| No Intervention: Control Group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | Count of doses of PrEP missed in the last 30 days by self report | 6, 12, 18 months | 
| PrEP Adherence | Number of participants with tenofovir-diphosphate (fmol/punch) of greater than 700 using dried blood spots analyzing peripheral blood mononuclear cells (PBMCs) and plasma concentration assay for tenofovir-diphosphate (TFV-DF) and emtricitabine-triphosphate (FTC-TP). | 6, 12, 18 months |