Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056544
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-09-05
Brief Title:
Client-Centered Care Coordination for Black Men Who Have Sex With Men
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Randomized Clinical Trial of Client-centered Care Coordination to Improve Preexposure Prophylaxis Use for Black Men Who Have Sex With Men
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Determine the efficacy of C4 for increasing PrEP adherence among Black MSM
2 Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence
3 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 ie 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
1 Determine the efficacy of C4 for increasing PrEP adherence among Black MSM
2 Identify the optimal dose of C4 implementation for maximizing its effect on PrEP adherence
3 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH134721 | NIH | None | httpsreporternihgovquickSearch1R01MH134721 |