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

Status Not yet recruiting

Clinical 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. 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 (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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT06056544
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Darren L Whitfield, PhD
Phone	410-706-6340
Email	darren.whitfield@ssw.umaryland.edu
Status	Not yet recruiting
Phase	N/A
Start date	July 2024
Completion date	August 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03411577` - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program	N/A
Active, not recruiting	`NCT03112369` - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use	N/A
Not yet recruiting	`NCT03642314` - HIV Self-testing in Implementation PrEP Study	N/A
Completed	`NCT01810315` - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity	Phase 1
Completed	`NCT00984971` - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet	Phase 1
Completed	`NCT00142935` - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1	N/A
Active, not recruiting	`NCT03255915` - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)	Early Phase 1
Completed	`NCT05037513` - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky	N/A
Recruiting	`NCT05087680` - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South	N/A
Recruiting	`NCT05804461` - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico	N/A
Completed	`NCT03148171` - Project WERK (Wellness Encouragement Respect Kinship)	N/A
Completed	`NCT04791007` - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults	Early Phase 1
Recruiting	`NCT05412433` - Clinic-based HIV Identification and Prevention Project Using Electronic Resources	N/A
Active, not recruiting	`NCT03977181` - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms	N/A
Recruiting	`NCT05165745` - Stick2PrEP Cisgender Women and Trans Individuals	N/A
Completed	`NCT03719053` - Single Dose Truvada Study	Phase 1
Recruiting	`NCT03856580` - Long-acting Biomedical HIV Prevention in Transgender Women	N/A
Completed	`NCT02750540` - Optimization of a Tenofovir Enema for HIV Prevention	Phase 1
Completed	`NCT01386294` - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection	Phase 3
Completed	`NCT00993811` - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention	Phase 1