Implantable Long-Acting Pre-Exposure Prophylaxis For MSM

Status Not yet recruiting

Clinical Trial Summary

The long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable PrEP (LA-PrEP) products in the future and identify the training needs of physicians. This project specifically focuses on men who have sex with men (MSM) seen in primary care settings in Texas. The main objective of this project is to examine perspectives of MSM and physicians in Texas regarding LA-PrEP, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices.

Clinical Trial Description

The long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable PrEP (LA-PrEP) products and identify the training needs of physicians. This project is based on the hypothesis that specific barriers to uptake of LA-PrEP may exist that must be addressed to support widespread implementation in primary care settings in the future. Primary care settings are the ideal setting for new PrEP medications that employ innovative strategies for use, including implantable formulations, particularly among men who have sex with men (MSM). Primary care settings have demonstrated acceptability for other implantable medications, and similar strategies may be helpful for uptake of PrEP. However, new training and strategies will be needed for physicians to use this type of product with their patients should it become available. At this time, little is known about physician willingness to do the procedures required to insert the implant and what training will be needed. In particular, it is important to assess what training may be needed to effectively engage in health conversations with MSM patients. Thus, the main objective of this project is as follows: To examine perspectives of MSM (n=50) and physicians (n=20) in Texas regarding LA-PrEP, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices. ;

Study Design

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT05420207
Study type	Observational
Source	University of Kentucky
Contact	Elizabeth Arnold, PhD
Phone	(859)562-3751
Email	Liz.Arnold@uky.edu
Status	Not yet recruiting
Phase
Start date	April 2024
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03411577` - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program	N/A
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
Active, not recruiting	`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
Active, not recruiting	`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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.