Implantable Long-Acting Pre-Exposure Prophylaxis For MSM

NCT ID: NCT05420207

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-14
• Study Completion Date: 2025-09-05

Brief 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.

Detailed 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.

Conditions

HIV Prevention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MSM patients

No intervention

Intervention Type: OTHER

No intervention included

Physician treating MSM patients

No intervention

Intervention Type: OTHER

No intervention included

Interventions

No intervention

No intervention included

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must meet the following criteria:

1. be a patient of one of the practices where physicians have agreed to participate or have been seen for a primary care visit in the past 12 months in the Dallas Austin, or San Antonio metro areas;

2. be aged 18-45;

3. be assigned male sex at birth and report having one or more male sexual partners in the past year; and

4. be HIV negative.

• Physicians who are interested in participating must be a practicing primary care physician in the Dallas, San Antonio, or Austin metropolitan area and be willing to allow recruitment of patient participants from their practice.

Exclusion Criteria

• Those individuals who speak a language other than English or Spanish will be excluded as well as those who present with a cognitive or other impairment that would prevent them for consenting to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Elizabeth Arnold

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Arnold

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elizabeth Arnold, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Dell Medical School, UT-Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

89030

Identifier Type: -

Identifier Source: org_study_id