Clinical trial NCT05420207: Implantable Long-Acting Pre-Exposure Prophylaxis For MSM
Official title: Implantable Long-Acting Pre-Exposure Prophylaxis for HIV Prevention With MSM: A Qualitative Study of Patient and Physician Perspectives
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Prevention
Keywords: Pre Exposure Prophylaxis
HIV
MSM
Primary Care
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: University of Texas at Austin
First posted: 2022-06-15
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Includes 2 cohorts :

1. Patients: Men who have sex with men (MSM) seen in primary care settings in Texas.
2. Physicians: Primary care physicians in Texas.

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.

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.

Primary outcomes:
measure: Patient readiness to use LA-PrEP assessed via patient interview
timeFrame: Baseline
measure: Patient readiness to use LA-PrEP as measured by a 10-item investigator developed questionnaire
timeFrame: Baseline
measure: Facilitators to LA-PrEP uptake and adherence assessed via patient interview
timeFrame: Baseline
measure: PrEP Stigma in both cohorts (MSM patients and primary care physicians)
timeFrame: Baseline
measure: Positive Attitudes towards PrEP in both cohorts (MSM patients and primary care physicians)
timeFrame: Baseline
measure: Physician comfort with PrEP Clinical Activities as measured by an adapted scale (Petroll and colleagues)
timeFrame: Baseline
measure: Facilitators to LA-PrEP uptake and adherence assessed via physicians' interview
timeFrame: Baseline
measure: Physician Training Needs as assessed via physician interview
timeFrame: Baseline
measure: Physician Training Needs rating as measured by investigator developed scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Austin
country: United States
facility: Dell Medical School, UT-Austin
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Kentucky
name: Elizabeth Arnold, PhD
role: PRINCIPAL_INVESTIGATOR
References: