Implantable Long-Acting Pre-Exposure Prophylaxis For MSM

NCT05420207 | Completed

• 1 other identifier: 89030
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Prevention

Keywords

Pre Exposure Prophylaxis; HIV; MSM; Primary Care

Outcome Measures

Primary Outcomes (9)

• Patient readiness to use LA-PrEP assessed via patient interview

  Patient readiness to use Long-Acting, implantable Pre-exposure prophylaxis (LA-PrEP) is assessed via interview asking men who have sex with men (MSM) patients to respond to the following question: There may be opportunities in the future to have access to products that prevent HIV that are long-acting (LA) and are implanted under the skin. What are your thoughts on using this type of product if it becomes available for use? This is a qualitative measure and will report the summary of responses.

  Baseline

• Patient readiness to use LA-PrEP as measured by a 10-item investigator developed questionnaire

  Patient readiness to use LA-PrEP is measured by a 10-item investigator developed questionnaire where participants will be asked to rate the importance of 10 items regarding their readiness to use implantable long-acting PrEP on a scale of 1-10. Each item will be rated on a scale of 1-10. The mean for each item will be reported. Higher score is higher readiness.

  Baseline

• Facilitators to LA-PrEP uptake and adherence assessed via patient interview

  Facilitators to LA-PrEP uptake and adherence is assessed by asking questions to MSM patients via an interview which will include 3 questions on the following: 1. Likeliness of using a long-acting HIV prevention subdermal implant that is implanted under the skin if it were available. 2. Recommended strategies to help increase uptake of LA-PrEP among MSM patients in primary care. 3. Perceptions on what physicians can do to increase uptake of LA-PrEP should it become available. This is a qualitative measure and will report the summary of responses.

  Baseline

• PrEP Stigma in both cohorts (MSM patients and primary care physicians)

  PrEP Stigma in both cohorts (MSM patients and MSM physicians) is measured by the PrEP stigma and positive attitude scale. The PrEP stigma scale is assessed by 7 questions in both cohorts (MSM patients and physicians). Possible scores range from 1-5 where higher score indicates higher levels of stigma. Scores will be calculated by using the mean score of all items for the factor.

  Baseline

• Positive Attitudes towards PrEP in both cohorts (MSM patients and primary care physicians)

  Positive Attitudes towards PrEP in both cohorts (MSM patients and MSM physicians) is measured by the PrEP stigma and positive attitude scale. The Positive Attitudes towards PrEP scale is assessed by 3 questions in both cohorts (MSM patients and physicians). Possible scores range from 1-5 where higher scores indicate more positive attitudes. Scores will be calculated by using the mean score of all items for the factor.

  Baseline

• Physician comfort with PrEP Clinical Activities as measured by an adapted scale (Petroll and colleagues)

  Physician comfort with PrEP Clinical Activities is measured by an adapted scale (Petroll and colleagues) that includes rating their comfort level regarding 11 clinical activities using a scale of 1-5 where 1 is "completely uncomfortable" and 5 is "completely comfortable." We will sum the total score.

  Baseline

• Facilitators to LA-PrEP uptake and adherence assessed via physicians' interview

  Facilitators to LA-PrEP uptake and adherence is assessed by asking questions to physicians via an interview which will include 2 questions on the following: 1. What would make it easier or more likely you would use an implantable form of PrEP with patients who are gay or bisexual men ? 2. What would make it easier to implement use of a LA subdermal HIV prevention implant in your practice and why? This is a qualitative measure and will report the summary of responses.

  Baseline

• Physician Training Needs as assessed via physician interview

  Physician Training Needs are assessed via physician interview that will include 2 questions asking the type of training required to prepare physicians - 1. to discuss LA-PrEP with patients, and, 2. to insert an LA-PrEP implant and remove it This is a qualitative measure and will report the summary of responses.

  Baseline

• Physician Training Needs rating as measured by investigator developed scale

  Physician Training Needs rating is measured by an investigator developed scale of 1-10 where participants will be asked to rate how helpful would it be to include 10 specific types of content in a training on long acting implantable PrEP. The mean rating for each item will be reported. Possible scores range from 1-10 where higher scores indicate higher levels of perceived helpfulness.

  Baseline

Study Arms (2)

MSM patients

Other: No intervention

Physician treating MSM patients

Other: No intervention

Interventions

No intervention OTHER

No intervention included

MSM patients; Physician treating MSM patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: To enroll, participants must be assigned male sex a birth and have had one or more sexual partners in the past year (patients only)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Patients must meet the following criteria:
• 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;
• be aged 18-45;
• be assigned male sex at birth and report having one or more male sexual partners in the past year; and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elizabeth Arnold: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Dell Medical School, UT-Austin

Austin, Texas, 78712, United States

Location

Study Officials

• Elizabeth Arnold, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: June 14, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)