HIV PreventionNCT05420207
Implantable Long-Acting Pre-Exposure Prophylaxis For MSM
An observational study of HIV Prevention, run by Elizabeth Arnold at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- HIV Prevention
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2024to 5 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dell Medical School, UT-Austin
Austin, Texas, 78712
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Implantable Long-Acting Pre-Exposure Prophylaxis for HIV Prevention With MSM: A Qualitative Study of Patient and Physician Perspectives
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.
Read the 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
- Being tested
- No intervention
- Keywords
- Pre Exposure Prophylaxis, HIV, MSM, Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention included
| Study group | Role | What they receive |
|---|---|---|
| MSM patients | Not described Receives: Other: No intervention | |
| Physician treating MSM patients | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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:
- Likeliness of using a long-acting HIV prevention subdermal implant that is implanted under the skin if it were available.
- Recommended strategies to help increase uptake of LA-PrEP among MSM patients in primary care.
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- What would make it easier or more likely you would use an implantable form of PrEP with patients who are gay or bisexual men ?
- 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.
Measured: 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 -
- to discuss LA-PrEP with patients, and,
- to insert an LA-PrEP implant and remove it
This is a qualitative measure and will report the summary of responses.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start14 Jun 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Arnold
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Elizabeth Arnold, University of Kentucky
- Investigators
- Elizabeth Arnold, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420207
- Sponsor's protocol ID
- 89030
- Status last verified
- Oct 2025
- First submitted
- 10 Jun 2022
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Long-Acting Pre-Exposure Prophylaxis for HIV Prevention With MSM: A Qualitative Study of Patient and Physician Perspectives
- ClinicalTrials.gov ID
- NCT05420207
- Acronym / sponsor ID
- 89030
- Conditions
- HIV Prevention
- Keywords
- Pre Exposure Prophylaxis, HIV, MSM, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Elizabeth ArnoldUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSM patients | – | Other: No intervention |
| Physician treating MSM patients | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Patients must meet the following criteria:
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention included | Other | MSM patients, Physician treating MSM patients |
Primary outcome
Patient readiness to use LA-PrEP assessed via patient interview
Time frame: Baseline
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.
Patient readiness to use LA-PrEP as measured by a 10-item investigator developed questionnaire
Time frame: Baseline
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.
Facilitators to LA-PrEP uptake and adherence assessed via patient interview
Time frame: Baseline
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.
PrEP Stigma in both cohorts (MSM patients and primary care physicians)
Time frame: Baseline
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.
Positive Attitudes towards PrEP in both cohorts (MSM patients and primary care physicians)
Time frame: Baseline
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.
Physician comfort with PrEP Clinical Activities as measured by an adapted scale (Petroll and colleagues)
Time frame: Baseline
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.
Facilitators to LA-PrEP uptake and adherence assessed via physicians' interview
Time frame: Baseline
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.
Physician Training Needs as assessed via physician interview
Time frame: Baseline
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.
Physician Training Needs rating as measured by investigator developed scale
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Arnold, PhD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Prevention, run by Elizabeth Arnold at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient readiness to use LA-PrEP assessed via patient interview (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.