HIV-1-infectionNCT05044286
Longer-Acting PrEP in Transgender and Gender Diverse Texans
An observational study of HIV-1-infection, run by University of Texas at Austin at 1 site in United States.
Trial summary
The long-term goal of this project is to increase uptake and adherence of LA-PrEP in TGD populations in Texas. The central hypothesis is that strategies to increase uptake of LA- PrEP that are patient centered and understand the needs of TGD people will improve uptake and adherence. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- How many people
- 565 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Aug 2023
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Transgender and gender diverse adults living in Texas.
Who may be able to join
None listed.
Who cannot join
- HIV positive,
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: An Observational Study to Understand Acceptability of Long-Acting Pre-Exposure Prophylaxis for HIV-1 Prevention in Transgender and Gender Diverse Populations in Texas
The long-term goal of this project is to increase uptake and adherence of LA-PrEP in TGD populations in Texas. The central hypothesis is that strategies to increase uptake of LA- PrEP that are patient centered and understand the needs of TGD people will improve uptake and adherence. The objective of this observational study is to investigate barriers, facilitators, and preferences regarding willingness and intention to use LA-PrEP in TGD populations in Texas. Data from this study will support future research on patient centered strategies for uptake and adherence of LA-PrEP in TGD populations.
Read the detailed description
Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention strategy that is more than 90% effective in preventing the transmission of HIV. Despite the promise of PrEP in eradicating HIV, uptake has been slow in transgender and gender diverse (TGD) individuals with only 3% of TGD individuals using PrEP. While awareness is a key factor related to PrEP uptake, TGD experience numerous contextual and structural barriers, including discrimination and mistreatment by medical providers, lack of availability and access (e.g., insurance, transportation, time), and broad distrust of the healthcare system that affect intention to use PrEP and reduce uptake. These barriers are further compounded by the social position of TGD people on which they are further stratified based on their race, ethnicity, and socioeconomic status. In addition to contextual and structural factors there are a number of individual factors that limit uptake including fear of side effects, issues with adherence, concerns related to stigma, and lack of trust in the medication's efficacy.
Longer-acting PrEP (LA-PrEP) regimens include different delivery modalities (e.g.. injectable, oral, subdermal implant) with different dosing protocols (e.g. monthly versus daily). There is potential for long-acting biomedical HIV prevention methods to address some of these barriers experienced by TGD individuals. However, to be successful an understanding of attitudes, norms, and other factors influencing LA-PrEP uptake and adherence is needed, specifically among racial and ethnic minority TGD individuals, and their preferences for LA-PrEP delivery. Developing patient-centered strategies for uptake and adherence, using human centered design principles will support uptake and adherence of LA-PrEP in these TGD people.
The investigators will achieve the study objective through the following aims:
Specific Aim 1. Identify factors that influence uptake and adherence of LA- PrEP among TGD individuals in Texas Activities: In collaboration with Transgender Education Network of Texas (TENT) and TransFORWARD: Texas Transgender Health (co-Is), a PCORI funded project in Texas to increase TGD patient-centered outcomes research and comparative effectiveness research capacity in Texas, the research team will recruit 40 TGD individuals to participate in a world café conversation to understand beliefs, attitudes, and preferences for LA-PrEP and interview 20 other relevant key stakeholders (e.g., medical providers, AIDS Service Organizations, TGD advocacy groups) to understand perceived barriers, facilitators, and needs regarding uptake and adherence to LA-PrEP in TGD communities. Anticipated outcomes: understanding of factors influencing uptake and adherence of LA-PrEP that will inform development of data collection instruments and provide insight about factors affecting potential LA-PrEP uptake.
Specific Aim 2: Understand factors influencing willingness and intention to use different regimens of LA- PrEP among TGD individuals living in Texas. Activities: The investigators will survey at least 500 TGD individuals from across the state about their attitudes, community norms, barriers and preferences regarding different PrEP modalities and regimens to better understand how these factors influence willingness and intention to use different forms of LA-PrEP. Anticipated Outcomes: Identification of factors that promote willingness and intention to use LA-PrEP.
- Conditions
- HIV-1-infection
- Being tested
- no intervention
- Keywords
- Transgender, Gender Diverse, Longer-acting pre-exposure prophylaxis (PrEP), Biomedical HIV prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 40 Transgender and Gender Diverse for World Café Conversation | We will host two world cafe conversations. The first (n = 20) will be specifically or black transgender and gender diverse adults (18+), who are HIV-negative, and have indications for PrEP. The second (n = 20) will be open to transgender and gender diverse adults, who are HIV-negative, and have indication for PrEP. Receives: Other: no intervention | |
| 20 Other Key stakeholders for World Café Conversation | We will interview 20 other key stakeholders including medical providers, HIV prevention specialists, outreach workers, PrEP navigators/educators. Receives: Other: no intervention | |
| 500 Transgender and Gender Diverse for Survey | We will survey 500 TGD adults (18+), who are HIV negative, and have indications for PrEP. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to use intramuscular injectable PrEP
Participants will be asked how willing they are to use intramuscular injectable PrEP using a 6-point Likert scale ranging from "I would definitely not use intramuscular injectable PrEP" to I would definitely use intramuscular injectable PrEP."
Measured: Data will be collected over a six month period using a cross-sectional online survey.
Willingness to use a montly oral PrEP
Participants will be asked how willing they are to use intramuscular injectable PrEP using a 6-point Likert scale ranging from "I would definitely not use monthly oral PrEP" to I would definitely use monthly oral PrEP."
Measured: Data will be collected over a six month period using a cross-sectional online survey.
Willingness to use a yearly subdermal PrEP implant
Participants will be asked how willing they are to use a yearly subdermal PrEP implant using a 6-point Likert scale ranging from "I would definitely not use a yearly subdermal PrEP implant" to "I would definitely use a yearly subdermal PrEP implant."
Measured: Data will be collected over a six month period using a cross-sectional online survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Feb 2022
- Primary completion17 Jan 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 565 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Health Institute, Merck Sharp & Dohme LLC, Transgender Education Network of Texas
- Responsible party
- Principal investigator, Phillip Schnarrs, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044286
- Sponsor's protocol ID
- MISP# 60761
- Status last verified
- Dec 2023
- First submitted
- 1 Sep 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnarrs PW, Zuniga J, Benitez G, Fliedner P, Norwood A, Croll M, Oviedo LDS, Buchorn J, Oeffinger J, Lane R, Schelling E, Pham G, Pate T, Arnold EM. Intention to Use Different Formulations of Longer Acting HIV Pre-Exposure Prophylaxis Among Transgender and Gender Expansive Individuals: The Roles of Social Vulnerability and Medical Mistrust. AIDS Patient Care STDS. 2024 Feb;38(2):51-60. doi: 10.1089/apc.2023.0211.
PubMed 38381948
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Understand Acceptability of Long-Acting Pre-Exposure Prophylaxis for HIV-1 Prevention in Transgender and Gender Diverse Populations in Texas
- ClinicalTrials.gov ID
- NCT05044286
- Acronym / sponsor ID
- MISP# 60761
- Conditions
- HIV-1-infection
- Keywords
- Transgender, Gender Diverse, Longer-acting pre-exposure prophylaxis (PrEP), Biomedical HIV prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 565 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Texas Health Institute, Merck Sharp & Dohme LLC, Transgender Education Network of Texas
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 14 Sep 2021 (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 increase uptake and adherence of LA-PrEP in TGD populations in Texas. The central hypothesis is that strategies to increase uptake of LA- PrEP that are patient centered and understand the needs of TGD people will improve uptake and adherence. The objective of this observational study is to investigate barriers, facilitators, and preferences regarding willingness and intention to use LA-PrEP in TGD populations in Texas. Data from this study will support future research on patient centered strategies for uptake and adherence of LA-PrEP in TGD populations.
Detailed description
Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention strategy that is more than 90% effective in preventing the transmission of HIV. Despite the promise of PrEP in eradicating HIV, uptake has been slow in transgender and gender diverse (TGD) individuals with only 3% of TGD individuals using PrEP. While awareness is a key factor related to PrEP uptake, TGD experience numerous contextual and structural barriers, including discrimination and mistreatment by medical providers, lack of availability and access (e.g., insurance, transportation, time), and broad distrust of the healthcare system that affect intention to use PrEP and reduce uptake. These barriers are further compounded by the social position of TGD people on which they are further stratified based on their race, ethnicity, and socioeconomic status. In addition to contextual and structural factors there are a number of individual factors that limit uptake including fear of side effects, issues with adherence, concerns related to stigma, and lack of trust in the medication's efficacy.
Longer-acting PrEP (LA-PrEP) regimens include different delivery modalities (e.g.. injectable, oral, subdermal implant) with different dosing protocols (e.g. monthly versus daily). There is potential for long-acting biomedical HIV prevention methods to address some of these barriers experienced by TGD individuals. However, to be successful an understanding of attitudes, norms, and other factors influencing LA-PrEP uptake and adherence is needed, specifically among racial and ethnic minority TGD individuals, and their preferences for LA-PrEP delivery. Developing patient-centered strategies for uptake and adherence, using human centered design principles will support uptake and adherence of LA-PrEP in these TGD people.
The investigators will achieve the study objective through the following aims:
Specific Aim 1. Identify factors that influence uptake and adherence of LA- PrEP among TGD individuals in Texas Activities: In collaboration with Transgender Education Network of Texas (TENT) and TransFORWARD: Texas Transgender Health (co-Is), a PCORI funded project in Texas to increase TGD patient-centered outcomes research and comparative effectiveness research capacity in Texas, the research team will recruit 40 TGD individuals to participate in a world café conversation to understand beliefs, attitudes, and preferences for LA-PrEP and interview 20 other relevant key stakeholders (e.g., medical providers, AIDS Service Organizations, TGD advocacy groups) to understand perceived barriers, facilitators, and needs regarding uptake and adherence to LA-PrEP in TGD communities. Anticipated outcomes: understanding of factors influencing uptake and adherence of LA-PrEP that will inform development of data collection instruments and provide insight about factors affecting potential LA-PrEP uptake.
Specific Aim 2: Understand factors influencing willingness and intention to use different regimens of LA- PrEP among TGD individuals living in Texas. Activities: The investigators will survey at least 500 TGD individuals from across the state about their attitudes, community norms, barriers and preferences regarding different PrEP modalities and regimens to better understand how these factors influence willingness and intention to use different forms of LA-PrEP. Anticipated Outcomes: Identification of factors that promote willingness and intention to use LA-PrEP.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40 Transgender and Gender Diverse for World Café Conversation | – | Other: no interventionWe will host two world cafe conversations. The first (n = 20) will be specifically or black transgender and gender diverse adults (18+), who are HIV-negative, and have indications for PrEP. The second (n = 20) will be open to transgender and gender diverse adults, who are HIV-negative, and have indication for PrEP. |
| 20 Other Key stakeholders for World Café Conversation | – | Other: no interventionWe will interview 20 other key stakeholders including medical providers, HIV prevention specialists, outreach workers, PrEP navigators/educators. |
| 500 Transgender and Gender Diverse for Survey | – | Other: no interventionWe will survey 500 TGD adults (18+), who are HIV negative, and have indications for PrEP. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Transgender and gender diverse adults living in Texas.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- HIV positive,
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 | Other | 20 Other Key stakeholders for World Café Conversation, 40 Transgender and Gender Diverse for World Café Conversation, 500 Transgender and Gender Diverse for Survey |
Primary outcome
Willingness to use intramuscular injectable PrEP
Time frame: Data will be collected over a six month period using a cross-sectional online survey.
Participants will be asked how willing they are to use intramuscular injectable PrEP using a 6-point Likert scale ranging from "I would definitely not use intramuscular injectable PrEP" to I would definitely use intramuscular injectable PrEP."
Willingness to use a montly oral PrEP
Time frame: Data will be collected over a six month period using a cross-sectional online survey.
Participants will be asked how willing they are to use intramuscular injectable PrEP using a 6-point Likert scale ranging from "I would definitely not use monthly oral PrEP" to I would definitely use monthly oral PrEP."
Willingness to use a yearly subdermal PrEP implant
Time frame: Data will be collected over a six month period using a cross-sectional online survey.
Participants will be asked how willing they are to use a yearly subdermal PrEP implant using a 6-point Likert scale ranging from "I would definitely not use a yearly subdermal PrEP implant" to "I would definitely use a yearly subdermal PrEP implant."
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 28 Dec 2023.
- Derived from this study: PubMed 38381948Schnarrs PW, Zuniga J, Benitez G, Fliedner P, Norwood A, Croll M, Oviedo LDS, Buchorn J, Oeffinger J, Lane R, Schelling E, Pham G, Pate T, Arnold EM. Intention to Use Different Formulations of Longer Acting HIV Pre-Exposure Prophylaxis Among Transgender and Gender Expansive Individuals: The Roles of Social Vulnerability and Medical Mistrust. AIDS Patient Care STDS. 2024 Feb;38(2):51-60. doi: 10.1089/apc.2023.0211.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by University of Texas at Austin at 1 site 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 0 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 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Willingness to use intramuscular injectable PrEP (time frame: Data will be collected over a six month period using a cross-sectional online survey.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044286, which also lists 1 linked publication.
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 28 Dec 2023.