Longer-Acting PrEP in Transgender and Gender Diverse Texans

December 19, 2023 updated by: Phillip Schnarrs, University of Texas at Austin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

565

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • The University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Transgender and gender diverse adults living in Texas.

Description

Inclusion Criteria: Transgender/Gender diverse, HIV negative, 18 years of age or older, Indications for PrEP, Texas resident.

Exclusion Criteria:

  • HIV positive,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: no intervention
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.
Other: no intervention
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.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Data will be collected over a six month period using a cross-sectional online survey.
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."
Data will be collected over a six month period using a cross-sectional online survey.
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."
Data will be collected over a six month period using a cross-sectional online survey.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

Merck Sharp & Dohme LLC
Texas Health Institute
Transgender Education Network of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

January 17, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MISP# 60761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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