Longer-Acting PrEP in Transgender and Gender Diverse Texans

NCT ID: NCT05044286

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 565 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-08-31

Brief 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. 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.

Conditions

HIV-1-infection

Keywords

Transgender; Gender Diverse; Longer-acting pre-exposure prophylaxis (PrEP); Biomedical HIV prevention

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

no intervention

Intervention Type: 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.

no intervention

Intervention Type: 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.

no intervention

Intervention Type: OTHER

no intervention

Interventions

no intervention

no intervention

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• HIV positive,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Health Institute

UNKNOWN

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Transgender Education Network of Texas

UNKNOWN

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Phillip Schnarrs

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The University of Texas at Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38381948 (View on PubMed)

Other Identifiers

MISP# 60761

Identifier Type: -

Identifier Source: org_study_id