Longer-Acting PrEP in Transgender and Gender Diverse Texans

NCT05044286 | Completed

• 1 other identifier: MISP# 60761
• Study Type: observational
• Target: 565
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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."

  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."

  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."

  Data will be collected over a six month period using a cross-sectional online survey.

Study Arms (3)

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

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

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

Interventions

no intervention OTHER

no intervention

20 Other Key stakeholders for World Café Conversation; 40 Transgender and Gender Diverse for World Café Conversation; 500 Transgender and Gender Diverse for Survey

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transgender and gender diverse adults living in Texas.

You may not qualify if:

• HIV positive,

Sponsors & Collaborators

• University of Texas at Austin: lead
• Texas Health Institute: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Transgender Education Network of Texas: collaborator

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 38381948 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 14, 2021
• Study Start: February 1, 2022
• Primary Completion: January 17, 2023
• Study Completion: August 31, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)