Longer-Acting PrEP in Transgender and Gender Diverse Texans
Condition: HIV-1-infection
Study type: Observational

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.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Transgender and gender diverse adults living in Texas.
      
Keywords: Transgender; Gender Diverse; Longer-acting pre-exposure prophylaxis (PrEP); Biomedical HIV prevention