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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 23, 2024
Open Peer Review Period: Apr 24, 2024 - Jun 5, 2024
Date Accepted: Jun 18, 2024
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States

Wirtz AL, Poteat T, Borquez A, Linton S, Stevenson M, Case J, Brown C, Lint A, Miller M, Radix A, Althoff KN, Schneider JS, Haw JS, Wawrzyniak A, Rodriguez A, Cooney E, Humes E, Pontes C, Seopaul S, White C, Beyrer C, Reisner SL, ENCORE Study Group

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States

JMIR Res Protoc 2024;13:e59846

DOI: 10.2196/59846

PMID: 39190916

PMCID: 11387927

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): a Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States

  • Andrea L. Wirtz; 
  • Tonia Poteat; 
  • Annick Borquez; 
  • Sabriya Linton; 
  • Megan Stevenson; 
  • James Case; 
  • Carter Brown; 
  • Arianna Lint; 
  • Marissa Miller; 
  • Asa Radix; 
  • Keri N Althoff; 
  • Jason S. Schneider; 
  • J. Sonya Haw; 
  • Andrew Wawrzyniak; 
  • Allan Rodriguez; 
  • Erin Cooney; 
  • Elizabeth Humes; 
  • Ceza Pontes; 
  • Shannon Seopaul; 
  • Camille White; 
  • Chris Beyrer; 
  • Sari L. Reisner; 
  • ENCORE Study Group

ABSTRACT

Background:

In the United States (US), transgender women are disproportionately impacted by HIV and prioritized in the national strategy to end the epidemic. Individual, interpersonal, and structural vulnerabilities underly the HIV acquisition among transgender women, and fuel syndemic conditions, yet no nationwide cohort monitors their HIV and other health outcomes.

Objective:

Our objective was to develop a nationwide cohort to estimate HIV incidence, identify risk factors, and investigate syndemic conditions co-occurring with HIV vulnerability and/or acquisition among US transgender women. The study is informed by the Syndemics Framework and the Social Ecological Model, positing that stigma-related conditions are synergistically driven by shared multi-level vulnerabilities.

Methods:

To address logistical and cost barriers while minimizing technology barriers and research distrust, we established a novel, hybrid community hub-supported digital cohort (N=3,000). A digital cohort is the backbone of the study and is enhanced by hubs strategically located across the US, for increased engagement and in-person support. Study participants are English- or Spanish-speaking, aged >=18 years, identifying as transgender women or along the transfeminine spectrum, living in the 50 states or Puerto Rico, and do not have HIV (laboratory-confirmed). Participants are followed for 24 months, with semi-annual assessments. These include a questionnaire and laboratory-based HIV testing using self-collected specimens. Questionnaires measure demographics, health history, gender euphoria and pride, relationships, violence victimization, and discrimination. Using residential ZIP codes, person-level data will be merged with contextual geolocated data, including population health measures, economic, housing, and other social and structural factors. Analyses will: (1) evaluate the contribution of hub support to the digital cohort using descriptive statistics, (2) estimate and characterize syndemic patterns among transgender women using latent class analysis, (3) examine the role of contextual factors in driving syndemics and HIV prevention over time using multi-level regression models, (4) estimate HIV incidence in transgender women and examine the effect of syndemics and contextual factors on HIV incidence using Poisson regression models, and (5) develop dynamic, compartmental models of multilevel combination HIV prevention interventions among transgender women to simulate their impact on HIV incidence through 2030.

Results:

Initial enrollment and data collection phases occurred from March 15 – June 30, 2023, and November 1 – December 15, 2023. As of February 24, 2024, 3,084 individuals were screened and 996 (32%) met criteria and enrolled into the cohort: 2% (23/996) enrolled at a hub and 54% (534/996) enrolled through a community hub-supported strategy. Recruitment through purely digital methods contributed 61% (1895/3084) of those screened and 43% (425/996) of those enrolled in the cohort.

Conclusions:

Study findings will inform the development of evidence-based interventions to reduce HIV acquisition and syndemic conditions among US transgender women and advance efforts to end the US HIV epidemic. Methodological findings will also have critical implications for the design of future innovative approaches to HIV research.


 Citation

Please cite as:

Wirtz AL, Poteat T, Borquez A, Linton S, Stevenson M, Case J, Brown C, Lint A, Miller M, Radix A, Althoff KN, Schneider JS, Haw JS, Wawrzyniak A, Rodriguez A, Cooney E, Humes E, Pontes C, Seopaul S, White C, Beyrer C, Reisner SL, ENCORE Study Group

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE): Protocol for a Nationwide Hybrid Cohort for Transgender Women in the United States

JMIR Res Protoc 2024;13:e59846

DOI: 10.2196/59846

PMID: 39190916

PMCID: 11387927

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