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A Cautionary Tale: Digital Clinical Trial Implementation of a Couples-Based HIV Prevention Study among Transgender Women and Their Partners in the United States

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Abstract

This study investigates baseline differences in couples enrolled in the “It Takes Two” HIV prevention intervention for transgender women and their partners, comparing in-person participation pre-COVID-19 and digital participation during the pandemic. Among 52 couples (40% in-person, 60% digital), bivariate analyses revealed that in-person participants were more likely to be African American, have cisgender male partners, report higher unemployment, incarceration histories, greater relationship stigma, and lower relationship quality. The findings highlight the limitations of digital modalities in engaging transgender women of color and those with structural vulnerabilities. The study emphasizes that reliance on digital methods in HIV research jeopardizes the inclusion of those lacking technological access and literacy, especially communities disproportionately impacted by HIV. Researchers must incorporate hybrid or in-person options and engage communities to ensure equity and inclusion, thus overcoming barriers and ensuring comprehensive population reach in HIV prevention studies.

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Acknowledgements

The authors would like to thank the couples who participated in this study. This study was funded by a grant from the National Institute of Mental Health (R01MH115765) and the authors were in supported in part by grants from the National Institutes of Health (P2CHD041028; R25MH067127).

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Correspondence to Kristi E. Gamarel.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Gamarel, K.E., Stein, E.S., Correll-King, W.M. et al. A Cautionary Tale: Digital Clinical Trial Implementation of a Couples-Based HIV Prevention Study among Transgender Women and Their Partners in the United States. AIDS Behav 29, 37–44 (2025). https://doi.org/10.1007/s10461-024-04477-x

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