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Accepted for/Published in: JMIR Public Health and Surveillance

Date Submitted: Sep 26, 2024
Date Accepted: Apr 2, 2025
(closed for review but you can still tweet)

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

The American Transformative HIV Study: Protocol for a US National Cohort of Sexual and Gender Minority Individuals With HIV

Grov C, D'Angelo A, Dearolf M, Hoeppner E, Guo Y, Richards N, Ehsan R, Kulkarni S, Nash D, Patel V, Duncan D, Ray M, Bartholomew T, Manuzak J, Manuel J, McCollister K, Westmoreland D, Carrico A

The American Transformative HIV Study: Protocol for a US National Cohort of Sexual and Gender Minority Individuals With HIV

JMIR Public Health Surveill 2025;11:e66921

DOI: 10.2196/66921

PMID: 40402549

PMCID: 12121540

The American Transformative HIV Study (AMETHST): Protocol for and profile of a U.S. national cohort of HIV-vulnerable sexual and gender minority individuals, with an emphasis on overenrolling people who use methamphetamine

  • Christian Grov; 
  • Alexa D'Angelo; 
  • Michelle Dearolf; 
  • Elena Hoeppner; 
  • Yan Guo; 
  • Nicole Richards; 
  • Rifa Ehsan; 
  • Sarah Kulkarni; 
  • Denis Nash; 
  • Viraj Patel; 
  • Dustin Duncan; 
  • Meredith Ray; 
  • Tyler Bartholomew; 
  • Jennifer Manuzak; 
  • Jennifer Manuel; 
  • Kathryn McCollister; 
  • Drew Westmoreland; 
  • Adam Carrico

ABSTRACT

Background:

Sexual and gender minority (SGM) individuals represent 2-5% of the US population, yet continue to account for more than two-thirds of new HIV infections annually.

Objective:

The American Transformative HIV Study (AMETHST) is an ongoing online cohort study of 5,364 SGM individuals from all 50 US states and Puerto Rico, enrolled in 2022 and 2023 and will be followed through 2027. Greater than half of participants are persons of color, and we oversampled persons who use methamphetamine (53.1%). Its focus on identifying multi-level (i.e., structural, psychological, and social) and bio-behavioral (i.e., rectal cytokines/chemokines) determinants of amplified HIV seroconversion risk for SGM individuals, including those who use methamphetamine, will serve to guide targeted, combination interventions to reduce HIV incidence. To be eligible, participants had to report meeting objective criteria for PrEP care, but not be taking PrEP.

Methods:

We used established internet-based strategies to enroll individuals aged 16-49 years at high risk of HIV acquisition via sexual networking applications. Participants complete annual online surveys (baseline, 12-, 24-, and 36-months) and are asked to provide self-collected oral fluid samples for HIV testing and two rectal swabs (the Aptima Multi-Test Swab and the Zymo DNA/RNA shield swab) following each assessment. Oral fluid samples are analyzed immediately, while rectal swabs are banked for a future nested case-cohort analysis to assess changes in inflammatory markers following a new infection.

Results:

Nearly all participants (84.7%) were cisgender male, 3.7% (201/5364) were transgender women, and 1.1% (61/5364) were transgender men who have sex with men. There were also n = 560 (10.4%) individuals who self-identified outside of the gender binary—all reported being assigned male sex at birth. In total, 56.5% (3031/5364) were persons of color, and 31.8% (1714/5365) were aged 16 to 29 years. In total, 4,054 baseline HIV test kits were returned, including n = 371 HIV reactive samples—3.3% were HIV-positive among those who did not report methamphetamine use, and 15.5% were HIV-positive among those reporting methamphetamine use. Based on participant’s HIV results as well as self-reporting when their most recent prior HIV-negative test was, we estimated the incidence rate in this cohort in the 12-month period leading up to study enrollment was 10.06 (95% CI 8.65 – 11.64) per 100 person-years among those reporting methamphetamine use compared with 2.04 (95% CI 1.49 -2.73) among those not reporting methamphetamine use per 100 person-years.

Conclusions:

A large, US national, and racially diverse online cohort of SGM individuals at high risk for HIV has been successfully enrolled and will be followed through 2027. Persons who use methamphetamine have been oversampled and demonstrated an exceptionally greater risk for HIV. Our study will offer insight for the development and implementation of new interventions, which aim to have a meaningful impact on HIV transmission. Clinical Trial: N/A


 Citation

Please cite as:

Grov C, D'Angelo A, Dearolf M, Hoeppner E, Guo Y, Richards N, Ehsan R, Kulkarni S, Nash D, Patel V, Duncan D, Ray M, Bartholomew T, Manuzak J, Manuel J, McCollister K, Westmoreland D, Carrico A

The American Transformative HIV Study: Protocol for a US National Cohort of Sexual and Gender Minority Individuals With HIV

JMIR Public Health Surveill 2025;11:e66921

DOI: 10.2196/66921

PMID: 40402549

PMCID: 12121540

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