Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 14, 2019
Open Peer Review Period: Feb 15, 2019 - Feb 22, 2019
Date Accepted: Jul 5, 2019
(closed for review but you can still tweet)
Together 5000 (T5K): An online, PrEP-era cohort of vulnerable, HIV-negative gay and bisexual men and transmen and transwomen who have sex with men in the United States and Puerto Rico
ABSTRACT
Background:
Gay, bisexual, and other men who have sex with men (GBM) continue to bear the burden of the HIV epidemic in the U.S., and are among the only populations to see increased incidence in recent years.
Objective:
To recruit a racially and geographically diverse sample of HIV-negative men who have sex with men (MSM) who are not on PrEP to inform the design, implementation, scale-up, and evaluation of HIV prevention programs.
Methods:
We used established Internet-based strategies to enroll a large, racially diverse, national sample of HIV-negative GBM aged 16 to 49 at high risk of HIV acquisition via sexual networking apps. Study participants will be contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (attempts to access, PrEP initiation, PrEP discontinuation). Using serologic data and self-reported HIV testing history, we reconstructed a cohort of men who could all be classified as HIV-negative as of 12 months prior to cohort enrollment to estimate HIV incidence.
Results:
The study sample included 8,777 participants from all 50 U.S. states, Puerto Rico and Guam; 50.9% (n=4,468) were persons of color, and 25.3% (n=2,221) were young individuals aged 16-24 years. Per eligibility criteria, all T5K participants have sex with 2+ male partners in the 90 days prior to enrollment, being HIV-negative, and not taking PrEP. Additionally, 79.4% reported 2+ insertive condomless anal sex acts (CAS); 60.4% reported 1+ receptive CAS acts in the prior 90 days Participants will complete annual self-administered at-home HIV testing as well as annual at-home online surveys beginning 12 months after the baseline survey. Incidence rate estimates in the 6- and 12-month periods leading up to enrollment were 2.15 (95% CI 1.63-2.81) and 2.41 (95% CI 2.02-2.90) per 100 person-years, respectively.
Conclusions:
A large, national and racially diverse cohort of HIV-negative GBM at high risk for HIV seroconversion has successfully been recruited online into a longitudinal follow-up. This cohort of GBM at high risk for HIV acquisition can provide important insights related to the real world uptake, impact, and equity of HIV prevention interventions in the U.S. Clinical Trial: n/a
Citation
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Copyright
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