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Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years.
The
We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment.
The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years.
A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions.
RR1-10.2196/13715
Gay, bisexual, and other men who have sex with men (GBM) continue to bear the burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years [
Most data on PrEP uptake are based on insurance claims or pharmacy prescriptions for emtricitabine and tenofovir disoproxil fumarate. A major limitation of available insurance plan–based or even population-based data on PrEP uptake [
In response to a 2016 request for applications from the US National Institutes of Health (NIH) [
The T5K cohort study used established ([
Open enrollment for T5K began in October 2017 and concluded in June 2018, when 67,166 of the estimated 649,000 (67,166/649,000, 10.35%) males eligible for PrEP across the United States were using it [
Eligibility criteria for the
Eligibility criteria | Participants (N=8777), n (%) | |
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Aged 16 to 49 years | 8777 (100.00) |
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At least 2 male sex partners in the past 90 days | 8777 (100.00) |
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Not currently participating in a clinical trial for an HIV vaccine or pre-exposure prophylaxis | 8777 (100.00) |
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Not currently on pre-exposure prophylaxis | 8777 (100.00) |
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Never diagnosed with HIV (self-report) | 8777 (100.00) |
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Currently residing in the United States or territories | 8777 (100.00) |
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Not cisgender female | 8777 (100.00) |
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>1 receptive condomless anal sex acts with a male partner in the last 3 months | 6968 (79.39) |
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>2 insertive condomless anal sex acts with a male partner in the last 3 months | 5356 (61.02) |
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Used methamphetamines in the last 3 months | 1058 (12.05) |
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Rectal gonorrhea/chlamydia in the last 12 months | 684 (7.79) |
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Syphilis diagnosis in the last 12 months | 402 (4.58) |
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Used postexposure prophylaxis in the last 12 months | 219 (2.50) |
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Shared injection drug needles in the last 12 months | 180 (2.05) |
Potential participants were directed to a secure enrollment survey in their device’s Web browser and presented with a screen describing study participation and eliciting informed consent. The informed consent described the incentive schedule: US $15 for completing a secondary survey (ie, 1 after the enrollment survey) if they were eligible and another US $15 for completing self-administered at-home HIV testing (ie, oral fluid sample returned to the study laboratory for testing). Additional incentives, described in the informed consent, are available to participants who complete prospective longitudinal follow-up assessments.
Interested individuals were screened for eligibility via a Web-based survey collecting data on sexual behavior, substance use, demographic characteristics, history of PrEP use, and history of postexposure prophylaxis (PEP) use. The survey was programmed into Qualtrics survey software and tested by study staff. Measures had been previously used by the members of the research team or were derived from the published research. Our Web-based survey was divided into thematic blocks based on question content and used adaptive questions based on survey responses from the participants. Examples include survey questions about known HIV status, PrEP use, and main sexual partners. Survey items were not randomly ordered by participant. The number of items answered by the participants and displayed per page of the Web-based survey varied by subject and participant responses because of the skip and/or display logic used within the survey. However, to improve ease of use on mobile devices and reduce survey fatigue, each page contained 1 to 2 questions. Participants could not click back to view or change a previous response because of the skip and/or display logic depending on previous responses. If a participant chose an incorrect response, they could contact the study staff to reset that response. Before activating the survey, members of the study staff tested the survey extensively for usability and technical function. The survey was tested on Windows, Mac, iOS, and Android devices and on Chrome, Firefox, Internet Explorer, Opera, and Safari Web browsers. Eligible and consenting individuals were asked to provide contact information for longitudinal follow-up. All participants were assigned a unique identifier at study enrollment and this unique identifier was used for all study databases and datasets. Participants’ contact information was stored in an encrypted database separated from their questionnaire answers and other study-related information. Only designated study staff were allowed access to study databases.
Enrolled individuals were sent a secondary Web-based survey that assessed the psychosocial characteristics. As the study participation involved receiving and returning an at-home HIV test kit via mail, as well as follow-up HIV test kits, consenting participants were required to provide name, mailing address, email address, and other contact information. We followed established and effective measures to minimize repeat participation and fraudulent manipulation of HIV testing procedures, including recording internet protocol addresses of participants and using cookies to block repeated attempts (CG et al, unpublished data, 2019). Our enrollment survey blocked multiple submissions, our databases flagged duplicate contact information, and all mailing addresses were validated with the US postal service. Multiple entries were identified by email addresses and/or phone numbers. In addition, the data manager manually checked for duplicate entries during baseline data collection. We also assessed time to completion of our Web-based surveys and checked for variability in response sets.
Upon completing this secondary survey, participants were mailed an OraSure HIV-1 specimen collection device to use at home. Participants were also provided access to a study video along with printed instructions on completing the HIV test, as well as our phone number in case they had questions. Procedures involved taking an oral swab and placing it in an oral fluid container and mailing the specimen using provided prepaid shipping materials to the Wadsworth Center Laboratory of the New York State Department of Health for antibody testing (Avioq HIV-1 Microelisa System) and archiving. Participants indicated the date of collection and any samples received by the lab after 21 days were not analyzed. In these instances, participants were contacted to retest. Median number of days between specimen collection and lab receipt was 4 days (interquartile range 3 to 6 days).
Participants who enrolled and completed a baseline questionnaire but did not return an HIV test kit (baseline serostatus unknown) will continue to be followed and asked at regular intervals to submit an oral fluid sample for HIV testing using the at-home sampling kit. For the purposes of prospectively estimating HIV incidence in the T5K cohort, these individuals will be excluded. However, we will conduct post hoc sensitivity analyses that make assumptions about having similar, lower, or higher HIV risk profiles than the T5K participants for whom baseline HIV status was determined.
We estimated pre-enrollment HIV incidence using baseline data on HIV serostatus and HIV testing history from T5K participants. Using these data, we reconstructed a cohort of individuals who could all be classified as HIV negative as of 12 months before cohort enrollment. For those HIV positive at enrollment, we estimated the time of seroconversion using self-reported data on the timing of the last HIV-negative test. Specifically, those self-reporting a negative HIV test within 6 months of T5K enrollment were classified as being HIV negative as of 6 months before enrollment, with seroconversion timing assumed to be distributed evenly during the 6 months leading up to study enrollment. Similarly, participants self-reporting a negative HIV test 7 to 12 months before T5K enrollment were classified as being HIV negative as of 12 months before enrollment, with seroconversion timing assumed to be distributed evenly during the 12 months leading up to study enrollment. We also estimated HIV incidence for the 6-month period leading up to cohort enrollment. For the purposes of identifying boundaries around minimum and maximum incidence rates, we conducted sensitivity analyses representing assumptions of the timing of seroconversion at the extremes.
Enrollment in T5K had a targeted sample size of 5000 participants with a confirmed HIV-negative test for prospective follow-up. The 5000 number was chosen to provide precise estimates of HIV incidence of 1.11 per 100 person-years (193 seroconversions of 17,329 person-years of follow-up over 48 months). This sample size also allows 80% power to detect binary exposures with frequencies between 20% and 80% for adjusted relative hazards ranging from 1.73 to 2.27 as statistically significant.
All data from the Web-based surveys and the laboratory testing were imported, cleaned, and merged using SAS. Data were geocoded to an exact address or Zone Improvement Plan (ZIP) code. Maps were created in ArcGIS and did not include exact participant location.
The T5K study protocol was approved by the Institutional Review Board of the City University of New York (CUNY) Graduate School of Public Health and Health Policy.
In total, 43,161 individuals began our enrollment survey and 22,091 (22,091/43,161, 51.18%) completed it (
The final sample was 8777 consented participants from all 50 US states, Puerto Rico, and Guam (
Consolidated Standards Of Reporting Trials diagram illustrating enrollment in the
Geographic distribution of the
The final cohort of 8777 individuals was geographically diverse, including participants from all 50 US states, Puerto Rico, and Guam (
Characteristics
Variable | Participants (N=8777), n (%) | Never on PrEPa (N=7525), n (%) | History of PrEP (N=1252), n (%) | Chi-square value ( |
||
|
10.2 (4) | .04 | ||||
White | 4309 (49.09) | 3672 (48.80) | 637 (50.88) | —b | — | |
Black | 1156 (13.17) | 1009 (13.41) | 147 (11.74) | — | — | |
Latino | 2227 (25.37) | 1932 (25.67) | 295 (23.56) | — | — | |
Asian/Pacific Islander | 311 (3.43) | 253 (3.36) | 58 (4.63) | — | — | |
Multiracial/other | 774 (8.82) | 659 (8.76) | 115 (9.19) | — | — | |
|
16.0 (3) | .001 | ||||
Cis male | 8554 (97.46) | 7343 (97.58) | 1211 (96.73) | — | — | |
Transwoman | 63 (0.72) | 59 (0.78) | 4 (0.32) | — | — | |
Transman | 53 (0.60) | 44 (0.58) | 9 (0.72) | — | — | |
Nonbinary (male at birth) | 107 (1.22) | 79 (1.05) | 28 (2.24) | — | — | |
|
39.6 (2) | <.001 | ||||
Gay identified | 7314 (83.33) | 6194 (82.31) | 1120 (89.46) | — | — | |
Bisexual identified | 1346 (15.33) | 1223 (16.25) | 123 (9.82) | — | — | |
Neither/other | 117 (1.33) | 108 (1.44) | 9 (0.72) | — | — | |
|
98.2 (6) | <.001 | ||||
16-19 | 517 (5.89) | 498 (6.62) | 19(1.52) | — | — | |
20-24 | 1704 (19.41) | 1523 (20.24) | 181 (14.46) | — | — | |
25-29 | 2360 (26.89) | 2003 (26.62) | 357 (28.51) | — | — | |
30-34 | 1664 (18.95) | 1373 (18.25) | 291 (23.24) | — | — | |
35-39 | 1186 (13.51) | 971 (12.90) | 215 (17.17) | — | — | |
40-44 | 738 (8.41) | 625 (8.31) | 113 (9.03) | — | — | |
45 and older | 608 (6.93) | 532 (7.06) | 76 (6.07) | — | — | |
No health insurancec (valid N=6283) | 1575 (25.07) | 1363 (25.32) | 212 (23.56) | 2.9 (1) | .23 | |
|
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Recent sexually transmitted infection diagnosis (last 12 months) | 1629 (18.56) | 1243 (16.52) | 386 (30.83) | 145.5 (1) | <.001 | |
Syphilis in lifetime | 1359 (15.48) | 1042 (13.85) | 317 (25.32) | 108.0 (1) | <.001 | |
Syphilis in the last 12 months | 402 (4.58) | 303 (4.03) | 99(7.91) | 115.8 (1) | <.001 | |
Rectal gonorrhea/chlamydia in the last 12 months | 684 (7.79) | 489 (6.50) | 195 (15.58) | 332.5 (1) | <.001 | |
Oral gonorrhea/chlamydia in the last 12 months | 1309 (14.91) | 958 (12.73) | 351 (28.04) | 198.1 (1) | <.001 | |
>1 receptive condomless anal sex acts with male in the last 3 months | 6968 (79.39) | 5973 (79.38) | 995 (79.47) | 0.01 (1) | .94 | |
>2 insertive condomless anal sex acts with male in the last 3 months | 5356 (61.02) | 4545 (60.40) | 811 (64.78) | 8.6 (1) | .003 | |
Having taken PEPd in the last 12 months | 219 (2.50) | 93 (1.24) | 126 (10.06) | 733.5 (1) | <.001 | |
Methamphetamine use in the last 3 months | 1058 (12.05) | 875 (11.63) | 183 (14.62) | 9.0 (1) | .003 | |
Sharing needles in the last 12 months | 180 (2.05) | 144 (1.91) | 36 (2.88) | 6.1 (1) | .05 | |
Sex work in the last 3 months | 1339 (15.26) | 1127 (14.98) | 212 (16.93) | 3.2 (1) | .08 | |
No primary health care providerc (valid N=6283) | 3057 (48.66) | 2700 (50.15) | 357 (39.67) | 34.0 (1) | <.001 | |
Disclosed sexual behavior to health care providere (valid N=3226) | 2343 (72.63) | 1848 (78.87) | 495 (91.16) | 112.1 (1) | <.001 | |
Never heard of PrEP | 476 (5.42) | 476 (6.33) | 0 (0.0) | — | — | |
|
414.9 (2) | <.001 | ||||
<12 months ago | 5362 (61.09) | 4277 (56.84) | 1085 (86.67) | — | — | |
12 or more months ago | 2292 (26.11) | 2145 (28.50) | 147 (11.74) | — | — | |
Never had an HIV test | 1123 (12.79) | 1103 (14.66) | 20 (1.60) | — | — |
aPrEP: pre-exposure prophylaxis.
bNot applicable.
cAmong those who completed our secondary survey.
dPEP: postexposure prophylaxis.
eAmong those who completed our secondary survey and reported having a health care provider.
Per eligibility criteria, at enrollment, all T5K participants reported sex with >2 male partners in the 90 days before enrollment, were HIV negative, and were not taking PrEP. In addition, 79.40% (6969/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days (
In
Of the 8777 participants enrolled, 6166 (70.25%) provided valid mailing addresses on the second survey and were sent an at-home HIV testing kit, and 5074 participants provided a sample to test (5074/6166, 82.29% of those sent a kit and 5074/8777, 57.81% of those enrolled). Compared with participants who did not provide a sample for testing (3703), those who did provide a sample (5074) were significantly more likely to report income >US $50,000 (22.12% vs 26.25%;
HIV testing outcomes among
Variable | Total participants (N=8777), n (%) | Never on PrEPa (N=7525), n (%) | History of PrEP N=1252), n (%) | Chi-square value |
||||
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5074 (57.81) | 4343 (57.71) | 731 (58.39) | 0.2 (1) | .66 | |||
|
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—e | — | — | 14.6 (1) | <.001 | ||
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HIV-negative test result | 4814 (94.88) | 4101 (94.43) | 713 (97.54) | — | — | |
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|
HIV-positive test result | 196 (3.86) | 186 (4.28) | 10 (1.37) | — | — | |
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|
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— | — | — | 5.0 (3) | .18e | |
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Self-reported HIV-negative test <6 months ago | 34 (17.35) | 30 (16.12) | 4 (40.00) | — | — |
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|
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Self-reported HIV-negative test 7-12 months ago | 36 (18.37) | 34 (18.28) | 2 (20.00) | — | — |
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|
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Self-reported HIV-negative test >12 months ago | 95 (48.47) | 91 (48.92) | 4 (40.00) | — | — |
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|
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No previous HIV test | 31 (15.82) | 31 (16.67) | 0 (0.00) | — | — |
aPrEP: pre-exposure prophylaxis.
bN=n value from returned HIV test.
cNot Applicable.
dN=n value from HIV-positive test result.
eMid
HIV incidence estimates among
Period before enrollment | All participants | No history of PrEPa use | History of PrEP use | Incidence rate ratio | |
|
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Number of presumed recent seroconversions, n (%) | 118 (100) | 110 (93) | 8 (7) | —b |
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Person-years at risk among seroconverters | 58.75 | 54.75 | 4 | — |
|
Person-years at risk among HIV-negative persons | 4814 | 4101 | 713 | — |
|
Incidence rate per 100 person years (95% CI) | 2.41 (2.02-2.90) | 2.63 (2.19-3.19) | 1.12 (0.52-2.13) | 2.36 (1.21-5.20) |
|
|||||
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Number of presumed recent seroconversions, n (%) | 52 (100) | 47 (90) | 5 (10) | — |
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Person-years at risk among seroconverters | 13.0 | 11.8 | 1.3 | — |
|
Person-years at risk among HIV-negative persons | 2407 | 2051 | 357 | — |
|
Incidence rate per 100 person-years (95% CI) | 2.15 (1.63-2.81) | 2.28 (1.70-3.01) | 1.40 (0.52-3.12) | 1.63 (0.69-4.61) |
aPrEP: pre-exposure prophylaxis.
bNot applicable.
Prospective closed follow-up of T5K participants includes completion of an annual self-administered at-home HIV testing and extensive Web-based surveys beginning 12 months after the baseline survey. In addition, participants will be contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, diagnosis, and PrEP use (ie, attempts to access PrEP, PrEP initiation, PrEP adherence, and PrEP discontinuation). Participants who self-report being on PrEP are asked to provide proof in the form of a picture of the medication bottle with their prescription information. A comprehensive list of key study measurements by study wave is included in
Follow-up measures in the
Measuresa | Number of items | Administered at | |||||
Enrollment survey | Secondary survey | 12 months | 24 months | 36 months | 48 months | ||
Sociodemographic questionnaire | 14 | Xb | —c | X | X | X | X |
PrEPd and PEPe history | 5 | X | — | X | X | X | X |
Men who have sex with men risk indexf | 10 | X | — | X | X | X | X |
History of sexually transmitted infections and HIV testing | 13 | X | — | X | X | X | X |
Main sexual partner | 7 | X | — | X | X | X | X |
Drug, alcohol, and cigarette use | 4 | X | — | X | X | X | X |
Incarceration and recent arrest | 3 | — | X | X | X | X | X |
Connor-Davidson resilience scale | 10 | — | X | X | X | X | X |
Alcohol, smoking, and substance involvement screening test | 13-86 | — | X | X | X | X | X |
Alcohol use disorder identification test | 10 | — | X | X | X | X | X |
Generalized anxiety disorder | 2 | — | X | X | X | X | X |
Patient health questionnaire | 2 | — | X | X | X | X | X |
Internalized homophobia scale | 14 | — | X | X | X | X | X |
Lesbian, gay, bisexual, and transgender resources and policies | 14 | — | X | X | X | X | X |
General PrEP experiences and acceptability | 12 | — | X | X | X | X | X |
Barrier to PrEP uptake | 14 | — | X | X | X | X | X |
Partner violence questionnaire | 12 | — | X | X | X | X | X |
Hepatitis C virus risk score | 6 | — | X | X | X | X | X |
Multidimensional scale of perceived social support | 12 | — | X | X | X | X | X |
Multidimensional peer-victimization scaleg | 14 | — | X | — | — | — | — |
Position preference | 1 | — | X | — | — | — | — |
Sexual debut and childhood sexual abuse | 7 | — | X | — | — | — | — |
aThere are brief check-in surveys at 6, 18, 30, and 42 months.
bConstruct is assessed.
cConstruct is not assessed.
dPrEP: pre-exposure prophylaxis.
ePEP: postexposure prophylaxis.
fModified to include questions about female, transmale, and transfemale sex partners and condomless sex acts with female sex partners.
gProvided as published scale to currently enrolled high school students, modified from
Given the novel nature of this entirely Web-based nationwide cohort, we elected to longitudinally follow
Participants who were HIV negative at baseline and who indicate that they tested HIV positive between study assessments will be asked and incentivized to provide HIV status documentation and will not be asked to complete additional HIV tests for study purposes. These participants will be classified as recent seroconverters. Among the remaining participants, those who test positive in the 12-month home test will also be classified as recent seroconverters, and those who test negative will be classified as remaining seronegative. We will contact recent seroconverters to capture information about and facilitate the process of linkage to care. In addition to referral for treatment, approximately 3 months after their diagnosis via the study, we will invite a sample of seroconverting participants to complete a semistructured individual telephone interview to identify missed HIV prevention opportunities and barriers/facilitators of their entry into HIV care and subsequent retention. We will follow these participants until the end of the study to document movement through the HIV care continuum [
We have successfully recruited an entirely Web-based national cohort of confirmed HIV-negative men, transgender men, and transgender women who have sex with men and are at very high risk for HIV into longitudinal follow-up. Importantly, none of the T5K cohort members were on PrEP at enrollment but all met the objective criteria for PrEP use. This will allow our study to fill critical knowledge gaps that can improve the understanding of barriers to PrEP uptake and engagement among those most in need of HIV prevention interventions. This cohort also offers opportunities to examine the effect of different implementation strategies aimed at improving the uptake of and engagement with HIV prevention interventions, including those that can be delivered on the Web.
We observed a higher rate of several recent and lifetime STIs among persons with a history of PrEP compared with those who were never on PrEP. This could represent differences in the risk profile of persons who have used PrEP (ie, they were at higher risk for an STI in the past before or while using PrEP). However, many STIs are asymptomatic, making it likely that the STIs reported by this group at baseline would have been diagnosed as a result of them having initiated PrEP in the past, as PrEP services involve baseline and follow-up STI screening and treatment. We also observed that those with a history of PrEP were >8 times more likely to have taken PEP in the past. This could reflect better access to HIV prevention services or greater HIV risk among those with a history of PrEP use. Persons on PEP are usually good candidates for PrEP, and PrEP should be systematically discussed and offered to all persons completing PEP if there is a likelihood of ongoing HIV risk.
Our estimates of HIV incidence in the 12-month period leading up to T5K cohort enrollment (2.4% per year overall and 2.6% per year among those never on PrEP) suggest that the risk of HIV acquisition that we will observe prospectively will also be quite high, unless PrEP uptake increases dramatically. Indeed, we observed that HIV incidence was substantially higher among those never on PrEP compared with those with a history of PrEP before enrollment (IRR 2.36; 95% CI 1.21-5.20).
Major strengths of this cohort study include the large sample size, the wealth of self-reported information related to HIV risk and PrEP, direct measurement of HIV status and seroconversion, geographic representativeness, recruitment of participants independent of their access to/engagement with the health care system, and inclusion of large numbers of racial/ethnic minority GBM as well as those aged <25 years. Having every US state, Puerto Rico, and Guam represented allows for a robust exploration of state-level policies and other higher-level effects (ie, contextual factors) as potential determinants of PrEP uptake and HIV risk. More than 50% (4468/8777, 50.91%) of the cohort comprises HIV-negative men of color, allowing in-depth investigations into the mechanisms of racial/ethnic disparities in PrEP uptake, HIV incidence, and circumstances surrounding HIV seroconversion. Importantly, the T5K cohort study design, with semiannual Web-based at-home surveys and at-home self-sampling for HIV testing, reduces the potential for participation and questionnaire-response bias introduced by the Hawthorne effect, which could be stronger in face-to-face studies. Studies involving frequent face-to-face contact can cause participants to adopt behaviors that make them less representative of the high-risk populations from which they were drawn. Of note, McCabridge et al [
Recruiting participants and gathering data on the Web is a much less controlled research environment than face-to-face or telephone interview studies. Web-based recruitment also increases our vulnerability to repeat participation and fraudulent manipulation of HIV testing procedures (eg, someone else’s saliva, other than that of the enrolled participant, could be submitted to the lab). However, we followed established and effective measures to minimize these risks [
There have been many challenges and lessons learned in the launch and execution of the T5K study, which have been detailed elsewhere ([
Intervention studies are of great interest to the T5K study team. Our goal is to utilize key findings from this cohort to develop interventions, potentially including some delivered completely on the Web, once the observational phase is completed. There will likely be opportunity for natural experiment design studies that allow for rigorous examination of future state or national policy changes, an introduction of long-acting PrEP formulations or dosing recommendations, and other novel HIV prevention modalities. To facilitate such research, we will gather extant data via geolinking with T5K participant information [
T5K welcomes new collaborations. Instructions and a concept proposal form are available on our website or can be obtained by emailing the Principal Investigator (CG). Submitted concept proposals will be reviewed by CG and a core group of T5K investigators, with rapid turnaround.
Checklist for Reporting Results of Internet E-Surveys (CHERRIES) and Sensitivity analyses for HIV incidence estimates among
condomless anal sex
City University of New York
gay, bisexual, and other men who have sex with men
incidence rate ratio
National Institutes of Health
pre-exposure prophylaxis
sexually transmitted infection
Zone Improvement Plan
T5K was funded by the NIH—UG3 AI 133675 (PI Grov). VVP was supported by a career development award from the NIH (K23 MH102118). Other forms of support include the CUNY Institute for Implementation Science in Population Health, the Einstein, Rockefeller, and CUNY Center for AIDS Research (ERC CFAR, P30 AI124414), and the HIV Center for Clinical and Behavioral Studies (P30 MH043520).
Special thanks to the additional members of the T5K study team: Gloria Perez, Irvin Parker, Javier Lopez-Rios, and Sarah Kulkarni. The authors would also like to thank the program staff at NIH: Gerald Sharp, Sonia Lee, and Michael Stirratt and the members of their Scientific Advisory Board: Michael Camacho, Adam Carrico, Demetre Daskalakis, Sabina Hirshfield, Jeremiah Johnson, Claude Mellins, and Milo Santos.
None declared.