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Preexposure prophylaxis for HIV infection integrated with municipal- and community-based sexual health services.
Open accessAbstract
IMPORTANCE: Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). OBJECTIVE: To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States. DESIGN, SETTING, AND PARTICIPANTS: Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015. INTERVENTIONS: A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. MAIN OUTCOMES AND MEASURES: Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. RESULTS: Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion. CONCLUSIONS AND RELEVANCE: The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.
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“Clinical practice guidelines recommend STI screening for persons taking PrEP (80) because increased rates of STI acquisition have been described (85–87).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [85]
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Sexually Transmitted Infections Treatment Guidelines, 2021
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Metadata
- Authors
- Liu, A. Y., Cohen, S. E., Vittinghoff, E., Anderson, P. L., Doblecki-Lewis, S., Bacon, O., Chege, W., Postle, B. S., Matheson, T., Amico, K. R., Liegler, T., Rawlings, M. K., Trainor, N., Blue, R. W., Estrada, Y., Coleman, M. E., Cardenas, G., Feaster, D. J., Grant, R., Philip, S. S., Elion, R., Buchbinder, S., & Kolber, M. A.
- Affiliations
- University of California, San Francisco (US)
- Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora
- Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida
- National Institutes of Health (US)
- DF/Net Research, Inc, Seattle, Washington
- San Francisco Department of Public Health (US)
- University of Michigan (US)
- Gilead Sciences (United States) (US)
- University of Miami (US)
- Whitman-Walker Health (US)
- Gladstone Institutes (US)
- George Washington University (US)
- Corresponding author
- Liu, Albert Y.
- ORCID
- Venue
- JAMA Internal Medicine
- Publisher
- American Medical Association (AMA)
- Published
- 2016-01-01
- Volume
- 176
- Issue
- 1
- Pages
- 75
- ISSN
- 2168-6106 (ISSN-L)
- PMC
- PMC5042323
- OpenAlex
- W2173821673
- Cited by
- 602
- References
- 46
- Citations by year
- 2026: 12 · 2025: 29 · 2024: 42 · 2023: 45 · 2022: 57 · 2021: 47 · 2020: 68 · 2019: 87 · 2018: 83 · 2017: 71 · 2016: 57
- FWCI
- 55.55
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institutes of Health
- National Institute of Mental Health (R01MH095628)
- National Institute of Allergy and Infectious Diseases (R01AI118575, UM1AI069496, P30AI027763, P30AI073961)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Keywords
- pre-exposure prophylaxis, HIV prevention, men who have sex with men, transgender women, tenofovir disoproxil fumarate, emtricitabine, PrEP adherence, sexually transmitted infections, sexual partners, HIV acquisition, HIV testing, community health centers, STD clinics, housing stability
- MeSH terms
- Tenofovir, Assessment of Medication Adherence, Adenine, Adolescent, Adult, Bisexuality, Chlamydia Infections, Community Health Services, District of Columbia, Female, Florida, Gonorrhea, Humans, Male, Middle Aged, Organophosphates, Prospective Studies, San Francisco, Sexual Behavior, Syphilis, HIV Infections, Drug Monitoring, Homosexuality, Male, Anti-HIV Agents, Unsafe Sex, Medication Adherence, Young Adult, Reproductive Health, Transgender Persons, Pre-Exposure Prophylaxis
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