Preexposure prophylaxis for HIV infection integrated with municipal- and community-based sexual health services.

Liu, Albert Y.; Cohen, Stephanie E.; Vittinghoff, Eric; Anderson, Peter L.; Doblecki-Lewis, Susanne; Bacon, Oliver; Chege, Wairimu; Postle, Brian S.; Matheson, Tim; Amico, K. Rivet; Liegler, Teri; Rawlings, M. Keith; Trainor, Nikole; Blue, Robert Wilder; Estrada, Yannine; Coleman, Megan E.; Cardenas, Gabriel; Feaster, Daniel J.; Grant, Robert; Philip, Susan S.; Elion, Richard; Buchbinder, Susan; Kolber, Michael A.

doi:10.1001/jamainternmed.2015.4683

Cited by 602HIV/AIDS Research and InterventionsHIV, Drug Use, Sexual RiskHIV/AIDS drug development and treatment

Preexposure prophylaxis for HIV infection integrated with municipal- and community-based sexual health services.

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Liu, Albert Y., Cohen, Stephanie E., Vittinghoff, Eric, Anderson, Peter L., Doblecki-Lewis, Susanne, Bacon, Oliver, Chege, Wairimu, Postle, Brian S. +15 more·2016·JAMA Internal Medicine

DOI 10.1001/jamainternmed.2015.4683PMC PMC5042323

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Abstract

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 because increased rates of STI acquisition have been described.
“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]
Citation (85–87) is attached to the claim about increased STI acquisition, not the guideline recommendation cited to (80). The Results (Sexual and drug use behaviors and STIs; page unavailable) report high STI incidence among PrEP users but say it was stable across quarterly intervals. The Discussion likewise says STI incidence was stable over time, rather than increased. (LLM, conf=0.86)
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Authors' Reply
Cohen, S. E., Vittinghoff, E., Doblecki‐Lewis, S., Coleman, M. E., Bacon, O., Elion, R., Kolber, M. A., Buchbinder, S., & Liu, A. (2015) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000000716 · Cited by 6 · see citing works
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Research works printed but not linked: 6

[4]McCormack S Dunn D Pragmatic Open-Label Randomised Trial of Preexposure Prophylaxis: The PROUD Study [Abstract 22LB] Conference on Retroviruses and Opportunistic Infections (CROI) Seattle, WA February 23-26, 2015
[5]Molina JM Capitant C Spire B On Demand PrEP With Oral TDF-FTC in MSM: Results of the ANRS Ipergay Trial [Abstract 24LB] Conference on Retroviruses and Opportunistic Infections (CROI) Seattle, WA February 23-26, 2015 2015
[40]Liu A Developing and Implementing a Mobile Health (mHealth) Adherence Support System for HIV-Uninfected Men who have Sex with Men (MSM) Taking Pre-Exposure Prophylaxis (PrEP): The iText Study 8th International Conference on HIV Treatment and Prevention Adherence; [AB 229] Miami, FL June 2-4, 2013
[42]Scott H Vittinghoff E Irvin R Sex Pro: A Personalized HIV Risk Assessment Tool for Men Who Have Sex With Men [Abstract 1017] Conference on Retroviruses and Opportunistic Infections (CROI) Seattle, WA February 23-26, 2015
[43]Vallabhaneni S Hartogensis W Sheon N Harnessing mobile health technology in HIV research: a pilot study utilizing a smartphone-based daily-diary app to collect event-level sexual activity data [Abstract TUPE358] 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention 2013 Kuala Lampur, Malaysia
[46]Cohen SE Vittinghoff E Doblecki-Lewis S Response to “Race and the public health impact potential of PrEP in the United States” J Acquir Immune Defic Syndr 2015 PMC4558271 26049284

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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: Liu, Albert Y.
Cohen, Stephanie E.
Vittinghoff, Eric
Anderson, Peter L.
Bacon, Oliver
Chege, Wairimu
Matheson, Tim
Amico, K. Rivet
Rawlings, M. Keith
Estrada, Yannine
Coleman, Megan E.
Feaster, Daniel J.
Grant, Robert
Philip, Susan S.
Buchbinder, Susan
Kolber, Michael A.
Venue: JAMA Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2016-01-01
Volume: 176
Issue: 1
Pages: 75
ISSN: 2168-6106 (ISSN-L)
DOI: 10.1001/jamainternmed.2015.4683
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 · 2015: 3
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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Preexposure prophylaxis for HIV infection integrated with municipal- and community-based sexual health services.

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