PrEP Provider Toolkit

Resources

References


  1. Centers for Disease Control and Prevention. (2021). Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update a clinical practice guideline. U.S. Department of Health and Human Services. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf  

  2. Fiebig, Wright, D. J., Rawal, B. D., Garrett, P. E., Schumacher, R. T., Peddada, L., Heldebrant, C., Smith, R., Conrad, A., Kleinman, S. H., & Busch, M. P. (2003). Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS (London), 17(13), 1871–1879. https://doi.org/10.1097/00002030-200309050-00005 

  3. DetermineTM HIV-1/2 Ag/Ab Combo. (n.d.). Retrieved September 19, 2022, from https://www.globalpointofcare.abbott/en/product-details/determine-1-2-ag-ab-combo.html 

  4. Branson, B.M., Owen, M.S., Wesolowshi, L.G., Bennett, B., Werner, B.G., Wroblewski, K.E., Pentella, M.A. (2014). Laboratory testing for the diagnosis of HIV infection: updated recommendations. https://doi.org/10.15620/cdc.23447 

  5. Delaney, Hanson, D. L., Masciotra, S., Ethridge, S. F., Wesolowski, L., & Owen, S. M. (2017). Time until emergence of HIV test reactivity following infection with HIV-1: implications for interpreting test results and retesting after exposure. Clinical Infectious Diseases, 64(1), 53–59. https://doi.org/10.1093/cid/ciw666 

  6. Patel, Borkowf, C. B., Brooks, J. T., Lasry, A., Lansky, A., & Mermin, J. (2014). Estimating per-act HIV transmission risk: a systematic review. AIDS (London), 28(10), 1509–1519. https://doi.org/10.1097/QAD.0000000000000298 

  7. Masciotra, Luo, W., Westheimer, E., Cohen, S. E., Gay, C. L., Hall, L., Pan, Y., Peters, P. J., & Owen, S. M. (2017). Performance evaluation of the FDA-approved DetermineTM HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens. Journal of Clinical Virology, 91, 95–100. https://doi.org/10.1016/j.jcv.2017.03.019 

  8. Daar, Pilcher, C. D., & Hecht, F. M. (2008). Clinical presentation and diagnosis of primary HIV-1 infection. Current Opinion in HIV & AIDS, 3(1), 10–15. https://doi.org/10.1097/COH.0b013e3282f2e295 

  9. Centers for Disease Control and Prevention. (2021). Estimated HIV incidence and prevalence in the United States, 2015–2019. U.S. Department of Health and Human Services. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-26-1.pdf 

  10. Centers for Disease Control and Prevention. (2021). Diagnoses of HIV infection in the United States and dependent areas, 2019. U.S. Department of Health and Human Services.   https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf 

  11. Centers for Disease Control and Prevention. (2022). Diagnoses of HIV infection in the United States and dependent areas, 2020. U.S. Department of Health and Human Services.
    https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2020-updated-vol-33.pdf 

  1. Kahn, & Walker, B. D. (1998). Acute human immunodeficiency virus type 1 infection. The New England Journal of Medicine, 339(1), 33–39. https://doi.org/10.1056/NEJM199807023390107 

  2. Cohen, Shaw, G. M., McMichael, A. J., & Haynes, B. F. (2011). Acute HIV-1 infection. The New England Journal of Medicine, 364(20), 1943–1954. https://doi.org/10.1056/NEJMra1011874 

  3. Mayer, Molina, J.-M., Thompson, M. A., Anderson, P. L., Mounzer, K. C., De Wet, J. J., DeJesus, E., Jessen, H., Grant, R. M., Ruane, P. J., Wong, P., Ebrahimi, R., Zhong, L., Mathias, A., Callebaut, C., Collins, S. E., Das, M., McCallister, S., Brainard, D. M., … Hare, C. B. (2020). Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. The Lancet (British Edition), 396(10246), 239–254. https://doi.org/10.1016/S0140-6736(20)31065-5 

  4. Grant, Anderson, P. L., McMahan, V., Liu, A., Amico, K. R., Mehrotra, M., Hosek, S., Mosquera, C., Casapia, M., Montoya, O., Buchbinder, S., Veloso, V. G., Mayer, K., Chariyalertsak, S., Bekker, L.-G., Kallas, E. G., Schechter, M., Guanira, J., Bushman, L., … Glidden, D. V. (2014). Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. The Lancet Infectious Diseases, 14(9), 820–829. https://doi.org/10.1016/S1473-3099(14)70847-3 

  5. Grant, Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., Goicochea, P., Casapía, M., Guanira-Carranza, J. V., Ramirez-Cardich, M. E., Montoya-Herrera, O., Fernández, T., Veloso, V. G., Buchbinder, S. P., Chariyalertsak, S., Schechter, M., Bekker, L.-G., Mayer, K. H., Kallás, E. G., … Glidden, D. V. (2010). Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. The New England Journal of Medicine, 363(27), 2587–2599. https://doi.org/10.1056/NEJMoa1011205 

  6. Baeten, Donnell, D., Mugo, N. R., Ndase, P., Thomas, K. K., Campbell, J. D., Wangisi, J., Tappero, J. W., Bukusi, E. A., Cohen, C. R., Katabira, E., Ronald, A., Tumwesigye, E., Were, E., Fife, K. H., Kiarie, J., Farquhar, C., John-Stewart, G., Kidoguchi, L., … Celum, C. (2014). Single-agent tenofovir versus combination emtricitabine plus tenofovir for pre-exposure prophylaxis for HIV-1 acquisition: an update of data from a randomised, double-blind, phase 3 trial. The Lancet Infectious Diseases, 14(11), 1055–1064. https://doi.org/10.1016/S1473-3099(14)70937-5 

  7. Thigpen, Kebaabetswe, P. M., Paxton, L. A., Smith, D. K., Rose, C. E., Segolodi, T. M., Henderson, F. L., Pathak, S. R., Soud, F. A., Chillag, K. L., Mutanhaurwa, R., Chirwa, L. I., Kasonde, M., Abebe, D., Buliva, E., Gvetadze, R. J., Johnson, S., Sukalac, T., Thomas, V. T., … Brooks, J. T. (2012). Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. The New England Journal of Medicine, 367(5), 423–434. https://doi.org/10.1056/NEJMoa1110711 

  8. Choopanya, Martin, M., Suntharasamai, P., Sangkum, U., Mock, P. A., Leethochawalit, M., Chiamwongpaet, S., Kitisin, P., Natrujirote, P., Kittimunkong, S., Chuachoowong, R., Gvetadze, R. J., McNicholl, J. M., Paxton, L. A., Curlin, M. E., Hendrix, C. W., & Vanichseni, S. (2013). Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir study): a randomised, double-blind, placebo-controlled phase 3 trial. The Lancet (British Edition), 381(9883), 2083–2090. https://doi.org/10.1016/S0140-6736(13)61127-7 

  9. Martin, Vanichseni, S., Suntharasamai, P., Sangkum, U., Mock, P. A., Chaipung, B., Worrajittanon, D., Leethochawalit, M., Chiamwongpaet, S., Kittimunkong, S., Gvetadze, R. J., McNicholl, J. M., Paxton, L. A., Curlin, M. E., Holtz, T. H., Samandari, T., & Choopanya, K. (2016). Factors associated with the uptake of and adherence to HIV pre-exposure prophylaxis in people who have injected drugs: an observational, open-label extension of the Bangkok Tenofovir study. The Lancet HIV, 4(2), e59–e66. https://doi.org/10.1016/S2352-3018(16)30207-7 

  10. Landovitz, Donnell, D., Clement, M. E., Hanscom, B., Cottle, L., Coelho, L., Cabello, R., Chariyalertsak, S., Dunne, E. F., Frank, I., Gallardo-Cartagena, J. A., Gaur, A. H., Gonzales, P., Tran, H. V., Hinojosa, J. C., Kallas, E. G., Kelley, C. F., Losso, M. H., Madruga, J. V., … Sued, O. (2021). Cabotegravir for HIV prevention in cisgender men and transgender women. The New England Journal of Medicine, 385(7), 595–608. https://doi.org/10.1056/NEJMoa2101016 

  11. Delany-Moretlwe, Hughes, J. P., Bock, P., Hunidzarira, P., Kalonji, D., Kayange, N., Makhema, J., Mandima, P., Mathew, C., Spooner, E., Mpendo, J., Mukwekwerere, P., Mgodi, N., Ntege, P. N., Nakabiito, C., Nuwagaba-Biribonwoha, H., Panchia, R., Singh, N., Farrior, J., … Marzinke, M. A. (2022). Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. The Lancet (British Edition), 399(10337), 1779–1789. https://doi.org/10.1016/S0140-6736(22)00538-4 

  12. Molina, Capitant, C., Spire, B., Pialoux, G., Cotte, L., Charreau, I., Tremblay, C., Le Gall, J.-M., Cua, E., Pasquet, A., Raffi, F., Pintado, C., Chidiac, C., Chas, J., Charbonneau, P., Delaugerre, C., Suzan-Monti, M., Loze, B., Fonsart, J., … Delfraissy, J.-F. (2015). On-demand preexposure prophylaxis in men at high risk for HIV-1 infection. The New England Journal of Medicine, 373(23), 2237–2246. https://doi.org/10.1056/NEJMoa1506273 

  13. Antoni, Tremblay, C., Delaugerre, C., Charreau, I., Cua, E., Rojas Castro, D., Raffi, F., Chas, J., Huleux, T., Spire, B., Capitant, C., Cotte, L., Meyer, L., Molina, J.-M., Aboulker, J.-P., Bajos, N., Baril, J.-G., Besnier, M., Binesse, J., … Chidiac, C. (2020). On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial. The Lancet HIV, 7(2), e113–e120. https://doi.org/10.1016/S2352-3018(19)30341-8 

  14. Eisinger, Dieffenbach, C. W., & Fauci, A. S. (2019). HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable. JAMA: The Journal of the American Medical Association, 321(5), 451–452. https://doi.org/10.1001/jama.2018.21167 

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  17. Freeman, Weiss, H. A., Glynn, J. R., Cross, P. L., Whitworth, J. A., & Hayes, R. J. (2006). Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS (London), 20(1), 73–83. https://doi.org/10.1097/01.aids.0000198081.09337.a7 

  18. Atashili, Poole, C., Ndumbe, P. M., Adimora, A. A., & Smith, J. S. (2008). Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS (London), 22(12), 1493–1501. https://doi.org/10.1097/QAD.0b013e3283021a37 

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  20. Centers for Disease Control and Prevention. (2018). Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV—United States, 2016. U.S. Department of Health and Human Services.  https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

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  22. Mugo, Heffron, R., Donnell, D., Wald, A., Were, E. O., Rees, H., Celum, C., Kiarie, J. N., Cohen, C. R., Kayintekore, K., & Baeten, J. M. (2011). Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. AIDS (London), 25(15), 1887–1895. https://doi.org/10.1097/QAD.0b013e32834a9338 

  23. Thomson, Hughes, J., Baeten, J. M., John-Stewart, G., Celum, C., Cohen, C. R., Ngure, K., Kiarie, J., Mugo, N., & Heffron, R. (2018). Increased risk of HIV acquisition among women throughout pregnancy and during the postpartum period: a prospective per-coital-act analysis among women with HIV-infected partners. The Journal of Infectious Diseases, 218(1), 16–25. https://doi.org/10.1093/infdis/jiy113 

  24. Mugwanya, John-Stewart, G., & Baeten, J. (2017). Safety of oral tenofovir disoproxil fumarate-based HIV pre-exposure prophylaxis use in lactating HIV-uninfected women. Expert Opinion on Drug Safety, 16(7), 867–871. https://doi.org/10.1080/14740338.2017.1338271 

  25. Benaboud, Pruvost, A., Coffie, P. A., Ekouévi, D. K., Urien, S., Arrivé, E., Blanche, S., Théodoro, F., Avit, D., Dabis, F., Tréluyer, J.-M., & Hirt, D. (2011). Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Côte d’Ivoire, in the ANRS 12109 TEmAA study, step 2. Antimicrobial Agents and Chemotherapy, 55(3), 1315–1317. https://doi.org/10.1128/AAC.00514-10 

  26. Waitt, Olagunju, A., Nakalema, S., Kyohaire, I., Owen, A., Lamorde, M., & Khoo, S. (20 18). Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs. Journal of Antimicrobial Chemotherapy, 73(4), 1013–1019. https://doi.org/10.1093/jac/dkx507 

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  28. Cazanave, Dupon, M., Lavignolle-Aurillac, V., Barthe, N., Lawson-Ayayi, S., Mehsen, N., Mercié, P., Morlat, P., Thiébaut, R., & Dabis, F. (2008). Reduced bone mineral density in HIV-infected patients: prevalence and associated factors. AIDS (London), 22(3), 395–402. https://doi.org/10.1097/QAD.0b013e3282f423dd 

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  37. Ogbuagu, Ruane, P. J., Podzamczer, D., Salazar, L. C., Asmuth, D. M., Wohl, D., Gilson, R., Shao, Y., Cox, S., Kintu, A., Carter, C., Baeten, J. M., Brainard, D. M., Whitlock, G., Brunetta, J. M., Spinner, C. D., Antinori, A., Apea, V., Avery, A., … Brar, I. (2021). Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet HIV, 8(7), e397–e407. https://doi.org/10.1016/S2352-3018(21)00071-0 

  38. Nelson, Weng, M. K., Hofmeister, M. G., Moore, K. L., Doshani, M., Kamili, S., Koneru, A., Haber, P., Hagan, L., Romero, J. R., Schillie, S., & Harris, A. M. (2020). Prevention of hepatitis A virus infection in the United States: recommendations of the advisory committee on immunization practices, 2020. MMWR. Morbidity and Mortality Weekly Report. Recommendations and Reports, 69(5), 1–38. https://doi.org/10.15585/mmwr.rr6905a1 

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