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Prevention Clinical Trials: Highlights of Evidence and Research

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  • Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany ABM, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D, On behalf of the CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168–74.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Abdool Karim S. Is the UNAIDS target sufficient for HIV control in Botswana? The Lancet HIV. 2016;3(5):e195–6.

    Article  Google Scholar 

  • Abdool Karim SS, Kashuba A, Werner L, Abdool Karim Q. Drug concentrations following topical and oral antiretroviral pre-exposure prophylaxis: implications for HIV prevention in women. Lancet. 2011;378:279–81.

    Article  PubMed Central  Google Scholar 

  • Abdool Karim Q, Leask K, Kharsany A, Humphries H, Ntombela F, Samsunder N, Baxter C, Frohlich J, van der Elst L, Abdool Karim SS. Impact of conditional cash incentives on HSV-2 and HIV prevention in rural South African high school students: results of the CAPRISA 007 cluster randomized controlled trial [Abstract TUAC0101LB]. 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention. 2015 19–22 July, Vancouver.

    Google Scholar 

  • Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta M, Puren A. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 trial. PLoS Med. 2005;2(11):1112–22.

    Article  Google Scholar 

  • Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Bouscaillou J, Peytavin G, Mahiane SG, Sitta R, Puren A, Lewis D. Association of the ANRS-12126 male circumcision project with HIV levels among men in a South African township: evaluation of effectiveness using cross-sectional surveys. PLoS Med. 2013;10(9):e1001509.

    Article  PubMed  PubMed Central  Google Scholar 

  • Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, Siva S, Bekker L-G, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Pather A, Naidoo L, Husnik M, Richardson BA, Parikh UM, Mellors JW, Marzinke MA, Hendrix CW, van der Straten A, Ramjee G, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Mayo A, Scheckter R, Berthiaume J, Livant E, Jacobson C, Ndase P, White R, Patterson K, Germuga D, Galaska B, Bunge K, Singh D, Szydlo DW, Montgomery ET, Mensch BS, Torjesen K, Grossman CI, Chakhtoura N, Nel A, Rosenberg Z, McGowan I, Hillier S. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. New England Journal of Medicine. 2016. doi:10.1056/NEJMoa1506110.

  • Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007;369(9562):643–56.

    Article  PubMed  Google Scholar 

  • Baird S, Chirwa E, McIntosh C, Ozler B. The short-term impacts of a schooling conditional cash transfer program on the sexual behavior of young women. Health Econ. 2009. doi:10.1002/hec.1569.

  • Bhave G, Lindan CP, Hudes ES, Desai S, Wagle U, Tripathi SP, Mandel JS. Impact of an intervention on HIV, sexually transmitted diseases, and condom use among sex workers in Bombay, India. AIDS. 1995;9(1):S21–30.

    PubMed  Google Scholar 

  • Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S. 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. Lancet. 2013;381(9883):2083–90.

    Article  PubMed  Google Scholar 

  • Coates TJ, Kulich M, Celentano DD, Zelaya CE, Chariyalertsak S, Chingono A, Gray G, Mbwambo JK, Morin SF, Richter L, Sweat M, van Rooyen H, McGrath N, Fiamma A, Laeyendecker O, Piwowar-Manning E, Szekeres G, Donnell D, Eshleman SH, NIMH Project Accept (HPTN 043) Study Team. Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health. 2014;2(5):e267–77.

    Article  PubMed  PubMed Central  Google Scholar 

  • Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR, Team HS. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016;375(9):830–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J, Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR. Prevention of HIV-1 Infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493–505.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • CONRAD. Facts 001: safety and effectiveness of tenofovir gel in the prevention of human immunodeficiency virus (hiv-1) infection in young women and the effects of tenofovir gel on the incidence of herpes simplex virus (HSV-2) infection. 2011. http://clinicaltrials.gov/ct2/show/NCT01386294. Accessed 20 Sept 2013.

  • Corey L, Gilbert PB, Tomaras GD, Haynes B. F, Pantaleo G, Fauci AS. Immune correlates of vaccine protection against HIV-1 acquisition. Sci Transl Med. 2015;7(310): 310rv317.

    Google Scholar 

  • Fideli US, Allen SA, Musonda R, Trask S, Hahn BH, Weiss H, Mulenga J, Kasolo F, Vermund SH, Aldrovandi GM. Virologic and immunologic determinants of heterosexual transmission of human immunodeficiency virus type 1 in Africa. AIDS Res Hum Retroviruses. 2001;17(10):901–910.

    Article  PubMed  PubMed Central  Google Scholar 

  • Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587–99.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369(9562):657–66.

    Article  PubMed  Google Scholar 

  • Grosskurth H, Mosha F, Todd J, Mwijarubi E, Klokke A, Senkoro K, Mayaud P, Changalucha J, Nicoll A, ka-Gina G, et al. Impact of improved treatment of sexually transmitted diseases on HIV infection in rural Tanzania: randomised controlled trial. Lancet. 1995;346(8974):530–6.

    Article  CAS  PubMed  Google Scholar 

  • Iwuji C, Orne-Gliemann J, Balestre E, Larmarange J, Thiebaut R, Tanser F, Okesola N, Makowa T, Dreyer J, Herbst K, Mc Grath N, Barnighausen T, Boyer S, De Oliveira T, Rekacewicz C, Bazin B, Newell M-L, Pillay D, Dabis F, For the ANRS 12249 TasP Study Group. The impact of universal test and treat on HIV incidence in a rural South African population: ANRS 12249 TasP trial, 2012–2016. Paper presented at the AIDS 2016; 2016; Durban, South Africa.

    Google Scholar 

  • Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, Palanee T, Nakabiito C, van der Straten A, Noguchi L, Hendrix CW, Dai JY, Ganesh S, Mkhize B, Taljaard M, Parikh UM, Piper J, Mâsse B, Grossman C, Rooney J, Schwartz JL, Watts H, Marzinke MA, Hillier SL, McGowan IM, Chirenje ZM. Tenofovir-based preexposure prophylaxis for hiv infection among African women. N Engl J Med. 2015;372(6):509–18.

    Article  PubMed  PubMed Central  Google Scholar 

  • Molina J-M, Capitant C, Spire B, Pialoux G, Chidiac C, Charreau I, Tremblay C, Meyer L, Delfraissy JF, On behalf of the ANRS Ipergay Study Group. On demand PrEP with oral TDF-FTC in MSM: results of the ANRS Ipergay Trial. [Abstract 23LB]. Paper presented at the Conference on Retroviruses and Opportunistic Infections (CROI); 2015; Seattle, Washington.

    Google Scholar 

  • Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z, Ring Study T. Safety and efficacy of a dapivirine vaginal ring for HIV prevention in women. N Engl J Med. 2016;375(22):2133–43.

    Article  CAS  PubMed  Google Scholar 

  • Ng BE, Butler LM, Horvath T, Rutherford GW. Population-based biomedical sexually transmitted infection control interventions for reducing HIV infection. Cochrane Database Syst Rev. 2011;(3):CD001220.

    Google Scholar 

  • Pettifor A, MacPhail C, Nguyen N, Rosenberg M. Can money prevent the spread of HIV? A review of cash payments for HIV prevention. AIDS and Behavior. 2012;16(7):1729–38.

    Article  PubMed  PubMed Central  Google Scholar 

  • Qian HZ, Ruan Y, Liu Y, Milam DF, L. Spiegel HM, Yin L, Li D, Shepherd BE, Shao Y, Vermund SH. Lower HIV Risk Among Circumcised Men Who Have Sex With Men in China: Interaction With Anal Sex Role in a Cross-Sectional Study. J Acquir Immune Defic Syndr. 2016;71(4):444–451.

    Google Scholar 

  • Quinn TC, Wawer MJ, Sewankambo N, Serwadda D, Li C, Wabwire-Mangen F, Meehan MO, Lutalo T, Gray RH. Viral load and heterosexual transmission of human immunodeficiency virus type 1: Rakai Project Study Group. N Engl J Med. 2000;342(13):921–9.

    Article  CAS  PubMed  Google Scholar 

  • Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Kaewkungwal J, Chiu J, Paris R, Premsri N, Namwat C, de Souza M, Adams E, Benenson M, Gurunathan S, Tartaglia J, McNeil JG, Francis DP, Stablein D, Birx DL, Chunsuttiwat S, Khamboonruang C, Thongcharoen P, Robb ML, Michael NL, Kunasol P, Kim JH. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009;361(23):2209–20.

    Article  CAS  PubMed  Google Scholar 

  • The VCT efficacy study group. Efficacy of voluntary HIV-1 counselling and testing in individuals and couples in Kenya, Tanzania, and Trinidada: a randomised trial. Lancet. 2000;356:103–12.

    Article  Google Scholar 

  • Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–34.

    Article  CAS  PubMed  Google Scholar 

  • Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, Malahleha M, Owino F, Manongi R, Onyango J, Temu L, Monedi MC, Mak’Oketch P, Makanda M, Reblin I, Makatu SE, Saylor L, Kiernan H, Kirkendale S, Wong C, Grant R, Kashuba A, Nanda K, Mandala J, Fransen K, Deese J, Crucitti T, Mastro TD, Taylor D, For the FEM-PrEP Study Group. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367:411–22.

    Article  PubMed  PubMed Central  Google Scholar 

  • Vissers DC, Voeten HA, Nagelkerke NJ, Habbema JD, de Vlas SJ. The impact of pre-exposure prophylaxis (PrEP) on HIV epidemics in Africa and India: a simulation study. PLoS One. 2008;3(5):e2077.

    Article  PubMed  PubMed Central  Google Scholar 

  • Wagman JA, Gray RH, Campbell JC, Thoma M, Ndyanabo A, Ssekasanvu J, Nalugoda F, Kagaayi J, Nakigozi G, Serwadda D, Brahmbhatt H. Effectiveness of an integrated intimate partner violence and HIV prevention intervention in Rakai, Uganda: analysis of an intervention in an existing cluster randomised cohort. Lancet Glob Health. 2015;3(1):e23–33.

    Article  PubMed  Google Scholar 

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Baxter, C., Karim, Q.A. (2017). Prevention Clinical Trials: Highlights of Evidence and Research. In: Hope, T., Richman, D., Stevenson, M. (eds) Encyclopedia of AIDS. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9610-6_256-1

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