REFERENCES
- UNAIDS/WHO. Report on the Global HIV/AIDS Epidemic 2008. Geneva, Switzerland: UNAIDS; 2008.
- Underhill K, Montgomery P, Operario D. Abstinence-plus programs for HIV infection prevention in high-income countries. Cochrane Database Syst Rev. 2008;CD007006.
- Underhill K, Operario D, Montgomery P. Abstinence-only programs for HIV infection prevention in high-income countries. Cochrane Database Syst Rev. 2007;CD005421.
- Denison JA, O'Reilly KR, Schmid GP, et al. HIV voluntary counseling and testing and behavioral risk reduction in developing countries: a meta-analysis, 1990-2005. AIDS Behav. 2008;12:363–373.
- Noar SM. Behavioral interventions to reduce HIV-related sexual risk behavior: review and synthesis of meta-analytic evidence. AIDS Behav. 2008;12:335–353.
- Auvert B, Taljaard D, Lagarde E, et al. Randomized, con-trolled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005;2:e298.
- Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a ran-domised controlled trial. Lancet. 2007;369:643–656.
- Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666.
- Sangani P, Rutherford G, Wilkinson D. Population-based interventions for reducing sexually transmitted infections, including HIV infection. Cochrane Database Syst Rev. 2004;CD001220.
- Padian NS, Buve A, Balkus J, et al. Biomedical interven-tions to prevent HIV infection: evidence, challenges, and way forward. Lancet. 2008;372:585–599.
- Mills E, Cooper C, Anema A, Guyatt G. Male circumcision for the prevention of heterosexually acquired HIV infection: a meta-analysis of randomized trials involving 11,050 men. HIV Med. 2008;9:332–335.
- Okwundu Cl, Okoromah C. Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high risk individuals (Protocol). Cochrane Database Syst Rev. 2008;CD007189.
- Wilkinson D, Ramjee G, Tholandi M, Rutherford G. Non-oxyno1-9 for preventing vaginal acquisition of HIV infec-tion by women from men. Cochrane Database Syst Rev. 2002;CD003936.
- Moher D, Schulz KF, Altman D. The CONSORT state-ment: revised recommendations for improving the qual-ity of reports of parallel-group randomized trials. JAMA. 2001;285:1987–1991.
- Moher D. CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. JAMA. 1998;279:1489–1491.
- Higgins JPT, Green S, eds. Cochrane Handbook for Sys-tematic Reviews of Interventions. Version 5.0.0. Cochrane Collaboration; 2008. Available at: www.cochrane.org.
- Cuzick J. A Wilcoxon-type test for trend. Stat Med. 1985;4:87–89.
- Kamali A, Quigley M, Nakiyingi J, et al. Syndromic man-agement of sexually-transmitted infections and behav-iour change interventions on transmission of HIV-1 in rural Uganda: a community randomised trial. Lancet. 2003;361:645–652.
- Karim SA, Coletti A, Richardson B, et al. Safety and effec-tiveness of vaginal microbicides buffergel and 0.5% PRO 2000/5 gel for the prevention of HIV infection in women: results of the HPTN 035 Trial. Abstract presented at: 16th Conference on Retroviruses and Opportunistic Infections; February 2009; Montreal, Quebec.
- Van Damme L, Govinden R, Mirembe FM, et al. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med. 2008;359: 463–472.
- Van Damme L, Ramjee G, Alary M, et al. Effectiveness of COL-1492, a nonoxyno1-9 vaginal gel, on HIV-1 transmis-sion in female sex workers: a randomised controlled trial. Lancet. 2002;360:971–977.
- Halpern V, Ogunsola F, Obunge O, et al. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria. PLoS ONE. 2008;3:e3784.
- Kreiss J, Ngugi E, Holmes K, et al. Efficacy of non-oxynol 9 contraceptive sponge use in preventing hetero-sexual acquisition of HIV in Nairobi prostitutes. JAMA. 1992;268:477–482.
- Richardson BA, Lavreys L, Martin HL Jr, et al. Evaluation of a low-dose nonoxyno1-9 gel for the prevention of sexu-ally transmitted diseases: a randomized clinical trial. Sex Transm Dis. 2001;28:394–400.
- Roddy RE, Zekeng L, Ryan KA, et al. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission of sexually transmitted diseases. N Engl J Med. 1998;339:504–510.
- Peterson L, Nanda K, Opoku BK, et al. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, dou-ble-blind, randomized, placebo-controlled trial in Ghana. PLoS ONE. 2007;2:e1312.
- Feldblum PJ, Adeiga A, Bakare R, et al. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS ONE. 2008;3:e1474.
- Tatoud R. MDP update: MDP301 phase III trial continues but one arm closes. Microbicides Development Pro-gramme, February 14, 2008. Available at: http://www.mdp.mrc.ac.uk. Accessed March 29, 2009.
- Wawer MJ, Sewankambo NK, Serwadda D, et al. Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial. Rakai Project Study Group. Lancet. 1999;353:525–535.
- Buchbinder SP, Mehrotra DV, Duerr A, et al. Efficacy assess-ment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008;372:1881–1893.
- Gray G, Allen MA, Bekker L, et al. Results from the Pham-bili (HVTN 503) study: A multicenter double-blind placebo-controlled phase IIB test-of-concept study to evaluate the safety and efficacy of the MRKad5 HIV-1 gag/pol/nef vaccine in HIV-1 uninfected South Africans. Abstract pre-sented at: AIDS Vaccine 2008 Conference; October 2008; Cape Town, South Africa.
- Peterson L, Taylor D, Roddy R, et al. Tenofovir disoproxil fumarate for prevention of HIV infection in women: a phase 2, double-blind, randomized, placebo-controlled trial. PLoS Clin Trials. 2007;2:e27.
- Padian NS, van der Straten A, Ramjee G, et al. Diaphragm and lubricant gel for prevention of HIV acquisition in south-ern African women: a randomised controlled trial. Lancet. 2007;370:251–261.
- Grosskurth H, Mosha F, Todd J, et al. Impact of improved treatment of sexually transmitted diseases on HIV infec-tion in rural Tanzania: randomised controlled trial. Lancet. 1995;346:530–536.
- Gregson S, Adamson S, Papaya S, et al. Impact and pro-cess evaluation of integrated community and clinic-based HIV-1 control: a cluster-randomised trial in eastern Zimba-bwe. PLoS Med. 2007;4:e102.
- Kaul R, Kimani J, Nagelkerke NJ, et al. Monthly antibiotic chemoprophylaxis and incidence of sexually transmitted infections and HIV-1 infection in Kenyan sex workers: a randomized controlled trial. JAMA. 2004;291:2555–2562.
- Flynn NM, Forthal DN, Harro CD, et al. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis. 2005;191:654–665.
- Mitka M. Critics bash HIV vaccine trial analysis. JAMA. 2003;289:1491.
- Ghys PD, Diallo MO, Ettiegne-Traore V, et al. Effect of interventions to control sexually transmitted disease on the incidence of HIV infection in female sex workers. AIDS. 2001;15:1421–1431.
- Celum C, Wald A, Hughes J, et al. Effect of aciclovir on HIV-1 acquisition in herpes simplex virus 2 seropositive women and men who have sex with men: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;371:2109–2119.
- Skoler-Karpoff S, Ramjee G, Ahmed K, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1977–1987.
- Altman DG. Statistics in medical journals: some recent trends. Stat Med. 2000;19:3275–3289.
- Watson-Jones D, Weiss HA, Rusizoka M, et al. Effect of herpes simplex suppression on incidence of HIV among women in Tanzania. N Engl J Med. 2008;358: 1560–1571.
- Pitisuttithum P, Gilbert P, Gurwith M, et al. Randomized, double-blind, placebo-controlled efficacy trial of a biva-lent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J Infect Dis. 2006;194:1661–1671.
- Lagakos SW, Gable AR. Challenges to HIV prevention - seeking effective measures in the absence of a vaccine. N Engl J Med. 2008;358:1543–1545.
- Altman DG, Schulz KF, Moher D, et al. The revised CON-SORT statement for reporting randomized trials: expla-nation and elaboration. Ann Intern Med. 2001;134:663–694.
- Laine C, Horton R, DeAngelis CD, et al. Clinical trial reg-istration--looking back and moving ahead. N Engl J Med. 2007;356:2734–2736.
- Gulmezoglu AM, Pang T, Horton R, Dickersin K. WHO facilitates international collaboration in setting standards for clinical trial registration. Lancet. 2005;365:1829–1831.
- Bates R, Bertelsen J, Chauvette P, et al. Development of a centralized trials registry for research on HIV/AIDS preven-tion. Presented at: 6th International Cochrane Colloquium; 1998; Baltimore.
- Roddy RE, Zekeng L, Ryan KA, et al. Effect of nonoxyno1-9 gel on urogenital gonorrhea and chlamydial infection: a randomized controlled trial. JAMA. 2002;287:1117–1122.
- Mauck CK, Straten A. Using objective markers to assess participant behavior in HIV prevention trials of vaginal micro-bicides. J Acquir Immune Defic Syndr 2008;49:64–69.
- Baeten JM, Richardson BA, Martin HL Jr, et al. Trends in HIV-1 incidence in a cohort of prostitutes in Kenya: impli-cations for HIV-1 vaccine efficacy trials. J Acquir Immune Defic Syndr 2000;24:458–464.
- Ramjee G, Kapiga S, Weiss S, et al. The value of site pre-paredness studies for future implementation of phase 2/ 11b/111 HIV prevention trials: experience from the HPTN 055 study. J Acquir Immune Defic Syndr 2008;47:93–100.
- Grijsen ML, Graham SM, Mwangome M, et al. Screen-ing for genital and anorectal sexually transmitted infec-tions in HIV prevention trials in Africa. Sex Transm Infect. 2008;84:364–370.
- de Bruyn G, Martinson N, Nkala B, et al. Male circumcision as a component of the standard for HIV prevention: Expe-rience from a phase Ilb vaccine trial in Soweto. Presented at: 15th Conference on Retroviruses and Opportunistic Infections; 2008; Boston.
- Auvert B, Males S, Puren A, et al. Can highly active anti-retroviral therapy reduce the spread of HIV?: A study in a township of South Africa. J Acquir Immune Defic Syndr. 2004;36:613–621.
- Gray RH, Li X, Wawer MJ, et al. Stochastic simulation of the impact of antiretroviral therapy and HIV vaccines on HIV transmission; Rakai, Uganda. AIDS. 2003;17: 1941–1951.
- Altman DG, Bland JM. Absence of evidence is not evi-dence of absence. BMJ. 1995;311:485.
- Huwiler-Muntener K, Juni P, Junker C, Egger M. Quality of reporting of randomized trials as a measure of method-ologic quality. JAMA. 2002;287:2801–2804.
- Raymond EG, Taylor D, Cates W Jr, et al. Pregnancy in effectiveness trials of HIV prevention agents. Sex Transm Dis. 2007;34:1035–1039.
- Hayes R, Mosha F, Nicoll A, et al. A community trial of the impact of improved sexually transmitted disease treatment on the HIV epidemic in rural Tanzania: 1. Design. AIDS. 1995;9:919–926.
- Wawer MJ, Gray RH, Sewankambo NK, et al. A random-ized, community trial of intensive sexually transmitted disease control for AIDS prevention, Rakai, Uganda. AIDS. 1998;12:1211–1225.
- Kamali A, Kinsman J, Nalweyiso N, et al. A community ran-domized controlled trial to investigate impact of improved STD management and behavioural interventions on HIV inci-dence in rural Masaka, Uganda: trial design, methods and baseline findings. Trop Med Int Health. 2002;7:1053–1063.
- Fonck K, Kaul R, Kimani J, et al. A randomized, placebo-controlled trial of monthly azithromycin prophylaxis to pre-vent sexually transmitted infections and HIV-1 in Kenyan sex workers: study design and baseline findings. Int J STD AIDS. 2000;11:804–811.
- Harro CD, Judson FN, Gorse GJ, et al. Recruitment and baseline epidemiologic profile of participants in the first phase 3 HIV vaccine efficacy trial. J Acquir Immune Defic Syndr 2004;37:1385–1392.