Syphilis — Oral Doxycycline for the Prevention of Syphilis in Men Who Have Sex With Men (DaDHS)
Citation(s)
Abudu L, Blair I, Fraise A, Cheng KK Methicillin-resistant Staphylococcus aureus (MRSA): a community-based prevalence survey. Epidemiol Infect. 2001 Jun;126(3):351-6. doi: 10.1017/s0950268801005416.
Aral SO, Blanchard JF The Program Science initiative: improving the planning, implementation and evaluation of HIV/STI prevention programs. Sex Transm Infect. 2012 Apr;88(3):157-9. doi: 10.1136/sextrans-2011-050389. Epub 2012 Feb 22.
Bolan RK, Beymer MR, Weiss RE, Flynn RP, Leibowitz AA, Klausner JD Doxycycline prophylaxis to reduce incident syphilis among HIV-infected men who have sex with men who continue to engage in high-risk sex: a randomized, controlled pilot study. Sex Transm Dis. 2015 Feb;42(2):98-103. doi: 10.1097/OLQ.0000000000000216.
Fedson DS, Scott JA The burden of pneumococcal disease among adults in developed and developing countries: what is and is not known. Vaccine. 1999 Jul 30;17 Suppl 1:S11-8. doi: 10.1016/s0264-410x(99)00122-x. Erratum In: Vaccine 1999 Nov 12;18(7-8):764. Scott G [corrected to Scott JA].
Fleming DT, Wasserheit JN From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect. 1999 Feb;75(1):3-17. doi: 10.1136/sti.75.1.3.
Sehgal SC, Sugunan AP, Murhekar MV, Sharma S, Vijayachari P Randomized controlled trial of doxycycline prophylaxis against leptospirosis in an endemic area. Int J Antimicrob Agents. 2000 Feb;13(4):249-55. doi: 10.1016/s0924-8579(99)00134-x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.