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Prevention, Screening, and Treatment of Sexually Transmitted Infections
Published in James M. Rippe, Lifestyle Medicine, 2019
Other barrier methods are available, including the female condom and diaphragm. There are two female condoms available that are sold over-the-counter and can be inserted up to eight hours before intercourse. The “FC” is a polyurethane sheath, and the “FC2” is a nitrile sheath. The Caya Contoured Diaphragm is a single-sized, reusable, non-latex diaphragm. It is made of silicone rubber molded over a circular nylon spring. It has two cup-like structures. The larger fits over the cervix and the smaller is for finger placement for removal. It may be effectively used with a contraceptive gel.5 Male and female condoms are effective barriers to STIs, but the diaphragm has limited data regarding its use as a means of preventing infection. Vaginal microbicides are a current area of research and development. Topical agents that would potentially prevent STI transmission and would function as an adjunct to another method, such as the male condom, are being studied.6
Investigational Antiviral Drugs
Published in M. Lindsay Grayson, Sara E. Cosgrove, Suzanne M. Crowe, M. Lindsay Grayson, William Hope, James S. McCarthy, John Mills, Johan W. Mouton, David L. Paterson, Kucers’ The Use of Antibiotics, 2017
John Mills, Suzanne M. Crowe, Marianne Martinello
Dapivirine (TMC120) is a diaryltriazine nonnucleoside reverse transcriptase inhibitor under development for topical use as a vaginal microbicide (cervical rings or vaginal coating) to prevent HIV infection in women. Dapivirine gel (0.05%) and film (1.25mg) deliver drug at concentrations that block HIV ex vivo. Although more difficult to insert than the gel, women find the film more comfortable with less leakage. The flexible ring is self-inserted every 4 weeks and slowly releases drug into the vaginal tissue. In vitro, it is well tolerated by T cells, epithelial cells, macrophages, and cervical explant cells and has potent and prolonged (up to 6 days) activity against a range of NNRTI-resistant HIV strains. It has a good safety profile in 17 phase I/II studies. A phase III, randomized, double-blind, placebo-controlled trial (MTN-020-ASPIRE) of a monthly vaginal ring containing 25 mg of dapivirine in 2629 women between the ages of 18 and 45 years was conducted in Malawi, South Africa, Uganda, and Zimbabwe. Overall 71 infections occurred in the dapivirine group and 97 in the placebo arm. The incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% confidence interval [CI]: 12–56; p = 0.007) than that in the placebo group in an analysis that excluded two sites that had reduced rates of adherence. Dapivirine is also being codeveloped as a vaginal microbicide in combination with maraviroc; with darunavir (Dapidar); and with tenofovir. As of July 2016, there were no active clinical trials including dapivirine listed at ClinicalTrials.gov. (Akil et al., 2014; Arien et al., 2016; Baeten et al., 2016; Bunge et al., 2016; Chen et al., 2015; Fletcher et al., 2009; Murphy et al., 2014; Nel et al., 2016).
Potential of mucoadhesive chitosan glutamate microparticles as microbicide carriers – antiherpes activity and penetration behavior across the human vaginal epithelium
Published in Drug Delivery, 2021
Emilia Szymańska, Małgorzata Krzyżowska, Krzysztof Cal, Barbara Mikolaszek, Jakub Tomaszewski, Sławomir Wołczyński, Katarzyna Winnicka
Among goals and priority actions established by the WHO Global Health Sector Strategy on Sexually Transmitted Infections (2016–2021), vaginal microbicides present a promising prophylactic approach against STDs, including genital herpes (World Health Organization, 2021). Microbicides refer to topically (vaginal or rectal) applied antimicrobial or antiviral agents intended to prevent infections (Karim & Karim, 2007). Several classes of microbicides have been proposed as HSV prophylactic strategy (AVAC, 2021; Clinical Trials, 2021; Cordis, 2021), but effective and safe products are still not available. Although efforts have been made toward finding and testing proper active microbicide agents, currently, more focus has been made on the development of novel delivery systems which ideally would provide the patient with a convenient vaginal application and simultaneously preserve or even enhance the protecting microbicide effect (Mesquita et al., 2019).
Stakeholder acceptability of adolescent participation in clinical trials for biomedical HIV prevention products: considerations from Tanzania and India
Published in AIDS Care, 2019
Allison P. Pack, Jayagowri Sastry, Elizabeth E. Tolley, Sylvia Kaaya, Jennifer Headley, Anna Kaale, Joy Noel Baumgartner
This analysis is based on qualitative interviews with key informants (KIs), who participated in the formative phase of a two-phase study assessing opportunities and challenges of recruiting AYW into future HPTs (clinicaltrials.gov identifier NCT00872261) (Tolley et al., 2014). Data were collected in 2010 when vaginal microbicide gels were considered a potentially viable HIV prevention option. However, results from the VOICE and FACTS 001 trials have questioned whether AYW can effectively use new products requiring daily dosing (Marrazzo et al., 2015; Rees, 2015). Our analysis provides a relevant context for this debate as it includes community perspectives from two distinct cultures on the potential inclusion of adolescent girls in HPTs. Specifically, this analysis explores Tanzanian and Indian KIs’: (1) perspectives on benefits of including adolescent girls in HPTs; (2) understanding of research concepts and how they perceive adolescent girls might understand them; (3) concerns about consent; and (4) perceptions of the broader community’s reactions to adolescent participation in HPTs.
Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men
Published in AIDS Care, 2019
Cheng-Shiun Leu, Rebecca Giguere, José A. Bauermeister, Curtis Dolezal, William Brown, Ivan C. Balán, Barbra A. Richardson, Jeanna M. Piper, Javier R. Lama, Ross D. Cranston, Alex Carballo-Diéguez
Few demographic variables were predictive of product use trajectories, with the exception of age (for both regimens) and being TW (for the oral tablet). Findings on acceptability and likelihood of use from this study (Carballo-Diéguez et al., 2017) and from another on oral PrEP (Sineath et al., 2013) also demonstrated no association with demographic variables. Two studies of vaginal microbicide gel use demonstrated lower adherence among a younger age group (Marrazzo et al., 2015; Rees et al., 2015). Possibly, older age may be associated with a more stable lifestyle, (Brose, Scheibe, & Schmiedek, 2013) which could facilitate daily product use, and older age has been associated with better adherence to antiretroviral therapy (Hinkin et al., 2004). TW were less likely than MSM to be high-adherers than low-adherers to the oral regimen. This finding is supported by the iPrex study, in which TW had lower adherence overall to a daily oral tablet than men (Deutsch et al., 2015). This highlights the importance of disaggregating the data of men from those of TW and of recruiting sufficient numbers of TW to have the statistical power to conduct analyses, so that researchers can understand better the biomedical HIV prevention needs of this key population.