Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda.

OBJECTIVES: Participation in HIV prevention trials could trigger risk compensation among participants. We evaluated potential risk compensation following use of a vaginal ring microbicide by women in a phase III trial in southwestern Uganda. METHODS: We used markers of sexual risk behaviour documented on standardised questionnaires, tested for STIs at baseline and quarterly for 2 years. Risk compensation was defined as a significant increase (trend p<0.05) in the proportion of women reporting risky sexual behaviour or a diagnosed STI between baseline and end of follow-up. RESULTS: Between September 2013 and December 2016, 197 women (active arm: n=132 and placebo: n=65) were enrolled at the Masaka site. There were decreases in all markers of sexual risk behaviour with statistically significant decreases in only the proportion of women reporting ≥2 sexual partners, p=0.026 and those diagnosed with Trichomonas vaginalis p<0.001 and or Neisseria gonorrhoeae p<0.001 CONCLUSIONS: No evidence of risk compensation was observed in this trial. TRIAL REGISTRATION NUMBER: NCT01539226.

Advances in microbicide vaginal rings.

Vaginal ring devices capable of providing sustained/controlled release of incorporated actives are already marketed for steroidal contraception and estrogen replacement therapy. In recent years, there has been considerable interest in developing similar ring devices for the administration of microbicidal compounds to prevent vaginal HIV transmission. Intended to be worn continuously, such coitally independent microbicide rings are being developed to maintain effective vaginal microbicide concentrations over many weeks or months, thereby overcoming issues around timing of product application, user compliance and acceptability associated with more conventional semi-solid formulations. In this article, an overview of vaginal ring technologies is presented, followed by a review of recent advances and issues pertaining to their application for the delivery of HIV microbicides. This article forms part of a special supplement on presentations covering intravaginal rings, based on the symposium "Trends in Microbicide Formulations", held on 25 and 26 January 2010, Arlington, VA.

Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey.

The diaphragm is not available in many countries, despite the recommendations of numerous authors that it has important advantages as a woman-controlled method that offers some protection against sexually transmitted diseases, and one that is safe and free of side effects. An interagency team collaborated to introduce the diaphragm in Colombia, the Philippines, and Turkey, using the same protocol to assess the acceptability, service delivery requirements and use-effectiveness of the method. Eighteen public and private sector service delivery sites were involved and a total of 550 women were enrolled in the study. Provider training aimed to improve the quality of care with which all methods were delivered and included counseling about sexuality and reproductive health risks. The cumulative 12-month pregnancy rate of 10.1 (SE 1.7) per 100 woman-years is on the low end of previous studies of the diaphragm, and the 12-month continuation rate (57.2 [SE 2.4] per 100) compares favorably with that for oral contraceptives and the intrauterine device. Focus group discussions conducted with clients and providers indicated that the method was an important alternative for some women, particularly those who had experienced health problems with other methods or were unable to negotiate condom use with their partners. Provider biases diminished as they observed the strategic niche that the diaphragm filled for their clients. While providing the diaphragm requires training and good client-provider interaction, the requirements are consistent with those called for in the Programme of Action of the International Conference on Population and Development (ICPD, 1994). With proper attention to quality of care, the diaphragm can be successfully offered in resource-poor settings.

The regulation of medical devices and quality of medical care.

Medical devices are now a pervasive part of modern medical care. They are in many cases associated with quality of care. In some cases, the use of devices has certainly improved quality. In other cases, devices can be associated with many problems. The approach to quality of devices has depended largely on regulation. However, regulation of devices in Europe is rather undeveloped, so in many cases the reliability and safety of a device has not been independently established and one cannot assume that a particular device in fact is reliable or safe. In addition, there are many problems in the interface between the machine and the user or the patient that are largely untouched by device regulation, and perhaps should be more often considered in quality assurance programs. As essential as device regulation is, it is not sufficient to assure quality. Education is particularly important in this area. Quality assurance programs need to be familiar with common problems with medical devices and how to approach them.