Assessment of Adherence to Product Dosing in a Pilot Microbicide Study

Microbicides for Prevention of HIV Infection: Clinical Efficacy Trials

“…Many of the early microbicide trials relied exclusively on self-reported use, which has several limitations (Mauck and Van de Straten 2008). Dye staining of applicators has been shown to be a reliable and objective method to test vaginal insertion in clinical microbicide trials (Hogarty et al 2007), but different plastics, dyes, and product formulations may impact the accuracy of this method (Austin et al 2009). Other novel technologies such as UV light assessment of vaginal applicators (Moench et al 2012) and wireless technologies, e.g., Wisebag (Gengiah et al 2010), are also being considered for microbicide trials to monitor adherence.…”

Microbicide safety and effectiveness: an overview of recent clinical trials

“…There were 3.3 HIV infections per 100 person-years (134 new cases) among women randomized to Carraguard, compared with 3.7 per 100 personyears (151 new cases) on placebo, a difference that did not reach statistical significance in the ITT analysis. Although 96% of participants reported using a gel with last sex, researchers utilized a staining method of verifying vaginal applicator use [39][40][41] and calculated that only 10% of women used the study gel 100% of the time, 20% used it on around 75% of occasions, and 30% used it on less than 25% of occasions [42]. Overall, the researchers estimated that only 44% of sex acts involved use of study gel.…”

“…Trials of microbicides have until now mostly relied on self-reported adherence estimates, which are influenced by recall and social desirability biases [21 ]. More objective measures are being developed [21 ] to corroborate self-reports of risk behavior and product use, including biomarkers of exposure to semen [27 ,72] such as prostate specific antigen and Y-chromosome DNA testing and an assay to evaluate whether applicators have been exposed to the vagina [39][40][41]. With many of the newer ARV-based microbicides, adherence can be monitored by measuring ARV levels in genital tract tissues [27 ], but the utility of this method will depend on factors such as product half-life and timing of last dose and study visit.…”

Adherence to biomedical HIV prevention methods: Considerations drawn from HIV treatment adherence research

“…Despite advances in optimizing the validity of self-reported adherence data, the persistent concern remains that self-reports overestimate adherence, even when they are conducted with care. Some objective methods may be specifi c to biomedical prevention methods, such as an innovative approach to assess microbicide use through an examination of applicator staining [25]. However, a variety of objective medication adherence measures have been used with success in the ARV adherence research, and could be employed in biomedical prevention trials.…”