A time-series intervention trial was conducted with commercial sex workers. The goal of the trial was to assess the impact of adding the female condom to a male condom distribution system, measured in terms of a change in the proportion of sex acts protected by condoms. Condom use was estimated by interviewing study participants about their use of protection in their last 10 sex acts. These measurements were to be made at 5 time points: twice following exposure to male condom promotion and distribution activities, and 3 times following promotion and distribution of both the male and female condom. 

The local principal investigator, a highly respected advocate for the sex workers, explained that women were very enthusiastic about participating in the female condom trial, as it would provide them free access to this innovative method of dual protection. 

The first round of condom use measurement was completed as planned. Preliminary data analysis revealed that study participants were reporting male condom use in over 95% of sex acts. Following verification of the interviewers’ techniques, a second round of interviews was completed. It yielded a similar, exceptionally high-level of male condom use. There is concern that introducing a new product will have a negative affect on the use of male condoms. In addition, there are questions about the availability and affordability of the female condoms after the conclusion of the study, even if the study is successful.

1. Continue the study as designed.
   
   
2. Terminate the study.
   
   
3. Suspend the study. Seek assurance that female condoms will be made available if proved successful.