Design of clinical studies of spermicides for prophylaxis against sexually transmitted diseases.

The clinical community is forced to analyze potentially effective spermicidal agents in nontraditional cultural and social settings. The experience of Family Health International in carrying out 4 clinical trials of spermicides and other products of prophylaxis for women at high risk for STDs is discussed. The difficulties met in these studies and the problems and possible solutions that could occur with the subject population study design and the clinic and subject compliance and follow-up are emphasized. Research protocol development must be paid attention to. Protocol should be reviewed before being finalized. In consistency or lack of compliance with product use and the unpredictability of people to return for follow-up visits is shown. An individual at high risk for an STD is one who has had 2 or more sexual partners in the past month and has had 1 verifiable clinically proved STD in the past year. Sociodemographic characteristics are shown for women in a 4-week trial in Bogota and Ibague Colombia. These women on average were 29 years old had finished 5 years of school and had had 2 children. The women reported averaging 14 acts of intercourse per week. Life styles and cultural backgrounds of subjects are very important. Many are prostitutes. It is difficult to get women to come back to the clinic for follow-up visits. A well-equipped clinic is a must in a clinical trial. Many clinics may be run down or in inadequate quarters. The principal investigator often had other commitments. The diagnostic laboratory often does not complete the required tests on time. Data on nonoxynol-9 foam and gel satisfaction and use among the 150 high-risk women in the Colombia is shown. The investigator and other clinic staff members and study participants must have a good relationship. A coital log is shown which has been developed to indicate consistency of condom and product use. The frequency of spermicide use in the Colombian trial is shown as are the characteristics of a model STD study clinic and its population and factors influencing subject compliance and follow-up.