Phase I safety & preliminary acceptability of nonoxynol-9 vaginal pessary as a vaginal microbicide in low risk women in Pune, India.

BACKGROUND & OBJECTIVES: Though nonoxynol-9 (N-9) is available in India as a spermicidal pessary, data on its safety as a potential microbicide among Indian women are not available. Nonoxynol-9 containing compounds have shown anti-HIV activity in in vitro studies and protection against cervical infections. Nonoxynol-9 is being extensively evaluated as a vaginal microbicide world-wide. We assessed the safety and preliminary acceptability of nonoxynol-9 pessary as a vaginal microbicide in women at low risk for human immunodeficiency virus (HIV) infection and sexually transmitted diseases (STDs). METHODS: Twenty three HIV seronegative women enrolled in the study were given Today pessarys containing 5 per cent of nonoxynol-9 for vaginal use at bedtime for 14 days. Colposcopy was done at enrollment and on day 14 and speculum examination on day 7 to assess the local toxicity. RESULTS: Most of the women (16/23, 69.6%) did not experience any symptoms of genital irritation. The remaining 7 (30.4%, 95% CI 11.6-49.2) women reported 11 episodes of mild irritative symptoms of short duration. On clinical examination, three adverse events were reported of which one could have been product related. Eight (34.8%) women showed willingness to use the product for protection against HIV transmission if it was approved. INTERPRETATION & CONCLUSION: Nonoxynol-9 vaginal pessary was found to be safe and acceptable in once daily dose in low risk women after consecutive use for 14 days. Willingness for future use, if found safe and effective for HIV prevention was shown by 8 (34.8%) women.

Awareness & knowledge of AIDS & HIV risk among women attending STD clinics in Pune, India.

The present study attempts to understand the awareness, knowledge and risk to HIV/AIDS among two groups of women: one reporting sex-work (FSW) and second reporting other work (FOW) from two clinics in Pune. The patients are screened for HIV and enrolled in the study. This paper includes 711 women covered between May 1993 and April 1995, 409 FSW and 302 FOW women, who differed by several characteristics. The FSW are older, less educated, unmarried, staying away from home, speak Kannada with 60 per cent using condoms for preventing pregnancy. FOW are ever-married women and among Family Planning method users only 7 per cent used condoms and 84 per cent had tubal ligation. At enrollment 47 per cent FSW and 14 per cent FOW were HIV positive with less than one third of all the women reporting AIDS knowledge. Among the knowledgeable women, 82 per cent understood the sexual route, half knew of transmission by blood and a third understood the vertical route of transmission; 77 per cent FSW and 48 per cent FOW knew that condom was protective. FSW reporting consistent condom use in past three months had greater knowledge of AIDS transmission, were more likely to have used condoms as contraceptive or had tubal ligation and less likely to have history of STD. This suggests the HIV/AIDS awareness and educational programs are having a limited effect specially among the married women who do not perceive of the risk of STD/HIV from their spouses and requires urgent preventive measures through innovative approaches that focus on female controlled methods. It is of critical importance that family planning and STD/HIV programs be integrated.

Evidence for high prevalence & rapid transmission of HIV among individuals attending STD clinics in Pune, India.

Prevalence and incidence of HIV-1 infection among persons attending two STD clinics in Pune between May 1993 and October 1995 are reported. On screening 5321 persons, the overall prevalence of HIV-1 infection was found to be 21.2 per cent, being higher in females (32.3%) than in males (19.3%). Analysis of behavioural and biological factors showed that old age, sex work, lifetime number of sexual partners, receptive anal sex, lack of circumcision, genital diseases and lack of formal education were related to a higher HIV-1 seroprevalence. The observed incidence rate of 10.2 per cent per year was very high, much higher in women than in men (14.2% and 9.5% per year respectively) and over three times higher among the sex workers. Females in sex work, males having recent contacts with female sex workers (FSWs) and living away from the family and persons with previous or present genital diseases had a higher risk of seroconversion. Condom usage was shown to have a protective effect in seroprevalence and seroincidence analysis. With limited available resources and lack of a suitable vaccine or a drug, long-term prevention policy of creating awareness in the community must be supplemented by strengthening STD control measures and promotion of condom use and safe sex. Factors related to availability and utilization of condoms must be carefully investigated.