Acceptability of Praneem polyherbal vaginal tablet among HIV uninfected women & their male partners in Pune, India--Phase I study.

BACKGROUND & OBJECTIVE The number of HIV infected women is steadily increasing worldwide and women controlled methods to prevent HIV are urgently needed. Vaginal microbicides are products for vaginal administration that can be used to prevent HIV infection and other sexually transmitted diseases (STDs). We conducted a Phase I safety and acceptability study of Praneem polyherbal tablet, a candidate microbicide, among HIV uninfected women in Pune, India. METHODS Twenty eligible women were requested to use the product intravaginally once daily for 14 consecutive days between menses. Safety was assessed by clinical examination, laboratory monitoring and colposcopy. Acceptability was assessed after 14 days of product use through structured questionnaires, focus group discussions among participating women, and in-depth interviews with a subset of 5 randomly selected male partners. RESULTS Praneem polyherbal tablet was found acceptable by the study participants with 90 per cent of the participants showing 80 per cent and more acceptability score. Discharge of the product residue was reported as a concern by 6 (30%) of participants. Nineteen (95%) female participants liked the smell and the same number reported that the product was easy to use and did not affect the usual sexual pleasure. However, men reported lack of sexual satisfaction. INTERPRETATION & CONCLUSION Product characteristics received good acceptability score in women. However, studies of long-term safety and acceptability among at-risk population would provide more detailed information about its long term acceptability.