Acceptability of PRO2000 Vaginal Gel among HIV un-infected Women in Pune, India

Abstract

Acceptability of PRO2000 Gel, a candidate vaginal microbicide, among participants of its Phase I safety study in Pune, India is reported here. Forty-two eligible women were enrolled in a study requiring twice daily intra-vaginal product use for 14 consecutive days between menses. Acceptability was assessed at study exit through structured questionnaires among 41 participants who completed the product use, and five focus group discussions involving 31 study participants. The participants generally liked the product (40/41, 97.2%), especially its colour (40, 97.2%) and consistency (35, 85.3%). Thirty-four participants reported sexual intercourse within one hour of product use, at least once during the study period and sexual pleasure was reported to be better or unaffected among (30, 88.2%) participants. Nearly 70% did not like its smell and mentioned preference for a product that would be unnoticeable to the male partner. Participating women were concerned about privacy in usage and storage of the product. Acceptability of PRO2000 vaginal gel was good, but its smell will have to be improved. Counselling to address women's concerns about privacy and storage will be crucial. Women's preference for unnoticeable product indicates their empowerment and willingness to accept female-controlled options for HIV prevention.

Acknowledgements

The study was sponsored by Division of AIDS, US National Institute of Allergy and Infectious Diseases, US National Institute of Child Health and Human Development, US National Institute on Drug Abuse, US National Institute of Mental Health and US National Institutes of Health and was co sponsored by Indevus (formerly Interneuron) Pharmaceuticals, Inc. We thank Indevus Pharmaceuticals for providing the study product. We also thank SCHARP, USA for data management. We also acknowledge Fogarty International Research Collaboration Award (FIRCA) and Family Health International, USA for their support. We also thank Jehangir Hospital (Hirabai Cowasji Jehangir Medical Research Institute) Pune, India, for providing the space for study implementation. We thank National AIDS Research Institute staff who helped in recruitment and completing the study. We acknowledge Dr. R.S. Paranjape, Director, NARI, and Dr. Robert Bollinger, Associate Professor, Johns Hopkins University and his team for their continuous help and encouragement. We also acknowledge Mr. Nitin Mane, Counsellor, NARI and Mr. M.S Mehendale, consultant Sevadham Trust, who provided great help in transcription and translations of Focus Group Discussions with the participants. We gratefully acknowledge the devoted participation and cooperation by the participants without whom the study would not have been possible.

http://www.nacoonline.org/publication/31.pdf accessed on line on 17^th Nov 2006.

National Baseline General Population behavioural Surveillance Survey-2001.