The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial.
OBJECTIVE
Vaginal microbicides will provide a woman-initiated prevention strategy that could substantially reduce rates of HIV infection. The acceptability of microbicides will greatly influence the use and, hence, effectiveness of such products. In this study, the acceptability of an investigational microbicide, PRO 2000 Gel (Indevus Pharmaceuticals, Inc., Lexington, MA), was assessed, and women's opinions about microbicides and their potential for real world use were gathered.


METHODS
Quantitative and qualitative data were collected from 30 U.S. and 33 South African women. All sexually active HIV-uninfected women and all sexually abstinent HIV-infected women participating in this phase I clinical trial stated in a survey that they would use PRO 2000 Gel if they had reason to be concerned about HIV and the product were available. Qualitative data, however, provided insight into the nuances of acceptability ratings. Women rated product safety, ease of use, and positive effects on sexual pleasure among the most important characteristics of acceptable microbicides.


RESULTS
Opinions regarding product leakage, contraceptive capability, and the ability to be used without partners noticing, as well as characteristics of the product itself, varied substantially based on the context of sex and perceptions of risk within each individual woman's life.


CONCLUSIONS
As microbicide development continues and the first investigational products move into efficacy trials, the needs and preferences of those women who constitute the potential users of microbicides become paramount. Providing woman-initiated microbicides that are safe, easy to use, and pleasurable will be key to the impact these products will have on the AIDS epidemic worldwide.
Morrow
Kathleen
K
Centers for Behavioral & Preventive Medicine, Brown Medical School, and The Miriam Hospital, Lifespan Academic Medical Center, Providence, Rhode Island 02903, USA. kmorrow@lifespan.org
Rosen
Rochelle
R
Richter
Linda
L
Emans
Anne
A
Forbes
Anna
A
Day
Jennifer
J
Morar
Neetha
N
Maslankowski
Lisa
L
Profy
Albert T
AT
Kelly
Cliff
C
Abdool Karim
Salim S
SS
Mayer
Kenneth H
KH
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D003268:Contraception Behavior / Q000208:ethnology; D004341:Drug Evaluation; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D009282:Naphthalenesulfonates / Q000627:therapeutic use*; D010342:Patient Acceptance of Health Care / Q000208:ethnology / Q000523:psychology; D011108:Polymers / Q000627:therapeutic use*; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D012959:Socioeconomic Factors; D013019:South Africa; D014481:United States; D014622:Vaginal Creams, Foams, and Jellies / Q000627:therapeutic use*
D000891:Anti-Infective Agents, Local; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers; D014622:Vaginal Creams, Foams, and Jellies