Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women.

BACKGROUND Vaginal microbicides are in development for the prevention of HIV transmission to women via sexual intercourse. Acceptability of the microbicide delivery method in the targeted population is important to product adherence and, therefore, product effectiveness. It is anticipated that multiple delivery methods will be required to satisfy personal preferences among future microbicide users. METHODS A total of 526 sexually active women aged 18-30 years participated in a consumer product preference study in Burkina Faso, Tanzania, and Zambia. Screened women who had given consent were instructed to use each of the three products (placebo formulations of a vaginal tablet, film, and soft-gel capsule) once daily for 7 consecutive days for a total of 21 days. Women were interviewed about their impressions of the product at the completion of each 7-day trial period. RESULTS Over 80% of women reported they liked using each dosage form, and over 85% said they would definitely use it. The film and soft-gel capsule were chosen significantly more often than the tablet as the preferred dosage form (39% and 37% vs. 25%, respectively) mainly because of faster dissolving time and easier insertion. Women in Burkina Faso and Tanzania preferred the soft-gel capsule (42%-46%), whereas Zambian women preferred the film (51%). Age, socioeconomic status, and marital status did not significantly affect product preference. CONCLUSIONS All three dosage forms were acceptable to the women surveyed. Preferred dosage forms varied by country. These data suggest that the availability of microbicides in multiple dosage forms may increase acceptability, adherence, and, therefore, effectiveness.

[1]  M. Beksinska,et al.  Prevalence and self‐reported health consequences of vaginal practices in KwaZulu‐Natal, South Africa: findings from a household survey , 2011, Tropical medicine & international health : TM & IH.

[2]  R. Pool,et al.  Intravaginal insertion in KwaZulu-Natal: sexual practices and preferences in the context of microbicide gel use , 2010, Culture, health & sexuality.

[3]  S. Mehendale,et al.  Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. , 2010, Transactions of the Royal Society of Tropical Medicine and Hygiene.

[4]  T. Hull,et al.  A cross cultural study of vaginal practices and sexuality: implications for sexual health. , 2010, Social science & medicine.

[5]  L. Rohan,et al.  Microbicide delivery: formulation technologies and strategies , 2008, Current opinion in HIV and AIDS.

[6]  S. Mehendale,et al.  Expanded safety study of Praneem polyherbal vaginal tablet among HIV-uninfected women in Pune, India: a phase II clinical trial report , 2008, Sexually Transmitted Infections.

[7]  K. Barnhart,et al.  Multicenter Comparison of the Contraceptive Ring and Patch: A Randomized Controlled Trial , 2008, Obstetrics and gynecology.

[8]  R. Sánchez-Borrego,et al.  Factors affecting women's selection of a combined hormonal contraceptive method: the TEAM-06 Spanish cross-sectional study. , 2007, Contraception.

[9]  S. Mehendale,et al.  Acceptability of Praneem polyherbal vaginal tablet among HIV uninfected women & their male partners in Pune, India--Phase I study. , 2006, The Indian journal of medical research.

[10]  K. Barnhart,et al.  Acceptability of five nonoxynol-9 spermicides. , 2005, Contraception.

[11]  P. Murphy Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial , 2004 .

[12]  S. A. Abdool Karim,et al.  Phase 1 trial of nonoxynol-9 film among sex workers in South Africa. , 1999, AIDS.

[13]  I. Kleinschmidt,et al.  The practice and prevalence of dry sex among men and women in South Africa: a risk factor for sexually transmitted infections? , 1999, Sexually transmitted infections.

[14]  P. Ulin,et al.  Views of Cameroonian sex workers on a woman-controlled method of contraception and disease protection , 1998, International journal of STD & AIDS.

[15]  R. Brown,et al.  Dry and tight: sexual practices and potential AIDS risk in Zaire. , 1993, Social science & medicine.

[16]  D. Civic,et al.  Dry sex in Zimbabwe and implications for condom use. , 1996, Social science & medicine.