Comparative acceptability of the SILCS and Ortho ALL-FLEX® diaphragms among couples in the Dominican Republic

Abstract

Background

The SILCS diaphragm is a new, single-size contraceptive diaphragm. The objective of this crossover pilot study was to assess the fit and acceptability of the SILCS diaphragm compared to the Ortho ALL-FLEX® diaphragm to validate the product design among parous women in a low-resource setting.

Study Design

Sexually active couples not at risk of pregnancy and at low risk of sexually transmitted infection were recruited and randomly assigned to one of two groups to determine order of device use. Couples used each device four times and provided feedback on key performance indicators via product-use questionnaires, a simple coital log and a gender-specific debriefing interview.

Results

Twenty couples provided data on a total of 160 product uses (80 for each device). Couples indicated that both diaphragms were acceptable with respect to ease of use, comfort and satisfaction with sex. At the end of the study, 19 of 20 women and 15 of 20 men reported preferring the SILCS diaphragm over the Ortho diaphragm (p≤.01 for both).

Conclusion

Short-term acceptability of the SILCS and Ortho diaphragms during use was comparable, although overall both women and men preferred the SILCS diaphragm over the Ortho diaphragm. Acceptance of diaphragms in general, and the SILCS diaphragm in particular, is likely among couples willing to use a barrier method.

Introduction

Data from several countries indicate that diaphragms are acceptable to sexually active women in low-resource settings [1], [2], [3], [4], [5], [6], [7]. Although diaphragms are not currently widely promoted in family planning programs, they offer an important option for protecting women's health [8]. Diaphragms provide good contraceptive protection when consistently and correctly used [9]. Data from observational studies indicate that diaphragms protect from some sexually transmitted infections (STIs) [10], [11], [12], and biological evidence suggests that protecting the cervix can reduce the risk of acquiring HIV [13]. While results from a recent randomized controlled trial in Africa dimmed enthusiasm that protecting the cervix alone could reduce the risk of infection [14], researchers suggest that diaphragms used either with a contraceptive gel or a microbicide could improve women's options for dual protection if identified limitations of standard diaphragms can be overcome.

Most diaphragms come in multiple sizes and require a trained provider to determine the appropriate fit. The SILCS diaphragm is a new cervical barrier designed to be easier to supply, fit and use than standard diaphragms. The single-size, reusable device has an anatomically shaped, contoured rim that allows coverage of the cervix without a wedged fit in most women. User evaluations in multiple sites in the United States over the past decade allowed product developers to refine features through an iterative process to improve comfort, ease of use, and acceptability for both partners. The newly designed diaphragm offers discreet dual protection for women who are unable or unwilling to use other methods or those whose partners are not willing to use condoms.

The SILCS diaphragm performed well in Phase I postcoital barrier effectiveness testing in the United States [15]. Results from a study using magnetic resonance imaging confirmed the single-size SILCS device fit for women of varying body mass and parity in a pilot study [16]. In the first acceptability study outside the United States, women from widely divergent regions (South Africa and Thailand) with no previous diaphragm experience learned to use the device easily, and women and their partners found the SILCS diaphragm acceptable during use when reporting on domains such as ease of insertion, comfort and acceptability of sensation during sex [17]. A contraceptive effectiveness study, which will provide the data necessary for approval of the SILCS device for marketing as a contraceptive, began at six sites in the United States in 2008.

The SILCS diaphragm was developed by PATH (Program for Appropriate Technology in Health) with funding from the United States Agency for International Development (USAID) through the Contraceptive Research and Development program (CONRAD) to increase options for women's barrier protection, especially for women in low-resource settings. This study represents design validation in preparation for the effectiveness study. The study design was a comparative crossover evaluation to assess the fit, ease of use, and acceptability of the SILCS diaphragm compared to the Ortho ALL-FLEX® diaphragm after multiple uses in a parous population from a low-resource setting.