Original research articleComparative acceptability of the SILCS and Ortho ALL-FLEX® diaphragms among couples in the Dominican Republic☆
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.
Section snippets
Materials
The SILCS diaphragm evaluated in this study (Fig. 1) is made of medical-grade silicone molded over a single-piece polymer spring core. The contoured spring allows gentle compression of the rim for easy insertion and removal. The rim surrounds a silicone membrane with two cup-like structures and a flat area. The larger cup fits loosely over the cervix, and the smaller cup aids in hooking the rim for removal. The SILCS diaphragm is inserted by squeezing the rim at the point of opposing sets of
Study participants and product uses
A total of 24 women from a sexual and reproductive health clinic in an urban area of Santo Domingo were screened for enrollment. Four women did not meet all the inclusion/exclusion criteria. The remaining 20 women and their partners were enrolled.
The study population was Hispanic, mostly of lower socioeconomic status. Demographic and reproductive health characteristics of the enrolled female participants are presented in Table 1. None of the women had ever used a diaphragm, although all but one
Discussion
Women in this study had no previous experience using diaphragms, yet they were able to use both types of diaphragms comfortably at home and found both types of diaphragm acceptable. This finding suggests that diaphragms can be used successfully by naïve users in a low-resource setting. The finding parallels reports from studies in Brazil, Colombia, India, Kenya, Madagascar, the Philippines, Turkey and Zimbabwe regarding acceptability of diaphragm use in low-resource settings [1], [2], [3], [4],
Acknowledgments
PATH and Profamilia would like to acknowledge the effort and commitment of our research partners Ana Gloria Garcia and Pedro Luis Berroa at Profamilia in Santo Domingo and the women and men who willingly shared their experiences and provided suggestions. In addition, we thank Susan Ballagh from the Eastern Virginia Medical School and Jill Schwartz and Marianne Callahan from CONRAD, who provided technical support and encouragement for this study and reviewed this manuscript.
References (22)
- et al.
Assessing the acceptability, service delivery requirements, and use-effectiveness of the diaphragm in Colombia, Philippines, and Turkey
Contraception
(2001) - et al.
Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomized controlled trial
Lancet
(2007) - et al.
Magnetic resonance imaging of SILCS diaphragm: anatomical considerations and corroboration with clinical fit
Contraception
(2007) - et al.
A Phase I study of the functional performance, safety, and acceptability of the BufferGel® Duet™
Contraception
(2008) - et al.
The promises and limitations of female-initiated methods of HIV/STI protection
Soc Science Med
(2006) - et al.
Is the diaphragm a viable option for women in Turkey?
Int Fam Plann Perspect
(2000) - et al.
Is the diaphragm a suitable method of contraception for low-income women: a users' perspectives study, Madras, India
Acceptability of the diaphragm among low-income women in Sao Paulo, Brazil
Int Fam Plann Perspect
(1995)- et al.
Predictors of diaphragm use as a potential sexually transmitted disease/HIV prevention method in Zimbabwe
Sex Transm Dis
(2005) - et al.
Acceptability and feasibility of continuous diaphragm use among sex workers in Madagascar
Sex Transm Infect
(2005)
Acceptability of the diaphragm in Mombasa, Kenya; a 6-month prospective study
Eur J Contracept Reprod Health Care
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An exploratory, randomized, crossover MRI study of microbicide delivery with the SILCS diaphragm compared to a vaginal applicator
2013, ContraceptionCitation Excerpt :Specifically, SILCS has a contoured spring that allows it to fit most women comfortably. SILCS acceptability and barrier effectiveness have been reported elsewhere [5–7]. SILCS is an investigational device not yet approved for use by any regulatory authority.
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The funding for this study was provided by CONRAD, Eastern Virginia Medical School, under USAID Cooperative Agreement #HRN-A-00-98-00020-00. The opinions expressed herein are those of the authors and do not necessarily reflect the views of USAID or CONRAD.