Background The SILCS diaphragm is a new, reusable, single-size cervical barrier device that is designed to offer the same barrier protection as a standard diaphragm with improved user acceptability.
Methods This non-randomised, non-blinded, non-significant risk, multi-site pilot study assessed the short-term acceptability of the SILCS diaphragm among women with no previous diaphragm experience. Sites in South Africa and Thailand recruited couples not at risk of pregnancy and at low risk of sexually transmitted infections. Couples used the SILCS diaphragm four times and provided feedback on the ease of handling, comfort, and sensation during sex. Data were collected via detailed product-use questionnaires, simple coital logs and gender-specific debriefing interviews.
Results A total of 41 couples completed the study, providing data from 164 product uses. The SILCS device fits women representing a range of diaphragm sizes, parity and body mass index. Women from both sites reported that the SILCS diaphragm was easy to use and provided good comfort and sensation in over 80% of all product uses. Men from both sites reported good comfort and sensation in over 60% of all product uses.
Conclusion The SILCS diaphragm appears to be acceptable to women and men in low-resource settings. These data suggest that the SILCS design should be tested in broader populations to assess effectiveness and acceptability.
- pilot study
- south africa
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