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  • Title: Diaphragm and lubricant gel acceptance, skills and patterns of use among women in an effectiveness trial in Southern Africa.
    Author: Montgomery ET, Blanchard K, Cheng H, Chipato T, de Bruyn G, Ramjee G, Padian N, van der Straten A, MIRA team.
    Journal: Eur J Contracept Reprod Health Care; 2009 Dec; 14(6):410-9. PubMed ID: 19929644.
    Abstract:
    OBJECTIVES: We examined diaphragm and gel-related skills, patterns of use, and problems, among women who participated in the MIRA study, a multisite phase III diaphragm trial in Zimbabwe and South Africa. METHODS: We evaluated whether baseline characteristics were associated with the ability to correctly insert/remove the diaphragm prior to randomisation by means of multivariate logistic regression modeling. Employing face-to-face interviews with intervention arm participants, patterns of use and comfort using the products were measured at Month 3 and Exit, and reported problems with the products were assessed quarterly. RESULTS: At baseline, 72.5% of women correctly inserted/removed the diaphragm within one attempt, and this skill was most strongly associated with the Johannesburg study site. At exit, over 90% of intervention women were very comfortable inserting, wearing, cleaning and removing the diaphragm; however, 31.8% reported usual removal of the diaphragm before the prescribed six hours after sex. During the 12-24 month follow-up period there were only 133 (<1%) reported problems with the diaphragm and gel over 14,544 follow-up visits. CONCLUSIONS: Diaphragm skills were easily acquired and few problems were reported during the course of the trial. Reviving the diaphragm as a contraceptive option or as a reusable microbicide delivery mechanism seems feasible in these settings.
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