Diaphragm and lubricant gel acceptance, skills and patterns of use among women in an effectiveness trial in Southern Africa

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.

KEYWORDS:

• Diaphragm
• Gel
• Zimbabwe
• South Africa
• Female-initiated barrier methods

Acknowledgements

We would like to acknowledge the women who participated in this study, and all the study staff at the University of California, San Francisco (UCSF); Ibis Reproductive Health; the University of Zimbabwe – UCSF Collaborative Research Programme; the Medical Research Council, HIV Prevention Research Unit (Durban); and Perinatal HIV Research Unit of the University of the Witwatersrand. For E. T. Montgomery, A. van der Straten and N. Padian most work for this study was conducted at UCSF, Department of Obstetrics, Gynecology and Reproductive Sciences.

This research was funded by the Bill and Melinda Gates Foundation (Grant#: 21082).

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.