1. Factors contributing to diaphragm size change in a Clinical Trial HIV PREVENTION RESEARCH UNIT Govender SM; Mtungwa LN; Manarsingh F; Naidoo VH; Ramjee G

2. INTRODUCTION

3. Current HIV prevention strategies include condom use, monogamy and the treatment of STI’s – often unavailable or not feasible Recent clinical trials are assessing the effectiveness of other prevention tools such as Microbicides, vaccines, male circumcision and cervical barriers as possible HIV intervention tools The diaphragm covers the cervix which has increased receptor cells for HIV and fragile epithelium

4. AIM To determine factors that contribute to diaphragm size changes

5. TRIAL DESIGN MIRA Methods for Improving Reproductive Health in Africa is a prospective, randomized controlled Phase 3 clinical trial assessing the effectiveness of the Ortho All Flex arcing spring diaphragm with a the Replens vaginal lubricant gel against the acquisition of HIV/STI’s among heterosexual women.

6. MIRA Trial Sites Harare, Zimbabwe n=2502 Soweto, South Africa n=1028 Durban, South Africa (Umkomaas & Bothas Hill) n=1515 TRIAL DESIGN

7. Diaphragm/Replens Lubricant and condoms N=757 Condoms only N=758 VCT Male condoms Safe sex counselling Diagnosis & treatment of STI's Diaphragm/gel and condom education 1515 enrolled BACKGROUND TRIAL DESIGN

8. METHOD Participants practiced insertion and removal of the diaphragm on a pelvic model following a demonstration by trained staff Clinicians performed a physical exam before commencing diaphragm fitting using sizes 55mm to 95mm Demonstrate the ability to insert and remove the diaphragm with gel correctly Diaphragm size checks were performed if indicated Qualitative and quantitative data collection methods were used to gather data from the participants randomized to the diaphragm arm. Simple frequency data analysis was conducted

9. RESULTS DIAPHRAGM SIZE DISTRIBUTION Participants in Diaphragm/Replens Gel Arm

10. DIAPHRAGM SIZE CHANGES RESULTS No Diaphragm change Diaphragm changeParticipant complaint Pregnancy related Other

11. CONCLUSION Diaphragm fitting was reasonably consistent with 62 % not requiring diaphragm size changes Factors that contributed to diaphragm size changes were : - Pregnancy - Participant complaints - Other factors

12. Evaluate participant complaints to exclude other cause of the complaint Monitor weight, as gross changes could result in changes of muscle tone and may result in inadequate cervical coverage Refit after outcome of any pregnancy of ≥ 14/52 gestation, changes of muscle tone and may result in inadequate cervical coverage Provide education and information on what merits a diaphragm refit RECOMMENDATIONS

13. ACKNOWLEDGEMENTS Participants of the Study MIRA -HPRU Research Team Medical Research Council - South Africa MIRA Bill and Melinda Gates Foundation IBIS Reproductive Health UCSF Jie Moore ( Data analysis) sharlene.govender@mrc.ac.za