Background: MDP 301 is a clinical trial testing the efficacy and safety of 0.5% and 2% PRO 2000/5 vaginal microbicide in preventing HIV infection. High pregnancy rates continue to pose a challenge to microbicide trials resulting in decreased microbicide exposure follow-up data and negatively impacting on the power of the study. We conducted an audit to determine reasons women are not on contraception at screening in order to implement strategies to improve uptake of contraception at enrollment. Methodology: This was a retrospective chart review of the first 1007 eligible women screened. Contraception data collected during sexual behaviour interviews was analysed. Results: 201 women (20%) were not on contraception. Reasons why participants chose not to be on contraception included: side effects (18.4%), no thought given to contraception (13.43%), menopausal (11.4%), personal choice (7.5%) and breastfeeding (5.9%). Side effects included general side effects (40.5%), weight gain (8.1%), menorrhagia (21.6%), watery vaginal discharge (8.1%) and amenorrhoea (10.8%) with injectibles and non-menstrual bleeding, back pain, lower abdominal pain and nose bleeds (2.7% each). 1.5% reported partner opposition and 0.5% parental opposition to contraception. Other reasons included hypertension (1.5%) and religious reasons (0.5%). Some perceptions existed amongst women such as: assumption they were infertile due to delays/inability to conceive in the past (4.5%), assumption partner is infertile (0.5%) and unlikely to conceive due to age (2.5%) or having had a baby in the past year (2.00%) Conclusion: Side effects are a common concern for participants. Insufficient family planning education is available to women in our communities. HIV prevention trials should invest in family planning issues to ensure safety of participants and minimal drop outs. Contraceptives with low side effect profiles should be made available.
Poster from Microbicides 2008, New Delhi, India, 24-27 February 2008