Hormonal contraception and the risks of STI acquisition: results of a feasibility study to plan a future randomized trial☆
Received 18 October 2007; received in revised form 18 December 2007; accepted 12 January 2008. published online 20 March 2008.
Abstract
Background
Because of limitations in observational studies, a randomized controlled trial (RCT) would help clarify whether hormonal contraception increases the risks of acquiring a sexually transmitted infection (STI). However, the feasibility of such a trial is uncertain.
Study Design
We conducted a study to assess the feasibility of conducting a RCT that would compare the acquisition risk for Chlamydia trachomatis and Neisseria gonorrhoeae in women randomized to an intrauterine device (IUD) or depot medroxyprogesterone acetate (DMPA). In our cross-sectional survey conducted at three clinics, we gave information on a potential RCT to clients, asked them questions to assess comprehensibility and finally asked respondents whether they would consider enrolling in such a trial. In addition, the 190 participants provided urine or endocervical swab specimens so we could estimate the prevalence of STIs.
Results
Overall, 70% of participants stated that they would take part in a future trial and accept randomization to either the IUD or DMPA. Participant understanding of the trial requirements was high. Twenty-nine percent of the participants were infected with either N. gonorrhoeae or C. trachomatis.
Conclusion
With a high prevalence of STI in this population and the apparent willingness of appropriate candidates to participate, an RCT to measure risks of incident STI infection from hormonal contraception appears feasible.
☆ Support for this research was provided by the Family Health International (FHI) with funds from the US Agency for International Development (AID/CCP-A-00-95-00022-00), although the views expressed in this publication do not necessarily reflect those of FHI or other participating institutions.
ABSTRACT