High rates of unwanted pregnancies in a prospective microbicide preparedness study in Mombasa, Kenya

Background: Unexpectedly high pregnancy rates have been observed in several microbicide clinical trials. Pregnancies in these trials raise important methodological and ethical concerns. A cohort study assessing HIV incidence involving 400 Female Sex Workers (FSW) observed high pregnancy rates (109/400) in the first year of follow-up, with most women indicating the pregnancies were unintended despite the availability of free family planning (FP) services (condoms, pills, injectables). A follow-up study was conducted to identify reasons for unintended pregnancies during the cohort study and to determine a more effective delivery and uptake of modern contraception. Methods: Research was conducted in Kisauni and Changamwe divisions in Mombasa District. Participants were recruited using convenience sampling from 400 FSW who participated in a cohort study to estimate HIV-1 incidence. Data relies on information from 76 women through 5 focus group discussions (FGD), 24 in-depth-interviews and 5 keyinformant-interviews with study staff. Participants in the FGDs were grouped by age. Data were analyzed using QSR NVivo 7.0 software. Results: Study participants displayed an ambivalent attitude towards FP. While viewed as important, low use of hormonal contraceptives was associated with untoward side effects including low libido, amenorrhea, perceived hypertension, weight gain or loss, excessive wetness and misconceptions regarding method use. The male condom was perceived as a more desirable option for pregnancy and STI prevention, although correct and consistent use was not always feasible with the intimate partners, when offered more money or when the partner is violent. Discussions also alluded to inadequacy of FP counseling by the study staff. Conclusion: Findings suggest low contraceptive use and high pregnancy rates as observed in other trials. Most notably, side effects, inadequate information, inconsistent condom use and client-FSW power differentials are barriers to FP use. There is need for strengthening staff training and to provide sustained personalized FP counseling