Abstract
BackgroundHIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. However, access to quality services and misconceptions associated with contraceptive methods may impact on their effective use in developing countries. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania) and factors that may have influenced their use during the trial.MethodsPregnancy prevention counseling was provided to female participants during informed consent process and at each study visit. Participants' methods of contraception used were documented. Methods of contraceptives were provided on site. Pregnancy testing was done at designated visits during the trial. Obstacles to contraceptive use were identified and addressed at each visit.ResultsOverall, 103 (31.8%) of a total of 324 enrolled volunteers were females. Female participants were generally young with a mean age of 29(±7.2), married (49.5%) and had less than high school education (62.1%). Hormonal contraceptives were the most common method of contraception (58.3%) followed by condom use (22.3%). The distribution of methods of contraception among the three sites was similar except for more condom use and less abstinence in Uganda. The majority of women (85.4%) reported to contraceptive use prior to screening. The reasons for not using contraception included access to quality services, insufficient knowledge of certain methods, and misconceptions.ConclusionAlthough hormonal contraceptives were frequently used by females participating in the vaccine trial, misconceptions and their incorrect use might have led to inconsistent use resulting in undesired pregnancies. The study underscores the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials.Trial RegistrationClinicalTrials.gov NCT00123968
Highlights
Women in Sub-Saharan Africa carry a disproportionately large burden of the HIV infection
It is of utmost importance that women in Sub Saharan Africa participate in HIV vaccine trials since they stand to benefit most from an effective HIV vaccine
We describe the pattern of contraceptive use at enrollment and factors that might have influenced their use, among 103 female participants in a phase I/IIa HIV Vaccine trial (RV 172) conducted at US Military HIV Research Program (USMHRP) sites in East Africa, May 2006 to August 2007
Summary
Women in Sub-Saharan Africa carry a disproportionately large burden of the HIV infection. Despite the risk for HIV infection, women are less likely to benefit from existing behavioral and biomedical HIV prevention interventions due to social, cultural and economic barriers [2]. It is of utmost importance that women in Sub Saharan Africa participate in HIV vaccine trials since they stand to benefit most from an effective HIV vaccine. Their participation will accelerate HIV vaccine development and allow for valid gender-specific assessment of efficacy and safety [3,4]. HIV vaccine trials generally require that pregnant women are excluded from participation, and contraceptive methods must be used to prevent pregnancy during the trial. We describe the pattern of contraceptive use in a multi-site phase I/IIa HIV Vaccine trial in East Africa (Uganda, Kenya and Tanzania) and factors that may have influenced their use during the trial
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