Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa
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Date
2009
Authors
Kibuuka, Hannah
Guwatudde, David
Kimutai, Robert
Maganga, Lucas
Maboko, Leonard
Watyema, Cecilia
Sawe, Fredrick
Shaffer, Douglas
Matsiko, Dickson
Millard, Monica
Journal Title
Journal ISSN
Volume Title
Publisher
PLoS ONE
Abstract
HIV 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.
Methods: Pregnancy 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.
Results: Overall, 103 (31.8%) of a total of 324 enrolled volunteers were females. Female participants were generally young
with a mean age of 29(67.2), 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.
Conclusion: Although 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.
Description
Keywords
Contraceptive Use, Women, HIV Vaccine Trials, East Africa
Citation
: Kibuuka H, Guwatudde D, Kimutai R, Maganga L, Maboko L, et al. (2009) Contraceptive Use in Women Enrolled into Preventive HIV Vaccine Trials: Experience from a Phase I/II Trial in East Africa. PLoS ONE 4(4): e5164. doi:10.1371/journal.pone.0005164