Contraceptive use in women enrolled into preventive HIV vaccine trials: experience from a phase I/II trial in East Africa.
BACKGROUND
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(+/-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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT00123968.
Kibuuka
Hannah
H
Makerere University-Walter Reed Project, Kampala, Uganda. hkibuuka@muwrp.org
Guwatudde
David
D
Kimutai
Robert
R
Maganga
Lucas
L
Maboko
Leonard
L
Watyema
Cecilia
C
Sawe
Fredrick
F
Shaffer
Douglas
D
Matsiko
Dickson
D
Millard
Monica
M
Michael
Nelson
N
Wabwire-Mangen
Fred
F
Robb
Merlin
M
D016915:AIDS Vaccines; D000328:Adult; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D003271:Contraceptive Agents, Female / Q000145:classification*; D003627:Data Interpretation, Statistical; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007630:Kenya; D008875:Middle Aged; D013636:Tanzania; D014454:Uganda
D016915:AIDS Vaccines; D003271:Contraceptive Agents, Female