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Contraception Use During HIV Vaccine Trial
MHRP researchers examined contraceptive use in women who were enrolled in a phase I/IIa HIV clinical trial in Uganda, Tanzania and Kenya. The results were recently published on PLoS One, an open-access online journal.
Women of childbearing potential are required to use effective contraception during their participation in HIV prevention trials, since little or no human data exist regarding vaccine safety during pregnancy. Understanding the factors influencing contraceptive use during vaccine trials provides vital information for pregnancy prevention counseling and could aid in recruitment and retention during such trials. Since young women in Sub-Saharan Africa are more likely to become infected with HIV than men of the same age, their participation in HIV vaccine trials is critical.
The vaccine study, known as RV 172, was a phase I/IIa HIV clinical trial to evaluate the safety and immunogenicity of a multiclade HIV DNA plasmid vaccine VRC-HIVDNA016-00-VP, boosted by a Multiclade HIV-1 Recombinant Adenovirus-5 vector vaccine, VRC-HIVADV014-00-VP, in uninfected adult volunteers in East Africa. Three MHRP sites in East Africa participated in the study: the Makerere University-Walter Reed Project in Kampala, Uganda; the Walter Reed Project-Kericho in Kenya; and the Mbeya Medical Research Council in Tanzania.
At all the three study sites, staff provided information on methods of contraception, discussed individual contraceptive choices and provided ongoing pregnancy prevention counseling throughout the trial. Myths, misconceptions and barriers to contraceptive use were identified during individual counseling and focus group discussions.
Hormone contraceptives were frequently used by females participating in the HIV vaccine trial, however this study indicates that misconceptions and the incorrect use of contraceptives might have resulted in undesired pregnancies. Barriers to contraceptive use included insufficient knowledge on the use of chosen contraceptive methods and lack of partner support. Other common misconceptions included: contraceptive use being a cause of congenital abnormalities, infertility, loss of libido, decrease of vaginal fluids and delaying conception regardless of type of contraception. Marital status also significantly influenced the pattern of contraceptive use.
The study suggests the need for an integrated approach to pregnancy prevention counseling during HIV vaccine trials. Full study here.