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    Pregnancy rates among female participants in phase I and phase IIA AIDS vaccine clinical trials in Kenya

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    Date
    2009-09
    Author
    Jaoko, Walter
    Ogutu, H.
    Wakasiaka, S
    Malogo, R.
    Ndambuki, R
    Nyange, J
    Omosa-Manyonyi, G.
    Fast, P
    Schmidt, C
    Verlinde, C
    Smith, C
    Bhatt, K.M
    Ndinya-Achola, JO
    Anzala, O
    Type
    Article
    Language
    en
    Metadata
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    Abstract
    Background: Female participants in AIDS candidate vaccine clinical trials must agree to use effective contraception to be enrolled into the studies, and for a specified period after vaccination, since the candidate vaccines’ effects on the embryo or foetus are unknown. Objectives: To review data on female participants’ pregnancy rates from phase I and IIA AIDS vaccine clinical trials conducted at the Kenya AIDS Vaccine Initiative (KAVI) and to discuss the challenges of contraception among female participants. Design: Descriptive observational retrospective study. Setting: KAVI clinical trial site, Kenyatta National Hospital and University of Nairobi, Kenya. Subjects: Thirty nine female participants were enrolled into these trials. They received family planning counselling and were offered a choice of different contraceptive methods, as per the protocols. All contraception methods chosen by the participants were offered at the study site at no cost to the participant. Results: Four women conceived during the study period when pregnancies were to be avoided. All four had opted for sexual abstinence as a contraceptive method, but reported having been coerced by their partners to have unprotected sexual intercourse. Conclusion: Abstinence is clearly not a reliable contraceptive option for women in developing-country settings. Effective female-controlled contraceptives, administered at the clinical trial site, may empower female participants to better control their fertility, leading to more complete clinical trial data.
    URI
    http://erepository.uonbi.ac.ke:8080/xmlui/handle/123456789/9935
    Citation
    East African Medical Journal Vol. 86 No. 9
    Subject
    AIDS
    Kenya AIDS Vaccine Initiative
    Pregnancy
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