Pregnancy rates among female participants in phase 1 and phase 2A AIDS vaccine clinical trials in Kenya

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

Herpes simplex virus type 2 antibody detection performance in Kisumu, Kenya, using the Herpeselect ELISA, Kalon ELISA, Western blot and inhibition testing

In certain parts of Africa, type-specific HSV type-2 ELISAs may have limited specificity. To date, no study has been conducted to validate HerpeSelect and Kalon type-specific HSV-2 ELISAs using both the Western blot (WB) and Recombinant gG ELISA inhibition testing as reference standards

Human Papillomavirus Detection by Penile Site in Young Men From Kenya

Limited data are available on whether sampling from the penile shaft or urethra increases detection of penile HPV infection in men beyond that found in the glans and coronal sulcus

Risk Compensation Is Not Associated with Male Circumcision in Kisumu, Kenya: A Multi-Faceted Assessment of Men Enrolled in a Randomized Controlled Trial

Three randomized controlled trials (RCTs) have confirmed that male circumcision (MC) significantly reduces acquisition of HIV-1 infection among men. The objective of this study was to perform a comprehensive, prospective evaluation of risk compensation, comparing circumcised versus uncircumcised controls in a sample of RCT participants.Between March 2004 and September 2005, we systematically recruited men enrolled in a RCT of MC in Kenya. Detailed sexual histories were taken using a modified Timeline Followback approach at baseline, 6, and 12 months. Participants provided permission to obtain circumcision status and laboratory results from the RCT. We evaluated circumcised and uncircumcised men's sexual behavior using an 18-item risk propensity score and acquisition of incident infections of gonorrhea, chlamydia, and trichomoniasis. Of 1780 eligible RCT participants, 1319 enrolled (response rate = 74%). At the baseline RCT visit, men who enrolled in the sub-study reported the same sexual behaviors as men who did not. We found a significant reduction in sexual risk behavior among both circumcised and uncircumcised men from baseline to 6 (p<0.01) and 12 (p = 0.05) months post-enrollment. Longitudinal analyses indicated no statistically significant differences between sexual risk propensity scores or in incident infections of gonorrhea, chlamydia, and trichomoniasis between circumcised and uncircumcised men. These results are based on the most comprehensive analysis of risk compensation yet done.In the context of a RCT, circumcision did not result in increased HIV risk behavior. Continued monitoring and evaluation of risk compensation associated with circumcision is needed as evidence supporting its' efficacy is disseminated and MC is widely promoted for HIV prevention

“When I Was Circumcised I Was Taught Certain Things”: Risk Compensation and Protective Sexual Behavior among Circumcised Men in Kisumu, Kenya

Background: Male circumcision has been shown to reduce the transmission of HIV from women to men through vaginal sex by approximately 60%. There is concern that men may engage in risk compensation after becoming circumcised, diminishing the benefits of male circumcision. Methods and Findings: We conducted qualitative interviews with 30 sexually active circumcised men in Kisumu, Kenya from March to November 2008. Most respondents reported no behavior change or increasing protective sexual behaviors including increasing condom use and reducing the number of sexual partners. A minority of men reported engaging in higher risk behaviors either not using condoms or increasing the number of sex partners. Circumcised respondents described being able to perform more rounds of sex, easier condom use, and fewer cuts on the penis during sex. Conclusions: Results illustrate that information about MC’s protection against HIV has disseminated into the larger community and MC accompanied by counseling and HIV testing can foster positive behavior change and maintain sexua

The right not to know HIV-test results

Large numbers of pregnant women in Africa have been invited to participate in studies on HIV infection. Study protocols adhere to guidelines on voluntary participation after pre-test and post-test counselling and informed consent; nevertheless, women may consent because they have been asked to do so without fully understanding the implications of being tested for HIV. Our studies in Nairobi, Kenya, show that most women tested after giving informed consent did not actively request their results, less than one third informed their partner, and violence against women because of a positive HIV-antibody test was common. It is important to have carefully designed protocols weighing the benefits against the potential harms for women participating in a study. Even after having consented to HIV testing, women should have the right not to be told their result

The right not to know HIV-test results

Large numbers of pregnant women in Africa have been invited to participate in studies on HIV infection. Study protocols adhere to guidelines on voluntary participation after pre-test and post-test counselling and informed consent; nevertheless, women may consent because they have been asked to do so without fully understanding the implications of being tested for HIV. Our studies in Nairobi, Kenya, show that most women tested after giving informed consent did not actively request their results, less than one third informed their partner, and violence against women because of a positive HIV-antibody test was common. It is important to have carefully designed protocols weighing the benefits against the potential harms for women participating in a study. Even after having consented to HIV testing, women should have the right not to be told their result