Adverse Events in HIV-Infected Persons Receiving Antiretroviral Drug Regimens in a Large Urban Slum in Nairobi, Kenya, 2003-2005

This article describes toxicities to antiretroviral therapy (ART) among HIV-infected patients receiving care at a clinic in a large urban slum in Nairobi, Kenya.

Patients were treated with nonnucleoside reverse transcriptase inhibitor-based ART and followed at scheduled intervals. Frequencies and cumulative probabilities of toxicities were calculated.

Among 283 patients starting ART, any and severe clinical toxicity were recorded as 65% and 6%, respectively. Cumulative probabilities for remaining free of any and severe clinical toxicities at 6, 12, and 18 months, were 0.47, 0.26, and 0.17, respectively and 0.98, 0.95, and 0.89, respectively. The probability of remaining free from elevated and grade 3 or 4 serum aminotransferase (AST) at 6, 12, and 18 months were 0.62, 0.42, and 0.21, respectively, and 0.99 at 6, 12, and 18 months.

ART toxicities were frequent, but severe toxicities were less common. In resource-limited settings, ART toxicity should not represent a barrier to care.

Female sex workers (FSWs) form a core group at high risk of both sexual HIV acquisition and secondary transmission. The magnitude of these risks may vary by sexual risk taking, partner HIV prevalence, host immune factors and genital co-infections. We examined temporal trends in HIV prevalence and per-act incidence, adjusted for behavioral and other variables, in FSWs from Nairobi, Kenya.

An open cohort of FSWs followed since 1985. Behavioral and clinical data were collected six monthly from 1985 to 2005, and sexually transmitted infection (STI) diagnostics and HIV serology performed. A Cox proportional hazards model with time-dependent covariables was used to estimate infection risk as a function of calendar time.

HIV prevalence in new FSW enrollees peaked at 81% in 1986, and was consistently below 50% after 1997. Initially uninfected FSWs remained at high risk of acquiring HIV throughout the study period, but the rate of HIV acquisition during unprotected sex with a casual client declined by over four-fold. This reduction correlated closely with decreases in gonorrhea prevalence, and predated reductions in the Kenyan HIV population prevalence by over a decade.

The per-act rate of HIV acquisition in high-risk Nairobi FSWs fell dramatically between 1985 and 2005. This decline may represent the impact of improved STI prevention/therapy, immunogenetic shifts in at-risk women, or changes in the proportion of HIV exposures occurring with clients who had acute HIV infection. Declining HIV incidence in high-risk cohorts may predict and/or be causally related to future reductions in population prevalence.

To develop a standard procedure for male circumcision in a resource-poor medical setting and prospectively evaluate the outcome in a randomized, controlled trial with the incidence of human immunodeficiency virus (HIV) as the main outcome, as studies suggest that circumcision is associated with a lower incidence of HIV and other sexually transmitted infections in high-risk populations.

Healthy, uncircumcised, HIV-seronegative men aged 18-24 years from Kisumu District, Kenya, were offered participation in a clinical trial using a standard circumcision procedure based on "usual" medical procedures in Western Kenya. The follow-up included visits at 3, 8 and 30 days after circumcision, with additional visits if necessary. Healing, satisfaction and resumption of activities were assessed at these visits and 3 months from randomization.

Overall, 17 (3.5%) of the 479 circumcisions were associated with adverse events judged definitely, probably or possibly related to the procedure. The most common adverse events were wound infections (1.3%), bleeding (0.8%), and delayed wound healing or suture line disruption (0.8%). After 30 days, 99% of participants reported being very satisfied with the procedure; approximately 23% reported having had sex and 15% reported that their partners had expressed an opinion, all of whom were very satisfied with the outcome. About 96% of the men resumed normal general activities within the first week after the procedure.

Safe and acceptable adult male circumcision services can be delivered in developing countries should male circumcision ultimately be advocated as a public-health measure.

To develop a standard procedure for male circumcision in a resource-poor medical setting and prospectively evaluate the outcome in a randomized, controlled trial with the incidence of human immunodeficiency virus (HIV) as the main outcome, as studies suggest that circumcision is associated with a lower incidence of HIV and other sexually transmitted infections in high-risk populations.

Healthy, uncircumcised, HIV-seronegative men aged 18-24 years from Kisumu District, Kenya, were offered participation in a clinical trial using a standard circumcision procedure based on "usual" medical procedures in Western Kenya. The follow-up included visits at 3, 8 and 30 days after circumcision, with additional visits if necessary. Healing, satisfaction and resumption of activities were assessed at these visits and 3 months from randomization.

Overall, 17 (3.5%) of the 479 circumcisions were associated with adverse events judged definitely, probably or possibly related to the procedure. The most common adverse events were wound infections (1.3%), bleeding (0.8%), and delayed wound healing or suture line disruption (0.8%). After 30 days, 99% of participants reported being very satisfied with the procedure; approximately 23% reported having had sex and 15% reported that their partners had expressed an opinion, all of whom were very satisfied with the outcome. About 96% of the men resumed normal general activities within the first week after the procedure.

Safe and acceptable adult male circumcision services can be delivered in developing countries should male circumcision ultimately be advocated as a public-health measure.