ObjectiveTo assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.MethodsWe enrolled 427 men ages 18–49 at one fixed and two outreach clinics. Procedures were performed by trained clinical officers and nurses. The first 50 enrollees were scheduled for six follow-up visits, and remaining men were followed at Days 7 and 42. We recorded adverse events (AEs) and time to complete healing, and interviewed men about acceptability and pain.ResultsPlacement and removal procedures each averaged between 3 and 4 minutes. Self-reported pain was minimal during placement but was fleetingly intense during removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence interval [CI] 3.8%–8.5%), all of which resolved without sequelae. AEs included 5 device displacements, 2 spontaneous foreskin detachments, and 9 cases of insufficient foreskin removal. Surgical completion of MMC was required for 9 men (2.1%). Among the closely monitored first 50 participants, the probability of complete healing by Day 42 was 0.44 (95% CI 0.30–0.58), and 0.90 by Day 56. A large majority of men was favorable about their MMC procedure and would recommend PrePex to friends and family.ConclusionsThe PrePex device was effective for MMC in Kenya, and well-accepted. The AE rate was higher than reported for surgical procedures there, or in previous PrePex studies. Healing time is longer than following surgical circumcision. Provider experience and clearer counseling on post-placement and post-removal care should lead to lower AE rates.Trial RegistrationClinicalTrials.gov NCT01711411

ObjectivesThe primary objective was to measure HIV incidence in two prospective cohorts of HIV-negative women. Secondary objectives included measuring pregnancy rates and participant retention rates.DesignCross-sectional HIV screening of women selected for higher risk behaviours, with a subsequent prospective study of uninfected women, followed monthly for up to 6 months.SettingClinics established for research purposes in Bloemfontein and Rustenburg, South Africa.ParticipantsThe authors enrolled women 18–35 years old and presumed at higher risk of sexual acquisition of HIV as indicated by self-reported sexual behaviour or recent sexually transmitted infection symptoms. In Bloemfontein, 1364 women were screened, 1154 were eligible for HIV testing and 1145 agreed to be tested. The prospective study enrolled 401 HIV-negative women. In Rustenburg, 946 women were screened, 540 were eligible and underwent HIV testing and 223 HIV-negative women entered the prospective study.Primary and secondary outcomesBaseline prevalences of HIV infection and HIV incidence rates in the prospective cohorts, according to a double rapid test algorithm with a third rapid test for discrepant or indeterminate results. Pregnancy prevalences and pregnancy incidence rate in Bloemfontein. Participant retention rates in the prospective cohort until the study end.ResultsIn Bloemfontein, 1145 women were tested, 391 entered follow-up and 92.3% of participants completed six study visits. In Rustenburg, 540 women were tested, 194 entered follow-up and retention up to the point of early study termination was 88.6%. Overall HIV prevalence was 21.2% (95% CI 18.9% to 23.6%) in Bloemfontein and 23.5% (95% CI 19.9% to 27.1%) in Rustenburg. Overall HIV incidence was 5.5/100 person-years (95% CI 2.5 to 10.4) in Bloemfontein and 3.0/100 person-years (95% CI 0.4 to 10.8) in Rustenburg. Cross-sectional pregnancy prevalences were 6.5% in Bloemfontein and 8.6% in Rustenburg.ConclusionsThe authors observed substantial HIV incidence rates in both cohorts. Vigorous prevention efforts are needed in these smaller cities.

Introduction: In this study, we describe and depict unexpected sequelae of adult medical male circumcision (MMC) using the PrePex device. Materials and Methods: The PrePex system is an elastic compression device for adult MMC. The device is well studied, has been pre-qualified by the World Health Organization (WHO), and its use is being scaled-up in African countries targeted by WHO. We conducted a PrePex implementation study in routine service delivery among 427 men in the age range of 18-49 in western Kenya. We captured penile photographs to create a record of adverse events (AEs) and to monitor healing. Several unexpected AEs ensued, including some that have not been reported in other PrePex studies. We describe and depict those unexpected complications and resulting treatments to alert circumcision providers in the relevant areas. Results: We observed 5 device displacements (1.2%); 3 cases of early sloughing of foreskin tissue (0.7%) among men with long foreskins; 2 cases of a long foreskin obstructing urine flow, as it became dry and necrotic (0.5%); and 2 cases of insufficient foreskin removal caused by invagination for which surgical completion was necessary (0.5%). All of the participants healed completely by day 42 post-circumcision or shortly thereafter. Conclusion: The potential for these complications should be incorporated into PrePex training programs. Integration of devices into MMC programs in medically underserved areas requires the availability of prompt surgical intervention for some sequelae, particularly displacement events.

Objectives:To explore factors associated with healing requiring more than 6 weeks after placement of the PrePex device for adult medical male circumcision.Methods:We enrolled 427 men ages 18–49 years in an observational study of PrePex at 1 urban and 2 peripheral clinics in western Kenya. Participants were scheduled for device removal at day 7 and a follow-up visit at day 42 (allowable range, 40–44) at which the provider recorded wound status, with complete healing defined as a dry wound without any scab, later confirmed by site investigator review of digital penile photographs. We performed univariate and multivariate logistic regression to explore associations between selected demographic, surgical, and follow-up factors and delayed healing (not healed by day 42 visit).Results:Of the 427 men, 341 completing a day 42 visit with physical examination and recorded healing status were included. Fifty-four percent of included men were healed by day 42 visit. Factors associated with delayed healing in univariate analysis and remaining significant in the multivariate analysis were as follows: age 25 years or older [odds ratio (OR): 1.8; 95% confidence interval (CI): 1.4 to 2.4], an adverse event by day 44 (OR: 1.4; 95% CI: 1.03 to 2.0), and severe pain during device removal (protective association: OR: 0.7; 95% CI: 0.5 to 0.99).Conclusions:Older age (25+ years), occurrence of an adverse event, and lesser self-reported pain at device removal were associated with delayed wound healing. If confirmed by larger surveillance studies, these results should be incorporated into the counseling given to male circumcision clients.