Time to complete wound healing in HIV-positive and HIV-negative men following medical male circumcision in Kisumu, Kenya: a prospective cohort study.

While voluntary medical male circumcision (VMMC) has been shown to be protective against HIV-acquisition, the procedure may place men and their partners at risk of HIV infection in the period following circumcision if sex is resumed before the wound is healed. This prospective cohort study evaluates post-circumcision wound healing to determine whether the 42-day post-circumcision abstinence period, recommended by the World Health Organization and adopted by VMMC programs, is optimal.Men were circumcised by forceps-guided method and their post-circumcision wounds examined weekly for seven weeks and at 12 weeks. Time to complete healing was recorded in completed weeks since circumcision, and its associations with baseline covariates were assessed by Kaplan-Meier methods and Cox Proportional Hazard Models. A total of 215 HIV-negative and 108 HIV-positive men aged 18-35 years (median 26, IQR 23-30) were enrolled. 97.1% of scheduled follow-up visits were completed. At week 4, 59.3% of HIV-positive men and 70.4% of age-matched HIV-negative men were healed. At week 6, these percentages rose to 93.4% in HIV-positive men and 92.6% in age-matched HIV-negative men. There was no difference in the hazard of healing between 108 HIV-positive and 108 age-matched HIV-negative men (HR 0.91 95% CI 0.70-1.20). Early post-operative infection was associated with delayed healing in both HIV-positive and HIV-negative men (HR 0.48 95% CI 0.23-1.00).Our results indicate that the WHO recommendation for 42-days post-circumcision sexual abstinence should be maintained for both HIV-positive and HIV-negative men. It is important to stress condom use upon resumption of sex in all men undergoing circumcision

Time to complete wound healing in age-matched HIV-positive and HIV-negative individuals (log-rank = 0.69, p = 0.41).

<p>Time to complete wound healing in age-matched HIV-positive and HIV-negative individuals (log-rank = 0.69, p = 0.41).</p

Characteristics of HIV-positive (HIV+) men, their HIV-negative (HIV-) matches, and all HIV-negative men at enrollment.

<p>p-values are for the difference between HIV+ and HIV− matches.</p

Results of univariate Cox Proportional Hazard Models of the hazard of complete healing by demographic, biological, behavioral and surgical variables.

*<p>Indicates variables included in multivariate models due either to being a primary exposure of interest or a covariate significantly associated with time to healing at the p<0.05 level.</p

The cumulative proportion of HIV-positive and HIV-negative men healed at weekly intervals following medical male circumcision.

<p>The cumulative proportion of HIV-positive and HIV-negative men healed at weekly intervals following medical male circumcision.</p

Agreement between self-reported and physically verified male circumcision status in Nyanza region, Kenya: Evidence from the TASCO study.

Self-reported male circumcision (MC) status is widely used to estimate community prevalence of circumcision, although its accuracy varies in different settings depending on the extent of misreporting. Despite this challenge, self-reported MC status remains essential because it is the most feasible method of collecting MC status data in community surveys. Therefore, its accuracy is an important determinant of the reliability of MC prevalence estimates based on such surveys. We measured the concurrence between self-reported and physically verified MC status among men aged 25-39 years during a baseline household survey for a study to test strategies for enhancing MC uptake by older men in Nyanza region of Kenya. The objective was to determine the accuracy of self-reported MC status in communities where MC for HIV prevention is being rolled out.Agreement between self-reported and physically verified MC status was measured among 4,232 men. A structured questionnaire was used to collect data on MC status followed by physical examination to verify the actual MC status whose outcome was recorded as fully circumcised (no foreskin), partially circumcised (foreskin is past corona sulcus but covers less than half of the glans) or uncircumcised (foreskin covers half or more of the glans). The sensitivity and specificity of self-reported MC status were calculated using physically verified MC status as the gold standard.Out of 4,232 men, 2,197 (51.9%) reported being circumcised, of whom 99.0% were confirmed to be fully circumcised on physical examination. Among 2,035 men who reported being uncircumcised, 93.7% (1,907/2,035) were confirmed uncircumcised on physical examination. Agreement between self-reported and physically verified MC status was almost perfect, kappa (k) = 98.6% (95% CI, 98.1%-99.1%. The sensitivity of self-reporting being circumcised was 99.6% (95% CI, 99.2-99.8) while specificity of self-reporting uncircumcised was 99.0% (95% CI, 98.4-99.4) and did not differ significantly by age group based on chi-square test. Rate of consenting to physical verification of MC status differed by client characteristics; unemployed men were more likely to consent to physical verification (odds ratio [OR] = 1.48, (95% CI, 1.30-1.69) compared to employed men and those with post-secondary education were less likely to consent to physical verification than those with primary education or less (odds ratio [OR] = 0.61, (95% CI, 0.51-0.74).In this Kenyan context, both sensitivity and specificity of self-reported MC status was high; therefore, MC prevalence estimates based on self-reported MC status should be deemed accurate and applicable for planning. However MC programs should assess accuracy of self-reported MC status periodically for any secular changes that may undermine its usefulness for estimating community MC prevalence in their unique settings

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.We 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.Placement 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.The 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.ClinicalTrials.gov NCT01711411

Safety, effectiveness and acceptability of the PrePex device for adult male circumcision in Kenya.

To assess the safety, effectiveness and acceptability of the PrePex device for adult medical male circumcision (MMC) in routine service delivery in Kenya.We 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.Placement 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.The 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.ClinicalTrials.gov NCT01711411

Safety of over twelve hundred infant male circumcisions using the Mogen clamp in Kenya.

BACKGROUND: Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya. METHODS: AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤ 2 months and weighing ≥ 2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors. FINDINGS: A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR=1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed. CONCLUSION: IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life