A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.

BACKGROUND: The World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision. METHODS AND FINDINGS: This Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device. CONCLUSIONS: The trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe. TRIAL REGISTRATION: ClinicalTrials.gov NCT01956370.

Population-level impact of Zimbabwe's National Behavioural Change Programme.

OBJECTIVE: To assess the impact of Zimbabwe's National Behavioural Change Programme (NBCP) on biological and behavioral outcomes. METHODS: Representative household biobehavioral surveys of 18- to 44-year-olds were conducted in randomly selected enumeration areas in 2007 and 2011 to 2012. We examined program impact on HIV prevalence among young women, nonregular partnerships, condom use with nonregular partners, and HIV testing, distinguishing between highly exposed and low-exposed communities and individuals. We conducted (1) difference-in-differences analyses with communities as unit of analysis and (2) analyses of key outcomes by individual-level program exposure. RESULTS: Four thousand seven hundred seventy-six people were recruited in 2007 and 10,059 in 2011 to 2012. We found high exposure to NBCP in 2011. Prevalence of HIV and reported risky behaviors declined between 2007 and 2011. Community-level analyses showed a smaller decline in HIV prevalence among young women in highly exposed areas (11.0%-10.1%) than low-exposed areas (16.9%-10.3%, P = 0.078). Among young men, uptake of nonregular partners declined more in highly exposed areas (25%-16.8%) than low-exposed areas (21.9%-20.7%, P = 0.055) and HIV testing increased (27.2%-46.1% vs. 31.0%-34.4%, P = 0.004). Individual-level analyses showed higher reported condom use with nonregular partners among highly exposed young women (53% vs. 21% of unexposed counterparts, P = 0.037). CONCLUSIONS: We conducted the first impact evaluation of a NBCP and found positive effects of program exposure on key behaviors among certain gender and age groups. HIV prevalence among young women declined but could not be attributed to program exposure. These findings suggest substantial program effects regarding demand creation and justify program expansion.