Safety and Acceptability of the PrePex Device When Used in Routine Male Circumcision Service Delivery During Active Surveillance in Zimbabwe.

BACKGROUND: Male circumcision devices have the potential to accelerate voluntary medical male circumcision roll-out, with PrePex being one promising device. Here, we present findings on safety and acceptability from active surveillance of the implementation of PrePex among 1000 males circumcised in Zimbabwe. METHODS: The first 1000 men consecutively circumcised using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for postcircumcision visits, and adverse events (AEs). A survey was conducted among 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS: A total of 2156 men aged 18 years or older were circumcised across the 6 PrePex active surveillance sites. Of these, 1000 (46.4%) were circumcised using PrePex. Among them, 4 (0.4%) self-removals that required surgery (severe AEs) were observed. Six (0.6%) removals by providers (moderate AEs) did not require surgery. A further 280 (28%) AEs were mild or moderate pain during device removal. There were also 12 (1.2%) moderate AEs unrelated to pain. All AEs resolved without sequelae. There was high adherence to follow-up appointments, with 97.7% of clients attending the scheduled day 7 visit. Acceptability of PrePex was high among survey participants, 93% indicated willingness to recommend the device to peers. Of note, 95.8% of respondents reported experiencing pain when the device was being removed. Additionally, 85.2% reported experiencing odor while wearing the device or during removal. CONCLUSIONS: Active surveillance of the first 1000 men circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery.

WHO 2010 guidelines for prevention of mother-to-child HIV transmission in Zimbabwe: modeling clinical outcomes in infants and mothers.

BACKGROUND: The Zimbabwean national prevention of mother-to-child HIV transmission (PMTCT) program provided primarily single-dose nevirapine (sdNVP) from 2002-2009 and is currently replacing sdNVP with more effective antiretroviral (ARV) regimens. METHODS: Published HIV and PMTCT models, with local trial and programmatic data, were used to simulate a cohort of HIV-infected, pregnant/breastfeeding women in Zimbabwe (mean age 24.0 years, mean CD4 451 cells/µL). We compared five PMTCT regimens at a fixed level of PMTCT medication uptake: 1) no antenatal ARVs (comparator); 2) sdNVP; 3) WHO 2010 guidelines using "Option A" (zidovudine during pregnancy/infant NVP during breastfeeding for women without advanced HIV disease; lifelong 3-drug antiretroviral therapy (ART) for women with advanced disease); 4) WHO "Option B" (ART during pregnancy/breastfeeding without advanced disease; lifelong ART with advanced disease); and 5) "Option B+:" lifelong ART for all pregnant/breastfeeding, HIV-infected women. Pediatric (4-6 week and 18-month infection risk, 2-year survival) and maternal (2- and 5-year survival, life expectancy from delivery) outcomes were projected. RESULTS: Eighteen-month pediatric infection risks ranged from 25.8% (no antenatal ARVs) to 10.9% (Options B/B+). Although maternal short-term outcomes (2- and 5-year survival) varied only slightly by regimen, maternal life expectancy was reduced after receipt of sdNVP (13.8 years) or Option B (13.9 years) compared to no antenatal ARVs (14.0 years), Option A (14.0 years), or Option B+ (14.5 years). CONCLUSIONS: Replacement of sdNVP with currently recommended regimens for PMTCT (WHO Options A, B, or B+) is necessary to reduce infant HIV infection risk in Zimbabwe. The planned transition to Option A may also improve both pediatric and maternal outcomes.