Dataset Information

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

ABSTRACT: BACKGROUND:Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe. METHODS:The first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome measures included PrePex uptake, attendance for post-circumcision visits and adverse events (AEs). A survey was conducted amongst 500 consecutive active surveillance clients to assess acceptability and satisfaction with PrePex. RESULTS:A total of 1,811 adolescent males were circumcised across the three PrePex active surveillance sites. Of these, 870 (48%) opted for PrePex but only 618/870 (71%) were eligible. Among the 618, two (0.3%) self-removals requiring surgery (severe AEs), were observed. Four (0.6%) removals by providers (moderate AEs) did not require surgery. Another 6 (1%) mild AEs were due to: bleeding (n = 2), swelling (n = 2), and infection (n = 2). All AEs resolved without sequelae. Adherence to follow-up appointments was high (97.7% attended 7 day visit). A high proportion (71.6%) of survey respondents said they heard about PrePex from a mobilizer; 49.8% said they chose PrePex because they wanted to avoid the pain associated with the surgical procedure/surgery on their penis. Acceptability and satisfaction with PrePex was high; 95.4% indicated willingness to recommend PrePex to peers. A majority (92%) reported experiencing pain when PrePex was being removed. CONCLUSIONS:Active surveillance of the first 618 adolescent males circumcised using PrePex suggests that the device is both safe and acceptable when used in routine service delivery among 13-17 year-olds. There is need to intensify specific demand generation activities for PrePex male circumcision among this group of males.

SUBMITTER: Mavhu W

PROVIDER: S-EPMC6411138 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

Mavhu Webster W Hatzold Karin K Madidi Ngonidzashe N Maponga Brian B Dhlamini Roy R Munjoma Malvern M Xaba Sinokuthemba S Ncube Getrude G Mugurungi Owen O Cowan Frances M FM

PloS one 20190311 3

<h4>Background</h4>Male circumcision devices have the potential to accelerate adolescent voluntary medical male circumcision roll-out. Here, we present findings on safety, acceptability and satisfaction from active surveillance of PrePex implementation among 618 adolescent males (13-17 years) circumcised in Zimbabwe.<h4>Methods</h4>The first 618 adolescents consecutively circumcised from October 2015 to October 2016 using PrePex during routine service delivery were actively followed up. Outcome ...[more]

PMID: 30856228

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Project description:BackgroundVoluntary Medical Male Circumcision (VMMC) is an effective method for HIV prevention and the World Health Organization (WHO) has recommended its expansion in 14 African countries with a high prevalence of HIV and low prevalence of male circumcision. The WHO has recently pre-qualified the PrePex device, a non-surgical male circumcision device, which reduces procedure time, can increase acceptability of VMMC, and can expand the set of potential provider cadres. The PrePex device was introduced in Zimbabwe as a way to scale-up VMMC services in the country. With the rapid scale-up of the PrePex device, as well as other similar devices, a strong surveillance system to detect adverse events (AE) is needed to monitor the safety profile of these devices. We performed a systems-based evaluation of the PrePex device AE active surveillance system in Zimbabwe.MethodsThe evaluation was based on the Centers for Disease Control and Prevention's Updated Guidelines for Evaluating Public Health Surveillance Systems. We adapted these guidelines to fit our local context. The evaluation incorporated the review of the standard operating procedures and surveillance system documents. Additionally, structured, in-person interviews were performed with key stakeholders who were users of the surveillance system at various levels. These key stakeholders were from the Ministry of Health, implementing partners, and health facilities in Harare.ResultsClients were requested to return to the facility for follow-up on days 7, 14 and 49 after placement of the device. In the event of a severe AE, a standard report was generated by the health facility and relayed to the Ministry of Health Child and Care and donor agencies through predefined channels within 24 hours of diagnosis. Clinic staff reported difficulties with the amount of documentation required to follow up with clients and to report AEs. The surveillance system's acceptability among users interviewed was high, and users were motivated to identify all possible AEs related to this device. The surveillance system was purely paper-based and both duplicate and discrepant reporting forms between sites were identified.ConclusionThe PrePex AE active surveillance system was well accepted among participants in the health system. However, the amount of documentation which was required to follow-up with patients was a major barrier within the system, and might lead to decreased timeliness and quality of reporting. A passive surveillance system supported by electronic reporting would improve acceptance of the program.

Project description:BackgroundTiming of routine follow-up visits after adult male circumcision (MC) differs by country and method. Most men do not attend all routine follow-up visits. This cross-sectional study aimed to further understanding of AE timing within a large-scale, routine, MC program to improve patient safety.MethodsFrom 2013-2017, ZAZIC consortium performed 192,575 MCs in Zimbabwe; the reported adverse event (AE) rate was 0.3%. Three scheduled, routine, follow-up visits intend to identify AEs. For surgical MC, visits were days 2, 7 and 42 post-procedure. For PrePex (device-based), visits were days 7, 14 and 49. Descriptive statistics explored characteristics of those patients with AEs. For each MC method, chi-square tests were used to evaluate associations between AE timing (days from MC to AE diagnosis) and factors of interest (age, AE type, severity).ResultsOf 421 AEs, 290 (69%) were surgical clients: 55 (19%) AEs were ≤2 days post-MC; 169 (58%) between 3-7 days; 47 (16%) between days 8-14; and 19 (7%) were ≥15 post-MC. Among surgical clients, bleeding was most common AE on/before Day 2 while infections predominated in other follow-up periods (p<0.001). Younger surgical MC patients with AEs experienced AEs later than older clients (p<0.001). Among 131 (31%) PrePex clients with AEs, 46 (35%) were ≤2 days post-MC; 59 (45%) between 3-7 days; 16 (12%) between days 8-14; and 10 (7%) ≥15 post-MC. For PrePex clients, device displacements were more likely to occur early while late AEs were most commonly infections (p<0.001).ConclusionAlmost 23% of surgical and 8% of PrePex AEs occurred after Visit 2. Later AEs were likely infections. Clinicians, clients, and caregivers should be more effectively counseled that complications may arise after initial visits. Messages emphasizing attention to wound care until complete healing could help ensure client safety. Younger boys, ages 10-14, and their caregivers would benefit from improved, targeted, post-operative counseling.

Project description:BackgroundThe 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 findingsThis 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.ConclusionsThe 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 registrationClinicalTrials.gov NCT01956370.

Dataset Information

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

Publications

Is the PrePex device an alternative for surgical male circumcision in adolescents ages 13-17 years? Findings from routine service delivery during active surveillance in Zimbabwe.

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