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Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting.

ABSTRACT: BACKGROUND: Safe Male Circumcision is a proven approach for partial HIV prevention. Several sub Saharan African countries have plans to reach a prevalence of 80% of their adult males circumcised by 2015. These targets require out of ordinary organization, demand creation, timely execution and perhaps the use of SMC devices. OBJECTIVE: To profile Adverse Events rate and acceptance of PrePex, a non surgical device for adult male circumcision. METHODS: A prospective study, conducted at International Hospital Kampala, Uganda, between August and October 2012. Ethical approval was obtained from Uganda National Council of Science and Technology. RESULTS: Of 1,040 men received to undergo SMC, 678 opted for PrePex, 36 were excluded at an initial physical examination screening. 642 were enrolled and consented, and another 17 were excluded before device placement. 625 underwent the procedure. Average age was 24 years (± 7). Twelve moderate AEs occurred among 10 participants 12/625, (1.9%). These were all reversible. Five had device displacement, one had an everted foreskin; five had bleeding after the device was removed and one had voiding difficulties. The majority (279 out of 300) of men interviewed complained of some pain within the week of placement. Mean pain score at device placement (using visual analogue scale) was 0.5, at device removal 4.5 and within 2 min of removal the pain score was 1.4. Over 70% of the devices were placed and removed by non-physician clinicians. Presented with a choice, 60% of men chose PrePex over surgical SMC. Close to 90% would recommend the device to their friends. Odour from the necrotic skin was a concern. Removals done 1-2 days earlier than day 7 were beneficial and conferred no extra risk. CONCLUSION: AEs of a moderate or severe nature associated with PrePex were low and reversible. PrePex is feasible for mass safe male circumcision scaling up.

SUBMITTER: Galukande M

PROVIDER: S-EPMC3904949 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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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:BackgroundMale 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.MethodsThe 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.ResultsA 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.ConclusionsActive 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.

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Adverse events profile of PrePex a non-surgical device for adult male circumcision in a Ugandan urban setting.

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