Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya
|ClinicalTrials.gov Identifier: NCT02277795|
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Male Circumcision||Device: AccuCirc||Not Applicable|
Male circumcision (MC) is a research-tested, evidence-based HIV prevention strategy that has been shown to be cost-saving. Randomized trials have provided compelling evidence that MC reduces men's risk of heterosexually-acquired HIV-1 infection by about 60%. The World Health Organization (WHO) recommends MC as part of comprehensive HIV prevention strategies and says, "Since neonatal circumcision is a less complicated and risky procedure than circumcision performed in young boys, adolescents or adults … countries should consider how to promote neonatal circumcision in a safe, culturally acceptable and sustainable manner."
In 2010, the WHO published the "Manual for early infant male circumcision under local anaesthesia, ", which included the Mogen, Gomco and Plastibell devices. At the time of publication, the AccuCirc was relatively new (approved by the United States Food and Drug Administration in 2007) but has promise as a device that will facilitate scale-up of early infant male circumcision (EIMC). It must, however, undergo field evaluation before it can be included in the WHO's list of prequalified EIMC devices so that it can be accessible for programmatic adoption. The investigators propose an implementation study to address several salient operations research questions that remain with regard to the role of devices in scale-up of EIMC programs in sub-Saharan Africa.
This study will include a field evaluation of the AccuCirc device with the aim of providing data that would allow evaluation of the device for WHO prequalification. Other aspects of the current study aim to understand how EIMC can be optimized and successfully implemented in routine public health settings.
The investigators therefore propose the following specific aims:
Aim 1: Complete a field evaluation of the AccuCirc device for EIMC in Nyanza Province, Kenya, with a target enrollment of 600 infants, including intensive follow-up of the first 50 infants undergoing EIMC with the AccuCirc device.
Aim 2: Qualitatively assess provider experiences and preferences with regard to EIMC devices and the relationship to future routine provision of EIMC. Research staff will train providers in both Mogen clamp and AccuCirc devices and ask them to compare the benefits and drawbacks they perceive for each device, and possible implications for scale-up.
Aim 3: Assess parental decision-making about EIMC using qualitative methods, including whether the device for EIMC would influence parental decision-making about circumcision for a son. Parents will be informed about the risks and benefits of EIMC in general, and the Mogen clamp and AccuCirc specifically, before qualitative data about decision-making is gathered.
Aim 4: Identify factors associated with having a male infant circumcised, including if, when, where and by whom EIMC services were offered to mothers, and the role of devices for EIMC in decision-making, if any. Mothers whose infants were circumcised and a comparison group of mothers of uncircumcised infants will be administered a questionnaire that will identify factors associated with uptake of EIMC and whether the device affected the circumcision decision.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||704 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of the AccuCirc for Early Infant Male Circumcision in Nyanza, Kenya|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
The AccuCirc procedure is performed according to manufacturer instructions: http://www.clinicalinnovations.com/site_files/files/AccuCirc_IFUs.pdf
Before the surgery, the mother (and father, if available) will be counseled on benefits and risks of EIMC in their language of choice (English, Kiswahili, DhoLuo). At least one parent/guardian will provide documented informed consent using IRB-approved Consent Form. Providers will record demographic and locator information and EIMC eligibility criteria. If the infant is eligible for EIMC, the provider will perform the procedure and document the outcome of the surgery on a post-operative form. Information recorded will include: amount and type of anesthesia provided, intra-operative adverse event and outcome, and procedure start and end time.
Circumcision with the use of the AccuCirc device.
Other Name: Early Infant Male Circumcision
- Number of participants with Adverse Events as a Measure of Safety [ Time Frame: Up to 4 weeks following circumcision ]Adverse events have been defined in four categories. 1) Bleeding: a) requires anything beyond initial post-procedure local pressure (Minor); b) Suture (Moderate); c) Separate clinic visit or infant hospitalization for bleeding at the circumcision site (Major); d) Surgical intervention (Major); or, e) Transfusion (Major). 2) Infection (believed to be definitely or probably related to the EIMC procedure as evaluated by study staff): a) Local (Minor); or, b) Systemic (Major). 3) Structural: Removal of too much or incorrect tissue; or removal of too little tissue necessitating repeat procedure (Major). 4) Other: major directly-related adverse events (e.g. penile torsion, problem with urination requiring medical attention, other).
- Parental Satisfaction [ Time Frame: Approximately three days following the procedure (at the follow-up visit) ]Parents will be asked a few questions from a standardized questionnaire about their satisfaction with the procedure and with the written care instructions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277795
|Nyanza Reproductive Health Society|
|Study Director:||Fredrick Otieno, MD||Nyanza Reproductive Health Society|