Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia

Study Overview
=================
Brief Summary
-----------------
In this study of neonatal male circumcision (NMC), the investigators will examine acceptability of among parents, feasibility of training providers and implementing services in various clinical settings, and the safety of service provision comparing three different surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is being conducted to inform the scale up of neonatal male circumcision in Zambia.

Detailed Description
-----------------
As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it is important to understand the acceptability, feasibility, and safety of implementing NMC services in various clinical settings. In this study, we will examine the acceptability of neonatal male circumcision among parents in several ways. First, we will administer a structured questionnaire on NMC to 1000 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care clinics in Lusaka. All parents approached, regardless of whether or not they complete the survey, will also be offered an opportunity to have their sons circumcised. Uptake will be calculated as the percent of parents approached who consent for their sons to be circumcised. Finally, we will assess parental satisfaction with results of the procedure. To examine the feasibility of training providers and implementing neonatal male circumcision services in various clinical settings, we will train a group of 15-20 health care providers in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3 study sites. We will recruit 600 infants to be circumcised during the training. We will use structured questionnaires and skill assessments to evaluate provider competence after completing the training curriculum, provider preferences among the three circumcision methods, and opinion about how NMC should be scaled up within the existing health care system. We will also document logistical difficulties of scaling up NMC services at the study sites. Finally, we will examine the safety of implementing NMC by collecting and analyzing data on complications resulting from the different circumcision methods.

Official Title
-----------------
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision at the University Teaching Hospital in Lusaka, Zambia and in the Lusaka District in Zambia Using Gomco; Plastibell; and Mogen Methods

Conditions
-----------------
Neonatal Male Circumcision

Intervention / Treatment
-----------------
* Procedure: Neonatal male circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male infants who are in the first day of life (including infants < 24 hours old) and up to 4 weeks of age will be considered for circumcision Gestational age >37 weeks at birth Exclusion Criteria: Any current illness Bleeding diathesis or family history of bleeding disorder Abnormality of urethra or penile shaft such as hypospadias Local infection defined as redness, swelling, or a purulent discharge from the infant penis Greater than four weeks of age

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gomco<br>NMC performed using a Gomco clamp | Procedure: Neonatal male circumcision<br>* Circumcision performed on a male infant within the first month of life, using one of 3 devices<br>|
| Active Comparator: Mogen clamp<br>NMC performed using a Mogen clamp | Procedure: Neonatal male circumcision<br>* Circumcision performed on a male infant within the first month of life, using one of 3 devices<br>|
| Active Comparator: Plastibell<br>NMC performed using a Plastibell device | Procedure: Neonatal male circumcision<br>* Circumcision performed on a male infant within the first month of life, using one of 3 devices<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems | 0-6 weeks after the circumcision procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of NMC | Defined as % of parents of newborn boys approached during recruitment who consent to having their sons cirucumcised | Ongoing, over the course of the study (1.5 years) | 
| Provider Preferences | Measure of provider preferences among 3 circumcision devices being compared | Upon completion of training in NMC | 
| Parent Satisfaction | Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure | 6 weeks following the circumcision procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonatal male circumcision, Gomco, Plastibell, Mogen, Safety, Uptake, Acceptability, Feasibility, Zambia