Clinical trial NCT01956396: Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
Official title: Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Circumcision Adult
HIV CDC Category B2
HIV Infections
Keywords: male circumcision
HIV
Zimbabwe
Lead sponsor: Ministry of Health and Child Welfare, Zimbabwe
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe

Detailed description: Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.

The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.

Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.

Eligibility criteria: Inclusion Criteria:

* Ages 18 - 30 years
* Uncircumcised
* Wants to be circumcised
* Agrees to be circumcised by any of the study methods,PrePex or Surgical as appropriate
* HIV sero-negative
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
* Subject agrees to anonymous video and photographs of the procedure and follow up visits
* Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

Exclusion Criteria:

* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* HIV sero-positive
* Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality
* Uncontrolled diabetes
* Subject that to the opinion of the investigator is not a good candidate
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits
* Refusal to take HIV test.

Primary outcomes:
measure: The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
timeFrame: 8 week post-procedure follow up appointment and examination
Secondary outcomes:
measure: Evaluating the procedure duration
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating the pain at key time points
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating the discomfort during daily activities
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating the compliance during use (with follow-up)
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating the procedure acceptability by Doctors
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Glans fully exposed
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating time to complete healing
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Evaluating the cosmetic results
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Procedure acceptability by Nurses
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Satisfaction by subjects
timeFrame: 8 week post-procedure follow up appointment and examination
measure: Satisfaction by providers
timeFrame: 8 week post-procedure follow up appointment and examination
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Znfpc Spilhaus Center
Study officials:
affiliation: PS- MoHCW
name: Gerald Gwinji, MBChB, MPH
role: PRINCIPAL_INVESTIGATOR
References: