Clinical trial NCT03132285: Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
Official title: Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Lead sponsor: Ministry of Health, Zambia
Sponsor class: OTHER_GOV
First posted: 2017-04-27
Enrollment: 500
Sex: MALE
Minimum age (years): 13
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Detailed description: To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex.

Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

Eligibility criteria: Inclusion Criteria:

* Ages - 13 to 49 years
* Uncircumcised
* Participant wants to be circumcised
* Participant assent to the procedure
* Legal guardian consent to the procedure for ages 13-18 years
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse for 8 weeks after circumcision
* Agrees to abstain from masturbation for at least 2 weeks after Removal
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 weeks total)
* Participant 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

Exclusion Criteria:

* Legal guardian withholds consent for ages 13-18 years
* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the participant from undergoing a circumcision
* Participant with the following diseases/conditions: phimosis, paraphimosis, adhesions, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality, uncontrolled diabetes
* Participant that to the opinion of the investigator is not a good candidate
* Diabetes Mellitus
* HIV Sero-positive

Primary outcomes:
measure: Number of incidents related to the change in procedure
timeFrame: 8 weeks
measure: Acceptability of the changes procedure to patients
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of the change in procedure on circumcision healing time
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Matero Main Clinic
state: Lusaka province
city: Livingstone
country: Zambia
facility: Dambwa North Clinic
Study officials:
References: