HIV Prevention
Conditions
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.
Interventions
DEVICEPrePex
Prepex is a non surgical male circumcision device
Sponsors
Ministry of Health, Zambia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
13 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of incidents related to the change in procedure | 8 weeks | To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses |
| Acceptability of the changes procedure to patients | 8 weeks | To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal * Patients willingness to wait for foreskin removal * Odour while device is in situ * Pain at key time points on Removal visit * Discomfort of any type to patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the change in procedure on circumcision healing time | 8 weeks | To assess the circumcision healing time period. |
Countries
Zambia
Outcome results
None listed