Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03132285
• Date of registration: 04/04/2017
• Prospective Registration: No
• Primary sponsor: Ministry of Health, Zambia
• Public title: Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device
• Scientific 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
• Date of first enrolment: March 11, 2017
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03132285
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Zambia

Key inclusion & exclusion 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



Age minimum: 13 Years
Age maximum: 49 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV Prevention

Intervention(s)

Device: PrePex

Primary Outcome(s)

Acceptability of the changes procedure to patients [Time Frame: 8 weeks]

Number of incidents related to the change in procedure [Time Frame: 8 weeks]

Secondary Outcome(s)

Effect of the change in procedure on circumcision healing time [Time Frame: 8 weeks]

Secondary ID(s)

0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors