Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia

Male Circumcision Clinical Trial

Official title:

Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242565
• Other study ID #: 576424
• Secondary ID: 010-04-14
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: September 28, 2017
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.

Description:

We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Must be aged 18 to 49 years;

• Must be HIV-uninfected per same-day routine voluntary testing at the clinic;

• Must be uncircumcised (on examination);

• Must be in good general health, at the discretion of the clinician;

• Must be free of genital ulcerations or other visible signs of STI (on examination);

• Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;

• Must freely consent to participate in the study and sign a written informed consent form;

• Must provide full contact information including cell phone number, address, and other locator information.

Exclusion Criteria:

• Has an active genital infection upon visual inspection;

• Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;

• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or

• Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia

• Has a self-reported allergy or sensitivity to lidocaine or other local

• Is not available to be circumcised on the same day as screening.

Related Conditions & MeSH terms

• Male Circumcision

Intervention

Device:
• ShangRing
ShangRing device for male circumcision

Locations

Country	Name	City	State
Zambia	Chilenje Urban Health Centre	Lusaka
Zambia	The University Teaching Hospital (UTH)	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	Bill and Melinda Gates Foundation, Ministry of Health, Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (1)

Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acqu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.	To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.	42 days
Secondary	Percentage of men who cannot be properly fitted with a ShangRing device	Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.	42 days
Secondary	Evaluate the acceptability of ShangRing procedures among participants and providers	Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm.; Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.	42 days
Secondary	Percentage of men with complete healing at 42 days	Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.	Day 42