NCT02242565

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 15, 2014

Last Update Submit

September 28, 2017

Conditions

Male Circumcision

Keywords

HIV preventionShangRingadverse eventswound healingvoluntary medical male circumcision (VMMC)medical deviceZambia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percentage of men who cannot be properly fitted with a ShangRing device

    42 days

  • Evaluate the acceptability of ShangRing procedures among participants and providers

    42 days

  • Percentage of men with complete healing at 42 days

    Day 42

Study Arms (2)

Control: all-sizes of ShangRing

OTHER

All-sizes of ShangRings will be available.

Device: ShangRing

Reduced-sizes

ACTIVE COMPARATOR

7 adult sizes of ShangRings will be available

Device: ShangRing

Interventions

ShangRingDEVICE

ShangRing device for male circumcision

Control: all-sizes of ShangRingReduced-sizes

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chilenje Urban Health Centre

Lusaka, Zambia

Location

The University Teaching Hospital (UTH)

Lusaka, Zambia

Location

Related 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 Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.

    PMID: 27331587RESULT

Study Officials

  • Robert Zulu, MD

    University Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • Paul Feldblum, PhD

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

ZA(2)