NCT02309710

Brief Summary

This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi

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 phase_1

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

November 21, 2014

Last Update Submit

January 20, 2016

Conditions

Male Circumcision

Outcome Measures

Primary Outcomes (1)

  • The percentage of men with moderate and severe adverse events will be tabulated with 95% confidence intervals

    up to 42 days following circumcision procedure

Secondary Outcomes (5)

  • proportion of men ineligible for MMC with ShangRing

    up to four months

  • Percentage distribution of overall satisfaction for study participants

    at Day 42 visit

  • Percentage preference for ShangRing procedure among study MC providers

    an expected average of one month after study initiation

  • Complete Healing at final follow up visit

    up to 42 days

  • Percentage preference for ShangRing procedure among study MC providers

    An expected average of six months after study initiation

Study Arms (1)

ShangRing

EXPERIMENTAL

ShangRing administered to men seeking medical male circumcision

Device: ShangRing

Interventions

ShangRingDEVICE

ShangRing administered to males seeking medical male circumcision

ShangRing

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 HIV testing and counseling (HTC) 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 sexually transmitted infections(STI) on examination;
  • Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
  • Must be able to communicate in English or Chichewa;
  • Must freely consent to participate in the study, be available for follow-up visits, and sign a written informed consent form (ICF); and
  • Must provide full contact information including cell phone number, address, and other locator information

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Christian Health Association of Malawi

Lilongwe, Malawi

Location

St Gabriel's Hospital

Namitete, Malawi

Location

Study Officials

  • Paul Feldblum, Ph.D.

    FHI 360

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 5, 2014

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

MA(2)