MedDataX Logo

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

NCT ID: NCT02242565

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Male Circumcision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control: all-sizes of ShangRing

All-sizes of ShangRings will be available.

Group Type OTHER

ShangRing

Intervention Type DEVICE

ShangRing device for male circumcision

Reduced-sizes

7 adult sizes of ShangRings will be available

Group Type ACTIVE_COMPARATOR

ShangRing

Intervention Type DEVICE

ShangRing device for male circumcision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ShangRing

ShangRing device for male circumcision

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Ministry of Health, Zambia

OTHER_GOV

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Zulu, MD

Role: PRINCIPAL_INVESTIGATOR

University Teaching Hospital

Paul Feldblum, PhD

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chilenje Urban Health Centre

Lusaka, , Zambia

Site Status

The University Teaching Hospital (UTH)

Lusaka, , Zambia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Zambia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27331587 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

010-04-14

Identifier Type: OTHER

Identifier Source: secondary_id

576424

Identifier Type: -

Identifier Source: org_study_id