NCT02511548

Brief Summary

The main objective of this study is to reach 80% circumcised men in a random sample of men living in the township of Orange Farm (South Africa).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_3

Status
unknown

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

July 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

July 28, 2015

Last Update Submit

July 29, 2015

Conditions

Circumcision, MaleCircumcision Status: Circumcised, Uncircumcised

Outcome Measures

Primary Outcomes (1)

  • Male circumcision uptake

    The proportion of participants who will accept to become circumcised during the course of the study in each arm.

    3 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Financial incentive

Other: Financial incentive

Control

NO INTERVENTION

No financial incentive

Interventions

Financial incentiveOTHER

Financial incentive will be proposed to participant of the intervention arm

Intervention

Eligibility Criteria

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

You may qualify if:

  • Uncircumcised men
  • Willing to participate
  • Living in Orange Farm
  • Able to speak and read English, Sotho or Zulu

You may not qualify if:

  • Unable to give informed consent
  • Planning to leave the study area within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Auvert B, Taljaard D, Rech D, Lissouba P, Singh B, Bouscaillou J, Peytavin G, Mahiane SG, Sitta R, Puren A, Lewis D. Association of the ANRS-12126 male circumcision project with HIV levels among men in a South African township: evaluation of effectiveness using cross-sectional surveys. PLoS Med. 2013;10(9):e1001509. doi: 10.1371/journal.pmed.1001509. Epub 2013 Sep 3.

    PMID: 24019763BACKGROUND

  • Thirumurthy H, Masters SH, Rao S, Bronson MA, Lanham M, Omanga E, Evens E, Agot K. Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial. JAMA. 2014 Aug 20;312(7):703-11. doi: 10.1001/jama.2014.9087.

    PMID: 25042290BACKGROUND

Study Officials

  • Bertran Auvert, MD, PhD

    University of Versailles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertran Auvert, MD, PhD

CONTACT

bertran.auvert@uvsq.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Investigator

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 30, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

July 30, 2015

Record last verified: 2015-07