NCT03098329

Brief Summary

This study, named "Check it," is a bundled program for African American (AA) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,907

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 14, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

4 years

First QC Date

March 14, 2017

Last Update Submit

November 15, 2021

Conditions

Keywords

Screeningmenexpedited treatment

Outcome Measures

Primary Outcomes (1)

  • Rate of chlamydia in women

    primary outcome

    up to 60 months

Secondary Outcomes (1)

  • Rate of gonorrhea in women

    up to 60 months

Study Arms (1)

Ct/GC screening

EXPERIMENTAL

Community screening of men for Ct and GC is not normally done. We are testing to see if this intervention will impact the rates of Ct and GC among women

Other: Ct/GC screening

Interventions

Men aged 15-26 years old will be tested for chlamydia and gonorrhea at community based venues; positive men and their sexual partners will be offered expedited treatment at participating pharmacies; positive men will be asked to be rescreened for Ct/GC at 3 months post treatment.

Ct/GC screening

Eligibility Criteria

Age15 Years - 26 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIdentifies as male
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Identifies as African American or Black
  • Identifies as male
  • years of age
  • Lives or spends most of his time in Orleans Parish
  • Had vaginal sex with at least one woman
  • Has not taken azithromycin in the past 7 days

You may not qualify if:

  • Unwilling or unable to provide informed consent
  • Unable to speak or understand English
  • Previously enrolled in the study by self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

  • Campbell MB, Ratnayake A, Gomes G, Stoecker C, Kissinger PJ. Effectiveness of Incentivized Peer Referral to Increase Enrollment in a Community-Based Chlamydia Screening and Treatment Study Among Young Black Men. J Racial Ethn Health Disparities. 2024 Jun;11(3):1173-1181. doi: 10.1007/s40615-023-01595-5. Epub 2023 Apr 24.

MeSH Terms

Conditions

GonorrheaMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Community based screening of young men for chlamydia and gonorrhea, expedited treatment for positive subjects and their sexual partners
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2017

First Posted

March 31, 2017

Study Start

May 22, 2017

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations