NCT02121548

Brief Summary

Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

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

Study Start

First participant enrolled

October 10, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2015

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

April 21, 2014

Last Update Submit

October 15, 2018

Conditions

Cervical Cancer

Keywords

Screencervical, cancerHPVwomencommunity health workersHispanic/ LatinasHaitian

Outcome Measures

Primary Outcomes (1)

  • Having had a pap smear in last 6 months

    Primary Outcome: The primary outcome is patient self-reporting on whether they had a Pap smear of HPV testing done since the initial evaluation. As an additional analysis, patients whom were contacted by phone but do no wish to return for follow-up evaluation will be asked by phone if they had the Pap Smear of HPV testing done.

    6 months

Secondary Outcomes (1)

  • Cervical Cancer Knowledge and Access to Care

    6 months

Other Outcomes (1)

  • Subgroup Analysis

    6 months

Study Arms (3)

Outreach

PLACEBO COMPARATOR

Gets outreach materials and info on where to get screened by CHW.

Behavioral: CHW Outreach

CHW Outreach

ACTIVE COMPARATOR

Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation

Behavioral: CHW Outreach and HPV Self-sampling

CHW Outreach and HPV Self-Sampling

ACTIVE COMPARATOR

Same as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling

Behavioral: CHW Outreach

Interventions

CHW Outreach and HPV Self-samplingBEHAVIORAL

The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes. Women who are randomized to this arm will also include information on the alternative screening method. They will be told that cervical self-sampling is an alternative screening technique for the Pap smear and they will be offered the choice of having the HPV screen done during that home visit or have a Pap Smear at the participating FQHC.

CHW Outreach
CHW OutreachBEHAVIORAL

The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.

CHW Outreach and HPV Self-SamplingOutreach

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Haitian, Hispanic or African American women
  • ages 30-65 years
  • not having had a pap smear in the last three years
  • live in Miami-Dade County

You may not qualify if:

  • having had a hysterectomy
  • history of cervical cancer
  • plan to move out of the neighborhood during the next six months
  • are enrolled in any other cancer prevention/outreach related study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (5)

  • Carrasquillo O, McCann S, Amofah A, Pierre L, Rodriguez B, Alonzo Y, Ilangovan K, Gonzalez M, Trevil D, Byrne MM, Koru-Sengul T, Kobetz E. Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial. Trials. 2014 Jul 23;15:299. doi: 10.1186/1745-6215-15-299.

    PMID: 25056208BACKGROUND

  • Ilangovan K, Kobetz E, Koru-Sengul T, Marcus EN, Rodriguez B, Alonzo Y, Carrasquillo O. Acceptability and Feasibility of Human Papilloma Virus Self-Sampling for Cervical Cancer Screening. J Womens Health (Larchmt). 2016 Sep;25(9):944-51. doi: 10.1089/jwh.2015.5469. Epub 2016 Feb 18.

    PMID: 26890012BACKGROUND

  • Kenya S, Okoro IS, Wallace K, Ricciardi M, Carrasquillo O, Prado G. Can Home-Based HIV Rapid Testing Reduce HIV Disparities Among African Americans in Miami? Health Promot Pract. 2016 Sep;17(5):722-30. doi: 10.1177/1524839916629970. Epub 2016 Apr 18.

    PMID: 27091604BACKGROUND

  • Kenya S, Carrasquillo O, Fatil M, Jones J, Jean C, Huff I, Kobetz E. Human Papilloma Virus and Cervical Cancer Education Needs among HIV-Positive Haitian Women in Miami. Womens Health Issues. 2015 May-Jun;25(3):262-6. doi: 10.1016/j.whi.2014.12.007. Epub 2015 Apr 9.

    PMID: 25864021BACKGROUND

  • Carrasquillo O, Seay J, Amofah A, Pierre L, Alonzo Y, McCann S, Gonzalez M, Trevil D, Koru-Sengul T, Kobetz E. HPV Self-Sampling for Cervical Cancer Screening Among Ethnic Minority Women in South Florida: a Randomized Trial. J Gen Intern Med. 2018 Jul;33(7):1077-1083. doi: 10.1007/s11606-018-4404-z. Epub 2018 Mar 28.

    PMID: 29594933RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Olveen Carrasquillo, MD, MPH

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Division of General Internal Medicine

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Study Start

October 10, 2011

Primary Completion

July 7, 2014

Study Completion

February 17, 2015

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

US(1)