Cervical CancerSUCCESSNCT02121548
Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations
A study testing CHW Outreach and HPV Self-sampling and CHW Outreach in people with Cervical Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- CHW Outreach and HPV Self-sampling and CHW Outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2011to 17 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:
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.
Read the detailed description
Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.
- Conditions
- Cervical Cancer
- Being tested
- CHW Outreach and HPV Self-sampling, CHW Outreach
- Keywords
- Screen, cervical, cancer, HPV, women, community health workers, Hispanic/ Latinas, Haitian
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW Outreach and HPV Self-samplingBehavioural
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 OutreachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Outreach | Placebo comparator | Gets outreach materials and info on where to get screened by CHW. Receives: Behavioral: CHW Outreach |
| CHW Outreach | Active comparator | Comprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation Receives: 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 Receives: Behavioral: CHW Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Cervical Cancer Knowledge and Access to Care
Cervical Cancer Knowledge: Baseline and follow-up knowledge information will also be examined as a secondary outcome.
Access to Care: We will also examine access to care (having health insurance, usual of care of care and visits to a provider) as additional secondary outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start10 Oct 2011
- Primary completion7 Jul 2014
- Study completion17 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Health Choice Network, Center for Haitian Studies
- Responsible party
- Principal investigator, Olveen Carrasquillo, University of Miami
- Investigators
- Olveen Carrasquillo, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121548
- Sponsor's protocol ID
- 20100834
- Acronym
- SUCCESS
- Status last verified
- Oct 2018
- First submitted
- 21 Apr 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25056208Ilangovan 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.
PubMed 26890012Kenya 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.
PubMed 27091604Kenya 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.
PubMed 25864021Carrasquillo 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.
PubMed 29594933
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Project of the South Florida Center for Reducing Cancer Disparities (SUCCESS): Testing CHWs and HPV Self-Sampling to Increase Cervical Cancer Screening Among Minority Immigrants in Miami-Dade County:
- ClinicalTrials.gov ID
- NCT02121548
- Acronym / sponsor ID
- SUCCESS / 20100834
- Conditions
- Cervical Cancer
- Keywords
- Screen, cervical, cancer, HPV, women, community health workers, Hispanic/ Latinas, Haitian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Health Choice Network, Center for Haitian Studies
- Study start
- 10 Oct 2011 (actual)
- Primary completion
- 7 Jul 2014 (actual)
- Study completion
- 17 Feb 2015 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Outreach | Placebo comparator | Behavioral: CHW OutreachGets outreach materials and info on where to get screened by CHW. |
| CHW Outreach | Active comparator | Behavioral: CHW Outreach and HPV Self-samplingComprehensive CHW outreach including home visit, detailed 1:1 education, patient navigation |
| CHW Outreach and HPV Self-Sampling | Active comparator | Behavioral: CHW OutreachSame as Arm 2 with a CHW outreach but also option of doing HPV home self-sampling |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW Outreach and HPV Self-samplingThe 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. | Behavioural | CHW Outreach |
| CHW OutreachThe 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. | Behavioural | CHW Outreach and HPV Self-Sampling, Outreach |
Primary outcome
Having had a pap smear in last 6 months
Time frame: 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.
1 secondary outcome
Cervical Cancer Knowledge and Access to Care
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 25056208Carrasquillo 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.
- Background: PubMed 26890012Ilangovan 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.
- Background: PubMed 27091604Kenya 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.
- Background: PubMed 25864021Kenya 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.
- Results publication: PubMed 29594933Carrasquillo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olveen Carrasquillo, MD, MPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW Outreach and HPV Self-sampling and CHW Outreach in people with Cervical Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Having had a pap smear in last 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121548, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.