Healthy SubjectNCT04614155
Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women
A study testing Educational Intervention, HPV Self-Collection and Questionnaire Administration in people with Healthy Subject, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation. 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
- Healthy Subject
- What is being tested?
- Educational Intervention, HPV Self-Collection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 8 Aug 2025
- 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
- Self-identify as African American or Hispanic women.
- Valid home address reflective of residence in the participating housing development(s) at least 50% of the time.
- Functioning telephone number.
- Speak and read English or Spanish.
Who cannot join
- Self-reported hysterectomy.
- Self-reported personal history of cancer/cancer diagnosis.
- Self-reported as pregnant.
- Another household member is enrolled in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Texas State HPV Self-Collection Pilot Study
This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.
SECONDARY OBJECTIVES:
- Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.
II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.
OUTLINE:
Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.
After completion of study, participants are followed up at 1 month.
- Conditions
- Healthy Subject
- Being tested
- Educational Intervention, HPV Self-Collection, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Take part in health education session
HPV Self-CollectionProcedure or surgery
Also called At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Receive HPV self-collection kit
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Screening (questionnaire, health education, self-collection) | Experimental | Participants complete questionnaires, take part in a health education session, and receive HPV self-collection kit. Receives: Other: Educational Intervention; Procedure: HPV Self-Collection; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant consent rate
Measured: Up to 1 month
Human papillomavirus (HPV) self-collection uptake rate
Defined as the proportion of the participants who consent to the study and receive an HPV self-collection kit complete the self-collection and return the sample to the lab or research staff member or community health worker within timeline.
Measured: Up to 2 weeks after health education session
Secondary outcomes (3)
Cervical screening associated knowledge, attitudes and practices score
Paired t-tests or Wilcoxon signed-rank tests will be used to examine the change of the scores difference for cervical screening associated knowledge, attitudes and practices. For every participant, 'Knowledge' will be measured using a 12-question scale, which will have a 'Yes/No/Unsure' response. Each 'correct' response will be scored as 1, while 'incorrect' and 'unsure' as 0. A score 50% (≥6 correct responses) will be considered as optimal. 'Attitude' will be measured using a 6-question scale which will have 'Disagree/Neutral/Agree response. Attitude will be considered as favorable if we have three or more "Agree" responses. Being screened, before our education-intervention, for cervical cancer with Pap-smear, and after our intervention either with HPV self-sampling or Pap-smear, will be regarded as having good practice. Changes in Knowledge, Attitude and Practice, pre- and post-education intervention will be examined using Paired t-tests or Wilcoxon signed-rank tests.
Measured: Up to 1 month
Participants' self-reported Pap smear screening rate in last 3 years
Measured: Up to 1 month
HPV positive proportion
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start27 Aug 2019
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Surendranath S Shastri, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614155
- Sponsor's protocol ID
- 2019-0182
- Other IDs
- NCI-2019-04860, 2019-0182
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2020
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shastri SS, McNeill LH, Shete S. Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women. JCO Glob Oncol. 2024 May;10:e2400005. doi: 10.1200/GO.24.00005.
PubMed 38723214
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texas State HPV Self-Collection Pilot Study
- ClinicalTrials.gov ID
- NCT04614155
- Acronym / sponsor ID
- 2019-0182
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 3 Nov 2020 (actual)
- 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.
This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.
Detailed description
PRIMARY OBJECTIVES:
- To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.
SECONDARY OBJECTIVES:
- Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.
II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.
OUTLINE:
Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.
After completion of study, participants are followed up at 1 month.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (questionnaire, health education, self-collection) | Experimental | Other: Educational Intervention, Procedure: HPV Self-Collection, Other: Questionnaire AdministrationParticipants complete questionnaires, take part in a health education session, and receive HPV self-collection kit. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as African American or Hispanic women.
- Valid home address reflective of residence in the participating housing development(s) at least 50% of the time.
- Functioning telephone number.
- Speak and read English or Spanish.
Key exclusion criteria (4 listed)
- Self-reported hysterectomy.
- Self-reported personal history of cancer/cancer diagnosis.
- Self-reported as pregnant.
- Another household member is enrolled in this protocol.
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalTake part in health education session | Other | Screening (questionnaire, health education, self-collection) |
| HPV Self-CollectionAlso: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-CollectionReceive HPV self-collection kit | Procedure or surgery | Screening (questionnaire, health education, self-collection) |
| Questionnaire AdministrationComplete questionnaires | Other | Screening (questionnaire, health education, self-collection) |
Primary outcome
Participant consent rate
Time frame: Up to 1 month
Human papillomavirus (HPV) self-collection uptake rate
Time frame: Up to 2 weeks after health education session
Defined as the proportion of the participants who consent to the study and receive an HPV self-collection kit complete the self-collection and return the sample to the lab or research staff member or community health worker within timeline.
3 secondary outcomes
Cervical screening associated knowledge, attitudes and practices score
Time frame: Up to 1 month
Participants' self-reported Pap smear screening rate in last 3 years
Time frame: Up to 1 month
HPV positive proportion
Time frame: Up to 1 month
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 12 Aug 2025.
- Derived from this study: PubMed 38723214Shastri SS, McNeill LH, Shete S. Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women. JCO Glob Oncol. 2024 May;10:e2400005. doi: 10.1200/GO.24.00005.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Surendranath S Shastri principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, HPV Self-Collection and Questionnaire Administration in people with Healthy Subject, run by M.D. Anderson Cancer Center 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 12 Aug 2025. 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. 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?
Participant consent rate (time frame: Up to 1 month). The study lists 2 primary outcomes in all. 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 NCT04614155, which also lists 1 linked publication.
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 12 Aug 2025.