Cervical CancerNCT06577220
Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement
A study testing Telephone Recall, Mailed HPV Self-Sampling Kit and Patient Navigation in people with Cervical Cancer and Human Papillomavirus Infection, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing… 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, Human Papillomavirus Infection
- What is being tested?
- Telephone Recall, Mailed HPV Self-Sampling Kit and Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 24 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Asian ethnicity reported in the electronic health record
- no history of hysterectomy or cervical cancer
- no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
- patient of Harris Health System in Harris County (Houston), Texas
- have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
- be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months
Who cannot join
- no valid telephone contact information
- unable to communicate in English, Vietnamese or Spanish
- currently pregnant
- history of cervical dysplasia in the past 3.5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
Read the detailed description
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.
- Conditions
- Cervical Cancer, Human Papillomavirus Infection
- Being tested
- Telephone Recall, Mailed HPV Self-Sampling Kit, Patient Navigation
- Keywords
- Screening, Human Papillomavirus Infection, Self-Testing
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone RecallBehavioural
Participants receive a scripted telephone recall from a trained patient navigator.
Mailed HPV Self-Sampling KitBehavioural
Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.
Patient NavigationBehavioural
Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.
| Study group | Role | What they receive |
|---|---|---|
| Telephone Recall | Active comparator | Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System Receives: Behavioral: Telephone Recall |
| Mailed HPV Self-Sampling Kit | Experimental | Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope Receives: Behavioral: Telephone Recall; Behavioral: Mailed HPV Self-Sampling Kit |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Experimental | Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education. Receives: Behavioral: Telephone Recall; Behavioral: Mailed HPV Self-Sampling Kit; Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary screening participation
completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening
Measured: [Time Frame: within 6 months of randomization
Secondary outcomes (2)
Screening tests results
Results of HPV test using self-collected samples (positive, negative, or inadequate)
Measured: Time Frame: within 6 months of randomization
completion of clinical follow-up among women with an abnormal screening test result
Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling
Measured: Time Frame: within 12 months of screening test result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start28 Sep 2023
- Primary completion24 Jan 2025
- Study completion24 Jan 2026 (estimated)
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 Cervical CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jane Montealegre, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577220
- Sponsor's protocol ID
- H-44944 S1
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5.
PubMed 33087164
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women
- ClinicalTrials.gov ID
- NCT06577220
- Acronym / sponsor ID
- H-44944 S1
- Conditions
- Cervical Cancer, Human Papillomavirus Infection
- Keywords
- Screening, Human Papillomavirus Infection, Self-Testing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
Detailed description
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telephone Recall | Active comparator | Behavioral: Telephone RecallParticipants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System |
| Mailed HPV Self-Sampling Kit | Experimental | Behavioral: Telephone Recall, Behavioral: Mailed HPV Self-Sampling KitParticipants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope |
| Mailed HPV Self-Sampling Kit + Patient Navigation | Experimental | Behavioral: Telephone Recall, Behavioral: Mailed HPV Self-Sampling Kit, Behavioral: Patient NavigationParticipants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Asian ethnicity reported in the electronic health record
- no history of hysterectomy or cervical cancer
- no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
- patient of Harris Health System in Harris County (Houston), Texas
- have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
Key exclusion criteria (4 listed)
- no valid telephone contact information
- unable to communicate in English, Vietnamese or Spanish
- currently pregnant
- history of cervical dysplasia in the past 3.5 years
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 |
|---|---|---|
| Telephone RecallParticipants receive a scripted telephone recall from a trained patient navigator. | Behavioural | Mailed HPV Self-Sampling Kit, Mailed HPV Self-Sampling Kit + Patient Navigation, Telephone Recall |
| Mailed HPV Self-Sampling KitParticipants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing. | Behavioural | Mailed HPV Self-Sampling Kit, Mailed HPV Self-Sampling Kit + Patient Navigation |
| Patient NavigationParticipant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample. | Behavioural | Mailed HPV Self-Sampling Kit + Patient Navigation |
Primary outcome
Primary screening participation
Time frame: [Time Frame: within 6 months of randomization
completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening
2 secondary outcomes
Screening tests results
Time frame: Time Frame: within 6 months of randomization
completion of clinical follow-up among women with an abnormal screening test result
Time frame: Time Frame: within 12 months of screening test result
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Background: PubMed 33087164Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Recall, Mailed HPV Self-Sampling Kit and Patient Navigation in people with Cervical Cancer and Human Papillomavirus Infection, run by Baylor College of Medicine 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 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary screening participation (time frame: [Time Frame: within 6 months of randomization). 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 NCT06577220, 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 14 Oct 2025.