Recruiting

HPV Vaccination

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06109870

Conditions

HPV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRECEDE-PROCEED

Study Details

Brief summary:

Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Conditions

HPV

Study ID

NCT06109870

Start date

Oct 30, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provision of signed and dated informed consent form
  • Currently resident in RGV or other low-resource community in Texas
  • Stated willingness to comply with all study procedures
  • Females; Age ≥25 years
  • Have no history of hysterectomy with removal of the cervix
  • Have no history of cervical cancer or high-grade dysplasia
  • Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Unable to communicate in English or Spanish
  • Lack valid telephone contact information
  • Report being currently pregnant.

Study Design

Enrollment

920 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRECEDE-PROCEED

To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up.

Interventions

PRECEDE-PROCEED

delivered self-sampling (CHWSS) to increase screening participation.

Primary outcome measure

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average 1 year. ]

Central Contacts and Locations

Central contacts

Jane Montealegre, M D

(281) 814-7118jrmontealegre@mdanderson.org

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Marian Williams-Brown, MD

512-324-7036yvette.brown@austin.utexas.edu

Principal Investigator:

Marian Williams-Brown, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jane Montealegre, M. D.

281-814-7118jrmontealegre@mdanderson.org

Principal Investigator:

Jane Montealegre, M. D.

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-14.