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Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women

NCT04614155CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

M.D. Anderson Cancer Center

Enrollment

Start Date

2019-08-27

Completion Date

2025-08-08

Study Type

INTERVENTIONAL

Official Title

Texas State HPV Self-Collection Pilot Study

Interventions

Educational InterventionHPV Self-CollectionQuestionnaire Administration

Conditions

Healthy Subject

Eligibility

Age Range

30 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Self-reported hysterectomy.
* Self-reported personal history of cancer/cancer diagnosis.
* Self-reported as pregnant.
* Another household member is enrolled in this protocol.

Outcome Measures

Primary Outcomes

Participant consent rate

Time frame: 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.

Time frame: Up to 2 weeks after health education session

Secondary Outcomes

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.

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

Locations

M D Anderson Cancer Center, Houston, United States

Linked Papers

Culturally Competent Education and Human Papillomavirus Self-Sampling Achieves Healthy People 2030 Cervical Screening Target Among Low-Income Non-Hispanic Black and Hispanic Women

PURPOSE Disparities in cervical cancer screening, incidence, and mortality exist in the United States. Cervical cancer incidence and mortality rates in Texas are 20% and 32% higher, respectively, than national averages. Within Texas, these rates are significantly higher among non-Hispanic (NH) Black and Hispanic women. Cervical cancer screening uptake is lower among NH Black and Hispanic women (72.9% and 75.9%, respectively) compared with White women (85.5%) in Texas. METHODS During March-August 2023, we conducted a pilot study that offered culturally competent education and human papillomavirus (HPV) self-sampling kits to women in two public housing projects in Houston, TX, that have predominantly NH Black or Hispanic residents. Among those eligible for cervical cancer screening, 35% (n = 24) of the NH Black and 34% (n = 16) of the Hispanic women were found to be underscreened per the US Preventive Services Task Force Guideline. We recruited 40 (24 NH Black and 16 Hispanic) eligible women for our study. The study was approved by the MD Anderson institutional review board and registered with ClinicalTrials.gov ( NCT04614155 —March 11, 2020). RESULTS Seventy-five percent of the NH Black and 87% of the Hispanic participants completed the HPV self-sampling procedures per protocol. Samples of 17% NH Black and 12% Hispanic participants showed a performance error. Overall, cervical cancer screening uptake improved from 65% to 91% among NH Black and from 66% to 96% among Hispanic participants. CONCLUSION Culturally competent education and HPV self-sampling resulted in remarkable improvement in cervical cancer screening uptake among underscreened NH Black and Hispanic women residents of Houston public housing projects. Implementing this strategy could significantly reduce cervical cancer incidence and mortality among similar populations in the United States and globally.

Linked Investigators

Lorna H. McNeill

Sanjay Shete

Surendra S. Shastri