Skip to main content
OpenTrials
Completed

NCT Number: NCT04614155

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subject

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

I. 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:

I. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Intervention

Other

Take part in health education session

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

HPV Self-Collection

Procedure

Receive HPV self-collection kit

Other names: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Participant consent rate

    Time frame: Up to 1 month

  2. 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.

Secondary outcomes

  1. Cervical screening associated knowledge, attitudes and practices score

    Time frame: Up to 1 month

    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.

  2. Participants' self-reported Pap smear screening rate in last 3 years

    Time frame: Up to 1 month

  3. HPV positive proportion

    Time frame: Up to 1 month

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Texas State HPV Self-Collection Pilot Study

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 3, 2020
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.