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A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01605656
First received: May 18, 2012
Last updated: August 7, 2014
Last verified: August 2014
History of Changes
  Purpose

The goal of this study is to better understand the factors that might prevent HIV-positive women from having routine pap smear screenings. Researchers also want to learn what might make it easier or encourage women to have these screenings.


Condition Intervention
Cancer Prevention
Cervix
 Behavioral: Cognitive Interview
Behavioral: Questionnaires
Behavioral: Focus Groups

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • HIV Positive Women's Perceived Barriers to Cervical Cancer Screening [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Participants rank Nominal Group Technique (NGT) items (cervical cancer screening barriers and strategies to improve screening) from 1-5 (1-least important: 5-most important). Once two coders have calculated rankings, the 5 items receiving the highest number of points will be deemed the 5 barriers to cervical cancer screening. Similarly, the 5 strategy-based items receiving highest number of points will be deemed essential strategies to improving cervical cancer screening at Thomas Street Health Center (TSHC).
Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Focus Groups + Interviews + Questionnaires
HIV-positive women recruited from the population of individuals seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).
 Behavioral: Cognitive Interview
A research staff member will use a questionnaire to ask about many different health and social topics. The cognitive interview should take up to 45 minutes to complete.
Behavioral: Questionnaires

Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.

Phase II: Completion of 2 questionnaires. The first questionnaire will ask about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.

The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete.

Other Name: Surveys
Behavioral: Focus Groups

Phase I: There will be up to 8 women in each of the 5 focus groups.

Participants asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. Participants also asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes.

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV-positive women seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).

Criteria

Inclusion Criteria:

  1. English speaking
  2. Patient receiving HIV/AIDS care at Thomas Street Health Center
  3. Female
  4. 18 years of age or older
  5. Able to provide written informed consent to participate

Exclusion Criteria:

1) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605656

Locations
United States, Texas
Thomas Street Health Center, Harris County Hospital District
Houston, Texas, United States, 77009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Damon Vidrine, MS, DRPH, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01605656     History of Changes
Other Study ID Numbers: 2012-0240, R25T CA57730
Study First Received: May 18, 2012
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer Prevention
Cervix
Questionnaires
 Focus groups
Surveys
Interviews

ClinicalTrials.gov processed this record on March 03, 2015