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

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ClinicalTrials.gov Identifier: NCT01605656
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : March 29, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment
Cancer Prevention Cervix Behavioral: Cognitive Interview Behavioral: Questionnaires Behavioral: Focus Groups

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Study Design
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Study Type : Observational
Actual Enrollment : 188 participants
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
Study Start Date : July 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HIV Positive Women's Perceived Barriers to Cervical Cancer Screening [ Time Frame: 1 day ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 M.D. Anderson Cancer Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01605656     History of Changes
Other Study ID Numbers: 2012-0240
R25T CA57730 ( Registry Identifier: NCI )
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female