Clinical trial NCT01605656: A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Official title: A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Prevention
Cervix
Keywords: Cancer Prevention
Cervix
Questionnaires
Focus groups
Surveys
Interviews
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-05-25
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: Cognitive Interviews:

If you agree to take part in this study, you will be take part in a cognitive interview. A cognitive interview is a process that helps researchers test out questions on a few people so the questions can improved.

During the interview, a research staff member will use a questionnaire to ask you about many different health and social topics.

As the questions are read to you, please answer them, but also tell the research staff member what you're thinking. Please try to think out loud and say everything that comes to mind, whether it seems important or not. You will be asked how you came up with your answers and how you understood the questions. If any question seems unclear or hard to answer, please tell the research staff member. A member of the research staff will be taking notes during the interview.

The cognitive interview should take up to 45 minutes to complete.

Length of Study:

Your participation in this study will be over after you complete the cognitive interview.

This is an investigational study.

Up to 10 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.

Phase I:

If you agree to take part in this study, you will complete a questionnaire about your age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.

After completing the questionnaire, you will take part in a focus group discussion with other women who are patients at Thomas Street Health Center. There will be up to 8 women in each of the 5 groups.

In the focus group, you will be asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. You will also be 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.

The information discussed in the focus groups may be sensitive, so you will be asked to keep the information discussed in the group private.

Length of Study:

Your participation in this study will be over after you complete the questionnaire and participate in the focus group discussion.

This is an investigational study.

Up to 40 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.

Phase II:

If you agree to take part in this study, you will complete 2 questionnaires. The first questionnaire will ask about your 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.

Length of Study:

Your participation in this study will be over after you complete the 2 questionnaires.

This is an investigational study.

Up to 200 participants will be enrolled in this part of the study. All will take part at Thomas Street Health Center.

Eligibility 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

Primary outcomes:
measure: HIV Positive Women's Perceived Barriers to Cervical Cancer Screening
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Thomas Street Health Center, Harris County Hospital District
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Damon Vidrine, MS, DRPH, BA
role: PRINCIPAL_INVESTIGATOR
References: