ClinicalTrials.gg
CompletedNCT01605656Updated Mar 29, 2016

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

An observational study in Cancer Prevention and Cervix, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-29.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
188
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer Prevention
  • Cervix

Keywords

  • Cancer Prevention
  • Cervix
  • Questionnaires
  • Focus groups
  • Surveys
  • Interviews
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.

Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
188 participants (actual)

Groups and cohorts

  • 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 · Behavioral: Questionnaires · Behavioral: Focus Groups

Interventions

  • BehavioralCognitive 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.

  • BehavioralQuestionnaires

    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.

    Also known as: Surveys

  • BehavioralFocus 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.

06

What researchers measure

Primary outcomes

  1. HIV Positive Women's Perceived Barriers to Cervical Cancer Screening

    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).

    Time frame: 1 day

07

Study locations

1 site
  • Thomas Street Health Center, Harris County Hospital District
    Houston, Texas 77009, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01605656
Responsible party
Sponsor
First posted
May 25, 2012
Start date
Jul 2012
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Mar 29, 2016

Study contacts

Damon Vidrine, MS, DRPH, BA
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion