Cancer PreventionNCT01605656
A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
An observational study of Cancer Prevention and Cervix, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention, Cervix
- What is being tested?
- Cognitive Interview, Questionnaires and Focus Groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-positive women seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).
Who may be able to join
- English speaking
- Patient receiving HIV/AIDS care at Thomas Street Health Center
- Female
- 18 years of age or older
- Able to provide written informed consent to participate
Who cannot join
- 1) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Street Health Center, Harris County Hospital District
Houston, Texas, 77009
About this study
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.
- Conditions
- Cancer Prevention, Cervix
- Being tested
- Cognitive Interview, Questionnaires, Focus Groups
- Keywords
- Cancer Prevention, Cervix, Questionnaires, Focus groups, Surveys, Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive InterviewBehavioural
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.
QuestionnairesBehavioural
Also called Surveys
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.
Focus GroupsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Cognitive Interview; Behavioral: Questionnaires; Behavioral: Focus Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, MS, DRPH, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605656
- Sponsor's protocol ID
- 2012-0240
- Other IDs
- R25T CA57730
- Status last verified
- Mar 2016
- First submitted
- 18 May 2012
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
- ClinicalTrials.gov ID
- NCT01605656
- Acronym / sponsor ID
- 2012-0240
- Conditions
- Cancer Prevention, Cervix
- Keywords
- Cancer Prevention, Cervix, Questionnaires, Focus groups, Surveys, Interviews
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focus Groups + Interviews + Questionnaires | – | Behavioral: Cognitive Interview, Behavioral: Questionnaires, Behavioral: Focus GroupsHIV-positive women recruited from the population of individuals seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-positive women seeking care at Thomas Street Health Center (TSHC) of the Harris County Hospital District (HCHD).
Key inclusion criteria (5 listed)
- English speaking
- Patient receiving HIV/AIDS care at Thomas Street Health Center
- Female
- 18 years of age or older
- Able to provide written informed consent to participate
Key exclusion criteria (1 listed)
- 1) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive InterviewA 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. | Behavioural | Focus Groups + Interviews + Questionnaires |
| QuestionnairesAlso: SurveysPhase 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. | Behavioural | Focus Groups + Interviews + Questionnaires |
| Focus GroupsPhase 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. | Behavioural | Focus Groups + Interviews + Questionnaires |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Cancer Prevention
RecruitingObservational study
Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
Breast Carcinoma
Not yet recruiting
Development of Systems and Education for Cervical Cancer Prevention (DOSE-CC)
Cervical Cancer Screening, Cervical Cancer
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Active, not recruiting
Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)
Cervical Carcinoma, Human Papillomavirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon Vidrine, MS, DRPH, BA principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Prevention and Cervix, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Positive Women's Perceived Barriers to Cervical Cancer Screening (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2016.