- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01605656
A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77009
- Thomas Street Health Center, Harris County Hospital District
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
1) Physically deemed ineligible based on medical (HIV related or other condition) or psychiatric condition
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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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).
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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.
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.
Andre navne:
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HIV Positive Women's Perceived Barriers to Cervical Cancer Screening
Tidsramme: 1 day
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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).
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1 day
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Damon Vidrine, MS, DRPH, BA, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmoderhalssygdomme
- Livmodersygdomme
- HIV-infektioner
- Uterine cervikale neoplasmer
- HIV seropositivitet
Andre undersøgelses-id-numre
- 2012-0240
- R25T CA57730 (Registry Identifier: NCI)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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