- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01605656
A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77009
- Thomas Street Health Center, Harris County Hospital District
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
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).
|
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 navn:
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
HIV Positive Women's Perceived Barriers to Cervical Cancer Screening
Tidsramme: 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).
|
1 day
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Damon Vidrine, MS, DRPH, BA, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Uterine neoplasmer
- Genitale neoplasmer, kvinnelige
- Livmor livmorhalssykdommer
- Livmorsykdommer
- HIV-infeksjoner
- Uterine cervikale neoplasmer
- HIV seropositivitet
Andre studie-ID-numre
- 2012-0240
- R25T CA57730 (Registeridentifikator: NCI)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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