- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01605656
A Mixed-Methods Approach to Understanding Factors Associated With Cervical Cancer Screening Utilization Among Low-Income, HIV-Positive Women
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77009
- Thomas Street Health Center, Harris County Hospital District
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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.
Autres noms:
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HIV Positive Women's Perceived Barriers to Cervical Cancer Screening
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Damon Vidrine, MS, DRPH, BA, M.D. Anderson Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs utérines
- Tumeurs génitales, femme
- Maladies du col de l'utérus
- Maladies utérines
- Infections à VIH
- Tumeurs du col de l'utérus
- Séropositivité VIH
Autres numéros d'identification d'étude
- 2012-0240
- R25T CA57730 (Identificateur de registre: NCI)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .