- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01843478
The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling
A Test of an Intervention to Improve Pap Testing Among Women With HIV
Cervical cancer is the second most common type of cancer among women worldwide. Women with human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally, only 25% of women meet this recommendation. The mean annual Pap testing rate for federally funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate of 59%. This occurred despite interventions to address adherence issues were implemented, including nurse case management, co-location of HIV and gynecology services, flexible scheduling, and continuity of care. Women keep their appointments for HIV primary care more often than for gynecology care in the Moore Clinic, so an intervention that takes place during a primary care visit could improve cervical cancer screening rates.
The availability of HPV testing provides a unique opportunity to increase perceived susceptibility to and severity of cervical cancer among women with HIV, and to encourage follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2% risk of developing CIN. HPV testing can be easily conducted by women themselves through self-collection in a primary care visit. Studies of women without HIV who do not have regular Pap testing have demonstrated that self-collected HPV testing and results counseling increases the overall screening rate, and women who test positive for HPV have a high rate of follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in the HIV primary care setting to promote Pap testing among women with HIV.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21215
- Moore Clinic for HIV Care, Johns Hopkins Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- HIV infection 18 months or more since Pap test Speak & read English Eligible for cervical cancer screening Plans to have Pap testing at Johns Hopkins Hospital
Exclusion Criteria:
- History of hysterectomy Currently pregnant
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: HPV Self-Collection
The intervention is a self-collected HPV test, followed by results counseling by phone when the result is available (usually 2-3 weeks).
Women are encouraged to have Pap testing.
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The HPV self-collected test is followed by results counseling by phone when the result is available (usually 2-3 weeks).
Women are encouraged to have Pap testing.
Autres noms:
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Comparateur placebo: Usual Care
In the usual care arm, women do not receive the HPV test.
They are encouraged to have Pap testing.
In addition, there is a phone call as an attention control, where women are reminded to make a Pap test appointment about 2-3 weeks after the baseline visit.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pap test
Délai: 6 months
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The outcome measure is the completion of Pap testing within 6 months of the baseline study visit.
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6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hayley Mark, PhD, MPH, RN, Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- Infections à VIH
Autres numéros d'identification d'étude
- NA_00071156
- F31NR013633-01 (Subvention/contrat des NIH des États-Unis)
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