- ICH GCP
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- Essai clinique NCT02692274
Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics
Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Several new diagnostics generation devices are specifically designed to assist clinical staff replacing the equivalent laboratory tests and allowing a wide range of disease diagnoses to be performed immediately at the POC. The clinical impact of POC diagnostics has been shown in a variety of diseases conditions, particularly HIV/AIDS and TB. The World Health Organisation (WHO) called for new clinical diagnostics methods that are designed to function in setting with limited access to laboratory services. Thus, leading to an increase in marketing, manufacturing and development of POC diagnostics instruments and reagents for use in clinical POC. The advent of POC tests in South Africa has led to an improved control of infectious diseases such as HIV and mycobacterium tuberculosis (TB), in this era of drug-resistance. Increased availability of POC test in rural and resource-limited settings is encouraged.
To maximize the impact of novel diagnostics on patient outcomes in resource-limited settings, the implementation of new diagnostics must be performed within a given context and culture. However, the population-level of diagnostic utility in South Africa is not known. The investigators aim to estimate the level of POC diagnostic availability, usage and need in rural South Africa, using a cross sectional survey of rural primary healthcare (PHC) clinics in KwaZulu Natal (KZN). The survey focused on the conditions for which the respondent considered a POC test might help improve their clinical decision making during patient care. Determining the current accessibility, availability, usage and need for POC diagnostics in rural and resource limited settings can help inform developers and implementers of POC diagnostic services on context-specific deployment and implementation of POC diagnostics to address the unmet needs of patients in these settings.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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KwaZulu Natal
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Durban, KwaZulu Natal, Afrique du Sud, 4001
- University of KwaZulu Natal
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Primary Healthcare clinics located in rural and semi-rural settings
Exclusion Criteria:
- Primary Healthcare clinics located in urban settings
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Primary Health care clinics
A survey of 100 primary Health care clinics was carried out
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Pregnant and breast feeding women
208 patients were recruited from nine clinics that participated in the survey for evaluation of the accuracy of results produced by the HIV rapid test.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Accessibility and availability
Délai: Three months
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The accessibility and availability of point-of-care diagnostics for maternal health patients in rural primary healthcare clinics
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Three months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Usage
Délai: Three months
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The utility of point-of-care diagnostics for maternal health patients in rural South Africa
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Three months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tivani P Mashamba-Thompson, Masters, University of KwaZulu
- Directeur d'études: Benn K Sartorius, PhD, University of KwaZulu
- Directeur d'études: Paul K Drain, MD,MPH, University of Washington
Publications et liens utiles
Publications générales
- Drain PK, Hyle EP, Noubary F, Freedberg KA, Wilson D, Bishai WR, Rodriguez W, Bassett IV. Diagnostic point-of-care tests in resource-limited settings. Lancet Infect Dis. 2014 Mar;14(3):239-49. doi: 10.1016/S1473-3099(13)70250-0. Epub 2013 Dec 10.
- Drain PK, Garrett NJ. The arrival of a true point-of-care molecular assay-ready for global implementation? Lancet Glob Health. 2015 Nov;3(11):e663-4. doi: 10.1016/S2214-109X(15)00186-2. No abstract available.
- Nabyonga J, Orem J. From knowledge to policy: lessons from Africa. Sci Transl Med. 2014 Jun 11;6(240):240ed13. doi: 10.1126/scitranslmed.3008852. No abstract available.
- Thomas TL, DiClemente R, Snell S. Overcoming the triad of rural health disparities: How local culture, lack of economic opportunity, and geographic location instigate health disparities. Health Educ J. 2014 May;73(3):285-294. doi: 10.1177/0017896912471049.
- Mashamba-Thompson TP, Sartorius B, Drain PK. Operational assessment of point-of-care diagnostics in rural primary healthcare clinics of KwaZulu-Natal, South Africa: a cross-sectional survey. BMC Health Serv Res. 2018 May 29;18(1):380. doi: 10.1186/s12913-018-3207-6.
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
Autres numéros d'identification d'étude
- BE484/14
- HRKM 40/15 (Autre identifiant: KwaZulu Natal Department of Health)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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