Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics
NCT ID: NCT02692274
Last Updated: 2016-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
309 participants
OBSERVATIONAL
2015-04-30
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CROSS_SECTIONAL
Study Groups
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Primary Health care clinics
A survey of 100 primary Health care clinics was carried out
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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African Population and Health Research Center
OTHER
University of Washington
OTHER
University of KwaZulu
OTHER
Responsible Party
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Tivani Mashamba-Thompson
Mrs
Principal Investigators
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Tivani P Mashamba-Thompson, Masters
Role: PRINCIPAL_INVESTIGATOR
University of KwaZulu
Benn K Sartorius, PhD
Role: STUDY_DIRECTOR
University of KwaZulu
Paul K Drain, MD,MPH
Role: STUDY_DIRECTOR
University of Washington
Locations
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University of KwaZulu Natal
Durban, KwaZulu-Natal, South Africa
Countries
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References
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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.
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.
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.
Other Identifiers
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HRKM 40/15
Identifier Type: OTHER
Identifier Source: secondary_id
BE484/14
Identifier Type: -
Identifier Source: org_study_id
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