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Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02692274
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
African Population and Health Research Center
University of Washington
Information provided by (Responsible Party):
Tivani Mashamba-Thompson, University of KwaZulu

Brief Summary:
Diagnostic point-of-care (POC) tests are being rapidly developed and implemented in resource-limited settings. There has been a rapid rise of HIV and TB POC tests in South Africa during the last 10-15 years. The investigators sought to determine the existing availability, current usage and future need of POC tests among rural primary healthcare (PHC) clinics in South Africa's KwaZulu-Natal Province.

Condition or disease

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 309 participants
Time Perspective: Cross-Sectional
Official Title: Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Health care clinics
A survey of 100 primary Health care clinics was carried out
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.

Primary Outcome Measures :
  1. Accessibility and availability [ Time Frame: Three months ]
    The accessibility and availability of point-of-care diagnostics for maternal health patients in rural primary healthcare clinics

Secondary Outcome Measures :
  1. Usage [ Time Frame: Three months ]
    The utility of point-of-care diagnostics for maternal health patients in rural South Africa

Biospecimen Retention:   Samples With DNA
Blood samples for evaluating the accuracy of HIV rapid tests in rural KwaZulu Natal

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Rural Primary Healthcare clinics

Inclusion Criteria:

  • Primary Healthcare clinics located in rural and semi-rural settings

Exclusion Criteria:

  • Primary Healthcare clinics located in urban settings

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02692274

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South Africa
University of KwaZulu Natal
Durban, KwaZulu Natal, South Africa, 4001
Sponsors and Collaborators
University of KwaZulu
African Population and Health Research Center
University of Washington
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Principal Investigator: Tivani P Mashamba-Thompson, Masters University of KwaZulu
Study Director: Benn K Sartorius, PhD University of KwaZulu
Study Director: Paul K Drain, MD,MPH University of Washington

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tivani Mashamba-Thompson, Mrs, University of KwaZulu Identifier: NCT02692274     History of Changes
Other Study ID Numbers: BE484/14
HRKM 40/15 ( Other Identifier: KwaZulu Natal Department of Health )
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tivani Mashamba-Thompson, University of KwaZulu:
Point-of-care diagnostics
Rural primary health care
Maternal Health