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

HIV Clinical Trial

Official title:

Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692274
• Other study ID #: BE484/14
• Secondary ID: HRKM 40/15
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: February 22, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Primary Healthcare clinics located in urban settings

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
South Africa	University of KwaZulu Natal	Durban	KwaZulu Natal

Sponsors (3)

Lead Sponsor	Collaborator
University of KwaZulu	African Population and Health Research Center, University of Washington

Country where clinical trial is conducted

South Africa, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accessibility and availability	The accessibility and availability of point-of-care diagnostics for maternal health patients in rural primary healthcare clinics	Three months	No
Secondary	Usage	The utility of point-of-care diagnostics for maternal health patients in rural South Africa	Three months	No