NCT02692274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 18, 2016

Last Update Submit

February 22, 2016

Conditions

HIV

Keywords

Point-of-care diagnosticsRural primary health careAccessNeedUsageMaternal Health

Outcome Measures

Primary Outcomes (1)

  • Accessibility and availability

    The accessibility and availability of point-of-care diagnostics for maternal health patients in rural primary healthcare clinics

    Three months

Secondary Outcomes (1)

  • Usage

    Three months

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rural Primary Healthcare clinics

You may qualify if:

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

You may not qualify if:

  • Primary Healthcare clinics located in urban settings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of KwaZulu Natal

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (5)

  • 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.

    PMID: 26475005BACKGROUND

  • 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.

    PMID: 24332389BACKGROUND

  • 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.

    PMID: 24920657BACKGROUND

  • 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.

    PMID: 25242822BACKGROUND

  • 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.

    PMID: 29843711DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for evaluating the accuracy of HIV rapid tests in rural KwaZulu Natal

Study Officials

  • Tivani P Mashamba-Thompson, Masters

    University of KwaZulu

    PRINCIPAL INVESTIGATOR

  • Benn K Sartorius, PhD

    University of KwaZulu

    STUDY DIRECTOR

  • Paul K Drain, MD,MPH

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 26, 2016

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

February 26, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)