HIVNCT02692274
Operational Assessment of Point-of-Care Diagnostics in Primary Healthcare Clinics
An observational study of HIV, run by University of KwaZulu at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 309 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Rural Primary Healthcare clinics
Who may be able to join
- Primary Healthcare clinics located in rural and semi-rural settings
Who cannot join
- Primary Healthcare clinics located in urban settings
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of KwaZulu Natal
Durban, KwaZulu-Natal, 4001
About this study
Official title: Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa
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.
Read the 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.
- Conditions
- HIV
- Keywords
- Point-of-care diagnostics, Rural primary health care, Access, Need, Usage, Maternal Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accessibility and availability
The accessibility and availability of point-of-care diagnostics for maternal health patients in rural primary healthcare clinics
Measured: Three months
Secondary outcomes (1)
Usage
The utility of point-of-care diagnostics for maternal health patients in rural South Africa
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- African Population and Health Research Center, University of Washington
- Responsible party
- Principal investigator, Tivani Mashamba-Thompson, University of KwaZulu
- Investigators
- Tivani P Mashamba-Thompson, Masters, Principal investigator, University of KwaZuluBenn K Sartorius, PhD, Study director, University of KwaZuluPaul K Drain, MD,MPH, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692274
- Sponsor's protocol ID
- BE484/14
- Other IDs
- HRKM 40/15
- Status last verified
- Feb 2016
- First submitted
- 18 Feb 2016
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26475005Drain 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.
PubMed 24332389Nabyonga 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.
PubMed 24920657Thomas 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.
PubMed 25242822Mashamba-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.
PubMed 29843711
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accessibility and Utility of HIV-related Point of Care Diagnostic for Maternal Health in Rural South Africa
- ClinicalTrials.gov ID
- NCT02692274
- Acronym / sponsor ID
- BE484/14
- Conditions
- HIV
- Keywords
- Point-of-care diagnostics, Rural primary health care, Access, Need, Usage, Maternal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- African Population and Health Research Center, University of Washington
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rural Primary Healthcare clinics
Key inclusion criteria (1 listed)
- Primary Healthcare clinics located in rural and semi-rural settings
Key exclusion criteria (1 listed)
- Primary Healthcare clinics located in urban settings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Usage
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Background: PubMed 26475005Drain 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.
- Background: PubMed 24332389Drain 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.
- Background: PubMed 24920657Nabyonga 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.
- Background: PubMed 25242822Thomas 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.
- Derived from this study: PubMed 29843711Mashamba-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.
- Individual participant dataSharing planned: No
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tivani P Mashamba-Thompson, Masters principal investigator
University of KwaZulu
Benn K Sartorius, PhD study director
University of KwaZulu
Paul K Drain, MD,MPH study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of KwaZulu at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accessibility and availability (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692274, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.