TuberculosisTriageNCT02127983
Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus)
A study testing Early intervention and Delayed intervention in people with Tuberculosis and HIV, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, HIV
- What is being tested?
- Early intervention and Delayed intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200,000 participants
- Where
- 1 siteMalawi
- Study dates
- Jan 2009to Dec 2012
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- People accessing informal providers with possible TB or HIV
Who cannot join
- children
- people already with a diagnosis of TB or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial
The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.
Read the detailed description
A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.
- Conditions
- Tuberculosis, HIV
- Being tested
- Early intervention, Delayed intervention
- Keywords
- TB, HIV, case finding, access, informal providers
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early interventionBehavioural
Also called Early intervention arm engaging informal providers, Received the intervention early in the first 12 months
Training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness.
Front line public health personnel and community leaders were sensitised to support the intervention
Delayed interventionBehavioural
Delayed intervention arm, engaging informal providers Received the intervention after one year
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Early intervention arm engaging informal providers Received the intervention early in the first 12 months Receives: Behavioral: Early intervention |
| Delayed intervention | Active comparator | Delayed intervention arm, engaging informal providers Received the intervention after one year Receives: Behavioral: Delayed intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB and HIV treatment initiation
the cumulative counts of patients initiating TB and HIV treatment per 10,000 adults aged 12 years and above each month over the intervention period
Measured: 2 years
Secondary outcomes (1)
TB and HIV diagnostic uptake rates.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Research for Equity And Community Health REACH Trust, Ministry of Health, Malawi, LHL International Tuberculosis Foundation, University of Warwick
- Responsible party
- Sponsor
- Investigators
- Rachael Thomson, MSc, Principal investigator, LSTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127983
- Sponsor's protocol ID
- TriagePlus
- Acronym
- Triage
- Status last verified
- Dec 2012
- First submitted
- 29 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bello G, Faragher B, Sanudi L, Namakhoma I, Banda H, Malmborg R, Thomson R, Squire SB. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial. PLoS One. 2017 Sep 6;12(9):e0183312. doi: 10.1371/journal.pone.0183312. eCollection 2017.
PubMed 28877245
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial
- ClinicalTrials.gov ID
- NCT02127983
- Acronym / sponsor ID
- Triage / TriagePlus
- Conditions
- Tuberculosis, HIV
- Keywords
- TB, HIV, case finding, access, informal providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200,000 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Research for Equity And Community Health REACH Trust, Ministry of Health, Malawi, LHL International Tuberculosis Foundation, University of Warwick
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 May 2014 (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.
The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.
Detailed description
A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Behavioral: Early interventionEarly intervention arm engaging informal providers Received the intervention early in the first 12 months |
| Delayed intervention | Active comparator | Behavioral: Delayed interventionDelayed intervention arm, engaging informal providers Received the intervention after one year |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- People accessing informal providers with possible TB or HIV
Key exclusion criteria (2 listed)
- children
- people already with a diagnosis of TB or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early interventionAlso: Early intervention arm engaging informal providers, Received the intervention early in the first 12 monthsTraining non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention | Behavioural | Early intervention |
| Delayed interventionDelayed intervention arm, engaging informal providers Received the intervention after one year | Behavioural | Delayed intervention |
Primary outcome
TB and HIV treatment initiation
Time frame: 2 years
the cumulative counts of patients initiating TB and HIV treatment per 10,000 adults aged 12 years and above each month over the intervention period
1 secondary outcome
TB and HIV diagnostic uptake rates.
Time frame: 2 years
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 1 May 2014.
- Derived from this study: PubMed 28877245Bello G, Faragher B, Sanudi L, Namakhoma I, Banda H, Malmborg R, Thomson R, Squire SB. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial. PLoS One. 2017 Sep 6;12(9):e0183312. doi: 10.1371/journal.pone.0183312. eCollection 2017.
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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.
Rachael Thomson, MSc principal investigator
LSTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention and Delayed intervention in people with Tuberculosis and HIV, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 2 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 1 May 2014. 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 Malawi. 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?
TB and HIV treatment initiation (time frame: 2 years). 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 NCT02127983, which also lists 1 linked publication.
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 1 May 2014.