TuberculosisPhase 2/3mPATCH-TBNCT04285905
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
A Phase 2/3 study testing Access to Fast Track TB clinic, Information leaflet for male partner and Home sputum collection in people with Tuberculosis, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
The overall aim of the mPATCH-TB Study is to identify potentially cost-effective, feasible and scalable interventions that could increase rates of completion of screening for tuberculosis and HIV among male partners of women attending primary health care in Blantyre, Malawi. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Access to Fast Track TB clinic, Information leaflet for male partner and Home sputum collection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalawi
- Study dates
- 10 Apr 2019to 28 Mar 2020
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Attends study health centre with an acute care episode
- 18 years of age or older on the day of clinic attendance
- Has a primary male partner living within their household
- Reports that primary male partner has symptoms of pulmonary tuberculosis (cough)
- Is resident within urban Blantyre
Show all 15Show fewer
- Male
- Aged 18 years of age or older on the day of clinic attendance
- Has cough
- Is living with the female participant (defined as sleeping in the same dwelling on most nights during the previous 14 days)
- Exclusion criteria for primary male partner participants in trial (applied on the same day the female participant is recruited)
- Currently taking treatment for tuberculosis
- Has taken any treatment for tuberculosis in the 6-months prior to the female participant's clinic attendance
- Is taking isoniazid preventive therapy
- Plans to move out of Blantyre to live elsewhere in the following 2-months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial
The overall aim of the mPATCH-TB Study is to identify potentially cost-effective, feasible and scalable interventions that could increase rates of completion of screening for tuberculosis and HIV among male partners of women attending primary health care in Blantyre, Malawi.
Eligible women who consent to participate - and who have a primary male partner with cough at home -will be randomly allocated, by day of clinic attendance, into a standard of care group or one of up to four intervention groups. They will be asked to identify their primary male partner and will be offered interventions according to their allocated group.
The primary outcome will compare the proportion of primary male partner that complete TB screening (defined as receipt of result of a sputum Xpert or smear result) within 14 days of recruitment in each intervention group compared to the enhanced standard of care group.
- Conditions
- Tuberculosis
- Being tested
- Access to Fast Track TB clinic, Information leaflet for male partner, Home sputum collection, Home HIV testing, Financial incentive
- Keywords
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Fast Track TB clinicOther
Male partner can attend clinic with dedicated services for men
Information leaflet for male partnerOther
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collectionOther
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Home HIV testingOther
Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use
Financial incentiveOther
Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing
| Study group | Role | What they receive |
|---|---|---|
| Enhanced standard of care | Active comparator | * Access to Fast Track TB Clinic
* Information leaflet for primary male partner Receives: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner |
| Group 2 | Active comparator | * Access to Fast Track TB Clinic
* Information leaflet for primary male partner
* Female participant sputum collection from male partners Receives: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner; Other: Home sputum collection |
| Group 3 | Active comparator | * Access to Fast Track TB Clinic
* Information leaflet for primary male partner
* Female participant sputum collection from male partners
* Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic Receives: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner; Other: Home sputum collection; Other: Financial incentive |
| Group 4 | Active comparator | * Access to Fast Track TB Clinic
* Information leaflet for primary male partner
* Female participant sputum collection from male partners
* Female partner delivered oral HIV self-testing kits for primary male partner Receives: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner; Other: Home sputum collection; Other: Home HIV testing |
| Group 5 | Active comparator | * Access to Fast Track TB Clinic
* Information leaflet for primary male partner
* Female participant sputum collection from male partners
* Female partner delivered oral HIV self-testing kits for primary male partner
* Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic Receives: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner; Other: Home sputum collection; Other: Home HIV testing; Other: Financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB screening
The proportion of male partners that complete TB screening
Measured: Within 14 days of recruitment of female participant
Secondary outcomes (3)
TB case detection
The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment
Measured: Within 14 days of recruitment of female participant
Acceptability
The proportion of primary household male partners who report that they would be "very likely" or "likely" to recommend the interventions they received to their families or friends
Measured: Within 14 days of recruitment of female participant
Completion of HIV testing
The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV
Measured: Within 14 days of recruitment of female participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start10 Apr 2019
- Primary completion28 Mar 2020
- Study completion28 Mar 2020
Why it stopped: Due to Covid-19, fnding period expired and Phase 2 was not possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, London School of Hygiene and Tropical Medicine, University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285905
- Sponsor's protocol ID
- 18-020
- Acronym
- mPATCH-TB
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To facilitate reproducibility of analysis, an anonymised minimal final dataset and all code required to reproduce analysis will be published in the trial GitHub repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial
- ClinicalTrials.gov ID
- NCT04285905
- Acronym / sponsor ID
- mPATCH-TB / 18-020
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Covid-19, fnding period expired and Phase 2 was not possible.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Malawi-Liverpool-Wellcome Trust Clinical Research Programme, London School of Hygiene and Tropical Medicine, University of Liverpool
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 28 Mar 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 26 Feb 2020 (actual)
- 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 overall aim of the mPATCH-TB Study is to identify potentially cost-effective, feasible and scalable interventions that could increase rates of completion of screening for tuberculosis and HIV among male partners of women attending primary health care in Blantyre, Malawi.
Eligible women who consent to participate - and who have a primary male partner with cough at home -will be randomly allocated, by day of clinic attendance, into a standard of care group or one of up to four intervention groups. They will be asked to identify their primary male partner and will be offered interventions according to their allocated group.
The primary outcome will compare the proportion of primary male partner that complete TB screening (defined as receipt of result of a sputum Xpert or smear result) within 14 days of recruitment in each intervention group compared to the enhanced standard of care group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Enhanced standard of care | Active comparator | Other: Access to Fast Track TB clinic, Other: Information leaflet for male partner* Access to Fast Track TB Clinic * Information leaflet for primary male partner |
| Group 2 | Active comparator | Other: Access to Fast Track TB clinic, Other: Information leaflet for male partner, Other: Home sputum collection* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners |
| Group 3 | Active comparator | Other: Access to Fast Track TB clinic, Other: Information leaflet for male partner, Other: Home sputum collection, Other: Financial incentive* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners * Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic |
| Group 4 | Active comparator | Other: Access to Fast Track TB clinic, Other: Information leaflet for male partner, Other: Home sputum collection, Other: Home HIV testing* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners * Female partner delivered oral HIV self-testing kits for primary male partner |
| Group 5 | Active comparator | Other: Access to Fast Track TB clinic, Other: Information leaflet for male partner, Other: Home sputum collection, Other: Home HIV testing, Other: Financial incentive* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners * Female partner delivered oral HIV self-testing kits for primary male partner * Voucher for financial incentive (MKW 5000) that can be collected by the male partner upon attendance at the Fast Track Clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female
- Attends study health centre with an acute care episode
- 18 years of age or older on the day of clinic attendance
- Has a primary male partner living within their household
- Reports that primary male partner has symptoms of pulmonary tuberculosis (cough)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Access to Fast Track TB clinicMale partner can attend clinic with dedicated services for men | Other | Enhanced standard of care, Group 2, Group 3, Group 4, Group 5 |
| Information leaflet for male partnerFemale participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening | Other | Enhanced standard of care, Group 2, Group 3, Group 4, Group 5 |
| Home sputum collectionFemale participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner | Other | Group 2, Group 3, Group 4, Group 5 |
| Home HIV testingFemale participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use | Other | Group 4, Group 5 |
| Financial incentiveFemale participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing | Other | Group 3, Group 5 |
Primary outcome
TB screening
Time frame: Within 14 days of recruitment of female participant
The proportion of male partners that complete TB screening
3 secondary outcomes
TB case detection
Time frame: Within 14 days of recruitment of female participant
Acceptability
Time frame: Within 14 days of recruitment of female participant
Completion of HIV testing
Time frame: Within 14 days of recruitment of female participant
Results and safety
The study was stopped early (reason given: Due to Covid-19, fnding period expired and Phase 2 was not possible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Yes. To facilitate reproducibility of analysis, an anonymised minimal final dataset and all code required to reproduce analysis will be published in the trial GitHub repository.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Access to Fast Track TB clinic, Information leaflet for male partner and Home sputum collection in people with Tuberculosis, 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 25 Feb 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to Covid-19, fnding period expired and Phase 2 was not possible.). Results are not available in the source record.
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 screening (time frame: Within 14 days of recruitment of female participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.