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Due to Covid-19, fnding period expired and Phase 2 was not possible.
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| Name | Class |
|---|---|
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| University of Liverpool | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced standard of care | Active Comparator |
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| Group 2 | Active Comparator |
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| Group 3 | Active Comparator |
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| Group 4 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Access to Fast Track TB clinic | Other | Male partner can attend clinic with dedicated services for men |
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| Measure | Description | Time Frame |
|---|---|---|
| TB screening | The proportion of male partners that complete TB screening | Within 14 days of recruitment of female participant |
| Measure | Description | Time Frame |
|---|---|---|
| TB case detection | The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment | Within 14 days of recruitment of female participant |
| Acceptability |
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Inclusion criteria for female participants
Inclusion criteria for male partner participants
Exclusion criteria for primary male partner participants in trial (applied on the same day the female participant is recruited)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangwe Health Centre | Blantyre | Southern Region | Malawi |
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.
As soon as possible
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Group 5 | Active Comparator |
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| Information leaflet for male partner | Other | Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening |
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| Home sputum collection | Other | Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner |
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| Home HIV testing | Other | Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use |
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| Financial incentive | Other | Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing |
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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
| 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 | Within 14 days of recruitment of female participant |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |