Tuberculosis
Conditions
Keywords
Tuberculosis
Brief 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. 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.
Interventions
OTHERAccess to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
OTHERInformation leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
OTHERHome sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
OTHERHome HIV testing
Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use
OTHERFinancial incentive
Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing
Sponsors
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
London School of Hygiene and Tropical Medicine
University of Liverpool
Liverpool School of Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for female participants * 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 Inclusion criteria for male partner participants * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TB screening | Within 14 days of recruitment of female participant | The proportion of male partners that complete TB screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TB case detection | Within 14 days of recruitment of female participant | The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment |
| Acceptability | Within 14 days of recruitment of female participant | 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 |
| Completion of HIV testing | Within 14 days of recruitment of female participant | The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV |
Countries
Malawi
Outcome results
None listed