Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
NCT ID: NCT04285905
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2019-04-10
2020-03-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Enhanced standard of care
* Access to Fast Track TB Clinic
* Information leaflet for primary male partner
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Group 2
* Access to Fast Track TB Clinic
* Information leaflet for primary male partner
* Female participant sputum collection from male partners
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Group 3
* 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
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Financial 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
Group 4
* 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
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Home 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
Group 5
* 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
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Home 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
Financial 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
Interventions
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Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Home 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
Financial 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Malawi-Liverpool-Wellcome Trust Clinical Research Programme
OTHER
London School of Hygiene and Tropical Medicine
OTHER
University of Liverpool
OTHER
Liverpool School of Tropical Medicine
OTHER
Responsible Party
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Locations
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Bangwe Health Centre
Blantyre, Southern Region, Malawi
Countries
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Other Identifiers
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18-020
Identifier Type: -
Identifier Source: org_study_id
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