Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
NCT04285905 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2021-02-25
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.
Conditions
Interventions
- OTHER
-
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
- OTHER
-
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
- OTHER
-
Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
- OTHER
-
Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
- OTHER
-
Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Sponsors & Collaborators
-
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
collaborator OTHER -
London School of Hygiene and Tropical Medicine
collaborator OTHER -
University of Liverpool
collaborator OTHER -
Liverpool School of Tropical Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-10
- Primary Completion
- 2020-03-28
- Completion
- 2020-03-28
Countries
- Malawi
Study Locations
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