NCT04285905

Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi

Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Tuberculosis

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2019-04-10
• Primary completion: 2020-03-28
• Completion: 2020-03-28
• First posted: 2020-02-26
• Last updated: 2021-02-25

Locations

1 site across 1 country: Malawi