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

Phase 2

Terminated

• Conditions: Tuberculosis
• Interventions: Other: Access to Fast Track TB clinic; Other: Information leaflet for male partner; Other: Home sputum collection; Other: Financial incentive; Other: Home HIV testing

• Registration Number: NCT04285905
• Lead Sponsor: Liverpool School of Tropical Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-26
• Primary Completion: 2020-03-28
• Study Completion: 2020-03-28
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Access to Fast Track TB clinic	* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners
Group 2	Information leaflet for male partner	* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners
Group 3	Home sputum collection	* 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
Group 3	Financial incentive	* 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
Group 5	Information leaflet for male partner	* 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
Group 5	Home sputum collection	* 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
Enhanced standard of care	Access to Fast Track TB clinic	* Access to Fast Track TB Clinic * Information leaflet for primary male partner
Group 2	Home sputum collection	* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners
Group 3	Information leaflet for male partner	* 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
Group 4	Home HIV testing	* 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
Enhanced standard of care	Information leaflet for male partner	* Access to Fast Track TB Clinic * Information leaflet for primary male partner
Group 3	Access to Fast Track TB clinic	* 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
Group 4	Access to Fast Track TB clinic	* 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
Group 4	Information leaflet for male partner	* 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
Group 4	Home sputum collection	* 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
Group 5	Home HIV testing	* 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
Group 5	Access to Fast Track TB clinic	* 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
Group 5	Financial incentive	* 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

Primary Outcome Measures

Name	Time	Method
TB screening	Within 14 days of recruitment of female participant	The proportion of male partners that complete TB screening

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bangwe Health Centre; 🇲🇼 Blantyre, Southern Region, Malawi