Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi (mPATCH-TB)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Malawi
  • Southern Region
    • Blantyre, Southern Region, Malawi
      • Bangwe Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Enhanced standard of care; Access to Fast Track TB Clinic; Information leaflet for primary male partner	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
Active Comparator: Group 2; Access to Fast Track TB Clinic; Information leaflet for primary male partner; Female participant sputum collection from male partners	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
Active Comparator: 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	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: 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
Active Comparator: 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	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
Active Comparator: 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	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: 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB screening	The proportion of male partners that complete TB screening	Within 14 days of recruitment of female participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB case detection	The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment	Within 14 days of recruitment of female participant
Acceptability	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	Within 14 days of recruitment of female participant
Completion of HIV testing	The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV	Within 14 days of recruitment of female participant

Collaborators and Investigators

• Sponsor: Liverpool School of Tropical Medicine
• Collaborators: London School of Hygiene and Tropical Medicine; University of Liverpool; Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): March 28, 2020
• Study Completion (Actual): March 28, 2020

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Tuberculosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 18-020 (Other Identifier: MSKCC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: To facilitate reproducibility of analysis, an anonymised minimal final dataset and all code required to reproduce analysis will be published in the trial GitHub repository.
• IPD Sharing Time Frame: As soon as possible
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No