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

Primary Purpose

Tuberculosis

Status
Terminated
Phase
Phase 2
Locations
Malawi
Study Type
Interventional
Intervention
Access to Fast Track TB clinic
Information leaflet for male partner
Home sputum collection
Home HIV testing
Financial incentive
Sponsored by
Liverpool School of Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis focused on measuring Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bangwe Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Enhanced standard of care

Group 2

Group 3

Group 4

Group 5

Arm Description

Access to Fast Track TB Clinic Information leaflet for primary male partner

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 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 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 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

Outcomes

Primary Outcome Measures

TB screening
The proportion of male partners that complete TB screening

Secondary Outcome Measures

TB case detection
The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment
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
Completion of HIV testing
The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV

Full Information

First Posted
February 24, 2020
Last Updated
February 23, 2021
Sponsor
Liverpool School of Tropical Medicine
Collaborators
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, London School of Hygiene and Tropical Medicine, University of Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT04285905
Brief Title
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
Acronym
mPATCH-TB
Official Title
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to Covid-19, fnding period expired and Phase 2 was not possible.
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 28, 2020 (Actual)
Study Completion Date
March 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool School of Tropical Medicine
Collaborators
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, London School of Hygiene and Tropical Medicine, University of Liverpool

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
Tuberculosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced standard of care
Arm Type
Active Comparator
Arm Description
Access to Fast Track TB Clinic Information leaflet for primary male partner
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Access to Fast Track TB Clinic Information leaflet for primary male partner Female participant sputum collection from male partners
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Access to Fast Track TB clinic
Intervention Description
Male partner can attend clinic with dedicated services for men
Intervention Type
Other
Intervention Name(s)
Information leaflet for male partner
Intervention Description
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Intervention Type
Other
Intervention Name(s)
Home sputum collection
Intervention Description
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Intervention Type
Other
Intervention Name(s)
Home HIV testing
Intervention Description
Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use
Intervention Type
Other
Intervention Name(s)
Financial incentive
Intervention Description
Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing
Primary Outcome Measure Information:
Title
TB screening
Description
The proportion of male partners that complete TB screening
Time Frame
Within 14 days of recruitment of female participant
Secondary Outcome Measure Information:
Title
TB case detection
Description
The proportion of male partners with either microbiologically-confirmed TB assessment, or taking TB treatment
Time Frame
Within 14 days of recruitment of female participant
Title
Acceptability
Description
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
Time Frame
Within 14 days of recruitment of female participant
Title
Completion of HIV testing
Description
The proportion of primary male household partners not receiving ART at baseline who report having been tested for HIV
Time Frame
Within 14 days of recruitment of female participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Bangwe Health Centre
City
Blantyre
State/Province
Southern Region
Country
Malawi

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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