Study Stopped
Due to Covid-19, fnding period expired and Phase 2 was not possible.
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
mPATCH-TB
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2019
CompletedFirst Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2020
CompletedFebruary 25, 2021
February 1, 2021
12 months
February 24, 2020
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TB screening
The proportion of male partners that complete TB screening
Within 14 days of recruitment of female participant
Secondary Outcomes (3)
TB case detection
Within 14 days of recruitment of female participant
Acceptability
Within 14 days of recruitment of female participant
Completion of HIV testing
Within 14 days of recruitment of female participant
Study Arms (5)
Enhanced standard of care
ACTIVE COMPARATOR* Access to Fast Track TB Clinic * Information leaflet for primary male partner
Group 2
ACTIVE COMPARATOR* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners
Group 3
ACTIVE COMPARATOR* 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
ACTIVE COMPARATOR* 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
ACTIVE COMPARATOR* 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
Interventions
Male partner can attend clinic with dedicated services for men
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use
Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing
Eligibility Criteria
You may qualify if:
- Female
- Attends study health centre with an acute care episode
- 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
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bangwe Health Centre
Blantyre, Southern Region, Malawi
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 26, 2020
Study Start
April 10, 2019
Primary Completion
March 28, 2020
Study Completion
March 28, 2020
Last Updated
February 25, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- As soon as possible
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.