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

Tuberculosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04285905
• Other study ID #: 18-020
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 10, 2019
• Est. completion date: March 28, 2020

Study information

• Verified date: February 2021
• Source: Liverpool School of Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 28, 2020
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Access to Fast Track TB clinic
Male partner can attend clinic with dedicated services for men
• Information leaflet for male partner
Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
• Home sputum collection
Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
• 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
• 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

Locations

Country	Name	City	State
Malawi	Bangwe Health Centre	Blantyre	Southern Region

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	London School of Hygiene and Tropical Medicine, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Liverpool

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TB screening	The proportion of male partners that complete TB screening	Within 14 days of recruitment of female participant
Secondary	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
Secondary	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
Secondary	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