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

NCT04285905 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-02-25

No results posted yet for this study

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.

Conditions

Interventions

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

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

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

Sponsors & Collaborators

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • University of Liverpool

    collaborator OTHER
  • Liverpool School of Tropical Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-03-28
Completion
2020-03-28

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285905 on ClinicalTrials.gov