Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 9:40 PM
Study NCT ID:
NCT04285905
Status:
TERMINATED
Last Update Posted:
2021-02-25
First Post:
2020-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
Sponsor:
Liverpool School of Tropical Medicine
Organization:
Study Overview
Official Title:
Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Covid-19, fnding period expired and Phase 2 was not possible.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mPATCH-TB
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: