Clinical trial NCT04285905: Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi
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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Tuberculosis
Keywords: Tuberculosis
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: London School of Hygiene and Tropical Medicine
name: University of Liverpool
First posted: 2020-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: TB screening
timeFrame: Within 14 days of recruitment of female participant
Secondary outcomes:
measure: TB case detection
timeFrame: Within 14 days of recruitment of female participant
measure: Acceptability
timeFrame: Within 14 days of recruitment of female participant
measure: Completion of HIV testing
timeFrame: Within 14 days of recruitment of female participant
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Bangwe Health Centre
state: Southern Region
Study officials:
References: