Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi (mPATCH-TB)

Liverpool School of Tropical Medicine

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Tuberculosis

Treatments: Other: Financial incentive; Other: Access to Fast Track TB clinic; Other: Home HIV testing; Other: Home sputum collection; Other: Information leaflet for male partner

Study type: Interventional

Funder types: Other

Identifiers

NCT04285905

18-020 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Enhanced standard of care

Active Comparator group

Description:

* Access to Fast Track TB Clinic * Information leaflet for primary male partner

Treatment:

Other: Access to Fast Track TB clinic

Other: Information leaflet for male partner

Group 2

Active Comparator group

Description:

* Access to Fast Track TB Clinic * Information leaflet for primary male partner * Female participant sputum collection from male partners

Treatment:

Other: Home sputum collection

Other: Access to Fast Track TB clinic

Other: Information leaflet for male partner

Group 3

Active Comparator group

Description:

* 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

Treatment:

Other: Home sputum collection

Other: Access to Fast Track TB clinic

Other: Financial incentive

Other: Information leaflet for male partner

Group 4

Active Comparator group

Description:

* 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

Treatment:

Other: Home sputum collection

Other: Home HIV testing

Other: Access to Fast Track TB clinic

Other: Information leaflet for male partner

Group 5

Active Comparator group

Description:

* 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

Treatment:

Other: Home sputum collection

Other: Home HIV testing

Other: Access to Fast Track TB clinic

Other: Financial incentive

Other: Information leaflet for male partner