Male Partner-assisted Contact Tracing for HIV and Tuberculosis in Malawi: a Feasibility and Acceptability Study, and Multi-arm Cluster-randomised Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- TB screening
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for female participants
- •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
- •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)
排除标准
- •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
研究组 & 干预措施
Group 4
- 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
干预措施: Information leaflet for male partner (Other)
Group 4
- 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
干预措施: Home sputum collection (Other)
Group 4
- 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
干预措施: Home HIV testing (Other)
Enhanced standard of care
- Access to Fast Track TB Clinic
- Information leaflet for primary male partner
干预措施: Access to Fast Track TB clinic (Other)
Enhanced standard of care
- Access to Fast Track TB Clinic
- Information leaflet for primary male partner
干预措施: Information leaflet for male partner (Other)
Group 3
- 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
干预措施: Access to Fast Track TB clinic (Other)
Group 2
- Access to Fast Track TB Clinic
- Information leaflet for primary male partner
- Female participant sputum collection from male partners
干预措施: Access to Fast Track TB clinic (Other)
Group 2
- Access to Fast Track TB Clinic
- Information leaflet for primary male partner
- Female participant sputum collection from male partners
干预措施: Information leaflet for male partner (Other)
Group 2
- Access to Fast Track TB Clinic
- Information leaflet for primary male partner
- Female participant sputum collection from male partners
干预措施: Home sputum collection (Other)
Group 3
- 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
干预措施: Information leaflet for male partner (Other)
Group 3
- 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
干预措施: Home sputum collection (Other)
Group 3
- 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
干预措施: Financial incentive (Other)
Group 4
- 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
干预措施: Access to Fast Track TB clinic (Other)
Group 5
- 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
干预措施: Access to Fast Track TB clinic (Other)
Group 5
- 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
干预措施: Information leaflet for male partner (Other)
Group 5
- 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
干预措施: Home sputum collection (Other)
Group 5
- 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
干预措施: Home HIV testing (Other)
Group 5
- 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
干预措施: Financial incentive (Other)
结局指标
主要结局
TB screening
时间窗: Within 14 days of recruitment of female participant
The proportion of male partners that complete TB screening
次要结局
- Acceptability(Within 14 days of recruitment of female participant)
- TB case detection(Within 14 days of recruitment of female participant)
- Completion of HIV testing(Within 14 days of recruitment of female participant)