Male partner-assisted contact tracing for HIV and tuberculosis in Malawi: an adaptive multi-arm multi-stage randomised trial (mPATCH-TB)

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In Africa, tuberculosis and HIV (the virus that causes AIDS) are major health problems, and both affect millions of adults every year. HIV slowly weakens the immune system, and makes individuals very susceptible to developing severe tuberculosis. Although effective treatments are available for both tuberculosis and HIV, many individuals who need treatment don't receive it because they are unaware that they have the infection, or experience difficulties in accessing testing and treatment at clinics. Whilst they are not receiving treatment, they can transmit infection to others in their household or communities, and may die of the consequences of infection. Men in Africa experience particular difficulties in accessing testing and treatment for tuberculosis and HIV. Our previous research in Africa has shown that two-times as many men than women have untreated tuberculosis in the community. Men experience substantially longer delays than women in accessing diagnosis for HIV and TB (on average up to one year longer). This is for a number of reasons including masculine care-seeking behaviour, competing demands with employment, and perceptions that health centres are unwelcoming for men. We have additionally shown that men are responsible for up to 2/3rds of new tuberculosis infections in Africa. This means that improving timely diagnosis of TB and HIV among men could have important health benefits for men, women and children in the community by reducing infection risk. Building upon our substantial experience in undertaking HIV and tuberculosis research in sub-Saharan Africa, in this research we aim to rigorously identify strategies that could improve mens' rates of testing for tuberculosis and HIV. Women are substantially more likely than men to attend health centres with symptoms of tuberculosis, and are therefore a key group through which male partners with undiagnosed infection can be accessed. We have previously successfully demonstrated this approach in a recent study in which pregnant women attending clinics were asked to distribute HIV self-test kits to their partners. In the first stage of this research, we will conduct detailed interviews with men, women and health providers to identify and refine interventions that are likely to be feasible and acceptable when delivered by women to their male partners. We will base interventions upon those that we have experience of testing through previous studies. Types of interventions include: availability of a "male-friendly fast-track clinic"; written information and reminder phone-calls/text messages; home collection of sputum by partners; home HIV test delivery by partners; and varying levels of financial incentives. We will then conduct an innovative trial to identify which of these interventions has greatest potential to be effective, affordable and safe at increasing male partners' rates of TB and HIV testing. We will do this by recruiting a total of 445 women attending a health centre in Blantyre with symptoms of tuberculosis. Women participants will be tested for TB and HIV, and then randomly allocated to one of the five intervention groups according to the day they attend the clinic. After 30 days, we will assess how many male partners in each group have completed screening for tuberculosis and HIV. (To ensure equity of care, all household members will be able to access screening at the clinic, however the primary focus will be on male partners because of their high risk of disease). We will compare rates of testing between groups, and interventions that do not achieve rates of competing testing higher than the standard of care will be discarded, leaving only interventions with high potential for public health effectiveness. By the completion of the study, we will have identified 1-2 interventions that can be evaluated in a larger definitive trial that will investigate public health effectiveness in reducing the amount of undiagnosed TB and HIV.