Dr Modupe Amofa-Sekyi, manager of the Incidence of TB Infection Cohort Study for Zambia, reflects on launching TREATS field work

19 September 2018

  A member of the TREATS staff talks to a parents about the study before enrolling her child

A member of the TREATS staff talks to a parents about the study before enrolling her child

  A participant is enrolled in the study by a member of TREATS staff

A participant is enrolled in the study by a member of TREATS staff

  TREATS laboratory staff at Zambart House, Lusaka, process some of the first blood samples

TREATS laboratory staff at Zambart House, Lusaka, process some of the first blood samples

The Incidence of TB Infection Cohort Study is a key component of the TREATS project. Its aim is to assess the impact of a population level combined TB /HIV intervention on the incidence of infection of TB – in other words, the impact of this intervention on the rate of new TB infections across a community. The TB/HIV intervention, called PopART ran from 2013 to 2017, and involved universal testing and treatment for HIV, plus population level screening for TB, and treatment where needed.

The Incidence of TB Infection Cohort involves the four communities that were part of the PopART intervention and the four communities where standard care was offered during this time. A cohort of 300 young people, aged 15 – 24, will be recruited in each of these communities. Involvement is entirely voluntary. All participants must consent to take part in the study, and if they are under-18, they must also have the consent of their parent or guardian.  During the participants’ first visit they are tested for TB infection and offered a rapid HIV test. They will be followed for two years after this initial test, and tested again to see if they become infected with TB during this time.

Through a comparison between the communities that received the PopART intervention, and those that received standard care, this study could help identify methods for reducing the rates of new TB infection.

Additionally, during the recruitment process and throughout the study, those who test positive for TB disease or HIV will be referred to the local health facility where they will be offered treatment and care.

In the field

Recruitment for the Incidence of TB Infection Cohort began on July 12, 2018. We launched with TB awareness-raising and information sessions in each community, to let people know about the TREATS project, its aims and processes. Interested individuals that met the age criteria were then invited to participate in the project. After this initial engagement, TREATS project staff located at the communities’ local clinics welcomed and enrolled the project’s first participants.

The enrolment process involved determining eligibility to take part, receiving formal consent, completing a questionnaire on risk factors for TB and HIV infection, recording height and weight, and collecting sputum samples for testing. Blood samples for TB infection testing were also collected. The participants were also offered HIV testing using rapid tests at per national guidelines, and were given the results immediately after testing. Participants will be informed of their TB test results as soon as they are received from the central laboratory at Zambart House.

Participants were asked to come back for follow up visits after 12 months and then after 24 months. They will also receive contact phone calls between visits at months six and 18. This process will enable us to track rates of new TB infection across a community, and will help us understand more about TB.

Conversations in the community

The TREATS project has been well-received by community members so far. TREATS staff going door-to-door found that most households were interested in the work and supportive of its aims. Parents were keen to let their children participate in the programme, acknowledging the need for new ways to approach preventing and treating the disease. Many expressed their appreciation for the work of Zambart in their community and had not forgotten PopART. Many also recalled the PopART uniforms and were able to relate with the TREATS branding. This provided a good link for TREATS staff to talk about how the two studies were relate to each other.

Most of the community members met by the TREATS team had direct personal experience of TB - either  having TB themselves, or  living with a family member who currently has TB and is on treatment, or could recall a family member who had died from TB. Many people understood the relationship between HIV and TB, but the majority knew more about HIV than TB. Specifically there were low levels of knowledge about the difference between TB infection and TB disease. In some communities there was also a significant misconception that if a person has TB, they automatically have HIV. There was also some stigma surrounding both TB and HIV.

What’s next?

Recruitment will continue until we achieve our target number of participants. It’s our hope that as we engage the community, we will strengthen our existing relationships which will enable us address some of the misconceptions and information gaps we have discovered - and break down the stigma we have found relating to TB and HIV.

 

 

 

Dr Helen Ayles, project director introduces TREATS - a revolutionary study for TB and HIV testing

23 MARCH 2018

DrHelenAyles.png

In Zambia, where I have worked for the past 20 years, TB and HIV go hand-in-hand. From 2004 to 2011 I was one of the principal investigators of the ZAMSTAR study where we showed that by working in the community, going into TB patients’ homes and offering a combined package of TB and HIV diagnosis we could make a difference to TB at community level. Our problem was that the trial had borderline significance as we only directly covered about 6 percent of the population.

When we designed the HPTN 071 (PopART) study it was revolutionary. The intervention involved reaching out to the entire population -- visiting all homes in a community to provide a combination HIV prevention package, and linking to universal treatment for individuals living with HIV. With our previous experience in the ZAMSTAR study we could not ignore TB. And so PopART was designed with a community intervention that mirrored ZAMSTAR’s innovations, but modified according to the lessons we had learned. The scale of this intervention meant that we were testing every member of the population for HIV, as well as screening every member of the population for TB. It was true active case finding.

The TB side of the intervention was not popular with everyone. Many of the study team were much more familiar with working in HIV and so found the TB element of the study difficult to grasp. Our Community HIV Care Providers (CHiPs) also struggled as they were wholeheartedly focused on HIV --collecting sputum proved to be a new challenge. However we managed to win everyone round.

The TREATS project is so important as it will allow us, for the very first time, to measure the effect of a combination TB and HIV intervention delivered to the entire population in seven urban, high prevalence communities, and to compare this with seven matched communities that did not receive this intervention. It also allows us to measure several endpoints including: the incidence of TB infection in young people; the prevalence of active TB; TB notification and TB disease incidence in a random cohort of 18-44-year-olds. TREATS enable us to bring all this data together in order to understand the epidemiology of TB better.

Working in the field of TB is challenging. Our tools for diagnosing TB infection are limited -- this has hampered our understanding of the population dynamics of TB. And the tools necessary for large scale surveys, such as prevalence surveys, are expensive and difficult to use in this setting. The TREATS project will allow us to use the newest available tools to maximise additional scientific value. TB is also a feared and stigmatised disease.  A social science component built into the TREATS project will help us understand what worked well and what worked less well in the intervention, and ultimately to better understand stigma related to TB. This will enable us to design better TB services for the future. Mathematical and economic modelling will provide generalisable answers for how we can most effectively undertake these large scale interventions in the future.

For me personally, the TREATS project brings together 20 years of research into a combined strategy -- to end both TB and HIV at community level. It is a unique opportunity to assess an intervention on a massive scale. The TREATS consortium brings together a fantastic team of some of the best TB researchers and modellers, TB diagnostics companies and communications experts in TB. The study, I am sure, will involve many challenges. But it will also provide amazing data, and hopefully practical solutions to end TB.