5 Study site and population
5.1 Study site
The PROSPeCT Study will be conducted at Ndirande Health Centre, Blantyre, Malawi, where we have previously undertaken research demonstrating need for improved TB and HIV diagnosis and linkage to care.
Ndirande Health Centre is located within a busy urban neighbourhood in Blantyre, where adult HIV prevalence is estimated to be 18%, and prevalence of active tuberculosis >900 per 100,000.
At Ndirande Health Centre, comprehensive HIV care is available and includes: routine provider initiated HIV testing and counselling, screening and treatment of opportunistic infections, provision of chemoprophylaxis, and treatment with antiretroviral therapy. Malawi National Guidelines currently recommend a “Test and Treat” approach to HIV, with all individuals diagnosed with HIV being eligible for antiretroviral therapy. Our previous research has shown however that coverage of HIV testing and rates linkage to antiretroviral therapy are suboptimal, as in many other African settings.
TB diagnostics available at Ndirande Health Centre include sputum smear fluorescent microscopy with LED microscopes, and Xpert MTB/Rif. Although testing for tuberculosis is recommended for all individuals with symptoms of TB in Malawi and WHO guidelines (with Xpert preferred as the first time investigation for HIV-positive individuals), our previous research shows that TB diagnostics are underutilised.
5.2 Study population
Study participants will be adults with symptoms of tuberculosis who attend Ndirande Health Centre with an acute care episode. We will include pregnant women, as the diagnosis of TB is known to be suboptimal in this group.
As this is a pragmatic randomised trial that aims to provide evidence for policymakers under “real-life” conditions, eligibility criteria will be broad, and will reflect the characteristics of adults attending primary health centres with an acute care episode in Southern Africa to maximise generalisability.
5.3 Inclusion criteria
- Attends Ndirande Health Centre with an acute care episode
- 18 years of age or older on the day of clinic attendance
- Has symptoms of tuberculosis (any of: current cough, weight loss, night sweats, or fever)
- Is resident within urban Blantyre
5.4 Exclusion criteria
- Currently taking treatment for tuberculosis
- Has taken any treatment for tuberculosis in the 6-months prior to clinic attendance
- Is taking isoniazid preventive therapy
- Plans to move out of Blantyre to live elsewhere in the following 6-months
5.5 Identification of participants and recruitment
Participant and patient flow through the trial and clinic system are shown in the Figure below.
Study Research Assistants will be based at the clinic registration desk where, using electronic data collection tablets, they will screen all daily acute clinic attenders for eligibility against inclusion and exclusion criteria (Case Record Form A: Screening assessment (English)). As adults may attend the clinic on more than one occasion during the study period, the Research Assistant will record a digital fingerprint (SIMPRINTS, Cambridge, UK) from all clinic attenders to ensure that repeat clinic attendance episodes are recorded and so removing the potential for duplication in trial recruitment.
Participants meeting inclusion criteria will be provided with oral and written information about the study by the research assistant Appendix 1 Participant information forms and will be invited to provide written informed consent ([Appendix 2 Participant consent form]) to participate in the study. Participants who are illiterate will be asked to provide a thumbprint confirmation of consent, which will be observed and recorded by a witness independent of the study team. Completed consent forms will be securely stored as trial source documents within the trial folder.
Participant and patient flow in study clinic
Notes: TB: tuberculosis; HIV: Human immunodeficiency virus; HIV +ve: HIV-positive; HIV –ve: HIV-negative; TB +ve: TB positive; TB –ve: TB negative. Rx: treatment; CXR: chest x-ray; ART: antiretroviral therapy; HW: health worker