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Real-world data gives Africa a smarter path to fighting HIV and TB

- Wits University

African biostatisticians have offered a powerful, data-driven alternative that can accurately inform HIV policy, reduce healthcare costs, and save more lives.

HIV and tuberculosis (TB) treatment programmes have always relied on clinical trials to understand whether treatment interventions are actually working, but they’re costly and cumbersome. Meanwhile, African biostatisticians have offered a powerful, data-driven alternative that can accurately inform HIV policy, reduce healthcare costs, and save more lives.

Tuberculosis preventive treatment, known as TPT, is a simple and low-cost intervention that can reduce the risk of developing active TB by up to 90% among people living with HIV. Malawi, for example, now offers TPT to all eligible patients starting HIV treatment. What has been missing is evidence of how well the programme is working outside of clinical trials.

“Hospitals and clinics in Malawi face many challenges, including patchy medication supply, long waiting periods and overburdened staff. But HIV continues to affect thousands of people each year. Meanwhile, tuberculosis is the leading cause of death among people living with HIV, with children and adolescents particularly vulnerable,” notes Dr Geoffrey Singini, a sub-Saharan Africa Consortium for Advanced Biostatistics Training (SSACAB) Fellow.

SSACAB is a continental-wide Consortium led by the Wits School of Public Health, which trains biostatisticians to work with the complexities of African health systems data.

Singini and his colleagues at the Elizabeth Glaser Paediatric AIDS Foundation applied a statistical method, multivariable logistic regression, to existing routine data to understand how TB prevention protocols are functioning in real-world conditions.

The study analysed electronic medical records for adults and children who started antiretroviral therapy between January and March 2023 across 10 high-volume facilities in Malawi. Because the researchers relied on existing data, they were able to conduct a comprehensive assessment without the cost of a traditional study.

The results show clear progress. Of the 1,015 eligible patients, 81 per cent started treatment, and nearly three-quarters completed it. People who completed TPT were far less likely to develop TB. This confirms that TPT is effective in Malawi’s real-world health system.

At the same time, the study uncovered serious gaps. Children under 10 had the lowest initiation rates, followed by adolescents aged 10 to 19. This is worrying because children develop severe forms of TB more quickly than adults. Several factors may explain these gaps. The shorter weekly regimen, called 3HP, is only available to people who weigh at least 25 kilograms, which excludes many younger children. Urban clinics also had lower initiation rates, likely because of congestion and limited counselling time. Patients who were very ill when they started HIV treatment were also less likely to receive TPT.

By applying multivariable logistic regression to routine data, the study identified these specific factors.

This is where biostatistics becomes essential.

Instead of relying on assumptions or anecdotes, the analysis quantifies which groups face barriers and the extent of those barriers. According to Singini, reliable data removes subjectivity and helps the Ministry of Health understand exactly where to intervene. “The method was not complicated but is certainly effective,” says Singini.

The broader value of the study lies in what it represents for Malawi and the region. Many African countries do not have the financial resources to conduct large-scale clinical trials whenever a programme needs evaluation. Relying only on trials also delays decision-making because trials take years to design, fund, and complete. Routine data, combined with robust statistical methods, offers a faster, more affordable way to identify gaps, measure progress, and protect vulnerable groups.

This approach is also closely aligned with SSACAB’s work to strengthen biostatistical capacity in Africa. SSACAB trains African scientists to work with real-world data and conduct analyses that ministries can use immediately. Biostatisticians can rely on Malawi’s own data, analysed by African experts, to answer a pressing national question.

“The challenge now is to protect patients from TB during the first year of treatment, when their risk is highest. But the path forward is practical and achievable. Malawi can expand access to child-friendly TPT formulations, strengthen counselling for adolescents, improve triage in urban facilities, and continue promoting the shorter 3HP regimen. Most importantly, Malawi can continue using routine data and biostatistical analysis to monitor and adjust its programmes in real time,” notes Singini.

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