Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial
Authors' conclusion
In sub-Saharan Africa, integrated chronic care services could achieve a high standard of care for people with diabetes or hypertension without adversely affecting outcomes for people with HIV.
Study context
- Population
- Adults aged ≥18 years with confirmed HIV, diabetes or hypertension living in the catchment area of primary health-care facilities in Uganda and Tanzania32 health facilities
- Participants
- 7,028 adults
- Comparison
- Integrated care vs standard vertical care for HIV, diabetes and hypertension
- Primary endpoint
- Coprimary: retention in care (clinic attendance within the last 6 months of follow-up) in participants with diabetes or hypertension (superiority); plasma viral load suppression in participants with HIV (non-inferiority, 10% margin)
- Follow-up
- 12 months
Methodological detailspragmatic, stratified permuted block randomisation (1:1), coprimary outcomes: superiority (retention) and non-inferiority, 10% margin (HIV viral suppression), multicentre (Uganda and Tanzania), Follow-up 12 months, Randomisation June 30, 2020 to April 1, 2021; 17 facilities in Uganda, 15 in Tanzania
- Pragmatic
- Stratified permuted block randomisation (1:1)
- Coprimary outcomes: superiority (retention) and non-inferiority, 10% margin (HIV viral suppression)
- Multicentre (Uganda and Tanzania)
- Follow-up 12 months
- Randomisation June 30, 2020 to April 1, 2021; 17 facilities in Uganda, 15 in Tanzania
Primary result
As reported in the abstract
study end
Each group vs standard careEstimate (95% CI)P value
Integrated care
risk difference (unadjusted) −0.65 %(−5.76 to 4.46)
P = 0.80Integrated care
risk difference (adjusted) −0.60 %(−5.46 to 4.26)
P = 0.81Further findings
| Outcome | Integrated care | Standard care | Estimate | P value | |
|---|---|---|---|---|---|
| Coprimary: plasma viral load <1000 copies per mL (participants with HIV) · study endIntention-to-treat population | 97.0% | 97.3% | difference (unadjusted) −0.37 % (one-sided 95% CI −1.99 to 1.26) | P for non-inferiority < 0.0001 unadjusted | |
| Coprimary: plasma viral load <1000 copies per mL (participants with HIV) · study endIntention-to-treat population | difference (adjusted) −0.36 % (one-sided 95% CI −1.99 to 1.28) | P for non-inferiority < 0.0001 adjusted | |||
| −2−1012Difference, % (linear scale) |
- Coprimary: plasma viral load <1000 copies per mL (participants with HIV): non-inferiority, 10% margin
- Coprimary: plasma viral load <1000 copies per mL (participants with HIV): one-sided 95% CI
Original publication
Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial. Lancet. Published 7 October 2023. doi:10.
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