Trial results for the Harambee study, investigating integrated community-based HIV/NCD care and microfinance groups in Kenya, were posted on ClinicalTrials.gov on 2025-10-31, involving 1200 participants.
Background
People living with HIV (PLHIV) in Kenya, and globally, often face challenges in maintaining consistent care and achieving viral suppression, particularly when compounded by noncommunicable diseases (NCDs) like hypertension and diabetes. Traditional facility-based care models can present barriers to access and retention. The integration of community-based care with economic empowerment initiatives, such as microfinance, is hypothesized to improve treatment outcomes by enhancing household economic status and making care more accessible. This approach aims to address both health and socioeconomic determinants of health simultaneously.
Trial design
This completed study, designated as Phase NA, enrolled 1200 participants to investigate conditions including HIV/AIDS, Noncommunicable Diseases, Hypertension, and Diabetes. The trial evaluated a differentiated care delivery model across three groups: "Microfinance with Integrated, Community-based Care," "Microfinance with Usual (Facility-based) Care," and "Usual (Facility-based) Care." The central hypothesis was that integrating community-based HIV and NCD care with group microfinance would improve retention in care and rates of viral suppression (VS) among PLHIV in Kenya. The primary outcome for analysis was HIV-1 RNA Viral Load Suppression at 18-months.
Key results
The trial reported key measurements and analyses for viral load suppression, retention in care, and changes in NCD markers:
- HIV-1 RNA Viral Load Suppression at 18-months:
- 326 participants in the "Microfinance with Integrated, Community-based Care" group achieved viral suppression.
- 365 participants in the "Microfinance with Usual (Facility-based) Care" group achieved viral suppression.
- 275 participants in the "Usual (Facility-based) Care" group achieved viral suppression.
- Retention in Care Each Quarter During 18-months of Follow-up:
- 315 participants in the "Microfinance with Integrated, Community-based Care" group were retained.
- 235 participants in the "Microfinance with Usual (Facility-based) Care" group were retained.
- 51 participants in the "Usual (Facility-based) Care" group were retained.
- Change in Systolic Blood Pressure (SBP):
- "Microfinance with Integrated, Community-based Care" group showed a mean change of 0.25 mm Hg (Standard Deviation 15.89).
- "Microfinance with Usual (Facility-based) Care" group showed a mean change of 0.046 mm Hg (Standard Deviation 14.26).
- Change in Random Blood Sugar (mmol/L):
- "Microfinance with Integrated, Community-based Care" group showed a mean change of 0.276 mmol/L (Standard Deviation 1.62).
- "Microfinance with Usual (Facility-based) Care" group showed a mean change of -0.172 mmol/L (Standard Deviation 1.45).
Key analyses for viral suppression and retention in care included:
- For viral suppression at 18-months, the primary intention-to-treat analysis comparing "Microfinance with Integrated, Community-based Care" to "Microfinance with Usual (Facility-based) Care" yielded an Odds Ratio (log) of 0.84 (95% CI 0.63 to 1.12) with a p-value of 0.23.
- A secondary analysis comparing "Microfinance with Integrated, Community-based Care" to "Usual (Facility-based) Care" showed an Odds Ratio (log) of 2.16 (95% CI 1.48 to 3.19) with a p-value of 0.001.
- Another secondary analysis comparing "Microfinance with Usual (Facility-based) Care" to "Usual (Facility-based) Care" showed an Odds Ratio (log) of 1.42 (95% CI 1.05 to 1.92) with a p-value of 0.023.
- For retention in care, comparing "Microfinance with Integrated, Community-based Care" to "Microfinance with Usual (Facility-based) Care" yielded an Odds Ratio (log) of 3.31 (95% CI 2.58 to 4.26) with a p-value of 0.001.
- Comparing "Microfinance with Integrated, Community-based Care" to "Usual (Facility-based) Care" showed an Odds Ratio (log) of 7.51 (95% CI 6.0 to 9.55) with a p-value of 0.001.
- Comparing "Microfinance with Usual (Facility-based) Care" to "Usual (Facility-based) Care" showed an Odds Ratio (log) of 2.56 (95% CI 2.14 to 3.06) with a p-value of 0.001.
What this means
The Harambee trial results indicate that integrated community-based HIV care, especially when combined with microfinance, can significantly improve retention in care and viral suppression rates among people living with HIV in Kenya compared to usual facility-based care. While the primary comparison between the two microfinance arms for viral suppression did not reach statistical significance, secondary analyses demonstrated a clear benefit of both microfinance interventions over usual care. The most pronounced effect was observed for retention in care, where the "Microfinance with Integrated, Community-based Care" group showed a substantially higher likelihood of retention compared to usual care. Measurements for NCD markers like blood pressure and blood sugar were also collected, providing additional context on the comprehensive health approach.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04417127, titled "Harambee: Integrated Community-based HIV/NCD Care & Microfinance Groups in Kenya", were posted on 2025-10-31 on clinicaltrials.gov.