Background:
In Sub-Saharan Africa, distance to health facilities, vertical care delivery, increased burden of non-communicable diseases (NCDs), and limited socioeconomic resources are barriers to patients maintaining HIV viral suppression. The Harambee cluster randomized trial tested a differentiated care model delivering HIV+NCD care within microfinance (MF) groups of people living with HIV in western Kenya.
Methods:
Fifty-seven MF groups (n=855 participants) were randomized in a 1:1 ratio to receive integrated community-based (ICB) care or standard facility-based care (SOC). The ICB intervention included: (1) clinical care visits during MF group meetings inclusive of clinical consultations, NCD management, distribution of antiretroviral therapy (ART) and NCD medications; (2) support for ART adherence; and (3) facility referrals as needed. Primary outcome was viral suppression (<400 HIV-RNA/mL before January 1, 2023; <200 HIV-RNA/mL on or after January 1, 2023) at 18 months. Effectiveness was estimated as the difference in viral suppression at 18-months comparing the two trial arms using a doubly robust generalized estimating equation accounting for dropout and adjusting for baseline viral load. The primary outcome from both trial arms were also compared to an additional n=300 propensity-matched controls receiving usual care (UC) alone.
Results:
The sample was 52 years of age, 75% female and viral suppression at baseline was 94%. There was no intervention effect on viral suppression at 18-months when comparing MF+ICB to MF+SOC (odds ratio, OR: 1.20, 95% Confidence Interval CI: [0.90, 1.60], p-value =0.23). There was an increase in viral suppression in the MF+ICB (OR: 2.16, 95% CI [1.48, 3.19], p-value <0.001) and MF+SOC (OR: 1.42, 95% CI [1.05, 1.92], p-value = 0.023), compared to the matched UC group.
Conclusions:
Among MF groups, those who received integrated HIV+NCD care did not have statistically higher viral suppression compared to SOC. This may be due to high viral suppression at baseline in both arms. However, improvements in viral suppression among MF group participants compared to matched usual care patients suggests that microfinance improves HIV treatment outcomes among patients in rural Kenya, yet additional research is necessary to understand the mechanisms for how MF improves viral suppression. Differentiated care models for addressing multilevel barriers to the maintenance of HIV viral suppression may be more effective if socioeconomic barriers are mitigated.