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Community- Versus Clinic-Based
ART Boosts HIV Control in African Study
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CROI 2020, March 8-11, 2020, Boston
Mark Mascolini
Community-based antiretroviral therapy (ART) raised HIV control rates more than 10% compared with clinic-based ART in a South African study and eliminated gender-based disparities in viral suppression [1].
In many regions, especially those with large rural HIV populations, clinic-based ART poses considerable barriers to use, including long trips to the clinic, long wait times, and stigma. Community-based ART aims to overcome these barriers by taking antiretrovirals to the people who need them.
To assess the feasibility and effectiveness of community-based ART, US and African researchers collaborated on the DO ART Study (Delivery Optimization for Antiretroviral Therapy Study). The research focused on two regions, Uganda's Sheema district, which has an HIV prevalence of 10% and an overall viral suppression rate of 64% (55% in men), and South Africa's Kwa-Zulu Natal province, which has an HIV prevalence of 27% and an overall viral suppression rate of 54% (47% in men).
The study enrolled clinically stable people with untreated HIV infection randomized to (1) a clinic group, which began ART in a clinic and received monitoring and resupplied antiretrovirals at the clinic, (2) a hybrid group, which began ART in a clinic and got monitored and resupplied by mobile van, and (3) a community group, which began ART at home or in a mobile van and got monitored and resupplied by van. The primary outcome was a viral load below 20 copies 12 months after treatment began.
Eligible participants had clinically stable HIV infection, a CD4 count above 100, no antiretroviral experience, and a detectable viral load. Nurse-led community groups began ART in their neighborhood, received quarterly monitoring and prescription refills in the community, and had their charts updated electronically and at a clinic. Clinic-based participants received standard services. Participants completed an exit visit after 12 months that included a viral load measurement.
Of the 1531 eligible participants (62% of the 2479 who tested positive), 514 were assigned to the clinic group, 509 to the hybrid group, and 508 to the community group. Gender did not differ between these three groups (overall 51% men). Neither did age (overall 37% 18 to 29, 55% 30 to 49, and 8% 50 or older) or employment status (41% employed). Median pretreatment CD4 count was similar across the three groups (450 overall).
A large majority in the community group, 82%, completed their quarterly visits. Overall retention was 95% at the exit visit. Viral suppression rates at 12 months stood at 63% in the clinic group, 68% in the hybrid group, and 74% in the community group. An analysis adjusted for age over 30, baseline CD4 category, site, and gender determined that the community group had an 18% higher chance of reaching and maintaining a viral load below 20 copies at 12 months compared with the clinic group (RR 1.18, 95% confidence interval [CI] 1.07 to 1.29, P = 0.00053). The viral suppression rate in the hybrid group was noninferior to the rate in the clinic group (RR 1.08, 95% CI 0.98 to 1.19, P = 0.0049).
Community ART proved superior to clinic-based ART in attaining viral suppression in subanalyses of South African participants (RR 1.26, 95% CI 1.04 to 1.51, P = 0.00038) and South African men (RR 1.39, 95% CI 1.17 to 1.66, P < 0.0001). Hybrid ART also proved superior to clinic-based ART in South African men (RR 1.26, 95% CI 1.04 to 1.51, P = 0.016).
Further analysis showed that community-based ART eliminated differences between men and women in viral suppression. The 12-month sub-20-copy rate measured 70% in women and 51% in men in the clinic group, 69% in women and 65% in men in the hybrid group, and 73% in women and 72% in men in the community group.
Serious adverse events affected 1.6% in the community group, 0.9% in the hybrid group, and 1.8% in the clinic group.
The DO ART investigators concluded that this kind of community-based ART program can reach HIV-positive men and women (including young adults) likely to have a detectable viral load and can control HIV replication at higher rates than traditional clinic-based ART.
Reference
1. Barnabas RV, Szpiro A, van Rooyen H, et al. Community ART increases viral suppression and eliminates disparities for African men. Conference on Retroviruses and Opportunistic Infections (CROI). March 8-11, 2020. Boston. Abstract 49LB.
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