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SAME-DAY ART INITIATION AFTER HOME-BASED HIV TESTING: A RANDOMIZED CONTROLLED TRIAL
Niklaus D. Labhardt1, Isaac Ringera2, Thabo I. Lejone2, Thomas Klimkait3, Josephine Muhairwe2, Alain Amstutz1, Tracy R. Glass1
1Swiss Tropical and Public Health Institute, Basel, Switzerland,2SolidarMed, Luzern, Switzerland,3University of Basel, Basel, Switzerland
In sub-Saharan Africa, home-based HIV testing is frequently used to increase awareness of HIV status. However, effectiveness of this approach is limited by low percentages of individuals tested positive who link subsequently to care and start antiretroviral therapy (ART). The CASCADE trial tests if same-day home-based ART initiation improves linkage to care, retention in care and viral suppression in rural Lesotho, Southern Africa.
This open-label randomized controlled trial assigned individuals to either same-day ART start ([SD] arm) or referral to nearest clinic for preparatory counseling and ART start after ≥2 pre-ART clinic visits (standard of care SOC arm). Consenting ART-naïve HIV-infected individuals aged ≥18 years found HIV positive during home-based testing were eligible. Primary endpoints were linkage to care and viral suppression. Linkage to care was defined as presenting at the facility within 90 days after tested HIV-positive. Viral suppression was defined as viral load <100 copies/mL 12 months after tested HIV-positive. All analyses were done according to intention to treat. Trial registration: NCT02692027
A total of 274 ART-naïve individuals were enrolled from February to July 2016 (137 in each arm). Baseline participant characteristics were balanced: 65.7% female, median age 39 years, median CD4-cell count of 378 cells/µL, 78.1% were clinically asymptomatic. Linkage to care within 90 days was 68.6% (94/137) in the SD and 43.1% (59/137) in the SOC arm (p<0.001). In the SD arm 50.4% (69/137) had suppressed viral load 12 months after tested HIV-positive versus 37.9% (52/137) in SOC (p=0.039, see figure 1). Ninety days after tested HIV positive, 68.6% (94/137) in the SD and 31.4% (43/137) in the SOC arm had initiated ART (p<0.001). Retention in care 12 months after tested HIV-positive remained higher in the SD arm (56.2% (77/137) versus 43.1% (59/137), p=0.03).
Offering same-day ART initiation increased effectiveness of home-based HIV testing through higher proportions linking to HIV care at the facility and being retained in care with viral suppression 12 months after tested HIV-positive. Same-day ART initiation requires little additional resources as health care workers providing home-based HIV testing are already at the patients' home. If confirmed in other settings, same-day home-based ART initiation could become policy in countries with established home-based HIV testing.