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  Conference on Retroviruses
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Boston, Massachusetts
March 4-7, 2018
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Starting ART on Day of Home HIV Test Improves Linkage, Viral Suppression
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25th Conference on Retroviruses and Opportunistic Infections (CROI), March 4-7, 2018, Boston
Mark Mascolini
Starting antiretroviral therapy (ART) on the same day a person tests positive for HIV at home significantly improved entry to HIV care, retention in care, and viral suppression in the randomized CASCADE trial in rural Lesotho [1]. CASCADE investigators argued that same-day ART requires few additional resources because health workers are already in the home for the HIV test.
Home-based HIV testing has made inroads in sub-Saharan Africa, the Swiss research team observed, but its effectiveness remains limited because low percentages of people who test positive start care and ART. They conducted the randomized CASCADE trial to see whether offering same-day ART to people testing positive at home improves linkage, retention, and viral suppression. Adults were eligible for the trial if they tested positive in a home-based program and lived or worked in the study area. The trial excluded pregnant or breastfeeding women and people with WHO stage 4 HIV or cryptococcal infection.
From February through July 2016, researchers randomized 278 antiretroviral-naive positive testers to the intervention (immediate 30-day ART supply with spaced follow-up clinic visits) or to Lesotho's standard of care (referral to clinic for 2 or more pre-ART visits). The investigators defined linkage as making a clinic visit within 90 days of testing positive. They defined viral suppression as a viral load below 100 copies 12 months after testing positive. A ClinicalTrials.gov entry details the protocol [2].
The primary analysis included 137 people assigned to same-day ART and 137 assigned to standard care. Three quarters of participants were women, median age stood at 39 years, and median CD4 count measured 380. Half of participants completed primary education, and 23% had a regular job. Median time to get to the clinic was 1 hour, and 49% walked.
A significantly higher proportion in the same-day ART group entered care within 3 months (69% versus 43%, P < 0.001). Ninety days after testing positive, 69% in the same-day group versus 31% of the standard-care group had started ART (P < 0.001). Significantly more same-day participants attained viral suppression within 12 months (50% versus 38%, P < 0.039), and significantly more remained in care 12 months after testing positive (56% versus 43%, P = 0.03).
The CASCADE investigators concluded that in this rural region with high HIV prevalence, offering ART on the same day a person tests positive improves linkage, retention, and viral suppression through 12 months after a supervised home-based HIV test. If studies in other areas confirm these findings, they proposed, home-based same-day ART "could become policy in countries with established home-based HIV testing."
CASCADE results appeared in JAMA on March 6, 2018, the day of this presentation at CROI: https://jamanetwork.com/journals/jama/fullarticle/2674479
Webcast: http://www.croiwebcasts.org/console/player/37199?mediaType=slideVideo&&crd_fl=1&ssmsrq=1520454376533&ctms=5000&csmsrq=871
From publication pdf attached above for download
"Trial Design: The study protocol has been published13 and the full protocol is available in Supplement 1. This multicenter, 2-group, open-label, randomized clinical trial recruited participants who tested positive during home-based HIV testing and were randomly assigned (1:1 allocation) into same-day or usual care treatment groups. Participants randomized to the same-day group were offered home-based ART initiation the same day. Specifically, they were given a 1-month drug-supply and instructed to visit their health facility within 2 to 4 weeks for their first check-up and drug-refill. Subsequent visits to the health facility were scheduled at intervals of 1.5, 3, 6, 9, and 12 months after ART initiation. Usual care in Lesotho at the time involved monthly clinic visits, during which patients underwent a minimum of 2 pre-ART counseling sessions at the health facility with a subsequent offer to start ART, followed by monthly visits after ART initiation. In both groups, the quantity of the drug supply that a participant received during the clinic visit depended on the scheduled next visit (ie, 1 box if the next visit was scheduled in a month, 3 boxes if in 3 months).
Participants randomized to the usual care group followed the usual care provided in Lesotho, which is similar to most settings in southern Africa. They received posttest counseling in the home and an appointment at their nearest health facility within the next 28 days. Once linked to care, they had to undergo at least 2 pre-ART health facility visits. During the first health facility visit, blood was drawn for baseline laboratory work and a first pre-ART counseling session was conducted. At the second health facility visit, laboratory results were communicated and the patient's readiness to start ART was assessed. Depending on the judgment of the health facility staff, the participant was offered to start ART. Once ART was started, the participants were given monthly follow-up and drug refill dates.
In the same-day group, participants were offered same-day ART initiation. Participants received pre-ART counseling directly after testing, accompanied by a leaflet that summarized the key points of ART adherence. If they agreed to start therapy within the upcoming days, the study nurse left a 30-day supply of ART. Once participants linked to care at the health facility and had their first health facility visit (including ART dispensing), they followed the usual care for ART patients with the exception of longer intervals between follow-up visits (1.5, 3, 6, 9, and 12 months after ART start)."
1. Labhardt ND, Ringera I, Lejone TI, et al. Same-day ART initiation after home-based HIV testing: a randomized controlled trial. 25th Conference on Retroviruses and Opportunistic Infections (CROI). March 4-7, 2018. Boston. Abstract 94.
2. ClinicalTrials.gov. Same-day ART initiation versus standard of care after positive HIV-test result in rural Lesotho (CASCADE). https://clinicaltrials.gov/ct2/show/NCT02692027