Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

Niklaus Daniel Labhardt,Thomas Klimkait,Thabo Ishmael Lejone,Bernard Cerutti,T’Sepang Thaanyane,Phofu Masethothi,Christiane Fritz,Tracy Renée Glass,Ravi Shankar Gupta,Isaac Ringera,Kyaw Thin,Mashaete Kamele

doi:10.1186/s12889-016-2972-6

Abstract

BackgroundAchievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation.MethodsThis two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms.DiscussionThis trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to improve the care cascade in similar settings.Trial registrationNCT02692027, registered February 21, 2016

Highlights

Achievement of the United Nations Programme on Human Immune deficiency Virus (HIV)/AIDS (UNAIDS) 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care
The strategy aims at a massive scale-up in coverage of antiretroviral therapy (ART) among individuals infected with HIV
In 2015 two randomized controlled trials showed the benefit of starting ART as early as possible for infected individuals – even if CD4-cell counts were above the threshold of 500 cells/mL [5, 6], leading the World Health Organization (WHO) to recommend that anyone infected with HIV should start ART as soon as possible after diagnosis [7]

Summary

Methods

Trial design The CASCADE-trial is a two-armed open-label randomized controlled trial. If a household member tests HIV positive during the HTC campaign, the study nurse is called to assess whether the individual is eligible for the CASCADE trial. With an estimated uptake of HTC of 94 %, a prevalence of previously untreated HIV infection during home-based HTC campaigns of 5 %, and a 10 % trial participation refusal rate or choice of alternative health facility, we need to visit 6200 households to achieve the desired sample size of 260 households. For individuals testing HIV-positive and participating in the CASCADE-trial further documentation will be done by study nurses on standardized paper-based forms These forms will be scanned in Lesotho and subsequently processed with Data-Scan 5.7.7 (Neoptec, Montpellier, France) for electronic data capture. Nested study 1 is a cross-sectional study assessing the testing coverage that is achieved with two home-based HTC visits to the randomly chosen areas for HTC-campaigns during recruitment for the CASCADE-trial. In case there is no eligible HIV-negative individual in the same household, the eligible individual from the nearest household will be enrolled

Discussion

Background

Findings

37. World Health Organization