Image of Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/ PATH cluster randomized controlled trial

HIV & AIDS

Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/ PATH cluster randomized controlled trial

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Background: Though home-based human immunodeficiency virus (HIV) counseling and testing (HBHCT) is
implemented in many sub-Saharan African countries as part of their HIV programs, linkage to HIV care remains a
challenge. The purpose of this study is to test an intervention to enhance linkage to HIV care and improve HIV
viral suppression among individuals testing HIV positive during HBHCT in rural Uganda.
Methods: The PATH (Providing Access To HIV Care)/Ekkubo Study is a cluster-randomized controlled trial which
compares the efficacy of an enhanced linkage to HIV care intervention vs. standard-of-care (paper-based referrals)
at achieving individual and population-level HIV viral suppression, and intermediate outcomes of linkage to care,
receipt of opportunistic infection prophylaxis, and antiretroviral therapy initiation following HBHCT. Approximately
600 men and women aged 18-59 who test HIV positive during district-wide HBHCT in rural Uganda will be
enrolled in this study. Villages (clusters) are pair matched by population size and then randomly assigned to
the intervention or standard-of-care arm. Study teams visit households and participants complete a baseline
questionnaire, receive HIV counseling and testing, and have blood drawn for HIV viral load and CD4 testing. At
baseline, standard-of-care arm participants receive referrals to HIV care including a paper-based referral and then
receive their CD4 results via home visit 2 weeks later. Intervention arm participants receive an intervention
counseling session at baseline, up to three follow-up counseling sessions at home, and a booster session at the
HIV clinic if they present for care. These sessions each last approximately 30 min and consist of counseling to
help clients: identify and reduce barriers to HIV care engagement, disclose their HIV status, identify a treatment
supporter, and overcome HIV-related stigma through links to social support resources in the community. Participants in
both arms complete interviewer-administered questionnaires at six and 12 months follow-up, HIV viral load and CD4
testing at 12 months follow-up, and allow access to their medical records.
Discussion: The findings of this study can inform the integration of a potentially cost-effective approach to improving
rates of linkage to care and HIV viral suppression in HBHCT. If effective, this intervention can improve treatment
outcomes, reduce mortality, and through its effect on individual and population-level HIV viral load, and decrease
HIV incidence.

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Home-based HIV counseling and testing (HBHCT), Lin
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