North-South Corridor Demonstration Project: Ethical and Logistical Challenges in the Design of a Demonstration Study of Early Antiretroviral Treatment for Long Distance Truck Drivers along a Transport Corridor through South Africa, Zimbabwe, and Zambia
Background. Long-distance truck drivers are at risk of acquiring and transmitting HIV and have suboptimal access to care. New HIV prevention strategies using antiretroviral drugs to reduce transmission risk (early antiretroviral therapy (ART) at CD4 count >350？cells/μL) have shown efficacy in clinical trials. Demonstration projects are needed to evaluate “real world” programme effectiveness. We present the protocol for a demonstration study to evaluate the feasibility, acceptability, and cost of an early ART intervention for HIV-positive truck drivers along a transport corridor across South Africa, Zimbabwe, and Zambia, as part of an enhanced strategy to improve treatment adherence and retention in care. Methods and Analysis. This demonstration study would follow an observational cohort of truck drivers receiving early treatment. Our mixed methods approach includes quantitative, qualitative, and economic analyses. Key ethical and logistical issues are discussed (i.e., choice of drug regimen, recruitment of participants, and monitoring of adherence, behavioural changes, and adverse events). Conclusion. Questions specific to the design of tailored early ART programmes are amenable to operational research approaches but present substantial ethical and logistical challenges. Addressing these in demonstration projects can inform policy decisions regarding strategies to reduce health inequalities in access to HIV prevention and treatment programmes. 1. Introduction Recent studies have shown the impact of population mobility and transport infrastructure on the spread of HIV in Africa [1, 2]. While mobility can be considered an underlying determinant of HIV transmission, proximal factors include low perceptions of risk, differential HIV prevalence between the areas of origin and destination, and overlapping sexual networks [3]. Long-distance truck drivers, in particular, are highly mobile, spending long periods on the road away from their families. Their mobility in and of itself does not increase their risk of HIV acquisition or transmission directly. However, separation from families and communities, loneliness, and lack of access to HIV prevention, treatment, and care services make this mobile population particularly vulnerable to HIV, potentially favouring the spread of HIV into other lower-risk sexual networks [4–8]. Among truck drivers in the region, HIV prevalence estimates from the literature are scarce and highly heterogeneous (from 5% to over 50%): in 1993, 15% of drivers tested positive for HIV in Cameroon [9]; in 1994 and 1995, two studies in Kenya
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