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Home Delivery of Antiretrovirals for HIV Clients amidst Covid-19 and Insecurity Challenges: A Protocol for a Randomized Controlled Trial

Author(s): Ajagu Nnenna, Offu Ogochukwu, Okengwu Ogadinma Daughter, Ani Njieka Ifeoma, Umeh Ifeoma Blessing, Okoro Kenneth Obinna, Nduka Sunday, Ekwunife Ikechukwu Obinna

Background: Insecurity and Covid-19 has affected access to antiretroviral agents and it has resulted in suboptimal adherence to the antiretroviral therapy which could impact negatively on the overall treatment outcomes.

Objective: This study will evaluate the effectiveness, cost-benefit, and feasibility of a home-based antiretroviral delivery model in Anambra State, Nigeria.

Method/Design: The study is a randomized, non-blinded, controlled, and parallel-group trial, which will be conducted in two HIV treatment hospitals in Anambra State, Nigeria. Participants will be randomized into the intervention and control arm. Home delivery personnel will be trained to deliver the ARV drugs at 3 monthly intervals to the homes of those in the intervention group while those in the control group (Facility-based services group) will receive ARVs at the HIV treatment hospital. The study was approved by Nnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee (NAUTHHREC) (NAUTH/CS/66/VOL.13/VER III/23/2020/011) on 02/10/2020 and the trial registration number, from Pan Africa Trial registry, is PACTR202004535536808 approved on 08/04/2020, http://www.pactr.org/PACTR202004535536808 The interim analysis will be done on the 12th month and the final analysis will be done on the 24th month.

Results: The interim analysis will be done on the 12th month and the final analysis will be done on the 24th month.

Conclusions: The results of this study could provide the rationale for a larger study involving various geo-political zones in Nigeria to examine the effectiveness of the home delivery model.

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