Assessing Home Delivery Model Option For Improving Access To Antiretroviral Therapy; Protocol For A Cluster- Randomized Trial In Anambra State, Nigeria.

BackgroundAlthough different antiretroviral (ARV) agents delivery models have been explored in Nigeria, yet only about 55% and 35% of affected adults and children respectively are currently on these agents. This, therefore, underscores the need for the identification of newer effective antiretroviral therapy delivery models and best strategies to increase access to ARV therapy in Nigeria. Method and AnalysisThe study will be a cluster randomized controlled trial, which will be conducted in two HIV treatment centers in Anambra State, Nigeria. Participants will be randomized into intervention and control arm. Home delivery personnel will be trained to deliver the ARV drugs at 3months 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 primary outcome for the trial will be the difference between groups in the proportion with HIV viral load suppression ([≤]20 copies/mL) by 12 months and then 24months. Secondary outcome include adherence to ARVs, the cost-effectiveness of home delivery service, and patient satisfaction. Ethics and disseminationNnamdi Azikiwe University Teaching Hospital Health Research Ethics Committee (NAUTHHREC) approved this study (NAUTH/CS/66/VOL.13/VER III/23/2020/011) with a trial registration: Pan African Clinical Trials Registry, ID: PACTR202004535536808 on 8th April 2020. Study dissemination plans include holding advocacy meetings with stakeholders in HIV care, publishing study outcomes in an open-access peer-review journal, and presentation of the outcome at an international conference. Strength and Limitations of this studyO_LIThis is the first randomized trial assessing the effectiveness of the home delivery model of antiretroviral therapy. C_LIO_LIThe primary outcome in this trial will be measured by assessing the difference between baseline HIV viral load and 12/24 months in both the intervention and control arm. C_LIO_LIIn this study, patients will be assigned to treatment groups and non-treatment groups. This will help us to compare the effect of the home delivery model. C_LIO_LIIn this study, only one state in Nigeria and two HIV/AIDS treatment hospitals in the state will be used to access the impact of the home delivery model. This may not allow for the generalization of the study findings. C_LIO_LIThis study could serve as a pilot to a full-fledged national study to access the effectiveness of the home delivery model. C_LI