Protocol for a Pilot Quasi‐Experimental Study on the Effect of Patient‐Centered Education on HIV Virological Outcomes Among Adult People Live With HIV‐HBV Co‐Infection in North‐West Ethiopia: Protocol for a Pilot Quasi‐Experimental Study

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ABSTRACT Background Human immunodeficiency virus (HIV) remains a major public health challenge in sub‐Saharan Africa, including Ethiopia. Adults living with HIV are at increased risk of liver‐related complications, poor treatment outcomes, and suboptimal virological control, particularly when adherence to antiretroviral therapy (ART) is inadequate. Patient‐centered education has emerged as a promising strategy for improving treatment adherence, self‐management, and health outcomes among individuals with chronic diseases. However, evidence on the effect of patient‐centered education on HIV virological outcomes among adults living with HIV remains limited, particularly in resource‐constrained settings such as North‐West Ethiopia. Furthermore, limited evidence exists regarding the feasibility and acceptability of structured educational interventions tailored to this vulnerable population. This pilot quasi‐experimental study therefore aims to assess the effect of a patient‐centered education intervention on HIV virological outcomes among adults living with HIV in North‐West Ethiopia. Objective To evaluate the feasibility and preliminary effectiveness of a patient‐centered educational intervention on HIV virological outcomes, medication adherence, and HIV‐related knowledge among 120 adult people living with HIV–HBV co‐infection receiving ART in North‐West Ethiopia. Methods and Analysis This pilot quasi‐experimental study will employ non‐randomized intervention and comparison groups with baseline and 6‐month follow‐up assessments. A total of 120 participants (60 per group) will be enrolled from selected hospitals in North‐West Ethiopia. Participants in the intervention group will receive a structured patient‐centered education program integrated into routine ART services, while the comparison group will continue receiving standard care. Quantitative data will be entered into EpiData version 4.6 and analyzed using STATA version 18. Descriptive statistics will summarize baseline characteristics. Baseline differences between groups will be assessed using chi‐square tests for categorical variables and independent t‐tests or non‐parametric equivalents for continuous variables. The primary outcome will be the change in log‐transformed HIV viral load (log 10 copies/mL) from baseline to the end of the 6‐month follow‐up period. The intervention effect will be evaluated using paired t‐tests, difference‐in‐differences analysis, and multivariable linear regression while adjusting for potential confounders, including age, sex, educational status, baseline viral load, duration of ART, and medication adherence. Virological suppression, defined as HIV viral load < 1000 copies/mL, will be assessed as a secondary clinical outcome. Secondary outcomes will include medication adherence, HIV‐HBV‐related knowledge, self‐management practices, and retention in care. Statistical significance will be declared at p < 0.05. A qualitative study will be conducted at the end of the intervention period to assess the feasibility, acceptability, and implementation potential of the intervention. Qualitative data will be collected through focus group discussions with adult people live with HIV, in‐depth interviews with healthcare providers, and key informant interviews with hospital leaders and program managers. Audio‐recorded interviews will be transcribed verbatim and analyzed using directed thematic analysis with MAXQDA version 20. International Trial Registration Number The intervention protocol was registered on 15 November 2025 with the Pan African Clinical Trials Registry under identification number PACTR202512648125852.