Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan

Plain-language summary

This clinical trial aims to evaluate the effectiveness and cost-effectiveness of two levels of a pharmacist-led Medication Therapy Management (MTM) program, Basic MTM and Enhanced MTM, compared with usual care for HIV patients at high risk of adverse drug events in Khartoum, Sudan. The primary objective is to determine whether Basic MTM or Enhanced MTM improves medication adherence, measured by the Proportion of Days Covered (PDC ≥95%) at the primary 6-month assessment, with follow-up continuing for 24 months. Secondary objectives include evaluating the effects of the interventions on viral load suppression, CD4+ cell count, adverse drug events, drug-related problems, health-related quality of life, patient satisfaction, treatment self-efficacy, and cost-effectiveness. Participants will be randomly assigned in a 1:1:1 ratio to one of three study groups: Arm 1: Usual Care Arm 2: Basic Medication Therapy Management (Basic MTM) Arm 3: Enhanced Medication Therapy Management (Enhanced MTM) All participants will attend study visits at baseline and at 6, 12, 18, and 24 months to complete study questionnaires and undergo routine clinical assessments, including viral load and CD4+ measurements. Participants assigned to the Basic MTM group will receive usual care plus structured pharmacist-led Medication Therapy Management, including comprehensive medication reviews, a personal medication record, a medication action plan, five face-to-face MTM visits (baseline and every six months thereafter), and four scheduled telephone follow-up calls over the 24-month study period. Participants assigned to the Enhanced MTM group will receive all components of Basic MTM together with more frequent face-to-face visits, monthly during the first three months and every three months thereafter, additional telephone support for high-risk participants, adherence support tools (such as pill organizers and medication reminder tools), enhanced communication with prescribers, and home visits when appropriate. Do these MTM interventions improve clinical outcomes, such as viral load suppression and CD4+ cell count, compared to usual care? Researchers will compare three groups (Arm 1: Usual Care; Arm 2: Basic MTM; Arm 3: Enhanced MTM) to determine whether the MTM interventions lead to better medication adherence, fewer adverse drug events, improved quality of life, and greater cost-effectiveness. Participants will: Be randomly assigned to one of three groups: Usual Care, Basic MTM, or Enhanced MTM. Attend scheduled research assessment visits at baseline, 6, 12, 18, and 24 months to complete questionnaires (on adherence, quality of life, etc.) and provide blood samples for routine lab tests (viral load, CD4 count). If assigned to Basic MTM: Participate in 4 face-to-face sessions and 4 telephone follow-ups with a trained pharmacist over 24 months for medication reviews, education, and adherence support. If assigned to Enhanced MTM: Participate in 8 face-to-face sessions and 8 telephone follow-ups with a trained pharmacist over 24 months, and receive enhanced support tools (e.g., pillboxes, alarm devices) and potentially home visits.

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