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

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.

Conditions

• HIV Infections

Interventions

BEHAVIORAL

Basic MTM

A structured pharmacist-led Medication Therapy Management (MTM) program delivered over 24 months in addition to usual care. The intervention includes comprehensive medication reviews (CMRs), development of a Personal Medication Record (PMR) and a Medication Action Plan (MAP), patient education, medication adherence assessment and support, identification and resolution of drug-related problems, and pharmacist communication with prescribers when appropriate. Participants receive five face-to-face MTM visits at baseline and every 6 months thereafter (months 0, 6, 12, 18, and 24), together with four scheduled telephone follow-up calls at months 3, 9, 15, and 21. Participants in this group do not receive the additional support components provided in the Enhanced MTM intervention.

BEHAVIORAL

Enhanced MTM

An enhanced pharmacist-led Medication Therapy Management (MTM) program delivered over 24 months in addition to usual care. The intervention includes all components of the Basic MTM program, including comprehensive medication reviews (CMRs), a Personal Medication Record (PMR), a Medication Action Plan (MAP), patient education, medication adherence assessment and support, identification and resolution of drug-related problems, and pharmacist communication with prescribers when appropriate. Participants receive more frequent face-to-face MTM visits, monthly during the first 3 months and every 3 months thereafter, together with additional telephone follow-up for high-risk participants. Enhanced MTM also includes structured peer support group sessions, adherence support tools (including pill organizers and medication reminder tools), enhanced collaboration with prescribers through multidisciplinary team particip

Sponsors & Collaborators

• Federal Ministry of Health, Sudan

  collaborator OTHER_GOV

• Universiti Sains Malaysia

  lead OTHER

Principal Investigators

• Hasni Arsad Ibrahim, PhD · Universiti Sains Malaysia

• Mohd Yusmaidie Aziz, PhD · Universiti Sains Malaysia

• Christina Malini Christopher, PhD · Universiti Sains Malaysia (USM)

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-01-01

Completion

2026-04-01

Countries

• Sudan

Study Locations