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

NCT07750834 | Completed DMC

• 1 other identifier: USM/JEPeM/PP/24100928
• Study Type: interventional
• Target: 1,149
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV/AIDS; Medication Therapy Management; Treatment Adherence; Randomized Controlled Trial; Adverse Drug Events

Outcome Measures

Primary Outcomes (1)

• Medication Adherence - Proportion of Days Covered (PDC)

  Medication adherence will be assessed using the Proportion of Days Covered (PDC) calculated from pharmacy refill records as: (days covered by dispensed medication ÷ days in the observation period) × 100. Optimal adherence is defined as PDC ≥95%.

  Baseline, 6 months (primary endpoint), 12 months, 18 months, and 24 months

Secondary Outcomes (14)

• Viral Load Suppression

  Baseline, 6 months, 12 months, 18 months, 24 months

• CD4+ Cell Count

  Baseline, 6 months, 12 months, 18 months, 24 months

• Adverse Drug Events (ADEs) - Incidence

  From enrollment through 24 months

• Adverse Drug Events (ADEs) - Severity Distribution

  From enrollment through 24 months

• Drug-Related Problems (DRPs)

  Baseline, 6 months, 12 months, 18 months, and 24 months (MTM arms only)

Study Arms (3)

Arm 1: Usual Care (Control)

NO INTERVENTION

Participants assigned to the Usual Care arm received the standard HIV care routinely provided at the participating study sites in Sudan. Standard care included scheduled physician follow-up visits, routine clinical and laboratory monitoring (including viral load and CD4+ cell count assessments), monthly antiretroviral medication refills with routine dispensing counseling, and management according to national HIV treatment guidelines. No structured Medication Therapy Management (MTM) services or dedicated pharmacist-led follow-up beyond usual care were provided.

Arm2: Basic MTM

EXPERIMENTAL

Participants in Arm 2 received usual care plus a structured pharmacist-led Basic Medication Therapy Management (MTM) program over 24 months. The intervention included comprehensive medication reviews (CMRs) at enrollment and every 6 months, a Personal Medication Record (PMR), a Medication Action Plan (MAP), five face-to-face MTM visits at months 0, 6, 12, 18, and 24 (45 to 60 minutes each), and four scheduled telephone follow-up calls at months 3, 9, 15, and 21 (15 to 20 minutes each). Drug-related problems were identified and addressed during each CMR, with pharmacist-to-prescriber communication provided when appropriate. Participants did not receive the enhanced MTM components, such as structured peer support sessions, adherence aids, or home visits.

Behavioral: Basic MTM

Arm3: Enhanced MTM

EXPERIMENTAL

Participants in Arm 3 received usual care plus an enhanced pharmacist-led Medication Therapy Management (MTM) program over 24 months. The intervention included all components of Basic MTM, together with more frequent face-to-face visits (monthly during the first 3 months and every 3 months thereafter), home visits or additional telephone follow-up for high-risk participants, structured peer support group sessions, adherence support tools (including pill organizers and medication reminder tools), enhanced pharmacist-to-prescriber communication with participation in multidisciplinary team meetings, and additional pharmacist training in motivational interviewing and CFIR-informed implementation strategies.

Behavioral: Enhanced MTM

Interventions

Basic MTM BEHAVIORAL

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.

Arm2: Basic MTM

Enhanced MTM BEHAVIORAL

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

Arm3: Enhanced MTM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Age: ≥18 years at the time of enrollment. HIV Status: Laboratory-confirmed HIV infection. ART Duration: Receiving antiretroviral therapy (ART) for at least 3 months prior to enrollment.
• Language and Consent: Able to communicate in Arabic or English and willing and able to provide written informed consent.
• High-Risk Status: Meeting at least 2 of the following high-risk criteria:
• Receiving ≥8 chronic medications, including ART and medications for comorbidities.
• Having ≥3 chronic comorbidities (e.g., diabetes mellitus, hypertension, hepatitis, or tuberculosis).
• Documented or self-reported adverse drug event within the previous 12 months. Viral load \>200 copies/mL during the previous 6 months. Self-reported medication adherence \<95% or repeated missed clinic appointments. Attendance at the participating HIV clinic on at least 2 occasions during the assessment period.

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• Age \<18 years. Pregnancy. Significant cognitive impairment preventing informed consent or study participation.
• Terminal illness with expected life expectancy \<12 months. Concurrent participation in another pharmacological intervention study. Previous participation in a formal Medication Therapy Management (MTM) program within the past year.
• Planned relocation away from Khartoum State during the follow-up period. Inability to provide informed consent for any reason.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Federal Ministry of Health, Sudan: collaborator

Study Sites (1)

Omdurman teaching Hospital

Khartoum, Omdurman, 1111, Sudan

Location

Related Publications (1)

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

  PMID: 19664226 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; Treatment Adherence and Compliance; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Health Behavior; Behavior; Chemically-Induced Disorders

Study Officials

• Hasni Arsad Ibrahim, PhD

  Universiti Sains Malaysia

  STUDY CHAIR

• Mohd Yusmaidie Aziz, PhD

  Universiti Sains Malaysia

  STUDY DIRECTOR

• Christina Malini Christopher, PhD

  Universiti Sains Malaysia (USM)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an open-label trial for participants, pharmacist investigators, and study coordinators because of the nature of the pharmacist-led behavioral intervention. Laboratory personnel responsible for viral load and CD4+ measurements and the independent statistician performing the primary analyses remain blinded to treatment allocation. Study data are identified using unique participant study IDs, and treatment groups are coded during statistical analysis to maintain assessor blinding where applicable.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Model Details: This is a three-arm, parallel-group, superiority randomized controlled trial with 1:1:1 allocation comparing Usual Care, Basic Medication Therapy Management (MTM), and Enhanced Medication Therapy Management (MTM). Participants are randomly assigned using a computer-generated sequence with block randomization stratified by study site and baseline viral suppression status. The study evaluates the comparative effectiveness, implementation, and cost-effectiveness of the two pharmacist-led MTM interventions over a 24-month follow-up period.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: August 6, 2026
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)