Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,149
- 试验地点
- 1
- 主要终点
- Medication Adherence - Proportion of Days Covered (PDC)
研究概览
简要总结
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.
详细描述
This three-arm, parallel-group, open-label randomized controlled trial evaluates the effectiveness and cost-effectiveness of two levels of pharmacist-led Medication Therapy Management (MTM), Basic MTM and Enhanced MTM, compared with usual care among HIV patients at high risk of adverse drug events in Khartoum, Sudan. The study also includes an implementation evaluation guided by the Consolidated Framework for Implementation Research (CFIR).
Participants are randomly assigned in a 1:1:1 ratio to one of three study arms using a computer-generated random sequence prepared by an independent statistician. Randomization is performed using variable block sizes and is stratified by study site and baseline viral suppression status. Allocation concealment is maintained using sequentially numbered, sealed, opaque envelopes opened only after completion of baseline assessments.
Because of the nature of the MTM intervention, participants and pharmacist investigators are not blinded to treatment allocation. Laboratory personnel responsible for viral load and CD4 measurements and the independent statistician performing the primary analyses remain blinded to treatment allocation.
The primary analysis follows the intention-to-treat principle and includes all randomized participants. Missing outcome data are handled using multiple imputation by chained equations (MICE). A prespecified per-protocol sensitivity analysis includes participants who complete at least 80% of scheduled MTM visits and have complete outcome data. Primary and secondary outcomes are assessed over a 24-month follow-up period using appropriate statistical methods specified in the study protocol.
The study includes clinical, patient-reported, economic, and implementation outcomes, including medication adherence, viral load suppression, CD4+ cell count, adverse drug events, drug-related problems, health-related quality of life, treatment self-efficacy, patient satisfaction, and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1: Usual Care (Control)
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
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.
干预措施: Basic MTM (Behavioral)
Arm3: Enhanced MTM
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.
干预措施: Enhanced MTM (Behavioral)
结局指标
主要结局
Medication Adherence - Proportion of Days Covered (PDC)
时间窗: Baseline, 6 months (primary endpoint), 12 months, 18 months, and 24 months
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%.
次要结局
- 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))
- Number of Hospitalizations(From enrollment through 24 months)
- Number of Emergency Department Visits(From enrollment through 24 months)
- Health-Related Quality of Life - EQ-VAS Score(Baseline, 6 months, 12 months, 18 months, 24 months)
- Direct Medical Costs(From enrollment through 24 months)
- Serious Adverse Events (SAEs)(From enrollment through 24 months)
- Medication Self-Efficacy Score(Baseline, 6 months, 12 months, 18 months, 24 months)
- Health-Related Quality of Life (EQ-5D-3L Index Score)(Baseline, 6 months, 12 months, 18 months, and 24 months)
- Patient Satisfaction with Pharmaceutical Care(6 months, 12 months, 18 months, and 24 months (MTM arms only))
- Medication Knowledge Score(Baseline, 6 months, 12 months, 18 months, and 24 months)
研究者
Nada Abdelrahman Ibrahim
Clinical Pharmacist
Universiti Sains Malaysia