HIV InfectionsHIV-MTM-SUDAN-NCT07750834
Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan
A study testing Basic MTM and Enhanced MTM in people with HIV Infections, run by Universiti Sains Malaysia at 1 site in Sudan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Basic MTM and Enhanced MTM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,149 participants
- Where
- 1 siteSudan
- Study dates
- 1 Jan 2021to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
Study oversight is provided by the Trial Steering Committee, which reviews study progress and data annually. No formal interim analyses or stopping rules are planned because the study evaluates a low-risk pharmacist-led behavioral intervention. Any protocol deviations are documented and managed according to the study protocol.
- Conditions
- HIV Infections
- Being tested
- Basic MTM, Enhanced MTM
- Keywords
- HIV/AIDS, Medication Therapy Management, Treatment Adherence, Randomized Controlled Trial, Adverse Drug Events
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Treatment Adherence and Compliance, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic MTMBehavioural
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.
Enhanced MTMBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced MTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline, 6 months (primary endpoint), 12 months, 18 months, and 24 months
Secondary outcomes (14)
Viral Load Suppression
Proportion of participants achieving plasma HIV RNA <200 copies/mL at each assessment time point
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
CD4+ Cell Count
Absolute CD4+ T-lymphocyte count measured by flow cytometry. Analyses include the change in CD4+ cell count from baseline and the proportion of participants achieving CD4+ cell counts >500 cells/µL.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Adverse Drug Events (ADEs) - Incidence
Number and severity of adverse drug events (ADEs) occurring during the study period. ADEs are defined as any untoward medical occurrence associated with medication use and are classified according to standardized severity criteria.
Measured: From enrollment through 24 months
Adverse Drug Events (ADEs) - Severity Distribution
Distribution of adverse drug events (ADEs) according to severity (mild, moderate, severe, and life-threatening) using standardized severity classification criteria. Results will be reported as the proportion of ADEs within each severity category.
Measured: From enrollment through 24 months
Drug-Related Problems (DRPs)
Number and types of drug-related problems (DRPs) identified using the modified Pharmaceutical Care Network Europe (PCNE) Classification Version 9.1. DRPs will be classified according to PCNE categories and reported as the number of DRPs identified per participant.
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months (MTM arms only)
Medication Self-Efficacy Score
Medication self-efficacy assessed using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES), a 12-item instrument in which each item is rated on a scale from 0 (cannot do at all) to 10 (certain can do). Total scores range from 0 to 120, with higher scores indicating greater self-efficacy and confidence in taking medications as prescribed."
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Number of Hospitalizations
Total number of hospitalizations during the 24-month study period, including the reason for hospitalization (HIV-related or non-HIV-related) and the cumulative duration of hospitalization. Hospitalizations will be identified from medical records and study documentation.
Measured: From enrollment through 24 months
Number of Emergency Department Visits
Total number of emergency department visits during the 24-month study period, including the primary reason for each visit. Emergency department visits will be identified from medical records and study documentation.
Measured: From enrollment through 24 months
Health-Related Quality of Life (EQ-5D-3L Index Score)
Health-related quality of life assessed using the EuroQol Five-Dimension Three-Level (EQ-5D-3L) descriptive system. Responses across the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on three levels, are converted to a single health utility index score using the [specify value set, used., UK] validated value set. Index scores range from -0.594 to 1.0 (using the UK value set; the exact minimum varies by value set), where 1.0 represents full health, 0 represents a health state equivalent to death, and negative values represent health states considered worse than death. Higher scores indicate better health-related quality of life." Note : why choosing (e.g. UK, Arab-region proxy) since Sudan does not yet have a locally derived value set. The minimum value will depend on that choice and should be explicitly stated.
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Health-Related Quality of Life - EQ-VAS Score
Health-related quality of life assessed using the EuroQol Visual Analogue Scale (EQ-VAS). Participants rate their overall health on a visual analogue scale from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Patient Satisfaction with Pharmaceutical Care
Patient satisfaction with pharmacist-provided pharmaceutical care assessed using a modified version of the Pharmaceutical Care Satisfaction Questionnaire (PCSQ). The modified instrument comprises [X] items, each rated on a [Y]-point Likert scale (e.g., 1 = strongly disagree to [Y] = strongly agree). Total scores range from [minimum] to [maximum], with higher scores indicating greater satisfaction with the pharmaceutical care services received."
Measured: 6 months, 12 months, 18 months, and 24 months (MTM arms only)
Direct Medical Costs
Total direct medical costs from the healthcare system perspective, including costs associated with hospitalizations, emergency department visits, outpatient visits, laboratory tests, medications, and delivery of Medication Therapy Management (MTM) services. Costs will be reported in Sudanese Pounds (SDG) and converted to US Dollars (USD) using the prespecified exchange rate.
Measured: From enrollment through 24 months
Serious Adverse Events (SAEs)
Number of serious adverse events (SAEs) occurring during the study period. An SAE is defined as any adverse event resulting in death, a life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or another medically important event.
Measured: From enrollment through 24 months
Medication Knowledge Score
Medication knowledge assessed using a validated 15-item medication knowledge questionnaire. Each correct response is assigned one point, with total scores ranging from 0 to 15. Higher scores indicate better medication knowledge. Medication knowledge assessed using the
Note : This is a study-specific instrument developed for this trial, state: "a validated 15-item Medication Knowledge Questionnaire (MKQ) developed and validated for the purposes of this study."
Measured: Baseline, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jan 2021
- Primary completion1 Jan 2023
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Sudan
- Responsible party
- Principal investigator, Nada Abdelrahman Ibrahim, Universiti Sains Malaysia
- Investigators
- Hasni Arsad Ibrahim, PhD, Study chair, Universiti Sains MalaysiaMohd Yusmaidie Aziz, PhD, Study director, Universiti Sains MalaysiaChristina Malini Christopher, PhD, Study director, Universiti Sains Malaysia (USM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750834
- Sponsor's protocol ID
- USM/JEPeM/PP/24100928
- Acronym
- HIV-MTM-SUDAN-
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on standard ethical and regulatory considerations for this study context, IPD will not be shared for the following reasons: Confidentiality of HIV status Participants are living with HIV in Sudan, where stigma and discrimination remain significant concerns. Sharing IPD could increase risk of unintended disclosure. Ethics committee restrictions The Sudanese Federal Ministry of Health Research Ethics Committee and USM JEPEM approvals likely restrict data sharing to protect vulnerable populations. No participant consent for data sharing The informed consent form (Appendices C and D) does not explicitly include permission for public data repository sharing. Local regulatory requirements Sudanese data protection and research regulations may prohibit transfer of HIVHIV-related data outside approved research teams.
Publications
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.
PubMed 19664226
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan
- ClinicalTrials.gov ID
- NCT07750834
- Acronym / sponsor ID
- HIV-MTM-SUDAN- / USM/JEPeM/PP/24100928
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS, Medication Therapy Management, Treatment Adherence, Randomized Controlled Trial, Adverse Drug Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Sudan
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study oversight is provided by the Trial Steering Committee, which reviews study progress and data annually. No formal interim analyses or stopping rules are planned because the study evaluates a low-risk pharmacist-led behavioral intervention. Any protocol deviations are documented and managed according to the study protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Basic MTMParticipants 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. |
| Arm3: Enhanced MTM | Experimental | Behavioral: Enhanced MTMParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic MTMA 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. | Behavioural | Arm2: Basic MTM |
| Enhanced MTMAn 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 | Behavioural | Arm3: Enhanced MTM |
Primary outcome
Medication Adherence - Proportion of Days Covered (PDC)
Time frame: 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%.
14 secondary outcomes
Viral Load Suppression
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
CD4+ Cell Count
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Adverse Drug Events (ADEs) - Incidence
Time frame: From enrollment through 24 months
Adverse Drug Events (ADEs) - Severity Distribution
Time frame: From enrollment through 24 months
Drug-Related Problems (DRPs)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months (MTM arms only)
Medication Self-Efficacy Score
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Number of Hospitalizations
Time frame: From enrollment through 24 months
Number of Emergency Department Visits
Time frame: From enrollment through 24 months
Health-Related Quality of Life (EQ-5D-3L Index Score)
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Health-Related Quality of Life - EQ-VAS Score
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Patient Satisfaction with Pharmaceutical Care
Time frame: 6 months, 12 months, 18 months, and 24 months (MTM arms only)
Direct Medical Costs
Time frame: From enrollment through 24 months
Serious Adverse Events (SAEs)
Time frame: From enrollment through 24 months
Medication Knowledge Score
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 19664226Damschroder 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.
- Individual participant dataSharing planned: No. Based on standard ethical and regulatory considerations for this study context, IPD will not be shared for the following reasons: Confidentiality of HIV status Participants are living with HIV in Sudan, where stigma and discrimination remain significant concerns. Sharing IPD could increase risk of unintended disclosure. Ethics committee restrictions The Sudanese Federal Ministry of Health Research Ethics Committee and USM JEPEM approvals likely restrict data sharing to protect vulnerable populations. No participant consent for data sharing The informed consent form (Appendices C and D) does not explicitly include permission for public data repository sharing. Local regulatory requirements Sudanese data protection and research regulations may prohibit transfer of HIVHIV-related data outside approved research teams.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasni Arsad Ibrahim, PhD study chair
Universiti Sains Malaysia
Mohd Yusmaidie Aziz, PhD study director
Universiti Sains Malaysia
Christina Malini Christopher, PhD study director
Universiti Sains Malaysia (USM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic MTM and Enhanced MTM in people with HIV Infections, run by Universiti Sains Malaysia at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence - Proportion of Days Covered (PDC) (time frame: Baseline, 6 months (primary endpoint), 12 months, 18 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07750834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.