Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604767921319 Date of Registration: 21/04/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating a Medication Therapy Management Program to Improve Safety in High-Risk HIV Patients in Khartoum, Sudan
Official scientific title Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan
Brief summary describing the background and objectives of the trial Little is known about the effectiveness or optimal design of medication therapy management (MTM) programs as mechanisms for improving patient safety, inspiring this multicentre trial for people living with AIDS in Khartoum, Sudan. Research indicates that non-adherence to medication is a significant risk factor for poor clinical outcomes, particularly in resource-poor settings like Sudan, where data on medication adherence is scarce (Abdelrahman et al., 2020). Three hundred subjects at high risk of adverse drug events (ADEs) will be enrolled across three study sites. The study is designed as a randomized controlled trial with three arms. The control group (Arm 1) will receive usual care and have no MTM visits. Intervention groups (Arms 2 and 3) will undergo two MTM visits with a clinical pharmacist over 2 years (24) months.The main safety outcomes are the number of ADEs, hospital admissions, and emergency room visits at 90 and 180 days, which will be compared among all three study arms. Previous studies have shown that pharmacy-based MTM can significantly reduce ADEs and improve patient outcomes, particularly in populations with chronic diseases (Smith et al., 2019). Additional safety outcomes include measures of MTM process and delivery. This study evaluates the impact of pharmacy-based MTM on enhancing patient safety for individuals with chronic diseases who are also suffering from stigma in low-resource countries, where the burden of disease is compounded by limited access to healthcare resources (Jones et al., 2021).The main aim of this trial is to implement and assess an MTM program structured to prioritize patient safety the main components of the patient safety-oriented MTM model used in this study are medication reconciliation (MR), assessment of DRPs, and resolution of identified DRPs
Type of trial RCT
Acronym (If the trial has an acronym then please provide) not applicable
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 15/04/2020
Actual trial start date 01/01/2021
Anticipated date of last follow up 30/04/2026
Actual Last follow-up date 11/03/2023
Anticipated target sample size (number of participants) 1452
Actual target sample size (number of participants) 1149
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
USM MALYSIA JEPeM-USM PP/2410092
FMOHS RD/FMOH/144/2020
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MEDICATION THERAPY MANAGMENT 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts 6 month for 2 years Experimental Group: MTM in its most fundamental form: clinical pharmacists are the providers of the most essential medication therapy management services Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. 380
Control Group USUAL CARE ONLY 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts 6 MONTH FOR 2 YEARS Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. 382 Uncontrolled
Experimental Group Enhanced MTM 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts 6 month for two years A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM. 387
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults ≥18 years with confirmed HIV, • HIV-positive individuals aged 18 years and older. • Primary use of English or Arabic for oral and written communication. • ≥3 comorbid conditions associated with increased healthcare utilization (e.g., CHF, DM, COPD, HTN, opportunistic infections). • ≥2 visits to a physician or advanced practice provider at the study site clinic over the past year. • ≥8 chronic prescription medications over the 6 months prior to study enrollment. • Have a telephone line available for at least 6 months. • Willingness to participate in the study and provide informed consent. • Situation placing the patient at risk for a drug-related problem (DRP): Change in medication, new physician visit, ER visit, hospitalization, invasive procedure within the last 30 days, or seeing 3 or more providers within 12 months. • Terminal condition with life expectancy ≤6 months • Previous enrolment in the MTM program with medication reconciliation or assessment for DRPs within 12 months. • Inability to provide informed consent or participate in the study due to cognitive impairment or other reasons. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/07/2025 Jawatankuasa Etika Penyelidikan
Ethics Committee Address
Street address City Postal code Country
16150 Kubang Kerian, Kelantan, Malaysia Kubang Kerian, Kelantan 16150 Malaysia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/12/2020 National Ministry of Health General Directorate of planning and international health directorate of health research
Ethics Committee Address
Street address City Postal code Country
River avenue street Khartoum 303 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Medication Adherence Description: Medication adherence to antiretroviral therapy measured by Proportion of Days Covered (PDC) from pharmacy refill records. PDC = (Number of days with medication available) / (Number of days in measurement period) × 100. High adherence defined as PDC ≥ 95%. Metric/Method of Measurement Proportion of Days Covered (PDC) calculated from pharmacy refill records 6 months post-randomization
Secondary Outcome 1. Viral Load Suppression Proportion of participants with HIV RNA <200 copies/mL 6 months
Secondary Outcome 2. CD4 Count Change Mean change in CD4+ T-lymphocyte count from baseline 6 months
Secondary Outcome 3. Drug-Related Problems Number and types identified and resolved (PCNE classification) 3 and 6 months
Secondary Outcome 4. Adverse Drug Events Incidence and severity using Naranjo criteria 3 and 6 months
Secondary Outcome 5. Healthcare Utilization Number of hospitalizations, emergency visits, unscheduled clinic visits 6 months
Secondary Outcome 6. Health-Related Quality of Life EQ-5D-5L instrument score 6 months
Secondary Outcome 7. Patient Satisfaction Pharmaceutical care satisfaction questionnaire score 6 months
Secondary Outcome 8. Medication Knowledge Validated medication knowledge questionnaire 3 and 6 months
Secondary Outcome 9. Self-Efficacy HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES) 6 months
Secondary Outcome 10. Cost-Effectiveness Incremental cost per QALY gained 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Khartoum State SUDAN KHARTOUM BAHRI OMDURMAN KHARTOUM NA Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Nada Abdelrahman Mohamed Ibrahim Arbeen street Omdurman 11111 Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor USM 13200 Kepala Batas Pulau Pinang 13200 Malaysia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nada Ibrahim nadaaboras@student.usm.my 00966599468860 Al arbeen Street
City Postal code Country Position/Affiliation
Omdurman 11111 Sudan consultant Clinical pharmacist
Role Name Email Phone Street address
Scientific Enquiries Christina Malini Christopher cmalini@usm.my +60126276040 Kepala Batas
City Postal code Country Position/Affiliation
Pulau Pinang 13200 Malaysia Senior Lecturer Universiti Sains Malaysia
Role Name Email Phone Street address
Public Enquiries Hasni bin Arsad hasniarsad@usm.my +6045622415 Kepala Batas
City Postal code Country Position/Affiliation
Pulau Pinang 13200 Malaysia Deputy Director Research and Networking Advanced Medical and Dental Institute Universiti Sains Malaysia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be shared due to confidentiality concerns related to HIV status and the sensitive nature of data collected from this vulnerable population. Data contain confidential patient information that cannot be fully de-identified. Informed consent documents did not include provisions for public data sharing. Aggregate data will be published in the final thesis and peer-reviewed journals Study Protocol not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 13/02/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 30/03/2026 Result - 01/03/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/03/2026 the approved name from USM university for PHD degree and the same name in all ethical approval letters Implementation and Evaluation of a Structured Medication Therapy Management Program for HIV Patients at High Risk of Adverse Drug Events in Khartoum, Sudan Implementation and Assessment of a Medication Therapy Management Program in HIV Patients at High Risk of Adverse Drug Events at Khartoum, Sudan
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 12/03/2026 the study start after Corona this the exact date the study start 01 Jan 2022 01 Jan 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 12/03/2026 the exact date the study stop due Sudan war the place of conducting the study and return back on 2024 to revise follow up .Duration 2 continue year from 2021 -2023 11 Dec 2024 11 Mar 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 12/03/2026 this the final revised version :Total screened: 1,452 patients Excluded: 303 patients Randomized: 1,149 participants 1140 1149
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 30/03/2026 The total n assessed for eligibility was 1452 and 303 were excluded (not meet criteria 156 +declined participant 89+ planned to transfer 38+ cognitive impairment 20 1149 1452
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 12/03/2026 final revised by supervisors Total screened: 1,452 patients Excluded: 303 patients Randomized: 1,149 participants Completed the study: 1,060 participants (92.3% retention) Lost to follow-up: 89 participants (7.7%) 930 1060
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 30/03/2026 Randomized 1149(1452-303) 1060 1149
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 12/03/2026 I have check that you have ticked all applicable age groups, including the minimum age according to reviewer comment Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 12/03/2026 I write the information wrong this the right way 51122, FMOH sudan FMOHS, RD/FMOH/144/2020
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/03/2026 The study show three arm that Arm 1 the Control the size is 346 i can not enter the number 346 Experimental Group, MEDICATION THERAPY MANAGMENT PROGRAM , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 4, Experimental Group, MEDICATION THERAPY MANAGMENT PROGRAM , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 350,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Experimental Group, MEDICATION THERAPY MANAGMENT PROGRAM , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 350, Experimental Group, MEDICATION THERAPY MANAGMENT PROGRAM , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 380,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Experimental Group, MEDICATION THERAPY MANAGMENT PROGRAM , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 380, Experimental Group, MEDICATION THERAPY MANAGMENT , 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for 2 years , Experimental Group: MTM in its most fundamental form: clinical pharmacists are the providers of the most essential medication therapy management services Assignment: Intervention Intervention Type: Other (Pharmaceutical Care / Medication Therapy Management) Description: Structured pharmacist-led MTM program including comprehensive medication review, personal medication record, medication-related action plan, adherence counseling, drug-related problem identification and resolution, and scheduled follow-up consultations over 6 months. , 380,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/03/2026 they are 3 arm arm 2 is 346 but I can not save the right number now I correct as I write it by mistake 4 it is actually 346 approximated 350 when the system did not accept it Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 4, Uncontrolled Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 350, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 350, Uncontrolled Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 380, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 380, Uncontrolled Control Group, USUAL CARE ONLY, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 MONTH FOR 2 YEARS , Assignment: Control Intervention Type: Other (Usual Care) Description: Standard HIV care as per Sudan National HIV/AIDS Treatment Guidelines, including routine physician consultations, laboratory monitoring, basic adherence counseling by nurses or counselors, and medication dispensing without structured pharmaceutical care services. , 382, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Experimental Group, Enhanced MTM, , 6 month for two years , A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM., 380,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Experimental Group, Enhanced MTM, , 6 month for two years , A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM., 380, Experimental Group, Enhanced MTM, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for two years , A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM., 380,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/03/2026 Randomization (Three Arms - 1:1:1 allocation): Arm 1 - Usual Care: n = 380 Arm 2 - Basic MTM: n = 382 Arm 3 - Enhanced MTM: n = 387 Total enrolled in RCT: 1,149 participants Experimental Group, Enhanced MTM, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for two years , A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM., 380, Experimental Group, Enhanced MTM, 4 structured sessions (60-90 min initial, 45-60 min follow-up, 15-20 min phone call, 30-45 min final) plus as-needed contacts, 6 month for two years , A full MTM service that includes additional patient education and support after the fact is referred to as enhanced MTM., 387,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/03/2026 this all letters form Federal Ministry of health and state Ministry of Health Sudan considering approval which I get before war if you need more document I will try to bring them as now I am resident at KSA TRUE, National Ministry of Health General Directorate of planning and international health directorate of health research , River avenue street , Khartoum , 303, Sudan, , 05 Dec 2020, 00249120724492, researchdepfmoh@gmail.com, 39918_38264_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/03/2026 this all letters form Federal Ministry of health and state Ministry of Health Sudan considering approval which I get before war if you need more document I will try to bring them as now I am resident at KSA TRUE, National Ministry of Health General Directorate of planning and international health directorate of health research , River avenue street , Khartoum , 303, Sudan, , 05 Dec 2020, 00249120724492, researchdepfmoh@gmail.com, 39918_38264_4737.pdf TRUE, National Ministry of Health General Directorate of planning and international health directorate of health research , River avenue street , Khartoum , 303, Sudan, , 05 Dec 2020, 00249120724492, researchdepfmoh@gmail.com, 39918_38264_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/03/2026 This merged pdf show all letters form Sudan Federal Ministry of health and State Ministry of Health Sudan plus participated hospitals approvals all in one merge pdf start with Khartoum state approval ,hospital and federal accordingly I collect data from Sudan TRUE, National Ministry of Health General Directorate of planning and international health directorate of health research , River avenue street , Khartoum , 303, Sudan, , 05 Dec 2020, 00249120724492, researchdepfmoh@gmail.com, 39918_38264_4737.pdf TRUE, National Ministry of Health General Directorate of planning and international health directorate of health research , River avenue street , Khartoum , 303, Sudan, , 05 Dec 2020, 00249120724492, researchdepfmoh@gmail.com, 39918_38264_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 01/03/2026 the principle investigator name self funded , arbeen street, Omdurman , 11111, Sudan, Self Funded, Nada Abdelrahman Mohamed Ibrahim , Arbeen street, Omdurman , 11111, Sudan, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 01/03/2026 The principal investigator country is Sudan but now She is resident At Kingdum of Saudia Arabia du to war at khartom Principal Investigator, Nada , Ibrahim , Dr., nadaaboras@student.usm.my, nadaaboras8@gmail.com, 00966599468860, Al Amir Abd Aleah bin Abdelaziz, Unizah, 56434, Saudi Arabia, consultant Clinical pharmacist Principal Investigator, Nada , Ibrahim , Dr., nadaaboras@student.usm.my, nadaaboras8@gmail.com, 00966599468860, Al arbeen Street, Omdurman , 11111, Sudan, consultant Clinical pharmacist
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 30/03/2026 the most updated result file 39918_28174_1045.pdf 39918_28174_1045.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file 2 01/03/2026 this the last result file after the study finished 39918_28174_1046.pdf 39918_28174_1046.pdf