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.: PACTR202509529555665 Date of Registration: 11/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Strengthening HIV/AIDS, Sexual and Reproductive Health and Non-communicable Diseases Integration for Equity In Africa through Digital Innovation (SHINE).
Official scientific title Strengthening HIV/AIDS, Sexual and Reproductive Health and Non-communicable Diseases Integration for Equity In Africa through Digital Innovation (SHINE): A Cluster Randomized Trial in SSA
Brief summary describing the background and objectives of the trial Sub-Saharan Africa faces interconnected epidemics of HIV, diabetes, hypertension, and sexual/reproductive health needs, exacerbated by fragmented health systems. Despite WHO recommendations for integrated care, most services remain siloed, creating barriers to comprehensive management. The SHINE project addresses this challenge by developing and evaluating an integrated service model combining HIV, diabetes, hypertension and SRH care at primary health facilities. Using a cluster-randomized design across 90 health centers in Ethiopia, Kenya and Ghana, SHINE compares standard care against two intervention approaches: basic integration and digitally-enhanced integration with clinical decision support. The study aims to determine whether integrated care improves disease detection, treatment initiation and health outcomes, particularly for people living with HIV who face elevated diabetes and cardiovascular risks. Secondary objectives examine implementation processes, cost-effectiveness, and health system readiness for chronic disease integration. By generating robust evidence on effective service delivery models, SHINE will inform policy decisions to strengthen Africa's health systems and address its growing dual burden of infectious and non-communicable diseases.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SHINE
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Tuberculosis
Purpose of the trial Education /Training
Anticipated trial start date 02/02/2026
Actual trial start date 06/04/2026
Anticipated date of last follow up 31/07/2030
Actual Last follow-up date 30/01/2031
Anticipated target sample size (number of participants) 9600
Actual target sample size (number of participants) 9600
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SHINE The study employs a cluster-randomized trial (cRT) design, with PHCUs serving as the unit of randomization. PHCUs will be randomly allocated to either the intervention or control arm, with allocation stratified according to urban/rural location and community type (pastoralist or agrarian) to ensure balance across study arms. The design integrates the RE-AIM framework to guide evaluation and contextual understanding of integrated care delivery. Specifically: • Reach: Assesses the proportion and characteristics of patients attending PHCUs who are eligible and participate in integrated care services, ensuring that diverse populations, including marginalized or rural groups, are represented. • Effectiveness: Measures patient-level health outcomes, including reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. This dimension evaluates whether integrated care achieves meaningful improvements in health across different settings. • Adoption: Examines the proportion of PHCUs implementing integrated care and the extent to which staff and facilities adopt recommended practices for digital health–supported NCD, HIV/TB, and SRH integration. • Implementation: Evaluates fidelity to integrated care protocols, quality of service delivery, and adherence to clinical guidelines within PHCUs, considering variations across urban, rural, pastoralist, and agrarian contexts. • Maintenance: Assesses the sustainability of integrated care practices at both the facility and patient levels over time, including continued delivery of services and retention of patients in care. The use of RE-AIM ensures that evaluation captures both the effectiveness of integrated care and its potential for scale-up and sustainability in real-world settings. Study Arms PHCUs will be allocated into two arms: Intervention Arm includes PHCUs implementing the integrated care model for NCDs, HIV/TB, and SRH services, with digital health support (WP 2 and WP3). The Control Arm consists of PHCUs continuing standard care without the integrated model or digital health support as stated in the following section. four and half years Study Design and Interventions The SHINE trial will randomize 96 Primary Health Care Units (PHCUs) across Ethiopia, Kenya, and Ghana into three arms. In the Control Arm, PHCUs will continue implementing standard national protocols for SRH, HIV/TB, and NCD services without modifications, with routine monitoring and baseline surveys providing comparison data. The Integrated Care Arm will implement a comprehensive SRH-HIV/TB-CVD/diabetes care model. This includes training health workers in integrated service delivery, establishing task-shifting protocols for chronic disease management, strengthening governance structures for multi-condition care, and implementing standardized monitoring of SRH, HIV, and CVD/diabetes indicators. The Enhanced Digital Arm will deliver the full integrated care model plus advanced digital health components. This includes AI-supported clinical decision tools for risk stratification and treatment optimization, interactive dashboards for real-time performance monitoring, and full interoperability with national health information systems to ensure continuity of care. Digital tools will also facilitate community-to-clinic linkages through mobile health reporting by community health workers. All arms will be evaluated using standardized metrics for clinical outcomes (e.g., disease detection rates, treatment adherence) and implementation success (reach, adoption, sustainability). The three-arm design allows direct comparison of conventional care versus integrated care with and without digital augmentation in real-world African primary care settings. 4800
Control Group Comparison group Follow up for 4 and half years Four and Half years Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. 4800 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Districts and Primary Healthcare Units that provide SRH, HIV/AIDS, Tuberculosis programs will be included. All adult patients coming for SRH, TB/HIV and NCD services will be eligible. Primary Healthcare units that do not provide HIV/AIDS, TB, SRH and NCD services will be excluded. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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
No 15/09/2025 Ethiopian Public Health Institute
Ethics Committee Address
Street address City Postal code Country
Addis Ababa Addis Ababa 1245 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/09/2025 KEMRI
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road Nairobi 54840-00 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/09/2025 Council for Scientific and Industrial Research
Ethics Committee Address
Street address City Postal code Country
Agostino Neto Road Accra M.32 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD 6, 30 and 60 months of the intervention
Secondary Outcome • Successfully implement integrated HIV/TB/SRH/NCD care in 90% of participating health centers • Demonstrate ≥20% improvement in early detection of diabetes and hypertension 6, 30 and 60 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethiopia Addis Ababa Addis Ababa Nairobi Accra Ethiopia
Nairobi Two sub-cities Nairobi Kenya
Ghana three sub-cities Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
European Union Rue du Champ de Mars 21 brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Horizon Europe Rue du Champ de Mars 21 Brussels Belgium Funding Agency
COLLABORATORS
Name Street address City Postal code Country
University of Antwerp Universiteitsplein 1, 2610 Wilrijk Antwerp Belgium
Bahir Dar University Kebele 07 Bahir Dar Ethiopia
ABH Parners Bole Road Addis Ababa Ethiopia
University of Nairobi Main Campus, Gandhi Wing Nairobi Kenya
Ghana University Legon Boundary Road Accra Ghana
Heidelberg University 69117 Heidelberg Heidelberg Germany
Karolinska Institute SE-171 77 Stockholm Stockholm Sweden
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Amare Deribew amare.deribew@gmail.com +251912639369 Bole Road
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia ABH Partners
Role Name Email Phone Street address
Principal Investigator Robert Colebunders robert.colebunders@uantwerpen.be +32486920149 Campus Dire Eiken
City Postal code Country Position/Affiliation
Antwerp Belgium UA
Role Name Email Phone Street address
Public Enquiries Netsanet Fantahun netsanetfentahun01@gmail.com +251913516677 Kebele 07
City Postal code Country Position/Affiliation
Bahir Dar Ethiopia BDU
Role Name Email Phone Street address
Principal Investigator Reson Marima reson@fyj.uonbi.ac.ke +25721952652 main campus
City Postal code Country Position/Affiliation
Nairobi Kenya NU
Role Name Email Phone Street address
Principal Investigator Eleni Aklillu eleni.aklillu@ki.se +46852480000 SE171 77 Stockholm
City Postal code Country Position/Affiliation
Stockholm Sweden KI
Role Name Email Phone Street address
Principal Investigator Lauren Maxwell lauren.maxwell@uni-heidelberg.de +496221540 Im Neuenheimer Feld 672
City Postal code Country Position/Affiliation
Heidelberg Germany HU
Role Name Email Phone Street address
Principal Investigator Emilia Asuquo Udofia eudofia@ug.edu.gh +233243259018 community Depart
City Postal code Country Position/Affiliation
Accra Ghana UG
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The SHINE trial The SHINE trial will share de-identified individual participant data (IPD) upon reasonable request following study completion and primary publication. Researchers may submit data access requests to the SHINE Steering Committee, accompanied by a scientifically valid research proposal. Summary results will be publicly available through the trial registry within 12 months of study completion as required by WHO guidelines, while full IPD will become accessible 24 months after the main publication. All data sharing will be governed by data use agreements and require appropriate ethical approvals, ensuring compliance with WHO requirements for trials registered after January 2019 and adherence to ICMJE guidelines for responsible data sharing. This approach balances scientific transparency with participant confidentiality protections.will share main findings to the public. Study Protocol February 2027 and Jan 2031 The SHINE trial will make anonymized individual participant data (IPD) available to qualified researchers upon request to support further scientific analysis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
will be available after some months No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
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 Public title 20/08/2025 The title is now written non only in capital letter STRENGTHENING HIV/AIDS, SEXUAL AND REPRODUCTDIVE HEALTH AND NON-COMMUNICABLE DISEASES INTEGRATION FOR EQUITY IN AFRICA THROUGH DIGITAL INNOVATION Strengthening HIV/AIDS, Sexual and Reproductive Health and Non-communicable Diseases Integration for Equity In Africa through Digital Innovation (SHINE).
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 20/08/2025 The title is now written non only in capital letter STRENGTHENING HIV, SRH, AND NCD INTEGRATION FOR EQUITY IN AFRICA THROUGH DIGITAL INNOVATION (SHINE): A PARALLEL CLUSTERED RANDOMIZED TRIAL IN AFRICA Strengthening HIV/AIDS, Sexual and Reproductive Health and Non-communicable Diseases Integration for Equity In Africa through Digital Innovation (SHINE): A Cluster Randomized Trial in SSA
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 29/08/2025 The revised sample size is 9600 (4800 in the intervention and 4800 in the control arm) 9000 9600
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 29/08/2025 The sample size is 9600. The system didn't save this number repeatedly. 9000 9600
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 20/08/2025 The age range is above 13 years since hypertension and CVD are common in adults. 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
Intervention Intervention List 20/08/2025 comments were given to adjust the trial size Experimental Group, SHINE, Study Design and Interventions The SHINE trial will randomize 96 Primary Health Care Units (PHCUs) across Ethiopia, Kenya, and Ghana into three arms. In the Control Arm, PHCUs will continue implementing standard national protocols for SRH, HIV/TB, and NCD services without modifications, with routine monitoring and baseline surveys providing comparison data. The Integrated Care Arm will implement a comprehensive SRH-HIV/TB-CVD/diabetes care model. This includes training health workers in integrated service delivery, establishing task-shifting protocols for chronic disease management, strengthening governance structures for multi-condition care, and implementing standardized monitoring of SRH, HIV, and CVD/diabetes indicators. The Enhanced Digital Arm will deliver the full integrated care model plus advanced digital health components. This includes AI-supported clinical decision tools for risk stratification and treatment optimization, interactive dashboards for real-time performance monitoring, and full interoperability with national health information systems to ensure continuity of care. Digital tools will also facilitate community-to-clinic linkages through mobile health reporting by community health workers. All arms will be evaluated using standardized metrics for clinical outcomes (e.g., disease detection rates, treatment adherence) and implementation success (reach, adoption, sustainability). The three-arm design allows direct comparison of conventional care versus integrated care with and without digital augmentation in real-world African primary care settings. , The study employs a cluster-randomized trial (cRT) design, with PHCUs serving as the unit of randomization. PHCUs will be randomly allocated to either the intervention or control arm, with allocation stratified according to urban/rural location and community type (pastoralist or agrarian) to ensure balance across study arms. The design integrates the RE-AIM framework to guide evaluation and contextual understanding of integrated care delivery. Specifically: • Reach: Assesses the proportion and characteristics of patients attending PHCUs who are eligible and participate in integrated care services, ensuring that diverse populations, including marginalized or rural groups, are represented. • Effectiveness: Measures patient-level health outcomes, including reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. This dimension evaluates whether integrated care achieves meaningful improvements in health across different settings. • Adoption: Examines the proportion of PHCUs implementing integrated care and the extent to which staff and facilities adopt recommended practices for digital health–supported NCD, HIV/TB, and SRH integration. • Implementation: Evaluates fidelity to integrated care protocols, quality of service delivery, and adherence to clinical guidelines within PHCUs, considering variations across urban, rural, pastoralist, and agrarian contexts. • Maintenance: Assesses the sustainability of integrated care practices at both the facility and patient levels over time, including continued delivery of services and retention of patients in care. The use of RE-AIM ensures that evaluation captures both the effectiveness of integrated care and its potential for scale-up and sustainability in real-world settings. Study Arms PHCUs will be allocated into two arms: Intervention Arm includes PHCUs implementing the integrated care model for NCDs, HIV/TB, and SRH services, with digital health support (WP 2 and WP3). The Control Arm consists of PHCUs continuing standard care without the integrated model or digital health support as stated in the following section. , four and half years, 96,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 25/08/2025 The sample size will be 9600 individuals Experimental Group, SHINE, Study Design and Interventions The SHINE trial will randomize 96 Primary Health Care Units (PHCUs) across Ethiopia, Kenya, and Ghana into three arms. In the Control Arm, PHCUs will continue implementing standard national protocols for SRH, HIV/TB, and NCD services without modifications, with routine monitoring and baseline surveys providing comparison data. The Integrated Care Arm will implement a comprehensive SRH-HIV/TB-CVD/diabetes care model. This includes training health workers in integrated service delivery, establishing task-shifting protocols for chronic disease management, strengthening governance structures for multi-condition care, and implementing standardized monitoring of SRH, HIV, and CVD/diabetes indicators. The Enhanced Digital Arm will deliver the full integrated care model plus advanced digital health components. This includes AI-supported clinical decision tools for risk stratification and treatment optimization, interactive dashboards for real-time performance monitoring, and full interoperability with national health information systems to ensure continuity of care. Digital tools will also facilitate community-to-clinic linkages through mobile health reporting by community health workers. All arms will be evaluated using standardized metrics for clinical outcomes (e.g., disease detection rates, treatment adherence) and implementation success (reach, adoption, sustainability). The three-arm design allows direct comparison of conventional care versus integrated care with and without digital augmentation in real-world African primary care settings. , The study employs a cluster-randomized trial (cRT) design, with PHCUs serving as the unit of randomization. PHCUs will be randomly allocated to either the intervention or control arm, with allocation stratified according to urban/rural location and community type (pastoralist or agrarian) to ensure balance across study arms. The design integrates the RE-AIM framework to guide evaluation and contextual understanding of integrated care delivery. Specifically: • Reach: Assesses the proportion and characteristics of patients attending PHCUs who are eligible and participate in integrated care services, ensuring that diverse populations, including marginalized or rural groups, are represented. • Effectiveness: Measures patient-level health outcomes, including reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. This dimension evaluates whether integrated care achieves meaningful improvements in health across different settings. • Adoption: Examines the proportion of PHCUs implementing integrated care and the extent to which staff and facilities adopt recommended practices for digital health–supported NCD, HIV/TB, and SRH integration. • Implementation: Evaluates fidelity to integrated care protocols, quality of service delivery, and adherence to clinical guidelines within PHCUs, considering variations across urban, rural, pastoralist, and agrarian contexts. • Maintenance: Assesses the sustainability of integrated care practices at both the facility and patient levels over time, including continued delivery of services and retention of patients in care. The use of RE-AIM ensures that evaluation captures both the effectiveness of integrated care and its potential for scale-up and sustainability in real-world settings. Study Arms PHCUs will be allocated into two arms: Intervention Arm includes PHCUs implementing the integrated care model for NCDs, HIV/TB, and SRH services, with digital health support (WP 2 and WP3). The Control Arm consists of PHCUs continuing standard care without the integrated model or digital health support as stated in the following section. , four and half years, 96,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2025 The sample size will be in the intervention group will be 4800. Similar number of individuals will be included in the control group Experimental Group, SHINE, Study Design and Interventions The SHINE trial will randomize 96 Primary Health Care Units (PHCUs) across Ethiopia, Kenya, and Ghana into three arms. In the Control Arm, PHCUs will continue implementing standard national protocols for SRH, HIV/TB, and NCD services without modifications, with routine monitoring and baseline surveys providing comparison data. The Integrated Care Arm will implement a comprehensive SRH-HIV/TB-CVD/diabetes care model. This includes training health workers in integrated service delivery, establishing task-shifting protocols for chronic disease management, strengthening governance structures for multi-condition care, and implementing standardized monitoring of SRH, HIV, and CVD/diabetes indicators. The Enhanced Digital Arm will deliver the full integrated care model plus advanced digital health components. This includes AI-supported clinical decision tools for risk stratification and treatment optimization, interactive dashboards for real-time performance monitoring, and full interoperability with national health information systems to ensure continuity of care. Digital tools will also facilitate community-to-clinic linkages through mobile health reporting by community health workers. All arms will be evaluated using standardized metrics for clinical outcomes (e.g., disease detection rates, treatment adherence) and implementation success (reach, adoption, sustainability). The three-arm design allows direct comparison of conventional care versus integrated care with and without digital augmentation in real-world African primary care settings. , The study employs a cluster-randomized trial (cRT) design, with PHCUs serving as the unit of randomization. PHCUs will be randomly allocated to either the intervention or control arm, with allocation stratified according to urban/rural location and community type (pastoralist or agrarian) to ensure balance across study arms. The design integrates the RE-AIM framework to guide evaluation and contextual understanding of integrated care delivery. Specifically: • Reach: Assesses the proportion and characteristics of patients attending PHCUs who are eligible and participate in integrated care services, ensuring that diverse populations, including marginalized or rural groups, are represented. • Effectiveness: Measures patient-level health outcomes, including reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. This dimension evaluates whether integrated care achieves meaningful improvements in health across different settings. • Adoption: Examines the proportion of PHCUs implementing integrated care and the extent to which staff and facilities adopt recommended practices for digital health–supported NCD, HIV/TB, and SRH integration. • Implementation: Evaluates fidelity to integrated care protocols, quality of service delivery, and adherence to clinical guidelines within PHCUs, considering variations across urban, rural, pastoralist, and agrarian contexts. • Maintenance: Assesses the sustainability of integrated care practices at both the facility and patient levels over time, including continued delivery of services and retention of patients in care. The use of RE-AIM ensures that evaluation captures both the effectiveness of integrated care and its potential for scale-up and sustainability in real-world settings. Study Arms PHCUs will be allocated into two arms: Intervention Arm includes PHCUs implementing the integrated care model for NCDs, HIV/TB, and SRH services, with digital health support (WP 2 and WP3). The Control Arm consists of PHCUs continuing standard care without the integrated model or digital health support as stated in the following section. , four and half years, 9600,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 20/08/2025 The trial arms are now two with a total of 96 primary healthcare units, 48 in each arm Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 30, Historical Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 48, Historical
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 25/08/2025 The trial arms are now two with a total of 96 primary healthcare units, 48 in each arm. The total study participants will be 9600 Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 48, Historical Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 9600, Historical
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2025 The trial arms are now two with a total of 96 primary healthcare units, 48 in each arm. The total study participants will be 9600 Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 9600, Historical Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 4800, Historical
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/09/2025 The trial arms are now two with a total of 96 primary healthcare units, 48 in each arm. The total study participants will be 9600 Control Group, SHINE, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 4800, Historical Control Group, Comparison group, Follow up for 4 and half years, Four and Half years, Activities in the Control Districts PHCUs in the control arm will continue implementing existing national HIV/AIDS, SRH and NCD protocols without additional interventions. However, baseline surveys and monitoring of key indicators will be conducted in parallel with intervention districts, allowing for comparison of health outcomes and process measures. These districts provide a benchmark to evaluate the added value of integrated care and digital innovations, without altering routine service delivery or existing workflows. , 4800, Historical
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 20/08/2025 Now we have included facility and individual level outcomes. Primary Outcome, Primary Outcome: • Reduce the burden and complications of cardiovascular disease and diabetes by at least 25% among the interventions Districts , Every quarter for four and half years Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. , Every quarter for four and half years
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/08/2025 Now we have included facility and individual level outcomes. Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. , Every quarter for four and half years Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. , 12, 24, 36 and 54 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 29/08/2025 Now we have included facility and individual level outcomes. Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Reduction in co-morbidities related to NCDs, HIV/TB, and SRH problems. , 12, 24, 36 and 54 months Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD , 12, 24, 36 and 54 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 05/09/2025 The main outcome variables will be assessed at 6, 30 and 60 months of the intervention Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD , 12, 24, 36 and 54 months Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD , 6, 30 and 60 months
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 11/09/2025 PACTR Admin Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD , 6, 30 and 60 months Primary Outcome, Primary Outcome: • Facility-level outcome: Proportion of PHCUs implementing a digital health–supported integrated care model for NCDs, HIV/TB, and SRH services. • Patient-level outcome: Proportion of HIV, TB and SRH clients diagnosed and treated for NCD , 6, 30 and 60 months of the intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 20/08/2025 Time of the assessment of the outcome is corrected as per the comment. Secondary Outcome, • Successfully implement integrated HIV/TB/SRH/NCD care in 90% of participating health centers • Demonstrate ≥20% improvement in early detection of diabetes and hypertension , Quarterly Secondary Outcome, • Successfully implement integrated HIV/TB/SRH/NCD care in 90% of participating health centers • Demonstrate ≥20% improvement in early detection of diabetes and hypertension , 12, 24, 36 and 54 months.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 05/09/2025 The main outcome variables will be assessed at 6, 30 and 60 months. Secondary Outcome, • Successfully implement integrated HIV/TB/SRH/NCD care in 90% of participating health centers • Demonstrate ≥20% improvement in early detection of diabetes and hypertension , 12, 24, 36 and 54 months. Secondary Outcome, • Successfully implement integrated HIV/TB/SRH/NCD care in 90% of participating health centers • Demonstrate ≥20% improvement in early detection of diabetes and hypertension , 6, 30 and 60 months
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 20/08/2025 We need to add each country in a separate lines Three countries , Addis Ababa, Addis Ababa Nairobi Accra, , Ethiopia Ethiopia, Addis Ababa, Addis Ababa Nairobi Accra, , Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 20/08/2025 We need to add each country in a separate lines Nairobi, Two sub-cities , Nairobi, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 20/08/2025 We need to add each country in a separate lines Ghana, three sub-cities , Accra, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/08/2025 Ethical approval will be sought in Sept FALSE, KEMRI, Off Mbagathi Road, Nairobi, 54840-00, Kenya, 30 Sep 2025, , +254202722541, info@kemri.org, 36027_33211_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 20/08/2025 Ethical approval will be sought in Sept FALSE, Council for Scientific and Industrial Research, Agostino Neto Road, Accra, M.32, Ghana, 30 Sep 2025, , +233302777951, info@csir.org.gh, 36027_33212_4737.pdf