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.: PACTR202306693114717 Date of Approval: 26/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in South Africa
Official scientific title Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in South Africa (Sentinel-South Africa)
Brief summary describing the background and objectives of the trial To achieve global goals for the treatment of HIV, many countries are piloting and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries however, we have little evidence on progress and challenges at the facility level—the number of patients actually participating in DSD models, health outcomes and non-health outcomes, effects on service delivery capacity and clinic efficiency and operations, and costs to providers and patients. The Sentinel-South Africa study is examining the effect of DSD models on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in patient-level medical records. The first round of Sentinel-SA was conducted in 2021. We are now amending the protocol to allow up to four additional annual rounds of data collection, in 2022-2025. We collected clinic aggregate data, conducted surveys of patients and providers, and observedoperations at a selected set of 24 South African healthcare facilities and their affiliated DSD models in Round 1. Round 2 (2022) and later rounds will collect the same types of data and will expand the study’s research questions to include differentiated models of HIV testing and linkage to care. Results are expected to inform South African policy makers and other local and international stakeholders on the actual implications of DSD models for patients, health system operations, and healthcare budgets. The goal of the study, called Sentinel-South Africa, is to complement medical record data with primary information not currently available to policy makers through existing monitoring and evaluation procedures. Results are expected to inform South African policy makers and other local and international stakehold
Type of trial CCT
Acronym (If the trial has an acronym then please provide) Sentinel 2.0
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial To examine the effect of Differentiated Service Delivery models of HIV treatment on patient and provider satisfaction, service delivery capacity and quality, costs to patients, and other outcomes for which data are not routinely collected in medical records
Anticipated trial start date 23/08/2021
Actual trial start date 23/08/2021
Anticipated date of last follow up 31/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 15520
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M210241 University of Witwatersrand Human Research Ethics Committee - Medical
H41402 Boston University Medical Campus
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 Non-randomised 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 Domain 1 Provider time A sample of up to five providers will be selected at each study site, for a total sample size of up to 120 for up to 24 sentinel sites in each round of the study. (All data collection rounds expected to be completed by Dec 2025) The providers involved will include nurses, lay counsellors and/or community health workers, doctors/medical officers, and/or DSD model-specific staff, based on their role in providing HIV treatment. The participants will be purposively selected from within the site’s staff cadre and invited to participate, in agreement with the individual serving as facility in-charge or facility manager. Different calendar days will be observed during the study period, with days selected based on when each site schedules ART care and to represent typical patient care days for each cadre of provider. To minimize the burden on participants, no provider will be observed for more than two days. Questions in Domain 1 pertain to the allocation and efficiency of provider time use within the study clinics, which are expected to change as result of the scaling up of DSD models. These questions will be answered with a time-and-motion study. Data collection procedures and tools have been submitted and approved by the ethics committee. 600
Experimental Group Domain 2 Provider experiences We will administer a questionnaire to a sample of up to 10 providers per study site per data collection round (All data collection rounds to be completed by Dec 2025) For each round of the survey, we will enroll up to 10 providers per facility, preferentially including all staff who manage ART patients and the site’s operations manager, one or more lay counselors or community health workers, a pharmacist or pharmacy assistant, and any other cadre that is relevant to the DSD model program, as identified by the site. To select participants, we will ask the facility in-charge (facility manager) to choose the individuals in each cadre who are most involved in DSD model implementation. Questions in Domain 2 pertain to providers’ experiences with DSD models. These questions will be answered through a survey of providers at the study sites. Questionnaires will include both closed- and open-ended questions about the strengths and weaknesses of the models; how the advent of DSD models has changed provider responsibilities, work burden, and time allocation; and the effect of DSD models on job satisfaction. We will also ask participants to comment on challenges faced in implementing DSD models, the impact of DSD models on provider time allocation and efficiency (average time spent treating each patient) while caring for ART or non-ART patients, the implementation of differentiated HIV testing models, and other related topics. Data collection procedures and tools have been submitted and approved by the ethics committee. 1200
Experimental Group Domain 3 Patient experiences with service delivery We will aim to enroll up to 10 patients per site per model of care. We will include conventional care defined as two models: 1) patients eligible for, but not enrolled, in a differentiated model other than conventional care and 2) patients not eligible for DSD models, for each round (All data collection rounds to be completed by Dec 2025) A quantitative, structured questionnaire will be administered to ART patients at each annual round of data collection to understand patients’ satisfaction with their current model of care, motivation for enrolling in that model, and direct and indirect costs of accessing care. The focus will be on treatment service delivery, not on clinical aspects or outcomes of HIV treatment itself. Questions will address: 1. Costs to patients of seeking care (transport, time, lost wages, child care, etc.) 2.Time required for seeking care (travel, time at healthcare facility, time participating in DSD interactions) 3. Patient satisfaction with their current model of care 4. Patient’s preferences as to best and worst aspects of seeking care. Data collection procedures and tools have been submitted and approved by the ethics committee. 8600
Control Group Domain 4 Resources We will collect facility-level, aggregate data on patient volumes, reasons for visits for HIV and non-HIV patients, staff complements, and other operational indicators during each round of data collection (All data collection rounds to be completed by Dec 2025) The data to be collected for Domain 4 include routine reports and records generated by the facilities, District Health Offices, and nongovernmental partners. We will aim to collect the number of HIV, ART, and non-HIV patients presenting at the site in each time period and the number of full-time equivalent staff at the site in each time period, by cadre, including lay counselors, community health workers, and staff paid by external partners. We will also describe in detail the site’s operating procedures with relevance to models of HIV treatment. Data collection procedures have been submitted and approved by the ethics committee. 120 Active-Treatment of Control Group
Experimental Group Domain 5 Patient experience with differentiated HIV testing We will recruit individuals who are participating in facility-run HIV testing during the recruitment period. We will aim to enroll up to 50 patients per site. (All data collection rounds to be completed by Dec 2025) A structured questionnaire, designed for quantitative analysis, will be administered to a sample of patients at each site. Questions will address the testing modality, reason for testing, location in the clinic tested, department referred from, other services provided, and HIV testing history. For those testing HIV positive, questions will address prior ART exposure and readiness to initiate ART. For those who have previously been on ART, the questionnaire will ask about timing and reasons for disengagement, timing and reasons for re-engagement, and what services were provided at reengagement. For those testing HIV negative, questions will address the offer and uptake of PrEP and other preventive strategies after the negative test result. A structured questionnaire, designed for quantitative analysis, will be administered to a sample of patients at each site. Questions will address the testing modality, reason for testing, location in the clinic tested, department referred from, other services provided, and HIV testing history. For those testing HIV positive, questions will address prior ART exposure and readiness to initiate ART. For those who have previously been on ART, the questionnaire will ask about timing and reasons for disengagement, timing and reasons for re-engagement, and what services were provided at reengagement. For those testing HIV negative, questions will address the offer and uptake of PrEP and other preventive strategies after the negative test result. 5000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Domain 1 (Provider time) ● Patient-facing or patient-supporting service provider at the study site (patient-supporting providers include data clerks, pharmacists, etc.) ● Directly or indirectly involved in the site’s implementation of ART and DSD models ● Employed in current role at the study site for at least six months ● Provides written informed consent to participate Domain 2 (Provider experiences) ● Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.) ● Directly or indirectly involved in the site’s implementation of ART and DSD models ● Employed in current role at the study site for at least six months ● Provides written informed consent to participate. Domain 3 (Patient experiences with service delivery) ● Living with HIV and on ART for at least six months at the study site ● ≥ 18 years old (18 and older considered adult for research purposes in South Africa) ● Enrolled in a specified model of care (including conventional care) up to the target number of participants for that model and have received at least one medication refill under this model ● Provide written informed consent to participate Domain 5 (Patient experience with differentiated HIV testing) ● Undergoing HIV testing at the study site or other testing site within the catchment area ● ≥ 18 years old (18 and older considered adult for research purposes in South Africa) ● Provide written informed consent to participate. Domain 1 (Provider time) ● None Domain 2 (Provider experiences) ● Direct or indirect service provider at the study site (indirect providers include supervisors, technical advisors, etc.) ● Directly or indirectly involved in the site’s implementation of ART and DSD models ● Employed in current role at the study site for at least six months ● Provides written informed consent to participate. Domain 3 (Patient experiences with service delivery) ● Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant ● Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff. ● Unwilling to take the time required to complete the questionnaire on the day of consent. Domain 5 (Patient experience with differentiated HIV testing) ● Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant ● Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff. ● Unwilling to take the time required to complete the questionnaire on the day of consent. Adult: 19 Year-44 Year 18 Year(s) 100 Year(s) Female
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 14/06/2023 University of Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
8 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
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 14/06/2023 University of Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
38 Princess of Wales Terrace Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increased clinic efficiency and capacity After completion of each round of data collection for SENTINEL
Primary Outcome Lower costs to providers and patients After completion of each round of data collection for SENTINEL
Primary Outcome Better health outcomes for HIV and non-HIV patients After completion of each round of data collection for SENTINEL
Primary Outcome Improved access and greater satisfaction with healthcare for patients After completion of each round of data collection for SENTINEL
Secondary Outcome Provider and patient satisfaction After completion of each round of data collection for SENTINEL
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fanyana Nhlapho C/O Mmusong And Kagiso Avenue Krugersdorp 1754 South Africa
Krugersdorp Central 1740 Jeppe Street Krugersdorp 1754 South Africa
Tarlton Plot 09 Cecilia Street Tarlton 1739 South Africa
Bekkersdal East 3510 Khomo ea Hlaba Ave, Bekkersddal Westonaria 1772 South Africa
Simunye 3409 Kgotlelela Drive Westonaria 1779 South Africa
Zuurbekom Plot 179, 2nd street Westonaria 1772 South Africa
Kanyamazane 23 Cobra Street Kanyamazane 1214 South Africa
Legogote 14 Mganduzeni Rd White River 1257 South Africa
Manzini Stand No 445 Kabokweni 1245 South Africa
Nelspruit CHC 30 Waterfall Ave, Riverside Nelspruit 1201 South Africa
Msogwaba 2b Msogwaba Road, Nelspruit 1201 South Africa
White River Chief Mgiyeni Drive White River 1240 South Africa
Khandisa Lot 176 Mfundo Street, uMhlathuze Vulendlela Empangeni 3880 South Africa
Mandlanzini uMhlathuze Near to Richards Bay Airport Richards Bay 3900 South Africa
Umkhontokayise 1 Port Dunford Empangeni 3880 South Africa
Ntuze District Rd, Off R102 Empangeni 3880 South Africa
Phaphamani J1 Lot 661 Ndlebetshona str, Esikhawini Richards Bay 3887 South Africa
Richards Bay 6 Mark Strasse Richards Bay Central 3900 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North, Seattle, WA Seattle 98109 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda Gates Foundation 500 Fifth Avenue North, Seattle, WA Seattle 98109 United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Clinton Health Access Initiative Zambia 175 Kudu Rd Lusaka 10101 Zambia
Clinton Health Access Initiative Malawi Private Bag 68 Lilongwe 207201 Malawi
Boston University 233 Bay State Road Boston 02215 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Amy Huber ahuber@heroza.org 0100012653 32 Princess of Wales Terrace, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Researcher
Role Name Email Phone Street address
Principal Investigator Sophie Pascoe spascoe@heroza.org 0100012661 32 Princess of Wales Terrace, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Principal Researcher
Role Name Email Phone Street address
Public Enquiries Idah Mokhele imokhele@heroza.org 0100017930 32 Princess of Wales Terrace
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes To protect patients against loss of confidentiality, patient identifiers will be collected and stored separately from all other individual data. Identifiers will be entered on site and stored in encrypted, password protected files, so that no paper records containing identifying information are removed from the sites. De-identified patient electronic data files will be stored on secure, protected drives at the Health Economics and Epidemiology Research Office (HE2RO) in Johannesburg, with access limited to relevant study staff. HE2RO share de-identified patient data with collaborators at Boston University (BU) and Clinton Health Access Initiative (CHAI), using the file transfer protocol (FTP) over VPN to transfer data remotely between the organizations. FTP allows a user to connect remotely to the HE2RO FTP server securely from within the host network, transfer files to a designated folder and disconnect once done. Upon completion of the study, computer files and any data collection forms containing study data will be retained for seven years and then destroyed. As is often required by journals for publication of research manuscripts, we will post completely anonymized data sets to a public repository after all analysis and publication has been completed. The informed consent forms will alert participants to this and indicate that in providing consent, they are also consenting to the posting of completely de-identified data to a research repository. Analytic Code,Informed Consent Form,Study Protocol Immediately following publication. No end date De-identified data will be used for study reporting. For investigators wishing to use these data for analyses beyond the scope for which they were collected, a sound proposal that has been approved by an independent review committee will be required.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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