None listed
Conditions
Brief summary
Cervical cancer is common and often found too late in Eswatini, partly because many women who could be screened are not screened or do not return for follow-up. This study tests a practical package of changes, called ESCO, designed to help three primary health clinics and their community health workers reach more eligible women, offer screening during routine visits, and support women to complete any follow-up or treatment they need. The changes include community health workers visiting households to share information and help women get to the clinic, nurses routinely offering screening to eligible women, and monthly meetings where clinic teams review their own numbers and make small improvements. We will introduce these changes at the three clinics one after another, and each month we will measure the proportion of eligible women attending each clinic who are up to date with cervical screening. We expect this proportion to increase after ESCO begins, compared with the period beforehand, showing that the approach helps more women get screened and cared for.
Interventions
The Eswatini Screening Cascade Optimisation (ESCO) intervention is a multicomponent, community-informed, service-strengthening intervention delivered within routine public primary health care in Eswatini. It is being evaluated in relation to cervical screening, referral, treatment and follow-up processes among eligible women attending participating public primary health care clinics. The intervention is delivered by Ministry of Health-recognised Community Health Workers, also known locally as Rural Health Motivators, regional Community Health Worker programme coordinators, clinic nurses, clinic champions, and Ministry of Health/National Cancer Control Unit staff, with implementation support from the research team. Community Health Worker coordinators receive training-of-trainers preparation and support delivery of competency-based training to approximately 160 Community Health Workers. Clinic-based components are delivered by clinic nurses and supported by clinic champions, who are typically experienced screening nurses involved in cervical screening delivery and local service coordination. The intervention components are: (1) Community Health Worker / Rural Health Motivator capacity-building and household outreach: Regional Community Health Worker coordinators receive training-of-trainers preparation and support delivery of competency-based training for approximately 160 Community Health Workers. Trained Community Health Workers then deliver face-to-face household outreach in their usual clinic catchment areas. Outreach includes verbal cervical cancer education, eligibility screening for women aged 18–69 years, barrier discussion, informed-choice support, numbered referral slips, reminders, follow-up, and navigation support. Community Health Workers / Rural Health Motivators may use hard-copy visual and written materials during household outreach. These include plain-language pictorial key-message prompt cards, an eligibility screening script, and numbered referral slips. These materials were developed specifically for the ESCO study and are not pre-existing publicly available resources. They are used to support consistent delivery of verbal education and referral information; they are not used to record clinical results, HIV status, suspected diagnoses or treatment outcomes. Reminders to eligible women are provided face to face by Community Health Workers / Rural Health Motivators during routine household follow-up visits or other routine community contact within the clinic catchment area. No email, postal-letter or bulk SMS reminder system is planned for the community outreach component. (2) Provider-initiated screening workflow integrated into routine patient flow: Clinic nurses deliver this component face to face during routine clinic visits. The workflow includes a non-identifying visual prompt at triage or reception, systematic eligibility assessment, private offer of cervical screening, same-day screening where appropriate, and same-day treatment readiness for eligible screen-positive women. (3) Clinic readiness strengthening: Clinic staff, clinic champions, Ministry of Health/National Cancer Control Unit staff, and the research team conduct structured readiness assessment and remediation at each participating clinic. This includes identifying and addressing practical barriers to screening delivery, such as staffing, patient flow, equipment, supplies, space, privacy, documentation, and referral pathways. (4) Monthly audit-and-feedback with quality-improvement cycles: Clinic champions and clinic staff participate in monthly audit-and-feedback meetings using clinic dashboards. These meetings review screening, referral, treatment, follow-up, and implementation data, and use Plan–Do–Study–Act quality-improvement cycles to identify local service-delivery issues and document agreed local actions. (5) Patient-experience monitoring: Patient experience is monitored through structured exit surveys and anonymous suggestion boxes at participating clinics. The structured exit surveys are administered face to face by trained research staff in English or SiSwati, according to participant preference, after the participant’s clinic encounter. Surveys are expected to take approximately 10–15 minutes to complete. Responses are recorded electronically on secure tablets where feasible, with paper-based forms used as a backup. Anonymous suggestion boxes are available at participating clinics throughout the intervention period. The intervention is delivered in three public primary health care clinics and their surrounding catchment communities: Mpolonjeni-Siteki, Luyengo, and Ndzevane. ESCO is introduced sequentially across the clinics during the 18-month study period, starting at Clinic 1 in Month 7, Clinic 2 in Month 9, and Clinic 3 in Month 11. Active implementation therefore continues for approximately 12 months at Clinic 1, 10 months at Clinic 2, and 8 months at Clinic 3. Community outreach and clinic workflow activities occur throughout each clinic’s active intervention period; audit-and-feedback meetings occur monthly; and patient-experience monitoring occurs during the intervention period. Adherence and fidelity are monitored using training attendance records, competency assessments, refresher coaching where required, Community Health Worker logbooks, numbered referral slips, clinic attendance records, Client Management Information System data, clinic registers, monthly dashboards, Plan–Do–Study–Act documentation, supervision tools, clinic monitoring records, and patient-reported exposure data from exit surveys. These data are used to document delivery of intervention components and implementation issues requiring local remediation.
Sponsors
Study design
Eligibility
Inclusion criteria
Participating clinics and catchment areas Participating sites will be Ministry of Health public primary health care clinics and associated catchment areas in Eswatini. Clinics will be eligible if they: 1. serve more than 50 women aged 18–69 years per week; 2. currently offer VIA screening or have the staffing and physical capacity to do so; 3. use the national Client Management Information System; 4. have at least one trained cervical screening nurse; 5. have sufficiently low baseline cervical screening coverage to justify intervention; and 6. are located at least 30 km from another selected clinic to reduce contamination through overlapping CHW catchment areas or substantial client movement. Women contributing routine aggregate outcome data Women will be eligible for inclusion in routine aggregate outcome data if they: 1. attend a participating clinic during the 18-month observation period; 2. are aged 18–69 years; and 3. do not have a documented history of cervical cancer or hysterectomy. Routine outcome data will be extracted as aggregate clinic-level data by authorised clinic/HMIS personnel. No identifiable routine patient data will be transferred to the research team. Women participating in the Intervention-Exposure Exit Survey Women will be eligible to complete the Intervention-Exposure Exit Survey if they: 1. are aged 18–69 years; 2. attended a participating clinic on a scheduled survey day during that clinic’s intervention period; 3. have completed their clinic visit; 4. are not acutely unwell, visibly distressed, or requiring urgent care; and 5. are willing and able to provide written informed consent. Women will be eligible regardless of whether they were screened, offered screening but declined, attended for another service, or were referred by a CHW. Women participating in the Patient Cost Questionnaire Women will be eligible to complete the Patient Cost Questionnaire if they: 1. are aged 18–69 years; 2. receive a positive cervical screening result during the intervention period; 3. require treatment, referral or follow-up care; and 4. are willing and able to provide informed consent. Clinic nurses / clinic staff Clinic nurses will be eligible if they: 1. work at one of the participating clinics; 2. are involved in cervical screening delivery, patient triage, patient flow, referral/follow-up, or related data processes; and 3. are willing and able to provide written informed consent for research-specific activities, including interviews or staff-level data collection. Clinic champions Clinic champions will be eligible if they: 1. are nominated at one of the participating clinics; 2. are able to support local coordination of ESCO implementation, including clinic readiness, staff engagement, implementation monitoring, and liaison with the research team; 3. agree to undertake the clinic champion role according to the clinic champion terms of reference and facility arrangements; and 4. are willing and able to provide written informed consent for research-specific activities, including the optional end-of-study interview. Community Health Workers CHWs will be eligible if they: 1. are formally recognised by the Ministry of Health CHW Programme; 2. are currently active in one of the participating clinic catchment areas; 3. are available to attend ESCO training and supervision activities; 4. are willing to undertake ESCO training, outreach and supervision activities within their CHW Programme role; and 5. are willing and able to provide written informed consent for research-specific activities, including CHW research questionnaires and optional end-of-study interviews. Regional CHW programme coordinators Regional CHW programme coordinators will be eligible if they: 1. are employed or formally appointed within the CHW Programme; 2. have supervisory responsibility for CHWs in one of the participating clinic catchment areas; 3. are involved in ESCO training, supervision, monitoring, escalation or implementation support; and 4. are willing and able to provide written informed consent for research-specific activities, including the optional end-of-study interview. Ministry of Health / NCCU and regional implementation stakeholders Ministry of Health, National Cancer Control Unit and regional implementation stakeholders will be eligible if they: 1. are involved in cervical screening coordination, CHW programme coordination, data systems, referral pathways, clinic coordination, implementation oversight or policy translation relevant to ESCO; and 2. are willing and able to provide informed consent for research-specific activities, including end-of-study qualitative interviews.
Exclusion criteria
Participating clinics and catchment areas Clinics will be excluded if they: 1. do not meet the service-volume, VIA-capacity, CMIS, trained-screening-nurse, baseline-coverage or contamination-control criteria; 2. are not operationally suitable for implementation at the time of final NCCU verification; or 3. are unable to participate before baseline data collection begins. Women contributing routine aggregate outcome data Women will be excluded from routine aggregate outcome data if they: 1. are aged under 18 years or over 69 years; 2. do not attend a participating clinic during the observation period; or 3. have a documented history of cervical cancer or hysterectomy. Women participating in the Intervention-Exposure Exit Survey Women will be excluded from the exit survey if they: 1. are aged under 18 years or over 69 years; 2. did not attend a participating clinic on a scheduled survey day during that clinic’s intervention period; 3. have not yet completed their clinic visit; 4. are acutely unwell, visibly distressed, or requiring urgent care; or 5. are unwilling or unable to provide written informed consent. Women participating in the Patient Cost Questionnaire Women will be excluded from the Patient Cost Questionnaire if they: 1. are aged under 18 years or over 69 years; 2. do not receive a positive cervical screening result during the intervention period; 3. do not require treatment, referral or follow-up care; or 4. are unwilling or unable to provide informed consent. Clinic nurses / clinic staff Clinic nurses or staff will be excluded from research-specific staff data collection if they: 1. do not work at a participating clinic; 2. are not involved in cervical screening delivery, patient triage, patient flow, referral/follow-up, or related data processes; or 3. are unwilling or unable to provide written informed consent for research-specific activities. Clinic champions Clinic staff will be excluded from clinic champion research-specific data collection if they: 1. are not nominated as a clinic champion; 2. do not agree to undertake the clinic champion role under the terms of reference and facility arrangements; or 3. are unwilling or unable to provide written informed consent for research-specific activities. Community Health Workers CHWs will be excluded if they: 1. are not formally recognised by the Ministry of Health CHW Programme; 2. are no longer active in the CHW Programme; 3. are assigned outside the participating clinic catchment areas; 4. are unable to participate in ESCO training, supervision or outreach during the implementation period; or 5. are unwilling or unable to provide informed consent for research-specific activities. Regional CHW programme coordinators Regional CHW programme coordinators will be excluded from research-specific data collection if they: 1. are not employed or formally appointed within the CHW Programme; 2. do not have supervisory responsibility in one of the participating clinic catchment areas; 3. are not involved in ESCO training, supervision, monitoring or implementation support; or 4. are unwilling or unable to provide informed consent for research-specific activities. Ministry of Health / NCCU and regional implementation stakeholders Ministry of Health, NCCU and regional implementation stakeholders will be excluded from research-specific qualitative interviews if they: 1. are not involved in cervical screening coordination, CHW programme coordination, data systems, referral pathways, clinic coordination, implementation oversight or policy translation relevant to ESCO; or 2. are unwilling or unable to provide informed consent.