ANZCTR - Registration

Registration number

ACTRN12626001124325

Ethics application status

Approved

Date submitted

5/07/2026

Date registered

10/09/2026

Date last updated

10/09/2026

Date data sharing statement initially provided

10/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Optimising the proportion of eligible women attending public primary health care clinics in Eswatini who are up to date with cervical screening: a multiple-baseline study evaluating the Eswatini Screening Cascade Optimisation (ESCO) intervention

Scientific title

A Type 1 hybrid implementation-effectiveness multiple-baseline study evaluating the effect of the Eswatini Screening Cascade Optimisation (ESCO) intervention on the proportion of eligible women attending public primary health care clinics in Eswatini who are up to date with cervical screening

Additional trial identifiers [1]

APP2010271

Universal Trial Number (UTN)

Trial acronym

ESCO trial

Related trial records

Health condition

Health condition(s) studied:

Cervical cancer

Cervical pre-cancer

Cervical cancer screening and prevention

Condition category

Condition code

Cancer

Cervical (cervix)

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

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.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Behaviour

Intervention code [3]

Prevention

Description of the comparator or control

The comparator is usual cervical screening and follow-up care provided during the pre-intervention period at each participating public primary health care clinic. Within the multiple-baseline design, each clinic acts as its own control before the Eswatini Screening Cascade Optimisation intervention is introduced. During this comparator period, cervical screening and follow-up continue according to routine Ministry of Health practice and existing Eswatini cervical cancer screening and treatment pathways. Screening is available through routine clinic services and is generally offered opportunistically, most often when women request screening themselves, are identified during routine clinical care, or are referred through usual service pathways. Women with positive screening results are managed through existing treatment or referral pathways according to national guidance.

The comparator is delivered by existing Ministry of Health clinic staff, including nurses and other primary health care personnel involved in routine patient flow, cervical screening, treatment, referral and documentation. These staff have the usual clinical expertise and responsibilities required to provide cervical screening within public primary health care services. Community Health Workers may continue any general health promotion or referral-support activities that form part of their usual roles, but they do not receive ESCO-specific training and do not deliver structured ESCO cervical-screening outreach during the comparator period.

Comparator care is delivered face to face during routine individual clinic encounters at the participating public primary health care clinics. There are no study-specific comparator sessions, online components, group sessions, structured household visits, numbered referral slips, ESCO reminders, patient navigation procedures, clinic dashboards, patient-experience feedback loops, or Plan–Do–Study–Act quality-improvement cycles during the comparator period. Screening, treatment, referral and follow-up occur as part of ordinary clinic workflow and routine service delivery.

The comparator period is observed monthly. All three clinics contribute six months of concurrent usual-care baseline data before any intervention rollout. Clinics that have not yet commenced the intervention continue under usual care until their assigned intervention start month: month 7 for Clinic 1, month 9 for Clinic 2, and month 11 for Clinic 3. The comparator therefore consists of all pre-intervention clinic-months for each site.

Comparator care is delivered in the three participating public primary health care clinics and, where relevant, through routine community-level health promotion or referral activities in their catchment areas: Mpolonjeni-Siteki, Luyengo, and Ndzevane.

Because the comparator is usual care, there are no study-specific adherence strategies, reminders or fidelity procedures for the comparator itself. Routine documentation continues through the Client Management Information System and clinic registers. For trial measurement only, de-identified monthly aggregate data are extracted and checked for completeness and consistency; these monitoring procedures are used for outcome assessment and are not intended to change usual service delivery during the comparator period.

Control group

Active

Outcomes

Primary outcome [1]

Monthly proportion of unique eligible women attending each participating clinic who are up to date with cervical screening by the end of the index clinic visit or reporting month. A woman will be classified as up to date with cervical screening if she has: (1) a documented previous negative cervical screening result within the recommended screening interval for her HIV status and screening modality; (2) a documented negative cervical screening result from the current clinic visit or reporting month; or (3) a previous positive screening result followed by documented treatment, referral completion, or confirmatory assessment showing no disease, with no current indication for repeat assessment outside the recommended interval. Women screened during the current visit who have a positive result requiring treatment or referral will not be counted as up to date for this primary outcome unless appropriate treatment, referral completion, or confirmatory assessment is documented. These women will be captured under secondary cascade outcomes, including same-day treatment and referral/follow-up completion.

Timepoint [1]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [1]

Monthly proportion of eligible women attending each participating clinic who are not up to date with cervical screening and who receive cervical screening during the index clinic visit or reporting month.

Timepoint [1]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [2]

Monthly proportion of eligible, not-up-to-date women attending each participating clinic who are offered cervical screening during routine clinic care.

Timepoint [2]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [3]

Monthly proportion of women with a positive cervical screening result who are clinically eligible for same-day treatment and who receive treatment on the same day as screening.

Timepoint [3]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [4]

Monthly proportion of women requiring referral, higher-level assessment, treatment or follow-up after a positive or abnormal cervical screening result who complete the indicated referral or follow-up step within the recommended timeframe.

Timepoint [4]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation. Referral attendance linked to Community Health Worker referral slips will be assessed within 30 days of referral-slip issue.

Secondary outcome [5]

Composite patient-reported experience score for cervical screening and related clinic care, derived from four Intervention-Exposure Exit Survey items assessing: respectful treatment/dignity, privacy during screening, clarity of explanation about the procedure and its purpose, and comfort asking questions or raising concerns with the nurse. Each item is assessed using a five-point response scale. The composite score will be calculated by summing the four item scores, giving a total score from 4 to 20. Individual component items will also be summarised descriptively.

Timepoint [5]

Assessed on a continuous basis during each clinic's intervention-exposed period. Exit surveys will be administered to eligible women at the point of clinic exit following a screening-related visit, and responses will be aggregated at regular monthly intervals aligned with the trial's monthly data collection and audit-and-feedback cycle. Monthly summaries will allow patient experience to be tracked across the intervention period, and cumulative responses will also be summarised at the conclusion of the study.

Secondary outcome [6]

Number and proportion of eligible women reached through structured Community Health Worker household outreach in participating clinic catchment areas.

Timepoint [6]

Assessed monthly during each clinic's active intervention period, with routine monitoring monthly (maximum 12 months post-implementation; 8–12 months depending on the clinic's position in the staggered rollout).

Secondary outcome [7]

Extent to which core intervention components are delivered as intended, including Community Health Worker training and outreach, provider-initiated screening workflow, clinic readiness activities, referral follow-up, monthly audit-and-feedback, Plan–Do–Study–Act cycles and patient-experience feedback processes.

Timepoint [7]

Assessed monthly during each clinic's active intervention period, with routine monitoring monthly (maximum 12 months post-implementation; 8–12 months depending on the clinic's position in the staggered rollout).

Secondary outcome [8]

Acceptability of the Community Health Worker household outreach component among women attending participating clinics who report exposure to CHW/RHM outreach

Timepoint [8]

Assessed during scheduled exit-survey rounds in each clinic’s active intervention period, immediately after eligible women complete their clinic visit. Data collection will occur approximately monthly after implementation begins at each clinic, for a maximum of 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [9]

Incremental cost per additional woman up to date with cervical screening during the 18-month trial observation period. This will be estimated by linking incremental ESCO costs with the difference in the number of eligible women who are up to date with cervical screening, compared with usual care/baseline conditions

Timepoint [9]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [10]

Incremental cost per additional woman screened during the 18-month trial observation period. This will be estimated by linking incremental ESCO costs with the difference in the number of eligible women screened during the study period, compared with usual care/baseline conditions.

Timepoint [10]

Assessed monthly for each participating clinic across the 18-month observation period, including the 6-month concurrent baseline period and the staggered post-intervention periods following ESCO implementation.

Secondary outcome [11]

Acceptability of clinic-based cervical screening and related care among women attending participating clinics during the intervention period.

Timepoint [11]

Assessed during scheduled exit-survey rounds in each clinic’s active intervention period, immediately after eligible women complete their clinic visit. Data collection will occur approximately monthly after implementation begins at each clinic, for a maximum of 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [12]

Acceptability of ESCO among Community Health Workers / Rural Health Motivators involved in the community outreach component.

Timepoint [12]

The CHW acceptability questionnaire will be administered at the end of each clinic’s active implementation period. Qualitative interviews will be conducted at end of study or after the CHW has completed substantial involvement in ESCO delivery. The maximum active implementation duration is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [13]

Acceptability of ESCO among clinic staff involved in cervical screening, patient flow, treatment, referral, documentation or quality-improvement activities.

Timepoint [13]

Assessed at end-of-study qualitative interviews after each clinic has completed its active implementation period, with implementation monitoring records reviewed monthly during each clinic’s active intervention period. The maximum active implementation duration is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [14]

Acceptability of ESCO among clinic champions at participating clinics.

Timepoint [14]

Assessed at end-of-study qualitative interviews after each clinic has completed its active implementation period, with implementation monitoring records reviewed monthly during each clinic’s active intervention period. The maximum active implementation duration is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [15]

Acceptability of ESCO among relevant Ministry of Health, National Cancer Control Unit and regional implementation stakeholders involved in cervical screening coordination, CHW programme coordination, data systems, referral pathways or service implementation.

Timepoint [15]

Assessed at end-of-study qualitative interviews after completion of the intervention period, with implementation monitoring records reviewed monthly during each clinic’s active intervention period. The maximum active implementation duration is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [16]

Proportion of planned site-level ESCO implementation activities completed per site-month during each clinic’s active intervention period. For this indicator, “site” refers to the participating clinic and its associated catchment-area implementation system. The numerator will be the number of planned site-level implementation activities completed during the site-month. The denominator will be the number of planned site-level implementation activities due during that site-month, according to the pre-specified monthly implementation monitoring schedule. Activities that are not scheduled, not applicable, or only triggered under specific conditions will be excluded from the denominator unless the trigger occurs. Individual household outreach contacts delivered by CHWs will not be included in this denominator, as these are assessed separately under community reach, CHW outreach intensity and household outreach fidelity.

Timepoint [16]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum assessment duration is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [17]

Number and nature of adaptations made to ESCO delivery during each clinic’s active intervention period (assessed as individual outcomes)

Timepoint [17]

Assessed monthly during each clinic’s active intervention period, with summary assessment at the end of the study. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [18]

Number and severity of unplanned ESCO implementation gaps or interruptions during each clinic’s active intervention period (assessed as individual outcomes)

Timepoint [18]

Recorded as events occur and summarised monthly during each clinic’s active intervention period. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [19]

Proportion of trained CHWs who remain active in ESCO delivery at three-month intervals during each clinic catchment area’s active intervention period. The numerator will be the number of trained CHWs who remain active in ESCO delivery during the relevant assessment period. The denominator will be the number of trained CHWs activated for ESCO delivery in that clinic catchment area. A CHW will be considered active if they remain part of the ESCO outreach cohort and have documented participation in outreach, supervision, referral support, follow-up/navigation activity, logbook submission or related ESCO implementation activity during the relevant assessment period.

Timepoint [19]

Assessed at three-month intervals during each clinic catchment area’s active intervention period, with summary assessment at the end of the study. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [20]

Perceived feasibility of delivering the ESCO community outreach component within routine Community Health Worker roles.

Timepoint [20]

Assessed through end-of-study qualitative interviews after the CHW has completed substantial involvement in ESCO delivery. The active implementation period is up to 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [21]

Perceived feasibility of delivering ESCO clinic-based activities within routine public primary health care clinic workflows, from the perspective of clinic staff/nurses.

Timepoint [21]

Assessed through end-of-study qualitative interviews after the participant’s clinic has completed its active ESCO implementation period. The active implementation period is up to 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [22]

Perceived feasibility of the clinic champion role and associated ESCO coordination activities within routine clinic service delivery.

Timepoint [22]

Assessed through end-of-study qualitative interviews after each clinic has completed its active ESCO implementation period. The active implementation period is up to 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [23]

Perceived feasibility of supporting, maintaining and potentially scaling ESCO within regional CHW programme, Ministry of Health, and National Cancer Control Unit structures (assessed as individual outcomes)

Timepoint [23]

Assessed through end-of-study qualitative interviews after completion of the active intervention period, or after the participant has completed substantial involvement in ESCO implementation, coordination, supervision, or oversight. The active implementation period is up to 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [24]

Monthly proportion of eligible women attending each participating clinic who are assessed for cervical screening eligibility using the provider-initiated screening protocol.

Timepoint [24]

Assessed monthly during each clinic’s active intervention period. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [25]

Proportion of women issued a numbered CHW referral slip who attend the clinic within 30 days of referral-slip issue

Timepoint [25]

Assessed monthly during each clinic catchment area’s active intervention period, with attendance assessed within 30 days of referral-slip issue. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [26]

Proportion of enrolled CHWs who attend all required ESCO training sessions before deployment.

Timepoint [26]

Assessed at completion of the CHW training period before CHWs commence ESCO household outreach in each clinic catchment area. Refresher training attendance, where applicable, will be documented when refresher training occurs.

Secondary outcome [27]

Proportion of trained CHWs who achieve the minimum ESCO competency standard before deployment.

Timepoint [27]

Assessed immediately after CHW training and, where refresher coaching is required, after refresher coaching before CHW deployment.

Secondary outcome [28]

Proportion of documented CHW household outreach contacts in which all required ESCO outreach protocol elements are completed.

Timepoint [28]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [29]

Proportion of planned monthly audit-and-feedback cycles completed at each participating clinic during the active intervention period.

Timepoint [29]

Assessed monthly during each clinic’s active intervention period. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [30]

Proportion of identified high-risk IPC deficiencies for which a corrective action plan is initiated within the pre-specified timeframe.

Timepoint [30]

Assessed quarterly during each clinic’s active intervention period, following scheduled IPC assessments. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic

Secondary outcome [31]

Mean number of household outreach contacts delivered per active CHW per month during each clinic catchment area’s active intervention period.

Timepoint [31]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [32]

Mean number of follow-up contacts per referred woman who does not attend the clinic after the initial CHW referral.

Timepoint [32]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [33]

Number and proportion of planned structured group supervision meetings completed in each clinic catchment area (assessed as individual outcomes)

Timepoint [33]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [34]

Number of individual CHW coaching contacts completed in each clinic catchment area during the active intervention period

Timepoint [34]

Assessed monthly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [35]

Number and proportion of planned quarterly site visits completed in each clinic catchment area (assessed as individual outcomes).

Timepoint [35]

Assessed quarterly during each clinic catchment area’s active intervention period. The maximum active implementation period is 12 months in Clinic 1 catchment, 10 months in Clinic 2 catchment, and 8 months in Clinic 3 catchment.

Secondary outcome [36]

Number of suggestion-box reviews completed at each participating clinic during the active intervention period.

Timepoint [36]

Assessed monthly during each clinic’s active intervention period. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [37]

Number of patient-feedback review cycles completed at each participating clinic during the active intervention period.

Timepoint [37]

Assessed monthly during each clinic’s active intervention period. The maximum active implementation period is 12 months in Clinic 1, 10 months in Clinic 2, and 8 months in Clinic 3.

Secondary outcome [38]

Total cost of implementing and delivering the ESCO intervention from the health-system perspective, including costs incurred by the Ministry of Health and participating clinics.

Timepoint [38]

Resource use will be recorded throughout the 18-month observation period. Total health-system cost will be calculated at the end of the observation period.

Secondary outcome [39]

Total cost (composite score) of implementing and delivering the ESCO intervention from the societal perspective, comprising health-system costs, patient out-of-pocket expenditure and the monetary value of patients’ time away from usual activities.

Timepoint [39]

Health-system resource use will be recorded throughout the 18-month observation period. Patient costs and time will be assessed during the intervention period at a routine clinic or referral visit or subsequently by telephone. Total societal cost will be calculated at the end of the observation period.

Secondary outcome [40]

Incremental cost of the ESCO intervention: difference in total cost between the ESCO intervention and current cervical-screening practice, calculated separately from the health-system and societal perspectives.

Timepoint [40]

End of the 18-month trial period, with modelled projections over five years where appropriate.

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

69 Years

Sex

Females

Healthy volunteers

Yes

Key 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.

Study design

Statistical methods / analysis

The primary unit of analysis is the clinic-month, providing 54 observations across the study period (3 clinics × 18 months), based on approximately 10,800 eligible clinic attendances. The number of clinics and the 18-month observation window were determined by the multiple-baseline design, available implementation period, and feasibility of delivery across participating clinics. A simulation-based power calculation was then used to assess whether this configuration was adequate for the primary outcome. Assuming a first-order autoregressive within-clinic correlation of rho = 0.30, the planned design provides greater than 80% power at a two-sided alpha of 0.05 to detect a 15 percentage-point absolute increase in the proportion of eligible women who are up to date with cervical screening, from 10% at baseline to 25% after intervention implementation.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2026

Actual

Date of last participant enrolment

Anticipated

31/03/2028

Actual

Date of last data collection

Anticipated

30/04/2028

Actual

Sample size

Target

10800

Accrual to date

Final

Recruitment outside Australia

Country [1]

Eswatini

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) under the Global Alliance for Chronic Diseases (GACD)

Country [1]

Australia

Primary sponsor type

University

Name

The University of Newcastle

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Ministry of Health through the National Cancer Control Unit

Country [1]

Eswatini

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

http://www.newcastle.edu.au/research/research-services/human-ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2026

Approval date [1]

12/08/2026

Ethics approval number [1]

Ethics committee name [2]

Eswatini Health and Human Research Review Board (EHHRRB)

Ethics committee address [2]

Eswatini Health and Human Research Review Board Mbandzeni House, 3rd Floor, Church Street Mbabane, Hhohho H100 Eswatini

Ethics committee country [2]

Eswatini

Date submitted for ethics approval [2]

09/10/2026

Approval date [2]

Ethics approval number [2]

Summary

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.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Phinda Khumalo

Address

Hunter Medical Research Institute, 1 Kookaburra Cct, Newcastle New South Wales 2305

Country

Australia

Phone

+61 466158666

Email

[email protected]

Contact person for public queries

Name

Bheki Vilane

Address

Eswatini Health and Human Research Review Board Mbandzeni House, 1st Floor, Church Street Mbabane, Hhohho H100 Eswatini

Country

Eswatini

Phone

+268 7823 1551

Email

[email protected]

Contact person for scientific queries

Name

Phinda Khumalo

Address

Hunter Medical Research Institute, 1 Kookaburra Cct, Newcastle New South Wales 2305

Country

Australia

Phone

+61 466158666

Email

[email protected]

Type	Other Details	Attachment
Study protocol		Protocol_ANZCTR_Registration_v2.docx
Statistical analysis plan		ESCO_Statistical_Analysis_Plan_ANZCTR Registration.docx
Other	Plain language summary	Plain_Language_Summary_ANZCTR Registration.docx
Ethical approval		Ethical Approval_ESCO Study.pdf

Trial Review

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Documents added automatically