Table 2 ASPIRE Mayuge Evaluation Strategy

To compare the effectiveness of two self-collected CCS models at improving VIA follow-up: community health worker recruitment (door-to-door) versus community health day.

Which of the two self-collected CCS models is more effective at improving VIA follow-up among screened women: door-to-door screening or community health days?

Effectiveness (Individual level)

Primary Outcome: Follow-up attendance for VIA screening at a designated Health Center after a positive HR-HPV test out of all participants screened per arm

Quantitative analysis of clinical data: Mixed effect model with cluster as a random intercept and adjusted for all known confounders. Intention to treat and sensitivity analysis; Multivariate logistic regression

What is the: prevalence of HR-HPV types; incidence of cervical cancer; association between HPV and STIs (gonorrhea and chlamydia); and risk difference in VIA follow-up between WLWHA vs non HIV?

n/a

HR-HPV prevalence; cervical cancer incidence; STI-HPV association; HIV-HPV association; Risk difference in VIA follow-up attendance between WLWHA vs. non HIV

Quantitative analysis of clinical and survey data: Descriptive statistics: prevalence, incidence; Bi-variate analysis: adjusted odds ratio, Risk difference (adjusted for cluster and other confounders)

What is the effect of screening model on CCS knowledge retention and follow-up uptake? Are women aware of cervical cancer and how knowledgeable are they about CCS?

Effectiveness (Individual level)

Mean CCS knowledge scores; cervical cancer awareness;

Quantitative analysis of survey data: multi-level Poisson model;

What are the motivators or inhibitors of CCS behaviour among women?

Effectiveness (Individual level)

Primary and secondary factors that motivate self-collected CCS; Primary and secondary factors that motivate VIA follow-up; Primary and secondary factors that inhibit VIA follow-up; Perceived social support from CHWs;

Quantitative analysis of survey data: descriptive statistics; Chi squared; multivariate logistic regression; Qualitative analysis of open-ended survey questions: deductive thematic analysis

To evaluate the cost and feasibility of a community-based CCS program in a low resource setting.

Which CCS model is more cost-effective?

Implementation (Setting level)

Cost-effectiveness of each CCS model (total provider, laboratory, transportation, equipment, training, and treatment costs per arm)

Quantitative analysis of facility survey data: ICER and reduction in CCS over lifetime; sensitivity analysis

What are the costs associated with a CCS program?

Implementation (Setting level)

Monetary and time costs of CHWs and health care providers; training costs; laboratory costs; treatment costs; patient time costs;

Process evaluation: Narrative assessment/quantitative analysis of study logs: Descriptive statistics - univariate analysis (frequencies)

To identify the barriers and facilitators of implementation, implementation reach, and fidelity for each model of CCS.

What are patients’ preferences for integrated service delivery? (barriers/facilitators of implementation)

n/a

Patients’ preferences for integrated service delivery

Quantitative analysis of survey data: Chi squared; multivariate logistic regression

What is the acceptability of a community-based CCS program among participants? (barriers/facilitators of implementation)

Effectiveness (Individual level)

Patient-reported experiences with a community-based CCS program

Quantitative analysis of survey data: Descriptive statistics with time from sample collection to patient experiences survey as offset; Qualitative analysis of open-ended survey questions: deductive thematic analysis

What were the CCS program inputs? (Implementation reach)

Implementation (Setting level)

Total program inputs (financial, human, administrative, equipment resources)

Process evaluation. Narrative assessment/quantitative analysis of study logs: Descriptive statistics - univariate analysis (frequencies)

What was the reach of the program? (Implementation reach)

Reach (Individual level)

Participation at each level of the pathway to care; stakeholder engagement; Survey participation; sociodemographic characteristics of participants

Process evaluation. Quantitative analysis of survey, study log, and clinical data: Descriptive statistics - univariate analysis (proportion, frequency, mean); Chi squared; T-test;

How many participants were lost to follow-up? (fidelity)

Maintenance (Individual level)

Attrition at each level of the pathway to care

Process evaluation. Per-protocol analysis; Quantitative analysis of survey, study log, and clinical data: Descriptive statistics - univariate analysis (frequency); sociodemographic characteristics of those lost to follow-up

Was the CCS program implemented as intended? (fidelity)

Implementation (Setting level)

Planned vs actual intervention components (e.g. number of training sessions, number of specimens transported and tested, etc.)

Process evaluation. Quantitative analysis of study logs and clinical data: Descriptive statistics - univariate analysis (mean, frequency)

How successful was VIA training and quality monitoring during the trial? (fidelity)

Implementation (Setting level)

Detection rates of CIN2+ lesions over time; adverse and serious adverse events; Themes related to health care workers experiences;

Quantitative analysis of clinical data: descriptive statistics - univariate analysis (frequency); qualitative analysis; qualitative analysis of FGD data: deductive thematic analysis

How acceptable and feasible is the HPV screen and treat approach to women and health workers? (barriers/facilitators of implementation)

Implementation (Individual level)

Treatment rate vs. VIA + rate; patient reported experience measures from treatment; themes related to health care workers experiences

Quantitative analysis of clinical data: descriptive statistics - univariate analysis (frequency); qualitative analysis; qualitative analysis of FGD data: deductive thematic analysis

How representative were the included villages (clusters)?

Adoption (Setting level)

Participation, exclusion, and representativeness of included villages in Mayuge district

Literature review of Uganda National Planning Authority data

What modifications were made to the study’s original CCS program to meet the National program’s interests?

Maintenance (Setting level)

Modifications to original CCS program plans of the study to align with Uganda’s national CCS program interests

Narrative assessment of study’s program planning activities and National program interests

To understand the role that men play in CCS

How knowledgeable are men about HPV and cervical cancer?

n/a

HPV and cervical cancer knowledge

Qualitative analysis of survey data: Descriptive statistics - univariate analysis (mean)

What are men’s attitudes/perceptions of cervical cancer and screening?

n/a

Attitudes and perceptions of cervical cancer and CCS

Qualitative analysis of survey data: Descriptive statistics - univariate analysis (frequency)

What factors impact men’s supportiveness towards their partner seeking cervical cancer screening and treatment?

n/a

Factors that impact men’s supportiveness (e.g. willingness to support their partners at each level of the pathway to care)

Qualitative analysis of survey data: Descriptive statistics - univariate analysis (frequency)