Research Objective | Research Question | RE-AIM Outcome | Outcomes | Data Analysis Approach |
---|---|---|---|---|
Primary Objective | ||||
Self-collected cervical cancer screening effectiveness | ||||
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 | |
Secondary Objectives | ||||
Cost and feasibility | ||||
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) | |
Best Practices for integrated community care | ||||
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 | |
Other Objectives | ||||
Men’s role in cervical cancer screening | ||||
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) |