PROTOCOL P1836-2025 RE-AIM × IMARA × WHO 6 CLUSTER RCT · NI MARGIN 7.5% BASELINE + MIDLINE · V6.0

Study Design & Framework

Design Cluster RCT (non-inferiority; NI margin = 7.5%)
Facilities 50 (KEPH Level 2–4) across Nairobi, Kiambu, Kitui
Conditions HIV, Hypertension, Diabetes — all combinations
Intervention IMARA 5-domain HIV-NCD integration model
Analysis GLMM (binomial logit), facility random intercept, bobyqa
Status ✓ ARMS LIVE · Baseline + Midline Facility Data

Key Findings — Baseline Snapshot

All results at BASELINE. Findings update automatically with sidebar filters. Facility midline data available in Building Block tabs.

Condition Distribution by Arm

Clinical Outcomes vs Benchmark (by Arm)

Age Distribution by Arm

Participants by County

Sex Distribution by Arm

Table 1. Baseline Characteristics of EIS Study Participants

RE-AIM: Reach. Arm-stratified table provides baseline balance check for the CRT.

Table 2. Clinical Outcomes at Baseline by Condition Group

VL suppression: <200 copies/mL (UNAIDS 2023). BP control: <140/90 mmHg (JNC-8/WHO). Glycaemic: HbA1c<7.5% → FBS<7.2 → RBS<11.1 mmol/L. NI margin = 7.5%.

Table 3. Service Integration and Delivery Indicators

RE-AIM: Reach + Implementation. Integration indicators apply to comorbid patients (≥2 conditions). Acceptability scale: Unacceptable → Acceptable → Highly Acceptable.

Table 4. Patient Satisfaction with Healthcare Services

RE-AIM: Effectiveness (patient-reported). Ceiling effects expected in sub-Saharan Africa facility surveys. Aninanya et al. 2021 framework.

Satisfaction Ratings — Likert Profile

Stacked bar chart of satisfaction levels by domain (Part 10 of patient CRF). Five domains: Communication, Attentiveness, Privacy, Information provided, Concerns addressed. Agree/Strongly Agree colours indicate satisfaction; orange/red indicate dissatisfaction.
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Table 5. Out-of-Pocket Health Expenditure by Condition Group

RE-AIM: Maintenance | HF Pillar (Health Financing). CHE = catastrophic health expenditure (OOP >10% monthly income). KES = Kenyan Shillings (~1 USD ≈ 130 KES). SHA = Social Health Authority (replaced NHIF 2024).

Table 6. HIV-Related Stigma Profile Among PLHIV

Agree/Strongly Agree = stigma present. Bazant et al. 2014 SBM-R framework: stigma reduces provider quality perception and patient engagement. PLHIV only (filter applied).

HIV Stigma — Likert Profile

Stacked bar chart per stigma domain (Part 12 of patient CRF). Four domains: Perceived (others' assumptions), Internalized (shame/hesitancy), Anticipated (fear of disclosure), Experienced (discrimination). Green = Agree/Strongly Agree (stigma present). PLHIV only. Consistent with Turan et al. 2012 SHAIP pattern.
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Model Configuration

GLMM (binomial logit) · facility random intercept · bobyqa. Arm + County always included. Un-check covariates to simplify.

Fast mode uses nAGQ=0 (3-5× faster). Turn off for full adaptive quadrature.

ICC (facility clustering):

Model Output — Adjusted Odds Ratios

Forest Plot — Adjusted Odds Ratios

Figures match the Baseline Analysis Report. Use Arm/County filters (sidebar) to subset. All figures are interactive — hover, click legend to toggle arms.

Figure 1. Distribution of Chronic Disease Conditions

HIV-only = 44.1%; comorbid patients = 27.4% of total. Consistent with Kenya's dual burden of disease.

Figure 2. Clinical Outcome Prevalence at Baseline by Arm

VL suppression above benchmark; BP and glycaemic control below 50% target. Dashed = Kenya NCD 50% benchmark.

Figure 3. Transport Cost per Visit by Condition Group

Kitui patients face highest transport burden; comorbid patients disproportionately affected. Links to CHE.

Figure 4. Patient Satisfaction by Domain and Arm

High overall satisfaction; privacy scored lowest. Ceiling effects likely. See Aninanya et al. 2021.

Figure 5. HIV-Related Stigma Profile (PLHIV, by Arm)

Perceived > anticipated > internalized > experienced stigma — typical East Africa pattern (Turan et al. 2012).

Figure 6. Median OOP Cost by Component per Scheduled Visit

Medication dominates for NCD patients; HIV patients benefit from subsidised ART. Linked to SHA coverage.

Figure 7. Financial Coping Mechanisms Used by Patients

31% use harmful coping (borrowing, selling assets, skipping meals). Integration expected to reduce burden.

Figure 8. VL Suppression by Arm & County

Arm × County baseline VL suppression. Dashed = UNAIDS 95% target. County as key effect modifier.

🏥 BB1 · Service Delivery

RE-AIM: Reach + Effectiveness + Implementation. HIV/NCD clinical integration quality, appointment adherence, same-day integrated care.

Quick Navigation

This pillar covers: patient baseline profile, clinical outcomes, and integration quality. Use the sidebar sub-items or buttons below.

Figure 1. Condition Distribution by Arm

Figure 2. Clinical Outcome Prevalence at Baseline

💊 BB2 · Health Products & Technologies

WHO Building Block: Medicines, equipment, diagnostic supplies. Essential medicine availability and equipment readiness at baseline and midline.

Quick Navigation

Medicine Availability Score (0–5) by Arm

Equipment Availability by Arm

🖥️ BB3 · Health Information Systems

WHO Building Block: EMR adoption, KHIS reporting, DQA, digital health tool penetration, and patient volume data quality.

Quick Navigation

EMR Coverage by Service Type & Arm

DQA Conducted — Baseline vs Midline

🏛️ BB4 · Leadership & Governance

WHO Building Block: Facility readiness, guideline availability, MDT meetings, integration governance, focal person designation.

Quick Navigation

Guideline Availability by Arm (Baseline vs Midline)

Integration Meeting & MDT Activity by Arm

💰 BB5 · Health Financing

WHO Building Block: OOP expenditure, catastrophic health expenditure (CHE), SHA/NHIF coverage, harmful coping mechanisms, patient satisfaction.

Quick Navigation

Figure 6. Median OOP Cost by Component

Figure 7. Financial Coping Mechanisms

👩‍⚕️ BB6 · Health Workforce

WHO Building Block: Clinical staffing levels, training in HIV+NCD integration, staff attrition, and HIV-related stigma among PLHIV.

Quick Navigation

Staff Trained in Combined HIV+NCD by Arm

Figure 5. HIV Stigma Profile (PLHIV, by Arm)

Facility Roster — Baseline & Midline

🏛️ BB4 · Leadership & Governance — Facility Roster

50 facilities across 3 counties. Each facility has a Baseline and Midterm record.

Total Clinical Workforce by Arm & Level

Support Partner Presence by Arm

🏛️ BB4 · Readiness & Governance

Table F1. Facility Readiness & Governance Indicators

WHO Building Block: Leadership & Governance. Readiness: guidelines, MDT meetings, integration meetings, focal persons.

Guideline Availability by Arm

Integration Meeting & MDT Activity by Arm

👩‍⚕️ BB6 · Staffing Analysis

Table F2. Staffing Summary by Cadre, Arm & Time Point

WHO Building Block: Health Workforce. Staff trained in HIV vs NCD vs combined services. Baseline vs Midline change.

Staff Trained in Combined HIV+NCD by Arm

Staff Attrition (Left) by Arm

💊 BB2 · Medicines & Supplies

Table F3. Essential Medicine Availability

WHO Building Block: Health Products & Medicines. TLD (HIV), Metformin (DM), Amlodipine (HTN), Gliclazide (DM), Insulin (DM).

Medicine Availability Score (0–5) by Arm

Equipment Availability by Arm

🖥️ BB3 · HIS & Digital Health

Table F4. Health Information Systems & Digital Health Adoption

WHO Building Block: Health Information. EMR = Electronic Medical Records (OpenMRS, KenyaEMR, etc.).

EMR Coverage by Service Type & Arm

Digital Health Tool Adoption by Arm

🖥️ BB3 · Patient Volume Trends

Table F5. Monthly Patient Volumes by Condition — Baseline Year

Monthly data from facility registers for the baseline assessment period.

Total HIV Patients per Month by Arm

🖥️ BB3 · DQA & Reporting

Table F6. Data Quality Assurance (DQA) & KHIS Reporting

WHO Building Block: Health Information. DQA = Data Quality Audit. KHIS = Kenya Health Information System.

DQA Conducted — Baseline vs Midline

KHIS Reporting — HIV & NCD by Arm

PROTOCOL P1836-2025 RE-AIM × IMARA × WHO 6 CLUSTER RCT · NI MARGIN 7.5% BASELINE + MIDLINE · V6.0

Facility Roster — Baseline & Midline

50 facilities across 3 counties. Each facility has a Baseline and Midterm record. Filter by time point.

Total Clinical Workforce by Arm & Level

Support Partner Presence by Arm

Table F1. Facility Readiness & Governance Indicators

WHO Building Block: Service Delivery + Governance. Readiness indicators: guidelines available, MDT meetings, integration meetings, focal persons. Comparison: Baseline vs Midline.

Guideline Availability by Arm (Baseline vs Midline)

Integration Meeting & MDT Activity by Arm

Table F2. Staffing Summary by Cadre, Arm, and Time Point

WHO Building Block: Health Workforce. Staff trained in HIV vs NCD vs combined services. Baseline vs Midline change.

Staff Trained in Combined HIV+NCD by Arm

Staff Attrition (Left) by Arm — Baseline Period

Table F3. Essential Medicine Availability by Arm and Time Point

WHO Building Block: Health Products & Medicines. Products: TLD (HIV), Metformin (DM), Amlodipine (HTN), Gliclazide (DM), Insulin (DM). 'Yes' = in stock at time of data collection.

Medicine Availability Score (0–5) by Arm

Equipment Availability by Arm

Table F4. Health Information Systems & Digital Health Adoption

WHO Building Block: Health Information. EMR = Electronic Medical Records (OpenMRS, KenyaEMR, etc.). Digital health: appointment reminders, telemedicine.

EMR Coverage by Service Type & Arm

Digital Health Tool Adoption by Arm

Table F5. Monthly Patient Volumes by Condition — Baseline Year

Monthly data from facility registers for the baseline assessment period.

Total HIV Patients per Month by Arm

Table F6. Data Quality Assurance (DQA) & KHIS Reporting — Baseline vs Midline

WHO Building Block: Health Information. DQA = Data Quality Audit. KHIS = Kenya Health Information System (MOH 731 for HIV; MOH 740 for NCD). Numerators (n) and denominators (N) shown for each indicator. NA / 9999 treated as missing and excluded from denominators.

DQA Conducted — Baseline vs Midline (n/N facilities)

KHIS Reporting — HIV & NCD by Arm and Time Point

DQA & Reporting Indicator Definitions

Indicator CRF Variable Numerator Denominator Standard
DQA conducted — HIV HIS dqa_his Facilities with dqa_his = 'Yes' All facilities with non-missing dqa_his MoH HIS Standard — annual minimum
DQA conducted — NCD HIS dqa_his_ncd Facilities with dqa_his_ncd = 'Yes' All facilities with non-missing dqa_his_ncd MoH HIS Standard
DQA frequency dqa_conducted Categorical: Monthly / Quarterly / As needed All facilities with answer MOH-recommends quarterly minimum
Data review conducted conduct_data_review Facilities with conduct_data_review = 'Yes' All facilities with non-missing response Best practice indicator
Reports to KHIS — HIV (MOH 731) report_hiv_khis Facilities with report_hiv_khis = 'Yes' All facilities with non-missing response MoH mandatory — MOH 731
Reports to KHIS — NCD (MOH 740) report_ncd_khis Facilities with report_ncd_khis = 'Yes' All facilities with non-missing response MoH mandatory — MOH 740
Reports HIV to NDW report_hiv_ndw Facilities with report_hiv_ndw = 'Yes' All facilities with non-missing response National Data Warehouse (NASCOP)
Data backup plan data_backup_plan Facilities with data_backup_plan = 'Yes' All facilities with non-missing response WHO HIS Building Block

Intraclass Correlation Coefficients (Facility-level)

ICC quantifies facility-level clustering. ICC > 5% validates the cluster RCT design. High ICC for integrated care confirms facility-level intervention is appropriate.

Sensitivity Analyses

λ LaTeX Gold Standard CONSORT 2010 BMC · PLOS · Impl Sci · Lancet GH Live from Filtered Data

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PROTOCOL P1836-2025 NI MARGIN 7.5% HAYES & MOULTON 2017 V7.0

Calculator Parameters

Based on HIP Study Protocol P1836-2025 (Section 7.1). All parameters match the approved sample size calculation.
Non-Inferiority Design

Protocol default: 23.3% (VL suppression at baseline)

Protocol margin: 7.5%. Range 4–12% per DAWNING/GEMINI.

Protocol: ICC = 0.05 at facility level.

Power Simulation — HIP Protocol P1836

Study design: Cluster-randomised non-inferiority trial; 50 facilities (25/arm); KEPH Levels 2–4 across Nairobi, Kiambu, Kitui.

Protocol Parameters Reference Table

Reproduced from HIP Study Protocol P1836-2025, Section 7.1. Design effect range mirrors the dual-cohort structure (HIV + NCD arms).
DiD ANALYSIS BASELINE vs MIDLINE CLUSTER RCT V7.0
Difference-in-Differences (DiD): Formally tests whether the Intervention arm improved more than the Control arm from Baseline to Midline. The DiD estimator = (Post_Int − Pre_Int) − (Post_Ctrl − Pre_Ctrl). A positive DiD favours integration.

DiD Settings

Note: DiD requires both Baseline and Midline patient records. Analysis uses all patients with recorded outcome at both time points.

Interpretation Guide
DiD Sign Meaning
+ Integration improved outcome more
− Standard care improved more
≈0 No differential change (non-inferiority context)

DiD Results

Outcome Trends: Baseline → Midline by Arm

DiD Estimate with 95% CI (All Outcomes)

50 FACILITIES NAIROBI · KIAMBU · KITUI CLUSTER RCT MAP V7.0

Map Controls

Each marker = one cluster facility. Colour = Study Arm. Size = patient volume.

Click any marker for facility details. Use the zoom control or scroll to navigate.

County Summary

Facility Map — 50 Clusters across Nairobi, Kiambu & Kitui

CONSORT 2010 CRT EXTENSION LIVE FROM DATA V7.0

CONSORT Flow Diagram — Cluster Randomised Trial

CONSORT 2010 CRT Extension (Campbell et al. 2012). N-counts auto-populated from actual data. Allocation, enrolment, follow-up, and analysis stages shown. Print-quality output.
⬇ Download CONSORT (HTML)

Note: The CONSORT diagram is rendered as an interactive SVG. Hover over boxes for exact counts.

Download Reports

Output files match the EIS_Study_Baseline_Analysis_Report format. Files reflect current sidebar filter selection.

All tables include Arm stratification (Intervention vs Control). v7.1 adds publication SVG/PDF exports for all figures.

⬇ EIS_Baseline_Tables.docx
⬇ EIS_Baseline_Models.docx
⬇ EIS_Facility_Summary.docx
⬇ Cleaned Patient Dataset (.csv)
📊 EIS_Baseline_Slides.pptx

Export Notes

  • Tables Word doc: Tables 1–6 (patient-level, arm-stratified).
  • Models doc: All 7 GLMM model outputs with aOR, 95% CI, p-value.
  • Facility doc: Tables F1–F5 (readiness, staffing, meds, HIS, volumes).
  • Arm + County are fixed covariates in all models (geography-adjusted).
  • ICC table and sensitivity analyses are included in models doc.
  • Filtered data (arm/county/condition) is used for all patient exports.
  • CSV export contains all original + derived patient-level variables.

Figure Exports — Publication SVG + PDF VECTOR · JOURNAL-READY · 300+ DPI

SVG: submit directly to Lancet, BMJ, PLOS, Implementation Science — infinite resolution, editable in Inkscape/Illustrator.
PDF: embedded vector, compatible with pdfLaTeX/Overleaf. Both use publication theme (base_size=14, Arial, white bg, no minor gridlines).
📊 Manuscript Figures 1–8
Figure SVG PDF
Fig 1 · Condition Distribution ⬇ ⬇
Fig 2 · Clinical Outcomes at Baseline ⬇ ⬇
Fig 3 · Transport Cost by Condition ⬇ ⬇
Fig 4 · Patient Satisfaction by Domain ⬇ ⬇
Fig 5 · HIV Stigma Profile ⬇ ⬇
Fig 6 · Median OOP Cost by Component ⬇ ⬇
Fig 7 · Financial Coping Mechanisms ⬇ ⬇
Fig 8 · VL Suppression by Arm & County ⬇ ⬇
📈 Supplementary & Analytic Figures
Figure SVG PDF
Forest Plot (aOR, all models) ⬇ ⬇
Power Curve (Sample Size Calculator) ⬇ ⬇
DiD Trend (Baseline→Midline) ⬇ ⬇
DiD Forest Plot (DiD estimates) ⬇ ⬇
📊 Likert Chart Exports — Satisfaction & Stigma
Figure SVG PDF PNG
Patient Satisfaction Likert (By Arm) ⬇ ⬇ ⬇
HIV Stigma Likert (By Arm, PLHIV) ⬇ ⬇ ⬇
📦 Batch Download — All Figures as ZIP

SVG + PDF for all 12 figures, named EIS_Fig1.svg through EIS_Fig8_DiD_Forest.pdf.

⬇ Download All Figures (.zip)

λ LaTeX Gold Standard — Publication-Ready Manuscript PubMed · BMC · PLOS ONE · Implementation Science

Compile with: pdflatex EIS_Manuscript.tex → or paste into Overleaf (free, no install). Template follows CONSORT 2010 + STROBE extensions for cluster RCTs. All numbers auto-populated from live filtered data.
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