Source Document — Adapting WHO HIV DAK L2 Artifacts to Ethiopia: Authoring a Contextualized Decision-Support Table and Indicator

For: workshop session — adopting and adapting additional L2 artifacts to the Ethiopian context, with a hands-on focus on authoring contextualized decision-support and indicator .xlsx artifacts for the HIV DAK. Audience: national HIV program + digital health teams; the L2/L3 working groups. Scope (locked): one decision-support table and one indicator, authored end-to-end as worked examples. How to use this: Parts A–C are the method (what an L2 DAK is, the adopt-and-adapt process, the authoring conventions). Parts D–E are the two worked artifacts. Part F is the validation checklist and pitfalls. Part G is the open items to settle with the room. Appendix = evidence base and confidence.

Evidence note. The WHO methodology and authoring conventions below are verified against WHO primary sources (SMART Guidelines IG Starter Kit v2.0.0; WHO HIV DAK 2nd ed.; HIV IG v1.0.0). The Ethiopia specifics are now read directly from the localized data dictionary, diffed row-by-row against the WHO default — see the companion REPORT-Ethiopia-DAK-adaptation.md for the full delta (298 added, 204 removed, 1,124 modified elements). What remains [confirm: ETH] is narrower: cross-checking specific changes against current national guidelines.


Part A — The premise: the adaptation already exists; review, wire, and validate it

WHO publishes the HIV guidance as a Digital Adaptation Kit (DAK) — software-neutral documentation that distils clinical, public-health and data-use guidance into a form digital systems can implement. WHO's DAK outputs are intentionally generic and meant to be contextualized; the recommended workflow is adopt the WHO DAK, then adapt its content to local needs rather than authoring from scratch.

Ethiopia has already done much of that adaptation. The localized data dictionary differs from the WHO default by 298 added, 204 removed, and 1,124 modified data elements (full delta in REPORT-Ethiopia-DAK-adaptation.md): a new Surveillance module, national PrEP/PEP/ART regimens (incl. injectable Lenacapavir), a maternal testing algorithm, "Invalid" results and retest-before-ART steps, and updated value sets across registration, regimens, and disaggregators.

Part B — What an L2 DAK contains, and where our two artifacts live

The L2 DAK has nine components, delivered as a narrative PDF plus four Excel web annexes:

Web annex (.xlsx) Component This is where…
Annex A Core data elements (data dictionary) where every input/output value lives
Annex B Decision-support logic our decision table is authored
Annex C Indicators & performance metrics our indicator is authored
Annex D Functional / non-functional requirements system requirements

(Other components: health interventions/recommendations, generic personas, user scenarios, business processes/workflows, scheduling logic. Note: some older WHO material lists eight components, folding scheduling into decision support — participants may have seen that framing.)

The binding rule that connects the three annexes: collect once, use many times. Every value used by a decision table or an indicator must exist as a data element in Annex A. In the attached dictionary this is explicit — each data element row carries Linkages to Decision Support Tables and Linkages to Aggregate Indicators. That linkage is the backbone we author against.

Where it goes next (L2 → L3): L3 authoring takes the L2 as input and produces FHIR artifacts that correspond to it — decision tables → PlanDefinition + Library + CQL; indicators → FHIR Measure + CQL. So a clean L2 artifact is the direct, traceable input to fixing/building the L3 IG. WHO also recommends tracking versions of L2 content when adapting locally, to record changes and assess their impact (provenance).

Part C — The authoring conventions (use these exactly)

C1. Decision-support table (Annex B)

C2. Indicator (Annex C)

Author each indicator with these L2 template fields: short name · indicator definition · category · what it measures · rationale · numerator definition · numerator calculation · denominator definition · denominator calculation · disaggregation description · reference (plus DAK ID and the WHO Strategic Information reference number). - Numerator and denominator are built only from data elements already in Annex A. - Prioritize indicators derivable from routine primary-care data (collect once, use many). - Computability test before you start (critical): some HIV indicators are not computable from DAK routine data and must not be authored as clinical logic — e.g. condoms distributed (IND.1), needles/syringes (IND.10), condom use (IND.17), key populations who know status (IND.26), KP living with HIV on ART (IND.36) are labeled in the IG as "Not included in DAK; survey-based" or "…from multiple data sources." The authorable pattern is a count over coded data elements — model example: HIV.IND.2 / PRV.2 (PrEP recipients) = COUNT of clients with "PrEP for HIV prevention" prescribed in the reporting period, denominator = 1.

ID crosswalk caveat. The DAK data dictionary uses family IDs (HTS.*, ART.*, VER.*…); the L3 IG renumbers indicators as HIV.IND.N. The exact published HIV.IND inventory/numbering (including whether the remediation plan's IND.23, 97–100 exist) was not verified — check the live indicators page before relying on a specific number.


Part D — Worked artifact #1 (decision support): HIV.B7.DT — National HIV testing algorithm

Why this one. It is the single most country-specific artifact in the DAK, foundational (every diagnosis depends on it), and Ethiopia has already changed itHIV.B7.DT is among the most-adapted tables in the dictionary (+21 elements, −1, 31 modified). Ethiopia added an "Invalid" assay-result value, verification-on-discordance and retest-before-ART steps (the latter wired to HIV.D12.DT), and a maternal-serology reuse in PMTCT (HIV.E.ET.DE200–220, wired to B7/E4). Several of those additions still have blank linkage cells — added as data but not yet connected to the table. So this example is wiring and reconciling the existing Ethiopia changes, not authoring from scratch — which also fixes the real L3 gap (the smart-hiv B7 logic is hard-coded non-functional: define "Non-reactive result": false).

Clinical-safety logic to PRESERVE (WHO baseline — do not lose in adaptation): - Everyone is tested on Assay 1 (A1). - A1 non-reactive → report HIV-negative. - Reactive results proceed A1 → A2 → A3 (serial). - Discrepant handling: e.g., A1+ ; A2−repeat Assay 1. - Inconclusive outcomes → schedule retest at visit date + 14 days. - (Infants <18 months are diagnosed by virologic/EID testing, not this serology table — route to the EID/indeterminate-results logic, HIV.E12.DT.)

Decision table skeleton (Annex B format). Hit policy: Rule order. Inputs are the assay-result data elements from Annex A (HIV.B.DE94/97/100); the output is the HIV test result element (HIV.B.DE107, coded HIV-positive / HIV-negative / HIV-inconclusive).

Rule ID A1 result A2 result A3 result Output: HIV test result Action / Guidance Reference
B7-R1 = Non-reactive HIV-negative Report negative; counsel on window period / re-test if recent exposure WHO HTS 2019; [confirm: ETH]
B7-R2 = Reactive = Reactive = Reactive HIV-positive Verify positive status before ART per policy; link to care/ART WHO HTS 2019; [confirm: ETH]
B7-R3 = Reactive = Reactive = Non-reactive HIV-inconclusive Retest at visit date + 14 days WHO HTS 2019; [confirm: ETH interval]
B7-R4 = Reactive = Non-reactive (discrepant) repeat A1 Repeat Assay 1; if still discrepant → inconclusive → retest +14d WHO HTS 2019

Ethiopia adaptation slots — settle with the room [confirm: ETH]: 1. Which assays are A1 / A2 / A3 (national product list), and is the strategy serial (as above) or any parallel step? 2. Retest interval — confirm Ethiopia uses 14 days for inconclusive. 3. Verification testing before ART initiation — national policy (WHO recommends re-testing to verify a positive status before ART). 4. Entry points / who tests (PITC, VCT, index, ANC, community) — affects the modality value set used by the indicator. 5. Age routing: confirm the <18-month EID handoff and self-test confirmatory path.

L3 target: PlanDefinition (HIVB7DT) + CQL Library — replacing the current non-functional logic; preserve the rules above so the safety behavior is not re-broken.


Part E — Worked artifact #2 (indicator): HIV testing positivity (yield)

Why this one. Simple, high-value, computable from routine data, and it runs off the same element the B7 table produces (the HIV test result) — so one piece of contextualized logic drives both the point-of-care result and the report. Two Ethiopia-specific wrinkles make it a real worked example, not a copy: - The HIV test result now also lives in the new Surveillance module (HIV.Surveil.DE2, wired to HTS.2/3/7/8). The example must decide the source of truth the indicator reads (HTS visit vs Surveillance). - Several referenced elements moved or were removed (e.g. Date HIV test results returned), and disaggregation uses the localized value sets — re-point to the localized/Surveillance elements and adopt the national values.

Definition (Annex C fields): - Short name: HIV testing positivity (yield). - What it measures / rationale: the share of HIV tests that return positive — testing efficiency and case-finding yield; guides where to target testing. - Numerator definition: number of individuals with HIV test result = HIV-positive (HIV.B.DE107, the B7 outcome) during the reporting period. Numerator calculation: COUNT of clients where [HIV test result] = HIV-positive AND [HIV test date] in reporting period. - Denominator definition: number of individuals tested for HIV during the period. Denominator calculation: COUNT of clients where [HIV test performed/date] in reporting period. - Disaggregation: age band — include <1 and 1–14 explicitly (the pediatric case-finding gap), plus 15–19/20–24/25+; sex; testing modality/entry point; location. (KP disaggregation is sensitive and partly survey-bound — handle separately; do not fold KP-status indicators into this routine count.)

Simplest authorable variant (mirrors the IND.2 count pattern): number of individuals newly diagnosed HIV-positive in the period, denominator = 1 — useful if the team wants to start from a pure count before adding the denominator.

Maps to what Ethiopia reports [confirm: ETH]: PEPFAR MER HTS_TST / HTS_TST_POS; DHIS2/HMIS HTS testing+positivity. Confirm the exact national definitions/disaggregations so the contextualized indicator reconciles with existing numbers (a strong validation step — the new indicator should reproduce known totals).

L3 target: FHIR Measure + CQL (shared IndicatorLogic library).


Part F — Contextualization pitfalls & validation checklist

Run every authored artifact through this before calling it done:

Part G — Open items to resolve with the room

Now grounded in the actual adaptation (see REPORT-Ethiopia-DAK-adaptation.md and the work plan in IMPACT-ANALYSIS-DD-to-DT-indicators.md): 1. Wiring gaps — 233 added .ET elements have blank linkage cells. Connect each to its decision table / indicator (value-options inherit the parent's linkage; the impact analysis lists the targets). 2. Update Annexes B and C — they are still the WHO defaults; apply the Annex-A delta to the decision tables and indicators (this is the workshop's core output). 3. Re-derive the national-regimen tablesHIV.C23.DT (PrEP/PEP) and HIV.D21.x (ART / drug interactions) to the national formulary (incl. injectable Lenacapavir in PRV.*). 4. Govern the new Surveillance module — who owns it; its relationship to routine HMIS/MER; whether it is the indicator source of truth. 5. Terminology bindings for the coded elements (ICD-11/LOINC/SNOMED/national) and confirm the live HIV.IND numbering.


Appendix — Evidence base & confidence

Verified (WHO primary sources): the nine-component / four-annex DAK structure; adopt-and-adapt premise and replicable process; DMN decision-table conventions (columns, hit policy, ≤10-input guardrail); indicator template fields and "collect once, use many"; the non-computable survey-based indicators (IND.1/10/17/26/36); the count-based authorable pattern (IND.2/PRV.2); the named decision tables (B7, E4, E12, D17, D21.1); B7's A1/A2/A3 + discrepant + 14-day-retest logic; the L2→L3 mapping (PlanDefinition/Library/CQL; Measure/CQL); version/provenance recommendation.

To confirm against Ethiopian sources ([confirm: ETH]): national testing assays/intervals; ART/PMTCT/EID/PrEP specifics; the 52% pediatric-diagnosed figure; Ethiopia's actual MER/HMIS reporting set and definitions; terminology bindings; the live HIV.IND inventory.

Key references - WHO SMART Guidelines IG Starter Kit v2.0.0 — L2 authoring overview & DAK authoring: https://smart.who.int/ig-starter-kit/l2_authoring_overview.html · https://smart.who.int/ig-starter-kit/l2_dak_authoring.html · authoring overview (L2→L3): https://smart.who.int/ig-starter-kit/authoring_overview.html - WHO HIV DAK, 2nd ed. (Dec 2023): https://www.who.int/publications/i/item/9789240085138 - WHO HIV IG v1.0.0 — decision logic: https://smart.who.int/hiv/decision-logic.html · indicators: https://smart.who.int/hiv/indicators.html · example indicator logic: https://smart.who.int/hiv/Library-HIVIND2Logic.html - SMART Guidelines Pathfinder study (incl. Ethiopia), JMIR Med Inform 2025: https://medinform.jmir.org/2025/1/e58858 - WHO Consolidated Guidelines on HIV Testing Services (2019) — testing-strategy basis for B7. - Ethiopia national HIV / PMTCT guidance (validate specifics): Ethiopia HIV guideline (policyvault.africa ETH32); National Guideline for PMTCT of HIV; Ethiopia PEPFAR Strategic Direction Summary 2023. - Companion: smart-hiv IG REMEDIATION-PLAN.md (gap/safety items referenced in Parts D–F).