Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.

Name: Αlpha¹ Rigor Record — Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.
Item: Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.
Rating: 96
Author: Αlpha¹

Barsosio HC, Madanitsa M, Ondieki ED, Dodd J, Onyango ED, Otieno K, Wang D, Hill J, Mwapasa V, Phiri KS, Maleta K, Taegtmeyer M, Kariuki S, Schmiegelow C, Gutman JR, Ter Kuile FO

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Αlpha¹ Rigor Review — 4.75★ (Strong), 0 critical, 2 high issues for “Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 10, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

4.75 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingEthical approvals partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Problems surfaced2 types

Overstated conclusions1

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

Reporting gaps1

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Ethics/consent reporting incompleteAssessed

This Αlpha¹ Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The paper presents a well-designed and reported randomised controlled trial with strong methodological rigor. The main weaknesses are the absence of an explicit regulatory compliance statement (e.g., Declaration of Helsinki) and a missing reference to the CONSORT reporting guideline, both minor reporting gaps. The study's statistical analyses are sound, and data availability is adequately addressed.

Both independent reviewers (AI) agreed on all dimension statuses, with minor checklist-level disagreements on biological variables (sex justification) and statistical analysis (assumptions verification). The copyedit pass identified three minor issues. The statistics verification found 8/8 recomputed tests consistent, and no citation integrity issues were flagged.

9 major claims checked against the paper's own evidence: all adequately supported.

Recomputed 8 tests: 8 consistent, 0 inconsistent; 6 recomputed directly from the reported test statistics, 2 via agent-written checks.

Reporting

Eight Dimensions7 pass · 1 warn

The Introduction and 'Research in context' section cite prior trials of IPTp with mefloquine, the inconclusive Ugandan pilot of DHA-PPQ in efavirenz-based cART, and pharmacokinetic studies showing an efavirenz interaction, explicitly acknowledging weaknesses such as poor tolerability and drug–drug interactions. The premise is that antifolate resistance threatens co-trimoxazole and that dolutegravir-based cART avoids the prior interaction, directly motivating the trial. All three sub-criteria are adequately covered.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation, citing prior IPTp trials, their limitations, and the specific pharmacological rationale for testing DHA-PPQ with dolutegravir-based cART.

Evidence

direct quote[Introduction, paragraphs 2-3]

“IPTp with dihydroartemisinin–piperaquine has only been assessed in a small trial of 200 pregnant women living with HIV receiving efavirenz-based cART in Uganda. The study was inconclusive.”