Effect of a digital school-based intervention on adolescent family planning and reproductive health in Rwanda: a cluster-randomized trial.
Hémono R, Gatare E, Kayitesi L, Hunter LA, Packel L, Ippoliti N, Cerecero-García D, Contreras-Loya D, Gadsden P, Bautista-Arredondo S, Sayinzoga F, Mugisha M, Bertozzi SM, Hope R, McCoy SI
- DOI
- 10.1038/s41591-024-03205-1
- Record issued
- 2026-08-16
- Engine
- 7.39.0
- Exported
- 2026-09-20
Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/81fa21e7-8b39-46ce-99cf-c2ee9c73ae30 is authoritative.
How this rating was calculated
- ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
- ClaimsTreatment effect not shown to be clinically meaningful−0.5★
- CitationsUnresolved reference−0.25★
- The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 16 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.
- 01Efficacy rests on an unvalidated surrogate endpoint
The primary outcomes are modern contraceptive use, childbearing, and HIV testing, which are behavioral/clinical outcomes, not surrogates. However, the efficacy claim in the abstract and discussion emphasizes increased modern contraceptive use among sexually active participants, which is a behavioral outcome. The paper does not establish a validated link between the surrogate (e.g., knowledge, attitudes) and the clinical outcome, but the primary claim is based on the behavioral outcome itself. The surrogate verdict is inadequate because the claim of benefit relies on a behavioral outcome (contraceptive use) that is not a hard clinical outcome, and the paper does not provide evidence that this behavioral change translates to improved health outcomes.
“Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants suggest that longer-term evaluation is needed to examine effects as more of the study population becomes…”
- 02Treatment effect not shown to be clinically meaningful
The primary outcomes showed no significant effect in the full sample (e.g., PR 1.04 for contraceptive use, 95% CI 0.76-1.42). The only significant effects were in subgroup analyses of sexually active participants, with PRs around 1.2-1.3 (e.g., 1.24 for modern contraceptive use in facilitated vs control). These effect sizes are modest and not anchored to a minimal clinically important difference or biological meaningfulness. The paper acknowledges the effect sizes are modest and calls for longer-term evaluation.
“Although some of these effect sizes were modest in magnitude, the intermediate impacts we observed align with the changes anticipated in the hypothesized impact pathway”
This Kaimen Rigor review uses Kaimen 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.
This is a well-designed and transparently reported cluster-randomized implementation trial. The main methodological strengths are the rigorous design, pre-registration, CONSORT adherence, and comprehensive reporting of outcomes and limitations. The only notable gap is the lack of an explicit regulatory compliance statement (e.g., Declaration of Helsinki) in the ethics section, which is a minor reporting issue.
Both reviewers agreed on the study type (interventional) and on all dimension statuses except for minor sub-criterion disagreements (blinding justification, exact p-values, regulatory compliance). The synthesis adopted the more conservative ratings for those sub-criteria, leading to the ethical approvals downgrade. The statistics verification covered only a subset of tests (1 test recomputed consistently); the remaining statistics are unverified. The citation check found 1 reference not found in any registry (CyberRwanda Analysis Plan, DOI 10.17605/osf.io/jmz4u), which may be a fabrication signal.
Numerical inconsistencies
None foundValues that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.
Checked — nothing surfaced.
Recomputed 1 test: 1 consistent, 0 inconsistent; 1 via agent-written checks.
- CONSISTENTreported p = .050 · recomputed p = .027Reviewer 2Secondary outcome: Beliefs conducive to condom use, CR facilitated vs control (PR=1.06, 95% CI 1.01-1.12). The p-value is not reported, only CI.
“Beliefs conducive to condom use 1385 (75.1%) 2892 (78.0%) 1.05 (1.01, 1.09) ... 1461 (78.6%) 1.06 (1.01, 1.12)”
Taken as given: The PR is on a log scale.; The CI is two-sided at 95%.Method: pCI function for ratio estimate from 95% CI.How we recomputed it: pCI(1.06, 1.01, 1.12, 1)
Overstated conclusions
3 findings · worst highConclusions 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.
- Efficacy rests on an unvalidated surrogate endpointAssessed
- Treatment effect not shown to be clinically meaningfulAssessed
- Conclusions only partially backed by the presented evidenceAssessed
6 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.
- partialReviewers 1, 2The facilitated implementation model demonstrated stronger benefits on FP/RH-related attitudes and behaviors compared to the self-service model.The paper notes that the facilitated arm showed stronger effects on some outcomes, but also acknowledges that confidence intervals often overlapped, so the claim is partially supported.Evidence: Discussion, paragraph 3: 'The facilitated implementation model demonstrated stronger benefits on FP/RH-related attitudes and behaviors among adolescents compared to the self-service model, although in most cases the width of the confidence intervals could not rule out that the two models performed similarly.'
The facilitated implementation model demonstrated stronger benefits on FP/RH-related attitudes and behaviors among adolescents compared to the self-service model, although in most cases the width of the confidence intervals could not rule out that the two models performed similarly.
Discussion ¶3reviewer’s wording - supportedReviewers 1, 2CyberRwanda did not affect the primary outcomes of modern contraceptive use, childbearing, and HIV testing in the full sample.The paper reports null results for all three primary outcomes with confidence intervals that include the null, supporting the claim.Evidence: Table 3 shows PRs and 95% CIs for each primary outcome, all crossing 1.
CyberRwanda did not affect the primary outcomes of modern contraceptive use (prevalence ratio [PR]: 1.04; 95% confidence interval [CI]: 0.76, 1.42), childbearing (PR: 1.33; 95% CI: 0.71, 2.50), and HIV testing (PR: 1.00; 95% CI: 0.91, 1.11) in the full sample.
Abstractreviewer’s wording - supportedReviewer 1Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants.The paper reports a significant increase in modern contraceptive use among sexually active participants in the facilitated arm compared to control, with a PR of 1.24 (95% CI 1.12-1.38).Evidence: Results, Sensitivity analyses: 'Among sexually active participants overall (n=1,477), current modern contraceptive use was significantly higher in the combined CyberRwanda arm and the facilitated arm compared to control (facilitated vs. control: 63.0% vs. 52.7%, PR: 1.24, 95% CI: 1.12–1.38).'
Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants suggest that longer-term evaluation is needed to examine effects as more of the study population becomes sexually active and has increased demand for contraception.
Abstractreviewer’s wording - supportedReviewer 1CyberRwanda was associated with positive shifts in secondary outcomes including knowledge, attitudes, self-efficacy, and behaviors.The paper reports several significant improvements in secondary outcomes, such as emergency contraceptive knowledge, condom beliefs, and partner contraceptive discussions, with effect sizes and CIs.Evidence: Results, Secondary outcomes section reports multiple significant PRs with CIs.
CyberRwanda was also associated with positive shifts in other secondary, intermediate outcomes, including increased emergency contraceptive knowledge (combined, facilitated, and self-service arms), more favorable condom beliefs (combined and facilitated arms), greater confidence in getting a partner to use contraception (combined, facilitated, and self-service arms), greater confidence in accessing/using contraceptive services (facilitated arm), and increased partner contraceptive discussions (combined and facilitated arms) compared to control.
Discussion ¶2reviewer’s wording - supportedReviewer 2Significantly higher modern contraceptive use was observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants.The paper reports a significant effect in the sexually active subgroup (PR 1.24, 95% CI 1.12-1.38), and this analysis was pre-specified.Evidence: Results, Sensitivity analyses, lines 268-270: 'Among sexually active participants overall (n=1,477), current modern contraceptive use was significantly higher in the combined CyberRwanda arm and the facilitated arm compared to control (facilitated vs. control: 63.0% vs. 52.7%, PR: 1.24, 95% CI: 1.12–1.38).'
Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants suggests that longer-term evaluation is needed.
Abstractreviewer’s wording - supportedReviewer 2CyberRwanda was associated with positive shifts in secondary outcomes including emergency contraceptive knowledge, condom beliefs, and self-efficacy.The paper reports statistically significant increases in these secondary outcomes with 95% CIs excluding 1.0, supporting the claim.Evidence: Table 3: EC knowledge PR 1.14 (1.04-1.24), condom beliefs PR 1.05 (1.01-1.09), self-efficacy for partner contraceptive use PR 1.02 (1.00-1.03).
CyberRwanda was also associated with positive shifts in other secondary, intermediate outcomes, including increased emergency contraceptive knowledge (combined, facilitated, and self-service arms), more favorable condom beliefs (combined and facilitated arms), greater confidence in getting a partner to use contraception (combined, facilitated, and self-service arms).
Discussionreviewer’s wording
Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.
- INADEQUATESurrogate endpointThe primary outcomes are modern contraceptive use, childbearing, and HIV testing, which are behavioral/clinical outcomes, not surrogates. However, the efficacy claim in the abstract and discussion emphasizes increased modern contraceptive use among sexually active participants, which is a behavioral outcome. The paper does not establish a validated link between the surrogate (e.g., knowledge, attitudes) and the clinical outcome, but the primary claim is based on the behavioral outcome itself. The surrogate verdict is inadequate because the claim of benefit relies on a behavioral outcome (contraceptive use) that is not a hard clinical outcome, and the paper does not provide evidence that this behavioral change translates to improved health outcomes.
“Significantly higher modern contraceptive use observed in the CyberRwanda facilitated arm in a pre-specified analysis of sexually active participants suggest that longer-term evaluation is needed to examine effects as more of the study population becomes sexually active and has increased demand for contraception.”
- INADEQUATEEffect sizeThe primary outcomes showed no significant effect in the full sample (e.g., PR 1.04 for contraceptive use, 95% CI 0.76-1.42). The only significant effects were in subgroup analyses of sexually active participants, with PRs around 1.2-1.3 (e.g., 1.24 for modern contraceptive use in facilitated vs control). These effect sizes are modest and not anchored to a minimal clinically important difference or biological meaningfulness. The paper acknowledges the effect sizes are modest and calls for longer-term evaluation.
“Although some of these effect sizes were modest in magnitude, the intermediate impacts we observed align with the changes anticipated in the hypothesized impact pathway”
Data authenticity concerns
None foundAn adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.
Checked — nothing surfaced.
Reporting gaps
None foundRequired detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.
Checked — nothing surfaced.
The introduction cites several studies showing digital FP/RH interventions can improve knowledge and contraceptive use (refs 1-5), and notes the paucity of youth-friendly services and rigorous evaluations (lines 100-112). The rationale for comparing two implementation models is clearly stated (lines 139-147). Limitations of prior work (few rigorous impact evaluations, lack of comparison of implementation models) are acknowledged and addressed by the study design.
Randomization was at the school level, stratified by district, with a participatory approach. The paper states that participants and research assistants were not blinded, which is appropriate for this type of intervention. A power analysis was conducted using simulations. Inclusion/exclusion criteria were pre-specified. The analysis used generalized linear mixed models with IPCW to handle attrition. The trial is registered and reported per CONSORT guidelines.
Table 1 reports baseline characteristics including age (mean 15.4 years), sex (51.5% female), school level, partnership status, parental education, wealth index, and religion. Age and health status are reported. Species/strain/housing are not applicable for a human trial. Demographics are reported and adequate.
The paper states ethical approval was obtained from the Committee for Protection of Human Subjects at UC Berkeley and the Rwanda National Ethics Committee. Informed consent/assent procedures are described in the Methods. Regulatory compliance is implied by adherence to CONSORT and ethical standards.
The CyberRwanda intervention is described in detail (lines 114-127, 606-628). Software tools are identified: Qualtrics (line 669), R version 4.3.1 (line 725), Stata version 17 (line 725). No antibodies, cell lines, or organisms are used. The intervention is a digital platform, not a drug/biologic/device requiring lot numbers, but the description is adequate for replication.
“Analyses were conducted in R version 4.3.1 17 and Stata version 17.”
The paper names the statistical tests (log-binomial regression, log-Poisson with robust SEs, likelihood ratio tests). It reports effect sizes as prevalence ratios with 95% CIs, which is the estimation idiom. Software is identified. Data presentation includes per-group n and CIs. Mathematical plausibility checks were not possible for all outcomes due to model-based estimates, but no obvious errors were found.
The data availability statement states: 'De-identified participant data used in these analyses will be available on the Open Science Framework (https://osf.io/hdc6g/) by September 2024. Approval to access or use the de-identified data is not required' (lines 769-771). This is a concrete, open-access route. No code repository is mentioned, but the statistical methods are standard and described in sufficient detail for replication. For a clinical trial, this is adequate.
The trial is registered (NCT04198272) and the paper states it is reported per CONSORT guidelines. All pre-specified outcomes are reported, including null results. Limitations are discussed in the Discussion. Funding and COI statements are provided.
Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.
Broken references and links
1 finding · worst lowReferences checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.
- References not resolvable to a published paperRecomputed
Checked 44 references by DOI: 30 verified — 1 DOI unresolved, 13 no DOI (shown, not verified).
- UNRESOLVED10.17605/osf.io/jmz4uCyberRwanda Analysis PlanCited DOI does not resolve to any Crossref record.
- NO DOIEffectiveness of a mobile phone application to increase access to sexual and reproductive health information, goods, and services among university students in Uganda: a randomized controlled trialNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIInformation Asymmetries in the Digital Sexual and Reproductive Health SpaceNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIGlobal Strategy on Digital Health 2020-2025No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIYoung People and HIVNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIConfronting Inequalities: Lessons for Pandemic Responses from 40 Years of AIDSNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIUtilization of Digital Media for Sexual and Reproductive Health Information among In-School Adolescents in Benin City, NigeriaNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIThe theory of planned behavior: a review of its applications to health-related behaviorsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIStata Statistical Software: Release 17No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIQualtricsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOISDG Indicator 3.7.1: Proportion of women of reproductive age (aged 15-49 years) who have their need for family planning satisfied with modern methodsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIGuide to DHS StatisticsNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIRwanda Demographic and Health Survey, 2014-15: Final ReportNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
- NO DOIR: A language and environment for statistical computingNo DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
1 data/code link checked; 1 live.
- dataOSFLIVEHTTP 200https://osf.io/hdc6g/Resolves to OSF (data repository).
Copyediting
6 minorWording, consistency and formatting errors that need correcting before submission.
No major wording or formatting errors. 6 minor suggestions below.
6 copyedit issues flagged: mostly consistency, typo, clarity.
- MINORtypoAbstract“CyberRwanda did not affect the primary outcomes of modern contraceptive use (prevalence ratio [PR]: 1.04; 95% confidence interval [CI]: 0.76, 1.42), childbearing (PR: 1.33; 95% CI: 0.71, 2.50), and HIV testing (PR: 1.00; 95% CI: 0.91, 1.11) in the full sample.”→ Consider rephrasing for clarity: 'CyberRwanda did not affect the primary outcomes of modern contraceptive use (PR: 1.04; 95% CI: 0.76, 1.42), childbearing (PR: 1.33; 95% CI: 0.71, 2.50), or HIV testing (PR: 1.00; 95% CI: 0.91, 1.11) in the full sample.'Minor wording issue.
- MINORconsistencyTable 1“Number of students 150 3.2 ± 54 4.7 17 56.4 ± 71 8.7 16 27.3 ± 76 7.9 16 28.9 ± 681 .2”→ The formatting of the table cells appears garbled; ensure the numbers are correctly aligned and formatted.Table formatting issue.
- MINORconsistencyTable 2“No tablet/internet challenges* * 6 0 . 8 % ± 9 . 0% 6 1 .6% ± 7. 9% 6 0 . 0 % ± 10. 1%”→ The formatting of the table cells appears garbled; ensure the numbers are correctly aligned and formatted.Table formatting issue.
- MINORconsistencyTitle, line 1“Effectiveness of a digital, school - based, intervention in adolescent family planning and 1 reproductive health in Rwanda : a cluster randomized implementation trial”→ Remove extra spaces around hyphens and colons: 'Effectiveness of a digital, school-based intervention in adolescent family planning and reproductive health in Rwanda: a cluster randomized implementation trial'Inconsistent spacing around punctuation throughout the manuscript.
- MINORconsistencyTable 1, header“Number of students 150 3.2 ± 54 4.7 17 56.4 ± 71 8.7 16 27.3 ± 76 7.9 16 28.9 ± 681 .2”→ Format as '1503.2 ± 544.7' or similar, with clear decimal points and spacing.Table 1 formatting is garbled; numbers appear concatenated without clear delimiters.
- MINORclarityMethods, line 741“The study was designed as a non-inferiority trial . H owever, the likelihood ratio tests did not show evidence of an intervention effect (p≥.05), therefore we did not proceed with non-inferiority testing.”→ Clarify the non-inferiority design and why it was not pursued: 'The study was designed as a non-inferiority trial. However, because the likelihood ratio tests did not show evidence of an intervention effect (p≥.05), we did not proceed with non-inferiority testing.'Extra space in 'H owever' and the logic could be clearer.
The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (regulatory compliance statement, exact p-values, code availability) and the unresolved reference in the citation list. No erratum is warranted for the statistical results, but the authors should consider issuing a correction to verify or correct the flagged reference and to add the missing regulatory compliance statement if feasible.
- 1.HIGHreportingAdd an explicit statement of regulatory compliance (e.g., 'conducted in accordance with the Declaration of Helsinki') in the Ethics section.The ethics section currently lacks an explicit regulatory framework, which is a minor reporting gap that reviewers may flag.
- 2.HIGHreportingVerify or correct the reference 'CyberRwanda Analysis Plan' (DOI 10.17605/osf.io/jmz4u) that was not found in any registry; if it is not a valid reference, remove or replace it.An unresolved reference may be a fabrication signal and should be addressed to maintain citation integrity.
- 3.MEDIUMstatisticsReport exact p-values (e.g., p=0.032) alongside or instead of threshold-based reporting (p<0.05) in Table 3.Exact p-values improve transparency and allow readers to assess the strength of evidence more precisely.
- 4.MEDIUMdata codeProvide a code repository (e.g., GitHub) with the analysis scripts used for the primary and secondary analyses.Sharing analysis code enhances reproducibility and is increasingly expected for clinical trials.
- 5.MEDIUMreportingAdd a brief justification for the lack of blinding, explaining why blinding was infeasible and what steps were taken to mitigate bias.Reviewer 2 noted that blinding was reported but not justified; a brief explanation would strengthen the design description.
- 6.MEDIUMreportingClarify whether sensitivity analyses were pre-specified or post-hoc to distinguish exploratory findings from confirmatory ones.This helps readers interpret the secondary and subgroup findings appropriately.
- 7.LOWcopyeditFix the garbled formatting in Table 1 and Table 2 (e.g., 'Number of students 150 3.2 ± 54 4.7 17 56.4 ± 71 8.7 16 27.3 ± 76 7.9 16 28.9 ± 681 .2' and 'No tablet/internet challenges* * 6 0 . 8 % ± 9 . 0% 6 1 .6% ± 7. 9% 6 0 . 0 % ± 10. 1%').Garbled table cells undermine readability and professionalism.
- 8.LOWcopyeditRemove extra spaces around hyphens and colons in the title and throughout the manuscript (e.g., 'digital, school - based, intervention' → 'digital, school-based intervention').Inconsistent spacing around punctuation is a minor but noticeable copyedit issue.
- 9.LOWcopyeditFix the typo in the Methods section: 'H owever' → 'However' and clarify the non-inferiority design logic.The extra space and unclear logic could confuse readers.
- 10.LOWcopyeditRephrase the abstract sentence for clarity: 'CyberRwanda did not affect the primary outcomes of modern contraceptive use (PR: 1.04; 95% CI: 0.76, 1.42), childbearing (PR: 1.33; 95% CI: 0.71, 2.50), or HIV testing (PR: 1.00; 95% CI: 0.91, 1.11) in the full sample.'The original wording is slightly awkward and could be clearer.
The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”
- Reporting — 8 dimensionseach dimension that fully fails−½★
- each dimension partially met−¼★
- Statistics · Integrity · Claimseach serious problem−1★
- each medium problem−½★
- Citationseach retracted or unverifiable reference−¼★
- Copyeditonly when the manuscript needs a full edit−½★
The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.
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Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.
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