{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T07:19:03Z","timestamp":1787901543778,"version":"build-2784847793"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.25011.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000}}],"reference-count":38,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["224309"],"award-info":[{"award-number":["224309"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Global Challenges Research Fund (GCRF) ,","award":["(MR\/T029803\/1)"],"award-info":[{"award-number":["(MR\/T029803\/1)"]}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"crossref","award":["5R01MH114560-03"],"award-info":[{"award-number":["5R01MH114560-03"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"crossref","award":["224309\/Z\/21\/Z"],"award-info":[{"award-number":["224309\/Z\/21\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000272","name":"NIHR","doi-asserted-by":"crossref","award":["NIHR301634"],"award-info":[{"award-number":["NIHR301634"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>Background Young people remain at highest risk of HIV, sexually transmitted infections (STIs) and early pregnancy. The WHO Global School Health Initiative acknowledges the opportunity to promote effective health interventions within the sustainable infrastructure of schools. Safer Choices is a school-based multiple-component whole-school intervention effective in reducing sexual risk behaviours and preventing HIV, STIs and pregnancy among high-school learners. The overall aim of this study is to adapt and evaluate a Safer Choices program to improve uptake of sexual reproductive health (SRH) and HIV-prevention amongst 15-19-year-old learners in rural KwaZulu-Natal, South Africa. Methods This study will use a mixed-method study design guided by the MRC-framework for development and evaluation of complex interventions. We will use the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) to document modifications to Safer Choices. The study will be conducted across six purposively selected high schools in uMkhanyakude district. The study will be divided into three work-packages (WP): WP1 to adapt and refine Safer Choices to context using participatory research methods; WP2 to pilot and assess acceptability and feasibility of the adapted intervention followed by a process evaluation to understand reach, uptake, acceptability and feasibility of intervention. We will conduct pre\/post intervention surveys with 390 randomly selected learners aged 15-19 to measure exposure, satisfaction, changes in self-reported SRH and HIV-risk behaviours. WP3 will include collection of exploratory data on the effect of the intervention on improving resilience and uptake of HIV-prevention and SRH services 60-days post-intervention delivery. Discussion This study protocol paper reports the details of our design for adaptation and evaluation of Safer Choices, with the aim of informing efforts elsewhere and scale-up of this evidence-based intervention. Integrating Safer Choices with SRH and HIV services will likely amplify its effectiveness, offering a holistic framework that addresses the multifaceted nature of HIV prevention.<\/ns3:p>","DOI":"10.12688\/wellcomeopenres.25011.2","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T11:44:05Z","timestamp":1784288645000},"page":"153","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Developing and pretesting a sexual reproductive health (SRH) school health promotion intervention (Safer Choices program) in rural South Africa: Study Protocol"],"prefix":"10.12688","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3125-978X","authenticated-orcid":false,"given":"Natsayi","family":"Chimbindi","sequence":"first","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"},{"name":"London England University College London Institute for Global Health"},{"name":"Durban KwaZulu-Natal University of KwaZulu-Natal School of Nursing and Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Faith","family":"Magut","sequence":"additional","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1046-1479","authenticated-orcid":false,"given":"Ursula","family":"Ngema","sequence":"additional","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bongimpilo","family":"Zulu","sequence":"additional","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0583-5272","authenticated-orcid":false,"given":"Janet","family":"Seeley","sequence":"additional","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"},{"name":"Durban KwaZulu-Natal University of KwaZulu-Natal School of Nursing and Public Health"},{"name":"London England London School of Hygiene and Tropical Medicine Department of Global Health and Development"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2812-5377","authenticated-orcid":false,"given":"Andrew","family":"Gibbs","sequence":"additional","affiliation":[{"name":"London England University College London Institute for Global Health"},{"name":"Gender and Health Research Unit Pretoria South African Medical Research Council"},{"name":"Exeter England University of Exeter"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abigail","family":"Harrison","sequence":"additional","affiliation":[{"name":"Providence Rhode Island Brown University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7784-9000","authenticated-orcid":false,"given":"Alun","family":"Davies","sequence":"additional","affiliation":[{"name":"Oxford England University of Oxford"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maryam","family":"Shahmanesh","sequence":"additional","affiliation":[{"name":"Durban KwaZulu-Natal Africa Health Research Institute"},{"name":"London England University College London Institute for Global Health"},{"name":"Durban KwaZulu-Natal University of KwaZulu-Natal School of Nursing and Public Health"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2560","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"key":"ref1","article-title":"Young people and HIV.","year":"2021"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"e0203193","DOI":"10.1371\/journal.pone.0203193","article-title":"Persistently high incidence of HIV and poor service uptake in adolescent girls and young women in rural KwaZulu-Natal, South Africa prior to DREAMS.","volume":"13","author":"N Chimbindi","year":"2018","journal-title":"PLoS One."},{"key":"ref3","first-page":"e2013164118","article-title":"Large age shifts in HIV-1 incidence patterns in KwaZulu-Natal, South Africa.","volume":"118","author":"A Akullian","year":"2021"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"8125","DOI":"10.3390\/ijerph19138125","article-title":"The HIV epidemic in South Africa: key findings from 2017 national population-based survey.","volume":"19","author":"K Zuma","year":"2022","journal-title":"Int. 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We have revised and now include study hypotheses aligned with each objective. We have stated in line 74-78 page 7 that \u201cWe hypothesise that the adapted Safer Choices intervention can be successfully adapted and optimised to include biomedical HIV prevention services. We further hypothesise that the adapted intervention will be feasible to implement in schools and acceptable to learners. Finally, we hypothesise that the exposure to the intervention will be associated with increased uptake of SRH and biomedical HIV prevention services\u201d.  Insufficient definition of variables The primary and secondary variables are not clearly defined in operational terms.  We have revised the manuscript to explicitly define all primary and secondary variables in operational terms, including how each variable is measured, the relevant timeframes, and the corresponding data sources. These details are now presented in Table 2 on page 14 line 337  Insufficient bias management: Add a section dedicated to biases and control strategies. (social desirability bias (very critical here), selection bias, cross-school contamination bias)  We have added a section titled \u201cpotential biases and mitigation strategies\u201d line 420-437 page 17-18, outlining key sources of bias and control strategies. We address social desirability bias by using self-administered questionnaires to enhance privacy and reporting accuracy. We also consider selection bias, including loss to follow-up, and describe both recruitment strategies and analytical approaches such as inverse probability weighting as control strategies. Given the pre\u2013post design, cross-school contamination is less likely to bias comparisons; however, we acknowledge potential variation in exposure across schools and describe steps taken to ensure standardised implementation.  Incomplete statistical analysis plan: Although models are mentioned, the following are missing: variables included in the models, adjustment strategy, handling of missing data, significance threshold)  We have expanded the statistical analysis section in line 363-397 page 16 to clearly specify the variables included in the models, the adjustment strategy, and the handling of missing data. We now clearly outline that the confounding variables were selected based on prior knowledge and outline the modelling approach for each outcome. In addition, we have clarified the approach to missing data, including assumptions and planned methods, and specified the significance threshold used for statistical inference. &nbsp; \n<b>Minor points for improvement<\/b>  External validity \/ generalizability: Limitations of generalizability are not discussed. Plan for dissemination of results: Not mentioned.  We have now included a discussion of the study\u2019s generalisability (line 493-501 page 19). We highlight that findings may be context-specific to the study setting and population. We describe key factors that may influence external validity, including the school-based design of the study and the characteristics of participating learners, and discuss how these may affect the applicability of results to other settings. We have also added a section (line 502-508 page 19) outlining plans for dissemination of study findings. Findings of the study will be shared with key stakeholders, including participating schools and department of health and education, and disseminated through other ways such as peer-reviewed publications and conference presentations. &nbsp; \n<b>Decision: Major revisions<\/b> The study is relevant and well-designed, but requires significant methodological improvements to ensure scientific rigor and reproducibility.  Thank you for the very useful reviews which will strengthen our manuscript, we have responded point-by-point and made updates to the manuscript to increase clarity of our hypothesis and improved on the methodology section. We hope this addresses the reviewer\u2019s concerns.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-153\/v2#referee-comment-6639","order":1,"name":"referee-comment-6639","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.29984.r161331, Tonderai Mabuto, The Aurum Institute, Johannesburg, 25 Jul 2026, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-153\/v2#referee-response-161331","order":2,"name":"referee-response-161331","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.29984.r162380, Jennifer N. Githaiga, University of Cape Town, Cape Town, 28 Aug 2026, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/11-153\/v2#referee-response-162380","order":3,"name":"referee-response-162380","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by Wellcome [224309] ,  NIHR  (NIHR 301634) , National Institutes of Health under award number 5R01MH114560-03 , Wellcome [224309\/Z\/21\/Z] ,Global Challenges Research Fund (GCRF) (MR\/T029803\/1), National Institutes of Health (5R01MH114560-03). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}