{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T04:39:36Z","timestamp":1764995976138,"version":"3.46.0"},"reference-count":22,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Oxford Health Biomedical Research Centre"},{"name":"Medical Research Council"},{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["201433\/Z\/16\/A","MR\/P006965\/1"],"award-info":[{"award-number":["201433\/Z\/16\/A","MR\/P006965\/1"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000276","name":"Department of Health and Social Care","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000276","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100014013","name":"UK Research and Innovation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014013","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100020171","name":"Foreign, Commonwealth & Development Office","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100020171","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,7,12]]},"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.<\/jats:p>\n                    <jats:p>Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.<\/jats:p>\n                    <jats:p>The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.<\/jats:p>\n                    <jats:p>\n                      Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12\u2009months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet\n                      <jats:italic>et al<\/jats:italic>\n                      \u2019s methodology (2022).\n                    <\/jats:p>\n                    <jats:p>A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5\/23\/08\/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31\u201317), UK.<\/jats:p>\n                    <jats:p>Consent for publication is not applicable since no participant data are used in this protocol.<\/jats:p>\n                    <jats:p>We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration details<\/jats:title>\n                    <jats:p>ISRCTN registry #11\u2009284\u2009870 (14\/11\/2017) and SANCTR DOH-27-102020-9097 (17\/11\/2017).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-082977","type":"journal-article","created":{"date-parts":[[2024,8,3]],"date-time":"2024-08-03T13:04:00Z","timestamp":1722690240000},"page":"e082977","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Protocol of a cost-effectiveness analysis of a combined intervention for depression and parenting compared with enhanced standard of care for perinatally depressed, HIV-positive women and their infants in rural South Africa"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4740-6561","authenticated-orcid":false,"given":"Carmen Sue","family":"Christian","sequence":"first","affiliation":[{"name":"Department of Economics, Faculty of Economics and Management Sciences, University of the Western Cape, Bellville, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lungiswa","family":"Nkonki","sequence":"additional","affiliation":[{"name":"Health Systems and Public Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chris","family":"Desmond","sequence":"additional","affiliation":[{"name":"School of Economics and Finance, University of the Witwatersrand, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecilia","family":"Hoegfeldt","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samukelisiwe","family":"Dube","sequence":"additional","affiliation":[{"name":"Africa Health Research Institute, Durban, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tamsen","family":"Rochat","sequence":"additional","affiliation":[{"name":"Department of Psychology, Faculty of Health and Education, Manchester Metropolitan University, Manchester, UK"},{"name":"SAMRC\/Wits Developmental Pathways for Health Research Unit, University of the Witwatersrand Johannesburg, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan","family":"Stein","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, University of Oxford, Oxford, UK"},{"name":"MRC\/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand Johannesburg, Johannesburg, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,8,3]]},"reference":[{"key":"2025120520043825000_14.8.e082977.1","doi-asserted-by":"crossref","first-page":"914","DOI":"10.1186\/s13063-021-05672-0","article-title":"An evaluation of a combined psychological and parenting intervention for HIV-positive women depressed in the perinatal period, to enhance child development and reduce maternal depression: study protocol for the insika yomama cluster randomised controlled trial","volume":"22","author":"Rochat","year":"2021","journal-title":"Trials"},{"key":"2025120520043825000_14.8.e082977.2","unstructured":"Spedding MF , Stein DJ , Sorsdahl K . Task-shifting psychosocial interventions in public mental health: a review of the evidence in the South African context. S Afr Health Rev 2014;73\u201387."},{"key":"2025120520043825000_14.8.e082977.3","doi-asserted-by":"crossref","first-page":"706","DOI":"10.1007\/s10461-014-0694-2","article-title":"Pregnant women living with HIV (WLH) supported at clinics by peer WLH: a cluster randomized controlled trial","volume":"18","author":"Richter","year":"2014","journal-title":"AIDS Behav"},{"key":"2025120520043825000_14.8.e082977.4","doi-asserted-by":"crossref","DOI":"10.1017\/S0266462321001732","article-title":"Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations","volume":"38","author":"Husereau","year":"2022","journal-title":"Int J Technol Assess Health Care"},{"key":"2025120520043825000_14.8.e082977.5","doi-asserted-by":"crossref","first-page":"983","DOI":"10.1016\/S2215-0366(16)30148-1","article-title":"Maternal depression and mental health in early childhood: an examination of underlying mechanisms in low-income and middle-income countries","volume":"3","author":"Herba","year":"2016","journal-title":"Lancet Psychiatry"},{"key":"2025120520043825000_14.8.e082977.6","doi-asserted-by":"crossref","first-page":"14096","DOI":"10.4088\/JCP.14r09186","article-title":"Perinatal depression in HIV-infected african women: a systematic review","volume":"76","author":"Sowa","year":"2015","journal-title":"J Clin Psychiatry"},{"key":"2025120520043825000_14.8.e082977.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61277-0"},{"key":"2025120520043825000_14.8.e082977.8","doi-asserted-by":"publisher","DOI":"10.1186\/s12888-019-2321-2"},{"key":"2025120520043825000_14.8.e082977.9","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyaa264"},{"key":"2025120520043825000_14.8.e082977.10","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-15-457"},{"key":"2025120520043825000_14.8.e082977.11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2005.00045.x"},{"key":"2025120520043825000_14.8.e082977.12","unstructured":"Cleary S , Castillo-Riquelme M . Economic evaluation. In: Joubert G , Ehrlich R , eds. In epidemiology: a research manual for South Africa. South Africa: Oxford University Press, 2007: 328\u201338."},{"key":"2025120520043825000_14.8.e082977.13","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/17.1.112"},{"key":"2025120520043825000_14.8.e082977.14","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0079784","article-title":"Costs of promoting exclusive breastfeeding at community level in three sites in South Africa","volume":"9","author":"Nkonki","year":"2014","journal-title":"PLOS ONE"},{"key":"2025120520043825000_14.8.e082977.15","doi-asserted-by":"publisher","DOI":"10.1111\/nyas.13679"},{"key":"2025120520043825000_14.8.e082977.16","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2022-008926","article-title":"Priority setting in early childhood development: an analytical framework for economic evaluation of interventions","volume":"7","author":"Verguet","year":"2022","journal-title":"BMJ Glob Health"},{"key":"2025120520043825000_14.8.e082977.17","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2018-022022","article-title":"Cost-effectiveness of interventions for perinatal anxiety and\/or depression: a systematic review","volume":"8","author":"Camacho","year":"2018","journal-title":"BMJ Open"},{"key":"2025120520043825000_14.8.e082977.18","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1186\/s12884-018-1738-9","article-title":"Identifying and assessing the benefits of interventions for postnatal depression: a systematic review of economic evaluations","volume":"18","author":"Gurung","year":"2018","journal-title":"BMC Pregnancy Childbirth"},{"key":"2025120520043825000_14.8.e082977.19","doi-asserted-by":"publisher","DOI":"10.3310\/hta20220"},{"key":"2025120520043825000_14.8.e082977.20","doi-asserted-by":"crossref","unstructured":"Saronga HP , Kaaya S , Fawzi MCS . 2021 Cost-effectiveness of the healthy options group psychosocial intervention for perinatal women living with hiv and depression in tanzania. In Rev. doi:10.21203\/rs.3.rs-881037\/v1","DOI":"10.21203\/rs.3.rs-881037\/v1"},{"key":"2025120520043825000_14.8.e082977.21","doi-asserted-by":"publisher","DOI":"10.1002\/hec.4730030206"},{"key":"2025120520043825000_14.8.e082977.22","doi-asserted-by":"publisher","DOI":"10.1093\/heapol\/16.4.435"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-082977","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T04:04:50Z","timestamp":1764993890000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-082977"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":22,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2024,8,3]]},"published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1136\/bmjopen-2023-082977"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-082977","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2024,8]]}}}