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In some areas, up to a third of HIV-positive women experience perinatal depression. Perinatal depression is associated with negative effects on parenting and key domains of child development including cognitive, behavioural and growth, especially in socio-economically disadvantaged communities. Several studies have documented the benefits of psychological interventions for perinatal depression in low- and middle-income countries, but none have evaluated an integrated psychological and parenting intervention for HIV-positive women using task-sharing. This randomised controlled trial aims to evaluate the effect of a home-based intervention, combining a psychological treatment for depression and a parenting programme for perinatally depressed HIV-positive women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study is a cluster randomised controlled trial, consisting of 48\u201360 geospatial clusters. A total of 528 pregnant HIV-positive women aged \u2265 16\u2009years who meet the criteria for depression on the Edinburgh Postnatal Depression Scale (EPDS, score \u2265 9)) are recruited from antenatal clinics in rural KwaZulu-Natal, South Africa. The geospatial clusters are randomised on an allocation ratio of 1:1 to either the intervention or Enhanced Standard of Care (ESoC). The intervention group receives 10 home-based counselling sessions by a lay counsellor (4 antenatal and 6 postnatal sessions) and a booster session at 16\u2009months. The intervention combines behavioural activation for depression with a parenting programme, adapted from the UNICEF\/WHO Care for Child Development programme. The ESoC group receives two antenatal and two postnatal counselling support and advice telephone calls.<\/jats:p>\n                    <jats:p>In addition, measures have been taken to enhance the routine standard of care.<\/jats:p>\n                    <jats:p>The co-primary outcomes are child cognitive development at 24\u2009months assessed on the cognitive subscale of the Bayley Scales of Infant Development-Third Edition and maternal depression at 12\u2009months measured by the EPDS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Analysis<\/jats:title>\n                    <jats:p>The primary analysis will be a modified intention-to-treat analysis. The primary outcomes will be analysed using mixed-effects linear regression.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>If this treatment is successful, policymakers could use this model of mental healthcare delivered by lay counsellors within HIV treatment programmes to provide more comprehensive services for families affected by HIV.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ISRCTN registry #\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN11284870\">11284870<\/jats:ext-link>\n                      (14\/11\/2017) and SANCTR DOH-27-102020-9097 (17\/11\/2017).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-021-05672-0","type":"journal-article","created":{"date-parts":[[2021,12,13]],"date-time":"2021-12-13T05:05:44Z","timestamp":1639371944000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"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"],"prefix":"10.1186","volume":"22","author":[{"given":"Tamsen J.","family":"Rochat","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samukelisiwe","family":"Dube","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kobus","family":"Herbst","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia A.","family":"Hoegfeldt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Redinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thandeka","family":"Khoza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruth Margret","family":"Bland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Richter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Linsell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Desmond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aisha K.","family":"Yousafzai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Craske","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ed","family":"Juszczak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melanie","family":"Abas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taygen","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Ekers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8207-2822","authenticated-orcid":false,"given":"Alan","family":"Stein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,12,13]]},"reference":[{"key":"5672_CR1","volume-title":"The costs of perinatal mental health problems","author":"A Bauer","year":"2014","unstructured":"Bauer A, Parsonage M, Knapp M, Iemmi V, Adelaja B. 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