{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T10:59:45Z","timestamp":1765709985256,"version":"3.48.0"},"reference-count":12,"publisher":"BMJ","issue":"11","funder":[{"DOI":"10.13039\/501100001322","name":"South African Medical Research Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,10,26]]},"published-print":{"date-parts":[[2017,11]]},"abstract":"\n Introduction<\/jats:title>\n \n This is the protocol for an ancillary study to the multicentre Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial, a three-arm randomised trial comparing the effects of depot medroxyprogesterone acetate (DMPA), the levonorgestrel (LNG) implant and the copper intrauterine device (IUD) on HIV incidence (\n NCT02550067<\/jats:ext-link>\n pre-results). The ancillary study will compare other non-contraceptive effects of these three long-acting, reversible contraceptions about which there is little existing comparative evidence.\n <\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n Women randomised to IUD, DMPA and LNG implant (1:1:1) at one of the ECHO trial sites will be asked to participate in the ancillary study at the 1-month follow-up visit. Research staff will interview women that consent to participate at the 3-month follow-up visit. Primary outcomes are depression, sexual dysfunction and menstrual disturbances. The Beck Depression Inventory will be used to assess depression and the Arizona Sexual Experiences Scale to assess sexual dysfunction. Participants will also be asked to prospectively complete a 28-day symptom diary. The required sample size is 522 participants. Depression scores will be analysed as continuous and categorical variables. Analysis will be by intention to treat.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The ancillary study protocol received ethical approval from the University of the Witwatersrand Committee for Research on Human Subjects on 17 February 2016 (reference no. 14112). The results will be disseminated in a peer-reviewed open-access journal.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n PACTR201706001651380.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-019205","type":"journal-article","created":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T15:19:13Z","timestamp":1715959153000},"page":"e019205","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Psychological, behavioural and physiological effects of three long-acting reversible contraception (LARC) methods: protocol for an ancillary study of the ECHO randomised trial"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct02550067","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct02550067","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Mandisa","family":"Singata-Madliki","sequence":"first","affiliation":[{"name":"Effective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G Justus","family":"Hofmeyr","sequence":"additional","affiliation":[{"name":"Effective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florence","family":"Carayon-Lefebvre d\u2019Hellencourt","sequence":"additional","affiliation":[{"name":"FHI 360, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theresa Anne","family":"Lawrie","sequence":"additional","affiliation":[{"name":"Effective Care Research Unit (ECRU), East London Hospital Complex, University of Fort Hare, East London, South Africa"},{"name":"Cochrane Office, Education Centre, Royal United Hospital, Bath, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,11,12]]},"reference":[{"key":"2025121402563253000_7.11.e019205.1","first-page":"CD007043","article-title":"Copper containing intra-uterine devices versus depot progestogens for contraception","volume":"6","author":"Hofmeyr","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121402563253000_7.11.e019205.2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-0528.1998.tb09940.x"},{"key":"2025121402563253000_7.11.e019205.3","doi-asserted-by":"publisher","DOI":"10.1136\/jfprhc-2015-101334"},{"key":"2025121402563253000_7.11.e019205.4","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1186\/s12978-016-0153-9","article-title":"Effects of the copper intrauterine device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in South Africa: a pragmatic randomized controlled trial","volume":"13","author":"Hofmeyr","year":"2016","journal-title":"Reprod Health"},{"key":"2025121402563253000_7.11.e019205.5","doi-asserted-by":"crossref","first-page":"615","DOI":"10.1016\/j.contraception.2014.09.005","article-title":"Hypothesis: amenorrhea-inducing contraception may reduce HIV acquisition risk","volume":"90","author":"Hofmeyr","year":"2014","journal-title":"Contraception"},{"key":"2025121402563253000_7.11.e019205.6","unstructured":"ECHO Consortium. Evidence for contraception options and HIV outcomes study. http:\/\/echo-consortium.com\/study-design\/ (accessed 05 Jun 2017)."},{"key":"2025121402563253000_7.11.e019205.7","unstructured":"Shisana O , Rehle T , Simbayi LC , et al . South African National HIV prevalence, incidence and behaviour survey, 2012. Cape Town: Human Sciences Research Council Press, 2014."},{"key":"2025121402563253000_7.11.e019205.8","doi-asserted-by":"publisher","DOI":"10.1016\/0272-7358(88)90050-5"},{"key":"2025121402563253000_7.11.e019205.9","doi-asserted-by":"publisher","DOI":"10.1080\/009262300278623"},{"key":"2025121402563253000_7.11.e019205.10","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1080\/15325020802537443","article-title":"Stress, coping styles, and spousal bereavement: exploring patterns of grieving among black widowed spouses in Rural South Africa","volume":"14","author":"Somhlaba","year":"2009","journal-title":"J Loss Trauma"},{"key":"2025121402563253000_7.11.e019205.11","doi-asserted-by":"crossref","first-page":"1076","DOI":"10.1212\/WNL.45.6.1076","article-title":"Relationship of headache to phase of the menstrual cycle among young women: a daily diary study","volume":"45","author":"Johannes","year":"1995","journal-title":"Neurol"},{"key":"2025121402563253000_7.11.e019205.12","unstructured":"StataCorp. 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