{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T07:25:46Z","timestamp":1740122746563,"version":"3.37.3"},"reference-count":7,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T00:00:00Z","timestamp":1668124800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T00:00:00Z","timestamp":1668124800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009633","name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","doi-asserted-by":"publisher","award":["R21HD095708"],"award-info":[{"award-number":["R21HD095708"]}],"id":[{"id":"10.13039\/100009633","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["AIDS Behav"],"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial found no substantial difference in HIV acquisition risk between women randomised to injectable intramuscular depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. We evaluated post-randomization sexual behavior using an objective marker of condomless vaginal sex in a subset of participants. We conducted a sub-study among 458 ECHO participants at three sites (Cape Town, Johannesburg, Kisumu) to evaluate the frequency of condomless vaginal sex, measured by prostate specific antigen (PSA) detection in vaginal swabs, collected at the month 6 and final visit and the concordance of self-reported condomless vaginal sex with PSA detection, by randomized arm. We compared PSA detection frequency and concordance of PSA and self-reported condomless vaginal sex, by randomized group using Cochran\u2013Mantel\u2013Haenszel tests and adjusted generalized logistic growth curve models. PSA was detected less frequently in the DMPA-IM (16%), compared to the Cu-IUD (21%) and LNG implant (24%) groups, although results were not statistically significant in the unadjusted model when accounting for pre-specified multiple-testing criteria. There were significant differences in PSA detection between the DMPA-IM and LNG-implant groups (odds ratio 0.61 (95% CI 0.40, 0.94) in the adjusted model. There was moderate discordance between self-reported condomless vaginal sex and detection of PSA that was similar across randomized groups. These data suggest that women randomized to Cu-IUD and LNG implant may have had condomless sex more frequently than women randomized to DMPA-IM. The discordance between detectable PSA and self-reported sexual behaviour has important implications for design of future HIV prevention studies.<\/jats:p>","DOI":"10.1007\/s10461-022-03834-y","type":"journal-article","created":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T03:02:41Z","timestamp":1668135761000},"page":"978-983","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Post-randomization Differences in Condomless Vaginal Sex Among Women Randomized to Intramuscular Depot Medroxyprogesterone Acetate Injections, a Copper Intrauterine Device or a Levonorgestrel Implant in the ECHO Trial"],"prefix":"10.1007","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1535-1076","authenticated-orcid":false,"given":"Jennifer","family":"Deese","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pai Lien","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoming","family":"Gao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Renee","family":"Heffron","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcia","family":"Hobbs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dana","family":"Lapple","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heather","family":"Jaspan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley","family":"Miller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gonasagrie","family":"Nair","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maricianah","family":"Onono","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thesla","family":"Palanee-Phillips","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krishnaveni","family":"Reddy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus J.","family":"Steiner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,11,11]]},"reference":[{"issue":"8","key":"3834_CR1","doi-asserted-by":"publisher","first-page":"501","DOI":"10.1097\/OLQ.0b013e3181a2b4bf","volume":"36","author":"MM Hobbs","year":"2009","unstructured":"Hobbs MM, Steiner MJ, Rich KD, et al. Good performance of rapid prostate-specific antigen test for detection of semen exposure in women: implications for qualitative research. Sex Transm Dis. 2009;36(8):501\u20136.","journal-title":"Sex Transm Dis"},{"issue":"3","key":"3834_CR2","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1016\/S0010-7824(99)00013-X","volume":"59","author":"M Macaluso","year":"1999","unstructured":"Macaluso M, Lawson L, Akers R, et al. Prostate-specific antigen in vaginal fluid as a biologic marker of condom failure. Contraception. 1999;59(3):195\u2013201.","journal-title":"Contraception"},{"issue":"10195","key":"3834_CR3","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1016\/S0140-6736(19)31288-7","volume":"394","author":"Evidence for Contraceptive Options and HIV Outcomes Consortium","year":"2019","unstructured":"Evidence for Contraceptive Options and HIV Outcomes Consortium. HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial. Lancet. 2019;394(10195):303\u201313.","journal-title":"Lancet"},{"key":"3834_CR4","volume-title":"Acceptability of genital mucosal sampling nested within a randomized contraceptive trial among women in Africa","author":"C Scoville","year":"2018","unstructured":"Scoville C, Palanee-Phillips T, Nair L, et al. Acceptability of genital mucosal sampling nested within a randomized contraceptive trial among women in Africa. Madrid: HIV Research for Prevention; 2018."},{"issue":"2","key":"3834_CR5","doi-asserted-by":"publisher","first-page":"332","DOI":"10.1097\/AOG.0000000000003089","volume":"133","author":"S Dianat","year":"2019","unstructured":"Dianat S, Fox E, Ahrens KA, et al. Side effects and health benefits of depot medroxyprogesterone acetate: a systematic review. Obstet Gynecol. 2019;133(2):332\u201341.","journal-title":"Obstet Gynecol"},{"issue":"5","key":"3834_CR6","doi-asserted-by":"publisher","first-page":"356","DOI":"10.1016\/j.contraception.2008.11.012","volume":"79","author":"D Hubacher","year":"2009","unstructured":"Hubacher D, Chen PL, Park S. Side effects from the copper IUD: do they decrease over time? Contraception. 2009;79(5):356\u201362.","journal-title":"Contraception"},{"issue":"11","key":"3834_CR7","doi-asserted-by":"publisher","first-page":"2491","DOI":"10.1093\/humrep\/dew222","volume":"31","author":"M Ali","year":"2016","unstructured":"Ali M, Akin A, Bahamondes L, et al. Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant. Hum Reprod. 2016;31(11):2491\u20138.","journal-title":"Hum Reprod"}],"container-title":["AIDS and Behavior"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10461-022-03834-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10461-022-03834-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10461-022-03834-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,21]],"date-time":"2023-02-21T21:04:51Z","timestamp":1677013491000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10461-022-03834-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,11]]},"references-count":7,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2023,3]]}},"alternative-id":["3834"],"URL":"https:\/\/doi.org\/10.1007\/s10461-022-03834-y","relation":{},"ISSN":["1090-7165","1573-3254"],"issn-type":[{"type":"print","value":"1090-7165"},{"type":"electronic","value":"1573-3254"}],"subject":[],"published":{"date-parts":[[2022,11,11]]},"assertion":[{"value":"23 August 2022","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 November 2022","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"No authors have any conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This research was implemented in accordance with the Declaration of Helsinki and Good Clinical Practice. Institutional review boards at FHI 360, the University of Washington and each clinical site approved the study protocol.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval (Include Appropriate Approvals or Waivers)"}},{"value":"All participants provided written informed consent for future research on their biological samples.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate (Include Appropriate Consent Statements)"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication (Consent Statement Regarding Publishing an Individual\u2019s Data or Image)"}}]}}