{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T15:53:12Z","timestamp":1782489192029,"version":"3.54.5"},"reference-count":41,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T00:00:00Z","timestamp":1777939200000},"content-version":"unspecified","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["R01 MH 123392"],"award-info":[{"award-number":["R01 MH 123392"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,3,8]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"\n Introduction<\/jats:title>\n While improvements have been made across the HIV care continuum in South Africa, gaps remain. Relationship-focused couples-based approaches may be one avenue to improve HIV-related outcomes for men and women. Prior couples-based studies have been found to improve several HIV care and treatment outcomes in this context, but few have considered viral suppression as the primary outcome. We aimed to compare a couples-based motivational-interviewing intervention delivered to couples to similar content delivered to men and women in couples separately. We will test the efficacy of this approach in a randomised controlled trial.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n Our goal is to enrol 270 heterosexual couples for this trial, with at least one partner living with HIV. Couples will be randomised into one of two arms, stratified by couples\u2019 HIV status. The intervention arm, Simunye (\u2018We are one\u2019 in isiZulu), will provide two sessions of motivational information and skills regarding HIV-related behaviours to couples together, along with relationship-focused content and skills. The content is based on Partner Steps (P-steps), a couples-focused adaptation of Life Steps, an evidence-based programme shown to improve adherence and viral suppression. The control group will receive two sessions as individuals, with similar HIV-related information but without relationship-focused content. Participants will be followed up at 6, 12 and 18\u2009months postrandomisation. The baseline questionnaire will include measures of relationship domains such as satisfaction and communication, and measures pertaining to HIV and reproductive health (eg, fertility intentions, HIV knowledge and risk perception, and sexual behaviour), and mental health (eg, depression symptoms). The primary outcome is viral suppression, based on dried blood spots. Secondary outcomes will include other aspects of treatment engagement. We will also examine hypothesised mediators of intervention participation, for example, relationship dynamics. Primary analyses will use a multilevel modelling approach, which will feature planned time-averaged comparisons of postbaseline measurements across the intervention and control groups to test the primary hypothesis. The analysis will account for the dyadic nature of the data, for example, participants nested within couples.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n This trial was approved by the Institutional Review Board (IRB) at the Human Sciences Research Council in South Africa, protocol number 2\/27\/01\/21, and the IRB at the University of Michigan (HUM 00203672). Human subjects\u2019 concerns or adverse events will be reported to both IRBs and the Data Safety and Monitoring Board. We will disseminate findings to community members and stakeholders via community meetings, as well as by conference presentations and publications in peer-reviewed journals.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n \n Clinicaltrials.gov Protocol Registration\n NCT05231707<\/jats:ext-link>\n registered on 8 February 2022. Protocol version 2.0, 31 October 2025.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-114075","type":"journal-article","created":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T13:25:40Z","timestamp":1777987540000},"page":"e114075","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Couple-based intervention for HIV prevention, care and treatment in South Africa: a study protocol for a randomised controlled trial of Simunye"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct05231707","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4738-6812","authenticated-orcid":false,"given":"Lynae A","family":"Darbes","sequence":"first","affiliation":[{"name":"Department of Health Behavior and Clinical Sciences, School of Nursing, University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1912-8402","authenticated-orcid":false,"given":"Buyisile","family":"Chibi","sequence":"additional","affiliation":[{"name":"Center for Community-Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nonkululeko","family":"Tesfay","sequence":"additional","affiliation":[{"name":"Center for Community-Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha E","family":"Dilworth","sequence":"additional","affiliation":[{"name":"Division of Prevention Sciences, School of Medicine, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8503-4127","authenticated-orcid":false,"given":"Hilton","family":"Humphries","sequence":"additional","affiliation":[{"name":"Center for Community-Based Research, Human Sciences Research Council, Pietermaritzburg, South Africa"},{"name":"Division of Social and Behavioural Sciences, School of Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, Western Cape, South Africa"},{"name":"Discipline of Psychology, University of KwaZulu-Natal, Pietermaritzburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leland","family":"Merrill","sequence":"additional","affiliation":[{"name":"Department of Health Behavior and Clinical Sciences, School of Nursing, University of Michigan, Ann Arbor, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0609-5077","authenticated-orcid":false,"given":"Amy A","family":"Conroy","sequence":"additional","affiliation":[{"name":"Division of Prevention Sciences, School of Medicine, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mallory O","family":"Johnson","sequence":"additional","affiliation":[{"name":"Division of Prevention Sciences, School of Medicine, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torsten B","family":"Neilands","sequence":"additional","affiliation":[{"name":"Division of Prevention Sciences, School of Medicine, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah A","family":"Gutin","sequence":"additional","affiliation":[{"name":"Division of Prevention Sciences, School of Medicine, University of California, San Francisco, San Francisco, California, USA"},{"name":"Department of Community Health Systems, School of Nursing, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alastair","family":"van Heerden","sequence":"additional","affiliation":[{"name":"SYNAPSE, Wits Health Consortium, University of Witwatersrand, Johannesburg, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,5,5]]},"reference":[{"key":"2026062608311064000_16.5.e114075.1","unstructured":"Council, Human Sciences Research . 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