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Early ART initiation is associated with post\u2010ART virologic control, particularly among African women, and anti\u2010HIV\u20101 broadly neutralizing antibodies (bnAbs) may modulate immune responses to HIV. We evaluate whether early ART with or without anti\u2010HIV\u20101 bnAb VRC01, present at HIV acquisition, is associated with later ART\u2010free control in African women and we assess potential associations with observed control.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Stakeholder engagement informed analytical treatment interruption (ATI) study design and implementation. Participants who received placebo or VRC01 and acquired HIV in the Antibody Mediated Prevention efficacy trial were assessed for ATI eligibility, including HIV acquisition within 8 weeks of receiving VRC01 or placebo, followed by early ART initiation and \u22651 year of viral suppression. Participation facilitators and barriers were assessed. From May 2021 to February 2024, participants enrolled, stopped ART and received frequent viral load and CD4+ T\u2010cell count monitoring for safety and assessment of meeting ART reinitiation criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirteen women enrolled from southern Africa. No ATI\u2010related serious adverse events (AEs), HIV transmissions, pregnancies or \u2265Grade 2 AEs were observed. Eight sexually transmitted infections were diagnosed in seven women during ATI. Two participants had tenofovir levels consistent with use during ATI; 2\/11 (18%) who completed ATI without antiretroviral use exhibited ART\u2010free control for \u226532 weeks. The median time to confirmed VL\u2265200 was 5.4 weeks (range 2.7\u2212112). The most common ART reinitiation criterion met was virologic (<jats:italic>n<\/jats:italic> = 7). VRC01 receipt proximate to HIV acquisition was not associated with control. Controllers versus non\u2010controllers did not differ by early post\u2010acquisition viral load kinetics, acquired virus characteristics, or time from estimated acquisition to closest infusion or to ART initiation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In a safe, well\u2010tolerated ATI, 18% of 11 African women exhibited post\u2010intervention control. Design and implementation lessons inform future ATIs in Africa. Analyses of peri\u2010acquisition and post\u2010ATI host and viral characteristics can inform the development of interventions for HIV cure, prevention and treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p>NCT04860323<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.26495","type":"journal-article","created":{"date-parts":[[2025,6,4]],"date-time":"2025-06-04T06:15:08Z","timestamp":1749017708000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Analytical treatment interruption among women with HIV in southern Africa who received VRC01 or placebo in the Antibody Mediated Prevention Study: ATI stakeholder engagement, implementation and early clinical data"],"prefix":"10.1002","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5946-9733","authenticated-orcid":false,"given":"Shelly","family":"Karuna","sequence":"first","affiliation":[{"name":"Vaccine and Infectious Disease Division Fred Hutchinson Cancer Center  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5231-9951","authenticated-orcid":false,"given":"Fatima","family":"Laher","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit Faculty of Health Sciences University of the Witwatersrand  Johannesburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sufia","family":"Dadabhai","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Johns Hopkins Bloomberg School of Public Health  Blantyre Malawi"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pei\u2010Chun","family":"Yu","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division Fred Hutchinson Cancer Center  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Doug","family":"Grove","sequence":"additional","affiliation":[{"name":"Vaccine and Infectious Disease Division Fred Hutchinson Cancer Center  Seattle Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Orrell","sequence":"additional","affiliation":[{"name":"Desmond Tutu HIV Centre Institute of Infectious Disease and Molecular Medicine &amp; Department of Medicine University of Cape Town  Cape Town South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Makhema","sequence":"additional","affiliation":[{"name":"Botswana Harvard AIDS Institute Partnership  Gaborone Botswana"},{"name":"Department of Immunology and Infectious Diseases Harvard T.H. 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