{
  "abstract": "Introduction: Latine individuals account for a disproportionate share of new HIV diagnoses in the USA, yet uptake of HIV pre-exposure prophylaxis (PrEP) remains critically low in this population. Lenacapavir, a twice-yearly long-acting injectable (LAI) PrEP agent, offers a promising opportunity to overcome key barriers to PrEP uptake and persistence. This study aims to evaluate implementation outcomes and real-world effectiveness of a culturally tailored, community-delivered LAI PrEP programme for Latine gay, bisexual and other men who have sex with men and transgender women.\n\nMethods and analysis: We will conduct a mixed-methods, hybrid type 3 implementation-effectiveness study from January 2026 to July 2027 at El Centro Hispano, the largest Latine community-based organisation in North Carolina. The study includes three phases: (1) pre-implementation identification of barriers and facilitators to LAI PrEP delivery guided by the Consolidated Framework for Implementation Research, informed by a community advisory board and focus group discussions; (2) implementation of a community-delivered lenacapavir PrEP programme and (3) post-implementation assessment through key informant interviews and in-depth interviews. Key implementation outcomes include acceptability, feasibility and sustainability. The primary effectiveness outcome is 12-month persistence on lenacapavir.\n\nEthics and dissemination: This study was approved by the Duke University Institutional Review Board (Pro00118575). Findings will inform strategies for delivering LAI PrEP to priority populations in North Carolina and support future scale-up of community-based LAI programmes among Latine communities. Results will be disseminated through peer-reviewed journal publications and conference presentations and shared locally with community and public health departments.\n\nTrial registration number: clinicaltrials.gov (#NCT07218211).",
  "abstract_shown": true,
  "affiliations": [
    "Infectious Diseases, Duke University, Durham, North Carolina, USA",
    "Duke University Department of Population Health Science, Durham, North Carolina, USA",
    "Duke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, USA",
    "Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA",
    "Duke University School of Nursing, Durham, North Carolina, USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Melissa K Cutshaw",
      "orcid": "0000-0002-9423-8399"
    },
    {
      "affs": [
        1
      ],
      "name": "Iris Navarro"
    },
    {
      "affs": [
        2
      ],
      "name": "Richard Barfield"
    },
    {
      "affs": [
        2
      ],
      "name": "Taylor Krajewski"
    },
    {
      "affs": [
        3
      ],
      "name": "Kayla W Kilpatrick",
      "orcid": "0000-0002-8678-9000"
    },
    {
      "affs": [
        0
      ],
      "name": "Mehri S McKellar"
    },
    {
      "affs": [
        4
      ],
      "name": "Tonia Poteat"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/c3xma1s2jnctr.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-124658",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13723852/",
  "id": "c3xma1s2jnctr",
  "issns": [
    "2044-6055",
    "2044-6055"
  ],
  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124658",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "1506"
    ],
    [
      "heading",
      "HIV/AIDS"
    ],
    [
      "heading",
      "Protocol"
    ]
  ],
  "openalex": null,
  "pdf_url": null,
  "pmcid": "PMC13723852",
  "pmid": "42957300",
  "published": "2026-10-29",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/c3xma1s2jnctr.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:44Z",
      "native_id": "10.1136/bmjopen-2026-124658",
      "source": "crossref",
      "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124658"
    },
    {
      "first_seen": "2026-11-04T12:22:24Z",
      "native_id": "PMC13723852",
      "source": "pmc",
      "url": "https://doi.org/10.1136/bmjopen-2026-124658"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:F27",
      "subfield": "general"
    }
  ],
  "title": "Implementation of long-acting injectable PrEP at a Latine community organization: protocol for a mixed-methods, hybrid type 3 implementation-effectiveness study",
  "title_text": "Implementation of long-acting injectable PrEP at a Latine community organization: protocol for a mixed-methods, hybrid type 3 implementation-effectiveness study",
  "type": "peer-reviewed",
  "updated_at": "2026-11-04T12:22:24Z",
  "url": "https://research.draconitic.com/paper/c3xma1s2jnctr",
  "venue": "BMJ Open",
  "versions": []
}