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Peer-reviewedCC BY-NC 4.0BMJ Open

Implementation of long-acting injectable PrEP at a Latine community organization: protocol for a mixed-methods, hybrid type 3 implementation-effectiveness study

  • Melissa K Cutshaw1
  • Iris Navarro2
  • Richard Barfield3
  • Taylor Krajewski3
  • Kayla W Kilpatrick4
  • Mehri S McKellar1
  • Tonia Poteat5
5 affiliations
  1. 1Infectious Diseases, Duke University, Durham, North Carolina, USA
  2. 2Duke University Department of Population Health Science, Durham, North Carolina, USA
  3. 3Duke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, USA
  4. 4Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA
  5. 5Duke University School of Nursing, Durham, North Carolina, USA
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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.

Methods 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.

Ethics 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.

Trial registration number: clinicaltrials.gov (#NCT07218211).

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Cite

BibTeXRIS
BibTeX
@article{cutshaw2026implementation,
  title = {{Implementation of long-acting injectable PrEP at a Latine community organization: protocol for a mixed-methods, hybrid type 3 implementation-effectiveness study}},
  author = {Melissa K Cutshaw and Iris Navarro and Richard Barfield and Taylor Krajewski and Kayla W Kilpatrick and Mehri S McKellar and Tonia Poteat},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-124658},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124658},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Implementation of long-acting injectable PrEP at a Latine community organization: protocol for a mixed-methods, hybrid type 3 implementation-effectiveness study
AU  - Melissa K Cutshaw
AU  - Iris Navarro
AU  - Richard Barfield
AU  - Taylor Krajewski
AU  - Kayla W Kilpatrick
AU  - Mehri S McKellar
AU  - Tonia Poteat
PY  - 2026
DA  - 2026/10/29
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-124658
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124658
AB  - 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.  Methods 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.  Ethics 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.  Trial registration number: clinicaltrials.gov (#NCT07218211).
SN  - 2044-6055
SN  - 2044-6055
ER  -