<p>Men who have sex with men (MSM) and transgender men (TGM) account for an estimated 67% and &lt; 1% of new HIV diagnoses in the United States, respectively. Long-acting cabotegravir (CAB LA), administered every 2&#xa0;months, is the first LA medication approved for HIV-1 prevention. We present MSM and TGM experiences from CAB LA initiation through Month (M) 12 in the Phase 4 PILLAR trial (NCT05374525). Participants completed feasibility, acceptability, stigma, and perception questionnaires and semi-structured interviews at baseline, M6, and M12. Questionnaires were analyzed descriptively, and interviews were analyzed using a framework analysis approach. Clinical outcomes included HIV acquisition and persistence. During June 2022–August 2024, 201 participants enrolled; 6% were TGM, 23% Black or African American, 39% Hispanic/Latino, and 78% had taken oral PrEP in the last 6&#xa0;months. Key reasons for choosing/switching to CAB LA were convenience, reduced adherence burden, and less worry about HIV. Most participants (92%) “always”/ “often” returned to usual activities immediately following injection. Persistence was 85% at M6 and 73% at M12, with no HIV acquisitions. At baseline, 15–29% of participants reported experiencing stigma and anxiety with oral PrEP versus 0–2% with CAB LA at M6 and M12. Participants reported greater engagement with sexual health and stronger patient–provider relationships. Feasibility and acceptability were high at M12 (mean scores of 4.4/5 and 4.6/5, respectively). Overall, CAB LA was perceived as highly feasible and acceptable, with high persistence and no HIV acquisitions, underscoring its potential to improve prevention outcomes and patient experience among MSM and TGM.</p><p><?qj left?><?noindent??><i>Trial registry</i> ClinicalTrials.gov number: NCT05374525 (May 2022).</p>

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Implementation Journey with CAB LA for PrEP Among Men Who Have Sex with Men and Transgender Men: Insights from the PILLAR Trial Through 12 Months

  • Nanlesta Pilgrim,
  • Hadrian Holder,
  • Julian A. Torres,
  • Roberto Ortiz,
  • William Valenti,
  • Dima Dandachi,
  • Peter Shalit,
  • Alvin Kingcade,
  • Peter Ruane,
  • Linda Mercado,
  • Bo Li,
  • Alison Gaudion,
  • Deanna Merrill,
  • Elizabeth Gibbons,
  • Nicola Barnes,
  • Larissa Stassek,
  • Riya Moodley,
  • Todd McKeon,
  • Katherine L. Nelson,
  • Harmony P. Garges,
  • Kimberley Brown,
  • Maggie Czarnogorski

摘要

Men who have sex with men (MSM) and transgender men (TGM) account for an estimated 67% and < 1% of new HIV diagnoses in the United States, respectively. Long-acting cabotegravir (CAB LA), administered every 2 months, is the first LA medication approved for HIV-1 prevention. We present MSM and TGM experiences from CAB LA initiation through Month (M) 12 in the Phase 4 PILLAR trial (NCT05374525). Participants completed feasibility, acceptability, stigma, and perception questionnaires and semi-structured interviews at baseline, M6, and M12. Questionnaires were analyzed descriptively, and interviews were analyzed using a framework analysis approach. Clinical outcomes included HIV acquisition and persistence. During June 2022–August 2024, 201 participants enrolled; 6% were TGM, 23% Black or African American, 39% Hispanic/Latino, and 78% had taken oral PrEP in the last 6 months. Key reasons for choosing/switching to CAB LA were convenience, reduced adherence burden, and less worry about HIV. Most participants (92%) “always”/ “often” returned to usual activities immediately following injection. Persistence was 85% at M6 and 73% at M12, with no HIV acquisitions. At baseline, 15–29% of participants reported experiencing stigma and anxiety with oral PrEP versus 0–2% with CAB LA at M6 and M12. Participants reported greater engagement with sexual health and stronger patient–provider relationships. Feasibility and acceptability were high at M12 (mean scores of 4.4/5 and 4.6/5, respectively). Overall, CAB LA was perceived as highly feasible and acceptable, with high persistence and no HIV acquisitions, underscoring its potential to improve prevention outcomes and patient experience among MSM and TGM.

Trial registry ClinicalTrials.gov number: NCT05374525 (May 2022).