Participants in the PILLAR study were satisfied with cabotegravir long-acting injectable (CAB LA). Of those with a history of oral PrEP use, 95% reported being happy they switched to CAB LA and would recommend this treatment option to others.
The phase 4 implementation study evaluated the feasibility and acceptability of real-world implementation strategies to deliver CAB LA for pre-exposure prophylaxis (PrEP) to men who have sex with men (MSM) and transgender men (TGM) in infectious clinics in the US.
In the first industry-led HIV implementation science trial to gender align participants per community request and include TGM, who are not often included in clinical studies, the investigators analyzed data from clients treated at 17 sites in the US, including non-profit and community-based organizations, academic and research institutions, federally qualified health centers, and private clinics.
Of the 201 participants who enrolled in the study from May 2022 to August 2023, 94% were MSM, 23% were Black, and 39% were Hispanic.
Overall, 142 participants completed month-12 electronic surveys, and 44 completed qualitative interviews. Respondents rated the feasibility and acceptability of CAB LA using the validated Feasibility of Intervention Measure (FIM) and the Acceptability of Interventions Measure (AIM) questionnaires. The researchers obtained qualitative data from semi-structured phone interviews with a sample of participants, and they analyzed the differences in implementation outcomes by study arm using t-tests.
The interviewers based their topics on the Consolidated Framework for Implementation Research and Proctor implementation outcomes taxonomy, and they used a framework analysis approach to analyze the data.
- Participants found CAB LA to be highly acceptable and feasible at baseline (mean AIM 4.44; FIM 4.41 and at month 12 (mean AIM 4.61; FIM 4.41).
- Qualitative data supported quantitative data, with 98% of respondents talking about how CAB LA fit into their daily lives at month 12.
- At baseline, stigma concerns were reported by 15-29% of respondents with oral PrEP. By contrast, these concerns were reported by only 1-2% of respondents with CAB LA at month 6 and remained low at month 12.
- At baseline, 53-54% of participants reported concerns about forgetting to take and running out of oral PrEP. By contrast, related concerns around forgetting or missing a CAB LA injection visit were reported by 2-9%.
- At month 12, the pain level reported for the first injection was generally higher than the level reported for their most recent injection.
- During month 12, qualitative interviews, 14% of respondents who reported pain and discomfort from CAB LA injections said the pain had become more manageable over time.
- At month 12, 94% of participants reported having no difficulty scheduling appointments or getting to the clinic every 2 months.
- Educational brochures, expectation videos, and a digital platform were reported as useful implementation support tools by 66-75% of participants.
The researchers concluded that study participants found CAB LA feasible and acceptable, and they reported little to no PrEP stigma and anxiety in months 6 and 12. They talked about the benefits of clinic visits every 2 months, including the ability to talk with health care professionals about sexually transmitted infection testing and other health issues. Flexible scheduling, reminders, and educational tools were effective in supporting CAB LA uptake and adherence.
Reference:
IAS 2025. Poster Exhibition TUPEE116.
