IGHID 12616 - Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy (RELAI) - The RELAI Study

Summary

Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care. Participants: 40 adult men and women living with HIV will be enrolled Procedures (methods): This is a pilot, open-label study to evaluate the acceptability, feasibility, and virologic impact of field-based LA-CAB-RPV for PWH who are out of care. This study will enroll 40 participants who accept field-based LA-CAB-RPV, targeting \>50% who reside in rural or semi-rural counties. Participants will be followed for 7 months, with duration of follow-up selected based on the FDA approved every 2 month LA-CAB-RPV injection schedule for virally suppressed patients, aligning with the 5th injection for an every two-month cycle

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Field-based LA-CAB/RPV

  Participants will receive their first does of long-acting cabotegravir 600 mg and rilpivirine 900 mg by separate intramuscular gluteal injections on Day 0 in a secure, community-based location of their choosing (such as their home). Additional field-based injections will be available at Week 4, and then every 2 months at Weeks 12, 20, and 28, though participants can instead choose to receive injections in the clinic instead.

Location