CAB LA IM every 2 months is approved in some countries as PrEP to reduce the risk of sexually acquired HIV in at-risk individuals. While awaiting approval and general availability of injectable cabotegravir for HIV prevention, there is, need to ensure continuous availability of an effective product among study participants who have benefited from it within the study context, while also evaluating long-term effects of CAB-LA. The purpose of this study is long-term evaluation of eligible participants who have completed US National Institute of Health sponsored pre-exposure prophylaxis (PrEP) study (HPTN 084) at the KEMRI Kisumu site. All participant will be given access to the injectable product. Eligible participants will be HIV negative at the last visit in the parent study (HPTN 084) and will have  good tolerance to the injectable product. The Kisumu Clinical Research Site (CRS) will enroll up to 58 participants. Each participant will be followed up for a duration of up to 3 years. Participants will continue to receive injectable cabotegravir and be followed up for new HIV infections, adverse events, serious safety concerns, and reasons leading to withdrawal. While ensuring continued access, we anticipate that the study will provide evidence on long-term safety of injectable cabotegravir when used for HIV prevention.

STUDY RATIONALE

The purpose of this study is to long-term evaluation of participants receiving CAB LA who are at risk of acquiring HIV and continue to benefit from CAB LA administration as evidenced by HIV negative status. Participants will transition from the DAIDS sponsored PrEP studies HPTN 083 and HPTN 084 parent studies and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, and safety as specified in the protocol.