Principal Investigator: Joseph Moeketsi Makhema (MB.ChB, F.R.C.P)

Study Objectives:

Primary Objective:

The primary objective of this clinical trial is to describe new HIV infections in adult and adolescent participants at risk of HIV acquisition included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.

Secondary Objective:

To describe any serious adverse events (SAEs), Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal in adult and adolescent participants included in the HPTN 083 and HPTN 084 studies and their associated sub-studies.

Study Design: This is a non-randomized, open label, multi-center long-term follow-up study with one treatment arm. The purpose of this study is long-term evaluation of eligible participants, who have completed DAIDS sponsored parent studies HPTN 083 and HPTN 084, and associated sub-studies, for new HIV diagnosis, SAEs, Grade 3 and Grade 4 ISRs, and AEs leading to withdrawal.

Study population:

In Botswana, a participant will be eligible to roll-over into this Long-Term Follow-up study, only if they are currently enrolled in the ongoing HPTN 084 study.

Pregnant participants from the HPTN 084 study are eligible to enroll into this study if they meet all eligibility criteria.  Based on the design of the parent studies, a maximum of 3500 participants from CAB PrEP studies could enroll in this study. About 65 participants from Botswana will take part in this study.

Sample size:

Global number of participants: About 3500 participants, will take part in this study.

Local / Botswana: About 65 participants from Botswana will take part in this study.

Study duration: 3 years (Approximately Mar 2024 – Mar 2027)

Sponsor: ViiV Healthcare UK Limited, GlaxoSmithKline is supporting ViiV Healthcare in the conduct of this study