HPTN 083-01

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Males – A sub-study of HPTN 083

Study Summary

What is HPTN 083-01?

HPTN 083-01 is a clinical trial examining whether injectable cabotegravir (CAB) for PrEP (pre-exposure prophylaxis) is safe and acceptable for adolescent males [assigned male at birth – including men who have sex with men (MSM), transgender women (TGW), and gender nonconforming people].

Who is participating in HPTN 083-01?

This study will be enrolling about 50 adolescent males (assigned male at birth – including MSM, TGW, and gender nonconforming people) under the age of 18 at sites in Boston, Chicago, and Memphis. 

Why is HPTN 083-01 important?

Adolescents and young adults make up a large number of new HIV infections worldwide. Although taking a daily pill for PrEP works to protect people from HIV, having to take a daily pill has proven to be difficult for some people. Long-acting injectable PrEP has the potential to protect people from HIV without having to take a daily pill.

What will happen during HPTN 083-01?

Participants will move through the study in 3 steps:

Step 1: Participants will take one CAB pill every day for five weeks

Step 2: Participants will receive a total of 5 CAB injections over 6 months

Step 3: Participants will come to the clinic for study visits quarterly and receive Truvada for PrEP for about one year.

083-01 schema

 

Study Documents

HPTN 083-01 Version 1.0

Other tools

Cabotegravir for PrEP - Injection Training: (video)