What is this study about?

In this study, we want to know if it is safe and acceptable for adolescent men who do not have HIV to take an anti-HIV drug called cabotegravir (CAB). We would also like to look at the tolerability, or side effects, of CAB. CAB is a new drug that is still being studied. Other studies showed that CAB can treat people who have HIV infection, and we have recently learned that it can also be used as PrEP to protect cisgender men and transgender women from getting HIV. CAB comes in the form of a pill (oral CAB) and also as an injection (CAB LA). CAB pills and injections are not yet approved for the treatment or prevention of HIV infection by the United States Food and Drug Administration (FDA) and are therefore considered experimental. CAB injections are not HIV vaccinations, so they will not make your child immune to HIV.

Your child is being invited to join this study because you live in the United States, where 21% of new HIV infections occur among young people ages 13 to 24. Most of these infections occur due to sexual activity and about half of the youth who have HIV don’t know it. This study will be offered to about 50 young men under 18 years old across several study sites in the US. The United States National Institutes of Health is paying for the study.

Before injectable CAB can be approved for PrEP among adolescent males, we need to answer the following questions in this study:

  • Is it safe for adolescents assigned male at birth to take CAB pills and CAB injections?
  • Is it acceptable and practical for adolescents assigned male at birth to use CAB for PrEP?
  • Are injection appointments every eight weeks at the clinic acceptable and convenient for adolescents assigned male at birth?
  • What do parents/guardians think about their child using CAB for HIV prevention?

Who will be caring for my child while on study?

The three sites implementing HPTN 083-01 are:

  • AYAR at CORE (Adolescent and Young Adult Research at the CORE Center), Chicago, IL
  • Fenway Health, Boston, MA
  • St. Jude Children’s Research Hospital, Memphis, TN

Sites were chosen for this study if they have shown proven ability to enroll and retain youth participants, astute awareness of the developmental and cultural issues experienced by youth, as well as outstanding productivity with previous bio-behavioral clinical trials. Each site also had to have demonstrated capacity to administer the long-acting formulation of cabotegravir for treatment or prevention (e.g. by participating as sites in HPTN 083 or IMPAACT 2017). In addition, these sites have long histories conducting adolescent prevention trials through the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN).

Participants are being recruited from the clinical sites’ patient populations, as well as through community-based venues, including working with sites’ community partners and community advisory boards, and through social media and/or other technology-based recruitment methods successfully used in previous PrEP studies for youth. Active inclusion of adolescents/young adults in community engagement activities, including but not limited to community advisory boards, is mandatory for each site.

What other HIV prevention options are available for my child?

Currently, the only known ways to prevent HIV infection from sex is to use condoms and/or take one of two available PrEP pills, called tenofovir/emtricitabine (TDF/FTC, Brand name: Truvada®) or emtricitabine/tenofovir alafenamide (FTC/TAF, Brand name: Descovy®), every day. But some people have a hard time remembering to take a pill every day, so it is a good idea to have other HIV prevention options. Results from HPTN 083 show that CAB LA is highly effective for PrEP among adult cisgender men and transgender women who have sex with mean. This means people could get injections every 8 weeks and would not have to remember to take a pill every day. It is important that we learn what happens when adolescents use CAB for HIV prevention and whether it is safe and acceptable.

You can find a description of this clinical trial on www.ClinicalTrials.gov.