What is this study about?
In this study, we want to know if it is safe and acceptable for adolescent cisgender girls 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. We have recently learned that CAB can also be used as pre-exposure prophylaxis (PrEP – an HIV prevention strategy that uses anti-HIV medications in people who do not have HIV to reduce the risk of getting HIV) to protect cisgender men and transgender women who have sex with men from getting HIV. CAB comes in the form of a pill (oral CAB) and 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.
Despite reductions of the numbers of individuals getting HIV in other age groups, the number of deaths from HIV is rising in the adolescent age group, with AIDS being the leading cause of death among adolescents in Africa and the second leading cause for adolescents worldwide. Girls and young women between 15 and 30 years old have an extraordinarily high rate of getting HIV (called “incidence”), particularly in countries such as South Africa, and adolescents may have a hard time taking an daily oral PrEP tablet (Truvada). This study will be offered to about 50 adolescent girls under 18 years old across three study sites in South Africa, Uganda, and Zimbabwe. The United States National Institutes of Health (NIH), Bill and Melinda Gates Foundation (BMGF), and ViiV healthcare are paying for the study.
Before injectable CAB can be approved for PrEP among adolescent females, we need to answer the following questions in this study:
- Is it safe for adolescents assigned female at birth to take CAB pills and CAB injections?
- Is it acceptable and practical for adolescents assigned female at birth to use CAB for PrEP?
- Are injection appointments every eight weeks at the clinic acceptable and convenient for adolescents assigned female 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 084-01 are:
- Ward 21 CRS, Johannesburg, South Africa
- MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda
- Spilhaus CRS, Harare, Zimbabwe
Sites were chosen for this study if they had a successful history of implementing clinical trials involving adolescents. Each site also had to have demonstrated experience of giving the long-acting formulation of cabotegravir for treatment or prevention (e.g. by participating as sites in HPTN 084 ).
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 a requirement for each site.
What other HIV prevention options are available for my child?
Currently, the only known way to prevent HIV infection from sex in cisgender women is to use condoms and/or take the available PrEP pill, called tenofovir/emtricitabine (TDF/FTC, Brand name: Truvada®), 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 men. 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, acceptable and has side effects.
You can find a description of this clinical trial on www.ClinicalTrials.gov.