HPTN 084-01 (The LIFT Study) is a clinical research study examining safety, acceptability, and tolerability (side effects) of injectable cabotegravir (CAB) for PrEP (pre-exposure prophylaxis) in cisgender female adolescents (assigned female at birth). Cisgender means having a gender identity that matches one’s assigned sex.

CAB is a new drug that is still being studied. Other studies showed that CAB can treat people who are HIV positive. More recent studies are beginning to show that CAB can also be effective when used to prevent new HIV infections. HPTN 084-01 is a sub-study of a larger clinical research study called HPTN 084 (The LIFE Study). HPTN 084 is examining the safety of injectable CAB for PrEP and whether it works better than daily oral Truvada for HIV prevention in cisgender women (assigned female at birth).
PrEP stands for Pre-Exposure Prophylaxis. PrEP is an HIV prevention strategy that uses anti-HIV medications to help people who do not have HIV reduce their risk of HIV infection. HPTN 084-01 is testing the safety and acceptability of long-acting injectable cabotegravir for PrEP, which is not currently approved for use among adolescents assigned female at birth. There are currently only two drugs approved for PrEP by the U.S. Food and Drug Administration (FDA) and both are single pills taken as prescribed that contain two anti-HIV drugs:
    • emtricitabine and tenofovir disoproxil fumarate (TDF/FTC), sold under the brand name Truvada®
    • emtricitabine and tenofovir alafenamide (TAF/FTC), sold under the brand name Descovy®
Truvada is approved for PrEP for all adults and adolescents at risk of HIV. Descovy is approved for HIV prevention in adult and adolescent cisgender men and transgender women who have sex with men but has not been studied in other populations.
The National Institute of Allergy and Infectious Diseases (NIAID) is working with the HIV Prevention Trials Network (HPTN), The Bill and Melinda Gates Foundation (BMGF), and ViiV Healthcare.
HPTN 084-01 began enrolling participants in November 2020 at study sites in South Africa, Uganda, and Zimbabwe.
HPTN 084-01 will enroll about 50 adolescents, assigned female at birth, under the age of 18. The total study duration per participant will be approximately 21 months.
Before injectable CAB can be approved for PrEP among adolescents assigned female at birth, 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?
      • What are the side effects of CAB LA in adolescents assigned female at birth?
      • 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 children using CAB for PrEP?
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 month
  • Step 3: Participants will come to the clinic for study visits every 3 months and have the option to receive Truvada (TDF/FTC) for PrEP for about one year or enroll in a CAB LA OLE (Open-Label Extension) study in their area, if available.
During study visits, participants will also receive physical health examinations, answer questions about their overall health, and receive counseling about HIV prevention and difficulties they may have during the study. Urine, blood, and vaginal swabs will be taken at visits throughout the study to test for HIV, Hepatitis, and sexually transmitted infections (STIs); and liver and kidney health and cholesterol.
Participants will receive support from clinic staff and counselors at each visit. Counselors may ask participants about difficulties that get in the way of attending study visits. Participants will be offered reminders about their visits if desired.
Yes, HPTN 083-01 is examining whether injectable CAB is safe and acceptable among adolescent males (assigned at birth). It is a sub-study of a larger clinical research study, HPTN 083, being conducted among adult cisgender men and transgender women who have sex with men.
Studies conducted so far in adults have shown CAB to be safe. Safety will continue to be assessed among adults in HPTN 083 and HPTN 084, as well as among adolescents in HPTN 083-01 and HPTN 084-01.
Yes. On November 5, 2020, a Data and Safety Monitoring Board (DSMB) reviewed HPTN 084 study data. The HPTN 084 study found that CAB LA injected once every eight weeks worked better than the TDF/FTC in preventing HIV. Among the 38 women in the trial who acquired HIV, four were receiving CAB LA and 34 were receiving daily oral TDF/FTC: in other words, approximately 9 times the number of new HIV infections were in women who received TDF/FTC pills than in women who received CAB LA injections. More information about HPTN 084 is available at 084life.org or hptn.org/research/studies/hptn084.  These results are similar to results from the HPTN 083 study which also showed that CAB LA prevented more new HIV infections than oral Truvada (TDF/FTC) in cisgender men and transgender women who have sex with men. More information about HPTN 083 is available at giveprepashot.org or hptn.org/research/studies/hptn083.  As a reminder, Truvada (TDF/FTC) is approved by the U.S. Food and Drug Administration (FDA) to treat people with HIV and to prevent people from getting HIV (PrEP), but CAB LA is not yet approved by the FDA. 
No, CAB LA is an antiretroviral drug, not a vaccine.
We are not changing how we are doing HPTN 084-01 because we still need to see if the CAB LA shots are safe and acceptable in youths. We need to find this out if we want CAB LA shots to be approved for use in youth. So, all participants in HPTN 084-01 will receive CAB LA shots. HPTN 083-01 and HPTN 084-01 will not show us if CAB works as PrEP among adolescents but will show us if CAB LA shots are safe and acceptable in youth.
HPTN 084-01 study participants will receive HIV prevention counseling, condoms and lubricant, as well as counseling to encourage and support taking the study pills. Participants will be tested for STIs throughout the study and referred for appropriate treatment if an STI is diagnosed. After participants stop getting injections, they will be offered Truvada (TDF/FTC) for PrEP or may join a CAB LA open-label extension study, if available in their area, for about a year.
We expect to have results in 2023.
Multiple individuals and groups will carefully monitor the safety of HPTN 084-01 study participants. Study sites will report and manage any adverse health outcomes daily, and the study team will monitor safety reports from the sites. In addition, a Clinical Management Committee will assist principal investigators if unexpected safety concerns arise. Additionally, both a Study Monitoring Committee and an independent Data and Safety Monitoring Board (DSMB) will conduct periodic reviews of participants’ safety. A DSMB is an unbiased group composed of clinical research and medical experts, statisticians, and ethicists who meet periodically during a study to review safety data. The DSMB will alert the study team if anything appears to raise a new safety concern for study participants or if it becomes clear that the study cannot answer one of the questions it was designed to address. If indicated, the DSMB can advise that the study be ended early.
Yes, long-acting contraception is required. Participants may not enroll if they are pregnant or desire to become pregnant because oral CAB and CAB LA are investigational drugs (a drug that has been approved for testing but is not known yet to be safe and effective). Participants must use study-approved methods of contraception (see below) during the trial and for 48 weeks after stopping CAB LA, or 30 days after stopping oral CAB.

Participants must be using one of the study-approved contraceptive methods by the Week 2 visit in Step 1 to transition to Step 2.

Study approved methods of contraception are:
  • Intrauterine device (IUD) or intrauterine system (IUS)
  • Hormone-based contraceptive (implants or injectables only; this excludes combined oral contraception)
All participants will also be encouraged to use condoms for prevention of HIV and other STIs.

All participants who are not currently pregnant and decide to discontinue long-acting contraception for any reason will immediately discontinue taking the study drugs (oral CAB or CAB LA injections).

Contraception may be provided by the study site.
Being in this study will not increase a participant’s risk for HIV, but a participant could get HIV through sex or other activities while in this study. Participants who get HIV will stop using CAB, but complete study visits to make sure they are doing okay if they are in Steps 2 or 3. If they get HIV during Step 1, they will leave the study. The study staff will provide counselling and referral for HIV treatment and other available services, but the study will not pay for this treatment. We will share any test results relevant to treatment decisions. Testing will be done to help select the best drugs to treat the HIV.
Because study participants are still minors, permission from a parent/guardian is needed before they can take part in the study. Once the parent/guardian agrees for the minor to participate, the minor may attend study visits alone. Every effort will be made to keep the study participant’s information private and confidential. No information about the study participant or the participant’s health will be shared with anyone, even the parent/guardian, without talking to the study participant first, except when the participant’s life is thought to be in danger.
Participants are not required to be enrolled in school. However, participants must be able to attend all study visits without missing school.