HPTN 084-01

Ancillary Study: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (LA CAB) for the Prevention of HIV among Adolescents

Study Summary
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Study Documents - Study Details - Key Study Personnel - Study Sites - Publications

 Visit the HPTN 084-01 Website 

 

What is HPTN 084-01?

HPTN 084-01 (The LIFT Study) is a clinical trial examining whether injectable cabotegravir (CAB) for PrEP (pre-exposure prophylaxis) is safe and acceptable for adolescent females (assigned female at birth).

Who is participating in HPTN 084-01?

This study will be enrolling about 50 adolescent females (assigned female at birth) under the age of 18 at sites in South Africa, Uganda, and Zimbabwe. 

Why is HPTN 084-01 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 084-01?

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.

 

 

084-01 schema

 

Study Documents

Version 1.0

➤ HPTN 084-01 SSP

(Click to Expand)
Previous versions of the SSP sections are available upon request
 
HPTN 084-01 Study-Specific Procedures Summary of Changes - 6 December 2022

 

Section 0: Cover Page

Section 1: Introduction

Section 2: Protocol

Section 3: Document Requirements

Section 4: Recruitment, Screening, and Enrollment

Section 5: Study Procedures Overview

Section 6: Visit Checklists

Section 7: Participant Retention

Section 8: Study Product Considerations

Section 9: Clinical Considerations

Section 10: Adverse Event Reporting and Safety Monitoring

Section 11: Laboratory and Specimen Management Procedures

Section 12: Counseling Considerations

Section 13: Data Management

Section 14: Computer Assisted Self-Interview (CASI)

Section 15: Reporting Plan

Section 16: Data Communiqués

Section 17: Qualitative

Appendix 1A: Record of Dispensation of Participant-Specific Study Product to Non-Pharmacy Staff

Appendix 1B: Record of Product Return of Participant-Specific Study Product by Non-Pharmacy Staff

Appendix II: Participant Transfer and Receipt Process within Medidata Rave

Appendix III: Guidance for the Management of “Discordant/discrepant” HIV Testing Results

Appendix IV: Study Schema

 

Other tools

Cabotegravir for PrEP - Injection Training: (video)

 

Presentations

CAB LA for HIV Prevention in African Cisgender Female Adolescents

Sybil Hosek, 21 February 2023

Depressive Symptoms of Adolescents Enrolling in a Clinical Trial of a Long-Acting Injectable for HIV Prevention

erica l. hamilton, 7 November 2022

In the Face of a Global Pandemic and Social Barriers, Cisgender Female Adolescents Enroll in HIV Prevention Trial HPTN 084-01 in Sub-Saharan Africa

Pamela Tshandu, 7 October 2021

 

More Study Documents

You must request access to private documents (i.e. call summaries) from the study team. Please email Gabriela Salinas-Jimenez at GSalinas-Jimenez@fhi360.org for access to these documents.

 

Study Details

Protocol Status: Closed to Follow Up
Study Purpose:

To establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

Study Design:

A Phase IIB single arm, open label safety, tolerability, and acceptability study

Study Population:

Sexually-active, healthy female adolescents aged below 18 years.

Study Size:

Approximately 50.

Study Duration:

Participant recruitment will take approximately 12 months. Oral study product will be administered for 5 weeks, followed by 34 weeks on injectable product then quarterly visits for 48 weeks after final injection. All participants who have received at least one injection will be followed for 48 weeks after their last injection. Waning levels of cabotegravir (the PK tail) will be covered with locally sourced oral TENOFOVIR/EMTRICITABINE (TRADE NAME: TDF/FTC, TRUVADA®) for daily use for 48 weeks. Total study duration per participant will be approximately 21 months.

Treatment Regimen:

Step 1 – oral cabotegravir (30mg tablet); Step 2 – injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection; Step 3 – TENOFOVIR/EMTRICITABINE (TRADE NAME: TDF/FTC, TRUVADA®) (300mg/200mg tablet)

Primary Objectives:

To evaluate the safety, tolerability and acceptability of CAB LA in healthy HIV-uninfected female adolescents aged below 18 years.

Secondary Objectives:

To examine adherence to and timeliness of injections over time among adolescent participants provided CAB LA and information regarding its safety and unknown efficacy.

To examine patterns of sexual risk behavior over time among adolescent participants provided CAB LA and information regarding its safety and unknown efficacy.

To evaluate the safety of CAB LA for up to 48 weeks of follow-up after final injection.

To characterize the pharmacokinetics of CAB LA.