IMPALA: Improving HIV Outcomes in Africa With Long Acting Antiretrovirals
Open IMPALA: Improving HIV Outcomes in Africa With Long Acting Antiretrovirals configuration options
IMPALA seeks to tackle the underlying challenge of maintaining virological suppression in people living with HIV in sub-Saharan Africa by investigating novel long-acting antiretrovirals.
Partners
Add other partner logos: JCRC, IDI, University of Nairobi, CAPRISA, DTHF, HARVARD.
About
Antiretroviral therapy (ART) has saved millions of lives over the last two decades. However, the need to take lifelong daily pills is difficult for many people; the reasons for this are manifold but include pill fatigue, fear of stigma, violence or abandonment if ART pill bottles are found at home. Difficulty in taking daily ART leads to poor control of the virus, resistance, weakened immune system, HIV-related illnesses, hospitalizations and deaths. There were 650,000 deaths from HIV/AIDS in 2021 alone.
A new promising innovation is long-acting (LA) injectable ART, LA cabotegravir and LA rilpivirine can be given every 2 months by intramuscular injection and may overcome the need to take daily pills. With 2-monthly cabotegravir and rilpivirine there are only 6 dosing days annually compared to 364 with oral ART. The regimen has been tested and is now being rolled out in HIV care in the global north but data from sub-Saharan Africa is needed to guide policy for the continent.
This study brings together experts from different regions globally to test the effectiveness of the injectable LA ART (2-monthly injectable cabotegravir + rilpivirine) compared to daily oral dolutegravir-based ART in adults with a history of sub-optimal HIV control in sub-Saharan Africa.
Our vision
A world where people living with HIV can lead long and healthy lives free of stigma.
Our mission
To test the effectiveness of and improve access to novel long-acting antiretroviral therapies and reduce suffering, morbidity and mortality caused by HIV/AIDS in sub-Saharan Africa.
Our focus
We put people with a history of sub-optimal HIV control at the center of our work. We believe that supporting these individuals to achieve virological suppression will be an important step towards ending the HIV epidemic and AIDS deaths.
Values
Innovation
The novel long-acting injectable formulation of cabotegravir and rilpivirine can be given by intramuscular injections every 2 months and may overcome the need to take daily pills to control HIV.
Sustainability
Use of injectables to control HIV may reduce the number of plastic pill bottles manufactured.
This project aligns with the 2030 UN Sustainable Development Goals:
- SDG 3 – Good Health and Well-being
- SDG 5 – Gender equality
- SDG 9 - Industry, Innovation and Infrastructure
- SDG 12 – Responsible consumption and production
Diversity and inclusion
Our target population is adults who have struggled with HIV control with the currently available oral drugs. We hope that injectable ART will be an important tool in reducing HIV stigma and improving health outcomes for this population.
Aim
To test the effectiveness of 2-monthly injectable LA cabotegravir + LA rilpivirine, compared to standard of care first-line treatment with dolutegravir-based daily oral therapy in adults with a history of sub-optimal HIV control.
The study hopes to provide data that will be useful for the World Health Organization in deciding how and where LA ART can be used in sub-Saharan Africa.
IMPALA seeks to tackle the underlying challenge of maintaining virological suppression in people living with HIV in sub-Saharan Africa.
Study design
The phase 3 open-label randomised clinical trial will be conducted across 7 sites in 3 countries: Uganda, Kenya and South Africa. The trial will include 540 virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. The study will not test for baseline HIV resistance mutations in line with local practice.
When compared to continuation of daily oral dolutegravir-based ART, our objectives in the randomized clinical trial include:
- To compare rates of virological suppression between LA CAB/RPV and dolutegravir-based oral ART at 12 and 24 months
- To describing the impact of injectable ART on the immune system and HIV-related disease
- To ensure switching to 2-monthly cabotegravir/rilpivirine is safe and tolerable.
- To explore lived experiences of LA ART, whether injectable ART improves health-related quality of life and to assess treatment preference.
- To examine cost-effectiveness of LA ART in people living with HIV who have struggled with HIV control with current standard of care.
- To assess treatment acceptability by different stakeholders e.g. study participants, healthcare workers, donors, Ministries of Health.