This framework is intended to inform stakeholders involved in all stages of product introduction from clinical research to rollout in low- and middle-income countries (LMICs). While the framework focuses on activities to begin in parallel to phase III clinical trials, stakeholders in early product development phases may also want to understand what to expect in terms of downstream product introduction needs. Stakeholders involved in early product development may also consider leveraging some of the activities included to anticipate future needs.
Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of HIV in High-Income Countries
This article from Clinical Infectious Diseases examines potential barriers to scale-up of injectable PrEP in high income countries.
Potential of Long-Acting Products to Transform the Treatment and Prevention of Human Immunodeficiency Virus (HIV) in Infants, Children, and Adolescents
This article from Clinical Infectious Diseases examines the potential of injectable PrEP for HIV prevention in infants, children, and adolescents.
Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of HIV in Low- and Middle-Income Countries
This article from Clinical Infectious Diseases examines potential barriers to scale-up of injectable PrEP in low and middle income countries.
A Qualitative Exploration of New and Existing HIV PrEP Modalities Among Men Who Have Sex with Men in Philadelphia
This article from Open Forum Infectious Diseases explores the treatment characteristics that may influence the willingness and uptake of long-acting injectable PrEP as opposed to the daily pills among a racially diverse sample of gay and bisexual men who have sex with men in Philadelphia, Pennsylvania, USA.
Transgender Women in HPTN 083: An evaluation of safety, efficacy, and gender affirming hormonal therapy interactions with long-acting cabotegravir
This poster from AIDS 2022 presents an analysis of results from the HPTN 083 study, looking at the impact of feminizing gender affirming hormones on cabotegravir (CAB) for PrEP pharmacokinetics.
Relative Cost-effectiveness of Long-acting Injectable Cabotegravir versus Oral Pre-exposure Prophylaxis in South Africa based on the HPTN 083 and HPTN 084 Trials: A modelled economic evaluation and threshold analysis
This article from The Lancet HIV estimates the incremental cost-effectiveness of long-acting injectable cabotegravir (CAB for PrEP) compared with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC oral PrEP) in South Africa, using methods standard to government planning, and determines the threshold price at which CAB for PrEP is as cost-effective as TDF/FTC oral PrEP.
Acceptability of Injectable Pre-exposure Prophylaxis among People who Inject Drugs in Three Urban U.S. Settings
This article from BMC Infectious Diseases examines acceptability of injectable PrEP amongst people who inject drugs in the US.
Long-Acting Injectable Cabotegravir for HIV Prevention: What do we know and need to know about the risks and consequences of cabotegravir resistance?
This article from The Science of Prevention summarizes what is known about cabotegravir (CAB) pharmacokinetics, activity, and emergence of resistance from in vitro, macaque and clinical studies, and evaluates the risk of resistance from CAB for PrEP with on-time injections and after CAB for PrEP discontinuation.
Coordinating Implementation Science for CAB for PrEP: Focus on Delivery Models
This second meeting of the BioPIC implementation science series focused on how cabotegravir (CAB) for PrEP can be integrated into existing community, pharmacy and facility-based delivery for HIV prevention.