A recent clinical trial has demonstrated success in preventing HIV in adolescent girls and young women. Conducted in Sub-Saharan Africa, the study faced significant challenges, including working in regions with limited research infrastructure, engaging a population requiring special protections, and addressing the stigma surrounding HIV.
The study focused on the efficacy of lenacapavir, a long-acting injectable medication, in preventing HIV. Adolescent girls and young women in regions with high HIV incidence were disproportionately affected, making them a priority for research. Traditionally, pharmaceutical trials begin with adults before moving to younger populations to ensure safety. However, this study took a different approach adolescents were included earlier after an independent data monitoring committee reviewed preliminary safety data from adult participants. This proactive approach minimized delays often associated with regulatory amendments.
Incorporating adolescents into a clinical trial at such an early stage is uncommon. While there has been advocacy for their inclusion in adult trials, this study took an intentional and ethical approach to ensure safety.
HIV stigma remains a significant issue, particularly in regions with high prevalence. The study took measures to maintain confidentiality, reassuring participants of their privacy. The twice-yearly injection also offered an advantage over daily oral pills by reducing the risk of unintended disclosure. Many participants favored injections over pills, with adherence exceeding 90%. In contrast, adherence to oral medication was significantly lower, as confirmed through drug level measurements.
Obtaining consent for adolescent participation required careful navigation of ethical and legal considerations. In some locations, emancipated minors could consent for themselves, while in others, community advisory groups provided consent. Laws governing consent vary by region, so researchers worked closely with experienced site staff to ensure compliance.
Despite being conducted during the early days of the pandemic, the trial maintained engagement through virtual meetings with site investigators and community representatives. Careful site selection played a crucial role in the study’s success, ensuring that the selected locations had experience working with adolescent populations.
The study highlights a shift toward including younger populations in clinical research earlier rather than sequentially. This approach, supported by thorough preclinical and early-phase data, can be replicated in other trials to accelerate access to prevention and treatment solutions for disproportionately affected populations.
Regulatory progress has been promising. The investigational new drug application for lenacapavir has received priority review, with a decision expected in mid-2025. Additionally, efforts are underway to facilitate approval through a process that allows regulatory bodies to assess its use beyond high-income countries, ensuring broader accessibility. Steps have also been taken to share intellectual property with generic manufacturers to expand distribution once approval is granted.
These findings reinforce the potential of long-acting injectable HIV prevention, particularly for populations where adherence to daily medication remains a challenge. By prioritizing inclusion, confidentiality, and accessibility, the study has paved the way for a new era in HIV prevention.
