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Long-acting HIV Treatments: Study Design, Logistics, and Access.

Nicholas A Murdock1, Nayri E Alajaji1, Robin Schaefer1

  • 1Forum for Collaborative Research, University of California, Berkeley, Washington, DC, USA.

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|July 10, 2024
PubMed
Summary

New long-acting HIV treatments show promise, but clinical trials often exclude key populations disproportionately affected by HIV. Improving trial inclusivity is crucial for effective long-acting HIV therapy access.

Keywords:
HIV-1inclusivitylong-acting HIV treatmentmarginalized populationstrial design

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Area of Science:

  • Clinical Trials
  • HIV/AIDS Research
  • Public Health

Background:

  • Long-acting HIV treatments offer a potential paradigm shift in managing the HIV epidemic.
  • Current Phase 3 clinical trials frequently underrepresent diverse populations disproportionately impacted by HIV.
  • Marginalized groups, including women, racial minorities, and individuals with substance use disorders, face adherence challenges with daily regimens.

Purpose of the Study:

  • To address the underrepresentation of key populations in clinical trials for long-acting HIV treatments.
  • To explore innovative study designs and implementation strategies for inclusive long-acting HIV therapy research.
  • To inform optimal care approaches, treatment guidelines, and access policies for long-acting HIV medications.

Main Methods:

  • Summary of discussions from a multistakeholder workshop focused on study designs for long-acting HIV treatments.
  • Analysis of challenges in clinical trial inclusivity for HIV treatment research.
  • Exploration of innovative trial designs and programmatic implementation strategies.

Main Results:

  • Identified significant underrepresentation of key populations in existing HIV treatment trials.
  • Highlighted the need for targeted approaches to improve inclusivity in long-acting HIV therapy research.
  • Discussed potential of innovative trial designs to enhance participation of marginalized groups.

Conclusions:

  • Inclusive clinical trial designs are essential for the equitable development and access of long-acting HIV treatments.
  • Addressing the specific needs of underrepresented populations can optimize care and inform policy.
  • Innovative strategies are needed to ensure long-acting HIV therapies benefit all populations affected by the epidemic.