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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.
Open Forum Infectious Diseases
|July 10, 2024
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.
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.
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