The representative studies rubric: 12 steps to address underrepresentation in HIV clinical research

BACKGROUND: HIV clinical research often fails to enroll samples of participants that are representative of the HIV epidemic. Failure to include representative study populations results in compromised generalizability, misclassification of study populations, disparities in PrEP regulation and coverage, safety and efficacy uncertainties of ARV use in pregnancy and breastfeeding, and undermined efforts to address health disparities. The underrepresentation of certain participant populations in HIV research occurs as a constellation of systemic processes, many of which are institutionalized within the field of clinical research. The presenters developed a tool, the Representative Studies Rubric (RSR), consisting of a 12-item questionnaire that can be applied to study protocols to facilitate enhanced inclusion of underrepresented populations.
DESCRIPTION: The RSR examines individual study protocols for their representativeness in terms of age, ethnicity, gender, injection drug use, pregnancy, race, and sex assigned at birth. The presenters pilot tested the RSR in a retrospective analysis of 100% of study protocols (47) conducted by the NIH-funded HIV/AIDS clinical trials networks that were actively enrolling study participants in September 2021: AIDS Clinical Trials Group (21 studies); COVID-19 Prevention Network (1 study); HIV Prevention Trials Network (5 studies); HIV Vaccine Trials Network (5 studies); HPTN/HVTN (3 studies); International Maternal Pediatric Adolescent AIDS Clinical Trials (10 studies); and Microbicide Trials Network (2 studies). Findings were presented to research leadership to activate process improvement.
LESSONS LEARNED: The systematic exclusion of underrepresented populations is widespread, and it most often occurs passively through ambiguous and exclusionary definitions of study populations. Too few studies prioritize representative sampling through the use of population-specific enrollment goals, and stigmatizing language is ubiquitous. However, research staff are highly committed to enrolling more representative study populations.
CONCLUSIONS: Institutionalized barriers in HIV research perpetuate the exclusion of underrepresented populations. The RSR should be implemented proactively in the development of study protocols to help correct these institutionalized barriers, advance scientific integrity, and facilitate equitable representation of study populations. The NIH-funded HIV/AIDS clinical trials networks are currently working to implement the RSR as a protocol development tool. Research entities outside these networks should consider implementing the RSR as well.

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