Inclusion of women in HIV research and clinical trials
Bibliographic record
Abstract
Inclusion of women is critical in the evolving landscape of clinical and translational HIV research.We will herein interchangeably use the terms "females" and "women" when referring to individuals born with a uterus, although we fully acknowledge that not all women are assigned female sex at birth.Globally, of the approximately 38 million people estimated to live with HIV, over half (54%) are female (1).Women have historically been underrepresented in clinical trials (2); often excluded from clinical trials due to pregnancy or lactation status, or even childbearing potential, with participation considered only if contraception requirements are met (3).Prior analyses of clinical trials in the field of immunology demonstrated among the lowest female participant representation relative to their burden of disability-adjusted life years experienced (4).The US Food and Drug Administration (FDA) publishes annual drug trial "snapshots" of demographic data for new molecular entities and original biologics, in an effort to enhance transparency, and these suggest that the representation of women in clinical trials has increased in recent years (5).In the field of HIV research, women remain underrepresented in HIV treatment, HIV vaccine, and HIV cure studies (6, 7); a discrepancy that is heightened for women of color.Notably, in a 2020 study, Black women were underrepresented by 35% relative to HIV prevalence rates in phase 3 randomized clinical trials of three modern antiretrovirals (6).Such underrepresentation of women limits the ability to assess differences related to sex, including with respect to treatment efficacy and potential adverse effects.In this issue, an observational study by Zhou et al (8) investigates involvement of treatment naïve US women in clinical trials of HIV treatment, specifically focusing on phase 3 clinical trials submitted to the FDA between 2008 and 2019.They report the participation to prevalence ratio (PPR), where a PPR between 0.8 and 1.2 reflects similar representation of females in the trial and the disease population, as well sex differences in both efficacy and safety outcomes (8).Overall, across 18 phase 3 clinical trials for HIV treatment, 15% of participants were female.Within the United States 11% of phase 3 clinical trial participants were female, corresponding to a PPR of 0.58, and consistent with underrepresentation (8).Moreover, of new HIV diagnoses in the United States 20% were in women in 2020 (2% identified as transgender women), again highlighting how the enrollment of women in clinical trials for treatment-naïve individuals falls short of representing national epidemiological trends (9).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.096 | 0.259 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.004 | 0.002 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.002 | 0.004 |
| Research integrity | 0.016 | 0.009 |
| Insufficient payload (model declined to judge) | 0.014 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".