Abstract
Background: Despite efforts by the AIDS Clinical Trials Group (ACTG) to enroll representative numbers of diverse women, participation in ACTG studies in the United States remains largely white and male. To address this gap in women’s participation in ACTG research, a one-year pilot study of dedicated women’s outreach workers (WOWs) was proposed. Objectives: included demonstrating that targeted recruitment efforts can expand community awareness of ACTG research and ensuring successful enrollment of women at the respective clinical research sites. Methods: The pilot study was conducted at two U.S. sites (Rutgers New Jersey Medical School and Emory Ponce de Leon Center in Atlanta, Georgia). The WOWs worked with site personnel to identify and reach out to women living with HIV and/or Hepatitis B or C at their respective sites and encourage them to join a clinical trial registry for those interested in participating in future clinical trials. Results: The Rutgers WOW approached 127 potential participants (of whom 100 joined the WOW registry) and screened 35 participants for open ACTG studies. The Emory WOW approached 120 participants, enrolling 86 into the WOW registry, and screened 51 potential participants for open ACTG studies during the WOW’s tenure. The majority of women screened at both sites were women of color. Conclusions: The WOW study team identified several lessons learned that can inform future efforts to engage women living with HIV in clinical research. First, success in engaging women is proportional to level of funding and institutional support. Second, there is a need for a more gender-inclusive scientific agenda as women are more likely to participate if studies address topics of interest to them. Third, meaningful engagement is a two-way street.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 37-45 |
| Number of pages | 9 |
| Journal | HIV Research and Clinical Practice |
| Volume | 22 |
| Issue number | 2 |
| DOIs | |
| State | Published - 2021 |
Funding
Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, U01AI69471, UM1 AI069418-08, UM1 AI069419-08, UM1 AI068636 and UM1 AI106701. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors acknowledge the study coordinators at the Rutgers and Emory sites, including Baljinder Singh (Rutgers) and Anna Benbrook (Emory). We also acknowledge the support of Michelle Cespedes and Jose Castillo-Mancilla of the ACTG’s UPC, Cindy Firnhaber and Elizabeth Connick of the ACTG’s WHISC, and Kris Coughlin, the ACTG’s chief data manager. We are grateful for the valuable input Catherine Godfrey, Sarah Looby and Aadia Rana provided during the development and implementation of this pilot. We acknowledge the support of ACTG leadership, including Judith Currier and Daniel Kuritzkes and are appreciative of the generative feedback provided by the editor and anonymous reviewers.
Keywords
- HIV treatment trials
- HIV/AIDS
- clinical trials
- community engagement
- gender
- outreach workers
- recruitment
- women
ASJC Scopus subject areas
- Infectious Diseases
- Pharmacology (medical)
