AIDS Clinical Trials Group (ACTG) - WOW

The ACTG community and leadership are concerned about suboptimal enrollment of women into ACTG clinical trials. Domestic recruitment of women consistently fails to match the demographics of the epidemic in the US. Among domestic sites, between 3/2012 and 2/2013, of the 1,767 enrolled in all studies (except A5128), only 16.1% were female and among only interventional studies, 13.4% were female. This disparity prevents the ACTG from realizing its full capacity as a leader in treatment and cure research. The under-enrollment of women results in a lack of generalizable, applicable results for HIV-positive women. Enrolling women in clinical trials often requires more time and resources, but sites are not currently funded to hire the necessary personnel such as outreach workers to devote to this mission. To remedy this situation, we propose a one-year, multi-site, domestic pilot study of a Women’s Outreach Worker (WOW) program. Four sites in diverse regions of the country will be funded to hire a full time outreach worker to engage with women in the community. These four sites will be selected based on the demographics of the area (metropolitan areas with the potential to enroll more women in trials), their expressed interest and investment in the WOW program, and their involvement with the Underrepresented Populations Subcommittee. This pilot program is intended to demonstrate that targeted recruitment efforts can expand community awareness of ACTG research, ensure successful enrolment for sites, link sites to local medical communities, contribute to the health of women, and increase community understanding of and investment in the clinical research process. The outreach worker will also work closely with on-site study personnel to engage HIV- and/or Hepatitis-infected women in ACTG clinical trials and encourage them to join a registry giving the site permission to contact them were relevant studies to become available.