Impact of dedicated women’s outreach workers (WOWs) on recruitment of women in ACTG clinical studies

Figures & data

Table 1. Demographics of participants enrolled in WOW registry.

	Rutgers University (%)	Emory University (%)
N	100	86
Sex/Gender
Male	55 (55%)	46 (53%)
Female	45 (45%)	38 (44%)
Transgender women	0 (0%)	2 (2%)
Race/Ethnicity
White, Non-Hispanic	8 (8%)	9 (11%)
Black or African American, Non-Hispanic	83 (83%)	67 (85%)
Hispanic	9 (9%)	3 (4%)
Diagnoses
HIV	95 (95%)	86 (100%)
HBV	6 (6%)	4 (5%)
HCV	12 (12%)	8 (9%)

Figure 1. Potential participants screened and enrolled (Rutgers).

Figure 2. Potential participants screened and enrolled (Emory).

Table 2. Lessons learned from WOW pilot program aimed at increasing enrollment of women in ACTG clinical trials (2016 – 2017).

Lessons	Implications
Lesson 1: Success in engaging women is proportional to level of funding and institutional support	It is possible to have a dedicated effort to increase the enrollment of women in ACTG trials, especially when funding and institutional support is available for that effort. Separate lines of funding can ensure that activities are appropriately staffed and maintained.
Lesson 2: Need for a gender-inclusive scientific agenda	The network’s scientific agenda must reflect the social determinants of health that impact multiply marginalized women. Prioritizing gender-inclusivity in all ACTG studies would allow the network’s researchers to answer the scientific questions that drive ACTG research in ways that are relevant for all people affected by HIV.
Lesson 3: Meaningful engagement is a two-way street	Engagement includes bringing community members “to the table” on CABs and research teams as well as going “into the field.” Research participants value referrals and other social services resources.

Table

Study Number	Brief Description	Enrolling at Rutgers	Enrolling at Emory
A5332 (REPRIEVE)	Evaluates the role of a statin medication (pitavastatin calcium) in preventing heart disease among people with HIV	Yes	Yes
A5320	Viral Hepatitis C Infection Long-term Cohort Study	Yes	No
A5324	Study of Maraviroc and Dolutegravir’s impact on neurocognitive performance	Yes	No
A5336	Phase II study of the safety of ruxolitinib (a kinase inhibitor) in virologically-suppressed, HIV-positive participants	No	Yes
A5337	Phase I/II study to evaluate the safety of sirolimus (a chemotherapy drug)	No	Yes
A5353	Phase II study of dolutegravir plus lamivudine as an initial regimen	No	Yes
A5354	Study of early ART initiation in acute HIV infection; participants are required to have a diagnosis of acute HIV within 7 days prior to enrollment	Yes	Yes