A survey with interventional components delivered on tablet devices versus usual care to increase pre-exposure prophylaxis uptake among cisgender Black women: a pilot randomized controlled trial

Background: Cisgender (cis) Black women in the USA are more likely to become HIV positive during their lifetime than other women. We developed and implemented a behavioral intervention, Increasing PrEP (iPrEP), the first pilot randomized controlled trial (RCT) aimed at motivating cis Black women to be willing to use PrEP for HIV prevention and attend an initial PrEP clinic visit following an emergency department visit.

Methods: Eligible participants were Black cisgender women ages 18-55 years who acknowledged recent condomless sex and substance use. Participants were randomized to iPrEP or usual care (UC). iPrEP is a survey-based intervention designed to raise awareness and knowledge about PrEP. Participants completed an assessment of knowledge of and willingness to use PrEP before and after the intervention, then received a warm-hand off with referral to a local PrEP clinic. Enrolled participants were followed for 6 months.

Results: Forty enrolled participants were ages 18-54 years. Education levels varied evenly between some high school education and graduate education. Most participants were single (n = 25) or married (n = 7). Twenty-two participants were employed full-time. Pre-test results indicated that 21 of 40 participants had heard of PrEP. All participants identified PrEP as a daily HIV prevention medication. For those randomized to iPrEP, the odds of knowing about PrEP at post-test, when controlling for baseline, were higher relative to UC (OR = 5.22, 95%CrI = 0.50, 94.1]. iPrEP did not have any effect on willingness relative to UC. The estimate for iPrEP on willingness is marginally higher (4.16 vs. 4.04; i.e., 0.12 points higher); however, the posterior probability of 67.9% does not suggest a strong degree of evidence in favor of an effect. During the post-test, those receiving iPrEP were less ready to take PrEP than those receiving UC.

Conclusions: Findings suggest that iPrEP increased knowledge about the PrEP medication but had a negative impact on readiness to take PrEP relative to UC. It is imperative that future research among cisgender Black women carefully considers the content provided in interventions designed to increase PrEP use, balancing the benefits of PrEP with the side effects and daily pill burden.

Trial registration: clinicaltrial.gov Identifier: NCT03930654, 29/04/2019.