Efforts to curb the HIV epidemic in the United States (US) are impeded by suboptimal adherence: only 63% of people diagnosed with HIV are virally suppressed. Women have lower adherence to oral antiretroviral therapy (ART) and viral suppression than men, contributing to their increased morbidity, mortality and onward HIV transmission. There is thus an urgent need for strategies to optimize women's viral suppression. Long-acting injectable (LAI) ART, an every 4 or 8 weeks intramuscular injection that was non-inferior to oral ART in Phase 3 trials, has the potential to transform HIV treatment by eliminating the need for daily pills. LAI ART may significantly reduce women's adherence barriers, but women constituted only 8%-33% of trial participants and their experiences with LAI ART are under-explored. To help fill this gap, our team conducted formative qualitative research with women living with HIV (WLWH) to explore their interest in LAI ART and barriers and facilitators to its use. Our research demonstrated that for LAI ART to reach its full potential we must: identify the women most likely to adhere to LAI ART, address barriers to its use, and support shared decision-making to ensure that a woman and her provider choose the HIV treatment modality that will best facilitate adherence to ART. Since no tools exist to support WLWH's shared decision-making of oral vs. LAI HIV medication, we propose to conduct a mixed-method study to develop a web-based patient decision aid, i.ART+support (i.ARTs). This R34 is led by an early-stage investigator and expert study team with a history of productive collaboration within the MACS/WIHS Combined Cohort Study (MWCCS). The R34 study will include MWCCS providers and WLWH (both in and out of care), who will eventually choose between oral and LAI ART.
In Aim 1 we will generate i.ARTs content through in-depth interviews with 45 providers and survey data from 1,500 women across nine MWCCS sites. This will identify the characteristics of women most likely to adhere to LAI ART, gender-specific drivers of women's LAI ART use and solutions to support LAI ART adherence.
In Aim 2 we will conduct five focus groups each with MWCCS providers and WLWH to iteratively develop i.ARTs content and assess and refine the web-based version of i.ARTs.
In Aim 3 we will pilot test i.ARTs with 180 WLWH in a Miami, FL clinic and compare outcomes between the i.ARTs arm and control arm (n=90 in each). We will assess i.ARTs' feasibility, usability and acceptability and its impact on women's ART-related decisional conflict, viral suppression, clinic attendance and medication refills. We will also interview women who choose LAI ART to explore ?real-world? barriers to use. In sum, this R34 will develop and pilot test a web-based patient decision aid to facilitate shared decision-making between WLWH and their provider to help identify whether oral or LAI ART best matches a woman's preferences and facilitates her ART adherence. The proposed R34 will develop a patient decision aid to help ensure that the full potential of LAI ART can be realized as it is being rolled out, and thus maximize its ability to significantly and sustainably impact the HIV epidemic.
Long-acting injectable antiretroviral therapy (LAI ART) has the potential to transform HIV treatment by eliminating the need for daily pill taking, which could then increase ART uptake, adherence and viral suppression. Women have poorer HIV-related outcomes than men and are underrepresented in ART-related research; consequently, the data necessary to support women's adherence and promote long-term HIV outcomes are lacking. The proposed R34 will advance women's LAI ART uptake and sustained use as LAI ART is being rolled out through the development and pilot testing of a web-based patient decision aid to facilitate shared decision-making between women and providers and help them choose the HIV treatment modality that will best match a woman's preferences and support her adherence to ART.
