A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD) among Black Women Living with HIV - Background: Black women are disproportionately affected by HIV, both nationally, and locally in Miami (a U.S. HIV epicenter) and 40% are not virally suppressed.1 There is no existing adherence intervention explicitly addressing the impact of the unique and intersectional adversities (e.g., trauma, discrimination, stigma, gender roles) faced by BWLWH that are associated with mental health symptoms, medication nonadherence, and viral non-suppression.5- 14,16-21 Evidence-based trauma treatment techniques (e.g., cognitive behavioral therapy) can be adapted to reduce trauma symptoms among BWLWH.44-48 However, existing trauma interventions for women with HIV show no effects on adherence and exclude critical adverse experiences of BWLWH46-48 and interventions promoting gender empower- ment (e.g., SISTA, WILLOW)53,54 do not address adherence. Our single session adherence intervention (LifeSteps) has proved fruitful but does not address intersectional adversities and promote resilience.57,58 To address these issues, the PI successfully completed a NIMH funded K23 that involved developing and pilot testing STEP-AD and the next logical step is a large scale RCT to assess efficacy. Preliminary work. Striving Towards EmPowerment and Medication Adherence (STEP-AD) is an individual ten session intervention that integrates CBT for PTSD symptoms, one LifeSteps session, and strategies for coping (informed by BWLWH & community via qualitative work) with discrimination/microaggressions, promoting gender empowerment, positive body image, and healthy relationships, and enhancing resilience in order to decrease trauma symptoms, increase adherence, and ultimately improve viral suppression. The current R01 proposal will assess the efficacy of STEP-AD in increasing viral suppression and is built on strong preliminary evidence of acceptability, feasibility, and efficacy via (i) formative qualitative work with BWLWH17 and community stakeholders26 (ii) an open pilot /case series of STEP-AD64 and (iii) a pilot RCT indicating that BWLWH who completed STEP-AD compared to enhanced treatment as usual had significantly higher adherence at intervention completion, higher CD4 count, and lower likelihood of a PTSD diagnosis.65 Conceptual Model: This is informed by Intersectional Theory,61,62,110 Minority Stress27, and the Biopsychosocial Model30,44 and aligned with NIH’s cross-institutional support for research projects promoting viral suppression among individuals from health disparity populations.107–109 Research Plan: 250 BWLWH in Miami, FL will be randomized to either the 10-session STEP-AD intervention or a time and intensity matched control condition. We will (1) determine the impact of STEP-AD compared to the control condition on viral suppression at 3- and 6- month post intervention (2) determine the impact of STEP-AD on secondary outcomes of sustained viral suppression at -9 and -12 months, and ART adherence, PTSD symptoms, and engagement in care compared to the control group at 3-, 6-, 9- and 12- months and (3) assess potential mediators (e.g., adherence, mental health, engagement in care) and moderators (i.e., who this intervention works best for). Potential Impact: Assessing the efficacy of STEP-AD may equip us with an evidence-based adherence intervention to improve viral suppression among BWLWH (a priority population) and reach the UN’s 95-95-95 goal.109
