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NCT05608421
1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
Conditions: Violence, Domestic, HIV, Stigma, Social, Engagement, Patient, Medication Adherence
Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: Johns Hopkins University
Summary
This study tests a 7-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train out-of-care Black women living with HIV (LWH) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g.
self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component.
The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV.Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline and 3-month follow-up visit); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy [ART] prescription, medication adherence, and viral load status during 3-month follow-up period).Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.
Eligibility Criteria
Inclusion Criteria:Cis-gender femaleBlack or African American≥ Age 18HIV positive status confirmed with Oraquick test≤ 1 HIV care visit in previous 12 monthsIPV within the previous 2 yearsAbility to attend in-person for up to 7 sessionsExclusion Criteria:Not a Cis-gender femaleNot Black or African American≤ Age17 or youngerNot HIV positive≥ 2 HIV care visits in previous 12 monthsNo IPV within the previous 2 yearsInability to attend in-person for up to 7 sessions
Source: ClinicalTrials.gov (NCT05608421). StuddyBuddy aggregates publicly available trial information.