About this trial
This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) 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, 3-month and 6-month follow-up visits); 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 and 6-month follow-up visits).
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
This trial does not accept healthy volunteersQualifiers
Cis-gender female
Black or African American
≥ Age 18
Living with HIV
Disqualifiers
Not a Cis-gender female
Not Black or African American
≤ Age17 or younger
Not living with HIV
Trial design
Parallel
Treatments tested in this trial
1MoreStep
BehavioralCognitive behavioral intervention to reduce HIV and IPV stigma.
1MoreStepControl
BehavioralThis is an equal attention control group.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of study as measured by the Treatment Acceptance Scale
This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.
Acceptability of study as measured by the Treatment Acceptance Scale
This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.
Acceptability of study as documented in in-depth interviews
Interviews will assess program fit, facilitators and barriers to participation, and use of 1MoreStep intervention skills.
Feasibility of study as measured by session attendance
Session attendance
Secondary outcomes
Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index
Four subscale scores will be evaluated independent of one another: accessing formal resources; accessing informal resources; placating strategies; and safety planning. Scores can range from a minimum of 0 to a maximum of 28. Scores which increase \>1 in magnitude from baseline will indicate increased use of Intimate Partner Violence safety strategies by the participant, and therefore would be a positive outcome.
Change in Self-reported HIV Care Engagement in the form of ART medication use
Self-reported use of ART medication (yes or no)
Change in Use of prescription ART medication as assessed by chart review of HIV Care Engagement
Chart review regarding use of prescription ART medication (yes or no)
Change in Number of HIV Care Provider visits as assessed by self-reported HIV Care Engagement
Self-reported HIV Care Engagement in the form of number of HIV Care Provider visits within the last year.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator