HIV Clinical Trial
Official title:
1MoreStep: Pilot Trial of an Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train 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, 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Cis-gender female - Black or African American - = Age 18 - Living with HIV - = 1 HIV care visit in previous 12 months OR virally unsuppressed (>50 copies/mL) OR at high risk for poor HIV care adherence (PHQ = 3, Generalized Anxiety Disorder (GAD) = 3, active substance use) - IPV within the previous 2 years - Ability to attend in-person for up to 8 sessions - Do not report immediate severe danger from their partner - English fluency Exclusion Criteria: - Not a Cis-gender female - Not Black or African American - = Age17 or younger - Not living with HIV - = 2 HIV care visits in previous 12 months - No IPV within the previous 2 years - Inability to attend in-person for up to 8 sessions - Reports immediate severe danger from their partner - Not fluent in English |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins School of Nursing | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Mental Health (NIMH) |
United States,
Sikkema KJ, Ranby KW, Meade CS, Hansen NB, Wilson PA, Kochman A. Reductions in traumatic stress following a coping intervention were mediated by decreases in avoidant coping for people living with HIV/AIDS and childhood sexual abuse. J Consult Clin Psychol. 2013 Apr;81(2):274-83. doi: 10.1037/a0030144. Epub 2012 Oct 1. — View Citation
Turan B, Hatcher AM, Weiser SD, Johnson MO, Rice WS, Turan JM. Framing Mechanisms Linking HIV-Related Stigma, Adherence to Treatment, and Health Outcomes. Am J Public Health. 2017 Jun;107(6):863-869. doi: 10.2105/AJPH.2017.303744. Epub 2017 Apr 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 7 | |
Primary | 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. | 3 month follow up | |
Primary | 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. | 3 month follow up | |
Primary | Feasibility of study as measured by session attendance | Session attendance | Week 7 | |
Secondary | 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. | Baseline, Week 7 and 3 month follow up | |
Secondary | Change in Self-reported HIV Care Engagement in the form of ART medication use | Self-reported use of ART medication (yes or no) | Baseline, Week 7 and 3 month follow up | |
Secondary | 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) | Baseline, 3 month follow up and 1 year | |
Secondary | 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. | Baseline, Week 7 and 3 month follow up | |
Secondary | Change in Number of HIV Care Provider visits as assessed by Chart review of HIV Care Engagement | Chart review regarding HIV Care Engagement in the form of HIV Care Provider visits within the last year. | Baseline, 3 month follow up and 1 year |
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