1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
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|ClinicalTrials.gov Identifier: NCT05608421|
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : May 24, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Violence, Domestic HIV Stigma, Social Engagement, Patient Medication Adherence||Behavioral: 1MoreStep Behavioral: 1MoreStepControl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are assigned to one of the two groups for the duration of the study.|
|Official Title:||1MoreStep: Pilot Trial of an Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV|
|Estimated Study Start Date :||June 2023|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||May 2025|
Experimental: 1MoreStep Intervention
The intervention arm is 7 sessions (6 group and one individual) that meet weekly with a community health educator who is a Black woman and has experience implementing prior behavioral interventions with people who have experienced trauma and/or are LWH.
Cognitive behavioral intervention to reduce HIV and IPV stigma.
Active Comparator: Equal Attention Control
The Equal Attention Control consists of 7 group-based sessions that meet weekly for 60-90 minutes. The control sessions provide equal attention and psychotherapeutic experience of a support group where participants can address issues important in their lives.
This is an equal attention control group.
- Acceptability of study as measured by the Treatment Acceptance Scale [ Time Frame: Week 7 ]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 [ Time Frame: 3 month follow up ]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 [ Time Frame: 3 month follow up ]Interviews will assess program fit, facilitators and barriers to participation, and use of 1MoreStep intervention skills.
- Feasibility of study as measured by session attendance [ Time Frame: Week 7 ]Session attendance
- Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index [ Time Frame: Baseline, Week 7 and 3 month follow up ]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 [ Time Frame: Baseline, Week 7 and 3 month follow up ]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 [ Time Frame: Baseline, 3 month follow up and 1 year ]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 [ Time Frame: Baseline, Week 7 and 3 month follow up ]Self-reported HIV Care Engagement in the form of number of HIV Care Provider visits within the last year.
- Change in Number of HIV Care Provider visits as assessed by Chart review of HIV Care Engagement [ Time Frame: Baseline, 3 month follow up and 1 year ]Chart review regarding HIV Care Engagement in the form of HIV Care Provider visits within the last year.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Identifies as "cisgender": a cisgender woman is a person who was assigned female at birth and presents as a woman|
|Accepts Healthy Volunteers:||No|
- Cis-gender female
- Black or African American
- ≥ Age 18
- Living with HIV
- ≤ 1 HIV care visit in previous 12 months
- IPV within the previous 2 years
- Ability to attend in-person for up to 7 sessions
- 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 7 sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05608421
|Contact: Kamila Alexanderfirstname.lastname@example.org|
|Contact: Karin Tobinemail@example.com|
|United States, Maryland|
|Johns Hopkins School of Nursing||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Kamila Alexander 443-287-8529 firstname.lastname@example.org|
|Principal Investigator:||Kamila Alexander||Johns Hopkins University|
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
R34MH124586-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||November 8, 2022 Key Record Dates|
|Last Update Posted:||May 24, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Intimate Partner Violence (IPV)
Cognitive behavioral approach
Randomized Control Trial (RCT)