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NCT05608421 · ClinicalTrials.gov registry record · NA
1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
A NA study of HIV and Medication Adherence, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05608421 is a NA study of HIV and Medication Adherence that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 100 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05608421, a NA study of HIV and Medication Adherence, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL 1MoreStep
- BEHAVIORAL 1MoreStepControl
Study Locations (1)
Maryland
- Johns Hopkins School of Nursing - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608421
The ClinicalTrials.gov registry entry for NCT05608421 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (77% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which 1MoreStep is the first listed.
NCT05608421 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05608421 about?
NCT05608421 is a clinical study titled "1MoreStep: 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 (BWLWHI) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access ...
What is the current status of trial NCT05608421?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-06-26. Estimated completion is 2026-12.
What conditions does trial NCT05608421 study?
This clinical trial studies the following conditions: HIV, Medication Adherence, Stigma, Social, Violence, Domestic, Engagement, Patient.
What interventions are being tested in trial NCT05608421?
The interventions under investigation include: 1MoreStep (BEHAVIORAL), 1MoreStepControl (BEHAVIORAL).
Who is sponsoring clinical trial NCT05608421?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608421 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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