1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05608421
Status
Recruiting
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Conditions

  • Engagement, Patient
  • HIV
  • Medication Adherence
  • Stigma, Social
  • Violence, Domestic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1MoreStep — BEHAVIORAL
    Cognitive behavioral intervention to reduce HIV and IPV stigma.
  • 1MoreStepControl — BEHAVIORAL
    This is an equal attention control group.

Study Details

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.

Key Dates

Start date
Jun 26, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1MoreStep Intervention
    The intervention arm is 8 sessions (7 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.
  • Active Comparator: Equal Attention Control
    The Equal Attention Control consists of 8 sessions (7 group and one individual) 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.

Primary Outcome Measure

Acceptability of study as measured by the Treatment Acceptance Scale [ Time Frame: Week 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of NursingBaltimoreMaryland21205
Kamila Alexander
[email protected]
443-287-8529

Find similar trials in Baltimore, MD

By condition
HIV
By specialty
Infectious disease
By research site
Johns Hopkins School of Nursing· Baltimore, MD

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