1MoreStep: Pilot Trial of an Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
Johns Hopkins School of Nursing
RECRUITING
Baltimore
Contact Information
Primary
Kamila Alexander
kalexan3@jhu.edu
443-287-8529
Backup
Karin Tobin
ktobin2@jhu.edu
410-502-5368
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov