RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-26
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05608421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cis-gender female
  2. * Black or African American
  3. * ≥ Age 18
  4. * Living with HIV
  5. * ≤ 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)
  6. * IPV within the previous 2 years
  7. * Ability to attend in-person for up to 8 sessions
  8. * Do not report immediate severe danger from their partner
  9. * English fluency
  1. * Not a Cis-gender female
  2. * Not Black or African American
  3. * ≤ Age17 or younger
  4. * Not living with HIV
  5. * ≥ 2 HIV care visits in previous 12 months
  6. * No IPV within the previous 2 years
  7. * Inability to attend in-person for up to 8 sessions
  8. * Reports immediate severe danger from their partner
  9. * Not fluent in English

Contacts and Locations

Study Contact

Kamila Alexander
CONTACT
443-287-8529
kalexan3@jhu.edu
Karin Tobin
CONTACT
410-502-5368
ktobin2@jhu.edu

Principal Investigator

Kamila Alexander
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Kamila Alexander, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-06-26
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Intimate Partner Violence (IPV)
  • Black women
  • Cognitive behavioral approach
  • Randomized Control Trial (RCT)

Additional Relevant MeSH Terms

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