NCT05608421 1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
| NCT ID | NCT05608421 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Violence, Domestic |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-06-26 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-06-26 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 8 sessions * Reports immediate severe danger from their partner * Not fluent in English
Contact & Investigator
Kamila Alexander
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05608421 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Violence, Domestic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05608421 currently recruiting?
Yes, NCT05608421 is actively recruiting participants. Contact the research team at kalexan3@jhu.edu for enrollment information.
Where is the NCT05608421 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05608421 clinical trial?
NCT05608421 is sponsored by Johns Hopkins University. The principal investigator is Kamila Alexander at Johns Hopkins University. The trial plans to enroll 100 participants.