NCT05608421Completed
1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
1MoreStep: Pilot Trial of an Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 31 Oct 2022
- Start date
- 26 Jun 2023
- Primary completion date
- 18 May 2026
- Lead sponsor
- Johns Hopkins University
- Diseases
- HIV
- NCT number
- NCT05608421
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 26 Jun 2023 to the primary completion date, 18 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ≥ 2 HIV care visits in previous 12 months
- No IPV within the previous 2 years
Other illness
- Not living with HIV
Other
- Not a Cis-gender female
- Not Black or African American
- ≤ Age17 or younger
- Inability to attend in-person for up to 8 sessions
- Reports immediate severe danger from their partner
- Not fluent in English
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins School of Nursing Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.