Recruiting

HIV Care Engagement

Sponsor:

Johns Hopkins University

Code:

NCT05608421

Conditions

Violence, Domestic

HIV

Stigma, Social

Engagement, Patient

Medication Adherence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

1MoreStep

1MoreStepControl

Study Details

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.

Conditions

Violence, Domestic

HIV

Stigma, Social

Engagement, Patient

Medication Adherence

Study ID

NCT05608421

Start date

Jun 26, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

1MoreStep

Cognitive behavioral intervention to reduce HIV and IPV stigma.

1MoreStepControl

This is an equal attention control group.

Primary outcome measure

  • Acceptability of study as measured by the Treatment Acceptance Scale [ Time Frame: Week 7 ]
  • Acceptability of study as measured by the Treatment Acceptance Scale [ Time Frame: 3 month follow up ]
  • Acceptability of study as documented in in-depth interviews [ Time Frame: 3 month follow up ]
  • Feasibility of study as measured by session attendance [ Time Frame: Week 7 ]

Central Contacts and Locations

Central contacts

Locations

Johns Hopkins School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-29.