1MoreStep Intervention for Domestic Violence

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins School of Nursing, Baltimore, MDDomestic Violence+4 More1MoreStep - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial tests a CBT program to help Black women w/ HIV & exposed to IPV access strength, safety strategies, knowledge, and reduce stigma, with communication skills & support to respond to HIV & IPV stigma, and address barriers to HIV care.

Eligible Conditions
  • Domestic Violence
  • HIV/AIDS
  • Social Stigma
  • Patient Engagement
  • Medication Adherence

Treatment Effectiveness

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Baseline, Week 7 and 3 month follow up

3 month follow up
Acceptability of study as documented in in-depth interviews
Acceptability of study as measured by the Treatment Acceptance Scale
Year 1
Change in Number of HIV Care Provider visits as assessed by Chart review of HIV Care Engagement
Change in Use of prescription ART medication as assessed by chart review of HIV Care Engagement
Month 3
Change in IPV safety strategies as measured by the IPV Safety Strategies Index
Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index
Change in Number of HIV Care Provider visits as assessed by self-reported HIV Care Engagement
Change in Self-reported HIV Care Engagement in the form of ART medication use
Week 7
Feasibility of study as measured by session attendance

Trial Safety

Trial Design

2 Treatment Groups

Equal Attention Control
1 of 2
1MoreStep Intervention
1 of 2

Active Control

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: 1MoreStep Intervention · No Placebo Group · N/A

1MoreStep Intervention
Behavioral
Experimental Group · 1 Intervention: 1MoreStep · Intervention Types: Behavioral
Equal Attention Control
Behavioral
ActiveComparator Group · 1 Intervention: 1MoreStepControl · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 7 and 3 month follow up

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,093 Previous Clinical Trials
31,769,425 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,584 Previous Clinical Trials
1,984,698 Total Patients Enrolled
Kamila AlexanderPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You were assigned female at birth and identify as a woman.
You have HIV.
This study does not include people who identify as Black or African American.
You have received the polio vaccine in the past two years.

Frequently Asked Questions

Are there any slots available for enrollment in this research endeavor?

"Affirmative, according to information on clinicaltrials.gov this study is currently recruiting patients. It was first initiated in February 1st 2023 and recently revised the 13th of that same month. The trial requires 100 participants from a single site for enrollment completion." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment rate for this trial?

"Affirmative. The information hosted on clinicaltrials.gov showcases this trial's ongoing recruitment efforts, which began February 1st 2023 and are still in progress today. An estimated 100 patients need to be enrolled from one medical site." - Anonymous Online Contributor

Unverified Answer

What key goals is this research attempting to accomplish?

"Over a 3-month observation period, this clinical trial is assessing the acceptability of study treatments and interventions as gathered through in-depth interviews. Secondary objectives include determining changes in intimate partner violence safety strategies (using the Intimate Partner Violence Safety Strategies Index), self-reported HIV care engagement and prescription ART medication use. The latter two will be assessed with yes/no measurements, while IPVSSI scores range from 0 to 28, with an increase of 1 or more indicating increased utilization of protective measures by participants - thus representing a positive outcome." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.