What is the mechanism of action of this treatment?

The most common treatment for HIV/AIDS is antiretroviral therapy (ART), which works by inhibiting the replication of the HIV virus, thereby reducing the viral load in the patient's body. This is crucial for preventing the progression to AIDS and reducing the risk of HIV transmission. The 1MoreStep intervention focuses on cognitive and behavioral skills to improve ART adherence and HIV care engagement, addressing internalized stigma and structural barriers to enhance the effectiveness of ART and improve overall health outcomes.

What side effects are associated with this type of intervention?

The most common treatments for HIV/AIDS involve antiretroviral therapy (ART), which can have several side effects. These include drug-drug interactions, inappropriate dosing, and adverse reactions such as metabolic complications. Patients may also experience issues like drug-related nutritional problems and psychological impacts, which can affect adherence to the treatment regimen. The 1MoreStep intervention aims to address these challenges by improving cognitive and behavioral skills, enhancing communication, and reducing stigma, thereby supporting better engagement in HIV care.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV/AIDS, including tenofovir alafenamide, tenofovir disoproxil fumarate, elvitegravir, cobicistat, and emtricitabine. These drugs are often coformulated to improve adherence and efficacy. For example, combinations like tenofovir alafenamide with elvitegravir, cobicistat, and emtricitabine have been shown to be effective in reducing viral load. The 1MoreStep intervention aims to improve engagement in HIV care and adherence to these ART regimens through cognitive behavioral strategies, which is crucial for maintaining viral suppression and overall health in individuals living with HIV.

What other types of research exist?

Promising alternatives to the 1MoreStep intervention for HIV/AIDS patients include: 1) The HIV Anxiety Reduction/Management Program (HAMRT), which integrates cognitive-behavioral therapy to manage anxiety and improve antiretroviral medication adherence. 2) Digital Cognitive Behavioral Therapy for Insomnia (CBT-I), which can be adapted to address sleep-related issues and overall psychological well-being in HIV patients. 3) Integrated multimodal interventions combining skills training, motivational enhancement therapy, and mutual help groups, which have shown mixed but potential benefits in managing co-occurring conditions and improving care engagement.

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1MoreStep Program for HIV Care Engagement and Intimate Partner Violence

N/A

Recruiting

Led By Kamila Alexander

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 7 and 3 month follow up

Awards & highlights

Summary

This trial tests a program called 1MoreStep, which helps Black women living with HIV who have faced intimate partner violence. The program teaches skills to build strength, improve safety, and better engage in HIV care. It aims to reduce the impact of violence and stigma on their health.

Who is the study for?

This trial is for Black, cis-gender women over 18 living with HIV who have had less than one HIV care visit in the past year and experienced intimate partner violence within the last two years. They must be able to attend up to seven in-person sessions.

What is being tested?

The '1MoreStep' program being tested aims to help participants manage HIV and reduce intimate partner violence through cognitive behavioral training, communication skills enhancement, stigma reduction strategies, and assistance from an HIV navigator.

What are the potential side effects?

Since this intervention involves counseling and education rather than medication, typical drug side effects are not expected. However, discussing sensitive topics like domestic violence may cause emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 7 and 3 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 7 and 3 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 7 and 3 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of study as documented in in-depth interviews

Acceptability of study as measured by the Treatment Acceptance Scale

Feasibility of study as measured by session attendance

Secondary study objectives

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 Chart review of HIV Care Engagement

Change in Number of HIV Care Provider visits as assessed by self-reported HIV Care Engagement

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 1MoreStep InterventionExperimental Treatment1 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.

Group II: Equal Attention ControlActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for HIV/AIDS is antiretroviral therapy (ART), which works by inhibiting the replication of the HIV virus, thereby reducing the viral load in the patient's body. This is crucial for preventing the progression to AIDS and reducing the risk of HIV transmission. The 1MoreStep intervention focuses on cognitive and behavioral skills to improve ART adherence and HIV care engagement, addressing internalized stigma and structural barriers to enhance the effectiveness of ART and improve overall health outcomes.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,307 Previous Clinical Trials

14,861,809 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,869 Previous Clinical Trials

2,777,436 Total Patients Enrolled

Kamila AlexanderPrincipal InvestigatorJohns Hopkins University

Media Library

1MoreStep Clinical Trial Eligibility Overview. Trial Name: NCT05608421 — N/A

HIV/AIDS Research Study Groups: 1MoreStep Intervention, Equal Attention Control

HIV/AIDS Clinical Trial 2023: 1MoreStep Highlights & Side Effects. Trial Name: NCT05608421 — N/A

1MoreStep 2023 Treatment Timeline for Medical Study. Trial Name: NCT05608421 — N/A

~29 spots leftby Apr 2025

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