1MoreStep Program for HIV Care Engagement and Intimate Partner Violence

Overseen By Karin Tobin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Antiretroviral therapy

Disqualifiers: Not Black, Not female, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black women living with HIV who have experienced intimate partner violence in the last two years. It tests a 5-session program called the 1MoreStep Program, which teaches skills for self-reliance, safety, and dealing with stigma. The program also enhances engagement with HIV care. Women who are a good fit have had limited HIV care visits recently or are struggling with treatment adherence, and they can attend in-person sessions.

As an unphased trial, it offers a unique opportunity to gain skills and support tailored to their needs.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does involve checking your HIV care engagement, including medication adherence, so it's best to discuss your current medications with the trial team.

What prior data suggests that the 1MoreStep intervention is safe?

Research has shown that the 1MoreStep program supports Black women living with HIV who have experienced intimate partner violence. This program helps participants develop skills to manage their HIV care and reduce stigma.

For safety, the 1MoreStep program focuses on behavior rather than medication, eliminating concerns about drug-related side effects. The program emphasizes teaching strategies and providing support, which generally carry low risks.

Previous studies have not identified any serious negative effects from this type of program. Participants typically handle the sessions well, as they involve learning coping skills and receiving support from others. While the trial continues to assess safety, the program's nature suggests it is safe for most people.

Prospective participants can expect a supportive environment aimed at enhancing well-being and healthcare involvement without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 1MoreStep Program because it offers a unique approach to supporting people living with HIV, especially those who have experienced intimate partner violence. Unlike traditional medical treatments that focus solely on managing HIV through medications, this program provides a behavioral intervention designed to enhance care engagement and emotional well-being. By conducting group and individual sessions led by a community health educator with trauma-informed experience, the program aims to address the psychological and social barriers to effective HIV care. This holistic approach sets it apart from standard treatments by integrating mental health and social support into HIV management.

What evidence suggests that the 1MoreStep intervention could be effective for HIV care engagement and intimate partner violence?

Research shows that the 1MoreStep program, which participants in this trial may receive, can help Black women living with HIV by teaching skills to manage partner violence and improve HIV care. Past studies have found that similar programs help women stay safe and follow their HIV treatment plans more effectively. The 1MoreStep program focuses on building self-confidence and support networks, leading to better adherence to HIV medication and care. Early findings suggest that participants learn to handle stigma better and strengthen their connection to healthcare resources. Overall, evidence suggests that this approach effectively supports women facing these challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Kamila Alexander

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a cisgender female.

IPV within the previous 2 years

Living with HIV

Exclusion Criteria

≥ 2 HIV care visits in previous 12 months

I am not a cisgender female.

Not living with HIV

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo an 8-session cognitive behavioral approach intervention called 1MoreStep, focusing on cognitive and behavioral skills, safety strategies, and HIV care engagement.

8 weeks

8 sessions (7 group, 1 individual)

Follow-up

Participants are monitored for changes in IPV safety strategies and HIV care engagement, with assessments at 3 and 6 months post baseline.

6 months

3-month and 6-month follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• 1MoreStep
• 1MoreStepControl

Trial Overview 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.

How Is the Trial Designed?

Group I: 1MoreStep Intervention Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 180 individuals with HIV in Lima, Peru, 45.6% reported experiencing intimate partner violence (IPV), which was linked to poorer medication adherence and care outcomes.

The study highlighted that psychosocial factors such as low social support, substance use, and HIV stigma contribute to IPV, suggesting that interventions should address these issues to improve care for people living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dynamics of Intimate Partner Violence and Its Impact on HIV Care: A Cross-Sectional Study of People of Mixed Gender and Sexual Preference in Lima, Peru. Nelson, AK., Denavit, C., Muñoz, M., et al.[2023]

Only two out of nine identified interventions addressing both HIV and intimate partner violence (IPV) were conducted in healthcare settings, highlighting a gap in integrated care for these co-occurring issues.

Community-based interventions showed promise in empowering women and improving HIV-related knowledge, but further research is needed to develop effective healthcare-specific strategies, including screening and prevention methods for HIV in the context of IPV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to address HIV and intimate partner violence in Sub-Saharan Africa: a review of the literature. Anderson, JC., Campbell, JC., Farley, JE.[2021]

The MTN-016 study successfully enrolled 420 pregnant women and 381 infants to collect important safety data on HIV prevention agents during pregnancy, demonstrating the feasibility of a multinational pregnancy exposure registry.

With a high retention rate of 86% for infants completing the 12-month follow-up, the study shows that it is possible to effectively gather perinatal safety data alongside ongoing clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. Mhlanga, FG., Noguchi, L., Balkus, JE., et al.[2019]

Intimate partner violence (IPV) is significantly linked to lower rates of antiretroviral treatment (ART) use among HIV-positive women, with a pooled odds ratio of 0.79, indicating that women experiencing IPV are less likely to engage in necessary HIV care.

Women reporting IPV also show poorer self-reported ART adherence (odds ratio of 0.48) and lower odds of achieving viral load suppression (odds ratio of 0.64), highlighting the critical need for healthcare programs to address IPV to improve health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intimate partner violence and engagement in HIV care and treatment among women: a systematic review and meta-analysis. Hatcher, AM., Smout, EM., Turan, JM., et al.[2022]

The Ryan White Part A HIV Care Coordination Program significantly improved engagement in care (EiC) among previously diagnosed clients, increasing from 73.7% to 91.3%, indicating effective strategies for promoting HIV care utilization.

Viral load suppression (VLS) also improved from 32.3% to 50.9% among previously diagnosed clients, demonstrating that comprehensive care coordination can lead to better health outcomes for individuals at risk of poor HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. Irvine, MK., Chamberlin, SA., Robbins, RS., et al.[2021]

Participation in treatment advocacy (TA) programs significantly improved adherence to antiretroviral treatment (ART) among HIV-positive clients, with 85.3% of TA participants taking their doses compared to 70.7% of non-participants.

TA participants also utilized more social services and reported fewer unmet needs, indicating that these programs not only enhance treatment adherence but also support broader social service engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community HIV treatment advocacy programs may support treatment adherence. Bogart, LM., Wagner, GJ., Mutchler, MG., et al.[2021]

A multidisciplinary approach that included individualized and culturally sensitive interventions significantly improved adherence to an enfuvirtide-based HIV treatment regimen in a patient with a history of poor adherence.

The comprehensive strategies, which involved daily observed therapy and support for symptom management and social relationships, led to notable improvements in the patient's clinical markers and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. Nicca, D., Moody, K., Elzi, L., et al.[2007]

A couples-based intervention significantly increased the uptake of couples HIV testing and counseling (CHTC) from 12% in the control group to 42% in the intervention group, demonstrating its efficacy in promoting mutual disclosure and linkage to care.

The intervention also reduced the time it took for couples to participate in CHTC, highlighting its potential to enhance public health efforts in communities heavily affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. Darbes, LA., McGrath, NM., Hosegood, V., et al.[2023]

In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.

The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

A comprehensive intervention has been created to enhance HIV medication adherence specifically targeting individuals who are at high risk of missing doses or medical appointments.

This initiative aims to address the challenges faced by these individuals, potentially leading to better health outcomes and improved management of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study looks at care model to improve drug adherence. Retention care counselor is major feature. [2007]

Following the presentation of the DAD cohort study, there was a significant 11% decrease in the prescription of abacavir (ABC) among 7280 antiretroviral medication-naive patients in Canada, indicating a shift in prescribing practices.

The odds of being prescribed ABC compared to tenofovir (TDF) decreased over time, with an adjusted odds ratio of 0.72 per year, suggesting that new safety data influenced clinicians' choices in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the Data Collection on Adverse Events of Anti-HIV Drugs cohort study on abacavir prescription among treatment-naive, HIV-infected patients in Canada. Antoniou, T., Gillis, J., Loutfy, MR., et al.[2016]

Early entry into and retention in HIV care are crucial for improving patient outcomes, as starting antiretroviral therapy (ART) early and adhering to it can significantly enhance health results.

Implementing evidence-based tools and behavioral interventions in clinical settings can optimize adherence to ART and monitor patient engagement, which is especially important for vulnerable populations like pregnant women and those with mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. Eaton, EF., Saag, MS., Mugavero, M.[2017]

A telephonic nursing program significantly improved adherence to antiretroviral therapy among 98 participants living with HIV, with a higher percentage achieving over 95% adherence after 6 months than typically expected for this population.

The study suggests that telephone counseling can effectively integrate cognitive-behavioral and motivational interviewing techniques into routine care, enhancing support for patients and potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone nurse counseling improves HIV medication adherence: an effectiveness study. Cook, PF., McCabe, MM., Emiliozzi, S., et al.[2019]

In a study of 211 married couples in Malawi, bidirectional intimate partner violence (IPV), where partners are both perpetrators and victims, was found to significantly lower adherence to HIV care, with the strongest impact seen in those experiencing bidirectional physical IPV (AOR: 0.10).

Bidirectional IPV was also linked to missing medical appointments, with adjusted odds ratios indicating that couples experiencing this type of violence were more likely to miss appointments compared to those with no violence, suggesting a need for couple-based interventions to address the health effects of IPV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional Violence Is Associated with Poor Engagement in HIV Care and Treatment in Malawian Couples. Conroy, AA., Leddy, AM., Darbes, LA., et al.[2022]

Citations

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1MoreStep: An Intervention to Increase HIV Care Engagemen... Secondary outcomes. 1. Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index. Four ...

2. withpower.com withpower.com/trial/phase-stigma-social-1-2023-949ff

1MoreStep Program for HIV Care Engagement and ... This N/A medical study run by Johns Hopkins University is evaluating whether 1MoreStep will have tolerable side effects & efficacy for patients with ...

3. reporter.nih.gov reporter.nih.gov/search/Jh5b2P8SKEWdfEMnzD217w/project-details/10258310

Project Details Black women living with HIV (LWH) continue to experience disparities in exposure to intimate partner violence (IPV) and sub-optimal HIV care engagement.

4. cochranelibrary.com cochranelibrary.com/content;jsessionid=686612DE2B176196DE4F19CFF0AF82C9?templateType=related&urlTitle=/central/doi/10.1002/central/CN-01479683&doi=10.1002/central/CN-01479683&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Dyadic, Skills-Based Primary Prevention for Partner ... Evaluation of a Brief Marriage Intervention for Internal Behavioral Health Consultants in Military Primary Care. NCT02571478. https://clinicaltrials.gov/show ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0070015

Patient Engagement (DBCOND0070015) 1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV, No drug interventions ...

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Top Domestic Violence Clinical Trials | Power The proposed research study seeks to develop, pilot-test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit within two community healthcare clinics ...