1MoreStep Program for HIV Care Engagement and Intimate Partner Violence

Recruiting in Palo Alto (17 mi)

Overseen by Kamila Alexander

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must be taking: Antiretroviral therapy

Disqualifiers: Not Black, Not female, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that 1MoreStep Program for HIV Care Engagement and Intimate Partner Violence is an effective treatment?

The available research shows that interventions aimed at improving HIV care engagement and adherence to medication are effective. For example, a study on telephone nurse counseling found that participants who received counseling had higher adherence to their medication. This suggests that programs like 1MoreStep, which focus on engaging patients in their care and supporting them in taking their medication, can be effective. Additionally, community HIV treatment advocacy programs have shown that participants had better adherence to their medication compared to those not in the program. These findings support the idea that the 1MoreStep Program can be an effective treatment for improving HIV care engagement. ^{1 2 3 4 5}

What safety data exists for the 1MoreStep Program?

The provided research does not contain specific safety data for the 1MoreStep Program or its variations. The studies focus on antiretroviral therapy adverse events, pregnancy safety data in HIV trials, and HIV care models, but none directly address the safety of the 1MoreStep Program. ^{1 6 7 8 9}

Is the 1MoreStep treatment a promising treatment for HIV care and intimate partner violence?

Yes, the 1MoreStep treatment is promising because it addresses both HIV care and intimate partner violence, which are often linked. By focusing on these issues together, it can help improve health outcomes and support people in staying engaged with their HIV care. ^{10 11 12 13 14}

Research Team

Kamila Alexander

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

I am 18 years old or older.

Exclusion Criteria

≥ 2 HIV care visits in previous 12 months

I am not a cisgender female.

Not living with HIV

Trial Timeline

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

Treatment Details

Interventions

• 1MoreStep (Behavioural Intervention)
• 1MoreStepControl (Behavioural Intervention)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Community HIV treatment advocacy programs may support treatment adherence. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Telephone nurse counseling improves HIV medication adherence: an effectiveness study. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. [2019]

8. United States 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. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Intimate partner violence and engagement in HIV care and treatment among women: a systematic review and meta-analysis. [2022]

11. United States 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Bidirectional Violence Is Associated with Poor Engagement in HIV Care and Treatment in Malawian Couples. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Interventions to address HIV and intimate partner violence in Sub-Saharan Africa: a review of the literature. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. [2023]