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.
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.59111314
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.1681012
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.12347
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.
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.Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Johns Hopkins School of NursingBaltimore, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Study looks at care model to improve drug adherence. Retention care counselor is major feature. [2007]Researchers have developed an extensive intervention aimed at improving HIV medical adherence among people most at risk of not taking their drugs or not showing up for medical appointments.
Comprehensive clinical adherence interventions to enable antiretroviral therapy: a case report. [2007]Adherence to antiretroviral therapy is key for successful treatment of HIV-infected persons. To enhance adherence, multilevel interventions are necessary. This is often a challenge, as this case of an HIV-infected man with a history of poor adherence and multiple virological failures shows. With a multidisciplinary approach, comprehensive intervention strategies were used to facilitate the patient's adherence to an enfuvirtide-based regimen. The interventions are described in detail and include adherence support with modified daily observed therapy, support regarding symptom management, and social relationships. The patient's clinical progress was monitored using indicators such as clinical surrogate markers, adherence to antiretroviral therapy, and HIV-related symptom and depression scores. The case illustrates how interventions that were individualized, culturally sensitive, and provided by a team of health care providers enabled a patient to optimize his adherence, which led to significant improvement in his clinical surrogate markers and subjective quality of life.
Telephone nurse counseling improves HIV medication adherence: an effectiveness study. [2019]Antiretroviral therapy remains a challenge for persons living with HIV (PLWH), who must maintain high levels of adherence to prevent viral resistance and treatment failure. This effectiveness study examined a telephonic nursing program to translate well-validated cognitive-behavioral and motivational interviewing adherence counseling into routine clinical care. Participants were 98 PLWH who were followed for up to 6 months after recruitment from HIV care settings across the United States. Each participant received telephone counseling (Mdn =three sessions) from a trained nurse who followed up with the participant over time. Nurses assessed participants' readiness for adherence, provided support to overcome identified barriers, and offered information based on participants' questions. At 6 months after the start of treatment, a greater percentage of participants had adherence at or above 95% than expected for this population, based on a clinical interview. Self-efficacy was related to baseline medication adherence, whereas other clinical and demographic variables were not. Attrition was a concern but was unrelated to adherence, self-efficacy, or clinical severity measures. Telephone counseling was associated with a relatively high percentage of participants reaching target antiretroviral therapy adherence levels and may be an effective method to disseminate psychologically based counseling into a broad range of care settings.
Community HIV treatment advocacy programs may support treatment adherence. [2021]Treatment advocacy (TA) programs, based in AIDS service organizations and clinics, aim to engage clients into care and support antiretroviral treatment (ART) adherence through client-centered counseling; advocate for patients with providers; and provide social service referrals. Systematic evaluations of TA are lacking. We conducted a non-randomized evaluation examining relationships of TA participation to adherence, care engagement, social services utilization, unmet needs, patient self-advocacy, and adherence self-efficacy among 121 HIV-positive clients (36 in TA, 85 not in TA; 87% male, 34% African American, 31% White, 19% Latino). In multivariate models, TA participants (vs. non-TA participants) showed higher electronically monitored [85.3% vs. 70.7% of doses taken; b(SE) = 13.16(5.55), p
Interventions to address HIV and intimate partner violence in Sub-Saharan Africa: a review of the literature. [2021]HIV and intimate partner violence (IPV) are commonly co-occurring epidemics affecting the health of women globally and especially in sub-Saharan Africa. There is a need for interventions that address both HIV and IPV in health care settings. Our review examined recent literature for intervention studies that explored both HIV and IPV. Of the nine interventions identified, only two were set in health care settings; the remainder were community based. Large multifaceted community-based interventions showed promise in the areas of addressing social norms in order to empower women. Educational interventions have shown short-term improvements in HIV-related knowledge and behavioral intention. Further research is needed to examine brief screening, intervention, and referral for HIV and IPV services within health care settings. Health care-specific interventions such as use of preexposure and postexposure prophylaxis to prevent HIV transmission must also be studied in the context of IPV.
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]To evaluate the trends in abacavir (ABC) prescription among antiretroviral (ARV) medication-naive individuals following the presentation of the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) cohort study.
Engagement in human immunodeficiency virus care: linkage, retention, and antiretroviral therapy adherence. [2017]Effective human immunodeficiency virus (HIV) care in the modern antiretroviral therapy (ART) era requires early entry into and retention in care. Early initiation and adherence to ART therapy improves outcomes. Many evidence-based tools and behavioral interventions are available to optimize adherence to care and ART and can be implemented in clinical settings. Monitoring care engagement and ART adherence creates the opportunity to intervene and prevent virologic failure or loss to follow up. Special HIV-infected populations, such as pregnant and mentally ill patients, require enhanced surveillance and care.
Improvements in HIV care engagement and viral load suppression following enrollment in a comprehensive HIV care coordination program. [2021]Substantial evidence gaps remain regarding human immunodeficiency virus (HIV) intervention strategies that improve engagement in care (EiC) and viral load suppression (VLS). We assessed EiC and VLS before and after enrollment in a comprehensive intervention for persons at risk of poor HIV care outcomes.
Intimate partner violence and engagement in HIV care and treatment among women: a systematic review and meta-analysis. [2022]We aimed to estimate the odds of engagement in HIV care and treatment among HIV-positive women reporting intimate partner violence (IPV).
Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. [2019]Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials.
Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. [2023]Although couples HIV testing and counseling (CHTC) is effective for facilitating mutual disclosure and linkage to HIV care, uptake remains low. Using a randomized controlled design, we tested the efficacy of a behavioral couples-based intervention aimed to increase CHTC.
Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]Antiretroviral therapy (ART) has modified the outcome of patients with HIV infection, providing virological control and reducing mortality. However, there are several reasons as to why patients may discontinue their antiretroviral therapy, with adverse events being one of the main reasons reported in the literature. This is a case-control nested in a cohort of people living with HIV/AIDS, conducted to identify the incidence of ART modification due to adverse events and the associated factors, in two referral services in Recife, Brazil, between 2011 and 2014. Of the modifications occurred in the first year of ART, 25.7% were driven by adverse events. The median time elapsed between initiating ART and the first modification due to adverse events was 70.5 days (95% CI: 26-161 days). The main adverse events were dermatological, neuropsychiatric and gastrointestinal. Dermatological events were the earliest to appear after initiating ART. Efavirenz was the most prescribed and most modified drug during the study period. The group of participants who used zidovudine, lamivudine, and efavirenz had a 2-fold greater chance (adjusted OR: 2.16 95% CI: 1.28-3.65) of switching ART due to adverse events when compared to the group that used tenofovir with lamivudine and efavirenz.
Bidirectional Violence Is Associated with Poor Engagement in HIV Care and Treatment in Malawian Couples. [2022]Growing evidence suggests that intimate partner violence (IPV) is a barrier to engagement in HIV care. Bidirectional IPV-being both a perpetrator and victim-may be the most common pattern of IPV, yet no research has examined its effect on engagement in care, which could identify couples in most need of interventions. Married couples (N = 211) with at least one partner on antiretroviral therapy were recruited from HIV clinic waiting rooms in Zomba, Malawi. Partners completed separate surveys on physical, sexual, and emotional IPV, medication adherence, and appointment attendance. We created categorical variables indicating no violence, perpetrator-only, victim-only, and bidirectional violence. Generalized estimating equation regression models tested for associations between IPV and engagement in care. The bidirectional pattern represented 25.4%, 35.5%, and 34.0% of all physical, sexual, and emotional IPV. Physical IPV victimization-only (adjusted odds ratio [AOR]: 0.28, 95% confidence interval [CI]: 0.08, 0.92) was associated with lower adherence, but the association was stronger for bidirectional physical IPV (AOR: 0.10, 95% CI: 0.02, 0.51). Bidirectional sexual IPV was also associated with lower adherence (AOR: 0.14, 95% CI: 0.02, 0.80). Bidirectional physical IPV (AOR: 4.04, 94% CI: 1.35, 12.14) and emotional IPV (AOR: 3.78, 95% CI: 1.78, 8.05) were associated with missing 1+ appointment. Interventions to address the health effects of bidirectional IPV, which may be greater than victim-only or perpetrator-only IPV, should intervene with both partners to break cycles of violence. Couple-based interventions may be a viable option by intervening on both partners' trauma and aggression simultaneously.
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]Intimate partner violence (IPV) is associated with a higher risk of contracting HIV and developing worse HIV outcomes. This cross-sectional, mixed methods study presents data on IPV using the Conflicts Tactics Scale (CTS2-S) among 180 persons with HIV in Lima, Peru, as well as qualitative interviews with 7 of them and 18 of their community caregivers. This study used data collected for a randomized controlled trial (RCT), CASAommunity Based Accompaniment with Supervised Antiretrovirals (CASA) Community-based Accompaniment with Supervised Antiretrovirals (CASA). Physical or sexual IPV was self-reported in 82 (45.6%) of participants reporting having been in a relationship in the last year and 59,8% of those were involved in bidirectional violence. Coping subscales, social support, and stigma were associated with IPV. Intimate partner violence negatively impacted patient adherence to medication and care, particularly during times of severe conflict. In conclusion, profound psychosocial vulnerability-including low social support, substance use as coping, and HIV stigma-contextualize IPV among people with HIV. Bidirectional violence often evolved over time as victims negotiated inter-personal strategies for survival, including retaliation. Interventions should focus on a deeper understanding IPV and facilitating of coping mechanisms to help people with HIV stay in care.