ACT + Exercise + Social Support for Women with HIV
(WE RISE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byMaile Karris, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Disqualifiers: Hospice, Video refusal, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this combination Type 1 hybrid and observational study is to evaluate the impact of a peer delivered intervention of acceptance and comittment therapy(ACT) + exercise + social support to address the substance (ab)use, violence, and AIDS/HIV (SAVA) to improve medication adherence for women living with HIV (WLWH). This intervention will be implemented by community based organizations that focus on WLWH across four counties. The main question it aims to answer are:
* Will peer provision of ACT, exercise, and social support improve medication adherence for WLWH?
* Will community based organizations be able to sustain the intervention after research is completed, and what changes will need to be made to sustain th eintervention.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on improving medication adherence, so it's likely you will continue your current HIV treatment.
What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) combined with exercise and social support for women with HIV?
Research suggests that Acceptance and Commitment Therapy (ACT) can help improve physical activity and engagement in HIV care, which are important for managing HIV. Additionally, ACT has shown promise in improving resilience and quality of life in other conditions, indicating its potential benefits for women with HIV.
12345Is the combination of ACT, exercise, and social support safe for women with HIV?
The research suggests that therapeutic exercise and social support are generally safe for people with HIV, as they can help with mental health issues like depression and improve adherence to treatment. However, the specific combination of ACT, exercise, and social support has not been directly studied for safety, but each component individually is considered safe.
678910How does the ACT + Exercise + Social Support treatment for women with HIV differ from other treatments?
This treatment is unique because it combines Acceptance and Commitment Therapy (ACT), which helps individuals accept their thoughts and feelings while committing to positive behavior changes, with physical exercise and empathetic social support. This holistic approach addresses both mental and physical health, aiming to improve overall well-being and engagement in HIV care, which is not typically the focus of standard HIV treatments.
211121314Eligibility Criteria
This trial is for women living with HIV who struggle with substance use, have experienced trauma, and may have difficulty sticking to their medication regimen. Participants should be connected to community organizations in the four target counties.Inclusion Criteria
I was assigned female at birth.
Able to read and understand English
Able to participate in a low intensity exercise program
+6 more
Exclusion Criteria
I am not willing to be recorded in video sessions.
Enrolled in hospice
I am unable or unwilling to follow the study's participation rules.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo the WE RISE intervention, which includes acceptance and commitment therapy, exercise, and social support, delivered twice a week for 8 weeks.
8 weeks
16 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at weeks 0, 8, 24, and 48.
48 weeks
4 visits (in-person)
Observational
Observational study focusing on the sustainability of the WE RISE intervention, with the same assessment schedule as in phase 1.
48 weeks
Participant Groups
The study tests a peer-delivered program combining Acceptance and Commitment Therapy (ACT), exercise routines, and empathetic social support. It aims to see if this approach helps improve medication adherence among women with HIV.
3Treatment groups
Experimental Treatment
Active Control
Group I: WE RISE InterventionExperimental Treatment3 Interventions
Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.
Group II: ObservationalExperimental Treatment3 Interventions
Observational study of participants undergoing WE RISE adapted for sustainability.
Group III: ControlActive Control1 Intervention
Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UC San Diego AntiViral Research Center (AVRC)San Diego, CA
University of California San DiegoSan Diego, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
By His StripesCollaborator
Christie's PlaceCollaborator
By His Stripes Wellness CenterCollaborator
Sister LoveCollaborator
APLA HealthCollaborator
References
A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]Acceptance and commitment therapy (ACT) appears to have some promise as a method of promoting physical activity.
Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. [2023]Roughly 40% of persons with HIV (PWH) are not consistently involved in HIV care in the US. Finding out-of-care PWH is difficult, but hospitalization is common and presents an opportunity to re-engage PWH in outpatient care. The aims of this study were to (1) develop an Acceptance and Commitment Therapy (ACT)-based intervention for hospitalized, out-of-care PWH who endorse avoidance-coping to improve HIV treatment engagement; (2) examine the intervention’s initial feasibility and acceptability; and (3) to revise the study protocol (including the intervention), based on stakeholder feedback, in preparation for a randomized controlled trial (RCT) comparing ACT to treatment as usual. Therapists and HIV care experts developed a four-session ACT-based intervention to be delivered during hospitalization. Fifteen hospitalized patients with poorly controlled HIV enrolled in the open trial, eight completed four sessions, two completed three sessions, and seven provided qualitative feedback. Patients universally liked the intervention and the holistic approach to mental health and HIV care. Refinements included repeating key concepts, including representative graphics, and translating to Spanish. Among the patients who attended ≥3 ACT sessions, 5/10 attended a HIV-care follow-up visit and 5/7 who had labs had a viral load
Pilot evaluation of a resilience training program for people with multiple sclerosis. [2020]To evaluate the feasibility and psychosocial outcomes of an Acceptance and Commitment Therapy (ACT)-based group resilience training program for people with multiple sclerosis (PwMS). Research Method/Design: The study used a pre-post group intervention design with 3-month follow-up. The intervention consisted of 8 group sessions of 2.5 hours each with 7 weekly sessions plus a booster Session 5 weeks later. Thirty-seven PwMS completed questionnaires. Primary psychosocial outcomes were resilience, quality of life (QoL), and distress. Secondary outcomes were the ACT processes: mindfulness, defusion, values and acceptance.
Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. [2022]Alcohol use among people living with HIV (PWH) has been increasingly recognized as an important component of HIV care. Transdiagnostic treatments, such as Acceptance and Commitment Therapy (ACT), that target core processes common to multiple mental health and substance-related problems, may be ideal in HIV treatment settings where psychological and behavioral health comorbidities are high. In advance of a randomized clinical trial (RCT), the overall objective of this study was to systematically adapt an ACT-based intervention originally developed for smoking cessation, into an ACT intervention for PWH who drink at hazardous levels. Consistent with the ADAPT-ITT model, the adaptation progressed systematically in several phases, which included structured team meetings, three focus group discussions with PWH (N = 13), and in-depth interviews with HIV providers (N = 10), and development of standardized operating procedures for interventionist training, supervision, and eventual RCT implementation. The procedures described here offer a template for transparent reporting on early phase behavioral RCTs.
Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. [2020]Acceptance-based treatment (ABT) for weight loss has shown promise for improving outcomes relative to standard behavioral treatment (SBT). One way in which ABT may improve outcomes is through increasing physical activity (PA) intentions and behavior but little research has examined these as mediators of ABT on weight change.
The impact of a therapeutic exercise intervention on depression and body self-image in HIV-positive women in sub-Saharan Africa. [2023]Attitudes, responses, and reactions of HIV-positive women in three sub-Saharan African regions toward a therapeutic exercise intervention, aimed to determine the presence of depression and low body self-image, were captured. This provided insight into body satisfaction and desire to exercise (Stage 1, n=60), body self-image and depression (Stage 2, n=60), and overall concerns around the often adverse side effects of antiretroviral treatment (ART). A program of therapeutic (specialty) exercise was developed for the experimental design (Stage 2), to quantify the psychological side effects of these variables.
Behavioral mediation of the relationship between psychosocial factors and HIV disease progression. [2022]The psychological and physical demands of coping with medication side effects and comorbid illnesses can be overwhelming and may influence behaviors, such as medication adherence, substance use, sexual risk behavior, and exercise that, in turn, affect health outcomes. Cross-sectional and prospective studies among diverse populations of persons living with HIV suggest that these behavioral mechanisms may be associated with HIV disease progression. The motivation to change behavior is often highest in the immediate aftermath of a stressor. However, over time the motivation to continue a particular behavior change is often challenged by habits, environmental influences, and psychosocial factors. Furthermore, a number of studies suggest that behavioral mechanisms may mediate the relationship between psychosocial variables (e.g., stress, depression, coping, and social support) and disease progression in HIV. Thus, developing clinical interventions that address these psychosocial factors and enhance protective health behaviors and reduce behaviors that convey risk to health are likely to lessen overall morbidity and mortality among patients living with HIV/AIDS.
Individual Factors of Social Acceptance in Patients Infected With Human Immunodeficiency Virus (HIV) at the Yazd Behavioral Consultation Center in Iran. [2020]A considerable number of patients infected with HIV also have mental health problems. Individual psychotherapy is an effective way to treat these issues. Lack of social acceptance is a barrier to patients receiving proper medication and emotional/psychological support.
Strategies for improving patient adherence to therapy and long-term patient outcomes. [2022]Adherence to treatment regimens is essential to the success of highly active antiretroviral therapy (HAART) in patients infected with HIV. Multiple research studies have clearly demonstrated the close association between proper adherence to HAART and decreases in both plasma HIV RNA levels and HIV-associated mortality rates. In an effort to maintain virologic suppression, adherence levels of 95% are required for patients treated with HAART. However, community reports suggest that actual adherence levels are often far lower than those required for successful HAART; many studies show that 40% to 60% of patients are less than 90% adherent. Multiple reasons for nonadherence to HAART regimens have been reported by patients infected with HIV. Patients with mental illness (e.g., depression) are more than seven times more likely not to adhere to HAART regimens compared with patients without mental illness. Substance abuse is also a major barrier to adherence, with approximately 66% of HIV-infected intravenous drug users reporting suboptimal adherence to HAART regimens. Other barriers to adherence include uncertainty about both the effectiveness of treatment and the consequences of poor adherence, regimen complexity, side effects of treatment, and lack of social support. This article will discuss the strategies that should be used by all members of the multidisciplinary team treating patients with HIV/AIDS to encourage patient adherence to treatment. These strategies include educating and motivating patients, simplifying treatment regimens and tailoring them to individual lifestyles, preparing for and managing side effects, and addressing the concrete issues that may present barriers to adherence. In addition, adherence-boosting interventions that have established efficacy in controlled trials, such as motivational interviewing, and nurse-based interventions for patient populations with low health-literacy will be reviewed.
Physical activity in a cohort of HIV-positive and HIV-negative injection drug users. [2018]Physical activity is beneficial for persons with HIV infection but little is known about the relationships between physical activity, HIV treatment and injection drug use (IDU). This study compared physical activity levels between HIV-negative and HIV-positive injection drug users (IDUs) and between HIV-positive participants not on any treatment and participants on highly active antiretroviral therapy (HAART). Anthropometric measurements were obtained and an interviewer-administered modified Paffenbarger physical activity questionnaire was administered to 324 participants in a sub-study of the AIDS Linked to Intravenous Experiences (ALIVE) cohort, an ongoing study of HIV-negative and HIV-positive IDUs. Generalized linear models were used to obtain univariate means and to adjust for confounding (age, gender, employment and recent IDU). Vigorous activity was lower among HAART participants than HIV-positive participants not on treatment (p=0.0025) and somewhat lower than HIV-negative participants (p=0.11). Injection drug use and viral load were not associated with vigorous activity. Energy expenditure in vigorous activity was also lower among HAART participants than both HIV-negative and HIV-positive participants not on treatment. Thus, HIV-positive participants on HAART spend less time on vigorous activity independent of recent IDU. More research is needed into the reasons and mechanism for the lack of vigorous activities, including behavioral, psychological and physiological reasons.
Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. [2023]Alcohol use is a significant problem in HIV care, and clinical trials of alcohol interventions for people living with HIV infection (PLWH) have produced mixed results. The purpose of this qualitative study was to collect preliminary data on the practical feasibility and acceptability of Acceptance and Commitment Therapy (ACT) as a treatment for PLWH who are hazardous drinkers. A total of 25 PLWH participated in individual interviews. Four major themes emerged from the thematic analysis: (I) Perceived Appropriateness for PLWH and People who use Alcohol and/or other Substances, (II) General Satisfaction and Dissatisfaction, (III) Positive and Negative Effects on Participants and (IV) Facilitators and Barriers to Implementing ACT Intervention Strategies.
Empowerment in pregnancy: ART adherence among women living with HIV in Cape Town, South Africa. [2023]Adherence to antiretroviral therapy (ART) is a global concern among pregnant and postpartum women living with HIV (WLHIV). Research focusing on peripartum WLHIV and how they balance adherence, engaging in HIV care, and other forms of self-care is limited. Women's empowerment theories have been applied to myriad health behaviors to understand patterns, establish mechanisms, and develop interventions; yet empowerment theory as applied to ART is under-researched.
Physical activity, social support and socio-economic status amongst persons living with HIV and AIDS: a review. [2019]Physical activity can be used for the effective and comprehensive management of HIV and AIDS. Social support and socio-economic status (SES) are two factors that shape physical activity behaviours. Individuals of low SES carry a disproportionate burden of the HIV and AIDS epidemic. In addition, limited resources constitute socio-ecological barriers predisposing such individuals to physical inactivity. The purpose of this narrative review is to examine the available literature on physical activity, social support and SES and to generate recommendations for designing and implementing physical activity interventions targeting people living with HIV and AIDS (PLWHA) of low SES. The review used literature from Google, Google Scholar and PubMed on physical activity of PLWHA, social support for physical activity, and SES and physical activity. Qualitative and quantitative studies in English were included from 1970 to 2016. The results show that social support plays a major role in promoting physical activity and counteracting the barriers to PA in PLWHA of low SES. The results on the role of social support and the influence of SES are integrated to help design appropriate physical activity interventions for PLWHA of low SES. Well-designed interventions should utilise social support and be contextualised for PLWHA of low SES, whose living conditions present multiple barriers to physical activity.
The Role of the Social Determinants of Health on Engagement in Physical Activity or Exercise among Adults Living with HIV: A Scoping Review. [2023]Physical activity (PA) and exercise are an effective rehabilitation strategy to improve health outcomes among people living with HIV (PLWH). However, engagement in exercise among PLWH can vary. Our aim was to characterize the literature on the role of social determinants of health (SDOH) on engagement in PA or exercise among adults living with HIV. We conducted a scoping review using the Arksey and O'Malley Framework. We searched databases between 1996 and 2021. We included articles that examined PA or exercise among adults with HIV and addressed at least one SDOH from the Public Health Agency of Canada Framework. We extracted data from included articles onto a data extraction charting form, and collated results using content analytical techniques. Of the 11,060 citations, we included 41 articles, with 35 studies involving primary data collection 23 (66%) quantitative, 8 (23%) qualitative, and four (11%) mixed methods. Of the 14,835 participants, 6398 (43%) were women. Gender (n = 24 articles), social support (n = 15), and income and social status (n = 14) were the most commonly reported SDOH in the literature with the majority of studies addressing only one SDOH. Future research should consider the intersection between multiple SDOH to better understand their combined impact on engagement in PA or exercise among PLWH.