ACT + Exercise + Social Support for Women with HIV

(WE RISE Trial)

Recruiting at 1 trial location

Overseen By Liliana Harkness

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Hospice, Video refusal, others

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

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

300 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{2 11 12 13 14}

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.

Research Team

Maile Karris, MD

Principal Investigator

UCSD

Eligibility 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

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.

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

Treatment Details

Interventions

• Acceptance and Commitment Therapy (ACT)
• Body weight circuit training
• Empathetic social support

Trial Overview 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.

Participant Groups

Group I: WE RISE Intervention Experimental Treatment 3 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: Observational Experimental Treatment 3 Interventions

Observational study of participants undergoing WE RISE adapted for sustainability.

Group III: Control Active Control 1 Intervention

Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

By His Stripes

Collaborator

Trials

1

Recruited

300+

Christie's Place

Collaborator

Trials

1

Recruited

300+

By His Stripes Wellness Center

Collaborator

Trials

1

Recruited

300+

Sister Love

Collaborator

Trials

1

Recruited

300+

APLA Health

Collaborator

Trials

2

Recruited

670+

Findings from Research

In a pilot study involving young adult females, those who participated in Acceptance and Commitment Therapy (ACT) showed a significant increase in physical activity compared to those who received an Education intervention.

The ACT intervention, which included mindfulness and values clarification techniques, suggests that this therapeutic approach can effectively promote short-term behavior change related to physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of acceptance and commitment therapy for promotion of physical activity. Butryn, ML., Forman, E., Hoffman, K., et al.[2022]

A new Acceptance and Commitment Therapy (ACT)-based intervention was developed for hospitalized patients with HIV who are not consistently engaged in care, showing high acceptability among participants.

Of the patients who attended at least three sessions, half followed up with HIV care and achieved a viral load of less than 20 copies/mL two months after the intervention, indicating potential efficacy in improving treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dindo, L., Moitra, E., Roddy, MK., et al.[2023]

A group resilience training program based on Acceptance and Commitment Therapy (ACT) significantly improved resilience, quality of life, and reduced depression and stress in 37 participants with multiple sclerosis over a 3-month period.

The program was well-received, demonstrating high participant engagement and retention, and highlighted the importance of ACT processes like defusion and acceptance in enhancing physical health quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of a resilience training program for people with multiple sclerosis. Pakenham, KI., Mawdsley, M., Brown, FL., et al.[2020]

This study adapted an Acceptance and Commitment Therapy (ACT) intervention for people living with HIV who engage in hazardous drinking, using a systematic approach that included input from both patients (13 participants) and healthcare providers (10 participants).

The adaptation process followed the ADAPT-ITT model, which provides a structured framework for developing behavioral interventions, ensuring that the new ACT intervention is tailored to the specific needs of PWH and can be effectively implemented in future randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. Woolf-King, SE., Firkey, M., Foley, JD., et al.[2022]

Acceptance-based treatment (ABT) for weight loss significantly increased participants' intentions to engage in physical activity compared to standard behavioral treatment (SBT), with notable improvements observed at mid-treatment and the end of treatment.

The study found that higher intentions for physical activity partially mediated the weight loss effects of ABT, as participants who intended to be more active also increased their actual moderate-to-vigorous physical activity over the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. Godfrey, KM., Schumacher, LM., Butryn, ML., et al.[2020]

HIV-positive women in sub-Saharan Africa expressed significant concerns about body image and the side effects of antiretroviral treatment (ART), highlighting the psychological impact of their condition and treatment.

A therapeutic exercise intervention showed some positive effects on body self-image, with statistical significance found in four out of nine subscale items, indicating that exercise may help improve body satisfaction among these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a therapeutic exercise intervention on depression and body self-image in HIV-positive women in sub-Saharan Africa. Daniels, AK., Van Niekerk, RL.[2023]

Coping with medication side effects and comorbid illnesses can significantly impact behaviors related to health, such as medication adherence and exercise, which may influence HIV disease progression.

Interventions that target psychosocial factors and promote healthy behaviors could potentially reduce morbidity and mortality in patients living with HIV/AIDS, highlighting the importance of addressing mental health alongside physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral mediation of the relationship between psychosocial factors and HIV disease progression. Gore-Felton, C., Koopman, C.[2022]

In a study of 50 HIV-infected patients, those who were employed reported higher levels of social acceptance and overall quality of life compared to unemployed or retired individuals, highlighting the importance of employment in social support for these patients.

The findings suggest that addressing social acceptance and employment status could be crucial in improving the mental health and quality of life for HIV-infected individuals, indicating a need for further research into effective support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Factors of Social Acceptance in Patients Infected With Human Immunodeficiency Virus (HIV) at the Yazd Behavioral Consultation Center in Iran. Bidaki, R., Mousavi, SM., Bashardoust, N., et al.[2020]

Adherence to highly active antiretroviral therapy (HAART) is crucial for reducing HIV levels and mortality, yet many patients struggle to meet the required 95% adherence rate, with 40% to 60% of patients often falling below 90% adherence.

Factors such as mental illness and substance abuse significantly hinder adherence, with patients suffering from mental health issues being over seven times more likely to not follow their HAART regimen, highlighting the need for tailored support strategies to improve treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for improving patient adherence to therapy and long-term patient outcomes. Battaglioli-DeNero, AM.[2022]

In a study of 324 participants, HIV-positive individuals on highly active antiretroviral therapy (HAART) engaged in significantly less vigorous physical activity compared to those not on treatment, indicating a potential impact of HAART on physical activity levels.

The study found that injection drug use and viral load did not influence the levels of vigorous activity, suggesting that other factors related to HAART may contribute to reduced physical activity among these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in a cohort of HIV-positive and HIV-negative injection drug users. Smit, E., Crespo, CJ., Semba, RD., et al.[2018]

Acceptance and Commitment Therapy (ACT) was found to be perceived as appropriate and relevant for people living with HIV who also engage in hazardous drinking, suggesting its potential as a tailored intervention.

Participants expressed both satisfaction and dissatisfaction with ACT, highlighting the need to address specific positive and negative effects, as well as identifying facilitators and barriers to effectively implementing this therapy in HIV care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. Woolf-King, SE., Sheinfil, AZ., Babowich, JD., et al.[2023]

A study involving 30 pregnant women living with HIV in South Africa highlighted that access to resources, such as support from family and partners, is crucial for maintaining adherence to antiretroviral therapy (ART).

The research suggests that enhancing women's sense of agency and focusing on their long-term health goals can improve ART adherence during the peripartum period, indicating a need for interventions that empower women in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowerment in pregnancy: ART adherence among women living with HIV in Cape Town, South Africa. DiClemente-Bosco, K., Weber, AZ., Harrison, A., et al.[2023]

Social support is crucial in promoting physical activity among people living with HIV and AIDS (PLWHA) of low socio-economic status (SES), helping to overcome barriers to exercise.

Interventions aimed at increasing physical activity in PLWHA of low SES should be designed to leverage social support and address the specific socio-ecological challenges they face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, social support and socio-economic status amongst persons living with HIV and AIDS: a review. Mabweazara, SZ., Ley, C., Leach, LL.[2019]

A scoping review of 41 studies involving 14,835 participants found that social determinants of health (SDOH), particularly gender, social support, and income, significantly influence engagement in physical activity among people living with HIV.

Most studies focused on only one SDOH at a time, highlighting the need for future research to explore how multiple SDOH interact and affect exercise participation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Social Determinants of Health on Engagement in Physical Activity or Exercise among Adults Living with HIV: A Scoping Review. Safa, F., McClellan, N., Bonato, S., et al.[2023]

References

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

A pilot study of acceptance and commitment therapy for promotion of physical activity. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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]

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

Pilot evaluation of a resilience training program for people with multiple sclerosis. [2020]

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

Development of a Telephone-Delivered Acceptance and Commitment Therapy Intervention for People Living with HIV who are Hazardous Drinkers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. [2020]

6. New Zealand pubmed.ncbi.nlm.nih.gov

The impact of a therapeutic exercise intervention on depression and body self-image in HIV-positive women in sub-Saharan Africa. [2023]

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

Behavioral mediation of the relationship between psychosocial factors and HIV disease progression. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Individual Factors of Social Acceptance in Patients Infected With Human Immunodeficiency Virus (HIV) at the Yazd Behavioral Consultation Center in Iran. [2020]

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

Strategies for improving patient adherence to therapy and long-term patient outcomes. [2022]

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

Physical activity in a cohort of HIV-positive and HIV-negative injection drug users. [2018]

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

Acceptance and Commitment Therapy (ACT) for HIV-infected Hazardous Drinkers: A Qualitative Study of Acceptability. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Empowerment in pregnancy: ART adherence among women living with HIV in Cape Town, South Africa. [2023]

13. South Africa pubmed.ncbi.nlm.nih.gov

Physical activity, social support and socio-economic status amongst persons living with HIV and AIDS: a review. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of the Social Determinants of Health on Engagement in Physical Activity or Exercise among Adults Living with HIV: A Scoping Review. [2023]