Online Intervention for HIV/AIDS

(ORCHID-Miami Trial)

Recruiting at 1 trial location

Overseen By Wilmar B Mondestin, MSPS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Under 18, Cognitive impairment, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), designed to improve mental health for people with HIV. It aims to help those at risk of discontinuing care by reducing depression and boosting positive emotions. The trial targets cis-gender women receiving HIV care at the University of Miami who have experienced cervical or anal dysplasia or HPV in the past year. Participants should also have a recent history of drug use, depression, anxiety, PTSD, or an unsuppressed HIV viral load. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for HIV care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this online intervention is safe for persons with HIV?

Research has shown that the ORCHID program is designed to help people with HIV improve their mental health. This is crucial because living with HIV can be stressful, and stress can hinder overall health.

While specific safety data from studies on ORCHID itself is not available, its nature as an online mental health program suggests it is likely low-risk. Online programs typically focus on skill-building and mental support, which generally do not have physical side effects like some medications.

Since ORCHID is neither a drug nor a physical treatment, it is less likely to cause serious physical side effects. Participants can expect the program to enhance mood and coping strategies, benefiting mental well-being. It is advisable to discuss any concerns with a healthcare provider before starting a new program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ORCHID treatment because it offers a unique online intervention specifically designed to address the emotional well-being of people living with HIV. Unlike traditional treatments that often focus solely on managing the physical aspects of the disease, ORCHID aims to improve depressive symptoms and enhance positive emotions, which are crucial for overall health. This digital approach allows for accessibility and continuous support, potentially providing mental health benefits over a six-month period without the need for regular in-person visits.

What evidence suggests that ORCHID is effective for improving mental health in persons with HIV?

Research shows that the ORCHID program, which participants in this trial will receive, may help people with HIV by reducing stress and improving mental well-being. Earlier studies found ORCHID promising in enhancing mental health for those experiencing high levels of depression. Participants reported feeling better and having a more positive outlook on life. Additionally, ORCHID strengthens resilience (the ability to bounce back from challenges) and coping skills, which are important for adhering to treatment plans. These early findings suggest that ORCHID could be a helpful tool for supporting mental health in people with HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Lunthita M Duthely, Ed.D.

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

The ORCHID trial is for adult women with HIV who are treated at the University of Miami Women's HIV Service. They must have had HPV or related health issues in the past year and may struggle with substance use or mental health conditions like depression, anxiety, or PTSD. Participants should not be cognitively impaired, imprisoned, under 18, unable to read/write English at a basic level, or have severe psychiatric disorders.

Inclusion Criteria

I am a cisgender woman with HIV receiving care at the University of Miami.

I have had cervical or anal issues, HPV, or mental health/drug use problems in the last year.

Exclusion Criteria

Not able to read/write English at the 6th grade level

Cognitively impaired adults (as documented in medical records)

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ORCHID online intervention to improve mental health status for up to 6 months

6 months

8 online sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ORCHID

Trial Overview ORCHID is an online program designed to help improve mental well-being in women living with HIV. It focuses on building skills to cope better and stay engaged in their healthcare. The study will evaluate how effective this intervention is for those who might be at risk of dropping out of care due to various challenges.

How Is the Trial Designed?

Group I: ORCHID Group Experimental Treatment 1 Intervention

Participants in the ORCHID group will receive an online intervention that improves depressive symptoms and positive affect (emotions) for clinic-based persons living with HIV, for up to 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

To achieve the UNAIDS 90-90-90 targets for HIV treatment, there is a critical need to address the psychosocial barriers that hinder vulnerable populations from accessing prevention, testing, and treatment services.

The supplement emphasizes the importance of resilience in HIV-affected individuals, showcasing innovative interventions that help them cope with challenges and improve their overall well-being, beyond just surviving with the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From surviving to thriving: the role of resilience in meeting global HIV goals. Harrison, SE., Li, X., Vermund, SH.[2023]

In a study of 2,864 HIV-infected individuals, four distinct coping strategies were identified, with 'passive' copers showing the highest emotional well-being and physical functioning, while those using blame-withdrawal coping experienced more symptoms and lower well-being.

The study found that coping strategies can change over time, with 46% of participants maintaining the same coping configuration after one year; those with fewer symptoms were more likely to adopt passive coping, indicating a link between emotional well-being and coping effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of coping among persons with HIV infection: configurations, correlates, and change. Fleishman, JA., Sherbourne, CD., Cleary, PD., et al.[2021]

A study of 166 HIV/AIDS patients in Uganda revealed that 76% experienced significant side effects from antiretroviral (ARV) medications, with common issues including tiredness, nightmares, and nausea, which negatively impacted their quality of life and treatment adherence.

Despite many patients using coping strategies like seeking information and social support, 27% reported non-adherence to their ARV medications as a way to manage side effects, highlighting the need for ongoing education and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal coping strategies for managing the side effects of antiretroviral therapy among patients at an HIV/AIDS clinic in Uganda. Kyajja, R., Muliira, JK., Ayebare, E.[2022]

The E-VOLUTION texting intervention, which sent automated reminders and support messages to 100 young adults living with HIV over 26 months, significantly improved adherence to medical appointments and viral load suppression, indicating its efficacy in enhancing HIV care.

Participants found the texting intervention acceptable, and the frequency of alerts triggered by their responses was positively correlated with better health outcomes, suggesting that this culturally responsive approach effectively engages youth in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-VOLUTION: A Text Messaging-Powered Intervention-Connection, Support, and HIV Eradication. Gerke, DR., Glotfelty, J., Schlueter, J., et al.[2021]

A qualitative study involving 28 participants from a pilot trial in rural Uganda found that many individuals living with HIV demonstrated resilience in adhering to antiretroviral therapy (ART) after the withdrawal of a technology-based adherence support intervention, indicating that they internalized the habit of medication adherence.

While most participants developed effective coping strategies and maintained adherence, a minority struggled without the intervention, highlighting the importance of ongoing support and the variability in individual resilience and social support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience after withdrawing a technology-based medication adherence support intervention from people living with HIV in rural Uganda. Musiimenta, A., Atukunda, EC., Tumuhimbise, W., et al.[2023]

A study involving 48 HIV-positive older adults identified key coping strategies, including reliance on religiosity and spirituality, adherence to treatment, and support from health professionals and social networks.

These coping strategies serve as sources of empowerment and hope, helping older adults with HIV to accept their diagnosis and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living with HIV: coping strategies of seropositive older adults. Brandão, BMGM., Angelim, RCM., Marques, SC., et al.[2021]

The Balance Project intervention, which consists of 5 sessions using cognitive behavioral techniques, effectively improves adherence to antiretroviral medication among individuals living with HIV who face significant distress from medication side effects.

By promoting adaptive coping strategies, this intervention has been shown to prevent nonadherence, highlighting its potential for enhancing health outcomes and reducing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming Barriers to HIV Treatment Adherence: A Brief Cognitive Behavioral Intervention for HIV-Positive Adults on Antiretroviral Treatment. Olem, D., Sharp, KM., Taylor, JM., et al.[2022]

A longitudinal study of 61 HIV-positive individuals showed that overall distress decreased significantly over 1.5 years, indicating that many people adapt well to living with HIV and maintain a good quality of life.

However, those with high distress levels, particularly drug users, often used ineffective coping strategies and reported a low quality of life, highlighting the need for professional support like psychotherapy for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal development of distress, coping and quality of life in HIV-positive persons. Leiberich, P., Engeter, M., Olbrich, E., et al.[2019]

The Positive Outlook Program, a 7-week online self-management program for HIV-positive gay men, significantly improved health-related quality of life and self-efficacy in managing psychosocial issues, as shown by positive outcomes in various subscales measured at baseline, post-intervention, and 12 weeks later.

Participants in the intervention group reported notable improvements in areas such as body change, social relationships, emotional distress, and health-directed activities, indicating that online self-management programs can effectively enhance well-being and coping skills for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Positive Outlook Study: A Randomised Controlled Trial Evaluating Online Self-Management for HIV Positive Gay Men. Millard, T., Agius, PA., McDonald, K., et al.[2019]

A study involving 10 diverse HIV-positive individuals found that using the Internet significantly enhances their coping abilities by promoting empowerment, increasing social support, and enabling them to help others.

This research highlights the importance of unstructured online resources for individuals managing HIV, suggesting that personal Internet use can be beneficial even without access to formal support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping in cyberspace: the impact of Internet use on the ability of HIV-positive individuals to deal with their illness. Reeves, PM.[2018]

The SECope measure, developed to assess coping strategies for HIV treatment side effects, has shown strong reliability and validity through analyses of two samples of HIV-positive individuals (N=173 and N=233).

Nonadherence to treatment as a coping strategy was linked to negative outcomes, such as poorer relationships with healthcare providers and lower treatment knowledge, highlighting the importance of addressing side effects to improve adherence and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with HIV treatment side effects: conceptualization, measurement, and linkages. Johnson, MO., Neilands, TB.[2022]

The Masivukeni multimedia intervention improved medication adherence by 10% among participants compared to an 8% decrease in the standard of care group, indicating its potential effectiveness in supporting HIV+ patients.

Participants using Masivukeni reported better attitudes towards medication disclosure, increased social support, and improved relationships with healthcare providers, suggesting that this approach enhances the psychosocial aspects of adherence counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Lay Counselor Capacity to Improve Patient Outcomes with Multimedia Technology. Robbins, RN., Mellins, CA., Leu, CS., et al.[2022]

In a study of 429 HIV/AIDS patients, positive religious coping strategies, like seeking spiritual support, were linked to better health outcomes, including improved quality of life and self-esteem over 12-18 months.

Conversely, spiritual struggle, such as feelings of anger towards God, was associated with negative health outcomes, highlighting the importance of addressing spiritual well-being in HIV/AIDS care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religious coping and physiological, psychological, social, and spiritual outcomes in patients with HIV/AIDS: cross-sectional and longitudinal findings. Trevino, KM., Pargament, KI., Cotton, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01997008

Study Details | Optimizing Resilience and Coping in HIV ... Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11428577/

A hybrid type II effectiveness-implementation trial of a positive ... Social support, positive states of mind, and HIV treatment adherence in men and women living with HIV/AIDS. Health Psychol. 2004;23(4):413 ...

3. trialx.com trialx.com/clinical-trials/listings/233341/a-hybrid-type-ii-trial-of-the-optimizing-resilience-and-coping-with-hiv-through-internet-delivery-in-ryan-white-clinics-in-chicago/?&geo_lat=41.9239939&geo_lng=-87.7483017&radius=10&place=Durate&user_country=United%20States

A Hybrid Type II Trial of the Optimizing Resilience and Coping ... The investigators propose to address this gap with ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery), a self-guided online-delivered ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-01526

A Skills-Building Intervention (ORCHID) to Improve Mental ... ORCHID may be an effective method to reduce stress and improve the overall well-being and quality of life in women with HIV and cervical or anal dysplasia.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05935644/orchid-an-online-intervention-for-persons-with-hiv-miami

An Online Intervention for Persons With HIV (Miami) The purpose of this research is to test ORCHID (Optimizing Resilience & Coping ... Hiv/aids. Treatment. ORCHID. Clinical Study ID. NCT05935644.

6. ctv.veeva.com ctv.veeva.com/study/a-hybrid-type-ii-trial-of-the-optimizing-resilience-and-coping-with-hiv-through-internet-delivery-in

A Hybrid Type II Trial of the Optimizing Resilience and Coping ... The National HIV/AIDS Strategy goals for engagement in each phase of the continuum include: 85% of those diagnosed with HIV linked to care ...

7. reporter.nih.gov reporter.nih.gov/search/HB_mkTibS0eHAvrP64AmVA/project-details/10995374

Developing a suicide prevention intervention for people with ... This study supports NIH HIV/AIDS Research Priorities to reduce mental health comorbidities of HIV and strengthen the HIV care continuum. Candidate: I am a ...

8. ujpronline.com ujpronline.com/index.php/journal/article/download/1324/1890

mental health trajectories in hiv-infected patients Coping mechanisms used by caregivers of HIV/AIDS orphans in North West province, South Africa. ... Effect of a WeChat-Based Hybrid Intervention on the Adaptation ...

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Long‐term success for people living with HIV: A framework ... ... HIV improves treatment outcome: a single-centre experience from the Middle East. AIDS Care – Psychol Socio-Med Asp AIDS/HIV. 2018; 30(9): ...

10. frontiersin.org frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2021.665723/full

An Intervention by and for Transgender Women Living With ... Evidence of the disproportionate rates of HIV infection, AIDS-related mortality, and uncontrolled viral load among transgender women has been rapidly increasing ...