Mental Health Program for People Living With HIV

(ORCHID Trial)

Not currently recruiting at 2 trial locations

Overseen By Katrin Bovbjerg

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: None

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new online program called BHS+ORCHID, designed to help people living with HIV improve mental health and manage depression. Participants will engage in self-guided training on positive thinking skills through weekly online sessions. The trial targets individuals receiving care at specific clinics in Chicago, who have experienced symptoms of depression and have daily internet access. The study aims to improve depression, health care involvement, and control of the HIV virus. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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. It seems likely that you can continue your current medications, as the focus is on mental health screening and an online intervention.

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 seems focused on mental health support rather than medication changes.

What prior data suggests that this mental health program is safe for people living with HIV?

Research shows that the BHS+ORCHID program, which includes a health questionnaire and an online activity to improve mood, is generally well-received by people living with HIV. Earlier studies tested this program, and results suggest it is both feasible and liked by participants. These studies have shown early signs of effectiveness without major negative side effects.

Since this trial is in Phase 2, the treatment has already passed initial safety tests in earlier studies. This phase focuses more on the treatment's effectiveness and continues to monitor its safety. If the treatment were unsafe, it likely wouldn't have reached this stage. While more information is always useful, current evidence suggests the treatment is safe for people to use so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BHS+ORCHID treatment for people living with HIV because it offers a novel approach by combining mental health screening with a positive affect skills training program. Unlike the traditional standard of care, which often focuses on managing the physical aspects of HIV, this intervention addresses mental health concerns like depression by equipping individuals with skills to boost their emotional well-being through weekly online sessions and daily exercises. This dual focus not only aims to improve mental health outcomes but also potentially enhances overall quality of life for those affected.

What evidence suggests that the BHS+ORCHID intervention could be effective for people living with HIV?

Research has shown that the ORCHID program, part of the BHS+ORCHID intervention studied in this trial, can improve mental health and overall well-being in people with HIV. Studies have found that increased positivity can lead to better mental health, slower HIV progression, and improved medication adherence. The ORCHID program, available online, has successfully increased positive feelings and reduced stress. This improvement has been linked to better control of the HIV virus and a higher quality of life. The program teaches skills to build resilience and manage stress, which are crucial for managing both mental and physical health in people with HIV. Participants in this trial may receive either the BHS+ORCHID intervention or standard care. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 living with HIV in Chicago, who are clients at Ryan White clinics and show signs of depression. Participants must speak English, have daily internet access, and agree to share their health information.

Inclusion Criteria

You are able to speak and understand English.

You are currently receiving medical care at one of the approved Ryan White clinics.

Your PHQ-9 score is higher than 5, indicating you may be experiencing depression, and you were referred by your medical case manager.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive self-guided training on 8 positive affect skills through weekly online sessions and daily practice exercises

8 weeks

Follow-up

Participants are monitored for changes in depression and engagement in care at 3 follow-up points

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BHS+ORCHID

Trial Overview The study tests a mental health intervention called ORCHID delivered online to improve mood and health outcomes in HIV patients. It involves screening for depression and providing resources through case managers using a stepped wedge design.

How Is the Trial Designed?

Group I: Behavioral Health Screener + ORCHID Intervention (BHS+ORCHID) Experimental Treatment 1 Intervention

At the clinic level, sites randomized to implement BHS+ORCHID will receive training, materials, and other support to administer behavioral health screening and refer their clients with elevated depression symptoms to ORCHID. At the individual level, those clients who are eligible and choose to enroll in ORCHID will receive self-guided training on 8 positive affect skills through weekly online sessions and daily practice exercises.

Group II: Standard of Care Active Control 1 Intervention

usual care

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

AIDS Foundation of Chicago

Collaborator

Trials

1

Recruited

300+

AIDS Foundation Chicago

Collaborator

Trials

1

Recruited

300+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

A study involving 299 participants living with HIV/AIDS in rural areas tested two telephone-delivered mental health interventions, but neither significantly reduced depressive or psychological symptoms.

Participants in the Information Support Group reported increased support from friends and fewer barriers to healthcare at follow-ups, suggesting that while the interventions may enhance social support, their overall impact on mental health symptoms was limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of two telephone-delivered, mental health interventions for HIV-infected persons in rural areas of the United States. Heckman, TG., Carlson, B.[2007]

In a study of 346 gay, bisexual, and other men who have sex with men living with HIV in Guatemala, increased frequency of health navigation interactions was associated with significant improvements in anxiety levels.

Participants who received high levels of informational support from navigators experienced greater reductions in anxiety, while more in-person interactions unexpectedly worsened anxiety, suggesting that navigation programs should focus on frequent and informative support to enhance mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining How Health Navigation Affects Mental Health Among Gay, Bisexual, and Other Men Who Have Sex with Men Living with Human Immunodeficiency Virus in Guatemala. Davis, DA., Angeles, G., McNaughton-Reyes, L., et al.[2022]

An online self-help program based on cognitive behavioral therapy is being tested for its effectiveness in reducing depressive symptoms in people living with HIV, with a study involving a randomized controlled design comparing an intervention group to a waiting list-control group.

Participants will engage with the program over 6 to 10 weeks, receiving weekly motivational support, and the study aims to identify which patients benefit most and the mechanisms that lead to treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial. van Luenen, S., Kraaij, V., Spinhoven, P., et al.[2018]

A pilot trial involving 22 women living with HIV showed that both cognitive behavioral therapy and supportive psychotherapy delivered via videoconferencing significantly reduced depression symptoms and maintained high adherence to antiretroviral therapy over 6 months.

The study demonstrated that telemedicine is a feasible and acceptable method for providing mental health support to women with HIV, with a high retention rate of 95% and positive participant satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and preliminary impact of telemedicine-administered cognitive behavioral therapy for adherence and depression among African American women living with HIV in the rural South. Junkins, A., Psaros, C., Ott, C., et al.[2022]

The CHAMP study demonstrated that 9 months of in-home mental health counseling significantly reduced psychiatric symptoms in 40 individuals with HIV and major mental disorders, as evidenced by improvements in the Brief Symptom Inventory scores.

Participants also showed significant enhancements in mental health, coping skills, and social support, suggesting that in-home treatment can effectively engage and support HIV-positive individuals facing mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-home mental health treatment for individuals with HIV. Reif, SS., Pence, BW., LeGrand, S., et al.[2021]

Over half of the 122,896 people with HIV studied (55.1%) were diagnosed with one or more mental health disorders, with the most common being depressive (39%) and anxiety disorders (28%).

While retention in HIV care was similar for those with and without mental health disorders, individuals with bipolar disorder and mental health multimorbidity showed slightly lower rates of viral suppression, indicating a potential need for targeted interventions in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of mental health disorders in people with HIV and the effects on the HIV care continuum. Lang, R., Hogan, B., Zhu, J., et al.[2023]

The systematic review highlights a significant connection between mental health and HIV, indicating that individuals with mental illness may have higher rates of HIV infection and face unique challenges in managing their health.

There is a pressing need for well-designed studies to explore effective mental health interventions within HIV treatment programs, as existing research suggests that factors like coping strategies and family support can improve mental health outcomes for those affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the relevance of mental health to HIV/AIDS care and treatment programs in developing countries? A systematic review. Collins, PY., Holman, AR., Freeman, MC., et al.[2022]

The systematic review highlights a significant prevalence of mental health disorders among people living with HIV/AIDS (PLHA) in India, indicating a critical need for targeted mental health support.

The study identifies gaps in existing policies and programs that fail to adequately address the mental health needs of PLHA, emphasizing the importance of addressing stigma and discrimination in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental health needs of people living with HIV/AIDS in India: a literature review. Das, S., Leibowitz, GS.[2018]

A systematic review of 26 studies on mental health interventions for people living with HIV in low and middle-income countries found that only four randomized controlled trials showed significant improvements in mental health outcomes, indicating limited efficacy of current interventions.

Most interventions were based on cognitive-behavioral approaches, but there is a need for further development and adaptation of these mental health services to better suit the resource-limited settings of LMICs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving mental health among people living with HIV: a review of intervention trials in low- and middle-income countries. Sikkema, KJ., Dennis, AC., Watt, MH., et al.[2022]

A study of 128 individuals with HIV in Montréal revealed that mental health distress is significantly influenced by factors such as age, sex, and source of income, with common issues including uncertainty about the future and feelings of helplessness.

Respondents in Montréal reported higher levels of distress compared to those in Toronto and Halifax, primarily due to demographic differences, highlighting the need for tailored mental health services for HIV-infected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological distress in persons afflicted with HIV in Montreal]. Lamping, DL., Joseph, L., Ryan, B., et al.[2006]

A qualitative study involving 42 people living with HIV revealed that telephone-delivered behavioral health services, such as mindfulness training and health coaching, are seen as convenient and flexible, allowing for easier scheduling and rapport-building with interventionists.

Participants noted some challenges, like network connectivity issues, but overall, they found telephone delivery to be a beneficial way to access mental health support and improve medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-delivered behavioral health interventions for people living with HIV: patients' perspectives from a qualitative study. Dunne, EM., Rosen, RK., Rich, C., et al.[2022]

HIV-infected individuals in impoverished settings experience significant mental health challenges, including depression and isolation, largely due to structural factors like poverty and stigma, as revealed through focus group discussions with patients and providers.

To effectively address the mental health issues faced by these individuals, it is crucial to integrate mental health services into HIV care and utilize community health workers, while also focusing on poverty alleviation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health Burden Among Impoverished HIV-Positive Patients in Peru. Shin, S., Muñoz, M., Caldas, A., et al.[2018]

Citations

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

Optimizing Resilience and Coping in HIV Via Internet ... Immune System Diseases. Behavioral Symptoms. Behavior. Acquired Immunodeficiency Syndrome. Depression. Stress, Psychological. Investigative Techniques. Methods.

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9204837/

Development of an implementation facilitation strategy to ... ... ORCHID (Optimizing Resilience and Coping with HIV through Internet Delivery) ... Published in final edited form as: J Acquir Immune Defic Syndr. 2022 Jul 1 ...

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. withpower.com withpower.com/trial/phase-3-9-2021-e6def

Mental Health Program for People Living With HIV A study involving 299 participants living with HIV/AIDS in rural areas tested two telephone-delivered mental health interventions, but neither significantly ...

6. sigma.larvol.com sigma.larvol.com/ott.php?e1=22762&e2=&DiseaseCatId=22762&tab=DiseaseOTT&sourcepg=TZ&sr=now&er=1+month&phase=2&ipwnd=on&rlink=,DiseaseCatId=22762,tab=DiseaseOTT&rflag=1&page=27

Online Trial Tracker NCT07090174: Testing for Safety and Immune Effects of PDS0101, an Anti ... Human Immunodeficiency Virus (HIV), Cardiovascular Risk Factor. 10/28. 01/29 ...

7. discover.pbcgov.org discover.pbcgov.org/communityservices/BHSUCOD/Documents/DRAFT_BHSUCOD_2024%20Plan%20Update_03122024.pdf

Behavioral Health and Substance Use Disorder Plan 2024 recovery through building of resilience. The CDT ... delivery fidelity and compliance, technology maintenance, information security, data collection, ... Outcomes ...

8. ldh.la.gov ldh.la.gov/assets/csoc/block_grant/FY_2026_2027_DRAFT_Block_Grant_Application.pdf

DRAFT FY 2026-2027 Combined Behavioral Health ... Optimizing Outcomes and Maintaining Safety: learning from experts by ... Immunodeficiency Virus (HIV), Hypodermic Needle Prohibition. Persons ...

9. uclahealth.org uclahealth.org/sites/default/files/documents/b7/steven-shoptaw-cv.pdf

Steven J. Shoptaw, Ph.D. Human Immunodeficiency Virus transmission by HIV Risk Group and Along the HIV. Care Continuum: A Contrast of 6 US Cities. J Acquir Immune Defic Syndr. 2022 ...