HIV/AIDSORCHID-MiamiNCT05935644
ORCHID: An Online Intervention for Persons With HIV (Miami)
A study testing ORCHID in people with HIV/AIDS and HPV Infection, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to test ORCHID (Optimizing Resilience \& Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- HIV/AIDS, HPV Infection
- What is being tested?
- ORCHID
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cis-gender women,
- Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
- Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:
- drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal
Who cannot join
- Under 18
- Not able to read/write English at the 6th grade level
- Cognitively impaired adults (as documented in medical records)
- Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
About this study
Official title: ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
The purpose of this research is to test ORCHID (Optimizing Resilience \& Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.
- Conditions
- HIV/AIDS, HPV Infection
- Being tested
- ORCHID
- Keywords
- depression, mobile applications, cortisol levels
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Papillomavirus Infections, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORCHIDBehavioural
The intervention includes 8 modules, which are delivered online, approximately 30 minutes per session, and participants will engage a minimum of once per week. Participants may also meet online or in-person with a navigator, up to 4 times.
| Study group | Role | What they receive |
|---|---|---|
| ORCHID Group | Experimental | 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. Receives: Behavioral: ORCHID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who Complete ORCHID
Average across all participants of the proportion of participants who login to all 8 ORCHID intervention sessions, calculated as total number of sessions opened (0-8) divided by 8.
Measured: Up to 6 months
Secondary outcomes (2)
Depression as measured by Patient Health Questionnaire (PHQ-9)
Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms
Measured: Up to 6 months
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)
Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Oct 2024
- Primary completion27 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunthita M. Duthely, University of Miami
- Investigators
- Lunthita M Duthely, Ed.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935644
- Sponsor's protocol ID
- 20221247
- Acronym
- ORCHID-Miami
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)
- ClinicalTrials.gov ID
- NCT05935644
- Acronym / sponsor ID
- ORCHID-Miami / 20221247
- Conditions
- HIV/AIDS, HPV Infection
- Keywords
- depression, mobile applications, cortisol levels
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to test ORCHID (Optimizing Resilience \& Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORCHID Group | Experimental | Behavioral: ORCHIDParticipants 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 may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cis-gender women,
- Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
- Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:
- drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal
Key exclusion criteria (5 listed)
- Under 18
- Not able to read/write English at the 6th grade level
- Cognitively impaired adults (as documented in medical records)
- Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORCHIDThe intervention includes 8 modules, which are delivered online, approximately 30 minutes per session, and participants will engage a minimum of once per week. Participants may also meet online or in-person with a navigator, up to 4 times. | Behavioural | ORCHID Group |
Primary outcome
Proportion of Participants who Complete ORCHID
Time frame: Up to 6 months
Average across all participants of the proportion of participants who login to all 8 ORCHID intervention sessions, calculated as total number of sessions opened (0-8) divided by 8.
2 secondary outcomes
Depression as measured by Patient Health Questionnaire (PHQ-9)
Time frame: Up to 6 months
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lunthita M Duthely, Ed.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORCHID in people with HIV/AIDS and HPV Infection, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who Complete ORCHID (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.