NCT07226128 The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV
| NCT ID | NCT07226128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-04-10 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.
Eligibility Criteria
Inclusion Criteria: * HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load. * Age ≥ 18 years. * Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening * Meets the depression definition for this trial: * (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND * (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND * (3) functional impairment (using the tenth PHQ-9 item assessing social/occupational impairment), AND * (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND * (5) no bipolar or psychotic disorders NOTE: The use of antidepressant medications is not exclusionary. * HbA1c \< 6.5% at Screening * HIV-1 RNA level \< 75 copies/mL at Screening NOTE: There are no CD4 cell count eligibility criteria for this trial. Exclusion Criteria: * Inability to complete written, informed consent * Inability to read and understand English as seen on a computer screen * Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5% * History of bipolar disorder or a psychotic disorder, including schizophrenia NOTE: Depressive disorders are not exclusionary. * Incarceration at the time of any study visit * Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix). * Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases). NOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation * End stage renal disease requiring renal replacement therapy (dialysis, transplantation). * Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit. NOTE: Localized treatment for skin cancers is not exclusionary. • Therapy for serious medical illnesses within 14 days prior to the Entry Visit NOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation. * Pregnancy or breastfeeding during the study. * Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit NOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors NOTE: Use of NSAIDS and aspirin are allowed • Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
Contact & Investigator
Samir K Gupta, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07226128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07226128 currently recruiting?
Yes, NCT07226128 is actively recruiting participants. Contact the research team at diground@iu.edu for enrollment information.
Where is the NCT07226128 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07226128 clinical trial?
NCT07226128 is sponsored by Indiana University. The principal investigator is Samir K Gupta, MD at Indiana University. The trial plans to enroll 150 participants.
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