The SOOTHE Trial is a clinical trial that investigates if pregnenolone, a neuroactive steroid, can improve brain health and depressed mood in people with HIV, without causing too many side effects. Study participants have an opportunity to contribute to scientists' knowledge about new treatments for depression in those living with HIV.

The trial takes place at MGH Main Campus and MGH Charlestown Navy Yard in Boston, MA. Participants travel to those locations for 4 in-person visits. We will provide local travel reimbursement and free on-site parking. MGH Main Campus: 55 Fruit St, Cox Building, Floor 6, Boston, MA 02114 MGH Charlestown Navy Yard: 149 13th Street, Martinos Center, Floor 1, Charlestown, MA 02129

We hope to enroll 120 adults with HIV.

Study staff will schedule 15-minute phone calls with participants between visits. During this time, we will ask about their mood and any side effects they may be experiencing.

It varies for each visit. Generally, participants complete questionnaires about how they are feeling, complete a brief physical exam with the study doctor, and get their blood drawn. The second and the fourth (final) visit will be longer than others due to a 2-hour MRI brain scan.

It takes about 2-3 months to complete the trial.

Yes. We provide compensation for time and participation at the end of each visit. Participants receive up to $609 at the completion of the study. We also offer travel reimbursement, free parking at MGH, and meal vouchers.

SOOTHE is funded by the National Institute of Health (NIH), more specifically the National Institute of Mental Health (NIMH) which is one of the centers that make up the NIH.