๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-05-20

Menopausal HT for Women Living With HIV (HoT) (NCT06856174)

Menopausal Hormone Therapy for Women Living With HIV (HoT)

๐ŸŸข Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if: * There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV * Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV * Hormone therapy is safe and tolerable for women living with HIV

Who can join: Review the eligibility criteria below.

Location: 31788 Alabama CRS โ€” Birmingham, Alabama

Age range: 40 Years to 60 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (23 Sites)

  • 31788 Alabama CRS โ€” Birmingham, Alabama
  • University of California, Los Angeles CARE Center CRS (601) โ€” Los Angeles, California
  • UCSD Antiviral Research Center CRS (701) โ€” San Diego, California
  • 801 University of California, San Francisco HIV/AIDS CRS โ€” San Francisco, California
  • Harbor - UCLA Med. Ctr. CRS โ€” Torrance, California
  • University of Colorado Hospital CRS (6101) โ€” Aurora, Colorado
  • The Ponce de Leon Center CRS (5802) โ€” Atlanta, Georgia
  • Northwestern University CRS (2701) โ€” Chicago, Illinois
  • 201 Johns Hopkins University CRS โ€” Baltimore, Maryland
  • 101 Massachusetts General Hospital (MGH) CRS โ€” Boston, Massachusetts
  • Brigham and Women's Hosp. ACTG CRS (107) โ€” Boston, Massachusetts
  • 2101 Washington University Therapeutics (WT) CRS โ€” St Louis, Missouri
  • New Jersey Medical School Clinical Research Center CRS (31786) โ€” Newark, New Jersey
  • Weill Cornell Chelsea CRS (7804) โ€” New York, New York
  • Columbia Physicians and Surgeons (P&S) CRS (30329) โ€” New York, New York
  • 3201 Chapel Hill CRS โ€” Chapel Hill, North Carolina
  • 3203 Greensboro CRS โ€” Greensboro, North Carolina
  • 2401 Cincinnati CRS โ€” Cincinnati, Ohio
  • Case CRS (2501) โ€” Cleveland, Ohio
  • Ohio State University CRS (2301) โ€” Columbus, Ohio
  • 6201 Penn Therapeutics CRS โ€” Philadelphia, Pennsylvania
  • Univ of Pittsburgh โ€” Pittsburgh, Pennsylvania
  • Houston AIDS Research Team CRS (31473) โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (301) 628-3348

Email: ACTGCT.gov@dlhcorp.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All HIV Infection clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—