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Search / Trial NCT06173544

HIV Engagement and Adolescent Depression Support (HEADS-UP)

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Dec 7, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The HIV Engagement and Adolescent Depression Support (HEADS-UP) trial is a study aimed at helping teenagers who are living with HIV and may also be dealing with depression or anxiety. The study will involve 105 adolescents aged 13 to 18, who will be randomly assigned to one of three groups: standard care, an adapted intervention, or an enhanced intervention called the Friendship Bench Intervention. This intervention focuses on providing counseling to help these young people manage their feelings and stay connected to their HIV care.

To be eligible to participate, teens must be between 13 and 18 years old and have a diagnosis of HIV. They also need to show signs of depression through a questionnaire. Participants can expect to receive support through counseling and will be monitored throughout the study. It’s important to know that the trial is currently recruiting participants, so if you think you or someone you know might be eligible, reach out to the clinic for more information.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age 13-18
  • diagnosed with HIV (vertically or horizontally)
  • scored ≥ 13 on the self-reported and previously used BDI-II
  • living in the clinic's catchment area with intention to remain for \> 1 year
  • willing to provide consent (age 18 or 16-17 years old and married (emancipated minors per Malawi law) or assent with parental consent (age 13-17)
  • Exclusion Criteria:
  • Less than 13 or greater than 18 years of age

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Lilongwe, , Malawi

Lilongwe, , Malawi

Lilongwe, , Malawi

Lilongwe, , Malawi

Lilongwe, , Malawi

Patients applied

0 patients applied

Trial Officials

Bradley N Gaynes, MD

Principal Investigator

University of North Carolina, Chapel Hill

Nivedita L Bhushan, PhD

Principal Investigator

RTI International

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported