HIV Engagement and Adolescent Depression Support (HEADS-UP)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Malawi
Area 18 Health Centre
RECRUITING
Lilongwe
Area 25 Health Centre
RECRUITING
Lilongwe
Kawale Health Centre
RECRUITING
Lilongwe
Lighthouse Health Centre
RECRUITING
Lilongwe
UNC Project Malawi
NOT_YET_RECRUITING
Lilongwe
Contact Information
Primary
Bradley N Gaynes, MD
bradley_gaynes@med.unc.edu
(919) 445-0214
Backup
Nivedita L Bhushan, PhD
nbhushan@rti.org
(919)-248-8509
Time Frame
Start Date: 2024-07-06
Estimated Completion Date: 2025-11
Participants
Target number of participants: 105
Treatments
Active_comparator: Standard of Care (SOC)
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi will be enrolled in this study arm during study recruitment. Enhanced usual care will include general training of the HIV providers and clinics about common mental disorder (CMD) identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Enhanced usual care will included a mental health evaluation provided by a rained study nurse; brief supportive counseling; information, education, and support on depression; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic or to the tertiary care hospital.
Experimental: Adapted Friendship Bench (AFB)
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the AFB protocol.
Experimental: Enhanced Friendship Bench (EFB)
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will receive 6 weekly counseling sessions and peer support per the EFB protocol.
Related Therapeutic Areas
Sponsors
Collaborators: RTI International, National Institute of Mental Health (NIMH)
Leads: University of North Carolina, Chapel Hill