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HIV Engagement and Adolescent Depression Support (HEADS-UP)

NCT06173544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Standard of Care (SOC)

Participants randomized to this arm will received enhanced standard of care.

BEHAVIORAL

Adapted Friendship Bench (AFB)

Participants randomized to this arm will receive the Adapted Friendship Bench protocol delivered by a trained counselor.

BEHAVIORAL

Enhanced Friendship Bench (EFB)

Participants randomized to this arm will receive the Enhanced Friendship Bench protocol delivered by a trained counselor and a peer supporter.

Sponsors & Collaborators

  • RTI International

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Bradley N Gaynes, MD · University of North Carolina, Chapel Hill

  • Nivedita L Bhushan, PhD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-06
Primary Completion
2025-10-22
Completion
2025-10-22

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173544 on ClinicalTrials.gov