HIV Engagement and Adolescent Depression Support (HEADS-UP)

NCT06173544 | Completed DMC

• 2 other identifiers: 23-2439R34MH130232
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 5

Brief 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

Depression; Anxiety; Adolescent Behavior; HIV Infections; Immune System Diseases

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate (Intervention Feasibility)

  This measure is the ability to successfully enroll adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

  Baseline

• Number of participants retained in the study (Intervention Feasibility)

  This measure of feasibility will be measured as the ability to retain adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.

  12 months

• Proportion of sessions attended (Intervention Feasibility)

  The number of sessions attended by participants out of total number of sessions offered.

  12 Months

• Number of sessions meeting Fidelity Threshold (Intervention Fidelity)

  Fidelity to content for sessions will be assessed by a member of the research team using a checklist of intervention characteristics. Intervention fidelity will be measured as the total number of sessions meeting or exceeding expectations for at least 80% of the total number of fidelity checklist items assessed per session.

  12 Months

• Overall Satisfaction among Participants (Intervention Acceptability)

  Acceptability will be assessed through brief exit interviews with a sample of adolescents living with HIV (ALWH), all study staff, and supervisors. Exit interviews will assess how easy the intervention was to participate in or deliver, the perceived usefulness of the intervention, suggestions for improvement, and will explore contextual factors that impeded or facilitated implementation. Intervention acceptability will be measured as the number of participants who were either very satisfied or somewhat satisfied with the intervention. Satisfaction will be measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.

  12 Months

Secondary Outcomes (3)

• Change in depression symptoms from baseline

  Baseline,12 months

• Number of adolescents living with HIV who attended at least one appointment per quarter

  12 months

• Number of Participants Achieving HIV Viral Suppression

  12 months

Study Arms (3)

Standard of Care (SOC)

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care (SOC)

Adapted Friendship Bench (AFB)

EXPERIMENTAL

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.

Behavioral: Adapted Friendship Bench (AFB)

Enhanced Friendship Bench (EFB)

EXPERIMENTAL

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.

Behavioral: Enhanced Friendship Bench (EFB)

Interventions

Standard of Care (SOC) BEHAVIORAL

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

Standard of Care (SOC)

Adapted Friendship Bench (AFB) BEHAVIORAL

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

Adapted Friendship Bench (AFB)

Enhanced Friendship Bench (EFB) BEHAVIORAL

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

Enhanced Friendship Bench (EFB)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Less than 13 or greater than 18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• RTI International: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (5)

Area 18 Health Centre

Lilongwe, Malawi

Location

Area 25 Health Centre

Lilongwe, Malawi

Location

Kawale Health Centre

Lilongwe, Malawi

Location

Lighthouse Health Centre

Lilongwe, Malawi

Location

UNC Project Malawi

Lilongwe, Malawi

Location

Related Publications (1)

• Dao TTD, Gaynes BN, Pence BW, Mphonda SM, Kulisewa K, Udedi M, Stockton MA, Kramer J, Waddell KG, Faidas M, Mortensen H, Bhushan NL. Friendship Bench intervention to address depression and improve HIV care engagement among adolescents living with HIV in Malawi: Study protocol for a pilot randomized controlled trial. PLoS One. 2025 Mar 19;20(3):e0302666. doi: 10.1371/journal.pone.0302666. eCollection 2025.

  PMID: 40106412 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Adolescent Behavior; HIV Infections; Immune System Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bradley N Gaynes, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Nivedita L Bhushan, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-Arm Individually Randomized Trial

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: July 6, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months after publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

MA (5)