HIV Engagement and Adolescent Depression Support (HEADS-UP)

NCT ID: NCT06173544

Last Updated: 2025-05-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-06
• Study Completion Date: 2025-11-30

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.

Detailed Description

Sub-Saharan Africa is home to the largest population of adolescents living with HIV (ALWH). Engaging ALWH in HIV care is challenging and reflected in lower rates of viral suppression and higher rates of loss to follow-up as compared to adults in the region. Depression has been identified as a significant barrier to initiating and remaining in HIV care. Indeed, this is the case for ALWH in Malawi where estimates of viral suppression range from 40%-78% and estimates of depression range from 18-26%. Resource-appropriate interventions that improve depression and address engagement in HIV care for ALWH are urgently needed.

The Friendship Bench (FB) is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings but has not been adapted to be youth-friendly or enhanced with peer support to facilitate engagement in HIV care among ALWH. FB is based on problem-solving therapy, which offers an ideal framework for youth-friendly adaption and integration of retention peer support into a proven depression treatment model.

The long-term goal of the study team is to adapt, test, and scale up resource-appropriate interventions to reduce depression and improve engagement in HIV care amongst ALWH. The specific aims are: 1) to conduct formative research for youth-friendly adaptation and peer support enhancement of FB; 2) to adapt the evidence-based FB protocol to meet the developmental and contextual needs of ALWH and enhance this adapted FB protocol with peer support to facilitate HIV care engagement among ALWH; and 3) to determine the feasibility, fidelity, and acceptability of the Adapted and Enhanced FB protocols to improve depression and engagement in HIV care among ALWH. For the latter, a 3-arm individually randomized pilot study will be conducted to compare the adapted FB and the enhanced FB to standard care. The proposed aims pave the way for a R01 application to test the adapted and enhanced Friendship Bench interventions in a cluster randomized controlled trial and represent an important step forward towards improving depression among ALWH.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Adapted Friendship Bench (AFB)

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Enhanced Friendship Bench (EFB)

Intervention Type: BEHAVIORAL

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

Interventions

Standard of Care (SOC)

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

Intervention Type: BEHAVIORAL

Adapted Friendship Bench (AFB)

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RTI International

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley N Gaynes, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Nivedita L Bhushan, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

Area 18 Health Centre

Lilongwe, , Malawi

Site Status: RECRUITING

Area 25 Health Centre

Lilongwe, , Malawi

Site Status: RECRUITING

Kawale Health Centre

Lilongwe, , Malawi

Site Status: RECRUITING

Lighthouse Health Centre

Lilongwe, , Malawi

Site Status: RECRUITING

UNC Project Malawi

Lilongwe, , Malawi

Site Status: NOT_YET_RECRUITING

Countries

Malawi

Central Contacts

Bradley N Gaynes, MD

Role: CONTACT

bradley_gaynes@med.unc.edu

(919) 445-0214

Nivedita L Bhushan, PhD

Role: CONTACT

nbhushan@rti.org

(919)-248-8509

Facility Contacts

Bradley L Gaynes, MD

Role: primary

bradley_gaynes@med.unc.edu

(919) 445-0214

References

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.

Reference Type: DERIVED

PMID: 40106412 (View on PubMed)

Other Identifiers

R34MH130232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2439

Identifier Type: -

Identifier Source: org_study_id