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Completed

NCT Number: NCT06173544

HIV Engagement and Adolescent Depression Support (HEADS-UP)

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.

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Key information

Conditions

Depression Adolescent Behavior Anxiety Anxiety Disorders Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Area 18 Health Centre, Lilongwe, Malawi

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care (SOC)

Behavioral

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

Adapted Friendship Bench (AFB)

Behavioral

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

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.

Primary outcomes

  1. Recruitment Rate (Intervention Feasibility)

    Time frame: Baseline

    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).

  2. Number of participants retained in the study (Intervention Feasibility)

    Time frame: 12 months

    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.

  3. Proportion of sessions attended (Intervention Feasibility)

    Time frame: 12 Months

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

  4. Number of sessions meeting Fidelity Threshold (Intervention Fidelity)

    Time frame: 12 Months

    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.

  5. Overall Satisfaction among Participants (Intervention Acceptability)

    Time frame: 12 Months

    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.

Secondary outcomes

  1. Change in depression symptoms from baseline

    Time frame: Baseline,12 months

    Change in depression symptoms from baseline will be evaluated using Beck's Depression Inventory (BDI-II). The Beck Depression Inventory (BDI-II) is a 21-item patient self-report measure of the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is zero and the maximum total score is 63. A total score of 0-13 is considered nondepressed, 14-19 represents mild depression, 20-28 represents moderate depression, and 29-63 represents severe depression. Lower scores represent better outcomes. Scores reported are change in symptoms relative to baseline.

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

    Time frame: 12 months

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

  3. Number of Participants Achieving HIV Viral Suppression

    Time frame: 12 months

    Number of participants achieving HIV viral suppression at 12 months (HIV RNA < 1000 copies/mL).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • RTI International

Registry information

Acronym: HEADS-UP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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