Clinical trial NCT06173544: HIV Engagement and Adolescent Depression Support (HEADS-UP)
Official title: HIV Engagement and Adolescent Depression Support (HEADS-UP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Adolescent Behavior
HIV Infections
Immune System Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: RTI International
name: National Institute of Mental Health (NIMH)
First posted: 2023-12-15
Enrollment: 105
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-Arm Individually Randomized Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment Rate (Intervention Feasibility)
timeFrame: Baseline
measure: Number of participants retained in the study (Intervention Feasibility)
timeFrame: 12 months
measure: Proportion of sessions attended (Intervention Feasibility)
timeFrame: 12 Months
measure: Number of sessions meeting Fidelity Threshold (Intervention Fidelity)
timeFrame: 12 Months
measure: Overall Satisfaction among Participants (Intervention Acceptability)
timeFrame: 12 Months
Secondary outcomes:
measure: Change in depression symptoms from baseline
timeFrame: Baseline,12 months
measure: Number of adolescents living with HIV who attended at least one appointment per quarter
timeFrame: 12 months
measure: Number of Participants Achieving HIV Viral Suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Area 18 Health Centre
city: Lilongwe
country: Malawi
facility: Area 25 Health Centre
city: Lilongwe
country: Malawi
facility: Kawale Health Centre
city: Lilongwe
country: Malawi
facility: Lighthouse Health Centre
city: Lilongwe
country: Malawi
facility: UNC Project Malawi
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Bradley N Gaynes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RTI International
name: Nivedita L Bhushan, PhD
role: PRINCIPAL_INVESTIGATOR
References: