DepressionHEADS-UPNCT06173544
HIV Engagement and Adolescent Depression Support (HEADS-UP)
A study testing Adapted Friendship Bench (AFB) and Enhanced Friendship Bench (EFB) in people with Depression and Anxiety, run by University of North Carolina, Chapel Hill at 5 sites in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Depression, Anxiety, Adolescent Behavior
- What is being tested?
- Adapted Friendship Bench (AFB) and Enhanced Friendship Bench (EFB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesMalawi
- Study dates
- 6 Jul 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Less than 13 or greater than 18 years of age
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Malawi5 sites
Area 18 Health Centre
Lilongwe
Area 25 Health Centre
Lilongwe
Kawale Health Centre
Lilongwe
Lighthouse Health Centre
Lilongwe
UNC Project Malawi
Lilongwe
About this study
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.
Read the 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
- Being tested
- Standard of Care (SOC), Adapted Friendship Bench (AFB), Enhanced Friendship Bench (EFB)
- Medical subject headings
- Depression, Anxiety Disorders, Adolescent Behavior, HIV Infections, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Behavioural
Participants randomized to this arm will received enhanced standard of care.
Adapted Friendship Bench (AFB)Behavioural
Participants randomized to this arm will receive the Adapted Friendship Bench protocol delivered by a trained counselor.
Enhanced Friendship Bench (EFB)Behavioural
Participants randomized to this arm will receive the Enhanced Friendship Bench protocol delivered by a trained counselor and a peer supporter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Enhanced Friendship Bench (EFB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled of the Participants Approached (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 number of participants enrolled of the participants approached.
Measured: 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.
Measured: 12 months
Number of Participants Who Received Full Intervention (Intervention Feasibility)
The number of participants who attended all 6 planned Friendship Bench counseling sessions.
Measured: 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. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.
Measured: 12 Months
Overall Satisfaction Among Participants (Intervention Acceptability)
Intervention acceptability was measured as the number of participants who would either probably or definitely recommend the Friendship Bench to other adolescents living with HIV with depression. Responses were measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
Measured: 6 Months
Secondary outcomes (3)
Change in Depression Symptoms From Baseline
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.
Measured: Baseline,12 months
Number of Adolescents Living With HIV Who Attended at Least One Appointment Per Quarter
Number of adolescents living with HIV who attended at least one appointment per quarter.
Measured: 12 months
Number of Participants Achieving HIV Viral Suppression
Number of participants achieving HIV viral suppression at 12 months (HIV RNA no detect + <839 copies/mL)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start6 Jul 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-Arm Individually Randomized Trial
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Bradley N Gaynes, MD, Principal investigator, University of North Carolina, Chapel HillNivedita L Bhushan, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173544
- Sponsor's protocol ID
- 23-2439
- Other IDs
- R34MH130232
- Acronym
- HEADS-UP
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2023
- Last updated
- 30 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Publications
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.
PubMed 40106412
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Engagement and Adolescent Depression Support (HEADS-UP)
- ClinicalTrials.gov ID
- NCT06173544
- Acronym / sponsor ID
- HEADS-UP / 23-2439
- Conditions
- Depression, Anxiety, Adolescent Behavior, HIV Infections, Immune System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- RTI International, National Institute of Mental Health (NIMH)
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Posted 30 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-Arm Individually Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Behavioral: 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. |
| Adapted Friendship Bench (AFB) | Experimental | Behavioral: 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. |
| Enhanced Friendship Bench (EFB) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Less than 13 or greater than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Participants randomized to this arm will received enhanced standard of care. | Behavioural | Standard of Care (SOC) |
| Adapted Friendship Bench (AFB)Participants randomized to this arm will receive the Adapted Friendship Bench protocol delivered by a trained counselor. | Behavioural | Adapted Friendship Bench (AFB) |
| 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. | Behavioural | Enhanced Friendship Bench (EFB) |
Primary outcome
Number of Participants Enrolled of the Participants Approached (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 number of participants enrolled of the participants approached.
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.
Number of Participants Who Received Full Intervention (Intervention Feasibility)
Time frame: 12 Months
The number of participants who attended all 6 planned Friendship Bench counseling sessions.
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. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.
Overall Satisfaction Among Participants (Intervention Acceptability)
Time frame: 6 Months
Intervention acceptability was measured as the number of participants who would either probably or definitely recommend the Friendship Bench to other adolescents living with HIV with depression. Responses were measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
3 secondary outcomes
Change in Depression Symptoms From Baseline
Time frame: Baseline,12 months
Number of Adolescents Living With HIV Who Attended at Least One Appointment Per Quarter
Time frame: 12 months
Number of Participants Achieving HIV Viral Suppression
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40106412Dao 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley N Gaynes, MD principal investigator
University of North Carolina, Chapel Hill
Nivedita L Bhushan, PhD principal investigator
RTI International
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Friendship Bench (AFB) and Enhanced Friendship Bench (EFB) in people with Depression and Anxiety, run by University of North Carolina, Chapel Hill at 5 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled of the Participants Approached (Intervention Feasibility) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.