HIVNCT06702722
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
A study testing Enhanced Friendship Bench in people with HIV and Depression, run by University of North Carolina, Chapel Hill at 5 sites in Malawi.
Trial summary
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV, Depression, Depression, Postpartum
- What is being tested?
- Enhanced Friendship Bench
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesMalawi
- Study dates
- 26 Feb 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting for antenatal care at one of our 5 recruitment sites
- ≥ 18 years of age
- ≤ 34 weeks gestation
- HIV-positive, based on medical records
- Initiating, re-initiating, or on established ART during index pregnancy
- Elevated depressive symptoms as indicated by a EPDS score ≥10. The EPDS is widely used to assess perinatal mood disorders that has been validated in perinatal populations in Malawi with this cut point to identify probable perinatal depression
Who cannot join
- Suicidal ideation evaluated as acute risk.
- Other health concerns requiring emergent response.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Angela Bengtson, PhD, MA contact
5 sites in 1 country
Malawi5 sites, 5 recruiting
- Not yet recruiting
Area 18 Health Center
Lilongwe
Steve Mphonda, 265-1755056, smphonda@unclilongwe.org
- Recruiting
Area 25 Health Center
Lilongwe
Steve Mphonda, 265-1755056, smphonda@unclilongwe.org
- Recruiting
Bwaila Hospital
Lilongwe
Steve Mphonda, 265-1755056, smphonda@unclilongwe.org
- Recruiting
Kawale Health Center
Lilongwe
Steve Mphonda, 265-1755056, smphonda@unclilongwe.org
- Recruiting
Likuni Mission Hosptial
Lilongwe
Steve Mphonda, 265-1755056, smphonda@unclilongwe.org
About this study
Official title: Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.
Read the detailed description
In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.
- Conditions
- HIV, Depression, Depression, Postpartum
- Being tested
- Enhanced Friendship Bench, Enhanced usual care
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Friendship BenchBehavioural
Friendship Bench problem-solving therapy involving 4 prenatal and 2 postnatal counseling sessions, enhanced for HIV care engagement with 2 social support building sessions and monthly home visits for ART delivery and counseling during the 3rd trimester and the first 3 months postpartum.
Enhanced usual careBehavioural
Usual care for mental health in public facilities in Malawi includes options for basic supportive counseling by a primary provider or nurse, medication management by the primary provider (amitriptyline is the one antidepressant typically available at primary health centers and is rarely prescribed for depression), referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For the proposed study, usual care will be enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Friendship Bench | Experimental | Friendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum. Receives: Behavioral: Enhanced Friendship Bench |
| Enhanced usual care | Active comparator | Continue with usual outpatient care, enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms
Depressive symptoms at baseline and 6 months post partum will be evaluated via the Edinburgh Postnatal Depression Scale (EPDS). This screening instrument is a 10-item self-rating questionnaire with scores ranging from 0-30. Higher scores identify women who may be experiencing symptoms of perinatal depression. The scale is designed for use during pregnancy as well as the postpartum period, making it a versatile tool in maternal health care. Change in EPDS scores will be considered the primary outcome because this measure is specific to a perinatal population.
The change in depressive symptoms from baseline to 6 months postpartum will be calculated as Baseline EPDS total score minus the 6 month post partum EPDS total score.
Measured: 6 months post partum
HIV Care Retention
Retention in HIV care will be defined as ≥2 HIV visits that are at least 30 days apart in the first 6 months post-delivery; AND at least one visit in the first 90 days post-delivery and at least one visit in the second 90 days post-delivery. This definition is based on the minimum expected HIV care appointment schedule per Malawi HIV clinical guidelines. COVID-19 led to an enduring shift in ART prescribing patterns in Malawi, with many clinics moving from dispensing a 30-day ART supply to dispensing a 90-day supply in an effort to de-densify clinics. Consequently, two clinic visits in a 6-month period are typically sufficient to ensure continuous ART supply. While other retention measures such as the Missed or Kept Visit Proportion have high relevance in the US, they are less applicable in Malawian health care where missed visits are typically not recorded and only the dates of kept visits are noted in the medical record.
Measured: 6 months post partum
Secondary outcomes (6)
Change in Depressive Symptoms
Depressive symptoms will be measured at baseline and 6 months post partum using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. The change in depressive symptom scores from baseline to 6 months postpartum is calculated as baseline PHQ-9 score minus the 6 month post partum PHQ-9 score.
Measured: 6 months post partum
Proportion of patients achieving depression remission
Depression remission will be defined as the proportion of patients who achieve depression remission at 6 months post partum.
Depressive symptoms will be measured at 6 months post partum using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. Depression remission is defined as achievement of no or minimal depressive symptoms as defined by the widely used definition of a PHQ-9 score <5 at 6 months follow-up.
Measured: 6 months post partum
Proportion of patients achieving HIV viral suppression
A secondary outcome for maternal HIV care engagement will be the proportion of patients with viral load suppression at 12 months. Viral load suppression will be defined as HIV RNA level <1000 copies/mL, the standard definition in Malawian medical care based on dried blood spot thresholds.
Measured: 12 months post partum
Infant Growth: height-for-age
A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of height-for-age. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).
Measured: 6 months post partum
Infant Growth: weight-for-age
A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of weight-for-age. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).
Measured: 6 months post partum
Infant Growth: weight-for-height
A secondary outcome for infant health will be infant growth at 6 months, defined as WHO z-score of weight-for-height. This refers to a standardized score calculated using a child's measured height, weight, and age compared to the reference population established by the World Health Organization (WHO).
Measured: 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- 2-arm individually randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brian Pence, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702722
- Sponsor's protocol ID
- 24-0690
- Other IDs
- R01MH134660
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- 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). Deidentified data will also be posted to the NIMH Data Archive pursuant to the requirements of that site.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health and HIV Outcomes in Malawi: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06702722
- Acronym / sponsor ID
- 24-0690
- Conditions
- HIV, Depression, Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.
Detailed description
In our R34 pilot trial, the Enhanced Friendship Bench intervention showed strong feasibility, acceptability, fidelity, and preliminary effectiveness to improve perinatal depression and engagement in HIV care. The goal of this proposal is to evaluate the effectiveness of the Enhanced Friendship Bench in a fully powered randomized control trial to improve perinatal depression, HIV care engagement, and infant health outcomes, examine mediators and moderators that help elucidate mechanisms of action, and collect key implementation measures to accelerate the translation of findings into practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm individually randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced Friendship Bench | Experimental | Behavioral: Enhanced Friendship BenchFriendship Bench problem-solving therapy, social support sessions and home visits during the 3rd trimester as well as postpartum. |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual careContinue with usual outpatient care, enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presenting for antenatal care at one of our 5 recruitment sites
- ≥ 18 years of age
- ≤ 34 weeks gestation
- HIV-positive, based on medical records
- Initiating, re-initiating, or on established ART during index pregnancy
Key exclusion criteria (2 listed)
- Suicidal ideation evaluated as acute risk.
- Other health concerns requiring emergent response.
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 |
|---|---|---|
| Enhanced Friendship BenchFriendship Bench problem-solving therapy involving 4 prenatal and 2 postnatal counseling sessions, enhanced for HIV care engagement with 2 social support building sessions and monthly home visits for ART delivery and counseling during the 3rd trimester and the first 3 months postpartum. | Behavioural | Enhanced Friendship Bench |
| Enhanced usual careUsual care for mental health in public facilities in Malawi includes options for basic supportive counseling by a primary provider or nurse, medication management by the primary provider (amitriptyline is the one antidepressant typically available at primary health centers and is rarely prescribed for depression), referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For the proposed study, usual care will be enhanced to provide a mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral for further follow-up at a mental health clinic or psychiatric unit. | Behavioural | Enhanced usual care |
Primary outcome
Change in Depressive Symptoms
Time frame: 6 months post partum
Depressive symptoms at baseline and 6 months post partum will be evaluated via the Edinburgh Postnatal Depression Scale (EPDS). This screening instrument is a 10-item self-rating questionnaire with scores ranging from 0-30. Higher scores identify women who may be experiencing symptoms of perinatal depression. The scale is designed for use during pregnancy as well as the postpartum period, making it a versatile tool in maternal health care. Change in EPDS scores will be considered the primary outcome because this measure is specific to a perinatal population. The change in depressive symptoms from baseline to 6 months postpartum will be calculated as Baseline EPDS total score minus the 6 month post partum EPDS total score.
HIV Care Retention
Time frame: 6 months post partum
Retention in HIV care will be defined as ≥2 HIV visits that are at least 30 days apart in the first 6 months post-delivery; AND at least one visit in the first 90 days post-delivery and at least one visit in the second 90 days post-delivery. This definition is based on the minimum expected HIV care appointment schedule per Malawi HIV clinical guidelines. COVID-19 led to an enduring shift in ART prescribing patterns in Malawi, with many clinics moving from dispensing a 30-day ART supply to dispensing a 90-day supply in an effort to de-densify clinics. Consequently, two clinic visits in a 6-month period are typically sufficient to ensure continuous ART supply. While other retention measures such as the Missed or Kept Visit Proportion have high relevance in the US, they are less applicable in Malawian health care where missed visits are typically not recorded and only the dates of kept visits are noted in the medical record.
6 secondary outcomes
Change in Depressive Symptoms
Time frame: 6 months post partum
Proportion of patients achieving depression remission
Time frame: 6 months post partum
Proportion of patients achieving HIV viral suppression
Time frame: 12 months post partum
Infant Growth: height-for-age
Time frame: 6 months post partum
Infant Growth: weight-for-age
Time frame: 6 months post partum
Infant Growth: weight-for-height
Time frame: 6 months post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- 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). Deidentified data will also be posted to the NIMH Data Archive pursuant to the requirements of that site.
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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.
Angela Bengtson, PhD, MA contact
Brian Pence, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Friendship Bench in people with HIV and Depression, 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Pence, PhD, MPH (1-919-966-7446, bpence@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms (time frame: 6 months post partum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.