DepressionSHARPNCT03711786

The Sub-Saharan Africa Regional Partnership for Mental Health Capacity Building

A study testing Basic implementation package and Enhanced implementation package in people with Depression, run by University of North Carolina, Chapel Hill at 12 sites in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depression
What is being tested?: Basic implementation package and Enhanced implementation package
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 946 participants
Where: 12 sitesMalawi
Study dates: 9 May 2019to 30 Jun 2022
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet the following eligibility criteria will be invited to participate:
Ages 18-65 years (antidepressant treatment considerations differ for those <18 or >65 years, and these age groups are expected to be very rare in the target clinics),
Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic
Elevated depressive symptoms (PHQ-9 score ≥5)

Who cannot join

Patients will be excluded if they have
a history of bipolar or psychotic disorder, or show emergent threat of self-harm.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Malawi12 sites

Chilumba Rural Hospital
Chilumba, Karonga
Karonga District Hospital
Karonga
MEIRU
Karonga
Kasungu District Hospital
Kasungu
Bwaila Hospital
Lilongwe
UNC Project Malawi
Lilongwe
Machinga District Hospital
Machinga
Mchinji District Hospital
Mchinji
Mulanje District Hospital
Mulanje
Phalombe Rural Health Center
Phalombe
Salima District Hospital
Salima
Zomba Central Hospital
Zomba

Other trials in Malawi

About this study

Official title: The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building

This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics in Malawi. Primary outcomes are clinical care indicators measured at the level of the visit (patient screened yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the level of the participant.

Read the detailed description

This 10-site cluster-randomized implementation science trial compares the success of two clinic-level strategies in achieving high-quality integration of depression treatment into 10 non-communicable diseases (NCD) clinics in Malawi. Clinics are randomized 1:1 to one of two clinic-level implementation strategies: a basic strategy involving an internal coordinator, and an enhanced strategy combining the internal coordinator with an external quality assurance monitoring and supervision team. During a pre-randomization run-in period (months 1-5), all clinics receive the basic strategy. During a post-randomization intervention period (months 6-38), half of the clinics continue to receive the basic strategy and half receive the enhanced strategy. Visit-level data (for primary outcomes) and participant enrollment and follow-up (for secondary outcomes) are collected from all 10 clinics during the run-in and intervention periods.

Conditions: Depression
Being tested: Basic implementation package, Enhanced implementation package
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Basic implementation packageOther
The basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.
Enhanced implementation packageOther
The enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.

Study groups in NCT03711786
Study group	Role	What they receive
Basic implementation package	Active comparator	Ten Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period. Receives: Other: Basic implementation package
Enhanced implementation package	Experimental	Ten Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period. Receives: Other: Enhanced implementation package

What is being measured

The primary outcome is the main question the study is designed to answer.

Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed
This primary outcome is measured at the level of the clinician-patient visit out of all clinic visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is not already engaged in depression treatment (denominator) and number of visits for which the patient is screened for depression (numerator) on each clinic day at each facility. Completion of depression screening (successful outcome) is defined as the clinician completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is >0, also completing the PHQ-9 with the patient.
Measured: Measured based on data from clinic visits on each clinic day throughout study period
Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification
This primary outcome is measured at the level of the clinician-patient visit out of all treatment-eligible visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is eligible for depression treatment (denominator) and number of visits for which the patient initiates depression treatment (numerator) on each clinic day at each facility. Eligible for depression treatment is defined as PHQ-9 total score of 5 or above. Initiating depression treatment is defined as prescription of antidepressant medication or referral to Friendship Bench psychosocial counselors within 30 days of positive screen.
Measured: Measured based on data from clinic visits on each clinic day throughout study period
Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines
This primary outcome is measured at the level of the clinician-patient visit out of all eligible visits during the intervention period. Eligible visits are clinical visits by consented participants within the first 90 days after initiating depression treatment. The outcome is based on clinic process data including number of clinic visits for which the participant is already engaged in depression treatment (denominator) and number of visits where the treatment decision follows the treatment algorithm (numerator) on each clinic day at each facility. Following the algorithm (positive outcome) is defined as: (1) if the participant has completed 6 counseling sessions, any action is acceptable; (2) otherwise, if the participant started counseling, either continuing counseling or starting medication; (3) if the participant started medication and PHQ-9 score <10, continuing medication; (4) if the participant started medication and PHQ-9 score >=10, continuing medication and increasing dose.
Measured: Within the first three months of follow-up after initiating depression treatment

Secondary outcomes (2)

Number of Participants Achieving Depression Remission at 3 Months
This secondary outcome is measured at the level of the consented participant. Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9; range 0-27). The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27, with 0-4 indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depression remission is defined as a score <5.
Measured: Three months post enrollment
Number of Participants With Well Controlled NCD at 3 Months
This secondary outcome is measured at the level of the consented participant. Hypertension is measured by research assistants at each study visit while fasting blood glucose is measured as part of routine clinical care and will be abstracted. Well-controlled non-communicable disease (NCD) will be defined for hypertension patients as systolic blood pressure (BP) <140 mmHg AND diastolic blood pressure <90 mmHg, and for diabetes patients as fasting blood glucose <130 mg/dl, following the Malawi Clinical Guidelines for the Management of NCDs.
Measured: Three months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201930 Jun 2022

First posted18 Oct 2018
Study start9 May 2019
Primary completion31 Mar 2022
Study completion30 Jun 2022

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 (6)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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.
Masking: None (open label)
Enrolment: 946 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03711786
Sponsor's protocol ID: 18-2211
Other IDs: 1U19MH113202-01
Acronym: SHARP
Status last verified: Aug 2022
First submitted: 12 Jan 2018
Last updated: 1 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data will be shared via the National Institute of Mental Health Data Archive. This will include de-identified individual-level data. Other researchers can apply to the National Institute of Mental Health Data Archive to access these data.

Publications

Zimba CC, Malava JK, Mbota M, Matewere M, Akello H, Akiba CF, Landrum KR, Morrison A, Go V, Hosseinipour MC, Gaynes BN, Udedi M, Masiye J, Pence BW. Barriers and potential solutions for effective integration of depression care into non-communicable diseases clinics in Malawi: a qualitative end-point evaluation of the SHARP randomized controlled trial. Int J Ment Health Syst. 2025 Mar 6;19(1):8. doi: 10.1186/s13033-025-00663-z.
PubMed 40050899
Pence BW, Gaynes BN, Udedi M, Kulisewa K, Zimba CC, Akiba CF, Dussault JM, Akello H, Malava JK, Crampin A, Zhang Y, Preisser JS, DeLong SM, Hosseinipour MC. Two implementation strategies to support the integration of depression screening and treatment into hypertension and diabetes care in Malawi (SHARP): parallel, cluster-randomised, controlled, implementation trial. Lancet Glob Health. 2024 Apr;12(4):e652-e661. doi: 10.1016/S2214-109X(23)00592-2. Epub 2024 Feb 23.
PubMed 38408462
Sansbury GM, Pence BW, Zimba C, Yanguela J, Landrum K, Matewere M, Mbota M, Malava JK, Tikhiwa H, Morrison AM, Akiba CF, Gaynes BN, Udedi M, Hosseinipour MC, Stockton MA. Improving integrated depression and non-communicable disease care in Malawi through engaged leadership and supportive implementation climate. BMC Health Serv Res. 2023 Dec 14;23(1):1413. doi: 10.1186/s12913-023-10344-7.
PubMed 38098079
Zimba CC, Akiba CF, Matewere M, Thom A, Udedi M, Masiye JK, Kulisewa K, Go VF, Hosseinipour MC, Gaynes BN, Pence BW. Facilitators, barriers and potential solutions to the integration of depression and non-communicable diseases (NCDs) care in Malawi: a qualitative study with service providers. Int J Ment Health Syst. 2021 Jun 11;15(1):59. doi: 10.1186/s13033-021-00480-0.
PubMed 34116699
Gaynes BN, Akiba CF, Hosseinipour MC, Kulisewa K, Amberbir A, Udedi M, Zimba CC, Masiye JK, Crampin M, Amarreh I, Pence BW. The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity-Building Scale-Up Trial: Study Design and Protocol. Psychiatr Serv. 2021 Jul 1;72(7):812-821. doi: 10.1176/appi.ps.202000003. Epub 2020 Dec 9.
PubMed 33291973
Akiba CF, Zimba CC, Thom A, Matewere M, Go V, Pence B, Gaynes BN, Masiye J. The role of patient-provider communication: a qualitative study of patient attitudes regarding co-occurring depression and chronic diseases in Malawi. BMC Psychiatry. 2020 May 19;20(1):243. doi: 10.1186/s12888-020-02657-2.
PubMed 32429877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity Building
ClinicalTrials.gov ID: NCT03711786
Acronym / sponsor ID: SHARP / 18-2211
Conditions: Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 946 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Ministry of Health, Malawi, Kamuzu University of Health Sciences
Study start: 9 May 2019 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 1 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.

Arm	Type	Receives
Basic implementation package	Active comparator	Other: Basic implementation packageTen Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period.
Enhanced implementation package	Experimental	Other: Enhanced implementation packageTen Malawi non-communicable diseases clinics will be randomized 1:1 to one of two implementation strategies to be used for two years followed by a 12-month follow-up period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ages 18-65 years (antidepressant treatment considerations differ for those <18 or >65 years, and these age groups are expected to be very rare in the target clinics),
Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic
Elevated depressive symptoms (PHQ-9 score ≥5)

Key exclusion criteria (2 listed)

Patients will be excluded if they have
a history of bipolar or psychotic disorder, or show emergent threat of self-harm.

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
Basic implementation packageThe basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.	Other	Basic implementation package
Enhanced implementation packageThe enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.	Other	Enhanced implementation package

Primary outcome

Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed
Time frame: Measured based on data from clinic visits on each clinic day throughout study period
This primary outcome is measured at the level of the clinician-patient visit out of all clinic visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is not already engaged in depression treatment (denominator) and number of visits for which the patient is screened for depression (numerator) on each clinic day at each facility. Completion of depression screening (successful outcome) is defined as the clinician completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is >0, also completing the PHQ-9 with the patient.
Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification
Time frame: Measured based on data from clinic visits on each clinic day throughout study period
This primary outcome is measured at the level of the clinician-patient visit out of all treatment-eligible visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is eligible for depression treatment (denominator) and number of visits for which the patient initiates depression treatment (numerator) on each clinic day at each facility. Eligible for depression treatment is defined as PHQ-9 total score of 5 or above. Initiating depression treatment is defined as prescription of antidepressant medication or referral to Friendship Bench psychosocial counselors within 30 days of positive screen.
Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines
Time frame: Within the first three months of follow-up after initiating depression treatment
This primary outcome is measured at the level of the clinician-patient visit out of all eligible visits during the intervention period. Eligible visits are clinical visits by consented participants within the first 90 days after initiating depression treatment. The outcome is based on clinic process data including number of clinic visits for which the participant is already engaged in depression treatment (denominator) and number of visits where the treatment decision follows the treatment algorithm (numerator) on each clinic day at each facility. Following the algorithm (positive outcome) is defined as: (1) if the participant has completed 6 counseling sessions, any action is acceptable; (2) otherwise, if the participant started counseling, either continuing counseling or starting medication; (3) if the participant started medication and PHQ-9 score <10, continuing medication; (4) if the participant started medication and PHQ-9 score >=10, continuing medication and increasing dose.

2 secondary outcomes

Number of Participants Achieving Depression Remission at 3 Months
Time frame: Three months post enrollment
Number of Participants With Well Controlled NCD at 3 Months
Time frame: Three months post enrollment

Results and safety

Results posted to the registry on 1 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Basic Implementation Package	168	148
Enhanced Implementation Package	189	183

Primary outcome: Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed

Time frame: Measured based on data from clinic visits on each clinic day throughout study period. Count of units. Unit: Visits

Measure	Basic Implementation Package n = 301	Enhanced Implementation Package n = 288
Value	14712	15888

Basic Implementation Package vs Enhanced Implementation Package: Odds Ratio (OR): 1.20 (95% CI 0.22 to 6.65), p = 0.836, Regression - GEE, logistic

Population analysed: The population for this outcome is all screening-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a small portion of all captured visits (n=27,187 and 33,587), but non-consented patients (who are not uniquely identified) represent a large portion.

Primary outcome: Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification

Time frame: Measured based on data from clinic visits on each clinic day throughout study period. Count of units. Unit: Visits

Measure	Basic Implementation Package n = 301	Enhanced Implementation Package n = 288
Value	601	538

Basic Implementation Package vs Enhanced Implementation Package: Odds Ratio (OR): 0.86 (95% CI 0.12 to 6.14), p = 0.877, Regression - GEE, logistic

Population analysed: The population for this outcome is all depression treatment-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a portion of all captured visits for this outcome (n=610 and 545), but non-consented patients (who are not uniquely identified) represent an additional portion.

Primary outcome: Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines

Time frame: Within the first three months of follow-up after initiating depression treatment. Count of units. Unit: Visits

Measure	Basic Implementation Package n = 74	Enhanced Implementation Package n = 69
Value	14	69

Basic Implementation Package vs Enhanced Implementation Package: Odds Ratio (OR): 18.36 (95% CI 3.23 to 104.23), p = 0.001, Regression - GEE, logistic

Population analysed: Population: all clinic visits for consented participants in the first 3 months after starting depression treatment. Analysis is restricted to consented participants because the clinic visit must be linked to information from the initial visit to define whether the treatment decision follows the algorithm. Participants may have multiple clinic visits during the three months. These are routine clinic visits and are not the 3-month research assessment referenced in the participant flow.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from consent through each participant's study completion, up to approximately 12 months post-consent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Basic Implementation Package	31 of 469 (6.6%)	54 of 469 (11.5%)	12 of 469
Enhanced Implementation Package	11 of 477 (2.3%)	90 of 477 (18.9%)	5 of 477

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40050899Zimba CC, Malava JK, Mbota M, Matewere M, Akello H, Akiba CF, Landrum KR, Morrison A, Go V, Hosseinipour MC, Gaynes BN, Udedi M, Masiye J, Pence BW. Barriers and potential solutions for effective integration of depression care into non-communicable diseases clinics in Malawi: a qualitative end-point evaluation of the SHARP randomized controlled trial. Int J Ment Health Syst. 2025 Mar 6;19(1):8. doi: 10.1186/s13033-025-00663-z.
Derived from this study: PubMed 38408462Pence BW, Gaynes BN, Udedi M, Kulisewa K, Zimba CC, Akiba CF, Dussault JM, Akello H, Malava JK, Crampin A, Zhang Y, Preisser JS, DeLong SM, Hosseinipour MC. Two implementation strategies to support the integration of depression screening and treatment into hypertension and diabetes care in Malawi (SHARP): parallel, cluster-randomised, controlled, implementation trial. Lancet Glob Health. 2024 Apr;12(4):e652-e661. doi: 10.1016/S2214-109X(23)00592-2. Epub 2024 Feb 23.
Derived from this study: PubMed 38098079Sansbury GM, Pence BW, Zimba C, Yanguela J, Landrum K, Matewere M, Mbota M, Malava JK, Tikhiwa H, Morrison AM, Akiba CF, Gaynes BN, Udedi M, Hosseinipour MC, Stockton MA. Improving integrated depression and non-communicable disease care in Malawi through engaged leadership and supportive implementation climate. BMC Health Serv Res. 2023 Dec 14;23(1):1413. doi: 10.1186/s12913-023-10344-7.
Derived from this study: PubMed 34116699Zimba CC, Akiba CF, Matewere M, Thom A, Udedi M, Masiye JK, Kulisewa K, Go VF, Hosseinipour MC, Gaynes BN, Pence BW. Facilitators, barriers and potential solutions to the integration of depression and non-communicable diseases (NCDs) care in Malawi: a qualitative study with service providers. Int J Ment Health Syst. 2021 Jun 11;15(1):59. doi: 10.1186/s13033-021-00480-0.
Derived from this study: PubMed 33291973Gaynes BN, Akiba CF, Hosseinipour MC, Kulisewa K, Amberbir A, Udedi M, Zimba CC, Masiye JK, Crampin M, Amarreh I, Pence BW. The Sub-Saharan Africa Regional Partnership (SHARP) for Mental Health Capacity-Building Scale-Up Trial: Study Design and Protocol. Psychiatr Serv. 2021 Jul 1;72(7):812-821. doi: 10.1176/appi.ps.202000003. Epub 2020 Dec 9.
Derived from this study: PubMed 32429877Akiba CF, Zimba CC, Thom A, Matewere M, Go V, Pence B, Gaynes BN, Masiye J. The role of patient-provider communication: a qualitative study of patient attitudes regarding co-occurring depression and chronic diseases in Malawi. BMC Psychiatry. 2020 May 19;20(1):243. doi: 10.1186/s12888-020-02657-2.
Individual participant dataSharing planned: Yes. Data will be shared via the National Institute of Mental Health Data Archive. This will include de-identified individual-level data. Other researchers can apply to the National Institute of Mental Health Data Archive to access these data.

Related trials for Depression

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

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.

Brian W Pence, PhD principal investigator

UNC-Chapel Hill

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Basic implementation package and Enhanced implementation package in people with Depression, run by University of North Carolina, Chapel Hill at 12 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 4 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: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 1 Mar 2023). 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?

Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed (time frame: Measured based on data from clinic visits on each clinic day throughout study period). The study lists 3 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 NCT03711786, which also lists 6 linked publications.

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 1 Mar 2023.