DepressionPhase 4INDEPTH-UgandaNCT02056106
Comparative Trial of Antidepressant Treatment Models in HIV Care in Uganda
A Phase 4 study testing antidepressant therapy in people with Depression, run by RAND at 1 site in Uganda.
Trial summary
This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- antidepressant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,252 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- age 18 years or above
- screens positive for depression (scores > 2 on PHQ-2)
- medically stable
- client at the HIV clinic (and hence, HIV positive)
Who cannot join
- active acute opportunistic infection
- about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks
Trial locations and contacts
1 site in 1 country.
Uganda1 site
health care facilities receiving technical assistance from Mildmay Uganda
Wakiso, Mpigi, Luwero, Mityana Districts
About this study
Official title: Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits
This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.
Read the detailed description
The study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV clinics. The model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care. This model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm). At each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months. We will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response). We will also examine the relationship between change in depression and key economic and public health outcomes (e.g. work status, condom use, HIV treatment adherence).
- Conditions
- Depression
- Being tested
- antidepressant therapy
- Keywords
- depression, Uganda, HIV, task-shifting, condom use, adherence
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidepressant therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Clinical acumen | Active comparator | Depression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care. Receives: Drug: antidepressant therapy |
| Protocolized Arm | Active comparator | Structured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment Receives: Drug: antidepressant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression diagnostic evaluation
Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression
Measured: baseline, Month 6, Month 12
Antidepressant prescription
Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9
Measured: baseline, Month 6, Month 12
Depressive symptoms
depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms
Measured: past 2 weeks at Month 6 and Month 12
Secondary outcomes (2)
Consistent condom use
A single likert scale item will be used to assess condom use in the past month; a single item will also be used to assess whether condom was used during last event of sexual intercourse
Measured: past 6 months prior to baseline, Month 6, Month 12
ART adherence
single variable to rate adherence to ART over the past month on scale of 0-100
Measured: past month prior to baseline, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Wagner, RAND
- Investigators
- Glenn Wagner, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056106
- Sponsor's protocol ID
- R01MH098996
- Acronym
- INDEPTH-Uganda
- Status last verified
- Oct 2015
- First submitted
- 3 Feb 2014
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wagner GJ, Ngo V, Goutam P, Glick P, Musisi S, Akena D. A Structured Protocol Model of Depression Care versus Clinical Acumen: A Cluster Randomized Trial of the Effects on Depression Screening, Diagnostic Evaluation, and Treatment Uptake in Ugandan HIV Clinics. PLoS One. 2016 May 11;11(5):e0153132. doi: 10.1371/journal.pone.0153132. eCollection 2016.
PubMed 27167852Wagner GJ, Ngo V, Glick P, Obuku EA, Musisi S, Akena D. INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial. Trials. 2014 Jun 25;15:248. doi: 10.1186/1745-6215-15-248.
PubMed 24962086
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits
- ClinicalTrials.gov ID
- NCT02056106
- Acronym / sponsor ID
- INDEPTH-Uganda / R01MH098996
- Conditions
- Depression
- Keywords
- depression, Uganda, HIV, task-shifting, condom use, adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,252 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Feb 2014 (estimated)
- 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.
This study compares two models for implementing antidepressant treatment in 10 HIV clinics in Uganda. Using a cluster randomization, 5 clinics implement a task-shifting, protocolized model, and 5 others rely on clinical acumen. The protocolized model includes (1) routine depression screening at each clinic visit for all adult patients by trained expert patients at triage, (2) training nurses to diagnose depression and prescribe and monitor antidepressant treatment using an algorithm-based protocol, and (3) monthly supervision and monitoring by hired study psychiatrists. The clinical acumen model also includes routine depression screening and ongoing supervision, but it relies on the clinical acumen of trained primary care providers to further evaluate and treat patients who show signs of depression at screening, as opposed to a structured protocol. The primary aim is to test the hypothesis that the nurse-driven protocolized model will result in greater uptake of antidepressant treatment and better quality of depression care outcomes. The study will also test the hypotheses that treatment of depression results in improved HIV treatment adherence, work functioning and consistent condom use.
Detailed description
The study evaluates a task-shifting approach to depression treatment that uses an algorithm-based, nurse-driven model for managing antidepressant treatment in 10 Ugandan HIV clinics. The model will include (1) case identification facilitated by routine depression screening at each clinic visit for all patients, (2) training nurses to assist primary care providers in implementing antidepressant treatment by performing the initial evaluation, monitoring symptoms and side effects, and making algorithm-based dose recommendations, and (3) layers of supervision and monitoring by psychiatric specialists to ensure safety and quality of care. This model will be implemented at 5 randomly selected clinics (protocolized arm), while 5 other clinics will be selected to also use routine depression screening but will rely on primary care providers to decide whether to further evaluate and treat depression (clinical acumen arm). At each site, random samples of 150 patients (total n=1500) who have screened positive for possible depression will be followed for 12 months. We will compare the two arms on depression evaluation, uptake of antidepressant treatment, and change in depression (treatment response). We will also examine the relationship between change in depression and key economic and public health outcomes (e.g. work status, condom use, HIV treatment adherence).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical acumen | Active comparator | Drug: antidepressant therapyDepression diagnosis and antidepressant treatment provided based on clinical acumen of primary care providers trained to provide depression care. |
| Protocolized Arm | Active comparator | Drug: antidepressant therapyStructured, algorithm-based protocol that guides depression diagnosis and antidepressant treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or above
- screens positive for depression (scores > 2 on PHQ-2)
- medically stable
- client at the HIV clinic (and hence, HIV positive)
Key exclusion criteria (2 listed)
- active acute opportunistic infection
- about to start HIV antiretroviral therapy or started antiretroviral therapy within past 4 weeks
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 |
|---|---|---|
| antidepressant therapy | Drug | Clinical acumen, Protocolized Arm |
Primary outcome
Depression diagnostic evaluation
Time frame: baseline, Month 6, Month 12
Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression
Antidepressant prescription
Time frame: baseline, Month 6, Month 12
Whether or not antidepressants were prescribed; this variable will be analyzed among the subset of patients categorized as depressed based on PHQ-9 > 9
Depressive symptoms
Time frame: past 2 weeks at Month 6 and Month 12
depressive symptoms present at Month 6 and Month 12 (in comparison to baseline) to assess treatment response; PHQ-9 will be used to measure depressive symptoms
2 secondary outcomes
Consistent condom use
Time frame: past 6 months prior to baseline, Month 6, Month 12
ART adherence
Time frame: past month prior to baseline, Month 6 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Derived from this study: PubMed 27167852Wagner GJ, Ngo V, Goutam P, Glick P, Musisi S, Akena D. A Structured Protocol Model of Depression Care versus Clinical Acumen: A Cluster Randomized Trial of the Effects on Depression Screening, Diagnostic Evaluation, and Treatment Uptake in Ugandan HIV Clinics. PLoS One. 2016 May 11;11(5):e0153132. doi: 10.1371/journal.pone.0153132. eCollection 2016.
- Derived from this study: PubMed 24962086Wagner GJ, Ngo V, Glick P, Obuku EA, Musisi S, Akena D. INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial. Trials. 2014 Jun 25;15:248. doi: 10.1186/1745-6215-15-248.
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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.
Glenn Wagner, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing antidepressant therapy in people with Depression, run by RAND at 1 site in Uganda.
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 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depression diagnostic evaluation (time frame: baseline, Month 6, Month 12). 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 NCT02056106, which also lists 2 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 5 Oct 2015.