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DepressionNCT03555669

Project SOAR-Mental Health Malawi: Depression and HIV Integration

A study testing Depression Treatment in people with Depression and HIV/AIDS, run by University of North Carolina, Chapel Hill at 2 sites in Malawi.

Completed

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

Official record
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Trial summary

Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, HIV/AIDS
What is being tested?
Depression Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,082 participants
Where
2 sitesMalawi
Study dates
24 Apr 2017to 31 May 2019
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (≥18 years)
  • HIV-infected
  • Newly initiating antiretroviral treatment at one of the program sites
  • Screened for depression

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Malawi2 sites

  • Area 18 Clinic

    Lilongwe

  • Area 25 Clinic

    Lilongwe

Other trials in Malawi

About this study

Official title: UNCPM 21609 Project SOAR Mental Health: Evaluation of the Impact of a Depression Treatment Program on Mental Health and HIV Care Outcomes in Malawi

Depression is highly prevalent among people living with HIV (PLHIV) in Malawi and elsewhere in sub-Saharan Africa (SSA). Besides its high prevalence, depression likely represents an important barrier to consistent HIV care engagement and long-term viral suppression. However, the potential for depression treatment to improve HIV care outcomes has received little attention in the region, in part because of limited mental health infrastructure. In this study, the investigators will evaluate the impact of a depression treatment program integrated within existing HIV clinics on depression response, retention in HIV care, and viral suppression. It is expected that this evaluation will yield important evidence on the impact of depression treatment integrated with HIV care for improving HIV care and mental health outcomes in Malawi.

Read the detailed description

Study population:

The evaluation will abstract screening data for adult (≥18 years old) patients newly initiating antiretroviral therapy (ART) who are screened for depression at the two clinics before and after the integration of the depression treatment program, and additional treatment and outcome data for those patients who screen positive for depression.

Study Size:

Across the two clinics, the investigators expect to abstract depression screening data for approximately 2,300 patients. The investigators expect to abstract further treatment and outcome data for approximately 640 patients who screen positive for mild, moderate, or severe depression.

Study Duration:

Evaluation and dissemination activities will last two years.

Study Evaluation:

To evaluate the impact of the mental health treatment program on HIV care outcomes, the investigators will collect data on HIV appointment adherence and viral load at 6 months following ART initiation.

To evaluate the impact of the mental health treatment program on mental health outcomes the investigators will collect data on depression symptoms at baseline through 6 months following ART initiation.

Study Design Overview:

The study will employ a pre-post design in two HIV clinics in Lilongwe to evaluate the impact of integrating the depression treatment program within existing clinic operations on HIV and mental health outcomes. The investigators will use existing medical records and the depression patient registry maintained by the Ministry of Health-run clinics to abstract routinely collected clinical data. Using these data, the investigators will compare mental health and HIV outcomes before and after the integration of the depression treatment program. Depressive symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) signs and symptoms of major depression. Additionally, the investigators will conduct short qualitative interviews with clinic and Ministry of Health staff about the integration of the depression screening and treatment program and with patients on their understanding of depression and satisfaction with depression screening and treatment.

Conditions
Depression, HIV/AIDS
Being tested
Depression Treatment
Keywords
Implementation Science, Malawi
Medical subject headings
Depression, Acquired Immunodeficiency Syndrome

What participants receive

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

  • Depression TreatmentOther

    The depression treatment program combines measurement-based antidepressant treatment with PST with clinical response appropriate to the level of depressive severity. Patients scoring 0-4 on the PHQ-9, indicating no depression, receive no treatment. Patients scoring 5-9 on the PHQ-9, indicating mild depressive symptoms that likely are not a full major depressive episode, are offered PST. Patients scoring 10 or above on the PHQ-9, indicating moderate-to-severe depressive symptoms, are first offered anti-depressants. For this group, PST will be an alternative or augmentation option for those who do not tolerate or respond to antidepressant treatment. All patients' depressive severity is monitored with the option of modifying their treatment plan if their symptoms worsen or do not improve.

Study groups in NCT03555669
Study groupRoleWhat they receive
Screening Phase (Pre) GroupNo interventionPatients who screen positive on the PHQ-9 for depression during the "pre" period will comprise the comparison group. Participants will receive "standard of care" depression treatment at the providers discretion.
Treatment Phase (Post) GroupExperimentalPatients who screen positive during on the PHQ-9 for depression during the "post" period will comprise the active group. Participants will receive the depression treatment intervention in the form of anti-depressants and/or problem solving therapy (PST) based on their PHQ-9 score.
Receives: Other: Depression Treatment

What is being measured

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

  1. Proportion of participants who are retained in care

    Retention in care is defined as attending sufficient HIV appointments to maintain ART supply through the first 6 months on ART.

    Measured: 6 months after ART initiation

  2. Proportion of participants who are virally suppressed

    Viral suppression is defined as HIV RNA viral load of <1,000 copies/mL. Viral loads are measured approximately 6 months after ART initiation.

    Measured: 6 months after ART initiation

Secondary outcomes (2)

  1. Proportion of participants who achieve depression remission (PHQ-9 score less than 5)

    Depression remission is defined as scoring less than 5 on the PHQ-9 approximately 6 months after ART initiation. The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression. The 9 items describe problems associated with depression, and participants must rate how often the patient has been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, with 0-4 being minimum and indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depressive symptoms will be measured with the PHQ-9 at baseline through approximately 6 months after ART initiation.

    Measured: 6 months after ART initiation

  2. Proportion of scheduled ART visits attended

    ART visit attendance is defined as attending scheduled ART appointments over the first 6 months on ART.

    Measured: 6 months after ART initiation

Timeline

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

  1. First posted13 Jun 2018
  2. Study start24 Apr 2017
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

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
Non-randomised
Intervention model
Sequential
Model description
The investigators will employ a multiple baseline evaluation design in two clinics to evaluate the impact of depression treatment on HIV outcomes. Patients who screen positive for depression using PHQ-9 during the "pre" period will comprise the comparison group, while patients who screen positive during the "post" period will comprise the active group.
Masking
None (open label)
Enrolment
2,082 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555669
Sponsor's protocol ID
16-2834
Status last verified
Jun 2019
First submitted
1 Jun 2018
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kulisewa K, Minnick CE, Stockton MA, Gaynes BN, Hosseinipour MC, Mphonda S, Sansbury G, Udedi MM, Pence BW. The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective. Glob Public Health. 2023 Jan;18(1):2201327. doi: 10.1080/17441692.2023.2201327.

    PubMed 37088107

  • Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Pence BW. The effectiveness of depression management for improving HIV care outcomes in Malawi: protocol for a quasi-experimental study. BMC Public Health. 2019 Jun 26;19(1):827. doi: 10.1186/s12889-019-7132-3.

    PubMed 31242877

  • Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Mwagomba BM, Mazenga AC, Pence BW. Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program. BMC Health Serv Res. 2018 Jul 31;18(1):593. doi: 10.1186/s12913-018-3388-z.

    PubMed 30064418

Questions about this trial

What is this clinical trial studying?

A study testing Depression Treatment in people with Depression and HIV/AIDS, run by University of North Carolina, Chapel Hill at 2 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 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

Proportion of participants who are retained in care (time frame: 6 months after ART initiation). 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?

On the ClinicalTrials.gov record for NCT03555669, which also lists 3 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 31 May 2023.

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