Project SOAR-Mental Health Malawi: Depression and HIV Integration

NCT03555669 | Completed

• 1 other identifier: 16-2834
• Study Type: interventional
• Target: 2,082
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Depression; HIV/AIDS

Keywords

Implementation Science; Malawi

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months after ART initiation

• 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.

  6 months after ART initiation

Secondary Outcomes (2)

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

  6 months after ART initiation

• Proportion of scheduled ART visits attended

  6 months after ART initiation

Study Arms (2)

Screening Phase (Pre) Group

NO INTERVENTION

Patients 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) Group

EXPERIMENTAL

Patients 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.

Other: Depression Treatment

Interventions

Depression Treatment OTHER

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.

Treatment Phase (Post) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (2)

Area 18 Clinic

Lilongwe, Malawi

Location

Area 25 Clinic

Lilongwe, Malawi

Location

Related Publications (3)

• 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.

  PMID: 37088107 DERIVED

• 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.

  PMID: 31242877 DERIVED

• 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.

  PMID: 30064418 DERIVED

MeSH Terms

Conditions

Depression; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Brian Pence, PhD, MPH

  UNC Gillings School of Global Public Health

  PRINCIPAL INVESTIGATOR

• Michael Udedi, MBA MPhil

  Malawi Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: April 24, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 31, 2023

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

MA (2)