health care facilities receiving technical assistance from Mildmay Uganda
Wakiso, Mpigi, Luwero, Mityana Districts, Uganda
NCT Number: NCT02056106
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Wakiso, Mpigi, Luwero, Mityana Districts, Uganda
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline, Month 6, Month 12
Whether or not the Patient Health Questionnaire (PHQ-9) was administered to assess severity of depression
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
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
Time frame: past 6 months prior to baseline, Month 6, Month 12
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
Time frame: past month prior to baseline, Month 6 and Month 12
single variable to rate adherence to ART over the past month on scale of 0-100
RAND
Other
Task Shifting Model of Depression Treatment to Unleash HIV Public Health Benefits
Acronym: INDEPTH-Uganda
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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