Trial Outcomes & Findings for Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform (NCT NCT04777006)

Integrating a Stepped Care Model of Screening and Treatment for Depression Into Malawi's National HIV Care Delivery Platform

Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as PHQ-9 score at 3-months (post-intervention). It is not a change score. Scale Name: Patient Health Questionnaire - 9 Scale Range (Min-Max): 0-27 Scale Notes: Higher value is considered more severe depression symptoms. There are no combined subscales.

Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as PHQ-9 score at 6-months (post-intervention). It is not a change score. Scale Name: Patient Health Questionnaire - 9 Scale Range (Min-Max): 0-27 Scale Notes: Higher value is considered more severe depression symptoms. There are no combined subscales.

Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as PHQ-9 score at 9-months (post-intervention). It is not a change score. Scale Name: Patient Health Questionnaire - 9 Scale Range (Min-Max): 0-27 Scale Notes: Higher value is considered more severe depression symptoms. There are no combined subscales.

Depression symptoms will be measured with the Patient Health Questionnaire 9 (PHQ-9). This will be quantified as PHQ-9 score at 12-months (post-intervention). It is not a change score. Scale Name: Patient Health Questionnaire - 9 Scale Range (Min-Max): 0-27 Scale Notes: Higher value is considered more severe depression symptoms. There are no combined subscales.

Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as WHODAS score at 3-months (post-intervention). It is not a change score. Scale Name: WHO Disability Assessment Schedule Scale Range (Min-Max): 12-60 Scale Notes: Higher value is considered more severe functional impairment. There are no combined subscales.

Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as WHODAS score at 6-months (post-intervention). It is not a change score. Scale Range (Min-Max): 12-60 Scale Notes: Higher value is considered more severe functional impairment. There are no combined subscales.

Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as WHODAS score at 9-months (post-intervention). It is not a change score. Scale Name: WHO Disability Assessment Schedule Scale Range (Min-Max): 12-60 Scale Notes: Higher value is considered more severe functional impairment. There are no combined subscales.

Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS). This will be quantified as WHODAS score at 12-months (post-intervention). It is not a change score. Scale Name: WHO Disability Assessment Schedule Scale Range (Min-Max): 12-60 Scale Notes: Higher value is considered more severe functional impairment. There are no combined subscales.

A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as EQ-5D-5L score at 3-months (post-intervention). It is not a change score. Scale Name: EuroQol, EQ-5D-5L Scale Range (Min-Max): 5-25 Scale Notes: Higher value is considered worse overall health. There are no combined subscales.

A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as EQ-5D-5L score at 6-months (post-intervention). It is not a change score. Scale Name: EuroQol, EQ-5D-5L Scale Range (Min-Max): 5-25 Scale Notes: Higher value is considered worse overall health. There are no combined subscales.

A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as EQ-5D-5L score at 9-months (post-intervention). It is not a change score. Scale Name: EuroQol, EQ-5D-5L Scale Range (Min-Max): 5-25 Scale Notes: Higher value is considered worse overall health. There are no combined subscales.

A health profile will be generated for each individual using the EuroQol (EQ-5D-5L). This will be quantified as EQ-5D-5L score at 12-months (post-intervention). It is not a change score. Scale Name: EuroQol, EQ-5D-5L Scale Range (Min-Max): 5-25 Scale Notes: Higher value is considered worse overall health. There are no combined subscales.

Prevalence of depression is calculated as the number of participants with a PHQ-9 score of 9 or greater at the time of measurement.

Prevalence of depression is calculated as the number of participants with a PHQ-9 score of 9 or greater at the time of measurement.

Prevalence of depression is calculated as the number of participants with a PHQ-9 score of 9 or greater at the time of measurement.

Prevalence of depression is calculated as the number of participants with a PHQ-9 score of 9 or greater at the time of measurement.

ART adherence will be measured in terms of whether patients with HIV have returned to their health clinic for antiretrovirals (ARVs) within the prior three months for quarterly medication pick-up, consistent with national guidelines. Adherence is calculated as the number who satisfy this criterion out of those who are eligible.

ART adherence will be measured in terms of whether patients with HIV have returned to their health clinic for antiretrovirals (ARVs) within the prior three months for quarterly medication pick-up, consistent with national guidelines. Adherence is calculated as the number who satisfy this criterion out of those who are eligible.

ART adherence will be measured in terms of whether patients with HIV have returned to their health clinic for antiretrovirals (ARVs) within the prior three months for quarterly medication pick-up, consistent with national guidelines. Adherence is calculated as the number who satisfy this criterion out of those who are eligible.

ART adherence will be measured in terms of whether patients with HIV have returned to their health clinic for antiretrovirals (ARVs) within the prior three months for quarterly medication pick-up, consistent with national guidelines. Adherence is calculated as the number who satisfy this criterion out of those who are eligible.

Viral suppression will be measured in terms of whether patients with HIV been measured in the previous three months and reported \<500 copies of the virus per mL of blood, consistent with national guidelines. Viral suppression is calculated as the number who satisfy this criterion out of those who are eligible (i.e., viral load measured in the prior three months).

Viral suppression will be measured in terms of whether patients with HIV been measured in the previous three months and reported \<500 copies of the virus per mL of blood, consistent with national guidelines. Viral suppression is calculated as the number who satisfy this criterion out of those who are eligible (i.e., viral load measured in the prior three months).

Viral suppression will be measured in terms of whether patients with HIV been measured in the previous three months and reported \<500 copies of the virus per mL of blood, consistent with national guidelines. Viral suppression is calculated as the number who satisfy this criterion out of those who are eligible (i.e., viral load measured in the prior three months).

Viral suppression will be measured in terms of whether patients with HIV been measured in the previous three months and reported \<500 copies of the virus per mL of blood, consistent with national guidelines. Viral suppression is calculated as the number who satisfy this criterion out of those who are eligible (i.e., viral load measured in the prior three months).

Controlled blood pressure will be measured in terms of whether patients with hypertension been measured in the previous three months and reported systolic blood pressure \<140 mmHg, consistent with national guidelines. Controlled blood pressure is calculated as the number who satisfy this criterion out of those who are eligible (i.e., systolic blood pressure measured in the prior three months, among hypertension patients).

Controlled blood pressure will be measured in terms of whether patients with hypertension been measured in the previous three months and reported systolic blood pressure \<140 mmHg, consistent with national guidelines. Controlled blood pressure is calculated as the number who satisfy this criterion out of those who are eligible (i.e., systolic blood pressure measured in the prior three months, among hypertension patients).

Controlled blood pressure will be measured in terms of whether patients with hypertension been measured in the previous three months and reported systolic blood pressure \<140 mmHg, consistent with national guidelines. Controlled blood pressure is calculated as the number who satisfy this criterion out of those who are eligible (i.e., systolic blood pressure measured in the prior three months, among hypertension patients).

Controlled blood pressure will be measured in terms of whether patients with hypertension been measured in the previous three months and reported systolic blood pressure \<140 mmHg, consistent with national guidelines. Controlled blood pressure is calculated as the number who satisfy this criterion out of those who are eligible (i.e., systolic blood pressure measured in the prior three months, among hypertension patients).

WHO staging will be measured the World Health Organization's clinical staging system for HIV/AIDS, which classifies disease progression based on the presence of specific clinical conditions and symptoms, ranging from Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses). Instrument Name: WHO's Clinical Staging System for HIV/AIDS Instrument Range: Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses) Instrument Notes: Higher stage considered more severe progression of illness. There are no combined subscales.

WHO staging will be measured the World Health Organization's clinical staging system for HIV/AIDS, which classifies disease progression based on the presence of specific clinical conditions and symptoms, ranging from Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses). Instrument Name: WHO's Clinical Staging System for HIV/AIDS Instrument Range: Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses) Instrument Notes: Higher stage considered more severe progression of illness. There are no combined subscales.

WHO staging will be measured the World Health Organization's clinical staging system for HIV/AIDS, which classifies disease progression based on the presence of specific clinical conditions and symptoms, ranging from Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses). Instrument Name: WHO's Clinical Staging System for HIV/AIDS Instrument Range: Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses) Instrument Notes: Higher stage considered more severe progression of illness. There are no combined subscales.

WHO staging will be measured the World Health Organization's clinical staging system for HIV/AIDS, which classifies disease progression based on the presence of specific clinical conditions and symptoms, ranging from Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses). Instrument Name: WHO's Clinical Staging System for HIV/AIDS Instrument Range: Stage I (asymptomatic) to Stage IV (AIDS-defining illnesses) Instrument Notes: Higher stage considered more severe progression of illness. There are no combined subscales.

HbA1C measurement will be measured using a laboratory-based immunoassay or high-performance liquid chromatography (HPLC) method, standardized to the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference, in accordance with international guidelines. Diabetes control was defined as an HbA1c level below 8.0%, consistent with WHO and ADA-recommended thresholds for glycemic control in resource-limited settings and among patients with comorbidities or limited life expectancy. Our primary outcome was the proportion of patients with type 2 diabetes achieving this target.

HbA1C measurement will be measured using a laboratory-based immunoassay or high-performance liquid chromatography (HPLC) method, standardized to the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference, in accordance with international guidelines. Diabetes control was defined as an HbA1c level below 8.0%, consistent with WHO and ADA-recommended thresholds for glycemic control in resource-limited settings and among patients with comorbidities or limited life expectancy. Our primary outcome was the proportion of patients with type 2 diabetes achieving this target.

HbA1C measurement will be measured using a laboratory-based immunoassay or high-performance liquid chromatography (HPLC) method, standardized to the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference, in accordance with international guidelines. Diabetes control was defined as an HbA1c level below 8.0%, consistent with WHO and ADA-recommended thresholds for glycemic control in resource-limited settings and among patients with comorbidities or limited life expectancy. Our primary outcome was the proportion of patients with type 2 diabetes achieving this target.

HbA1C measurement will be measured using a laboratory-based immunoassay or high-performance liquid chromatography (HPLC) method, standardized to the National Glycohemoglobin Standardization Program (NGSP) and traceable to the Diabetes Control and Complications Trial (DCCT) reference, in accordance with international guidelines. Diabetes control was defined as an HbA1c level below 8.0%, consistent with WHO and ADA-recommended thresholds for glycemic control in resource-limited settings and among patients with comorbidities or limited life expectancy. Our primary outcome was the proportion of patients with type 2 diabetes achieving this target.

Any seizures (yes/no) in the prior three months was self-reported among participants with diagnosed epilepsy.

Any seizures (yes/no) in the prior three months was self-reported among participants with diagnosed epilepsy.

Any seizures (yes/no) in the prior three months was self-reported among participants with diagnosed epilepsy.

Any seizures (yes/no) in the prior three months was self-reported among participants with diagnosed epilepsy.

Perceived burden of care will be measured according to the Burden Assessment Schedule (BAS). This will be quantified as household member's score at 6-months after initiation of treatment eligibility for the study trial participant. Scale Name: Burden Assessment Schedule Scale Range (Min-Max): 0-57 Scale Notes: Higher value indicates more severe perceived burden of care. There are no combined subscales.

Prevalence of depression is calculated as the number of household participants with a PHQ-9 score of 9 or greater at the time of measurement.

Functional impairment will be measured with the World Health Organization (WHO) Disability Assessment Schedule (WHODAS) among household members. This will be quantified as WHODAS score at 6 months after the start of study participant treatment eligibility. It is not a change score. Scale Name: WHO Disability Assessment Schedule Scale Range (Min-Max): 12-60 Scale Notes: Higher value is considered more severe functional impairment. There are no combined subscales.

A health profile will be generated for each household member using the EuroQol (EQ-5D-5L). This will be quantified as EQ-5D-5L score at 6-months after the start of study participants' treatment eligibility. It is not a change score. Scale Name: EuroQol, EQ-5D-5L Scale Range (Min-Max): 5-25 Scale Notes: Higher value is considered worse overall health. There are no combined subscales.

Perceived social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS). This will be quantified as MSPSS score at 3-months (post-intervention). It is not a change score. Scale Name: Multidimensional Scale of Perceived Social Support Scale Range (Min-Max): 12-84 Scale Notes: Higher value is considered greater social support. There are no combined subscales.

Perceived social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS). This will be quantified as MSPSS score at 6-months (post-intervention). It is not a change score. Scale Name: Multidimensional Scale of Perceived Social Support Scale Range (Min-Max): 12-84 Scale Notes: Higher value is considered greater social support. There are no combined subscales.

Perceived social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS). This will be quantified as MSPSS score at 9-months (post-intervention). It is not a change score. Scale Name: Multidimensional Scale of Perceived Social Support Scale Range (Min-Max): 12-84 Scale Notes: Higher value is considered greater social support. There are no combined subscales.

Perceived social support will be measured with the Multidimensional Scale of Perceived Social Support (MSPSS). This will be quantified as MSPSS score at 12-months (post-intervention). It is not a change score. Scale Name: Multidimensional Scale of Perceived Social Support Scale Range (Min-Max): 12-84 Scale Notes: Higher value is considered greater social support. There are no combined subscales.

Internalized mental health stigma will be measured with the Internalized Stigma of Mental Illness Scale (ISMI). This will be quantified as ISMI score at 3-months (post-intervention). It is not a change score. Scale Name: Internalized Stigma of Mental Illness Scale Scale Range (Min-Max): 10-40 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

Internalized mental health stigma will be measured with the Internalized Stigma of Mental Illness Scale (ISMI). This will be quantified as ISMI score at 6-months (post-intervention). It is not a change score. Scale Name: Internalized Stigma of Mental Illness Scale Scale Range (Min-Max): 10-40 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

Internalized mental health stigma will be measured with the Internalized Stigma of Mental Illness Scale (ISMI). This will be quantified as ISMI score at 9-months (post-intervention). It is not a change score. Scale Name: Internalized Stigma of Mental Illness Scale Scale Range (Min-Max): 10-40 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

Internalized mental health stigma will be measured with the Internalized Stigma of Mental Illness Scale (ISMI). This will be quantified as ISMI score at 12-months (post-intervention). It is not a change score. Scale Name: Internalized Stigma of Mental Illness Scale Scale Range (Min-Max): 10-40 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

AIDS-related stigma will be measured with the AIDS-Related Stigma Scale (ARSS). This will be quantified as ARSS score at 3-months (post-intervention). It is not a change score. Scale Name: AIDS-Related Stigma Scale Scale Range (Min-Max): 0-6 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

AIDS-related stigma will be measured with the AIDS-Related Stigma Scale (ARSS). This will be quantified as ARSS score at 6-months (post-intervention). It is not a change score. Scale Name: AIDS-Related Stigma Scale Scale Range (Min-Max): 0-6 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

AIDS-related stigma will be measured with the AIDS-Related Stigma Scale (ARSS). This will be quantified as ARSS score at 9-months (post-intervention). It is not a change score. Scale Name: AIDS-Related Stigma Scale Scale Range (Min-Max): 0-6 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.

AIDS-related stigma will be measured with the AIDS-Related Stigma Scale (ARSS). This will be quantified as ARSS score at 12-months (post-intervention). It is not a change score. Scale Name: AIDS-Related Stigma Scale Scale Range (Min-Max): 0-6 Scale Notes: Higher value is considered greater internalized stigma. There are no combined subscales.