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Integration of MHC3

Tezera Berheto (MPH)
Tezera Berheto (MPH)

This document outlines a research study that aims to determine the effect of integrating mental health services into antiretroviral therapy (ART) programs in Ethiopia. The study will use a cluster randomized controlled trial design to compare ART outcomes between clinics that provide integrated mental health services and standard ART care. The objectives are to assess how integration impacts ART outcomes like viral load, retention in care, and adherence, as well as to examine the prevalence of mental health disorders and feasibility of integration. The study involves collecting data on socioeconomics, biological markers, mental health status, and other indicators from ART clients at baseline and follow-ups. Analysis will compare the intervention and control groups on outcomes while accounting for clustering. The study aims to be

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The effect of Integrated mental health services on the outcome of Antiretroviral treatment in Ethiopia: a cluster randomized trial Tezera M (MPH) Wolaita Sodo University, College of Health Sciences, School of Public Health
Outline Main research questions Rationale Aim and Objectives Research Method Ethical approval References 2
Research questions If the integrated mental health services have an effect on the outcome of antiretroviral therapy? Whether integrating the mental health service is feasible and acceptable in Ethiopia? What is the magnitude of mental health problem amongst ART clients in Ethiopia? What are the types of mental health problem amongst ART clients in Ethiopia? 3
Rationale of the study HIV and mental health are highly related disorders HIV infection precipitate the development a mental health problem (Patel, V. et al 2007) Mental health problems are 2 to 5 times more prevalent in HIV infected people than general population (Deribew et al 2010) Depression (36%-50%) Alcohol UD (8-50%), substance use (10%) HIV is associated neuro-cognitive disorder(20-30%) Are the most common mental health problem in HIV infected people (HATiP, 2009) 4
Rationale Also People with mental Illness are at higher risk of being infected with HIV Mental illness, such as depression is associated with increased immune suppression which leads to a faster disease progression (Cook JL, et al 2004) The most important HIV-Mental health interplay is its effect on clinical management of HIV/AIDS It complicates the ART outcome by impairing adherence and increasing attrition from the care (Sin NL, et al 2014) 5
Rationale Mental illness is predicted to be the leading causes of disability by 2030 (WHO 2011) Mental illness is a single biggest contributor to the global burden of disease 14% (WHO 2001) According to Vigo, et al. 2016 , 32.4% of YLD 13.% of DALYs was accounted to Mental illness HIV/AIDS increasing YLDs and the fourth leading cause of death in sub-Saharan Africa (GBD 2013) 6
Rationale In Ethiopia the burden of MI and HIV are high The prevalence of MI was estimated to be (9.1 - 20%) in island and general population (Fekadu, A, et al. 2008 and Solomon, et al 2012) Most of the victims are not getting clinical help (http://www.mhsethio.org/ ) In 2016, the number of people who need ART were 770,621 The ART service was accessible for a majority in need of the treatment (MOH, 2015) However, attrition, poor adherence, drug resistant strain and viral failure are among the major challenges of ART (EPHI, 2015, MOH, 2015) 7
Rationale The primary factors associated with adverse treatment outcomes appears to be, depression, anxiety, mental distress, and alcohol abuse (Azar MM, et al 2010. Hodgson I et al 2014, Assefa Y, et al 2016) This is an indication to consider mental health service as integral part of HIV care WHO, Alma-Ata declaration and SDG; addressed that mental health issues as an essential component of holistic care Unfortunately mental health care still been neglected 8
Rationale The Ethiopian, National Mental Health Strategy (2013/142015/16 frame worked a plan for expanding mental health services in PHCU This plan has identified HIV infected People are as one of the vulnerable groups Accordingly, the pilot integrated mental health service was initiated in Tigray and Amhara region in 2014 However, the effectiveness and level of the integration is not well known 9
Aim and Objectives Aim: To determine the effect of mental health service integration on the outcome of ART in Ethiopia The outcome variables (1) Biological markers: (Viral load response, Progress in CD4 cell and clinical stage) (2) Retention on care: (LTF, discontinuation, early mortality) (3) Behavioral ends: adherence with recommended regimen (4) Mental health status: 10
Objectives: Objective 1: To assess the effect of mental health service integration on the outcomes of ART Objective 2: To determine the burden of mental health disorder amongst ART client Objective 3: To examine the feasibility and acceptability of mental health service integration in to ART clinic Objective 4: To explore strategies to provide necessary mental health service within the ART program 11
Research Method Design: A pragmatic Cluster based randomized controlled trials (RCT), with two arms This design will be used to compare the outcome of ART between the integrated mental health care and the standard ART follow up care Randomization: ART clinics will be randomly assigned to the intervention and the control arm Blinding: The patient and care provider will be blinded 12
Method Study Setting: The study will be conducted in randomly selected health facilities providing ART service in Ethiopia Ethiopia is the second most populous nation in Africa The prevalence of HIV is estimated to be 1.5% in the genera population (EDHS 2011) In 2015, ART service was available in 1045 Health facilities The ART coverage was 76% (MoH 2015) 13
Method Description of Interventions: The existing ART practices will be used as standard treatment (control arm) Standard ART care plus integrated mental health service (Intervention arm) ART service provider in the intervention arm will be trained to support the mental health needs of the ART client Study subjects: Aged 18 years or older Eligibility Criteria: Both male and female, initiated ART at the beginning of the study Who are not planned to move out during the follow-up period 14
Method Sample size: Is calculated based on an estimated proportion of loss to follow up after one year of care 26% (Berheto, et al 2014) Assuming a 20% reduction of loss to follow per year 80 % power, 留-level of 0.05, 10% drop-out rate, and considering 1.25 inter cluster correlation factor the sample size per each arm is determined to be 479 15
Method Data collection: Socio-demographics information will be collected at the base line using structured interviewer administered questionnaire Adherence to treatment will be collected at the 3, 6 and 9 months of follow-up Biological markers (CD4 count and viral load) will be measured in standard laboratory procedures at the baseline and end of the study The Patient Health Questionnaire (PHQ): will be used to measure mental health status, at baseline and follow up basis Other health indictors anthropometric, patient satisfaction and functional status will be assessed in follow-up basis 16
Method Data Analysis: An intention-to-treat approach will be used 2 square test will be used to compare intervention and control on categorical outcomes Independent samples T-test will be used to compare intervention and control conditions on continuous normally distributed data Analysis of covariance will be used to compare intervention and control on continuous measures, with a covariate Interval estimates of effect size will be calculated STATA 12 will be used to analyze the data 17
Method Time table: The study will be completed in 38 months Ethical approval: Will be obtained from the AAU From each cluster and individual participants The Ministries of Health 18
References Azar MM, Springer SA, Meyer JP, Altice FL: A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug and alcohol dependence 2010, 112(3):178-193. Hodgson I, Plummer ML, Konopka SN, Colvin CJ, Jonas E, Albertini J, Amzel A, Fogg KP: A Systematic Review of Individual and Contextual Factors Affecting ART Initiation, Adherence, and Retention for HIV- Infected Pregnant and Postpartum Women. PloS one 2014, 9(11):e111421. Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, Rahman A: No health without mental health. The Lancet 2007, 370(9590):859- 877. 19
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Integration of MHC3

  • 1. The effect of Integrated mental health services on the outcome of Antiretroviral treatment in Ethiopia: a cluster randomized trial Tezera M (MPH) Wolaita Sodo University, College of Health Sciences, School of Public Health
  • 2. Outline Main research questions Rationale Aim and Objectives Research Method Ethical approval References 2
  • 3. Research questions If the integrated mental health services have an effect on the outcome of antiretroviral therapy? Whether integrating the mental health service is feasible and acceptable in Ethiopia? What is the magnitude of mental health problem amongst ART clients in Ethiopia? What are the types of mental health problem amongst ART clients in Ethiopia? 3
  • 4. Rationale of the study HIV and mental health are highly related disorders HIV infection precipitate the development a mental health problem (Patel, V. et al 2007) Mental health problems are 2 to 5 times more prevalent in HIV infected people than general population (Deribew et al 2010) Depression (36%-50%) Alcohol UD (8-50%), substance use (10%) HIV is associated neuro-cognitive disorder(20-30%) Are the most common mental health problem in HIV infected people (HATiP, 2009) 4
  • 5. Rationale Also People with mental Illness are at higher risk of being infected with HIV Mental illness, such as depression is associated with increased immune suppression which leads to a faster disease progression (Cook JL, et al 2004) The most important HIV-Mental health interplay is its effect on clinical management of HIV/AIDS It complicates the ART outcome by impairing adherence and increasing attrition from the care (Sin NL, et al 2014) 5
  • 6. Rationale Mental illness is predicted to be the leading causes of disability by 2030 (WHO 2011) Mental illness is a single biggest contributor to the global burden of disease 14% (WHO 2001) According to Vigo, et al. 2016 , 32.4% of YLD 13.% of DALYs was accounted to Mental illness HIV/AIDS increasing YLDs and the fourth leading cause of death in sub-Saharan Africa (GBD 2013) 6
  • 7. Rationale In Ethiopia the burden of MI and HIV are high The prevalence of MI was estimated to be (9.1 - 20%) in island and general population (Fekadu, A, et al. 2008 and Solomon, et al 2012) Most of the victims are not getting clinical help (http://www.mhsethio.org/ ) In 2016, the number of people who need ART were 770,621 The ART service was accessible for a majority in need of the treatment (MOH, 2015) However, attrition, poor adherence, drug resistant strain and viral failure are among the major challenges of ART (EPHI, 2015, MOH, 2015) 7
  • 8. Rationale The primary factors associated with adverse treatment outcomes appears to be, depression, anxiety, mental distress, and alcohol abuse (Azar MM, et al 2010. Hodgson I et al 2014, Assefa Y, et al 2016) This is an indication to consider mental health service as integral part of HIV care WHO, Alma-Ata declaration and SDG; addressed that mental health issues as an essential component of holistic care Unfortunately mental health care still been neglected 8
  • 9. Rationale The Ethiopian, National Mental Health Strategy (2013/142015/16 frame worked a plan for expanding mental health services in PHCU This plan has identified HIV infected People are as one of the vulnerable groups Accordingly, the pilot integrated mental health service was initiated in Tigray and Amhara region in 2014 However, the effectiveness and level of the integration is not well known 9
  • 10. Aim and Objectives Aim: To determine the effect of mental health service integration on the outcome of ART in Ethiopia The outcome variables (1) Biological markers: (Viral load response, Progress in CD4 cell and clinical stage) (2) Retention on care: (LTF, discontinuation, early mortality) (3) Behavioral ends: adherence with recommended regimen (4) Mental health status: 10
  • 11. Objectives: Objective 1: To assess the effect of mental health service integration on the outcomes of ART Objective 2: To determine the burden of mental health disorder amongst ART client Objective 3: To examine the feasibility and acceptability of mental health service integration in to ART clinic Objective 4: To explore strategies to provide necessary mental health service within the ART program 11
  • 12. Research Method Design: A pragmatic Cluster based randomized controlled trials (RCT), with two arms This design will be used to compare the outcome of ART between the integrated mental health care and the standard ART follow up care Randomization: ART clinics will be randomly assigned to the intervention and the control arm Blinding: The patient and care provider will be blinded 12
  • 13. Method Study Setting: The study will be conducted in randomly selected health facilities providing ART service in Ethiopia Ethiopia is the second most populous nation in Africa The prevalence of HIV is estimated to be 1.5% in the genera population (EDHS 2011) In 2015, ART service was available in 1045 Health facilities The ART coverage was 76% (MoH 2015) 13
  • 14. Method Description of Interventions: The existing ART practices will be used as standard treatment (control arm) Standard ART care plus integrated mental health service (Intervention arm) ART service provider in the intervention arm will be trained to support the mental health needs of the ART client Study subjects: Aged 18 years or older Eligibility Criteria: Both male and female, initiated ART at the beginning of the study Who are not planned to move out during the follow-up period 14
  • 15. Method Sample size: Is calculated based on an estimated proportion of loss to follow up after one year of care 26% (Berheto, et al 2014) Assuming a 20% reduction of loss to follow per year 80 % power, 留-level of 0.05, 10% drop-out rate, and considering 1.25 inter cluster correlation factor the sample size per each arm is determined to be 479 15
  • 16. Method Data collection: Socio-demographics information will be collected at the base line using structured interviewer administered questionnaire Adherence to treatment will be collected at the 3, 6 and 9 months of follow-up Biological markers (CD4 count and viral load) will be measured in standard laboratory procedures at the baseline and end of the study The Patient Health Questionnaire (PHQ): will be used to measure mental health status, at baseline and follow up basis Other health indictors anthropometric, patient satisfaction and functional status will be assessed in follow-up basis 16
  • 17. Method Data Analysis: An intention-to-treat approach will be used 2 square test will be used to compare intervention and control on categorical outcomes Independent samples T-test will be used to compare intervention and control conditions on continuous normally distributed data Analysis of covariance will be used to compare intervention and control on continuous measures, with a covariate Interval estimates of effect size will be calculated STATA 12 will be used to analyze the data 17
  • 18. Method Time table: The study will be completed in 38 months Ethical approval: Will be obtained from the AAU From each cluster and individual participants The Ministries of Health 18
  • 19. References Azar MM, Springer SA, Meyer JP, Altice FL: A systematic review of the impact of alcohol use disorders on HIV treatment outcomes, adherence to antiretroviral therapy and health care utilization. Drug and alcohol dependence 2010, 112(3):178-193. Hodgson I, Plummer ML, Konopka SN, Colvin CJ, Jonas E, Albertini J, Amzel A, Fogg KP: A Systematic Review of Individual and Contextual Factors Affecting ART Initiation, Adherence, and Retention for HIV- Infected Pregnant and Postpartum Women. PloS one 2014, 9(11):e111421. Prince M, Patel V, Saxena S, Maj M, Maselko J, Phillips MR, Rahman A: No health without mental health. The Lancet 2007, 370(9590):859- 877. 19