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

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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?

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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)

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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)

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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

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Rationale…

• The Ethiopian, National Mental Health Strategy (2013/14–2015/16 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

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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:

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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

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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

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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)

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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 period14

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, α-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

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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

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Method…• Data Analysis:

• An intention-to-treat approach will be used

• χ2 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 data17

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

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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.

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Thank you

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