Effectiveness and cost-effectiveness of integrating the management of depression into routine HIV Care in Uganda (the HIV + D trial): A protocol for a cluster-randomised trial

Abstract

Background An estimated 8–30 % of people living with HIV (PLWH) have depressive disorders (DD) in sub-Saharan Africa. Of these, the majority are untreated in most of HIV care services. There is evidence from low- and middle- income countries of the effectiveness of both psychological treatments and antidepressant medication for the treatment of DD among PLWH, but no evidence on how these can be integrated into routine HIV care. This protocol describes a cluster-randomised trial to evaluate the effectiveness and cost-effectiveness of the HIV + D model for the integration of a collaborative stepped care intervention for DD into routine HIV care, which we have developed and piloted in Uganda. Methods Forty public health care facilities that provide HIV care in Kalungu, Masaka and Wakiso Districts will be randomly selected to participate in the trial. Each facility will recruit 10–30 eligible PLWH with DD and the total sample size will be 1200. The clusters will be randomised 1:1 to receive Enhanced Usual Care alone (EUC, i.e. HIV clinicians trained in Mental Health Gap Action Programme including guidelines on when and where to refer patients for psychiatric care) or EUC plus HIV + D (psychoeducation, Behavioural Activation, antidepressant medication and referral to a supervising mental health worker, delivered in a collaborative care stepwise approach). Eligibility criteria are PLWH attending the clinic, aged ≥ 18 years who screen positive on a depression screening questionnaire (Patient Health Questionnaire, PHQ-9 ≥ 10). The primary outcome is the mean depressive disorder symptom severity scores (assessed using the PHQ-9) at 3 months’ post-randomisation, with secondary mental health, disability, HIV and economic outcomes measured at 3 and 12 months. The cost-effectiveness of EUC with HIV + D will be assessed from both the health system and the societal perspectives by collecting health system, patient and productivity costs and mean DD severity scores at 3 months, additional to health and non-health related quality of life measures (EQ-5D-5 L and OxCAP-MH). Discussion The study findings will inform policy makers and practitioners on the cost-effectiveness of a stepped care approach to integrate depression management in routine care for PLWH in low-resource settings. Trial registration: ISRCTN, ISRCTN86760765. Registered 07 September 2017, 10.1186/ISRCTN86760765.

Predicting the impacts of land management for sustainable development on depression risk in a Ugandan case study

“…The PHQ-8 has been used internationally and is based on an instrument that has been used in Uganda 54 , 55 . However, western diagnostic criteria and psychological concepts might not be universally appropriate and overlook culturally relative syndromes 58 .…”

“…It has been used in multiple studies in Uganda (e.g. 54 , 55 ). One item related to suicidality appeared to be misinterpreted during piloting and was removed.…”

From surviving to thriving: integrating mental health care into HIV, community, and family services for adolescents living with HIV

“…36 This treatment gap reflects a broader gap in adolescent mental health services, 8,37 with limited evidence compared to adult mental health care. 38,39 For the highest-vulnerability groups of adolescents living with HIV who experience layered stigmasuch as adolescent sex workers, adolescents living with HIV and disabilities, and adolescents living on the streets -there is a near-total lack of evidence and service provision. There is increasing pressure from HIV advocacy groups to include end-users in the development of interventions and service delivery, but this practice remains very rare in adolescent HIV programming.…”

Predicting the impacts of land management for sustainable development on depression risk in a Ugandan case study

“…The PHQ-9 is widely used and is a recommended depression screening tool in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 44 . It has been used in multiple studies in Uganda (e.g., 45,46 ). One item -related to suicidality -appeared to be misinterpreted during piloting and was removed.…”

“…The PHQ-8 has been used internationally and is based on an instrument that has been used in Uganda 45,46 . However, western diagnostic criteria and psychological concepts might not be universally appropriate and overlook culturally relative syndromes 49 .…”