Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania

Mary C Smith Fawzi,Fileuka Ngakongwa,Elysia Larson,Janeth Kamala,Angelina Mwimba,Muhummed Nadeem Kasmani,Sylvia F Kaaya,Christopher R Sudfeld,Zenaice Aloyce,Amina Komba,Ricardo Araya,Anna Kaale,Anna Minja,Hellen Siril,Magreat Somba

doi:10.1186/s12889-019-7907-6

Abstract

BackgroundPerinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; however, in Tanzania there is limited access to services provided by mental health professionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocial support group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women living with HIV and depression in Dar es Salaam.MethodsA cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support group intervention; and 2) improved standard of mental health care. The study is implemented in reproductive and child health (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographic characteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial is registered under clinicaltrials.gov (NCT02039973).ResultsAmong 742 women enrolled, baseline characteristics were comparable for intervention and control groups, although more women in the control group had completed secondary school (25.2% versus 18.2%). Overall, findings suggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reporting intimate partner violence in the past 6 months.ConclusionsBaseline characteristics for the cluster RCT were comparable for intervention and control groups. The trial will examine the effectiveness of a psychosocial support group intervention for the treatment of depression among women living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerable population has implications in the short-term for improved HIV-related outcomes and for potential long-term effects on child growth and development.Trial registrationThe trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

Highlights

Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; in Tanzania there is limited access to services provided by mental health professionals
Utilizing a cluster randomized controlled trial study design we are comparing a task-sharing approach to improved standard of care for the treatment of depression among women living with HIV accessing PMTCT services in Dar es Salaam, Tanzania
Of the 895 pregnant, HIV-positive women approached 75 (8.4%) were excluded because their gestational age was beyond 30 weeks and two (0.2%) declined to participate

Summary

Introduction

Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are at an increased risk of depression; in Tanzania there is limited access to services provided by mental health professionals. Recent studies have documented the substantial burden of depression in resource-limited settings, which can result in significant disability, and premature mortality [2]. In a meta-analysis of ten studies, people living with HIV experienced a twofold increase in risk of major depressive disorder (MDD) compared to those who were HIV-negative [6]. It is critical to identify and treat depression among people living with HIV (PLH) to improve HIV-related outcomes as well as overall health and well-being

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