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

摘要

Background: Perinatal women accessing prevention of mother-to-child transmission of HIV (PMTCT) services are atan increased risk of depression; however, in Tanzania there is limited access to services provided by mental healthprofessionals. This paper presents a protocol and baseline characteristics for a study evaluating a psychosocialsupport group intervention facilitated by lay community-based health workers (CBHWs) for perinatal women livingwith HIV and depression in Dar es Salaam.Methods: A cluster randomized controlled trial (RCT) is conducted comparing: 1) a psychosocial support groupintervention; and 2) improved standard of mental health care. The study is implemented in reproductive and childhealth (RCH) centers providing PMTCT services. Baseline characteristics are presented by comparing sociodemographiccharacteristics and primary as well as secondary outcomes for the trial for intervention and control groups. The trial isregistered under clinicaltrials.gov (NCT02039973).Results: Among 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, findingssuggest that the population is highly vulnerable with over 45% demonstrating food insecurity and 17% reportingintimate partner violence in the past 6 months.Conclusions: Baseline characteristics for the cluster RCT were comparable for intervention and control groups. The trialwill examine the effectiveness of a psychosocial support group intervention for the treatment of depression amongwomen living with HIV accessing PMTCT services. A reduction in the burden of depression in this vulnerablepopulation has implications in the short-term for improved HIV-related outcomes and for potential long-termeffects on child growth and development.Trial registration: The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered onJanuary 20, 2014.