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

TY - JOUR

T1 - Healthy Options

T2 - Study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania

AU - Smith Fawzi, Mary C.

AU - Siril, Hellen

AU - Larson, Elysia

AU - Aloyce, Zenaice

AU - Araya, Ricardo

AU - Kaale, Anna

AU - Kamala, Janeth

AU - Kasmani, Muhummed Nadeem

AU - Komba, Amina

AU - Minja, Anna

AU - Mwimba, Angelina

AU - Ngakongwa, Fileuka

AU - Somba, Magreat

AU - Sudfeld, Christopher R.

AU - Kaaya, Sylvia F.

PY - 2020/1/20

Y1 - 2020/1/20

N2 - Background: Perinatal 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. Methods: A 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). 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, 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. Conclusions: Baseline 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 registration: The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

AB - Background: Perinatal 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. Methods: A 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). 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, 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. Conclusions: Baseline 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 registration: The trial is registered under clinicaltrials.gov (NCT02039973). Retrospectively registered on January 20, 2014.

KW - Depression

KW - HIV

KW - Intervention

KW - PMTCT

KW - Treatment

KW - Women

UR - http://www.scopus.com/inward/record.url?scp=85078470004&partnerID=8YFLogxK

U2 - 10.1186/s12889-019-7907-6

DO - 10.1186/s12889-019-7907-6

M3 - Article

C2 - 31959151

AN - SCOPUS:85078470004

SN - 1471-2458

VL - 20

JO - BMC Public Health

JF - BMC Public Health

IS - 1

M1 - 80

ER -