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Randomized Controlled Trial
. 2020 Jan 20;20(1):80.
doi: 10.1186/s12889-019-7907-6.

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  1 , Hellen Siril  2 , Elysia Larson  3 , Zenaice Aloyce  4 , Ricardo Araya  5 , Anna Kaale  4 , Janeth Kamala  4 , Muhummed Nadeem Kasmani  6 , Amina Komba  4 , Anna Minja  4 , Angelina Mwimba  4 , Fileuka Ngakongwa  7 , Magreat Somba  4 , Christopher R Sudfeld  3 , Sylvia F Kaaya  7
Affiliations
Randomized Controlled Trial

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 et al. BMC Public Health. .

Abstract

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.

Keywords: Depression; HIV; Intervention; PMTCT; Treatment; Women.

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Conflict of interest statement

The authors declare that they have no competing interests.

References

    1. Murray CJL, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2197–2223. doi: 10.1016/S0140-6736(12)61689-4. - DOI - PubMed
    1. Wulsin LR, Vaillant GE, Wells VE. A systematic review of the mortality of depression. Psychosom Med. 1999;61(1):6. doi: 10.1097/00006842-199901000-00003. - DOI - PubMed
    1. Golden SH, Lazo M, Carnethon M, Bertoni AG, Schreiner PJ, Roux AVD, et al. Examining a bidirectional association between depressive symptoms and diabetes. JAMA. 2008;299(23):2751–2759. doi: 10.1001/jama.299.23.2751. - DOI - PMC - PubMed
    1. Smit M, Olney J, Ford NP, et al. The growing burden of noncommunicable disease among persons living with HIV in Zimbabwe. AIDS. 2018;32(6):773–782. doi: 10.1097/QAD.0000000000001754. - DOI - PMC - PubMed
    1. Krebber AMH, Buffart LM, Kleijn G, et al. Prevalence of depression in cancer patients: a meta-analysis of diagnostic interviews and self-report instruments. Psychooncology. 2014;23(2):121–130. doi: 10.1002/pon.3409. - DOI - PMC - PubMed

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