Clinical trial NCT02039973: Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
Official title: Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: HIV
AIDS
Tanzania
depression
perinatal
psychotherapy
task-sharing
problem-solving
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-01-20
Enrollment: 742
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.

Detailed description: In resource-limited settings, there has been a significant increase in access to antiretroviral therapy (ART) in recent years. Although there remain serious limitations in access to ART in these settings, for many who have initiated and continue treatment, HIV disease is a chronic condition that needs to be managed over time. There is considerable evidence that individuals with chronic illness have an increased risk of depression, in part related to the challenges in coping and managing their illness. Rates for depression during pregnancy in women living with HIV are estimated to be higher.

Despite this relatively high burden of depression among persons living with HIV/AIDS (PLHA), it has been documented that clinical staff working with PLHA do not routinely identify or treat depression in this setting. This is in contrast to recent revisions in the Tanzanian health policy that emphasize integrating mental health and HIV care at district and lower level health care services. The long-term intent of the research is to bridge this gap between Tanzanian health policy and implementation of integrating mental health care among pre- and post-natal women receiving HIV care. Therefore, the overall goal of the proposed study is to examine the potential for successful integration of enhanced mental health care and group counseling among HIV-positive women receiving preventing mother to child transmission (PMTCT)-plus services and to evaluate a combination of evidence-based approaches in treatment of depression in this vulnerable population in Tanzania.

Specifically this application aims to:

1. Examine the acceptability and feasibility of integrating an enhanced standard of mental health care and group counseling with PMTCT-plus services provided at government-run maternal and child health (MCH) clinics, from the perspectives of: a) facility mental health care focal points and MCH clinic managers, b) perinatal direct care providers; and c) HIV-positive perinatal women;
2. Validate a depression screening tool for major depressive disorder (MDD) and suicidality for use in Tanzania; and
3. Conduct a cluster randomized controlled trial comparing a task-sharing approach (i.e. problem solving and cognitive behavioral therapy components delivered to groups facilitated by lay community based health care workers (CBHWs) versus improved standard

Eligibility criteria: Inclusion Criteria:

* pregnant women who access PMTCT-plus services at MCH clinics in Dar es Salaam
* HIV-positive serostatus
* screen positive for depression
* less than 28 weeks of gestation
* confirm they will attend postnatal services at the maternal and child health service they enrolled in for antenatal care for at least two years after they give birth

Exclusion Criteria:

* any woman less than 18 years of age
* HIV-negative
* screened negative for depression
* screened positive for depression and assessed to be of high suicide risk requiring immediate emergency referral for care
* not able to continue to receive care at the MCH clinic where they were initially enrolled for at least two years after giving birth

Primary outcomes:
measure: Depressive disorder and suicidality
timeFrame: Q3 2016 after an average of 1.5 years of follow-up
Secondary outcomes:
measure: Social support
timeFrame: Q3 2016 after an average of 1.5 years of follow-up
measure: Self-Efficacy
timeFrame: Q3 2016 after an average of 1.5 years of follow-up
measure: HIV-related stigma
timeFrame: Q3 2016 after an average of 1.5 years of follow-up
measure: Intimate partner violence
timeFrame: Q3 2016 after an average of 1.5 years of follow-up
measure: Infant birthwight
timeFrame: At time of birth
measure: Gestational Age and Prematurity
timeFrame: At time of birth
measure: Infant diarrheal disease
timeFrame: Two weeks after infant's birth
measure: Weight-for-height
timeFrame: Up to 1.5 years after infant birth
measure: Height-for-age
timeFrame: Up to 1.5 years after infant's birth
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Dar es Salaam City Health Department
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Mary Kay Smith-Fawzi, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Sylvia Kaaya, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, Kamala J, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Kaaya SF. 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. BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.