Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Harvard Medical School (HMS and HSDM)
- Enrollment
- 742
- Locations
- 1
- Primary Endpoint
- Depressive disorder and suicidality
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Mary Kay Smith Fawzi
Assistant Professor of Global Health and Social Medicine
Harvard Medical School (HMS and HSDM)
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
Outcomes
Primary Outcomes
Depressive disorder and suicidality
Time Frame: Q3 2016 after an average of 1.5 years of follow-up
Using a cut-off score based on the validation study, participants will be classified as having depressive and or suicidality or not. The trial aims to reduce rates of depression and suicidality among participants.
Secondary Outcomes
- Social support(Q3 2016 after an average of 1.5 years of follow-up)
- Self-Efficacy(Q3 2016 after an average of 1.5 years of follow-up)
- HIV-related stigma(Q3 2016 after an average of 1.5 years of follow-up)
- Intimate partner violence(Q3 2016 after an average of 1.5 years of follow-up)
- Gestational Age and Prematurity(At time of birth)
- Infant birthwight(At time of birth)
- Infant diarrheal disease(Two weeks after infant's birth)
- Weight-for-height(Up to 1.5 years after infant birth)
- Height-for-age(Up to 1.5 years after infant's birth)