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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH100338-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Task-sharing approach to group therapy | Experimental | The intervention will consist of problem-solving therapy as well as cognitive behavioral components. Core problem-solving therapy components will involve lay CBHW facilitated discussions to explore symptoms of depression and how problems are related to depression. Core cognitive behavioral components will include lay CBHW facilitated discussions to explain the purpose of the sessions, as well as effect a number of behavioral changes in participants. |
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| Enhanced standard of care | Active Comparator | The control condition will promote an enhanced standard of care. Clinicians and nurses at MCH clinics included in the study will receive a structured one day re-orientation training consistent with the World Health Organization (WHO) mh-GAP guidelines for assessment as well as basic psychosocial and drug treatment of moderate to severe depression in primary care settings. The training will be consistent with the standard of care for mental health among HIV-positive populations as outlined in Tanzanian health policy. In addition, clinical staff will be trained to encourage women to invite their male partners to accompany them at clinic visits, where psycho-education on perinatal depression for couples will be offered for those opting to participate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Task-sharing approach to group therapy | Behavioral | Participants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities. Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive disorder and suicidality | 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. | Q3 2016 after an average of 1.5 years of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Social support | For this measure, the Duke University-University of North Carolina Functional Social Support Questionnaire will be used; this scale has demonstrated positive correlations with other social support scales. A listing of ten items from this of this questionnaire has been used previously in Tanzania, reflecting dimensions of instrumental and emotional support | Q3 2016 after an average of 1.5 years of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Kay Smith-Fawzi, ScD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Sylvia Kaaya, MD, PhD | Muhimbili University of Health and Allied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dar es Salaam City Health Department | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36512631 | Derived | Kaaya S, Siril H, Fawzi MCS, Aloyce Z, Araya R, Kaale A, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Larson E. A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial. PLoS Med. 2022 Dec 13;19(12):e1004112. doi: 10.1371/journal.pmed.1004112. eCollection 2022 Dec. | |
| 31959151 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
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| Enhanced standard of care | Behavioral |
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| Self-Efficacy | The General Self-Efficacy Scale will be used to assess self-efficacy. This scale has demonstrated good internal consistency (Cronbach's alpha ranging from 0.81 to 0.91) and construct validity was shown through positive correlations with optimism and negative correlations with depression and anxiety. | Q3 2016 after an average of 1.5 years of follow-up |
| HIV-related stigma | The HIV Stigma Scale developed by Berger et al. will be used to assess stigma; it has been validated in a diverse sample in the U.S. demonstrated construct validity through factor analysis and internal consistency (Cronbach's alpha of 0.96). A sub-sample of these items also demonstrated construct validity of this scale has also been demonstrated in a resource-limited setting. | Q3 2016 after an average of 1.5 years of follow-up |
| Intimate partner violence | For intimate partner violence (IPV) the WHO Women's Health and Domestic Violence against Women Questionnaire will be used, which assesses emotional, sexual, and physical violence by intimate partners and has demonstrated good internal consistency ranging from 0.66 to 0.81. | Q3 2016 after an average of 1.5 years of follow-up |
| Infant birthwight | The infant's birth weight will be measured at the time of birth. | At time of birth |
| Gestational Age and Prematurity | The gestational age of the infant at the time of birth will be measured. Premature infants are those whose gestational age is less than 37 weeks. | At time of birth |
| Infant diarrheal disease | The occurrence of diarrheal disease among infants will be assessed during the first two weeks of the infant's life. | Two weeks after infant's birth |
| Weight-for-height | Wight and height will be measured as an outcome for the infant, with low weight-for-height being used to classify infants as wasting (more than two standard deviations below the mean). | Up to 1.5 years after infant birth |
| Height-for-age | Height and age of infants will be measured at the end of follow-up, and low height-for-age will be used to classify infants as stunted (more than two standard deviations below the mean). | Up to 1.5 years after infant's birth |
| D003141 |
| Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |