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Health care workers' negative behavior towards patients (likely a reflection of low job satisfaction, frustration with delivering HIV care and treatment in extremely resource-limited settings, and burnout) is one of the primary reasons people living with HIV abandon treatment in Mozambique. The purpose of this proposal is to test the impact and implementation of a provider resilience intervention and an anti-stigma intervention, individually and in combination, using a randomized controlled trial design at four health facilities. This potentially high-impact intervention offers the opportunity to test a low-cost, provider-focused approach to improving HIV treatment that, if proven effective at increasing adherence and retention in care, could be tested in a fully powered R01 trial in Mozambique.
Mozambique has made progress towards their 95-95-95 goals, yet only 65% of people newly initiated in HIV treatment remain in care at 12 months. HIV treatment adherence has been undermined by a lack of compassionate health care service delivery. People living with HIV in our study region of Zambezia province report being treated disrespectfully by health care workers as one of the leading causes of treatment abandonment. Common complaints include insulting patients' intellectual capacity, ignoring concerns with side effects or co-occurring infections, and refusing to treat patients seen as "unworthy". While health care worker behavior is appalling, it is likely a reflection of high rates of burnout, job dissatisfaction, and frustration with patients they perceive to be uncooperative.
The implementation of Estamos Juntos (We are Together) will allow us to test a multiprong intervention designed to address provider-barriers to delivering compassionate care via two synergistic components: (1) Resilience and well-being training for health care providers who have expressed low job satisfaction, frustration with delivering care in an extremely resource-limited setting, and burnout; and (2) Anti-stigma training for health care providers who see those with low socioeconomic status, low levels of education, and those living with HIV as "lesser-than" themselves. We propose to pilot test the implementation and impact of each psychosocial intervention individually, and in combination, using a randomized controlled trial design at four health facilities. We hypothesize that the facility where health care workers receive both resilience and anti-stigma training will see the greatest change in health care worker outcomes, including decreased stigmatizing attitudes, emotional exhaustion, and depersonalize of their patients, as well as increased resilience and job satisfaction. Patients receiving care and treatment from intervention providers will show increased retention and medication adherence, as well as improvements in health care services satisfaction, medical mistrust, and perceived stigma from health care providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Health care providers in this arm will receive no intervention | |
| Resilience intervention | Experimental | Providers in this arm will receive training to improve their resilience and well-being |
|
| Resilience and Stigma group | Experimental | Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients. |
|
| Anti-stigma group | Experimental | Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral therapy and education | Behavioral | Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Burnout | We assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative. | 6 months |
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Provider Criteria
Inclusion Criteria:
Exclusion Criteria:
Patient Criteria
Inclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Health | Quelimane | Zambezia Province | Mozambique |
Mozambique is in the process of determining what IPD can be shared to researchers not on the approved study team. Once we know their new legal process we will update this plan.
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We recruited 25 health care workers from each of four health facilities. Health care workers consented to participate and interacted with the study team. All eligible patients who they treated during the subsequent 6 months were included in the clinical outcome data.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Health care providers in this arm will receive no intervention |
| FG001 | Resilience Intervention | Providers in this arm will receive training to improve their resilience and well-being Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| FG002 | Resilience and Stigma Group | Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| FG003 | Anti-stigma Group | Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Provider Baseline Data and Patient Data are collapsed together here.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Health care providers in this arm will receive no intervention |
| BG001 | Resilience Intervention | Providers in this arm will receive training to improve their resilience and well-being Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Provider Baseline Data | These data are from the 100 providers that were enrolled in the study |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Burnout | We assessed burnout using the Copenhagen Burnout Inventory (CBI) at baseline and again at 6 months. Higher numbers indicate greater levels of burnout. We are reporting the change in burnout scores from baseline to 6 months post-intervention. The scores can range from a minimum of 0 to a maximum of 100. We are reporting changes in scores, so some numbers are negative. | Posted | Median | Inter-Quartile Range | units on a scale | 6 months |
|
The data were collected from providers over a six-month period. Per protocol, adverse event data were not collected from patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Health care providers in this arm will receive no intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Audet | Vanderbilt University Medical Center | 615-343-2418 | carolyn.m.audet@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 27, 2024 | Aug 11, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| BG002 | Resilience and Stigma Group | Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| BG003 | Anti-stigma Group | Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Patient Data | This is the data from patients only. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Provider Baseline Data | These data are from the 100 health care providers enrolled in the study | Count of Participants | Participants |
|
| Sex: Female, Male | These are data from the patients treated at the study sites | These data only include patients seen at the study clinics | Count of Participants | Participants |
|
| Race (NIH/OMB) | Provider and Patient Baseline Data | Count of Participants | Participants |
|
| Region of Enrollment | Provider and Patient Baseline Data | Number | participants |
|
| Number of Years Working in this Health Facility | Provider Baseline Data | This only includes provider data | Mean | Standard Deviation | years |
|
| OG002 | Resilience and Stigma Group | Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
| OG003 | Anti-stigma Group | Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Resilience Intervention | Providers in this arm will receive training to improve their resilience and well-being Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Resilience and Stigma Group | Providers in this group will receive training to improve their resilience and well-being as well as receive sessions about the impact of stigmatizing their patients. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Anti-stigma Group | Providers in this group will receive sessions focusing on the impact that stigmatizing patients can have on themselves and their patients. Strategies to minimize negative feelings will be developed. Behavioral therapy and education: Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions. | 0 | 25 | 0 | 25 | 0 | 25 |
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| 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 |
| Male |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|