Hiv
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALbehavioral therapy and education
Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Provider Criteria Inclusion Criteria: * Adult individuals, 18 years of age or older; * working as physicians, nurses, medical technicians, health counselors, community health care workers, or other clinical and non-clinical staff (e.g., receptionists, data entry clerk) who provide health services to adults living with HIV at one of the four study sites; * willing to be followed as a study participant during the 6-month study period, and does not intend to transfer to another health facility (HF) during the study period (per investigator's assessment at time of recruitment), as self-reported. * Be able to read and write in Portuguese, as self-reported.
Exclusion criteria
* Those who are not permanent members of the health facility staff (i.e., floating providers that work at multiple sites in a given week); * Any clinical or mental condition, including the influence of drugs or alcohol at the time of study recruitment, that as per the investigator's opinion/assessment, would preclude the provision of informed consent or make study participation unsafe or unethical; * Individuals working in the health facility but from the following cadres: drivers, security personnel, and workers with no patient-facing roles. Patient Criteria Inclusion: * Adult individuals, 18 years of age or older * Active in care (i.e., not in default) * Receiving HIV care and treatment at one of the four study sites.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burnout | 6 months | 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. |
Countries
Mozambique
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Health care providers in this arm will receive no intervention | 4,622 |
| 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. | 12,929 |
| 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. | 6,349 |
| 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. | 4,548 |
| Total | 28,448 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 | 2 | 2 |
Baseline characteristics
| Characteristic | Standard of Care | Resilience Intervention | Resilience and Stigma Group | Anti-stigma Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 10.6 | 29.7 years STANDARD_DEVIATION 18.86 | 32.11 years STANDARD_DEVIATION 10.49 | 30.6 years STANDARD_DEVIATION 10.11 | 30.8 years STANDARD_DEVIATION 14.91 |
| Number of Years Working in this Health Facility | 3.4 years STANDARD_DEVIATION 1.95 | 6.1 years STANDARD_DEVIATION 6.05 | 5.5 years STANDARD_DEVIATION 3.7 | 4.2 years STANDARD_DEVIATION 3.09 | 4.8 years STANDARD_DEVIATION 4.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4622 Participants | 12929 Participants | 6349 Participants | 4548 Participants | 28448 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Mozambique | 4622 participants | 12929 participants | 6349 participants | 4548 participants | 28448 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 19 Participants | 15 Participants | 63 Participants |
| Sex: Female, Male Male | 1553 Participants | 3846 Participants | 1945 Participants | 1597 Participants | 8941 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care | Burnout | -2.0 units on a scale |
| Resilience Intervention | Burnout | -5.9 units on a scale |
| Resilience and Stigma Group | Burnout | -5.3 units on a scale |
| Anti-stigma Group | Burnout | -3.9 units on a scale |