Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers

Hiv Clinical Trial

Official title:

Estamos Juntos (We Are Together): Improving HIV Care Delivery by Capacitating Health Care Providers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05938621
• Other study ID #: R34MH127975
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 21, 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: Carolyn M Audet, PhD
• Phone: 6153432418
• Email: carolyn.m.audet[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16100
• Est. completion date: March 21, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hiv

Intervention

Behavioral:
• behavioral therapy and education
Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.

Locations

Country	Name	City	State
Mozambique	Ministry of Health	Quelimane	Zambezia

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

Mozambique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burnout	Burnout screening tool	6 months
Primary	Antiretroviral Therapy (ART) adherence	Medication possession ratio	12 months