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

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.

Study Overview

• Status: Recruiting
• Conditions: Hiv
• Intervention / Treatment: Behavioral: behavioral therapy and education

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.

• Study Type: Interventional
• Enrollment (Estimated): 16100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolyn M Audet, PhD; Phone Number: 6153432418; Email: carolyn.m.audet@vumc.org
• Study Contact Backup: Name: Erin Graves, MPH; Email: erin.r.graves.1@vumc.org

Study Locations

• Mozambique
  • Zambezia
    • Quelimane, Zambezia, Mozambique
      • Recruiting
      • Ministry of Health
      • Contact: Caroline DeSchacht, MD; Phone Number: +258823393460; Email: caroline.deschacht@fgh.org.mz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Health care providers in this arm will receive no intervention
Experimental: Resilience intervention; Providers in this arm will receive training to improve their resilience and well-being	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.
Experimental: 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: behavioral therapy and education; Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.
Experimental: 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: behavioral therapy and education; Sessions that focus on developing self-awareness and strategies to improve well-being will be the focus of the interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burnout	Burnout screening tool	6 months
Antiretroviral Therapy (ART) adherence	Medication possession ratio	12 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 21, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R34MH127975 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No