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

NCT05938621 | Completed Results

• 1 other identifier: R34MH127975
• Study Type: interventional
• Target: 28,448
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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

Behavioral: behavioral therapy and education

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.

Behavioral: behavioral therapy and education

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.

Behavioral: behavioral therapy and education

Interventions

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.

Anti-stigma group; Resilience and Stigma group; Resilience intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Ministry of Health

Quelimane, Zambezia Province, Mozambique

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Behavior Therapy; Educational Status

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Carolyn Audet
• Organization: Vanderbilt University Medical Center

carolyn.m.audet@vanderbilt.edu

615-343-2418

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Policy

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 10, 2023
• Study Start: December 1, 2023
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Locations

MO (1)