Positive Deviance to Improve Retention in HIV Care HIV Care in South Africa

NCT06157281 | Completed

• 2 other identifiers: HCAAD058-1000R34MH119889
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot trial is to test the effectiveness of a newly developed multicomponent clinic-level intervention for improving retention in HIV care among people living with HIV in South Africa. The intervention was developed based on intensive study of clinics with high retention rates. The main question this study aims to answer is: Does the intervention improve retention in HIV care for people with HIV (PWH)? The intervention, called "Connect," consists of several strategies within three domains, as follows: Domain 1: Engage, Encourage, Support Staff Strategy 1a: Monthly staff huddle with staff recognition activities and compassion-focused rounds Strategy 1b: Compassion training Domain 2: Create a welcome physical environment Strategy 2a: Aesthetic improvements toward a warm, welcoming environment Domain 3: Expedite and augment workflow practices Strategy 3a: Pre-pull patient folders; hold folders for immediate tracking; map patients to identify locations Strategy 3b: Integrate welcome-back services for those who miss follow-up appointments HIV staff at three clinics with below-average retention rates who consent to participate will take part in intervention activities. Results will be compared to those of all other lower-retention clinics within the same health system.

Conditions

Hiv

Outcome Measures

Primary Outcomes (2)

• Antiretroviral Therapy (ART) Retention

  Proportion of patients in care at the same clinic 6 months after ART initiation

  6 months

• Viral Load Suppression (VLS)

  Proportion of patients with VLS 6 months\* after initiating ART (\<50 copies/mL)

  6 months

Study Arms (2)

Connect Intervention

EXPERIMENTAL

HIV providers withing each clinic will participate in the Intervention. The intervention, called "Connect," consists of several strategies within three domains, as follows: Domain 1: Engage, Encourage, Support Staff Strategy 1a: Monthly staff huddle with staff recognition activities and compassion-focused rounds Strategy 1b: Compassion training Domain 2: Create a welcome physical environment Strategy 2a: Aesthetic improvements toward a warm, welcoming environment Domain 3: Expedite and workflow practices Strategy 3a: Pre-pull patient folders; hold folders for immediate tracking; map patients to identify locations Strategy 3b: Integrate welcome-back services for those who miss follow-up appointments

Behavioral: Connect

Control

NO INTERVENTION

Staff in control clinics will not receive an intervention.

Interventions

Connect BEHAVIORAL

A multicomponent, clinic-level intervention consisting of strategies aimed at improving retention and viral load suppression by enhancing the patient and staff experience.

Connect Intervention

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Administrator or other staff member of one of three participating clinics

You may not qualify if:

• N/A

Sponsors & Collaborators

• RAND: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Stellenbosch: collaborator
• Western Cape Department of Health and Wellness: collaborator

Study Sites (1)

Western Cape Department of Health and Wellbeing CDH or CHC

Cape Town, Western Cape, 8000, South Africa

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Officials

• Allison J Ober, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Health Policy Researcher

Model Details: 3 lower-retention clinics will receive the intervention. Outcomes will be compared to those at all other lower-retention clinics of the same type within the same health system.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: November 15, 2022
• Primary Completion: April 30, 2024
• Study Completion: October 31, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)