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

Combining Positive Deviance and Implementation Science to Improve Retention in HIV Care in South Africa

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Behavioral: Connect

Detailed Description

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 is based on intensive interviews, focus groups and surveys conducted with HIV staff within 3 clinics in a health system with lower-than-average retention rates. The next step is to conduct a pilot trial to test whether the intervention can improve care for people living with HIV.

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. Each clinic holds a monthly huddle toward team cohesion, support and a shared vision for retention. Consists of some core activities, such as "Rounds", staff recognition; and activities to build team cohesion and staff wellbeing.

Strategy 1b: Compassion training. Based on evidenced-based compassion training, train and support staff on interacting with other providers and patients in compassionate ways.

Domain 2: Create a welcome physical environment.

Strategy 2a: Aesthetic improvements toward a warm, welcoming environment. Examples include bright paint in waiting areas, murals on outside walls, plants, posters with positive messaging on walls.

Domain 3: Expedite and augment workflow practices.

Strategy 3a: Pre-pull patient folders; hold folders for immediate tracking; map patients to identify locations. Staff pull folders for next-day appointments, communicate no-shows with trackers, use mapping to have patients indicate approximate living areas to facilitate tracking.

Strategy 3b: Welcome-back services for those who miss follow-up appointments. Integrate specialized, patient-centered services for those who miss their 1-month or 3-month visit to re-enter care easily. The key elements of this are genuine concern for the patient, avoiding scolding or blaming the patients, checks on patient health and symptoms, and exploration of barriers including how to overcome these and facilitate ongoing treatment.

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 8000
      • Western Cape Department of Health and Wellbeing CDH or CHC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connect Intervention; 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; A multicomponent, clinic-level intervention consisting of strategies aimed at improving retention and viral load suppression by enhancing the patient and staff experience.
No Intervention: Control; Staff in control clinics will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: National Institute of Mental Health (NIMH); University of Stellenbosch; Western Cape Department of Health and Wellness
• Investigators: Principal Investigator: Allison J Ober, PhD, RAND

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HCAAD058-1000; R34MH119889 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregated retention and VLS data by clinic can be made available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No