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

Sponsor

RAND (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06157281

Collaborator

National Institute of Mental Health (NIMH) (NIH), University of Stellenbosch (Other), Western Cape Department of Health and Wellness (Other)

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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 questions this study aims to answer are:

Does the intervention improve retention in HIV care for people living with HIV (PLWH)?
Does the intervention improve viral load suppression for PLWH on antiretroviral therapy?

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.

Condition or Disease	Intervention/Treatment	Phase
Hiv	Behavioral: Connect	N/A

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 questions this study aims to answer are:

Does the intervention improve retention in HIV care for people living with HIV (PLWH)?
Does the intervention improve viral load suppression for PLWH on antiretroviral therapy?

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Antiretroviral Therapy (ART) Retention [6 months]
Proportion of patients in care at the same clinic 6 months after ART initiation
Viral Load Suppression (VLS) [6 months]
Proportion of patients with VLS 6 months* after initiating ART (<50 copies/mL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Cape Department of Health and Wellbeing CDH or CHC	Cape Town	Western Cape	South Africa	8000

Sponsors and Collaborators

RAND
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allison Ober, Senior Health Policy Researcher, RAND

ClinicalTrials.gov Identifier:

NCT06157281

Other Study ID Numbers:

HCAAD058-1000
R34MH119889

First Posted:

Dec 5, 2023

Last Update Posted:

Dec 5, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 5, 2023