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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06157281
• Other study ID #: HCAAD058-1000
• Secondary ID: R34MH119889
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. Does the intervention improve retention in HIV care for people living with HIV (PLWH)?

2. 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.

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:

1. Does the intervention improve retention in HIV care for people living with HIV (PLWH)?

2. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: November 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Administrator or other staff member of one of three participating clinics

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
South Africa	Western Cape Department of Health and Wellbeing CDH or CHC	Cape Town	Western Cape

Sponsors (4)

Lead Sponsor	Collaborator
RAND	National Institute of Mental Health (NIMH), University of Stellenbosch, Western Cape Department of Health and Wellness

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antiretroviral Therapy (ART) Retention	Proportion of patients in care at the same clinic 6 months after ART initiation	6 months
Primary	Viral Load Suppression (VLS)	Proportion of patients with VLS 6 months* after initiating ART (<50 copies/mL)	6 months