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Completed

NCT Number: NCT06157281

Positive Deviance to Improve Retention in HIV Care 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western Cape Department of Health and Wellbeing CDH or CHC

Cape Town, Western Cape, 8000, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

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.

Primary outcomes

  1. Antiretroviral Therapy (ART) Retention

    Time frame: 6 months

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

  2. Viral Load Suppression (VLS)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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