HivNCT06157281
Positive Deviance to Improve Retention in HIV Care HIV Care in South Africa
A study testing Connect in people with Hiv, run by RAND at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Nov 2022to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Administrator or other staff member of one of three participating clinics
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Western Cape Department of Health and Wellbeing CDH or CHC
Cape Town, Western Cape, 8000
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Hiv
- Being tested
- Connect
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConnectBehavioural
A multicomponent, clinic-level intervention consisting of strategies aimed at improving retention and viral load suppression by enhancing the patient and staff experience.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Connect |
| Control | No intervention | Staff in control clinics will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiretroviral Therapy (ART) Retention
Proportion of patients in care at the same clinic 6 months after ART initiation
Measured: 6 months
Viral Load Suppression (VLS)
Proportion of patients with VLS 6 months* after initiating ART (<50 copies/mL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Nov 2022
- Primary completion30 Apr 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Stellenbosch, Western Cape Department of Health and Wellness
- Responsible party
- Principal investigator, Allison Ober, RAND
- Investigators
- Allison J Ober, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157281
- Sponsor's protocol ID
- HCAAD058-1000
- Other IDs
- R34MH119889
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2023
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated retention and VLS data by clinic can be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Positive Deviance and Implementation Science to Improve Retention in HIV Care in South Africa
- ClinicalTrials.gov ID
- NCT06157281
- Acronym / sponsor ID
- HCAAD058-1000
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Stellenbosch, Western Cape Department of Health and Wellness
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Connect Intervention | Experimental | Behavioral: ConnectHIV 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 |
| Control | No intervention | –Staff in control clinics will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Administrator or other staff member of one of three participating clinics
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConnectA multicomponent, clinic-level intervention consisting of strategies aimed at improving retention and viral load suppression by enhancing the patient and staff experience. | Behavioural | Connect Intervention |
Primary outcome
Antiretroviral Therapy (ART) Retention
Time frame: 6 months
Proportion of patients in care at the same clinic 6 months after ART initiation
Viral Load Suppression (VLS)
Time frame: 6 months
Proportion of patients with VLS 6 months* after initiating ART (<50 copies/mL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. Aggregated retention and VLS data by clinic can be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison J Ober, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect in people with Hiv, run by RAND at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiretroviral Therapy (ART) Retention (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.