PIMA point-of-care CD4 testing and its impact on ART initiation, linkage to care and retention

Testing the operational role of PIMA point-of-care (POC) CD4+ T cell testing and its impact on ART initiation, linkage to care, and retention in care in a Primary Health Care clinic in Durban, South Africa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14220457

Enrollment

600

Registered

2018-06-11

Start date

2015-04-13

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV CD4 cell testing for care and treatment in primary health care Infections and Infestations Human immunodeficiency virus [HIV] disease

Interventions

PIMA point-of-care CD4 testing as the intervention with conventional laboratory based CD4 testing at the National Health Laboratory (Beckman Coulter) as the control. The time periods (weeks) are rando

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV positive adults not on ART 2. Patients willing to provide informed consent for samples to be tested

Exclusion criteria

Exclusion criteria: 1. HIV negative patients 2. Children under 18 years old 3. Pregnant women 4. Patients on ART

Design outcomes

Primary

Measure	Time frame
The percentage improvement in the rate of ART initiation (within 3 months of testing) using PIMA POC CD4 testing with same day provision of results versus the routine standard of care NHLS CD4 monitoring	—

Secondary

Measure	Time frame
1. The difference in time to initiate ART treatment for those eligible for ARV therapy in the implementation PIMA POC group compared to the standard NHLS group 2. The linkage to care for non-ART patients who receive PIMA POC CD4 results vs NHLS CD4 results as measured by their return for CD4 testing within 6-8 months of previous test 3. The impact of certain variables (disclosure, family support and family members engagement in care) on a patient’s linkage to care 4. The benefit if any to the patient of receiving same day results with respect to time and cost savings	—

Measure

Time frame

1. The difference in time to initiate ART treatment for those eligible for ARV therapy in the implementation PIMA POC group compared to the standard NHLS group 2. The linkage to care for non-ART patients who receive PIMA POC CD4 results vs NHLS CD4 results as measured by their return for CD4 testing within 6-8 months of previous test 3. The impact of certain variables (disclosure, family support and family members engagement in care) on a patient’s linkage to care 4. The benefit if any to the patient of receiving same day results with respect to time and cost savings

—

Countries

South Africa

Contacts

Public ContactElizabeth Spooner

bethspoons@gmail.com+27 (0)723510284

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026