Clinic systems should be adapted to maximize the benefits of point-of-care CD4 technology Point-of-Care CD4 Systems Integration in Uganda December 2011

Evaluation: Time From Diagnosis To CD4 Staging And ART Initiation shows similar results in Uganda Point-of-Care CD4 is highly effective at cutting loss to follow-up (LTFU) and reducing time to initiation 2 Uganda 2 Time to initiation: Time between enrollment and initiation of ART-eligible patients reduced from 56 days to 9 days. Uganda 2 Time to initiation: Time between enrollment and initiation of ART-eligible patients reduced from 56 days to 9 days. Mozambique 3 LTFU: 50% increase in retention from diagnosis to ART initiation ART Initiation: 85% increase in ART initiation Time to initiation: Time between enrollment and ART initiation reduced by 28 days Mozambique 3 LTFU: 50% increase in retention from diagnosis to ART initiation ART Initiation: 85% increase in ART initiation Time to initiation: Time between enrollment and ART initiation reduced by 28 days Malawi 1 LTFU: Increase of PMTCT initiation during pregnancy from 51 to 78% Time to CD4 result: time from CD4 blood draw to result reduced from 11 to 0 days Malawi 1 LTFU: Increase of PMTCT initiation during pregnancy from 51 to 78% Time to CD4 result: time from CD4 blood draw to result reduced from 11 to 0 days Source: 1 MOH Malawi; 2 MOH Uganda; 3 Jani et al (2010)

Rationale: Need for Point-of-Care (POC) CD4 in Uganda active acredited centres offer ART and pre-ART care ( 2010 ART-ACP report ) serving an estimated 945,000 HIV+ patients Only 138 facilities had equipment to measure CD4 counts All in-country equipment was conventional CD4: o Require skilled technicians and a fully equipped laboratory with a stable power source, air conditioning, refrigeration. o Patient samples must be referred to larger hospitals, and numbers of samples tested are limited. Over half of lost patients in a 2011 MoH Uganda review of pre-ART care never received a single CD4 test result Given the need for improved access to CD4 testing in local health facilities with limited infrastructure, the Ministry of Health decided to conduct an operational pilot of the Pima point-of-care CD4 diagnostic

Uganda Point of Care (POC) CD4 pilot with Pima The Ministry of Health ran a 3-month pilot in 7 mid-level (III-IV) health facilities Jan-April 2011 using the Pima point-of-care CD4 diagnostic The Pima TM point-of-care CD4 diagnostic operates at room temperature without a fully equipped laboratory or external sample processing, and uses a re-chargeable battery Alere’s Pima TM The study showed drastic improvements in time from enrollment in HIV care to CD4 staging and to ART initiation. User satisfaction with the diagnostic was very high While the pilot confirmed that the point-of-care CD4 diagnostic would be very useful in Uganda, it also demonstrated that systems integration is necessary for the diagnostic to improve access as much as is possible 4

Turnaround Time – Without POC Turnaround Time –With POC 3 Days Time from diagnosis to CD4 staging and ART initiation significantly reduced with POC testing in Uganda 7 Days 1 Day 8 Days CD4 Test PerformedCD4 Staging and ART InitiationBlood DrawEnrollmentDiagnosis 48 Days 2 Days 1 Day ART InitiationEnrollmentDiagnosis Blood Draw, CD4 Test Performed, and CD4 Staging

Why system integration? – Uganda pilot results 6 Many clients who qualified for CD4 tests were not tested, despite availability of the diagnostic. For those tested, CD4 results often failed to reach the clients’ ART records for use in HIV monitoring.

7 Key issues identified in the pilot: Data management was poor – many test results did not reach patient records 2 Sample testing was concentrated at limited times, so facilities did not run as many tests as were needed 3 Communication between the lab, ART and MCH clinics was poor, resulting in results being lost and patients not being sent to the POC operator at the right times 4 Many patients who qualified for CD4 testing did not receive CD4 results 1

8 Systems to address key issues: Active use of CD4 in monitoring for all HIV positive patients 1 Adapt scheduling of CD4 testing and all linked services to complement new technology Structures to ensure all CD4 test results are incorporated into patient records Improve communication between ART clinic, laboratory, and other centers in the health facility 3 4 2

9 Systems to address key issues: Communicate guidelines on how to determine Which patients qualify for CD4 testing Which patients are eligible for ART initiation based on both CD4 count and WHO clinical staging Active use of CD4 in monitoring for all HIV positive patients 1 Which adults are eligible for ART in Uganda? CD4 ≤ 350WHO stage III or IV any WHO stageany CD4 with

10 Systems to address key issues: Structures to ensure all CD4 test results are incorporated into patient records 2 All patients are enrolled in care and receive ART or MCH ID numbers before CD4 testing POC operator records patient ID numbers for each test Patients bring CD4 results back to ART or MCH care-point Care-point staff record CD4 results in their client records immediately Care-point staff collect back-up copies of CD4 results from the POC operator daily and enter in records

11 Systems to address key issues: Adapt scheduling of CD4 testing and all linked services to complement new technology 3 POC operators bleed and test patients all day, every weekday ART and MCH staff refer patients for testing throughout the day, every day Patients receive results the same day they are tested Patients who test HIV positive are enrolled in care and referred for same-day CD4 tests, even on days with no ART clinic

12 Systems to address key issues: Improve communication between ART clinic, laboratory, and other centers in the health facility 4 At every health facility where the diagnostic is introduced, master trainers train staff from the lab, ART and MCH on POC systems integration. This training includes: Addressing the previously discussed issues in CD4 testing Assigning responsibilities and setting procedures with staff from multiple departments

Conclusions The Pima POC instrument has been evaluated and shown to be effective as a CD4 tester at lower-level health facilities System integration is vital in the rollout of the point of care testing program as means of addressing the system challenges in increasing access to testing