Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants

HIV Infections Clinical Trial

— CDC Detect  

Official title:

To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133728
• Other study ID #: UAB Neo 016
• Status: Completed
• Start date: May 30, 2019
• Est. completion date: September 29, 2020

Study information

• Verified date: October 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children using a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers.

Description:

The purpose of the study is to test the effect of the Alere™ q HIV-1/2 Detect (diagnostic assay) on uptake of HIV testing among HIV-exposed infants and young children, and health outcomes for HIV-infected infants and young children through a novel POC EID Community Model in Zambia. The study will also assess the feasibility of field implementation of this novel diagnostic tool and its acceptability among HIV-infected mothers and frontline health workers. The knowledge generated from this study will enable the Zambia Ministry of Health (MOH) to make informed policy decisions about the implementation and scale up of point of care (POC) diagnostic tools for early infant diagnosis and pediatric HIV treatment programs in Zambia and the region.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1682
• Est. completion date: September 29, 2020
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Months

Eligibility

Inclusion criteria include IYCs:

1. 0 days (at birth) - 17 months of age;

2. Probable or known HIV exposure documented through maternal sero-positivity or reactive infant HIV antibody test;

3. The IYC must be born to mothers who:

1. attended =1 ANC visits without HIV testing; or

2. delivered at home and did not return for post-natal care at a health facility, and thus the mother or their child were not tested for HIV; or

3. were documented as HIV-infected but never initiated ART; or

4. disengaged from HIV care after ART initiation/have not returned for ARV refills; or

5. have not returned to the facility with their infant for initial EID testing or follow-up EID testing (after a negative test at birth or 6 weeks); or

6. IYC not tested 6 weeks after cessation of breastfeeding.

4. With a parent/guardian =18 years of age, and willing and able to provide written informed consent in a study language (English, Nyanja, or Bemba).

Exclusion criteria include IYCs:

1. With documented age-appropriate, guideline-adherent receipt of DBS-based EID HIV PCR testing;

2. Already known to be HIV-infected / receiving ART.

Related Conditions & MeSH terms

• Hiv
• HIV Infections

Intervention

Diagnostic Test:
• Alere Q Testing
Infants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation.

Locations

Country	Name	City	State
Zambia	George Primary Health Clinic	Lusaka
Zambia	Kalingalinga Primary Health Clinic	Lusaka
Zambia	Kamwala Primary Health Clinic	Lusaka
Zambia	Makeni Primary Health Clinic	Lusaka
Zambia	Matero Ref Primary Health Clinic	Lusaka
Zambia	N'gombe Primary Health Clinic	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centers for Disease Control and Prevention, Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC)	Number of IYCs who were initiated on ARVs following a positive HIV test divided by the number of IYCs who tested positive for HIV.	Baseline to 18 months
Secondary	Age at first early infant HIV testing among HIV-exposed IYCs	Average chronological ages of all IYCs when presenting for initial EID HIV testing.	Baseline to 18 months
Secondary	3-month survival for HIV-infected IYC receiving ART	Number of HIV-infected IYCs receiving ART who presented alive at 3 month visit divided by the total number of HIV-infected IYCs enrolled into ART.	Baseline to 18 months
Secondary	3-month retention in care for HIV-infected IYC receiving ART	Number of HIV-infected IYCs receiving ART who were retained in care at 6 month visit divided by the total number of HIV-infected IYCs enrolled in ART.	Baseline to 18 months
Secondary	Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect	Average time of ART initiation by IYCs who present for at initial HIV test following positive screening test within 17 months of age.	Baseline to 18 months
Secondary	Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model	A pre-defined set of questions will be asked to all the parent/guardians to evaluate their knowledge regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in in-depth interviews (IDIs).	Baseline to 18 months
Secondary	Describe attitudes of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model	A pre-defined set of questions will be asked to all the parent/guardians to evaluate their attitudes regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in IDIs.	Baseline to 18 months
Secondary	Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model	A pre-defined set of questions will be asked to all the parent/guardians to evaluate their knowledge regarding the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 parents/guardians of HIV-exposed IYC (3-4 will be recruited from each clinic) to participate in IDIs.	Baseline to 18 months
Secondary	Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers	A pre-defined set of questions will be asked to all the healthcare providers to characterize the feasibility of using the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 healthcare providers who have used the platform to participate in IDIs.	Baseline to 18 months
Secondary	Characterize the acceptability of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers	A pre-defined set of questions will be asked to all the healthcare providers to characterize the acceptability of using the Alere ™ q HIV-1/2 Detect platform and POC EID Community Model. The Investigators will enroll a total of 20 healthcare providers who have used the platform to participate in IDIs.	Baseline to 18 months