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

University of Alabama at Birmingham1,682 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,682

Conditions

HIV Infections Hiv

Interventions

Alere Q TestingDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 17 Months

Medical Language ↔ Plain English

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.

Locations (6)

George Primary Health Clinic

Lusaka, Zambia

Kalingalinga Primary Health Clinic

Lusaka, Zambia

Kamwala Primary Health Clinic

Lusaka, Zambia

Makeni Primary Health Clinic

Lusaka, Zambia

Outcomes

Primary Outcomes

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.