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

CompletedN/A

Sponsor: University of Alabama at Birmingham

Conditions: HIV Infections, Hiv

Interventions: Alere Q Testing

Countries: Zambia

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.

Eligibility overview

Sex: ALL

Age: 1 Minute to 17 Months

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Lusaka, Zambia
Lusaka, Zambia
Lusaka, Zambia
Lusaka, Zambia
Lusaka, Zambia
Lusaka, Zambia