Clinical trial NCT03133728: Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants
Official title: To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Hiv
Keywords: EID HIV
Early Infant Diagnosis
Point of Care
Infant
HIV
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Centers for Disease Control and Prevention
First posted: 2017-04-28
Enrollment: 1682
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-exposed infants and young children (up to 17 months of age)

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC)
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Age at first early infant HIV testing among HIV-exposed IYCs
timeFrame: Baseline to 18 months
measure: 3-month survival for HIV-infected IYC receiving ART
timeFrame: Baseline to 18 months
measure: 3-month retention in care for HIV-infected IYC receiving ART
timeFrame: Baseline to 18 months
measure: Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect
timeFrame: Baseline to 18 months
measure: Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
timeFrame: Baseline to 18 months
measure: Describe attitudes of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
timeFrame: Baseline to 18 months
measure: Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model
timeFrame: Baseline to 18 months
measure: Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
timeFrame: Baseline to 18 months
measure: Characterize the acceptability of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: George Primary Health Clinic
city: Lusaka
country: Zambia
facility: Kalingalinga Primary Health Clinic
city: Lusaka
country: Zambia
facility: Kamwala Primary Health Clinic
city: Lusaka
country: Zambia
facility: Makeni Primary Health Clinic
city: Lusaka
country: Zambia
facility: Matero Ref Primary Health Clinic
city: Lusaka
country: Zambia
facility: N'gombe Primary Health Clinic
Study officials:
affiliation: University of Alabama at Birmingham
name: Albert Manasyan, MD
role: PRINCIPAL_INVESTIGATOR
References: