Clinical Trials

MainTitle

Diagnosis of HIV and Early Antiretroviral Therapy Initiation Among HIV-1 Infected Infants (CDC Detect)

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2019 by Albert Manasyan, University of Alabama at Birmingham

Sponsor
University of Alabama at Birmingham

Collaborator
Centre for Infectious Disease Research in Zambia
Centers for Disease Control and Prevention

Information provided by (Responsible Party)
Albert Manasyan, University of Alabama at Birmingham

ClinicalTrials.gov Identifier
NCT03133728

First received: April 4, 2017
Last updated: May 30, 2019
Last Verified: May 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections
Hiv

Diagnostic Test : Alere Q Testing

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: To Improve Rates of Antiretroviral Therapy Initiation for HIV-1 Infected Infants Through Point-of-Care Diagnosis

Further study details as provided by Albert Manasyan, University of Alabama at Birmingham:

Primary Outcome Measures

  • Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC) [ Time Frame: Baseline to 18 months ]
    Number of IYCs who were initiated on ARVs following a positive HIV test divided by the number of IYCs who tested positive for HIV.
Secondary Outcome Measures:
  • Age at first early infant HIV testing among HIV-exposed IYCs [ Time Frame: Baseline to 18 months ]
    Average chronological ages of all IYCs when presenting for initial EID HIV testing.
  • 3-month survival for HIV-infected IYC receiving ART [ Time Frame: Baseline to 18 months ]
    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.
  • 3-month retention in care for HIV-infected IYC receiving ART [ Time Frame: Baseline to 18 months ]
    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.
  • Time to ART initiation among HIV-infected IYCs using Alere™ q HIV-1/2 Detect [ Time Frame: Baseline to 18 months ]
    Average time of ART initiation by IYCs who present for at initial HIV test following positive screening test within 17 months of age.
  • Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model [ Time Frame: Baseline to 18 months ]
    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).
  • Describe attitudes of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model [ Time Frame: Baseline to 18 months ]
    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.
  • Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model [ Time Frame: Baseline to 18 months ]
    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.
  • Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers [ Time Frame: Baseline to 18 months ]
    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.
  • Characterize the acceptability of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers [ Time Frame: Baseline to 18 months ]
    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.
  • Collect field performance data on mobile confirmatory EID testing done immediately at the point of care using the same Alere™ q HIV-1/2 Detect platform [ Time Frame: Baseline to 18 months ]
    Data from the referral central laboratory where the HIV DBS PCR testing will be conducted will be collected and compared with the Alere™ q HIV-1/2 Detect platform. The investigators will evaluate the performance of the POC platform in a mobile setting against the gold standard. Variables such as sensitivity, specificity, error rates of the Alere™ q HIV-1/2 Detect platform and its cartridge will be collected.

Estimated Enrollment: 1628
Study Start Date: May 30, 2019
Estimated Study Completion Date: September 29, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Pre-Intervention Group
The Investigators will visit each of the selected 3 clusters (i.e. 6 primary health clinics) to construct a retrospective cohort of high-risk HIV-infected women who entered the national PMTCT program and received the SOC between June 1, 2017 and May 31, 2018. Using existing data through the electronic health record information (SmartCare and LIMS), the investigators will gather individual-level retrospective data on high-risk Mother-Infant Pairs (MIPs) from PMTCT enrolment through the child's ART enrolment, initiation, and retention rate at 3 months.
Post-Intervention Group
Study Research Assistants (RA) will review routine patient files and registers, augmented by existing electronic health record information, to identify a new cohort of high-risk Mother-Infant Pairs (MIPs) at each study site. The outreach team will include, at a minimum, the study RA, a study peer, and an HIV counselor from the health facility, who will carry the Alere™ q HIV-1/2 Detect with them. When the outreach team contacts a high-risk MIP at community level, the team will approach the MIP for study screening, consent, and enrolment procedures. Study staff will ask the parent/guardian if the parent/guardian would like the IYC to be tested at their home, at a community health post, or other private space in the community. The IYC will be tested using both the Alere™ q HIV-1/2 Detect platform and a reflex DBS PCR test to evaluate performance of the POC platform in a mobile setting against the gold standard.
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.

Other Name: Alere™ q HIV-1/2 Detect Test Point-of-Care Testing

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

Eligibility

Ages Eligible for Study: up to 17 Months  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV-exposed infants and young children (up to 17 months of age)

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.
      1. 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.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03133728

    Contacts

    Contact:   Albert Manasyan, MD 00-260-976448994 Albert.Manasyan@cidrz.org

    Locations

    Zambia
    George Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Linda Phiri
    Kalingalinga Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Precious Sakanya
    Kamwala Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Sharon Mwansa
    Makeni Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Patricia Shabalu
    Matero Ref Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Talandila Phiri
    N'gombe Primary Health Clinic Recruiting
    Lusaka, Zambia
    Contact: Leukanji Nalwamba

    Sponsors and Collaborators

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

    Investigators

    Principal Investigator: Albert Manasyan, MD University of Alabama at Birmingham
    More Information

    More Information


    Responsible Party: Albert Manasyan, Principal Investigator, University of Alabama at Birmingham  
    ClinicalTrials.gov Identifier: NCT03133728   History of Changes  
    Other Study ID Numbers: UAB Neo 016  
    Study First Received: April 4, 2017  
    Last Updated: May 30, 2019  
    Individual Participant Data    
    Plan to Share IPD: No  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by Albert Manasyan, University of Alabama at Birmingham:

    EID HIV
    Early Infant Diagnosis
    Point of Care
    Infant
    HIV

    Additional relevant MeSH terms:
    HIV Infections
    Anti-Retroviral Agents

    ClinicalTrials.gov processed this data on July 22, 2019
    This information is provided by ClinicalTrials.gov.