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

Completed

• Conditions: HIV Infections; Hiv
• Interventions: Diagnostic Test: Alere Q Testing

• Registration Number: NCT03133728
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2019-05-30
• Primary Completion: 2020-09-29
• Study Completion: 2020-09-29
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1682

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Intervention Group	Alere Q Testing	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 between the dates of June 1, 2019 and May 31, 2020. 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.

Primary Outcome Measures

Name	Time	Method
Uptake of Antiretroviral Therapy (ART) among HIV-infected Infants and Young Children (IYC)	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

Name	Time	Method
3-month survival for HIV-infected IYC receiving ART	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.
Age at first early infant HIV testing among HIV-exposed IYCs	Baseline to 18 months	Average chronological ages of all IYCs when presenting for initial EID HIV testing.
Describe preferences of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model	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.
Describe knowledge of HIV-infected mothers regarding the Alere™ q HIV-1/2 Detect platform and POC EID Community Model	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	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.
3-month retention in care for HIV-infected IYC receiving ART	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	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.
Characterize feasibility of using the Alere™ q HIV-1/2 Detect platform and POC EID Community Model by the health care workers	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	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.

Trial Locations

Locations (6)

Kamwala Primary Health Clinic; 🇿🇲 Lusaka, Zambia

George Primary Health Clinic; 🇿🇲 Lusaka, Zambia

Matero Ref Primary Health Clinic; 🇿🇲 Lusaka, Zambia

Makeni Primary Health Clinic; 🇿🇲 Lusaka, Zambia

N'gombe Primary Health Clinic; 🇿🇲 Lusaka, Zambia

Kalingalinga Primary Health Clinic; 🇿🇲 Lusaka, Zambia