Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants

NCT01222130 | Completed

• 1 other identifier: MQ-00-6-300-01206-0-00
• Study Type: observational
• Target: 1,126
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to develop and evaluate a set of non-virologic diagnostic algorithms to monitor HIV-exposed children of unknown infection status for treatment eligibility during the first year of life. The results of this cross sectional study are expected to be used in development of a series of non-virologic algorithms to determining treatment eligibility among HIV-exposed children in settings where polymerase chain reaction (PCR) testing is not available and to guide the judicious use of PCR testing among HIV-exposed children in settings where PCR is available. These results will directly inform program implementation in Zambia.

Conditions

HIV Infections

Keywords

HIV; Infant infection; Diagnosis; Non-virological algorithm

Outcome Measures

Primary Outcomes (1)

• performance (i.e., sensitivity, specificity, negative and positive predictive value) of different algorithms in predicting virologically confirmed HIV infection

  within first 12 months of life

Eligibility Criteria

• Age: Up to 60 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

HIV-infected mothers and their exposed infants seek care in a primary care setting in Lusaka, Zambia

You may qualify if:

• mother with documented HIV infections
• mother willing to give informed consent for participation
• mother willing to allow child to participant in the study
• infant equal or less than 60 weeks of age

You may not qualify if:

• infants accompanied by someone other than the mother
• infants already received antiretroviral therapy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator

Study Sites (3)

George Health Centre

Lusaka, Lusaka Province, 10101, Zambia

Location

Kamwala Health Centre

Lusaka, Lusaka Province, 10101, Zambia

Location

Matero Reference Health Centre

Lusaka, Lusaka Province, 10101, Zambia

Location

MeSH Terms

Conditions

HIV Infections; Disease

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

ZA (3)