HIV Diagnosis in Hospitalized Malawian Infants
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Purpose
Purpose: The purpose of this research study is to learn about two HIV tests - a clinical "presumptive diagnosis" (PD) that a trained healthcare provider can quickly use to determine if a child is likely to be HIV-infected and in need of HIV medicines and an "expedited" gold standard RNA-PCR test (expedited PCR) that is done at the UNC Project lab located at the hospital and the result given within 48 hours. Both of these tests can obtain results quickly while the current test called dried blood spot DNA-PCR goes to a lab and the result may take up to one month. The performance of PD and expedited PCR will be compared to one another with respect to HIV-infected infants correctly initiating life-saving antiretroviral therapy.
Participants: Hospitalized children younger than 12 months of age who are HIV DNA-PCR eligible at Kamuzu Central Hospital (KCH), in Lilongwe, Malawi. Other participants will be patient caregivers and clinical officers who provide healthcare for children that could be HIV-infected. Clinical officers will be trained to conduct the presumptive diagnosis test.
Procedures (methods): Patients will be randomized to either standard of care (PD and dried blood spot DNA-PCR) or expedited PCR. A consultant pediatrician and a clinical officer will perform the PD. If the PD or expedited PCR test results are positive, hospital care could include HIV medicine.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Device: Point of care HIV RNA PCR |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Presumptive and Definitive Virologic HIV Diagnosis in Hospitalized Malawian Infants |
- ART initiation of HIV-infected infants [ Time Frame: Participants will be followed for an expected average of 2 months, or until their HIV-status is confirmed ] [ Designated as safety issue: Yes ]The primary outcome will be the proportion of HIV+ children initiated on ART in the hospital. We will need a sample size of 400 infants assuming the standard of care will initiate 60% and the experimental group will initiate 85% of HIV-infected infants on ART prior to hospital discharge, respectively. These assumptions also take into consideration a predicted inpatient HIV-prevalence in HIV-exposed infants of 25% and a 5% absconding rate, using a confidence interval of 10% and confidence level of p < 0.05.
| Enrollment: | 300 |
| Study Start Date: | June 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Point of Care HIV RNA PCR
Patients randomized to this arm will be followed prospectively from the time of clinical evaluation in the hospital until 12 months after returning for outpatient care at the KCH HIV clinic. The counselor will collect infant blood for point of care RNA PCR testing, number the sample, and transport it to the central laboratory for processing. Patients determined to be HIV-uninfected or HIV-exposed uninfected will not continue in the study beyond virologic test result disclosure, which will occur as an inpatient at KCH for this arm. If the patient does not return for outpatient care for three months after hospitalization then the patient's participation in the study will end.
|
Device: Point of care HIV RNA PCR
The intervention is a HIV RNA PCR test for which UNC Project laboratory personnel will process samples in 48 hours so that patients can receive results prior to hospital discharge.
|
|
No Intervention: Standard of Care
Patients randomized to this arm will be followed prospectively from the time of clinical evaluation in the hospital until 12 months after returning for outpatient care at the KCH HIV clinic. The counselor will collect infant blood for dried blood spot DNA PCR testing, number the sample, and transport it to the central laboratory for processing. If the patient is PD positive then the patient will be offered ART initiation prior to hospital discharge. Patients determined to be HIV-uninfected or HIV-exposed uninfected will not continue in the study beyond virologic test result disclosure, which will occur as an outpatient at KCH for this arm. If the patient does not return for outpatient care for three months after hospitalization then the patient's participation in the study will end. |
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female children
- Less than 12 months of age
- Inpatient at KCH
- HIV DNA-PCR test eligible
- No prior definitive PCR test result
Exclusion Criteria:
- Caregiver does not want to be contacted by study team
- Mother initiated on ART prior to pregnancy
Contacts and Locations| Malawi | |
| Kamuzu Central Hospital | |
| Lilongwe, Malawi | |
| Principal Investigator: | Eric D McCollum, MD | UNC Project |
| Principal Investigator: | Mina Hosseinipour, MD, MPH | University of North Carolina, Chapel Hill |
More Information
Publications:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01388452 History of Changes |
| Other Study ID Numbers: | 10-0441, R24TW007988, 5P30AI050410 |
| Study First Received: | June 14, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government Malawi: National Health Sciences Research Committee |
Keywords provided by University of North Carolina, Chapel Hill:
|
HIV routine HIV testing provider-initiated HIV testing and counseling early infant diagnosis Africa South of the Sahara |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013