Early Infant HIV DiagnosisNCT02682810
Point of Care Virologic Testing to Improve Outcomes of HIV-Infected Children
A study testing DNA PCR HIV diagnostic test and Alere Q in people with Early Infant HIV Diagnosis, run by University of North Carolina, Chapel Hill at 6 sites in Zambia.
Trial summary
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings. Read more about this study
- Who is it for?
- Ages 4 to 12 weeks
- Conditions the study is for
- Early Infant HIV Diagnosis
- What is being tested?
- DNA PCR HIV diagnostic test and Alere Q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 6 sitesZambia
- Study dates
- Feb 2016to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4 to 12 weeks of life
- documented HIV exposure through seropositive maternal or infant HIV antibody test
- with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment
Who cannot join
- Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Zambia6 sites
Chawama Health Centre
Lusaka
Chelstone Health Centre
Lusaka
Chilenje Health Centre
Lusaka
Chipata Health Centre
Lusaka
Kanyama Health Centre
Lusaka
Mtendere Health Centre
Lusaka
About this study
Official title: Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
Read the detailed description
At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).
HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.
The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.
- Conditions
- Early Infant HIV Diagnosis
- Being tested
- DNA PCR HIV diagnostic test, Alere Q
- Keywords
- HIV, point-of-care HIV diagnosis, Alere Q, diagnostic, children
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA PCR HIV diagnostic testDevice
standard of care
Alere QDevice
POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
| Study group | Role | What they receive |
|---|---|---|
| DNA PCR HIV diagnostic test | Active comparator | SOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing. Receives: Device: DNA PCR HIV diagnostic test |
| Alere Q POC nucleic acid-based platform | Experimental | POC test to provide same-day diagnosis Receives: Device: Alere Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis
Measured: time of initial diagnosis through 12 months post diagnosis
Secondary outcomes (2)
Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis
Short-term benefit
Measured: time of initial diagnosis through 6 months post diagnosis
Proportion of children starting ART who remain in care for 12 months following the initial diagnosis
Long-term retention benefit
Measured: time of initial diagnostic blood draw through 12 months post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Early Infant HIV DiagnosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Stringer, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682810
- Sponsor's protocol ID
- 12-1346
- Other IDs
- 5U01AI100053-03
- Status last verified
- Jan 2022
- First submitted
- 10 Feb 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008 Nov 20;359(21):2233-44. doi: 10.1056/NEJMoa0800971.
PubMed 19020325UNAIDS. 2014 Progress Report on The Global Plan: http://www.unaids.org/sites/default/files/documents/JC2681_2014-Global-Plan-progress_en.pdf. Accessed: 01 February 2015.
Stringer EM, Ekouevi DK, Coetzee D, Tih PM, Creek TL, Stinson K, Giganti MJ, Welty TK, Chintu N, Chi BH, Wilfert CM, Shaffer N, Dabis F, Stringer JS; PEARL Study Team. Coverage of nevirapine-based services to prevent mother-to-child HIV transmission in 4 African countries. JAMA. 2010 Jul 21;304(3):293-302. doi: 10.1001/jama.2010.990.
PubMed 20639563Stringer JS, Sinkala M, Maclean CC, Levy J, Kankasa C, Degroot A, Stringer EM, Acosta EP, Goldenberg RL, Vermund SH. Effectiveness of a city-wide program to prevent mother-to-child HIV transmission in Lusaka, Zambia. AIDS. 2005 Aug 12;19(12):1309-15. doi: 10.1097/01.aids.0000180102.88511.7d.
PubMed 16052086World Health Organization. Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access (2010 Revision): http://www.who.int/hiv/pub/paediatric/infants2010/en/index.html Accessed 2011.
Braun M, Kabue MM, McCollum ED, Ahmed S, Kim M, Aertker L, Chirwa M, Eliya M, Mofolo I, Hoffman I, Kazembe PN, van der Horst C, Kline MW, Hosseinipour MC. Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):e122-8. doi: 10.1097/QAI.0b013e31820a7f2f.
PubMed 21224736Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F; Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004 Oct 2-8;364(9441):1236-43. doi: 10.1016/S0140-6736(04)17140-7.
PubMed 15464184Laursen L. Point-of-care tests poised to alter course of HIV treatment. Nat Med. 2012 Aug;18(8):1156. doi: 10.1038/nm0812-1156. No abstract available.
PubMed 22869167UNITAID. HIV/AIDS diagnostic technology landscape.Tech. Rep., WHO, Geneva, Switzerland, 2012.
Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, Quevedo JI, Lehe JD, Loquiha O, Vojnov L, Peter TF. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):e1-4. doi: 10.1097/QAI.0000000000000250.
PubMed 24933096Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.
PubMed 6528136Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931.
PubMed 20942667Bolton-Moore C, Mubiana-Mbewe M, Cantrell RA, Chintu N, Stringer EM, Chi BH, Sinkala M, Kankasa C, Wilson CM, Wilfert CM, Mwango A, Levy J, Abrams EJ, Bulterys M, Stringer JS. Clinical outcomes and CD4 cell response in children receiving antiretroviral therapy at primary health care facilities in Zambia. JAMA. 2007 Oct 24;298(16):1888-99. doi: 10.1001/jama.298.16.1888.
PubMed 17954540Chibwesha CJ, Mollan KR, Ford CE, Shibemba A, Saha PT, Lusaka M, Mbewe F, Allmon AG, Lungu R, Spiegel HML, Mweni E, Mwape H, Kankasa C, Chi BH, Stringer JSA. A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia. Clin Infect Dis. 2022 Aug 25;75(2):260-268. doi: 10.1093/cid/ciab923.
PubMed 34718462Chibwesha CJ, Ford CE, Mollan KR, Stringer JS. Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children in Zambia: A Clinical Trial Protocol. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S197-201. doi: 10.1097/QAI.0000000000001050.
PubMed 27355509
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z 1303 - Point-of-Care Virologic Testing to Improve Outcomes of HIV-Infected Children
- ClinicalTrials.gov ID
- NCT02682810
- Acronym / sponsor ID
- 12-1346
- Conditions
- Early Infant HIV Diagnosis
- Keywords
- HIV, point-of-care HIV diagnosis, Alere Q, diagnostic, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Feb 2016 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-arm, unmasked, randomized, controlled trial to test the effectiveness of the Alere Q point-of-care (POC) HIV diagnostic assay for use in resource-poor settings.
Detailed description
At public sector clinics in Lusaka, Zambia, approximately 4,000 HIV-exposed infants between 4 and 12 weeks of life will be randomized in this trial of point-of-care virologic testing to improve outcomes of HIV-infected children in Zambia. There is a standard of care (SOC) or control arm and an intervention arm known as the Alere arm. In both study arms, early infant diagnosis (EID) will be provided at 6 weeks of life. Infants randomized to the SOC arm will receive EID through the existing prevention of mother-to-child-transmission (PMTCT) program, with samples sent to an off-site laboratory for DNA PCR testing. Infants randomized to the intervention arm will receive POC diagnostic Alere Q qualitative test (along with a dried blood spot (DBS) drawn for confirmatory DNA PCR).
HIV-infected infants will be followed for 12 months. The acceptability of point-of-care testing for EID will also be determined through the use of cross-sectional surveys of clinicians, laboratory personnel, and parents/guardians.
The feasibility will be assessed by a time-in-motion (TIM) and value stream mapping (VSM) analyses will also be conducted to compare the Alere Q to two additional testing technologies.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA PCR HIV diagnostic test | Active comparator | Device: DNA PCR HIV diagnostic testSOC or control arm through existing PMTCT program, with DBS samples sent to an off-site laboratory for DNA PCR testing. |
| Alere Q POC nucleic acid-based platform | Experimental | Device: Alere QPOC test to provide same-day diagnosis |
Who may qualify
- Ages
- 4 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 4 to 12 weeks of life
- documented HIV exposure through seropositive maternal or infant HIV antibody test
- with a parent or guardian will and able to provide written informed consent and to have the participant followed for 12 months after study enrolment
Key exclusion criteria (1 listed)
- Infants will be excluded from participation if they have major congenital anomalies or other medical conditions that would require management at a referral facility or otherwise interfere with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA PCR HIV diagnostic teststandard of care | Device | DNA PCR HIV diagnostic test |
| Alere QPOC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR) | Device | Alere Q POC nucleic acid-based platform |
Primary outcome
Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis
Time frame: time of initial diagnosis through 12 months post diagnosis
2 secondary outcomes
Proportion of HIV-infected children who start anti-retroviral therapy (ART) within 6 months of the initial diagnosis
Time frame: time of initial diagnosis through 6 months post diagnosis
Proportion of children starting ART who remain in care for 12 months following the initial diagnosis
Time frame: time of initial diagnostic blood draw through 12 months post diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Background: PubMed 19020325Violari A, Cotton MF, Gibb DM, Babiker AG, Steyn J, Madhi SA, Jean-Philippe P, McIntyre JA; CHER Study Team. Early antiretroviral therapy and mortality among HIV-infected infants. N Engl J Med. 2008 Nov 20;359(21):2233-44. doi: 10.1056/NEJMoa0800971.
- BackgroundUNAIDS. 2014 Progress Report on The Global Plan: http://www.unaids.org/sites/default/files/documents/JC2681_2014-Global-Plan-progress_en.pdf. Accessed: 01 February 2015.
- Background: PubMed 20639563Stringer EM, Ekouevi DK, Coetzee D, Tih PM, Creek TL, Stinson K, Giganti MJ, Welty TK, Chintu N, Chi BH, Wilfert CM, Shaffer N, Dabis F, Stringer JS; PEARL Study Team. Coverage of nevirapine-based services to prevent mother-to-child HIV transmission in 4 African countries. JAMA. 2010 Jul 21;304(3):293-302. doi: 10.1001/jama.2010.990.
- Background: PubMed 16052086Stringer JS, Sinkala M, Maclean CC, Levy J, Kankasa C, Degroot A, Stringer EM, Acosta EP, Goldenberg RL, Vermund SH. Effectiveness of a city-wide program to prevent mother-to-child HIV transmission in Lusaka, Zambia. AIDS. 2005 Aug 12;19(12):1309-15. doi: 10.1097/01.aids.0000180102.88511.7d.
- BackgroundWorld Health Organization. Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access (2010 Revision): http://www.who.int/hiv/pub/paediatric/infants2010/en/index.html Accessed 2011.
- Background: PubMed 21224736Braun M, Kabue MM, McCollum ED, Ahmed S, Kim M, Aertker L, Chirwa M, Eliya M, Mofolo I, Hoffman I, Kazembe PN, van der Horst C, Kline MW, Hosseinipour MC. Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2011 Apr 15;56(5):e122-8. doi: 10.1097/QAI.0b013e31820a7f2f.
- Background: PubMed 15464184Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F; Ghent International AIDS Society (IAS) Working Group on HIV Infection in Women and Children. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004 Oct 2-8;364(9441):1236-43. doi: 10.1016/S0140-6736(04)17140-7.
- Background: PubMed 22869167Laursen L. Point-of-care tests poised to alter course of HIV treatment. Nat Med. 2012 Aug;18(8):1156. doi: 10.1038/nm0812-1156. No abstract available.
- BackgroundUNITAID. HIV/AIDS diagnostic technology landscape.Tech. Rep., WHO, Geneva, Switzerland, 2012.
- Background: PubMed 24933096Jani IV, Meggi B, Mabunda N, Vubil A, Sitoe NE, Tobaiwa O, Quevedo JI, Lehe JD, Loquiha O, Vojnov L, Peter TF. Accurate early infant HIV diagnosis in primary health clinics using a point-of-care nucleic acid test. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):e1-4. doi: 10.1097/QAI.0000000000000250.
- Background: PubMed 6528136Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409-22. doi: 10.1002/sim.4780030421. No abstract available.
- Background: PubMed 20942667Palumbo P, Lindsey JC, Hughes MD, Cotton MF, Bobat R, Meyers T, Bwakura-Dangarembizi M, Chi BH, Musoke P, Kamthunzi P, Schimana W, Purdue L, Eshleman SH, Abrams EJ, Millar L, Petzold E, Mofenson LM, Jean-Philippe P, Violari A. Antiretroviral treatment for children with peripartum nevirapine exposure. N Engl J Med. 2010 Oct 14;363(16):1510-20. doi: 10.1056/NEJMoa1000931.
- University of North Carolina websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Stringer, MD principal investigator
University of North Carolina, Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA PCR HIV diagnostic test and Alere Q in people with Early Infant HIV Diagnosis, run by University of North Carolina, Chapel Hill at 6 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HIV-infected children in each arm who remain alive, in care, and with no HIV circulating in their bloodstream 12 months after initial diagnosis (time frame: time of initial diagnosis through 12 months post diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02682810, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.