HIVPhase 4NCT05393193
POC HIV Testing and Early DTG Use for Infants
A Phase 4 study testing Point-of-Care Cepheid Xpert HIV-1 and DTG/ABC/3TC in people with HIV, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial summary
This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- What is being tested?
- Point-of-Care Cepheid Xpert HIV-1 and DTG/ABC/3TC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteBotswana
- Study dates
- 4 Jul 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mother 18 years of age or older
- Mother willing and able to provide verbal consent for infant testing
- Infant birth weight ≥1.5kg
- Presence of any of the following risk factors:
- <12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time >24 weeks gestation in pregnancy; CD4 cell count known to be <350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)
Who cannot join
- 1) Medical condition making it unlikely that the infant will survive to 24 months
- Inclusion criteria for infant longitudinal treatment cohort:
- Mother 18 years of age or older
- Mother willing and able to provide written informed consent for study participation for herself and her infant
- Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
- Infant eligible for ART treatment in accordance with the Botswana government program
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- Infant birth weight ≥1.5 kg
- Exclusion criteria for infant longitudinal treatment cohort:
- Medical condition making it unlikely that the infant will survive to 24 months
- Infant unable to start treatment-dose ART < 168 hours of age
- Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.
- Conditions
- HIV
- Being tested
- Point-of-Care Cepheid Xpert HIV-1, DTG/ABC/3TC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care Cepheid Xpert HIV-1Diagnostic test
Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.
DTG/ABC/3TCDrug
Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| HIV-exposed neonates | Other | Point-of-care HIV testing at birth Receives: Diagnostic Test: Point-of-Care Cepheid Xpert HIV-1 |
| HIV-positive infants identified through birth HIV screening | Other | Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg. Receives: Drug: DTG/ABC/3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of high-risk HIV-exposed infants identified and tested
Analysis will largely be descriptive, highlighting the proportion of high-risk infants identified and tested at each facility. Proportions will be determined by populating actual numbers approached and screened matched against exact denominators obtained from surveillance data.
Measured: within 72 hours of life
Median time to HIV diagnosis and treatment-dose ART
We will describe the proportion of high-risk infants found to be HIV positive per risk category and compare this to findings from another cohort study of early-treated children. Average time to HIV diagnosis and treatment initiation will also be described.
Measured: 7 days
The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART
We will compare time to viral suppression and the proportion with complete HIV-1 RNA suppression (<40 copies/mL) at 12 weeks from ART start between infants on early DTG with another cohort of children on early LPV/r.
Measured: 12 weeks on ART
The proportion of children with successful DTG-based treatment through 96 weeks on ART
We will compare the proportion with complete HIV-1 RNA suppression and no need for treatment modification at all visits through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.
Measured: 96 weeks on ART
The proportion of infants with grade 3 or 4 adverse events/hospitalization/death
We will compare the proportion with grade 3 or 4 adverse events through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.
Measured: 96 weeks on ART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start4 Jul 2022
- Primary completion16 Mar 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Roger Shapiro, Harvard School of Public Health (HSPH)
- Investigators
- Roger L Shapiro, MD, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393193
- Sponsor's protocol ID
- 155BHP
- Other IDs
- P01HD107670
- Status last verified
- Jul 2026
- First submitted
- 23 May 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
- ClinicalTrials.gov ID
- NCT05393193
- Acronym / sponsor ID
- 155BHP
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2022 (actual)
- 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 study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-exposed neonates | Other | Diagnostic Test: Point-of-Care Cepheid Xpert HIV-1Point-of-care HIV testing at birth |
| HIV-positive infants identified through birth HIV screening | Other | Drug: DTG/ABC/3TCEarly antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mother 18 years of age or older
- Mother willing and able to provide verbal consent for infant testing
- Infant birth weight ≥1.5kg
- Presence of any of the following risk factors:
- <12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time >24 weeks gestation in pregnancy; CD4 cell count known to be <350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)
Key exclusion criteria (11 listed)
- 1) Medical condition making it unlikely that the infant will survive to 24 months
- Mother 18 years of age or older
- Mother willing and able to provide written informed consent for study participation for herself and her infant
- Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
- Infant eligible for ART treatment in accordance with the Botswana government program
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 |
|---|---|---|
| Point-of-Care Cepheid Xpert HIV-1Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis. | Diagnostic test | HIV-exposed neonates |
| DTG/ABC/3TCInfants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines. | Drug | HIV-positive infants identified through birth HIV screening |
Primary outcome
Proportion of high-risk HIV-exposed infants identified and tested
Time frame: within 72 hours of life
Analysis will largely be descriptive, highlighting the proportion of high-risk infants identified and tested at each facility. Proportions will be determined by populating actual numbers approached and screened matched against exact denominators obtained from surveillance data.
Median time to HIV diagnosis and treatment-dose ART
Time frame: 7 days
We will describe the proportion of high-risk infants found to be HIV positive per risk category and compare this to findings from another cohort study of early-treated children. Average time to HIV diagnosis and treatment initiation will also be described.
The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART
Time frame: 12 weeks on ART
We will compare time to viral suppression and the proportion with complete HIV-1 RNA suppression (<40 copies/mL) at 12 weeks from ART start between infants on early DTG with another cohort of children on early LPV/r.
The proportion of children with successful DTG-based treatment through 96 weeks on ART
Time frame: 96 weeks on ART
We will compare the proportion with complete HIV-1 RNA suppression and no need for treatment modification at all visits through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.
The proportion of infants with grade 3 or 4 adverse events/hospitalization/death
Time frame: 96 weeks on ART
We will compare the proportion with grade 3 or 4 adverse events through 96 weeks between infants on early DTG with another cohort of children on early LPV/r.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
Roger L Shapiro, MD, MPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Point-of-Care Cepheid Xpert HIV-1 and DTG/ABC/3TC in people with HIV, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 high-risk HIV-exposed infants identified and tested (time frame: within 72 hours of life). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.