NCT05393193Active, not recruitingPhase 4
POC HIV Testing and Early DTG Use for Infants
Point-of-Care HIV Testing and Early Dolutegravir Use for Infants
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 23 May 2022
- Start date
- 4 Jul 2022
- Primary completion date
- 16 Mar 2026
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Diseases
- HIV
- NCT number
- NCT05393193
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 900
- From 4 Jul 2022 to the primary completion date, 16 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\) Medical condition making it unlikely that the infant will survive to 24 months
- Medical condition making it unlikely that the infant will survive to 24 months
Age
- Infant unable to start treatment-dose ART \< 168 hours of age
Other
- Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
Who the study is looking for
- 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)
- 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
- Infant birth weight ≥1.5 kg
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Botswana Harvard Health Partnership Coordinator of this site? Confirm its status | Gaborone | Botswana | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.