POC HIV Testing and Early DTG Use for Infants (NCT05393193) | Clinical Trial Compass
Active — Not RecruitingPhase 4
POC HIV Testing and Early DTG Use for Infants
Botswana900 participantsStarted 2022-07-04
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of high-risk HIV-exposed infants identified and tested
Timeframe: within 72 hours of life
2
Median time to HIV diagnosis and treatment-dose ART
Timeframe: 7 days
3
The proportion of children with HIV-1 RNA <40 copies/mL at 12 weeks on ART
Timeframe: 12 weeks on ART
4
The proportion of children with successful DTG-based treatment through 96 weeks on ART
Timeframe: 96 weeks on ART
5
The proportion of infants with grade 3 or 4 adverse events/hospitalization/death