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New treatment option for HIV Infections
Official title Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT
ClinicalTrials.gov ID: NCT06250504
What this study is testing
What is APRETUDE (cabotegravir) 600 mg\3 mL?
APRETUDE (cabotegravir) 600 mg\3 mL is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hiv infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa. Researchers will compare adding the choice of long-acting PrEP, i.e.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 30. Healthy volunteers may be eligible.
You may be able to join if
- All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service
- Documented HIV negative test
- Suitable for PrEP and/or already on PrEP
- Weight \> 35 kg
- Understand the required dosing schedule and HIV testing.
You likely can't join if
- History or presence of allergy to the study drugs or their components
- Investigator assessment find them not suitable
- Additional exclusion criteria for specific products:
- CAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental...
- DapiRing: Pregnancy.
See the full eligibility criteria
- All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service
- Documented HIV negative test
- Suitable for PrEP and/or already on PrEP
- Weight \> 35 kg
- Understand the required dosing schedule and HIV testing.
- Aware that details can be shared with a peer navigator to support their follow-up
- If pregnant or breast feeding and/or planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast...
- History or presence of allergy to the study drugs or their components
- Investigator assessment find them not suitable
- Additional exclusion criteria for specific products:
- CAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental health disorder, Hep B surface antigen positive, living with hepatitis...
- DapiRing: Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Somkele, KwaZulu-Natal, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Somkele, KwaZulu-Natal, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.