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Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

RecruitingPhase 3Ages 15 Years - 30 YearsAllAfrica Health Research Institute
NCT06250504 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within t

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📋 Eligibility rules (as published)
Inclusion 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 feeding for CAB LA has not been established and oral daily PrEP is a safe alternative. Exclusion Criteria: 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 C and not yet treated, or abnormal liver function tests (ALT more than two times the upper limit of normal) DapiRing: Pregnancy.
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What it tests

  • APRETUDE (cabotegravir) 600 mg\3 mL
  • DAPIRING (Dapivirine) 25mg Vaginal Ring
  • tenofovir disoproxil and emtricitabine
  • Tenofovir Disoproxil, Lamuvidine and Dolutegravir
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Where

1 site
Africa Health Research Institute
Somkele, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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