Long-acting HIV prevention integrated with sexual and reproductive health services

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3B cluster randomized controlled trial aims to evaluate the effectiveness of offering a choice of long-acting HIV pre-exposure prophylaxis (PrEP) products, such as injectable cabotegravir and dapivirine vaginal rings, alongside daily oral PrEP in community-based sexual and reproductive health services. The study will compare the uptake and retention of these PrEP options among adolescents and young adults aged 15-30 in rural South Africa. Researchers will also assess the implementation challenges and community acceptance of these new PrEP options to enhance their delivery and effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Africa Health Research Institute
  Somkele, KwaZulu-Natal, South Africa Recruiting

Study contacts

• Study coordinator: Maryam G Shahmanesh, MBBChir PhD
• Email: m.shahmanesh@ucl.ac.uk
• Phone: +447776185572

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.