Long-acting HIV prevention integrated with sexual and reproductive health services
Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation
This study is testing if offering different long-acting HIV prevention options, like injections and vaginal rings, along with regular health services can help young people in rural South Africa stay safe from HIV.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 15 Years to 30 Years |
| Sex | All |
| Sponsor | Africa Health Research Institute Academic / other |
| Locations | 1 site (Somkele, KwaZulu-Natal) |
| Trial ID | NCT06250504 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are young men and women aged 15-30 who are HIV negative and reside in the study district.
Not a fit: Patients with a history of allergy to the study drugs or those deemed unsuitable by the investigator may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly increase the uptake and retention of effective HIV prevention methods among young people in rural areas.
How similar studies have performed: Other studies have shown success with similar approaches in increasing PrEP uptake, making this a promising but still innovative strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Somkele, KwaZulu-Natal
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.