ArticleBMC infectious diseases2026
The LEN4PrEP study: protocol for a phase 3B, non-randomised clinical trial integrating lenacapavir PrEP within multi-product HIV prevention services in primary care clinics in South Africa.
Article in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
introductionDespite the scale-up of HIV pre-exposure prophylaxis (PrEP), HIV incidence remains high. The highly effective, twice-yearly subcutaneous injectable lenacapavir for PrEP (L4P) has provided a potential breakthrough for HIV prevention, but there is limited real-world data on uptake, patterns of use and service delivery requirements when offered in public health settings. The LEN4PrEP study will evaluate the integration of L4P within existing multi-product HIV prevention services in real-world settings in South Africa.
methodsThe study is a prospective, mixed-methods, phase 3B clinical trial utilizing a non-randomised, open-label, effectiveness-implementation hybrid type 3 design. The study will take place in two fixed primary healthcare facilities and one linked roving mobile clinic in the Tshwane region, South Africa. Clients aged 16-65 years accessing comprehensive sexual and reproductive health services at the sites will be invited to enrol in the prospective cohort and offered a choice of L4P or oral PrEP. Clinical and socio-behavioural data will be collected over 12 months, with participants free to switch, discontinue and restart either PrEP product for the duration of the study. Ongoing safety monitoring will be conducted, with pregnancy and birth outcomes captured from pregnant participants, as well as HIV drug resistance monitoring in those who seroconvert. In-depth qualitative data will be collected from a sub-set of cohort participants to understand reasons for L4P use, as well as from healthcare providers involved in L4P delivery to explore health system requirements for implementation. Outcomes of the study will be guided by the RE-AIM framework and include patterns of use (uptake, adherence, persistence, continuation, switching, re-initiation, discontinuation), effectiveness (pregnancy and birth outcomes, seroconversions, adverse events) and facilitators and barriers to implementation. DISCUSSION: The LEN4PrEP study will provide real-world data on L4P implementation when offered within existing HIV prevention services in public health settings in South Africa, offering a more generalisable reflection on use, service delivery, effectiveness and safety. The data generated can be used alongside programmatic data to inform demand forecasting, training and planning for the national roll-out of L4P.
trial registrationSouth African National Clinical Trials Registry, DOH-27-102025-4927 ( https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=13831 ). Registered on 22 April 2025.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.