cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – Clinical Management
South Africa, 2024 - 2026
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AHRI.LAPIS.ESource.Clinical.Management.2025.v1
cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – Clinical Management
| Name | Country code |
|---|---|
| South Africa | ZA |
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. Offering a choice of long-acting PrEP, such as the 2 monthly injectable cabotegravir (CAB LA) within the community-based delivery of SRH integrated with oral PrEP, post-exposure prophylaxis, and dapivirine vaginal ring will overcome the uptake, adherence, and retention challenges of oral PrEP and lead to a population-level effect on sexually transmissible HIV. Young men and women aged 15-30 years from the 40 administrative clusters in the uMkhanyakude district who attend any integrated SRH/HIV service are eligible for enrolment.
Study Aim: Offering a choice of long-acting PrEP, such as the two-monthly injectable cabotegravir, in addition to the community-based oral PrEP and SRH will overcome the adherence, retention, and disclosure challenges of oral PrEP and lead to a population-level effect on sexually transmissible HIV.
Specific Objectives:
- To measure the effectiveness of the choice of oral and long-acting PrEP, including injectable (CAB LA) and vaginal ring (DapiRing), and post exposure prophylaxis (PEP) on increasing effective uptake (adoption), retention, and adherence of PrEP compared to oral PrEP in young people aged 15-30 in rural South Africa and to estimate the preliminary effect on transmissible HIV and HIV incidence.
- To understand real-world implementation:
a. To explore the acceptability, preference, and reach of CAB-LA from the perspective of young people aged 15-30 and their communities in rural South Africa.
b. To understand the feasibility, affordability, and scalability of delivering CAB-LA through community-based PrEP with SRH.
c. To identify implementation challenges and practical solutions for CAB-LA initiation, laboratory monitoring (e.g. RNA testing), and safe stopping within nurse-led and rural community-based clinical settings.
d. To evaluate the safety and tolerability of CAB-LA compared to oral PrEP.
PrEP user's clinical data
Sexual reproductive health and HIV-neutral service participants.
Version
v1.0.0
Scope
| Topic | Vocabulary | URI |
|---|---|---|
| Adolescents; young adults; HIV infections/prevention & control; South Africa/epidemiology; sexual health; randomised controlled trials, PrEP; HIV prevention; clinical adherence; patient management. | Africa Health Research Institute | www.ahri.org |
Coverage
Health and demographic surveillance site in the rural KwaZulu-Natal.
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. About 26,000 15-30 AYAs from 40 geographical areas (clusters) residing in the 40 clusters of the uMkhanyakude District in rural KwaZulu Natal are eligible to receive “LAPIS” intervention. Of these, ~20% are at risk of HIV acquisition and would benefit from PrEP and STI clinical management. The unit of randomisation is the administrative area supported by a pair of peer navigators: 40 administrative areas are randomised to receive the intervention.
Producers and sponsors
| Name | Affiliation |
|---|---|
| Prof. Maryam Shahmanesh | Africa Health Research Institute |
| Dr. Limakatso Lebina | Africa Health Research Institute |
| Name |
|---|
| Africa Health Research Institute |
| Name | Abbreviation | Role |
|---|---|---|
| Bill and Melinda Gates Foundation | BMG | Funder |
| Name | Affiliation | Role |
|---|---|---|
| Jaco Dreyer | Africa Health Research Institute | Data management, cleaning, and analysis |
Sampling
Clinical cohort: all young people aged 15-30 years who are residing in a trial cluster and attend one of the study clinics or public health clinics, following informed consent/assent. Baseline and endline surveys, n=3200, 16-30-year-old male and females randomly selected from the health and demographic surveillance survey area, following informed consent (aged 18 and above) and informed assent and parental/guardian informed consent (aged 16-17).
For the surveys, aged 16-30, residing in the HDSS and able to provide informed consent (18+) or informed assent and parental consent (aged 16-17). For the clinical cohort, aged 15-30, residing in the trial clusters, attending one of the study clinics or public health clinics, and providing informed consent/assent to use their clinical data
Data collection
| Start | End |
|---|---|
| 2024-05-01 | 2026-05-31 |
Data processing
The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster.
Data Access
Access to the data requires accurate completion of the online data access application form accessible on the AHRI Data repository(https://data.ahri.org/). Data users are required to abide by the data use conditions stipulated on the application for access to the data. Failure to do so may result in their data access privileges being revoked by the Data Custodian. In order to recognise the effort and intellectual contributions of AHRI investigators in producing and curating the data, users of AHRI data must acknowledge the source of the data and abide by the terms and conditions under which the data is accessed and must cite the dataset in publication using the citation provided as part of this documentation. All analytical datasets published on the AHRI Data Repository are assigned digital object identifier (DOIs) and the DOIs can be found on the Data Repository under Study Description tab - Access policy. AHRI data users are required to always cite the dataset using the relevant DOI.
Shahmanesh, Prof Maryam, & Lebina, Dr. Limakatso. (2025). cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – Clinical Management [Data set]. Africa Health Research Institute.
DOI:https://doi.org/10.23664/AHRI.LAPIS.ESource.Clinical.Management.2025
Metadata production
AHRI.LAPIS.ESource.Clinical.Management.2025.v1
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |