{"doc_desc":{"title":"cRCT of  Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) \u2013 HIV self-testing survey","idno":"AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1","producers":[{"name":"Africa Health Research Institute","abbr":"AHRI","affiliation":"","role":""}]},"study_desc":{"title_statement":{"idno":"AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1","title":"cRCT of  Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) \u2013 HIV self-testing survey"},"authoring_entity":[{"name":"Prof. Maryam Shahmanesh","affiliation":"Africa Health Research Institute "},{"name":"Dr. Limakatso Lebina","affiliation":"Africa Health Research Institute "}],"oth_id":[{"name":"Jaco Dreyer","affiliation":"Africa Health Research Institute ","email":"","role":"Data management, cleaning"},{"name":"Eva Ssozi","affiliation":"Africa Health Research Institute ","email":"","role":"Data management, cleaning"}],"production_statement":{"producers":[{"name":"Africa Health Research Institute","abbr":"AHRI","affiliation":"","role":""}],"funding_agencies":[{"name":"Bill and Melinda Gates Foundation","abbr":"BMG","role":"Funder"},{"name":"ViiV Healthcare","abbr":"ViiV","role":"Donor"}]},"version_statement":{"version":"v1.0.0"},"study_info":{"keywords":[{"keyword":"STI, HIV prevention.","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"topics":[{"topic":"Adolescents; young adults; HIV infections\/prevention & control; South Africa\/epidemiology; sexual health; PrEP; HIV prevention","vocab":"Africa Health Research Institute","uri":"www.ahri.org"}],"abstract":"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.\n\nStudy Aim: To evaluate how HIV self-testing can support the safe decentralisation of PrEP choice, including two-monthly injectable cabotegravir, within community-based PrEP and SRH service delivery among adolescents and young people, and its potential to address initiation and retention.","coll_dates":[{"start":"2025-01-01","end":"2026-01-31","cycle":""}],"nation":[{"name":"South Africa","abbreviation":"ZA"}],"geog_coverage":"Health and demographic surveillance site in the rural KwaZulu-Natal.","analysis_unit":"PrEP cohort participants.","universe":"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 \u201cLAPIS\u201d 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.","data_kind":"HIV self-testing interview"},"method":{"data_collection":{"sampling_procedure":"\u00b7 Acceptability and feasibility of HIV self-testing (HIVST)","sources":[{"name":"","origin":"","characteristics":""}],"cleaning_operations":"The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster."}},"data_access":{"dataset_use":{"cit_req":"Shahmanesh, M., & Lebina, L. (2026). cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) \u2013 HIV self-testing survey [Data set]. Africa Health Research Institute. \n\nDOI:https:\/\/doi.org\/10.23664\/AHRI.PREPIMPLEMENTATION.LAPIS.SELF.TESTING.2026.V1","conditions":"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."}}},"schematype":"survey"}