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cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – HIV self-testing survey

South Africa, 2025 - 2026
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Reference ID
AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1
Producer(s)
Prof. Maryam Shahmanesh, Dr. Limakatso Lebina
Metadata
Documentation in PDF DDI/XML JSON
Created on
Apr 10, 2026
Last modified
Apr 10, 2026
Page views
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  • Identification
  • Version
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Data collection
  • Data processing
  • Data Access
  • Metadata production

    • Identification

    Survey ID number

    AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1
    Title

    cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – HIV self-testing survey
    Country
    Name Country code
    South Africa ZA
    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.

    Study 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.
    Kind of Data

    HIV self-testing interview
    Unit of Analysis

    PrEP cohort participants.

    Version

    Version Description

    v1.0.0

    Scope

    Topics
    Topic Vocabulary URI
    Adolescents; young adults; HIV infections/prevention & control; South Africa/epidemiology; sexual health; PrEP; HIV prevention Africa Health Research Institute www.ahri.org
    Keywords
    STI, HIV prevention.

    Coverage

    Geographic Coverage

    Health and demographic surveillance site in the rural KwaZulu-Natal.
    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 “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

    Primary investigators
    Name Affiliation
    Prof. Maryam Shahmanesh Africa Health Research Institute
    Dr. Limakatso Lebina Africa Health Research Institute
    Producers
    Name
    Africa Health Research Institute
    Funding Agency/Sponsor
    Name Abbreviation Role
    Bill and Melinda Gates Foundation BMG Funder
    ViiV Healthcare ViiV Donor
    Other Identifications/Acknowledgments
    Name Affiliation Role
    Jaco Dreyer Africa Health Research Institute Data management, cleaning
    Eva Ssozi Africa Health Research Institute Data management, cleaning

    Sampling

    Sampling Procedure

    · Acceptability and feasibility of HIV self-testing (HIVST)

    Data collection

    Dates of Data Collection
    Start End
    2025-01-01 2026-01-31

    Data processing

    Data Editing

    The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster.

    Data Access

    Access 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.
    Citation requirements

    Shahmanesh, M., & Lebina, L. (2026). cRCT of Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – HIV self-testing survey [Data set]. Africa Health Research Institute.

    DOI:https://doi.org/10.23664/AHRI.PREPIMPLEMENTATION.LAPIS.SELF.TESTING.2026.V1

    Metadata production

    DDI Document ID

    AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1
    Producers
    Name Abbreviation
    Africa Health Research Institute AHRI
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