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          <![CDATA[cRCT of  Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – HIV self-testing survey]]>
        </titl>
        <IDNo>
          AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1
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        <AuthEnty affiliation="AHRI">
          Nompumelelo Mkwanazi
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          Africa Health Research Institute
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    <citation>
      <titlStmt>
        <titl>
          <![CDATA[cRCT of  Long-acting PrEP Integrated with Community-based Sexual Health (LAPIS) – HIV self-testing survey]]>
        </titl>
        <IDNo>
          AHRI.PrEPImplementation.LAPIS.Self.Testing.2026.v1
        </IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Africa Health Research Institute ">
          Prof. Maryam Shahmanesh
        </AuthEnty>
        <AuthEnty affiliation="Africa Health Research Institute ">
          Dr. Limakatso Lebina
        </AuthEnty>
        <othId role="Data management, cleaning" affiliation="Africa Health Research Institute ">
          <p>
            Jaco Dreyer
          </p>
        </othId>
        <othId role="Data management, cleaning" affiliation="Africa Health Research Institute ">
          <p>
            Eva Ssozi
          </p>
        </othId>
      </rspStmt>
      <prodStmt>
        <producer abbr="AHRI">
          Africa Health Research Institute
        </producer>
        <software version="4.0.9" date="2013-04-23">
          Nesstar Publisher
        </software>
        <fundAg abbr="BMG" role="Funder">
          Bill and Melinda Gates Foundation
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        <fundAg abbr="ViiV" role="Donor">
          ViiV Healthcare
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          v1.0.0
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    <stdyInfo>
      <subject>
        <keyword vocab="Africa Health Research Institute" vocabURI="www.ahri.org">
          STI, HIV prevention.
        </keyword>
        <topcClas vocab="Africa Health Research Institute" vocabURI="www.ahri.org">
          Adolescents; young adults; HIV infections/prevention &amp; control; South Africa/epidemiology; sexual health; PrEP; HIV prevention
        </topcClas>
      </subject>
      <abstract>
        <![CDATA[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.]]>
      </abstract>
      <sumDscr>
        <collDate date="2025-01-01" event="start"/>
        <collDate date="2026-01-31" event="end"/>
        <nation abbr="ZA">
          South Africa
        </nation>
        <geogCover>
          Health and demographic surveillance site in the rural KwaZulu-Natal.
        </geogCover>
        <anlyUnit>
          PrEP cohort participants.
        </anlyUnit>
        <universe>
          <![CDATA[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.]]>
        </universe>
        <dataKind>
          HIV self-testing interview
        </dataKind>
      </sumDscr>
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    <method>
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        <sampProc>
          · Acceptability and feasibility of HIV self-testing (HIVST)
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        <sources/>
        <cleanOps>
          The data collected and captured on REDCap was uploaded to a MySQL database server within AHRI's secure server cluster.
        </cleanOps>
      </dataColl>
    </method>
    <dataAccs>
      <useStmt>
        <citReq>
          <![CDATA[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]]>
        </citReq>
        <conditions>
          Access to the data requires accurate completion of the online data access application form accessible on the AHRI Data repository(&lt;https://data.ahri.org/&gt;). 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.
        </conditions>
      </useStmt>
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      </labl>
      <valrng>
        <range UNITS="REAL" min="1" max="96"/>
      </valrng>
      <sumStat type="vald">
        8
      </sumStat>
      <sumStat type="invd">
        1
      </sumStat>
      <catgry>
        <catValu>
          1
        </catValu>
        <labl>
          Will come to the clinic
        </labl>
        <catStat type="freq">
          1
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          Not having sex right now
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          3
        </catValu>
        <labl>
          Controverted
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          4
        </catValu>
        <labl>
          Refused
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          5
        </catValu>
        <labl>
          Out-migrated outside of PIPSA
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          6
        </catValu>
        <labl>
          Participant is unknown
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          7
        </catValu>
        <labl>
          Reschedule phone call
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          8
        </catValu>
        <labl>
          Someone else answered
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          96
        </catValu>
        <labl>
          Other
        </labl>
        <catStat type="freq">
          7
        </catStat>
      </catgry>
      <catgry missing="Y">
        <catValu>
          Sysmiss
        </catValu>
        <catStat type="freq">
          1
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
    <var ID="V4879" name="tm_calc_refuse_link" files="F39" dcml="0" intrvl="discrete">
      <location width="12"/>
      <labl>
        Calculated field: Refusal to link to care
      </labl>
      <valrng>
        <range UNITS="REAL" min="1" max="2"/>
      </valrng>
      <sumStat type="vald">
        9
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <catgry>
        <catValu>
          1
        </catValu>
        <labl>
          Yes
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          No
        </labl>
        <catStat type="freq">
          9
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
    <var ID="V4880" name="tm_calc_wrong_num" files="F39" dcml="0" intrvl="discrete">
      <location width="12"/>
      <labl>
        Calculated field: Wrong number
      </labl>
      <valrng>
        <range UNITS="REAL" min="1" max="2"/>
      </valrng>
      <sumStat type="vald">
        9
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <catgry>
        <catValu>
          1
        </catValu>
        <labl>
          Yes
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          No
        </labl>
        <catStat type="freq">
          9
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
    <var ID="V4881" name="tm_calc_not_comeback" files="F39" dcml="0" intrvl="discrete">
      <location width="12"/>
      <labl>
        Calculated field: Confirmed not coming back to clinic
      </labl>
      <valrng>
        <range UNITS="REAL" min="1" max="2"/>
      </valrng>
      <sumStat type="vald">
        9
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <catgry>
        <catValu>
          1
        </catValu>
        <labl>
          Yes
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          No
        </labl>
        <catStat type="freq">
          9
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
  </dataDscr>
</codeBook>
