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      <titlStmt>
        <titl>
          Thetha Nami ngithethe nawe (Let’s Talk)– STI Partner Treatment
        </titl>
        <IDNo>
          AHRI.PrEPImplementation.STI.Partner.Notification.2025.v1
        </IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="AHRI">
          Nompumelelo Mkwanazi
        </AuthEnty>
      </rspStmt>
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          Africa Health Research Institute
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          Nesstar Publisher
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    <citation>
      <titlStmt>
        <titl>
          Thetha Nami ngithethe nawe (Let’s Talk)– STI Partner Treatment
        </titl>
        <IDNo>
          AHRI.PrEPImplementation.STI.Partner.Notification.2025.v1
        </IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Africa Health Research Institute ">
          <![CDATA[Prof  Maryam Shahmanesh]]>
        </AuthEnty>
        <othId role="Data management, cleaning, and analysis" affiliation="Africa Health Research Institute ">
          <p>
            Jaco Dreyer
          </p>
        </othId>
        <othId role="Data management, cleaning, and analysis" affiliation="Africa Health Research Institute ">
          <p>
            Eva Ssozi
          </p>
        </othId>
      </rspStmt>
      <prodStmt>
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          Africa Health Research Institute
        </producer>
        <software version="4.0.9" date="2013-04-23">
          Nesstar Publisher
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        <fundAg abbr="BMG" role="Funder">
          Bill and Melinda Gates Foundation
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      <verStmt>
        <version>
          v1.0.0
        </version>
      </verStmt>
    </citation>
    <stdyInfo>
      <subject>
        <keyword vocab="Africa Health Research Institute" vocabURI="www.ahri.org">
          STI, partner notification, HIV prevention, clinical management
        </keyword>
        <topcClas vocab="Africa Health Research Institute" vocabURI="www.ahri.org">
          Adolescents; young adults; HIV infections/prevention &amp; control; South Africa/epidemiology; sexual health; randomised controlled trials, PrEP; HIV prevention; clinical adherence; patient management.
        </topcClas>
      </subject>
      <abstract>
        <![CDATA[Thetha Nami ngithethe nawe (Let's Talk): A stepped-wedge cluster randomised controlled trial of peer navigators' social mobilisation into community-based sexual health and HIV care (Including Pre-Exposure prophylaxis) to reduce sexual transmissible HIV among youth in rural KwaZulu-Natal, South Africa. The STI Partner Treatment component investigates the STI contact tracing, partner notification, and treatment among sexual reproductive health and HIV clinic mobile attendees in rural KwaZulu Natal.

· Study Aim: To assess the effectiveness and feasibility of STI partner treatment strategies to curb the reinfection rates among sexual partners, enhance overall sexual reproductive health outcomes, and enhance the STI's clinical management.

· Specific Objectives:
1.To evaluate the effect of healthcare worker STI contact tracing, notification, and treatment
2.To assess the feasibility of implementing healthcare worker partners' notification to augment the patient notification to curb STI transmission]]>
      </abstract>
      <sumDscr>
        <collDate date="2022-06-14" event="start"/>
        <collDate date="2025-01-20" event="end"/>
        <nation abbr="ZA">
          South Africa
        </nation>
        <geogCover>
          Health and demographic surveillance site in the rural KwaZulu-Natal
        </geogCover>
        <anlyUnit>
          Sexual reproductive health and HIV-neutral service participants.
        </anlyUnit>
        <universe>
          <![CDATA[About 26,000 15-30 AYAs from 40 geographical areas (clusters) of the uMkhanyakude District in the rural KwaZulu Natal are eligible to receive Thetha Nami ngithethe nawe" intervention. Of these, ~20% are at risk of HIV acquisition and would benefit from HIV 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, Thetha Nami ngithethe nawe: social mobilisation by peer navigators into mobile sexual and reproductive health clinics that provide tailored HIV prevention and care or the standard of care: access HIV care and prevention through primary care clinics.

Participants must be able and willing to give written informed consent for trial participation, or assent and parental consent in the case of those aged 15-17. Adults 18+ years who are eligible for PrEP.]]>
        </universe>
        <dataKind>
          PrEP user's clinical data
        </dataKind>
      </sumDscr>
    </stdyInfo>
    <method>
      <dataColl>
        <sampProc>
          <![CDATA[The primary outcome will be collected through three random representative population-based surveys: 

· n=2000 15-30-year-olds, 50 per cluster, at baseline, 
· n=3200 15-30-year-olds, 80 per cluster, at the end of period 1 (midline) and 
· n=3200 15-30-year-olds, 80 per cluster, at the end of period 2 (end-line).  

We use the AHRI health and demographic surveillance system (HDSS) as a sampling frame to randomly select three separate cross-sectional samples of: 

· n=3600 (90 per cluster) 15-30-year-olds stratified by gender at baseline. Based on previous studies in this setting, we anticipate that ~2800 will be contactable and eligible and that n=2000 (~50 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study.
· n=6000 (150 per cluster) 15-30-year-olds stratified by gender at the midline (before the second step of scale-up) and end-line. Based on previous studies in this setting, we anticipate that 4300 will be contactable and eligible and that n=3200 (~80 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study]]>
        </sampProc>
        <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, Prof Maryam. (2025). Thetha Nami ngithethe nawe (Let’s Talk)– STI Partner Treatment [Data set]. Africa Health Research Institute. 
DOI:https://doi.org/10.23664/AHRI.PREPIMPLEMENTATION.STI.PARTNER.NOTIFICATION.2025]]>
        </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>
    </dataAccs>
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          1
        </catValu>
        <labl>
          Once Daily
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          4 hourly
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          3
        </catValu>
        <labl>
          6 hourly
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          4
        </catValu>
        <labl>
          8 hourly
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          5
        </catValu>
        <labl>
          Apply PRN
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          6
        </catValu>
        <labl>
          12 hourly
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          7
        </catValu>
        <labl>
          24 hourly
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          8
        </catValu>
        <labl>
          24 hourly nocte
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          9
        </catValu>
        <labl>
          Insert nocte
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          10
        </catValu>
        <labl>
          Stat
        </labl>
        <catStat type="freq">
          86
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
    <var ID="V578" name="ds_sti_drug_name" files="F4" intrvl="discrete">
      <location width="5"/>
      <labl>
        Drug Code
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
    <var ID="V579" name="ds_sti_drug_label" files="F4" intrvl="discrete">
      <location width="28"/>
      <labl>
        Generic Drug Name
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
    <var ID="V580" name="ds_sti_drug_name_oth" files="F4" intrvl="discrete">
      <location width="13"/>
      <labl>
        Specify Other Generic Drug name
      </labl>
      <sumStat type="vald">
        2
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
    <var ID="V581" name="ds_sti_exp_date" files="F4" intrvl="discrete">
      <location width="11"/>
      <labl>
        Expiry date of medication
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="min">
        2023-01-31
      </sumStat>
      <sumStat type="max">
        2027-07-31
      </sumStat>
      <varFormat type="character" formatname="Nesstar.date" schema="other" category="date"/>
    </var>
    <var ID="V582" name="ds_sti_lotnumber" files="F4" intrvl="discrete">
      <location width="9"/>
      <labl>
        Lot Number
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
    <var ID="V583" name="ds_sti_qrcode" files="F4" intrvl="discrete">
      <location width="19"/>
      <labl>
        Scan QR Code: Package
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
    <var ID="V584" name="ds_sti_route" files="F4" dcml="0" intrvl="discrete">
      <location width="12"/>
      <labl>
        Route
      </labl>
      <valrng>
        <range UNITS="REAL" min="1" max="6"/>
      </valrng>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <catgry>
        <catValu>
          1
        </catValu>
        <labl>
          Oral adminstration
        </labl>
        <catStat type="freq">
          76
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          2
        </catValu>
        <labl>
          Intravenous injection
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          3
        </catValu>
        <labl>
          Topical Application
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          4
        </catValu>
        <labl>
          Intramuscular injection
        </labl>
        <catStat type="freq">
          10
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          5
        </catValu>
        <labl>
          Per Vagina
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <catgry>
        <catValu>
          6
        </catValu>
        <labl>
          Topical
        </labl>
        <catStat type="freq">
          0
        </catStat>
      </catgry>
      <varFormat type="numeric" schema="other"/>
    </var>
    <var ID="V585" name="ds_sti_staff_code" files="F4" intrvl="discrete">
      <location width="7"/>
      <labl>
        Staff Code
      </labl>
      <sumStat type="vald">
        86
      </sumStat>
      <sumStat type="invd">
        0
      </sumStat>
      <varFormat type="character" schema="other"/>
    </var>
  </dataDscr>
</codeBook>
