<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02994355</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001851</org_study_id>
    <secondary_id>1K24HD088229-01</secondary_id>
    <nct_id>NCT02994355</nct_id>
  </id_info>
  <brief_title>HIV Testing at Family Planning Clinics in Mombasa County, Kenya</brief_title>
  <official_title>HIV Testing at Family Planning Clinics in Mombasa County, Kenya: A Cluster-Randomized Trial Comparing the Systems Analysis and Improvement Approach (SAIA) to Usual Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Nairobi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kenyatta National Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Mombasa County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Location: Family Planning Clinics in Mombasa County, Kenya&#xD;
&#xD;
      Introduction:&#xD;
&#xD;
      Integration of HIV treatment and prevention with family planning (FP) services is a promising&#xD;
      approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well&#xD;
      as prevention services for those who are negative. In Mombasa County, the USAID-supported&#xD;
      AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to&#xD;
      capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our&#xD;
      overarching objective is to assess the effectiveness, costs, and budget impact of&#xD;
      implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in&#xD;
      FP clinics in Mombasa County.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA&#xD;
      approach versus usual procedures on rates of HIV testing in first-time attendees at 20&#xD;
      intervention versus 20 control FP clinics in Mombasa County. The investigators will compare&#xD;
      HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control&#xD;
      facilities after an additional year, during which FP clinics in the intervention arm will be&#xD;
      encouraged to continue to use the SAIA tools with minimal support from the study team as the&#xD;
      Mombasa County Ministry of Health will take ownership of implementation. Lastly, the&#xD;
      investigators aim to estimate the incremental cost and budget impact of applying SAIA versus&#xD;
      standard of care using an activity-based approach.&#xD;
&#xD;
      Anticipated Results:&#xD;
&#xD;
      The investigators anticipate that SAIA will produce significant and sustained improvement in&#xD;
      HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to&#xD;
      control facilities. The use of a rigorous study design will provide strong evidence to guide&#xD;
      integration of HIV testing into FP services in a wide range of settings. The inclusion of&#xD;
      costing and budget impact analyses will assist policy makers in reaching informed decisions&#xD;
      about implementation.&#xD;
&#xD;
      Anticipated Conclusion:&#xD;
&#xD;
      By addressing the crucial first step in the linkage of HIV and FP services, this research&#xD;
      holds considerable promise for improving women's health by opening the gateway to HIV care&#xD;
      and prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Integration of HIV treatment and prevention with family planning (FP) services is a promising&#xD;
      approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well&#xD;
      as prevention services for those who are negative. The need for integration of services is&#xD;
      evident in Africa, which bears a disproportionate burden of HIV, high birth rates, and&#xD;
      maternal mortality. A high and increasing proportion of African women use FP services, making&#xD;
      this a potentially efficient venue for reaching them.&#xD;
&#xD;
      Testing for HIV is the gateway to care and prevention. Integrating HIV testing into FP&#xD;
      clinics could open this essential gateway, decreasing stigma associated with seeking HIV&#xD;
      testing while reducing costs. The antenatal setting provides a useful example. In many&#xD;
      African countries, testing for HIV in antenatal clinics (ANCs) has become routine. Diagnosis&#xD;
      of HIV during pregnancy has paved the way to substantial reductions in mother-to-child&#xD;
      transmission of HIV and AIDS-related deaths in women of reproductive age. These achievements&#xD;
      demonstrate the feasibility and impact of wide-scale HIV testing through existing&#xD;
      reproductive health services. In contrast to ANCs, integration of HIV testing into FP&#xD;
      services remains at a formative stage in much of Africa. Recent reviews support the&#xD;
      feasibility of integrating these services, but invariably conclude that additional research&#xD;
      is needed.&#xD;
&#xD;
      In Kenya, the National AIDS and STD Control Program (NASCOP) states that the FP clinic is a&#xD;
      setting in which, &quot;Failure to offer HIV testing and counseling is unacceptable, and will be&#xD;
      considered negligent.&quot; However, there has been almost no operational assessment of HIV&#xD;
      testing in Kenyan FP clinics. In Mombasa County, the USAID-supported AIDS Population and&#xD;
      Health Integrated Assistance II Program revised the FP Clinic Register to capture HIV testing&#xD;
      in 2008. However, the rate of HIV testing in FP clinics remains low, and the County has&#xD;
      requested our assistance in addressing this prevention gap. Colleagues at the University of&#xD;
      Washington Department of Global Health have developed a systems analysis and performance&#xD;
      enhancement approach, using industrial and systems engineering techniques, that the&#xD;
      investigators believe will be useful in this setting. The overarching objective is to assess&#xD;
      the effectiveness, costs, and budget impact of implementing this systems analysis and&#xD;
      improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County. The&#xD;
      investigators specific aims are as follows:&#xD;
&#xD;
      AIM 1: To conduct a cluster-randomized trial comparing the effect of the SAIA approach versus&#xD;
      usual procedures on rates of HIV testing in first-time attendees at 12 intervention versus 12&#xD;
      control FP clinics in Mombasa County, Kenya.&#xD;
&#xD;
      HYP 1: After one year of study team support implementing SAIA vs. usual procedures, a higher&#xD;
      proportion of first-time FP clinic attendees will be tested for HIV at intervention compared&#xD;
      to control facilities&#xD;
&#xD;
      AIM 2: To determine whether the SAIA training results in a lasting effect, the investigators&#xD;
      will compare HIV testing rates for first-time FP clinic attendees in SAIA intervention versus&#xD;
      control facilities after an additional year, during which FP clinics in the intervention arm&#xD;
      will be encouraged to continue to use the SAIA tools with minimal support from the study&#xD;
      team. The Mombasa County Ministry of Health will take ownership of implementation during this&#xD;
      phase.&#xD;
&#xD;
      HYP 2: After an additional year with minimal support from the study team, there will continue&#xD;
      to be significantly higher rates of HIV testing in first-time FP clinic attendees at&#xD;
      intervention compared to control facilities.&#xD;
&#xD;
      AIM 3: To estimate the incremental cost and budget impact of applying SAIA versus standard of&#xD;
      care. Using an activity-based approach, the investigators will perform a costing analysis,&#xD;
      estimating cost per new HIV diagnosis, both during active support from the study team and&#xD;
      after a period without active support. The investigators will also estimate cost to scale up,&#xD;
      and conduct a budget impact analysis from a Department of Health (DOH) perspective.&#xD;
&#xD;
      Expected Outcome and Significance:&#xD;
&#xD;
      The investigators anticipate that the SAIA approach will produce significant and sustained&#xD;
      improvement in HIV-testing rates in first-time FP clinic attendees in intervention clinics&#xD;
      compared to control facilities. The use of a rigorous study design to evaluate this scalable&#xD;
      approach will provide strong evidence to guide integration of HIV testing into FP services in&#xD;
      a wide range of settings. The inclusion of costing and budget impact analyses will assist&#xD;
      policy makers in reaching informed decisions about implementation. By addressing the crucial&#xD;
      first step in the linkage of HIV and FP services, this research holds considerable promise&#xD;
      for improving women's health by opening the gateway to HIV care and prevention. Preliminary&#xD;
      data on linkage to care and prevention services will inform development of future grant&#xD;
      proposals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities</measure>
    <time_frame>Months 9-12 of the study</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline</measure>
    <time_frame>Months 9-12 of the study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support</measure>
    <time_frame>Months 13-24 of the study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Intervention Clinics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Clinics</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Systems Analysis and Improvement Approach</intervention_name>
    <description>Understanding the cascade from FP clinic enrollment to HIV testing&#xD;
Use process mapping to identify modifiable bottlenecks&#xD;
Define and implement workflow adaptations to eliminate modifiable bottlenecks&#xD;
Monitor change in performance&#xD;
Repeat the analysis and improvement cycle (steps 1-4)</description>
    <arm_group_label>Intervention Clinics</arm_group_label>
    <other_name>SAIA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for in-depth interviews:&#xD;
&#xD;
          -  Adult family planning clinic staff&#xD;
&#xD;
          -  If staff younger than 18 are encountered, they will be allowed to participate only if&#xD;
             they qualify as emancipated minors in Kenya (14 years or older and married or&#xD;
             pregnant).&#xD;
&#xD;
          -  Able to provide written informed consent for in-depth interviews&#xD;
&#xD;
        Inclusion criteria for FP clinics in Mombasa:&#xD;
&#xD;
        -Clinics providing assent for participation in both the preliminary review and&#xD;
        randomizations&#xD;
&#xD;
        Exclusion Criteria for FP clinics:&#xD;
&#xD;
          -  Clinics planning to be closed during the study period&#xD;
&#xD;
          -  Clinics unwilling to be randomized or to participate in the SAIA intervention/approach&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond S McClelland, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Medicine, Epidemiology, Global Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alfarooq</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jocham</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Junda Dispensary</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Junda</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kongowea</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magongo</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marimani</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mbuta</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mikindani</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mlaleo</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mrima</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mvita</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mwakirunge</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mwangaza</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pandya</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roadside</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ShikaAdabu</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shukurani</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singawa</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tudor</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waweni</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wema</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziwa la ngombe</name>
      <address>
        <city>Mombasa</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <reference>
    <citation>WHO, UNFPA, IPPF, UNAIDS, UCSF. Sexual and reproductive health and HIV linkages: evidence review and recommendations. Geneva: 2009.</citation>
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    <citation>UNAIDS. Global Report: UNAIDS Report on the Global AIDS Epidemic 2013. Geneva: 2013.</citation>
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    <citation>Uganda Bureau of Statistics, MEASURE DHS. Uganda demographic and health survey. 2011.</citation>
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    <citation>Central Statistical Office Zambia, Ministry of Health Zambia, Tropical Diseases Research Centre Zambia, University Teaching Hospital Virology Laboratory Zambia, University of Zambia, The DHS Program II. Zambia Demographic and Health Survey 2013-14: Preliminary Report. Rockville, MD: 2014 September 2014.</citation>
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    <citation>Oberzaucher N, Baggaley R. HIV voluntary counselling and testing: a gateway to prevention and care. Geneva, Switzerland: UNAIDS, 2002 June, 2002.</citation>
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    <citation>Kenya National Bureau of Statistics, Ministry of Health Kenya, National AIDS Control Council, Kenya Medical Research Institute, National Council for Population and Development Kenya. Kenya Demographic and Health Survey 2014: Key Indicators. Nairobi, Kenya: 2015 March 2015.</citation>
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  <reference>
    <citation>National AIDS/STD Control Programme MoPHaS. Guidelines for HIV testing and counselling in Kenya. Nairobi: NASCOP, 2008.</citation>
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    <citation>Bloom DE. 7 billion and counting. Science. 2011 Jul 29;333(6042):562-9. doi: 10.1126/science.1209290.</citation>
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    <citation>Hogan MC, Foreman KJ, Naghavi M, Ahn SY, Wang M, Makela SM, Lopez AD, Lozano R, Murray CJ. Maternal mortality for 181 countries, 1980-2008: a systematic analysis of progress towards Millennium Development Goal 5. Lancet. 2010 May 8;375(9726):1609-23. doi: 10.1016/S0140-6736(10)60518-1. Epub 2010 Apr 9.</citation>
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    <citation>Lozano R, Wang H, Foreman KJ, Rajaratnam JK, Naghavi M, Marcus JR, Dwyer-Lindgren L, Lofgren KT, Phillips D, Atkinson C, Lopez AD, Murray CJ. Progress towards Millennium Development Goals 4 and 5 on maternal and child mortality: an updated systematic analysis. Lancet. 2011 Sep 24;378(9797):1139-65. doi: 10.1016/S0140-6736(11)61337-8. Epub 2011 Sep 19.</citation>
    <PMID>21937100</PMID>
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  <reference>
    <citation>Lindegren ML, Kennedy CE, Bain-Brickley D, Azman H, Creanga AA, Butler LM, Spaulding AB, Horvath T, Kennedy GE. Integration of HIV/AIDS services with maternal, neonatal and child health, nutrition, and family planning services. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD010119. doi: 10.1002/14651858.CD010119.</citation>
    <PMID>22972150</PMID>
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  <reference>
    <citation>Kennedy CE, Spaulding AB, Brickley DB, Almers L, Mirjahangir J, Packel L, Kennedy GE, Mbizvo M, Collins L, Osborne K. Linking sexual and reproductive health and HIV interventions: a systematic review. J Int AIDS Soc. 2010 Jul 19;13:26. doi: 10.1186/1758-2652-13-26.</citation>
    <PMID>20642843</PMID>
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  <reference>
    <citation>Spaulding AB, Brickley DB, Kennedy C, Almers L, Packel L, Mirjahangir J, Kennedy G, Collins L, Osborne K, Mbizvo M. Linking family planning with HIV/AIDS interventions: a systematic review of the evidence. AIDS. 2009 Nov;23 Suppl 1:S79-88. doi: 10.1097/01.aids.0000363780.42956.ff.</citation>
    <PMID>20081392</PMID>
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    <citation>Madon T, Hofman KJ, Kupfer L, Glass RI. Public health. Implementation science. Science. 2007 Dec 14;318(5857):1728-9. doi: 10.1126/science.1150009. No abstract available.</citation>
    <PMID>18079386</PMID>
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  <reference>
    <citation>Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C. National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health. 2012 Jul;102(7):1274-81. doi: 10.2105/AJPH.2012.300755. Epub 2012 May 17.</citation>
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  <reference>
    <citation>UNAIDS. The GAP Report. Geneva: Joint United National Programme on HIV/AIDS (UNAIDS), 2014.</citation>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>September 13, 2022</results_first_submitted>
  <results_first_submitted_qc>October 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2022</results_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Scott McClelland</investigator_full_name>
    <investigator_title>Professor, Medicine, Epidemiology, and Global Health</investigator_title>
  </responsible_party>
  <keyword>Family planning clinics</keyword>
  <keyword>Implementation Science</keyword>
  <keyword>Systems Analysis and Improvement Approach (SAIA)</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 4, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02994355/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Clinics</title>
          <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
        </group>
        <group group_id="P2">
          <title>Control Clinics</title>
          <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Data was collected at the clinic level.&#xD;
Data was collected at the clinic level.</participants>
                <participants group_id="P2" count="NA">Data was collected at the clinic level.&#xD;
Data was collected at the clinic level.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA">Data was collected at the clinic level.&#xD;
Data was collected at the clinic level.</participants>
                <participants group_id="P2" count="NA">Data was collected at the clinic level.&#xD;
Data was collected at the clinic level.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="NA"/>
                <participants group_id="P2" count="NA"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>These are descriptions of entire family planning clinics.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Clinics</title>
          <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
        </group>
        <group group_id="B2">
          <title>Control Clinics</title>
          <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="NA"/>
            <count group_id="B2" value="NA"/>
            <count group_id="B3" value="NA"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Family Planning Clinics</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B2" value="NA">Data was collected at the clinic level.</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Public Clinic</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urban Clinic</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Complete auditory privacy</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Complete visual privacy</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FP clinic manager aware of most recent National HIV Guidelines</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of FP providers trained in HTC</title>
          <units>Family Planning Clinics</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B2" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clients required to pay for HIV testing</title>
          <units>Family Planning Clinics</units>
          <param>Count of Units</param>
          <units_analyzed>Family Planning Clinics</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities</title>
        <time_frame>Months 9-12 of the study</time_frame>
        <population>Data was collected at the clinic level.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Clinics</title>
            <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
          </group>
          <group group_id="O2">
            <title>Control Clinics</title>
            <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities</title>
          <population>Data was collected at the clinic level.</population>
          <units>Percentage tested for HIV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>FP Clinics</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="NA"/>
                <count group_id="O2" value="NA"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>FP Clinics</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="26"/>
                    <measurement group_id="O2" value="32" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Poisson Regression</method>
            <param_type>Prevalence rate ratio</param_type>
            <param_value>1.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.16</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline</title>
        <time_frame>Months 9-12 of the study</time_frame>
        <population>Data was collected at the clinic level.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Clinics</title>
            <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
          </group>
          <group group_id="O2">
            <title>Control Clinics</title>
            <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline</title>
          <population>Data was collected at the clinic level.</population>
          <units>Percentage counseled for HIV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>FP Clinics</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="NA"/>
                <count group_id="O2" value="NA"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>FP Clinics</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="27"/>
                    <measurement group_id="O2" value="67" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Poisson regression</method>
            <param_type>Prevalence rate ratio</param_type>
            <param_value>1.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.15</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support</title>
        <time_frame>Months 13-24 of the study</time_frame>
        <population>Data was collected at the clinic level.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Clinics</title>
            <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
          </group>
          <group group_id="O2">
            <title>Control Clinics</title>
            <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support</title>
          <population>Data was collected at the clinic level.</population>
          <units>% tested for HIV</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <units_analyzed>FP Clinics</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="NA"/>
                <count group_id="O2" value="NA"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>FP Clinics</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61" spread="7"/>
                    <measurement group_id="O2" value="19" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Poisson regression</method>
            <param_type>Prevalence rate ratio</param_type>
            <param_value>3.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.29</ci_lower_limit>
            <ci_upper_limit>4.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <desc>All cause mortality was not assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Clinics</title>
          <description>Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.&#xD;
Systems Analysis and Improvement Approach: 1. Understanding the cascade from FP clinic enrollment to HIV testing 2. Use process mapping to identify modifiable bottlenecks 3. Define and implement workflow adaptations to eliminate modifiable bottlenecks 4. Monitor change in performance 5. Repeat the analysis and improvement cycle (steps 1-4)</description>
        </group>
        <group group_id="E2">
          <title>Control Clinics</title>
          <description>Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>First, increases in HTC could not be independently verified through direct observation of HIV counseling sessions or through increases in consumption of HIV testing commodities. Second, due to collinearity, it was not possible to adjust for baseline differences in HIV testing as planned for this analysis. Lastly, this intervention focused on HIV testing, and did not extend to additional steps in the HIV prevention and care cascades.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. R. Scott McClelland</name_or_title>
      <organization>University of Washington</organization>
      <phone>+206-543-4278</phone>
      <email>mcclell@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02994355
org study id: STUDY00001851
secondary id: 1K24HD088229-01
nct id: NCT02994355
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Location: Family Planning Clinics in Mombasa County, Kenya

      Introduction:

      Integration of HIV treatment and prevention with family planning (FP) services is a promising
      approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well
      as prevention services for those who are negative. In Mombasa County, the USAID-supported
      AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to
      capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our
      overarching objective is to assess the effectiveness, costs, and budget impact of
      implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in
      FP clinics in Mombasa County.

      Methods:

      The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA
      approach versus usual procedures on rates of HIV testing in first-time attendees at 20
      intervention versus 20 control FP clinics in Mombasa County. The investigators will compare
      HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control
      facilities after an additional year, during which FP clinics in the intervention arm will be
      encouraged to continue to use the SAIA tools with minimal support from the study team as the
      Mombasa County Ministry of Health will take ownership of implementation. Lastly, the
      investigators aim to estimate the incremental cost and budget impact of applying SAIA versus
      standard of care using an activity-based approach.

      Anticipated Results:

      The investigators anticipate that SAIA will produce significant and sustained improvement in
      HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to
      control facilities. The use of a rigorous study design will provide strong evidence to guide
      integration of HIV testing into FP services in a wide range of settings. The inclusion of
      costing and budget impact analyses will assist policy makers in reaching informed decisions
      about implementation.

      Anticipated Conclusion:

      By addressing the crucial first step in the linkage of HIV and FP services, this research
      holds considerable promise for improving women's health by opening the gateway to HIV care
      and prevention.
Integration of HIV treatment and prevention with family planning (FP) services is a promising
      approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well
      as prevention services for those who are negative. The need for integration of services is
      evident in Africa, which bears a disproportionate burden of HIV, high birth rates, and
      maternal mortality. A high and increasing proportion of African women use FP services, making
      this a potentially efficient venue for reaching them.

      Testing for HIV is the gateway to care and prevention. Integrating HIV testing into FP
      clinics could open this essential gateway, decreasing stigma associated with seeking HIV
      testing while reducing costs. The antenatal setting provides a useful example. In many
      African countries, testing for HIV in antenatal clinics (ANCs) has become routine. Diagnosis
      of HIV during pregnancy has paved the way to substantial reductions in mother-to-child
      transmission of HIV and AIDS-related deaths in women of reproductive age. These achievements
      demonstrate the feasibility and impact of wide-scale HIV testing through existing
      reproductive health services. In contrast to ANCs, integration of HIV testing into FP
      services remains at a formative stage in much of Africa. Recent reviews support the
      feasibility of integrating these services, but invariably conclude that additional research
      is needed.

      In Kenya, the National AIDS and STD Control Program (NASCOP) states that the FP clinic is a
      setting in which, "Failure to offer HIV testing and counseling is unacceptable, and will be
      considered negligent." However, there has been almost no operational assessment of HIV
      testing in Kenyan FP clinics. In Mombasa County, the USAID-supported AIDS Population and
      Health Integrated Assistance II Program revised the FP Clinic Register to capture HIV testing
      in 2008. However, the rate of HIV testing in FP clinics remains low, and the County has
      requested our assistance in addressing this prevention gap. Colleagues at the University of
      Washington Department of Global Health have developed a systems analysis and performance
      enhancement approach, using industrial and systems engineering techniques, that the
      investigators believe will be useful in this setting. The overarching objective is to assess
      the effectiveness, costs, and budget impact of implementing this systems analysis and
      improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County. The
      investigators specific aims are as follows:

      AIM 1: To conduct a cluster-randomized trial comparing the effect of the SAIA approach versus
      usual procedures on rates of HIV testing in first-time attendees at 12 intervention versus 12
      control FP clinics in Mombasa County, Kenya.

      HYP 1: After one year of study team support implementing SAIA vs. usual procedures, a higher
      proportion of first-time FP clinic attendees will be tested for HIV at intervention compared
      to control facilities

      AIM 2: To determine whether the SAIA training results in a lasting effect, the investigators
      will compare HIV testing rates for first-time FP clinic attendees in SAIA intervention versus
      control facilities after an additional year, during which FP clinics in the intervention arm
      will be encouraged to continue to use the SAIA tools with minimal support from the study
      team. The Mombasa County Ministry of Health will take ownership of implementation during this
      phase.

      HYP 2: After an additional year with minimal support from the study team, there will continue
      to be significantly higher rates of HIV testing in first-time FP clinic attendees at
      intervention compared to control facilities.

      AIM 3: To estimate the incremental cost and budget impact of applying SAIA versus standard of
      care. Using an activity-based approach, the investigators will perform a costing analysis,
      estimating cost per new HIV diagnosis, both during active support from the study team and
      after a period without active support. The investigators will also estimate cost to scale up,
      and conduct a budget impact analysis from a Department of Health (DOH) perspective.

      Expected Outcome and Significance:

      The investigators anticipate that the SAIA approach will produce significant and sustained
      improvement in HIV-testing rates in first-time FP clinic attendees in intervention clinics
      compared to control facilities. The use of a rigorous study design to evaluate this scalable
      approach will provide strong evidence to guide integration of HIV testing into FP services in
      a wide range of settings. The inclusion of costing and budget impact analyses will assist
      policy makers in reaching informed decisions about implementation. By addressing the crucial
      first step in the linkage of HIV and FP services, this research holds considerable promise
      for improving women's health by opening the gateway to HIV care and prevention. Preliminary
      data on linkage to care and prevention services will inform development of future grant
      proposals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities
time frame: Months 9-12 of the study
measure: Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline
time frame: Months 9-12 of the study
measure: Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support
time frame: Months 13-24 of the study
arm group label: Intervention Clinics
arm group type: Experimental
description: Clinics randomized to the intervention will be introduced to the Systems Analysis and Improvement Approach (SAIA) to understand barriers to HIV testing in family planning clinics. Sequential process flow mapping will be used to highlight areas for improvement and then specific interventions will be implemented for the clinics with the goal of increasing HIV testing rates.
arm group label: Control Clinics
arm group type: No Intervention
description: Clinics randomized to the control arm of the study will continue HIV testing as per usual procedures.
intervention type: Other
intervention name: Systems Analysis and Improvement Approach
description: Understanding the cascade from FP clinic enrollment to HIV testing
Use process mapping to identify modifiable bottlenecks
Define and implement workflow adaptations to eliminate modifiable bottlenecks
Monitor change in performance
Repeat the analysis and improvement cycle (steps 1-4)
arm group label: Intervention Clinics
other name: SAIA
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Raymond S McClelland, MD, MPH
role: Principal Investigator
affiliation: Professor of Medicine, Epidemiology, Global Health
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country: Kenya
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PMID: 20382417
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responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Scott McClelland
investigator title: Professor, Medicine, Epidemiology, and Global Health
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: First, increases in HTC could not be independently verified through direct observation of HIV counseling sessions or through increases in consumption of HIV testing commodities. Second, due to collinearity, it was not possible to adjust for baseline differences in HIV testing as planned for this analysis. Lastly, this intervention focused on HIV testing, and did not extend to additional steps in the HIV prevention and care cascades.
point of contact: 