<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/NCT02244398</url>
  </required_header>
  <id_info>
    <org_study_id>467637</org_study_id>
    <nct_id>NCT02244398</nct_id>
  </id_info>
  <brief_title>Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda</brief_title>
  <official_title>Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FHI 360</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Uganda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>FHI 360</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the feasibility and acceptability of adding HIV&#xD;
      testing and counseling (HTC) services to the family planning (FP) services provided by&#xD;
      community health workers in Uganda.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Uganda Ministry of Health is implementing a Village Health Team strategy whereby lay&#xD;
      volunteers, called VHTs, provide a government-endorsed platform for all community-based&#xD;
      health programming. Where trained, VHTs already offered family planning services, including&#xD;
      injectable contraceptives. In this project, VHTs already providing family planning services&#xD;
      are trained to offer HIV testing and counseling services (HTC). The goal is to reach&#xD;
      individuals whose sexual and reproductive health needs may be underserved by clinic-based&#xD;
      services, while also attempting to mitigate some of the barriers to HTC like access and&#xD;
      stigma.&#xD;
&#xD;
      The study uses a two-arm post-test only randomized cluster design, with eight pair-matched&#xD;
      health centers in two districts randomly assigned to intervention or control arm. VHTs&#xD;
      supported by health centers in the intervention arm receive classroom training and supervised&#xD;
      practical experience in HTC. Supervision and commodity supply occur through health centers,&#xD;
      building on support mechanisms for family planning. External quality assurance is conducted&#xD;
      quarterly through health centers as part of program implementation. VHTs receive refresher&#xD;
      training after 8 months. VHTs in the intervention arm provide both family planning and HTC&#xD;
      services during the study period, and then return to providing family planning only at the&#xD;
      end of the project. VHTs in the control arm only provide family planning. HTC and/or family&#xD;
      planning services, as applicable, are available to all adults in the communities served by&#xD;
      the VHTs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>HIV testing attitude scale derived from Likert-scale statements in the client survey</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">292</enrollment>
  <condition>HIV Testing and Counseling</condition>
  <arm_group>
    <arm_group_label>FP and HTC services</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VHTs in the intervention arm provide both family planning and HTC services between May 2012 and September 2013, then return to providing family planning only at the end of the project. Services are made available to all adults in VHTs' communities. HIV testing is done using the national rapid testing algorithm. Clients who test positive for HIV are referred to a health center for care and treatment and receive disclosure support and information on peer support groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FP services</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VHTs in the control arm only provide family planning services.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FP and HTC services</intervention_name>
    <description>In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).</description>
    <arm_group_label>FP and HTC services</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FP services</intervention_name>
    <description>VHTs in the control arm only provide family planning services</description>
    <arm_group_label>FP services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least six months of experience providing family planning services, including&#xD;
             injectable contraceptives&#xD;
&#xD;
          -  Attached to one of the eight health centers selected for the study for supervision,&#xD;
             commodity supply, and referral management&#xD;
&#xD;
          -  All VHTs in the intervention group are trained in HTC service provision and&#xD;
             interviewed as part of the evaluation. VHTs in the control group are not interviewed.&#xD;
&#xD;
        Services (family planning and/or HTC) are made available to all adults in VHTs'&#xD;
        communities. Data collection involves a client survey. Inclusion criteria for participation&#xD;
        in the survey are:&#xD;
&#xD;
          -  Age 18 or more&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Revisit family planning clients of VHTs (will have received family planning services&#xD;
             from the VHT more than once)&#xD;
&#xD;
          -  Where this service is available, having received HTC from the VHT is not an&#xD;
             eligibility criterion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurélie Brunie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FHI 360</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FHI360 Uganda</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02244398
org study id: 467637
nct id: NCT02244398
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the feasibility and acceptability of adding HIV
      testing and counseling (HTC) services to the family planning (FP) services provided by
      community health workers in Uganda.
The Uganda Ministry of Health is implementing a Village Health Team strategy whereby lay
      volunteers, called VHTs, provide a government-endorsed platform for all community-based
      health programming. Where trained, VHTs already offered family planning services, including
      injectable contraceptives. In this project, VHTs already providing family planning services
      are trained to offer HIV testing and counseling services (HTC). The goal is to reach
      individuals whose sexual and reproductive health needs may be underserved by clinic-based
      services, while also attempting to mitigate some of the barriers to HTC like access and
      stigma.

      The study uses a two-arm post-test only randomized cluster design, with eight pair-matched
      health centers in two districts randomly assigned to intervention or control arm. VHTs
      supported by health centers in the intervention arm receive classroom training and supervised
      practical experience in HTC. Supervision and commodity supply occur through health centers,
      building on support mechanisms for family planning. External quality assurance is conducted
      quarterly through health centers as part of program implementation. VHTs receive refresher
      training after 8 months. VHTs in the intervention arm provide both family planning and HTC
      services during the study period, and then return to providing family planning only at the
      end of the project. VHTs in the control arm only provide family planning. HTC and/or family
      planning services, as applicable, are available to all adults in the communities served by
      the VHTs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions
time frame: 10 days
measure: HIV testing attitude scale derived from Likert-scale statements in the client survey
time frame: 10 days
arm group label: FP and HTC services
arm group type: Experimental
description: VHTs in the intervention arm provide both family planning and HTC services between May 2012 and September 2013, then return to providing family planning only at the end of the project. Services are made available to all adults in VHTs' communities. HIV testing is done using the national rapid testing algorithm. Clients who test positive for HIV are referred to a health center for care and treatment and receive disclosure support and information on peer support groups.
arm group label: FP services
arm group type: Active Comparator
description: VHTs in the control arm only provide family planning services.
intervention type: Other
intervention name: FP and HTC services
description: In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).
arm group label: FP and HTC services
intervention type: Other
intervention name: FP services
description: VHTs in the control arm only provide family planning services
arm group label: FP services
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aurélie Brunie, PhD
role: Principal Investigator
affiliation: FHI 360
facility: 
country: Uganda
responsible party type: Sponsor