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Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620073
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Alfred Osoti MBChB MMed, University of Washington

Study Description
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Brief Summary:

The investigators hypothesize that home based HIV counseling and testing can increase male partner uptake of HIV testing during pregnancy.

The investigators study aims through a randomized clinical trial to determine whether a home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake of HIV counseling and testing during pregnancy.


Condition or disease Intervention/treatment Phase
Male Partner HIV Counseling and Testing Home Based Pregnancy Other: HIV counseling and testing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial
Study Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Partner friendly arm
Proportion of males counseled and tested using routine standards of prenatal care
 Other: HIV counseling and testing
Male partner HIV counseling and testing
Experimental: Home based arm
Proportion of male partners accepting HIV counseling and testing following home visits for couple HIV counseling and testing during pregnancy
 Other: HIV counseling and testing
Male partner HIV counseling and testing


Outcome Measures
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Primary Outcome Measures :
  1. Number of Male Partners Counseled and Tested for HIV During Pregnancy [ Time Frame: 6 weeks ]
    To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women and their male partners

Exclusion Criteria:

  • Non-pregnant, minors, inability to live in study area for 6 weeks
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620073


Locations
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Kenya
Ahero Sub-District Hospital, Nyando, Kenya
Kisumu, Nyanza, Kenya, 254
Ahero Sub-District Hospital
Kisumu, Nyanza, Kenya, 254
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Alfred O Osoti, MBChB MMed University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alfred Osoti MBChB MMed, Doctor, University of Washington
ClinicalTrials.gov Identifier: NCT01620073    
Other Study ID Numbers: 42561
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Alfred Osoti MBChB MMed, University of Washington:
Male partner
HIV counseling and testing
Home based
Pregnancy