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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

Tracking Information
First Submitted Date  ICMJE June 12, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date August 28, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01620073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy
Official Title  ICMJE Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Male Partner
  • HIV Counseling and Testing
  • Home Based
  • Pregnancy
Intervention  ICMJE Other: HIV counseling and testing
Male partner HIV counseling and testing
Study Arms  ICMJE
  • Partner friendly arm
    Proportion of males counseled and tested using routine standards of prenatal care
    Intervention: Other: 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
    Intervention: Other: HIV counseling and testing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
488
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2012)
600
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women and their male partners

Exclusion Criteria:

  • Non-pregnant, minors, inability to live in study area for 6 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620073
Other Study ID Numbers  ICMJE 42561
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alfred Osoti MBChB MMed, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfred O Osoti, MBChB MMed University of Washington
PRS Account University of Washington
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP