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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfred Osoti MBChB MMed, University of Washington
ClinicalTrials.gov Identifier:
NCT01620073
First received: June 12, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention
Male Partner
HIV Counseling and Testing
Home Based
Pregnancy
Other: HIV counseling and testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Number of Male Partners Counseled and Tested for HIV During Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman.


Enrollment: 488
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620073

Locations
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
Principal Investigator: Alfred O Osoti, MBChB MMed University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfred Osoti MBChB MMed, Doctor, University of Washington
ClinicalTrials.gov Identifier: NCT01620073     History of Changes
Other Study ID Numbers: 42561
Study First Received: June 12, 2012
Last Updated: August 27, 2013
Health Authority: Kenya: Ethical Review Committee

Keywords provided by University of Washington:
Male partner
HIV counseling and testing
Home based
Pregnancy

ClinicalTrials.gov processed this record on April 15, 2014