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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014