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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS HIV/AIDS and Pregnancy

U.S. FDA Resources

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
Kisumu, Nyanza, Kenya, 254
Ahero Sub-District Hospital, Nyando, Kenya
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):

Osoti AO, John-Stewart G, Kiarie J, Richardson B, Kinuthia J, Krakowiak D, Farquhar C. Home visits during pregnancy enhance male partner HIV counselling and testing in Kenya: a randomized clinical trial. AIDS. 2014 Jan 2;28(1):95-103. doi: 10.1097/QAD.0000000000000023.


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 February 27, 2015

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