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NCT01620073 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01620073
Other study ID # 42561
Secondary ID
Status Completed
Phase N/A
First received June 12, 2012
Last updated August 27, 2013
Start date July 2012
Est. completion date July 2013

Study information
Verified date August 2013
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority Kenya: Ethical Review Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 488
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Pregnant women and their male partners

Exclusion Criteria:

- Non-pregnant, minors, inability to live in study area for 6 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• HIV counseling and testing
Male partner HIV counseling and testing

Locations
Country Name City State
Kenya Ahero Sub-District Hospital Kisumu Nyanza
Kenya Ahero Sub-District Hospital, Nyando, Kenya Kisumu Nyanza

Sponsors (1)
Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Male Partners Counseled and Tested for HIV During Pregnancy To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman. 6 weeks No
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