NCT01620073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

June 12, 2012

Last Update Submit

August 27, 2013

Conditions

Keywords

Male partnerHIV counseling and testingHome basedPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Partner friendly arm

OTHER

Proportion of males counseled and tested using routine standards of prenatal care

Other: HIV counseling and testing

Home based arm

EXPERIMENTAL

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

Interventions

Male partner HIV counseling and testing

Home based armPartner friendly arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women and their male partners

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ahero Sub-District Hospital, Nyando, Kenya

Kisumu, Nyanza, 254, Kenya

Location

Ahero Sub-District Hospital

Kisumu, Nyanza, 254, Kenya

Location

Related Publications (2)

  • Osoti AO, John-Stewart G, Kiarie JN, Barbra R, Kinuthia J, Krakowiak D, Farquhar C. Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study. BMC Infect Dis. 2015 Jul 30;15:298. doi: 10.1186/s12879-015-1053-2.

  • 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.

Study Officials

  • Alfred O Osoti, MBChB MMed

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations