NCT02027519|Completed
Enhanced HIV Prevention in Couples: Feasibility Study #3
EPIC
Enhanced HIV Prevention in Serodiscordant Couples Study #3: Feasibility of Home-based Partner Self Testing for HIV
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EPIC
Enhanced HIV Prevention in Serodiscordant Couples Study #3: Feasibility of Home-based Partner Self Testing for HIV
Sponsor study identifier
Secondary identifiers
NIH
observational
53
1 country
2
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)The purpose of this study is to gather information needed to develop a large prevention trial to decrease risk for Human Immunodeficiency Virus (HIV) transmission among HIV-discordant couples (where one person is HIV-positive and the other is HIV-negative) in Lesotho. The protocol team would like to explore new strategies for increasing the number of partners who receive an HIV test and whether this increase in testing also results in identifying HIV-discordant couples. These couples would be the focus of the future large prevention trial, therefore it is critical that the protocol team explore effective strategies for identifying and recruiting these couples. Men and women (index participants) who are attending Antenatal Care (ANC),Tuberculosis (TB) and antiretroviral therapy (ART) clinics will be recruited for this study. If they agree to take part, a testing team will visit their household and offer all adults staying in the house the opportunity to conduct a self-test for HIV. Seventy-five index participants will be enrolled into the study and have their homes visited by the testing team. The number of household members tested will depend on the number of people living in each household.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2, 2014
Actual (reported)January 6, 2014
Actual (reported)May 2014
Actual (reported)May 2014
Actual (reported)Number of partners tested
Consistent with the primary study objectives of this study, we will evaluate the feasibility of a home-based HIV self-testing strategy by monitoring the number of partners being tested for HIV.
9 months
Number of household members tested
Consistent with the primary study objectives of this study, we will evaluate the feasibility of a home-based HIV self-testing strategy by monitoring the number of members of the index participants' households being tested for HIV.
9 months
Number of sero-discordant couples identified
We will evaluate the effectiveness of a home-based HIV self-testing strategy by tracking the number of HIV-serodiscordant couples that are identified throughout this study.
9 months
Index participants who have tested positive for HIV will be provided with information regarding the importance of HIV testing for their partners and other household members and the role of home-based self-testing in potentially increasing the number of partners and household members tested for HIV. In addition, index participants will be counseled about ways in which to talk to partners and household members about HIV testing and provided with information sheets that can be distributed within the household. Lastly, index participants will be introduced to a member of the "testing team" that will present at their home and offer the study intervention.
Partners of the index participants and other household members will be offered HIV self-testing by the mobile "testing team". Those who consent to HIV self-testing with SCT confirmation will complete the following procedures: * Undergo standardized pre-test counseling and demonstration of use of HIV rapid test kit by trained study staff, including how to determine test results * Self-administer HIV rapid test and read test results * Provide study staff with self-testing result * Undergo confirmatory testing as well as post-test counseling by study staff (SCT) if the initial self-test is positive, there is any doubt about the results, or the test reveals couple discordance
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pregnant and postpartum women already tested for HIV and known to be HIV-infected attending participating antenatal clinics. Men and women already tested for HIV and known to be HIV infected receiving care and treatment at participating TB and/or ART clinics.
Mafeteng Hospital
Mafeteng, Lesotho
Ntseke Hospital
Mohale's Hoek, Lesotho
HIV rapid tests will be conducted using self-collected oral mucosa transudate. These tests use oral fluid and do not require blood drawing. Oral swab samples will not be stored. Following the completion of the self-testing, study staff will conduct confirmatory standard HIV testing. Following self-testing procedures, confirmatory rapid testing will be conducted using whole blood finger-stick. Blood samples from confirmatory tests will not be stored. If there is a discrepancy between the two tests, the individual will be counseled and referred for re-test in 4-6 weeks.
Wafaa M El-Sadr, MD/MPH
ICAP-NY, Columbia University
53 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2014
First Posted
January 6, 2014
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
September 30, 2014
Record last verified: 2014-09
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Source: ClinicalTrials.gov.
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