NCT02027441|Completed
Enhanced Prevention in Couples: Feasibility Study #2
EPIC
Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2
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EPIC
Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2
Sponsor study identifier
Secondary identifiers
NIH
observational
191
1 country
2
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2013
Actual (reported)Study Completion
September 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 (ANC) and Tuberculosis (TB) 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 receive an HIV test. Three hundred 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.
September 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.
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2013
Actual (reported)November 19, 2013
Actual (reported)January 6, 2014
Actual (reported)September 2014
Actual (reported)Number of partners tested
Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of partners being tested for HIV, the number of partners tested will be assessed.
12 months
Number of household members tested
Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of household members being tested for HIV, the number of household members tested will be assessed over the course of this study.
12 months
Number of HIV-serodiscordant couples identified
Consistent with the primary study objectives to evaluate the effectiveness of a home-based HIV testing strategy to identify HIV-serodiscordant couples, we will document the number of HIV-serodiscordant couples identified over the course of this study.
12 months
At enrollment, consenting index participants will provide the study staff with locator information and a complete list of individuals currently living in his/her home who may be eligible for home-based HIV testing intervention (Household Composition form). The study staff and index participant will schedule a date/time for the study staffto visit the index participant's home. Study staff will also provide the index participant with an information sheet to give to household members. A study testing team comprised of trained counselors and interviewers will visit the index participant's home on the pre-determined date/time and offer home-based HIV testing to those household members who are present.
Individuals who opt for standard counseling and testing will complete the following procedures: • Standardized pre- and post-test counseling and HIV testing using HIV rapid test per approved national guidelines
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 attending participating antenatal clinics. Men and women already tested for HIV receiving care and treatment at participating TB clinics. This study will recruit women attending ANC and men and women attending TB clinics. All men and women recruited for the study will have already been tested for HIV and received their test results. These facilities were selected as entry points for the study as these clinics are locations where large numbers of individuals are offered HIV testing and become engaged in HIV prevention and/or care and treatment services.
Mafeteng Hospital
Mafeteng, Lesotho
Ntsekhe Hospital
Mohale's Hoek, Lesotho
HIV rapid tests will also be conducted using whole blood finger-stick.Blood will be collected specifically for this study. Specimens will not be stored. All rapid HIV test kits will be labeled using a unique participant identification number. Participant names will not be included on the label.
Wafaa M El-Sadr, MD/MPH
ICAP-NY, Columbia University
191 participants (actual enrollment reported by the registry).
First Submitted
November 19, 2013
First Posted
January 6, 2014
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2013
Actual (reported)Study Completion
September 2014
Actual (reported)Last Updated
March 24, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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