Enhanced HIV Prevention in Couples: Feasibility Study #3
NCT ID: NCT02027519
Last Updated: 2014-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2013-12-31
2014-05-31
Brief Summary
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Detailed Description
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This is a feasibility study of the use of home-based HIV self-testing of partners and household members of individuals recruited from select Antenatal Care (ANC), Tuberculosis (TB) and antiretroviral therapy (ART) clinics in Lesotho. This study uses an observational design to evaluate the feasibility and acceptability of home-based self-testing for HIV testing of partners and the effectiveness of this intervention to identify HIV discordant couples. It is hypothesized that a home-based self-testing intervention will increase the number of partners testing for HIV and will result in increased identification of newly diagnosed HIV-discordant couples, the target population of the planned Enhanced Prevention in Couples (EPIC) study.
Primary objectives of this study include:
1. To evaluate the feasibility and acceptability of home-based self-testing for HIV testing of partners of index participants
2. To evaluate the effectiveness of home-based partner self-testing strategies to identify HIV-discordant couples
3. To evaluate the feasibility and acceptability of home-based self-testing for HIV testing of other household members of index participants
Seventy-five men and women (index participants) will be recruited from antenatal, TB and ART clinics. HIV testing teams will visit index participant households and offer home-based HIV testing to all adult household members.
Conditions
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Keywords
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Study Design
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CROSS_SECTIONAL
Study Groups
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Home-based Self-testing
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.
HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation
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
Interventions
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HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women and men at least 18 years of age
* Known HIV-positive status
* Receiving antenatal care or TB/ART care/treatment at participating clinics
o For men and women recruited from TB clinic: must have been on TB medications for at least 8 weeks
* Married or living with partner as if married
o Spouse must be a current member of index participant's household (i.e. married or living with the index participant, and currently residing in Lesotho)
* Willing to allow study team to visit home and offer HIV counseling and testing to partner and other household members
* Ability to speak English or Sesotho
* Willing and able to provide signed informed consent
Household Members
* A household member is defined as an individual who:
* Has been sharing a physical structure such as a compound or homestead with the index participant and who has been consuming or making some contribution to food and other shared household resources
Guests who stayed at the household the night before will also be offered participation
* Women and men at least 18 years of age
* Ability to speak English or Sesotho
* Willing and able to provide signed informed consent
* Individuals who report being HIV-infected (Household members only)
* Any condition which in the opinion of the investigators would interfere with participation in the study
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Columbia University
OTHER
Responsible Party
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Wafaa Mahmoud El-Sadr
Director, ICAP
Principal Investigators
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Wafaa M El-Sadr, MD/MPH
Role: PRINCIPAL_INVESTIGATOR
ICAP-NY, Columbia University
Locations
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Mafeteng Hospital
Mafeteng, , Lesotho
Ntseke Hospital
Mohale's Hoek, , Lesotho
Countries
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Other Identifiers
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AAAM6800
Identifier Type: -
Identifier Source: org_study_id