Enhanced HIV Prevention in Couples: Feasibility Study #3 (EPIC)
|ClinicalTrials.gov Identifier: NCT02027519|
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : September 30, 2014
|Condition or disease||Intervention/treatment|
|Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS)||Other: HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation|
In Lesotho, a country with estimated 16% discordance among heterosexual couples, reaching male partners and couples in order to engage them in HIV testing to enable identiﬁcation of discordant couples is an important ﬁrst step for any HIV prevention and treatment efforts.
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:
- To evaluate the feasibility and acceptability of home-based self-testing for HIV testing of partners of index participants
- To evaluate the effectiveness of home-based partner self-testing strategies to identify HIV-discordant couples
- 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.
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||Enhanced HIV Prevention in Serodiscordant Couples Study #3: Feasibility of Home-based Partner Self Testing for HIV|
|Study Start Date :||December 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
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.
Other: 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:
Other Name: Self-testing with SCT
- Number of partners tested [ Time Frame: 9 months ]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.
- Number of household members tested [ Time Frame: 9 months ]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.
- Number of sero-discordant couples identified [ Time Frame: 9 months ]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.
Biospecimen Retention: None Retained
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027519
|Mohale's Hoek, Lesotho|
|Principal Investigator:||Wafaa M El-Sadr, MD/MPH||ICAP-NY, Columbia University|