Enhanced HIV Prevention in Couples: Feasibility Study #3 (EPIC)

This study is currently recruiting participants.
Verified January 2014 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wafaa Mahmoud El-Sadr, Columbia University
ClinicalTrials.gov Identifier:
NCT02027519
First received: January 2, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Other: HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Enhanced HIV Prevention in Serodiscordant Couples Study #3: Feasibility of Home-based Partner Self Testing for HIV

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of partners tested [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 75
Study Start Date: December 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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:

  • 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 Name: Self-testing with SCT

Detailed Description:

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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

Index Participant

  • 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

Exclusion Criteria:

  • Individuals who do not meet the inclusion criteria outlined above
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027519

Contacts
Contact: Wafaa M El-Sadr, MD/MPH 212-342-0505 wme1@columbia.edu
Contact: Allison Zerbe, MPH 212-342-3154 az2258@columbia.edu

Locations
Lesotho
Mafeteng Hospital Recruiting
Mafeteng, Lesotho
Ntseke Hospital Recruiting
Mohale's Hoek, Lesotho
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Wafaa M El-Sadr, MD/MPH ICAP-NY, Columbia University
  More Information

No publications provided

Responsible Party: Wafaa Mahmoud El-Sadr, Director, ICAP, Columbia University
ClinicalTrials.gov Identifier: NCT02027519     History of Changes
Other Study ID Numbers: AAAM6800, 5R01AI083038
Study First Received: January 2, 2014
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Self-testing
Home-based testing
Lesotho
Discordant

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014