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Enhanced HIV Prevention in Couples: Feasibility Study #3

NCT02027519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 53

Last updated 2014-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Human Immunodeficiency Virus (HIV)
  • Acquired Immune Deficiency Syndrome (AIDS)

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Wafaa M El-Sadr, MD/MPH · ICAP-NY, Columbia University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Lesotho

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02027519 on ClinicalTrials.gov