Enhanced HIV Prevention in Couples: Feasibility Study #3

NCT02027519 | Completed

• 2 other identifiers: AAAM68005R01AI083038
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Self-testing; Home-based testing; Lesotho; Discordant

Outcome Measures

Primary Outcomes (3)

• Number of partners tested

  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.

  9 months

• Number of household members tested

  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.

  9 months

• Number of sero-discordant couples identified

  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.

  9 months

Study Arms (1)

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

Interventions

HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation OTHER

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

Also known as: Self-testing with SCT

Home-based Self-testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Mafeteng Hospital

Mafeteng, Lesotho

Location

Ntseke Hospital

Mohale's Hoek, Lesotho

Location

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.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Self-Testing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Self Care; Therapeutics

Study Officials

• Wafaa M El-Sadr, MD/MPH

  ICAP-NY, Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, ICAP

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 6, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

LE (2)