Enhanced Prevention in Couples: Feasibility Study #2

Human Immunodeficiency Virus (HIV) Clinical Trial

— EPIC  

Official title:

Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027441
• Other study ID #: AAAK4101
• Secondary ID: 5R01AI083038
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: March 23, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 (ANC) and Tuberculosis (TB) 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 receive an HIV test.

Three hundred 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.

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 testing of partners and household members of individuals recruited from select ANC and TB clinics in Lesotho. This study uses an observational design to evaluate the feasibility and acceptability of home-based testing for HIV testing of partners and the effectiveness of this intervention to identify HIV discordant couples. It is hypothesized that a home-based 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 testing for HIV testing of partners of index participants

2. To evaluate the effectiveness of home-based partner testing strategies to identify HIV-serodiscordant couples

3. To evaluate the feasibility and acceptability of home-based testing for HIV testing of other household members of index participants Three-hundred men and women (index participants) will be recruited from antenatal and TB clinics. HIV testing teams will visit index participant households and offer home-based HIV testing to all adult household members.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: September 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Index Participant

• Women and men at least 18 years of age

• Known HIV status

• For pregnant and post-natal women recruited from the ANC: must have tested for HIV during their current or most recent pregnancy

• For men and women recruited from TB clinic: must have tested in the last 3 months

• Receiving antenatal care or TB 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

• 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:

o 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

• Any condition which in the opinion of the investigators would interfere with participation in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Standard Counseling and Testing
Individuals who opt for standard counseling and testing will complete the following procedures: • Standardized pre- and post-test counseling and HIV testing using HIV rapid test per approved national guidelines

Locations

Country	Name	City	State
Lesotho	Mafeteng Hospital	Mafeteng
Lesotho	Ntsekhe Hospital	Mohale's Hoek

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Lesotho, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of partners tested	Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of partners being tested for HIV, the number of partners tested will be assessed.	12 months	No
Primary	Number of household members tested	Consistent with the primary study objectives to evaluate the feasibility of a home-based HIV testing strategy aimed at increasing the number of household members being tested for HIV, the number of household members tested will be assessed over the course of this study.	12 months	No
Primary	Number of HIV-serodiscordant couples identified	Consistent with the primary study objectives to evaluate the effectiveness of a home-based HIV testing strategy to identify HIV-serodiscordant couples, we will document the number of HIV-serodiscordant couples identified over the course of this study.	12 months	No