NCT02027441

Enhanced Prevention in Couples: Feasibility Study #2

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 191 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2014-09-01
• First posted: 2014-01-06
• Last updated: 2015-03-24

Locations

2 sites across 1 country: Lesotho