Human Immunodeficiency Virus (HIV) Clinical Trial
Official title:
Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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