Enhanced Prevention in Couples: Feasibility Study #2 (EPIC)
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.
Human Immunodeficiency Virus (HIV)
Acquired Immune Deficiency Syndrome (AIDS)
Other: Standard Counseling and Testing
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2|
- Number of partners tested [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Number of household members tested [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Number of HIV-serodiscordant couples identified [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
Biospecimen Retention: None Retained
HIV rapid tests will also be conducted using whole blood ﬁnger-stick.Blood will be collected speciﬁcally for this study. Specimens will not be stored. All rapid HIV test kits will be labeled using a unique participant identiﬁcation number. Participant names will not be included on the label.
|Study Start Date:||September 2012|
|Study Completion Date:||September 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
At enrollment, consenting index participants will provide the study staff with locator information and a complete list of individuals currently living in his/her home who may be eligible for home-based HIV testing intervention (Household Composition form).
The study staff and index participant will schedule a date/time for the study staffto visit the index participant's home. Study staff will also provide the index participant with an information sheet to give to household members.
A study testing team comprised of trained counselors and interviewers will visit the index participant's home on the pre-determined date/time and offer home-based HIV testing to those household members who are present.
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
Other Name: SCT
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:
- To evaluate the feasibility and acceptability of home-based testing for HIV testing of partners of index participants
- To evaluate the effectiveness of home-based partner testing strategies to identify HIV-serodiscordant couples
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02027441
|Mohale's Hoek, Lesotho|
|Principal Investigator:||Wafaa M El-Sadr, MD/MPH||ICAP-NY, Columbia University|