An observational study in Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), sponsored by Columbia University. Completed at 2 sites in Lesotho. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-30.
Sponsored by Columbia University · Observational
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.
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 self-testing of partners and household members of individuals recruited from select Antenatal Care (ANC), Tuberculosis (TB) and antiretroviral therapy (ART) clinics in Lesotho. This study uses an observational design to evaluate the feasibility and acceptability of home-based self-testing for HIV testing of partners and the effectiveness of this intervention to identify HIV discordant couples. It is hypothesized that a home-based self-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:
Seventy-five men and women (index participants) will be recruited from antenatal, TB and ART clinics. HIV testing teams will visit index participant households and offer home-based HIV testing to all adult household members.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 53 is below the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Index Participant
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)
Household Members
Guests who stayed at the household the night before will also be offered participation
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
The record gives a start of Dec 2013, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →