Human Immunodeficiency Virus (HIV)EPICNCT02027441
Enhanced Prevention in Couples: Feasibility Study #2
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 2 sites in Lesotho.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
- What is being tested?
- Standard Counseling and Testing
- How many people
- 191 participants
- Where
- 2 sitesLesotho
- Study dates
- Sep 2012to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant and postpartum women already tested for HIV attending participating antenatal clinics. Men and women already tested for HIV receiving care and treatment at participating TB clinics. This study will recruit women attending ANC and men and women attending TB clinics. All men and women recruited for the study will have already been tested for HIV and received their test results. These facilities were selected as entry points for the study as these clinics are locations where large numbers of individuals are offered HIV testing and become engaged in HIV prevention and/or care and treatment services.
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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.
Read the 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:
- 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.
- Being tested
- Standard Counseling and Testing
- Keywords
- Serodiscordant, Lesotho, Home-based testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Counseling and TestingOther
Also called SCT
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
| Study group | Role | What they receive |
|---|---|---|
| Home-based Testing | 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. Receives: Other: Standard Counseling and Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wafaa Mahmoud El-Sadr, Columbia University
- Investigators
- Wafaa M El-Sadr, MD/MPH, Principal investigator, ICAP-NY, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027441
- Sponsor's protocol ID
- AAAK4101
- Other IDs
- 5R01AI083038
- Acronym
- EPIC
- Status last verified
- Mar 2015
- First submitted
- 19 Nov 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced HIV Prevention in Serodiscordant Couples in Lesotho: Feasibility Study #2
- ClinicalTrials.gov ID
- NCT02027441
- Acronym / sponsor ID
- EPIC / AAAK4101
- Keywords
- Serodiscordant, Lesotho, Home-based testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based Testing | – | Other: Standard Counseling and TestingAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant and postpartum women already tested for HIV attending participating antenatal clinics. Men and women already tested for HIV receiving care and treatment at participating TB clinics. This study will recruit women attending ANC and men and women attending TB clinics. All men and women recruited for the study will have already been tested for HIV and received their test results. These facilities were selected as entry points for the study as these clinics are locations where large numbers of individuals are offered HIV testing and become engaged in HIV prevention and/or care and treatment services.
Key inclusion criteria (18 listed)
- Index Participant
- Women and men at least 18 years of age
- Known HIV status
- 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
Key exclusion criteria (3 listed)
- Individuals who do not meet the inclusion criteria outlined above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Counseling and TestingAlso: SCTIndividuals 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 | Home-based Testing |
Primary outcome
Number of partners tested
Time frame: 12 months
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wafaa M El-Sadr, MD/MPH principal investigator
ICAP-NY, Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS), run by Columbia University at 2 sites in Lesotho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of partners tested (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.