Sexually Transmitted DiseasesNCT01829282
Eban II: Intervention for HIV Sero-Discordant Couples
A study testing Risk Reduction in people with Sexually Transmitted Diseases and Disease Transmission, Infectious, run by University of California, Los Angeles at 8 sites in United States.
Trial summary
This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Disease Transmission, Infectious, Safe Sex
- What is being tested?
- Risk Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2012to Jun 2017
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be in a relationship with study partner for at least 3 months
- Both partners must be 18 years or older
- At least one partner must identify as African American/Black
- One partner must be HIV positive and one partner must be HIV negative
- Must be a heterosexual couple (one biological female and one biological man)
- Not currently expecting a child and not planning on having children within the year.
Who cannot join
- Less than 18 years old
- No partner
- Couple is not heterosexual
- Insufficient relationship length/commitment
- No reported incidents of unprotected intercourse in the past 90 days
- Neither partner is African American/Black
Show all 11Show fewer
- One/both partners unaware of others HIV status
- Couple is not serodiscordant
- One/both partners reported partner violence
- HIV diagnosis received recently (less than 3 months)
- One/both partners participated in a HIV Risk Reduction study within the past 12 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
Tarzana Treatment Centers
Long Beach, California, 90806
- Not yet recruiting
AIDS Project Los Angeles
Los Angeles, California, 90005
- Not yet recruiting
AIDS Healthcare Foundation
Los Angeles, California, 90015
- Not yet recruiting
O.A.S.I.S. Clinic
Los Angeles, California, 90059
- Recruiting
HIV Education & Prevention Project of Alameda County
Oakland, California, 94601
Melissa Struzzo, MPH, mstruzzo@casasegura.org
- Not yet recruiting
CAL-PEP
Oakland, California, 94608
- Not yet recruiting
Allen Temple
Oakland, California, 94612
- Not yet recruiting
Women Organized to Respond to Life-Threatening Disease
Oakland, California, 94612
About this study
Official title: Implementing Eban II: An Evidence-Based Intervention for HIV Sero-Discordant Couples
This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans.
The Specific Aims are as follows:
- To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information.
- To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.)
- To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.
Read the detailed description
The HIV/AIDS epidemic continues to disproportionately affect African Americans. The rate of HIV among African American men is six times the rate for White men and the rate among African American women is almost 15 times the rate for White women. An estimated 56,300 new HIV cases was reported in 2006, of which 49% were among African Americans and 80% were from heterosexual transmission. Sexually transmitted infections (STIs) also disproportionately affect African Americans, further increasing the risk for HIV transmission. Despite the fact that HIV and STIs are primarily transmitted in the context of relationships, few interventions address HIV risk in couples. Furthermore, few evidence-based HIV prevention interventions have been implemented in community-based organizations (CBOs). Thus, there is a substantial need to strengthen the availability and use of relationship oriented prevention interventions in community-based treatment settings.
This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans.
This study builds upon the multi-site, NIMH-funded "Eban" (a Yoruba term for "fence") trial, which tested this culturally congruent intervention versus a control condition among 535 heterosexual HIV serodiscordant couples in four cities. Couples in the intervention had significantly reduced incidents of unprotected sex and an increased proportion of condom use compared to couples in the control condition. Statistical projections from that study suggest that if Eban participants had not received the intervention, six female and four males would have been infected in one year, and 25 females and 15 males would have become HIV-infected in the next 5 years. Based on these successful outcomes in a controlled trial, it is now appropriate to test the effectiveness of the intervention as delivered in community-based setting. Thus, we propose to conduct a study of implementation - a study of methods to promote the uptake of Eban into community-based organizations (CBOs).
The Specific Aims are as follows:
- To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information.
- To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.)
- To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.
So please note, there are essentially two levels to this study -- first to see how well community agencies can implement or take up and execute the intervention (thus, the interviews with staff) - and the second, to see how effective Eban is in real world setting. We know it was highly effective in a controlled study but now we need to test how well it works in the "real" world(thus, the testing of the intervention with 180 couples). While doing this, we will also be examining the cost-effectiveness of the intervention in the "real" world setting.
- Being tested
- Risk Reduction
- Keywords
- Implementation, HIV, serodiscordant couples, African American, Cultural congruency
- Medical subject headings
- Sexually Transmitted Diseases, Communicable Diseases, Safe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk ReductionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Risk Reduction | Experimental | The Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following:
* Provide HIV and STI test results
* First Interview
* Attend 8 sessions - 1 session per week
* Second interview occurs immediately following the 8th session with HIV and STI tests
* Third interview occurs 3 months after the 8th session with HIV and STI tests Receives: Behavioral: Risk Reduction |
| Waitlist | Active comparator | The Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention.
* Provide HIV and STI test results
* First Interview
* No sessions for 8 weeks
* Second interview and proof of HIV and STI status occurs after the 8 weeks from when you were enrolled
* Third interview occurs 3 months after the 8th session with HIV and STI tests The Waitlist Group will then be invited to participate in the Risk Reduction group activities.
* Attend 8 sessions - 1 session per week
* Fourth interview occurs immediately after the 8th session with HIV and STI tests
* Fifth interview occurs 3 months after the 8th session with HIV and STI tests Receives: Behavioral: Risk Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Sex
Proportion of unprotected acts of sex.
Measured: within 3 months of completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJul 2012
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gail Wyatt, University of California, Los Angeles
- Investigators
- Gail E Wyatt, PhD, Principal investigator, University of California, Los AngelesJohn Williams, MD, Study director, University of California, Los AngelesBrian Mittman, PhD, Study director, VA Office of Research and DevelopmentAlison Hamilton, PhD, Study director, University of California, Los AngelesHector Myers, PhD, Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829282
- Sponsor's protocol ID
- 3294930
- Other IDs
- R01MH093230-01
- Status last verified
- Feb 2016
- First submitted
- 8 Apr 2013
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Eban II: An Evidence-Based Intervention for HIV Sero-Discordant Couples
- ClinicalTrials.gov ID
- NCT01829282
- Acronym / sponsor ID
- 3294930
- Keywords
- Implementation, HIV, serodiscordant couples, African American, Cultural congruency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2012
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Apr 2013 (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.
This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans.
The Specific Aims are as follows:
- To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information.
- To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.)
- To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.
Detailed description
The HIV/AIDS epidemic continues to disproportionately affect African Americans. The rate of HIV among African American men is six times the rate for White men and the rate among African American women is almost 15 times the rate for White women. An estimated 56,300 new HIV cases was reported in 2006, of which 49% were among African Americans and 80% were from heterosexual transmission. Sexually transmitted infections (STIs) also disproportionately affect African Americans, further increasing the risk for HIV transmission. Despite the fact that HIV and STIs are primarily transmitted in the context of relationships, few interventions address HIV risk in couples. Furthermore, few evidence-based HIV prevention interventions have been implemented in community-based organizations (CBOs). Thus, there is a substantial need to strengthen the availability and use of relationship oriented prevention interventions in community-based treatment settings.
This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans.
This study builds upon the multi-site, NIMH-funded "Eban" (a Yoruba term for "fence") trial, which tested this culturally congruent intervention versus a control condition among 535 heterosexual HIV serodiscordant couples in four cities. Couples in the intervention had significantly reduced incidents of unprotected sex and an increased proportion of condom use compared to couples in the control condition. Statistical projections from that study suggest that if Eban participants had not received the intervention, six female and four males would have been infected in one year, and 25 females and 15 males would have become HIV-infected in the next 5 years. Based on these successful outcomes in a controlled trial, it is now appropriate to test the effectiveness of the intervention as delivered in community-based setting. Thus, we propose to conduct a study of implementation - a study of methods to promote the uptake of Eban into community-based organizations (CBOs).
The Specific Aims are as follows:
- To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information.
- To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.)
- To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.
So please note, there are essentially two levels to this study -- first to see how well community agencies can implement or take up and execute the intervention (thus, the interviews with staff) - and the second, to see how effective Eban is in real world setting. We know it was highly effective in a controlled study but now we need to test how well it works in the "real" world(thus, the testing of the intervention with 180 couples). While doing this, we will also be examining the cost-effectiveness of the intervention in the "real" world setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Reduction | Experimental | Behavioral: Risk ReductionThe Risk Reduction group will receive the Eban II Intervention upon enrollment. This group will do the following: * Provide HIV and STI test results * First Interview * Attend 8 sessions - 1 session per week * Second interview occurs immediately following the 8th session with HIV and STI tests * Third interview occurs 3 months after the 8th session with HIV and STI tests |
| Waitlist | Active comparator | Behavioral: Risk ReductionThe Waitlist group will receive the same intervention after waiting for the Risk Reduction group to complete the entire intervention. * Provide HIV and STI test results * First Interview * No sessions for 8 weeks * Second interview and proof of HIV and STI status occurs after the 8 weeks from when you were enrolled * Third interview occurs 3 months after the 8th session with HIV and STI tests The Waitlist Group will then be invited to participate in the Risk Reduction group activities. * Attend 8 sessions - 1 session per week * Fourth interview occurs immediately after the 8th session with HIV and STI tests * Fifth interview occurs 3 months after the 8th session with HIV and STI tests |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must be in a relationship with study partner for at least 3 months
- Both partners must be 18 years or older
- At least one partner must identify as African American/Black
- One partner must be HIV positive and one partner must be HIV negative
- Must be a heterosexual couple (one biological female and one biological man)
Key exclusion criteria (11 listed)
- Less than 18 years old
- No partner
- Couple is not heterosexual
- Insufficient relationship length/commitment
- No reported incidents of unprotected intercourse in the past 90 days
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 |
|---|---|---|
| Risk Reduction | Behavioural | Risk Reduction, Waitlist |
Primary outcome
Safe Sex
Time frame: within 3 months of completion of the intervention
Proportion of unprotected acts of sex.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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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.
Gail E Wyatt, PhD principal investigator
University of California, Los Angeles
John Williams, MD study director
University of California, Los Angeles
Brian Mittman, PhD study director
VA Office of Research and Development
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Reduction in people with Sexually Transmitted Diseases and Disease Transmission, Infectious, run by University of California, Los Angeles at 8 sites in United States.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia M Eccles, MPH (310-794-9227, aeccles@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe Sex (time frame: within 3 months of completion of the intervention). 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 10 Feb 2016.