Eban II: Intervention for HIV Sero-Discordant Couples

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:

1. 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.

2. 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.)

3. 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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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