The impact of HIV/AIDS in the African American community continues to be a health crisis. Although African Americans constitute approximately 12% of the US population, they represent 42.4% of people living with AIDS in the US.1 During 2000-2005, African Americans represented more than half (51%) of the 184,991 reported new cases of HIV in the 33 states with confidential name-based reporting.2
Rates of HIV/AIDS among African American men were seven times higher than those among non-Hispanic white men and three times higher than those among Hispanic men in the years 2000-2003.1
During the same period, the HIV/AIDS rate for African American women was 19 times the rate for non-Hispanic white women and five times the rate for Hispanic women.2
Of special concern is the fact that African Americans experienced a shorter interval between testing HIV positive and being diagnosed with AIDS due to a delay in seeking treatment associated with poverty and stigma.3
According to the Centers for Disease Control and Prevention, in 2001, HIV/AIDS was among the three leading causes of death for African American men aged 25-54 years, among the four leading causes of death for African American women aged 20-54 years, and the leading cause of death among African American women 25-34 years of age.4
In the four cities selected for this Trial, the HIV/AIDS prevalence per 100,000 is disproportionately higher for African Americans (27.1 in Atlanta; 25.9 in Los Angeles; 59.2 in New York City; and 24.9 in Philadelphia).5
The cumulative number of HIV/AIDS cases in the four cities represents 25% of US cases.5
The prevalence of Chlamydia, the most common of reported STDs per 100,000, was varied (726.8 in Atlanta; 407.1 in Los Angeles; 437.5 in New York City; and 1,219 in Philadelphia.5
The large proportion of HIV/STDs cases and geographic diversity represented by the four cities enhances the generalizability of the proposed study data.5
This Trial is designed for couples because heterosexual contact is the leading route of HIV transmission among African American women and the second leading transmission mode among African American men.2
Wyatt and her colleagues reported that almost three of four HIV positive African American women were infected by their husbands or steady partners.6
Studies have noted low rates of condom use among African Americans,7
African American women with steady male partners,8,9,10,11
HIV positive African American women,6 and the HIV negative partners of HIV positive African American women.11 Evidence suggests that STDs facilitate the spread of HIV.12
A person with an STD is 2-5 times more likely to be HIV positive than a person without an STD.13
A recent review of condom efficacy studies led by the National Institutes of Health found that consistent condom use reduces the probability of HIV transmission per sex act by as much as 95%. Considerable evidence suggests that behavioral interventions can reduce HIV sexual risk behavior in various populations.14
A meta-analysis of 14 behavioral HIV/STD prevention interventions among heterosexual adults found statistically significant increases in condom use and reductions in incidence of biologically confirmed STDs.15
Interventions with small groups showed more favorable effects than those with individuals.
While no couples based interventions were included in the meta-analysis, studies with couples have provided compelling descriptive evidence of the utility of interventions for dyads. In a study examining couples, Allen and colleagues offered a confidential HIV testing and condom program for 1,458 childbearing women in Rwanda.16
While not originally designed as a couples study, 26 per cent of the male partners volunteered to view the educational videotape and receive an HIV test. Couples in whom both partners were tested were twice as likely to use condoms. The man’s participation was also associated with significant reductions in HIV and gonorrhea rates among the women. Of concern was the finding that seropositive women with untested partners comprised the group least likely to use condoms, which accounts for the rate of HIV seroconversion in this group being more than twice that for women whose partners were tested and received counseling. The strongest predictors of condom use were a seropositive test result in the woman and HIV testing and counseling of the male partner. At the 2-year follow-up, HIV negative women whose partners had participated were 50% less likely to become seropositive than were those whose partners had not participated. Allen continued to corroborate these results and this program is now being supported by the Global Health Program at the Centers for Disease Control and Prevention.17
In one of the first studies to evaluate couples based voluntary counseling and testing (VCT) in the US, Padian corroborated these results in a longitudinal intervention with mixed serostatus couples.18
The intervention focused on building skills for correctly using condoms and providing social support, and included role plays for problem solving how to implement safer sex behavior strategies. Although the study lacked a control group, the data suggest that the intervention had a positive impact. The proportion of couples reporting consistent condom use increased from 49 per cent at baseline to 88 per cent at follow-up. Among those couples at the 16-month follow-up no seronegative partner had become positive.
The European Study Group on Heterosexual Transmission of HIV documented similar patterns, suggesting that condom use was associated with fewer seroconversions in 304 serodiscordant couples.19
The couples were counseled and tested for HIV every six months over 20 months. Nearly half of the couples (48.4%) used condoms consistently, and experienced no seroconversions. Among those who did not use condoms consistently, 9.9 per cent seroconverted (4.8/100 person years).
Further evidence of the utility of couples interventions comes from a study in Haiti with 476 patients with HIV and their non-infected regular sex partners, who were evaluated at 3 and 6 months for HIV infection, sexually transmitted diseases, and sexual practices.20
Counseling and free condoms were provided. Only one seroconversion occurred among the 42 sexually active couples (23.7% of the 177 sexually active couples) who reported always using condoms. In contrast, the incidence in sexually active couples who infrequently used or did not use condoms was 6.8 per 100 person years (CI, 6.49 to 7.14 per 100 person years).21
Transmission of HIV was associated with genital ulcer diseases, syphilis, and vaginal or penile discharge in the HIV negative partner and with syphilis in the HIV infected partner.
The first multi-country randomized controlled trial (RCT) to test the efficacy of VCT with couples was conducted in Nairobi, Kenya, Dar es Salaam, Tanzania, and Port of Spain, Trinidad.22
Although it was not specifically designed for couples, the trial enrolled 586 couples, and randomly assigned them to receive either a couples based VCT or a basic health information intervention. The couples assigned to VCT reduced unprotected intercourse with their enrollment partners significantly more than couples assigned to the health information group. The proportion of individuals reporting unprotected intercourse with non-primary partners declined significantly more for those receiving VCT compared to those receiving health information (men, 35% reduction with VCT vs.13% reduction with health information; women, 39% reduction with VCT vs. 17% reduction with health information) and these results were maintained at the second follow-up. Individual HIV infected men were more likely than uninfected men to reduce unprotected intercourse with primary and non-primary partners, whereas HIV infected women were more likely than infected women to reduce unprotected intercourse with primary partners.
El Bassel and colleagues conducted one of the first RCTs to test the efficacy of a relationship based HIV/STD prevention intervention with low-income urban couples in the US.23,24,25
For this study, 217 low-income urban couples at elevated risk of HIV/STDs were randomized to one of three conditions: (1) a 6-session relationship based HIV/STD prevention intervention provided to couples; (2) the same 6 sessions provided to the women alone; or (3) a 1-session HIV/STD information session provided to the women alone, which served as the control condition. The 6-session interventions for couples or women alone were efficacious in reducing unprotected sex at both the 3-and 12-month follow-up assessments. This study provides additional evidence of the sustained efficacy of a relationship based intervention for increasing condom use among low-income urban couples.
While conducted in different settings with African and West Indian samples whose history of health care access utilization differs from African American couples in the US, the findings highlight the important of involving couples in HIV prevention efforts. In addition, all of these studies have one or more of the following methodological drawbacks: not being designed specifically for couples; relatively small samples sizes; and lacking a randomized control design, biological confirmed outcomes, or an attention control group. However, accumulating research has suggested that couples based HIV prevention interventions may be more efficacious in promoting condom use among HIV serodiscordant couples than traditional HIV prevention interventions aimed at individuals or groups.16,26,27,28,29,30,31,32
Couples based approaches have been found to be associated with increasing commitment in a relationship to protecting each other from HIV/STDs, reducing gender power imbalances that impact condom use, and increasing sexual communication and negotiation skills.23,33,34,35,36,37,38,39,40,41
The collective results from these studies support the development of a couples based intervention for African American HIV serodiscordant heterosexual couples.
The primary objective of this Trial was to develop a culturally congruent, couples based intervention and test its efficacy in African American serodiscordant couples in four US cities. The couples were randomized to one of two interventions: an eight session couple focused Eban HIV/STD Risk Reduction Intervention (treatment) or an eight session individual focused Eban Health Promotion Intervention (control), addressing health issues unrelated to sexual behavior. Both interventions involved couple and group sessions led by trained male and female co facilitators. The treatment intervention focused on couple goals on how to reduce HIV related risk behaviors and teach condom use and communication skills. In contrast, the control intervention focused on individual goals related to health promotion and providing factual information about health screening and teaching skills in exercise, diet management, and medication adherence.
There are four urban performance sites: Atlanta (Emory University), Los Angeles (University of California, Los Angeles), New York (Columbia University), and Philadelphia (University of Pennsylvania), and one data coordinating center (DCC) (University of Pennsylvania). Because this Trial is funded through a Cooperative Agreement, NIMH has a major role in the conduct of the study. Representatives from the sites, DCC, and NIMH formed a Scientific Steering Committee that developed a common protocol and procedures for the conduct of the Trial including the interventions; assessment questionnaire; biological specimen collection, storage, and analysis; study procedures and materials. The Steering Committee was also responsible for the conduct of all aspects of the Trial. A Data Safety and Monitoring Board (DSMB), appointed by NIMH, reviewed and approved the Protocol. The Trial organization appears in .