HIV Prevention Intervention for Couples

The broad, long-term objective of this research is to establish primary preventive
interventions to reduce human immunodeficiency virus (HIV) risk behavior among drug-using
minority women. Recent studies indicate that high rates of sexual risk behavior occur within
drug-using minority women's primary heterosexual relationships. Based on an integrated
theory of HIV risk behavior, it is predicted that (a) interventions administered to couples
rather than to women only, and (b) interventions that focus on relationship dynamics in the
context of HIV risk, will result in a reduction of sexual and drug-related risk behavior
among drug-using women and their primary partners. This four-year study employs a
randomized clinical trial (RCT) 3-group design to test the efficacy of HIV intervention
modality (couples versus women-only) and intervention content (relationship-focused versus
standard HIV counseling and testing) on crack, cocaine and heroin (injected and noninjected)
using women's sexual risk with primary partners.

A total of 390 women drug-users and their partners are recruited from the streets of Harlem
and the South Bronx in New York City. Participants are randomly assigned to one of three HIV
counseling and testing intervention conditions: (a) couples, relationship-focused; (b)
women-only, relationship-focused; or, (c) NIDA women-only standard HIV-CT (control). All
subjects are administered baseline, 3-month, and 9-month follow-up assessments using a
combination of computer-assisted personal interview (CAPI) and computer-assisted self
interview (CASI) techniques. In addition to sociodemographic characteristics, the interview
will measure drug-use patterns, HIV risk behavior, and dyadic- and individual-level
variables operationalized to test specific hypotheses of women's HIV risk behavior and
behavior change. In addition to testing the effectiveness of the experimental interventions,
data analyses will determine the theory-driven psychosocial mechanisms that act to mediate
and moderate any observed association between intervention treatment and subsequent risk
reduction. Incremental cost-effectiveness analyses will also be performed.

Results from this study will allow researchers to determine whether couple-based HIV
counseling and testing is a more effective (and cost-effective) approach to HIV prevention
than individual HIV counseling and testing. Analyses will further provide information on the
specific components of couple-based interventions that were most effective in reducing HIV
risk behavior, thereby contributing to theory development regarding intimate couples' HIV
risk.

Inclusion Criteria:

For women:

- 18 years of age or older

- self-reported use of crack, cocaine or heroin in prior 30 days

- has male sex partner identified as primary partner for at least one year

- had unprotected vaginal or anal sex with current partner in prior 30 days

- able to enlist partner in study enrollment

- would not feel threatened participating in the study with primary partner

- must not have participated in HIV/AIDS related study or attended HIV counseling and
testing session in six months

- self-reported HIV negative or sero-unaware

For men:

- 18 years of age or older