HIV/STI Prevention for Drug-Involved Couples

Study Design and Population This prospective, blinded randomized controlled trial was conducted between November 2004 and September 2009 in West Harlem, New York City. Participants were recruited through homeless shelters, soup kitchens, syringe exchange programs, street outreach and "word-of-mouth." Most qualified couples came through street outreach. Recruiters informed potential participants about the study, obtained consent to be screened, and screened them for eligibility. People who seemed to be eligible were asked to invite their main sexual partner to participate. A letter to their partner that introduced the study was given to potential participants. Partners interested in participating were screened. If eligible, the recruiter scheduled the couple for baseline data collection. Participants received monetary compensation for completing the baseline assessment and each follow up assessment. The study was approved by the Institutional Review Board of Columbia University. Written informed consent was obtained from all participants prior to enrollment.

Couples were eligible to participate if both were 18 and older and at least one partner was 18-40; (2) both tested HIV negative using Oratest procedures; (3) both identified each other as main, regular partner, boy/girlfriend, spouse, lover; (4) both reported that they have been together for at least 6 months; (5) both intended to remain together for at least one year; (6) at least one partner reported using illicit drugs in the prior 90 days and was seeking or in drug treatment; (7) at least one partner reported having had unprotected intercourse with the other in the prior 90 days. Additionally, at least one partner had to report one or more of the following HIV risk criteria: (1) having had sex with other partners in the prior 90 days; (2) injecting drugs in the prior 90 days; or (3) self-report being diagnosed with an STI in the prior 90 days. Couples were excluded from the study (1) if either partner reported experiencing severe intimate partner violence in the past year by the other partner as assessed by subscales of the Revised Conflict Tactics Scale (Straus, Hamby et al. 1996); (2) if either partner exhibited a severe cognitive or psychiatric impairment assessed during informed consent (3) if either partner did not have sufficient understanding of English and (4) if either partner reported intentions to have a baby in the next year and to relocate beyond a reasonable distance from the study site in the coming year.

Randomization Couples were randomized to the Couple Risk Reduction, Individual Risk Reduction, or the Couple Wellness Promotion conditions at the time of their arrival at their first session (within 10 days from baseline, allowing sufficient time to receive HIV and STI test results). A random number generator was used to assign each couple to one of the three arms with equal probability. The gender of index participant who reported drug use in the past 90 days and seeking or in substance abuse participant was used as a blocking factor to ensure that couples with drug-involved female and male participants were equally balanced across intervention arms. If both partners met above drug involvement criteria eligibility criteria, one partner was randomly selected as the index participant. The Data Coordinator informed the facilitator and couple as to which condition was assigned, entered the treatment assignment into a case report form that contained only the male and female participants' study identification numbers, and then destroyed the assignment card and envelope.

Procedures All three intervention conditions consisted of seven weekly structured 2-hour sessions delivered by female and male facilitators who had at least a bachelor's degree and 2 years of clinical experience in the HIV prevention field. Facilitators completed 40 hours of training and were trained to deliver all three conditions to minimize the threat of facilitator effects. To ensure the fidelity of implementation of all three conditions, facilitators used structured manuals with detailed implementation protocols and were asked to fidelity assessment forms after each session. In addition, facilitators met for weekly 60-minute group supervision to discuss clinical challenges and adherence to the protocol for all three conditions. All intervention sessions were digitally recorded. Recordings and session-specific quality assurance checklists were reviewed to monitor fidelity of implementation of all three conditions and to provide corrective feedback to facilitators.

The Couple-based HIV risk reduction intervention was guided by social cognitive theory (SCT) (Bandura 1992) and a relationship-oriented ecological framework (Bronfenbrenner 1979) which has been described elsewhere (El-Bassel et al., 2001). The core components of the intervention focus on both sexual and drug risk reduction (1) encouraging both partners to disclose and identify mutual drug-related and sexual risks (2) modeling, role-playing and practicing couple communication, negotiation and problem solving skills that both partners may employ together to reduce their drug-related and sexual risks; (3) practicing technical condom use placement skills along with a broader repertoire of pleasurable safer sex activities and syringe disinfection skills and (4) enhancing both couple's motivation to protect each other and set mutual risk reduction goals. Facilitators are trained to validate the relationship's strengths (e.g., commitment, love, trust) and empower the dyad to enact protective behaviors (El-Bassel, 2001, 2005, 2010C). A safe environment is created where sensitive or taboo topics (e.g., outside sexual partners) related to couple's risks may be disclosed and addressed.