HIV/STI Prevention for Drug-Involved Couples
Condition: Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This randomized controlled trial is designed to address gaps in couple-based HIV prevention
      research by focusing exclusively on HIV negative concordant couples where one or both
      partners are drug-involved. Building on prior couple-based HIV research that resulted in an
      evidence-based HIV prevention model for couples (Connect), intervention components were
      modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based
      HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV
      negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are
      recruited primarily through street outreach in drug using locations and randomized into one
      of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk
      Reduction, which delivered the same content as the couple-based condition but was provided to
      either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion,
      which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether
      the HIV risk reduction intervention provided to the couple or an individual partner would be
      more efficacious in decreasing number of unprotected acts of intercourse and having a lower
      cumulative incidence of biologically confirmed STIs over the 12-month follow-up period
      compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk
      reduction intervention would be more likely to decrease the number of unprotected acts and
      have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.
    

Detailed description: 
      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.

      The Individual Risk Reduction Intervention covered the same content, skills and sequencing of
      activities as the Couple Risk Reduction, but was delivered to either or the male or female
      drug-involved partner in individual sessions by a facilitator of the same gender. In these
      individual sessions, facilitators are trained to model and role play communication,
      negotiation and problem-solving skills with participants and encourage them to practice these
      HIV-related skills and share HIV information with their partners in homework activities.

      The Couple Wellness Promotion comparison intervention was designed to control for Hawthorne
      effects -- to reduce the likelihood that the effects of Connect II risk reduction
      intervention could be attributed to non-specific features, such as special attention, dosage
      and couple interaction. Guided by social cognitive theory, the core components of the
      intervention consist of 7 weekly sessions and employ the same structure as the HIV risk
      reduction sessions which focus on maintaining a healthy diet promoting physical fitness in
      daily routines, promoting age appropriate recommendations for screening for common diseases
      affecting men and women such as cancers, heart disease, diabetes, etc., improving access to
      health care services by identifying and addressing service barriers and learning
      stress-reducing exercises.

      The participants in all three conditions provided behavioral and biological outcome data at
      baseline, immediate post intervention IPT, 6- and 12-month post-intervention time points. An
      Audio Computer Assisted Self-Interview (ACASI) was used to collect self-reported data on
      drug-related and sexual behavioral outcomes and socio-demographic variables. ACASI provided
      both audio and video presentation of the questions and response options on a computer
      enabling participants with low literacy to respond to questions. ACASI was used collect data
      on self -reported sexual behaviors from participant with their study partners and with all
      other partners in the prior 90 days, including number of vaginal and anal intercourse acts,
      number of unprotected vaginal or anal intercourse acts with their study partners and with all
      other partners, proportion of condom protected acts of vaginal or anal intercourse (e.g. # of
      times condoms were used during vaginal sex/# of acts of vaginal intercourse), consistent
      condom use (e.g. used condom100% of time during vaginal sex), and incidence of concurrent
      sexual partners in the past 90 days at baseline and all follow-ups. The timeline follow-back
      method was used to enhance recall of sexual behaviors (REF). The primary behavioral outcome
      was the number of unprotected acts of vaginal intercourse.

      Drug risk behavioral outcomes included whether or not and number of times injecting drugs in
      the past 90 days and number or times sharing syringes, cookers, cotton, or rinse water with
      another user in the past 90 days. In addition, self-reported data on frequency and type of
      drug use in the prior 90 days were collected for the following substances: cocaine, crack,
      heroin, cannabis, and not prescribed sedatives, opiates and stimulants.

      To complement self-reports of primary behavioral outcome, we assessed biologically confirmed
      STI cumulative incidence over the 12-month follow-up period. All participants were asked to
      provide a self-collected urine specimen after completing the ACASI. Molecular assay of urine
      specimens for Chlamydia trachomatis and Neisseria gonorrhoeae using. Urine specimens were
      assayed for Trichomonas vaginalis using. Participants with positive STI test results were
      referred for single-dose antimicrobial treatment and risk-reduction counseling per CDC
      recommendations. If either partner tested positive for an STI, both were recommended for
      treatment. If participants tested positive for any STI at any assessment visit, they were
      considered an incident STI case for that visit. HIV testing was repeated at the 12-month
      follow up assessment using Oratest procedures.

      Statistical Analysis To assess intervention effects, multilevel mixed-effects models were
      constructed. . Each observation at the first level of the model represents an individual
      measurement at one of the three post-treatment time points. Random effect parameters in the
      model account for dependencies present with each of two types of grouping, couple and time
      point. Multilevel mixed-effects Poisson regressions were used to estimate effects of the
      intervention on the number of unprotected acts of intercourse. Effect estimates are reported
      as incident rate ratios (IRR) and corresponding 95% confidence intervals. Multilevel
      mixed-effects linear regressions were used for the proportion of protected acts of
      intercourse; adjusted mean differences and 95% confidence intervals are reported. Multilevel
      mixed-effects logistic regressions were used to estimate effects on consistent condom use,
      having concurrent partners, injecting drugs, sharing needles or syringes, and sharing works,
      cooker, cotton, or rinse water; for these effect estimates odds ratios (OR) and 95%
      confidence intervals are reported. Due to the low prevalence of STI at baseline and low
      cumulative incidence over the follow-up period, the biological outcomes were not included in
      multilevel analysis.

      Orthogonal contrast coding was used to test separately for intervention effect (Couple and
      Individual Risk Reduction jointly vs. Couple Wellness Promotion) and modality effect (Couple
      Risk Reduction vs. Individual Risk Reduction) within one model. To test for an intervention
      effect, the coding for Couple Risk Reduction, Individual Risk Reduction and Health Promotion
      were +1/3, +1/3, and -2/3 respectively. To test for modality effects, the coding for Couple
      Risk Reduction, Individual Risk Reduction and Health Promotion were+1/2, -1/2 and 0
      respectively. All the multilevel models adjusted for the baseline measure of the outcome and
      gender. The primary analyses used standard intent-to-treat methods in which all available
      data on all randomized participants were included.
    

Intervention name(s): Couple HIV/STI prevention intervention; Couple-based HIV/STI prevention; Individual HIV/STI prevention; Couple Wellness Promotion
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV, STI, condom use, drug use,