title: Uthando Lwethu ('our love'): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa.
abstract: BACKGROUND
  Couples-based HIV counseling and testing (CHCT) is a proven strategy to reduce the risk of HIV transmission between partners, but uptake of CHCT is low. We describe the study design of a randomized controlled trial (RCT) aimed to increase participation in CHCT and reduce sexual risk behavior for HIV among heterosexual couples in rural KwaZulu-Natal, South Africa. We hypothesize that the rate of participation in CHCT will be higher and sexual risk behavior will be lower in the intervention group as compared to the control.
  
  
  METHODS
  Heterosexual couples (N=350 couples, 700 individuals) are being recruited to participate in a randomized trial of a couples-based intervention comprising two group sessions (one mixed gender, one single gender) and four couples' counseling sessions. Couples must have been in a relationship together for at least 6 months. Quantitative assessments are conducted via mobile phones by gender-matched interviewers at baseline, 3, 6, and 9 months post-randomization. Intervention content is aimed to improve relationship dynamics, and includes communication skills and setting goals regarding CHCT.
  
  
  CONCLUSIONS
  The Uthando Lwethu ('our love') intervention is the first couples-based intervention to have CHCT as its outcome. We are also targeting reductions in unprotected sex. CHCT necessitates the testing and mutual disclosure of both partners, conditions that are essential for improving subsequent outcomes such as disclosure of HIV status, sexual risk reduction, and improving treatment outcomes. Thus, improving rates of CHCT has the potential to improve health outcomes for heterosexual couples in a rural area of South Africa that is highly impacted by HIV. The results of our ongoing clinical trial will provide much needed information regarding whether a relationship-focused approach is effective in increasing rates of participation in CHCT. Our intervention represents an attempt to move away from individual-level conceptualizations, to a more integrated approach for HIV prevention.
  
  
  BACKGROUND
  Study Name: Couples in Context: An RCT of a Couples-based HIV Prevention InterventionClinicalTrials.gov identifier: NCT01953133.South African clinical trial registration number: DOH-27-0212-3937.
authors.affiliation: Center for AIDS Prevention Studies, University of California, 50 Beale Street, San Francisco, CA 94105, USA. Lynae.darbes@ucsf.edu.
authors.forename: Lynae A
authors.initials: LA
authors.lastname: Darbes
authors.forename: Heidi
authors.initials: H
authors.lastname: van Rooyen
authors.forename: Victoria
authors.initials: V
authors.lastname: Hosegood
authors.forename: Thulani
authors.initials: T
authors.lastname: Ngubane
authors.forename: Mallory O
authors.initials: MO
authors.lastname: Johnson
authors.forename: Katherine
authors.initials: K
authors.lastname: Fritz
authors.forename: Nuala
authors.initials: N
authors.lastname: McGrath
mesh_terms: D002985:Clinical Protocols; D003376:Counseling; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control* / Q000523:psychology / Q000635:transmission; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008149:Love; D008297:Male; D008403:Mass Screening / Q000379:methods*; D011237:Predictive Value of Tests; D012107:Research Design; D040242:Risk Reduction Behavior; D019035:Rural Health Services; D012747:Sexual Partners / Q000523:psychology; D013019:South Africa / Q000453:epidemiology; D018454:Spouses / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D047568:Unsafe Sex / Q000517:prevention & control* / Q000523:psychology