title: Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.
abstract: BACKGROUND
  The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population.
  
  
  METHODS
  The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary outcomes for the main study, and the feasibility of their measurement will be determined in this pilot trial.
  
  
  CONCLUSIONS
  The manuscript describes the protocol for a pilot study to determine the feasibility of a behavioral intervention to improve consistent condom use among BB FSWs. The results of this pilot will inform a larger intervention for HIV prevention for this target group in Nigeria.
  
  
  BACKGROUND
  The Institutional Review Board (IRB) of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.
authors.affiliation: Maastricht University, Maastricht, The Netherlands.
authors.forename: Uchenna
authors.identifier: 0000-0002-3793-8284
authors.initials: U
authors.lastname: Okafor
authors.affiliation: Maastricht University, Maastricht, The Netherlands.
authors.forename: Rik
authors.initials: R
authors.lastname: Crutzen
authors.affiliation: Society for Family Health, Abuja, Nigeria.
authors.forename: Ifeanyi
authors.initials: I
authors.lastname: Okekearu
authors.affiliation: Population Council International, Abuja, Nigeria.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Adebajo
authors.affiliation: Society for Family Health, Abuja, Nigeria.
authors.forename: Adaora
authors.initials: A
authors.lastname: Uzoh
authors.affiliation: Society for Family Health, Abuja, Nigeria.
authors.forename: Egbe Aneotah
authors.initials: EA
authors.lastname: Awo
authors.affiliation: Society for Family Health, Abuja, Nigeria.
authors.forename: Chukwuemeka
authors.initials: C
authors.lastname: Chima
authors.affiliation: Society for Family Health, Abuja, Nigeria.
authors.forename: Ogechukwu
authors.initials: O
authors.lastname: Agwagwa
authors.affiliation: Maastricht University, Maastricht, The Netherlands.
authors.forename: Bart
authors.initials: B
authors.lastname: van den Borne
keywords: Brothel; Condom use; Female sex workers; HIV prevention; Intervention; Protocol