Okafor Uchenna, Crutzen Rik, Okekearu Ifeanyi, Adebajo Sylvia, Uzoh Adaora, Awo Egbe Aneotah, Chima Chukwuemeka, Agwagwa Ogechukwu, van den Borne Bart
Maastricht University, Maastricht, The Netherlands.
Society for Family Health, Abuja, Nigeria.
Pilot Feasibility Stud. 2017 Feb 20;3:10. doi: 10.1186/s40814-017-0124-0. eCollection 2017.
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/DESIGN: 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.
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.
The Institutional Review Board (IRB) of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.
在尼日利亚参与性工作的女性人群中，艾滋病毒的流行率引发了人们对针对这一亚人群的艾滋病毒预防项目的关注。以妓院为基础的女性性工作者（BB FSWs）的流行率为27.4%，是普通人群流行率的六倍。
方法/设计：随机试点试验中的群组将是妓院，居住在妓院的女性性工作者（FSWs）将成为研究参与者。参与者将获得免费避孕套分发以及关于避孕套使用和谈判技巧的艾滋病毒预防信息，以提高她们在自身环境中应对社会和性别权力博弈的自我效能感。12家妓院将被随机分为实验组和对照组，最小总样本量为200名参与者。参与者将从妓院内部招募。对照组将接受标准干预，包括与同伴教育者（PE）进行至少六次互动课程，通过小组讨论和使用预先设计的艾滋病毒预防信息进行一对一互动来接触她们的同伴。实验组将接受标准干预以及与妓院领导层（老板娘和妓院经理）的互动课程，以促进持续使用避孕套以及适当的避孕套使用政策、条件和信息传递。两种干预都将在最长16周的时间内进行，干预期间将分发男用和女用避孕套。将在基线和16周随访时进行定量评估，试点研究结果将为III期试验的可行性和样本量估计提供依据。所测量的主要结果是招募率、损耗率和对干预的依从性。妓院中FSWs与所有伴侣类型的持续避孕套使用结果以及与所有伴侣类型进行避孕套谈判的自我效能感增强将是主要研究的主要结果，其测量的可行性将在本次试点试验中确定。
该手稿描述了一项试点研究的方案，以确定一种行为干预措施在提高BB FSWs持续使用避孕套方面可行性。本次试点的结果将为尼日利亚针对这一目标群体进行的更大规模艾滋病毒预防干预提供参考。
尼日利亚人类病毒学研究所机构审查委员会（IRB）；方案编号NHREC/10/15/2014a - 026。
