BACKGROUND Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda. METHODS This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n = 330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S + FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S + FL + V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences. DISCUSSION When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness. TRIAL REGISTRATION ClinicalTrials.gov , ID: NCT03583541 .

中文翻译：

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针对乌干达弱势妇女性冒险行为的综合干预措施：整群随机临床试验的研究方案。

背景 撒哈拉以南非洲 (SSA) 的艾滋病毒/艾滋病感染者人数最多，其中尼日利亚、南非和乌干达占新增感染者的 48%。对 50 个低收入和中等收入国家从事性工作的妇女 (WESW) 的艾滋病毒负担进行的系统审查发现，相对于一般女性人口，她们感染艾滋病毒的几率更高。性工作环境、暴力、耻辱、文化问题和性工作刑事定罪等社会结构因素对于 WESW 及其乌干达客户的性传播感染 (STI)/HIV 风险至关重要。贫困是 SSA 从事性工作最常被提及的原因。在此背景下，本研究方案描述了一项随机对照试验（RCT），该试验测试了在传统的艾滋病毒风险降低（HIVRR）的基础上增加经济赋权的影响，以减少乌干达拉凯和大马萨卡地区的WESW中性传播感染和艾滋病毒的新发病率。方法 这项三臂随机对照试验将评估在传统 HIVRR 的基础上增加储蓄、金融知识和职业培训/指导对减少 33 个热点地区 990 名 WESW 中新发性传播感染发病率的效果。三组（每组 n = 330）为： 1) 对照组：仅 HIVRR 对比 2) 治疗组 1：HIVRR 加储蓄加金融知识 (HIVRR + S + FL)；3) 治疗组 2：HIVRR 加 S 加 FL 加职业技能培训和指导 (V) (HIVRR + S + FL + V)。将在基线（测试前）、干预开始后 6、12、18 和 24 个月收集数据。本研究将使用嵌入式实验混合方法设计，在所有条件下进行干预后收集定性数据，以探索参与者的体验。讨论 当 WESW 获得更多资本和/或替代就业形式并开始在性工作之外赚取正式收入时，他们可能能够更好地提高技能和就业能力以实现职业发展，从而降低性传播感染/艾滋病毒风险。研究结果可能会增进我们对如何在全球范围内最好地实施针对性别的艾滋病毒预防、让女性参与艾滋病毒治疗级联的理解。此外，结果将为干预措施减少性传播感染的功效提供证据，并为实施的可持续性提供信息，包括成本和成本效益。试验注册 ClinicalTrials.gov，ID：NCT03583541。