Govere Sabina Medal, Jarolimova Jana, Yan Joyce, Shezi Sthabile, Ngcobo Lungile M, Sagar Shruti, Zionts Dani, Dube Nduduzo, Parker R A, Psaros Christina, Bassett Ingrid
AIDS Healthcare Foundation, Durban, KwaZulu Natal, South Africa
Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
BMJ Open. 2024 Dec 20;14(12):e083621. doi: 10.1136/bmjopen-2023-083621.
Young women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (STIs), remains limited in South Africa, in part due to inadequate infrastructure and individual barriers to care. Integrated, community-based SRH services have the potential to overcome barriers to clinic-based care for women at risk of HIV, unintended pregnancy and STIs. We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.
We will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. Salons serving primarily female clients will be randomised either to an SRH service package (offer of PrEP, contraception, STI screening and health education) or to health education only. Interested female salon clients≥18 years old will be referred by trained stylists. In intervention salons, women who meet inclusion criteria will be offered HIV and pregnancy testing; if eligible, they will be offered oral PrEP, contraception (oral or injectable) and STI screening. Follow-up visits including monitoring side effects will be conducted at baseline and 3, 6, 9 and 12 months. We will measure intervention uptake as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures and evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued use of PrEP and/or contraception.
The study has been approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the Massachusetts General Brigham Institutional Review Board. The results will be disseminated to local and provincial Departments of Health, at scientific conferences and in peer-reviewed scientific journals.
NCT04222504. Registered January 2020.
在南非，年轻女性受艾滋病毒影响的比例过高，意外怀孕的发生率也很高。在南非，获得性健康和生殖健康（SRH）服务，包括艾滋病毒暴露前预防（PrEP）、避孕和性传播感染（STIs）筛查，仍然有限，部分原因是基础设施不足和个人护理障碍。基于社区的综合SRH服务有可能克服艾滋病毒、意外怀孕和性传播感染风险女性接受诊所护理的障碍。我们正在评估一项在美发沙龙提供PrEP、避孕和性传播感染筛查的新型干预措施的可行性、可接受性和初步有效性。
我们将在南非夸祖鲁-纳塔尔省城市的美发沙龙进行一项试点整群随机对照试验。主要服务女性客户的沙龙将被随机分为SRH服务包（提供PrEP、避孕、性传播感染筛查和健康教育）或仅接受健康教育。18岁及以上感兴趣的女性沙龙客户将由经过培训的造型师转介。在干预沙龙中，符合纳入标准的女性将接受艾滋病毒和怀孕检测；如果符合条件，她们将获得口服PrEP、避孕（口服或注射）和性传播感染筛查。在基线以及3、6、9和12个月时进行随访，包括监测副作用。我们将把干预措施的采用率衡量为同意在沙龙接受PrEP以及分别同意在沙龙接受避孕的符合条件女性的比例。我们将通过收集过程指标来评估可行性，并分别将PrEP和避孕的持续使用定义为在6个月内进行一次额外就诊且继续使用PrEP和/或避孕，以此来评估留存率。
该研究已获得夸祖鲁-纳塔尔大学医学研究伦理委员会和马萨诸塞州综合医院布莱根机构审查委员会的批准。研究结果将传播给地方和省级卫生部门、在科学会议上以及在同行评审的科学期刊上发表。
NCT04222504。于2020年1月注册。
