Feasibility pilot of home-based STI testing and risk self-assessment among adolescent girls in South Africa to trigger PrEP re-start

在南非少女中进行家庭性传播感染检测和风险自我评估以触发 PrEP 重新启动的可行性试点

• 批准号: 10678858
• 负责人: Renee A. Heffron
• 金额: $ 21.06万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10678858
• 关键词: AIDS prevention; Address; Adherence; Adolescence; Adolescent; Age; Age Years; Behavior assessment; Behavioral; COVID-19 pandemic; Caring; Chlamydia trachomatis; Clinic; Clinical Trials; Complication; Contraceptive Agents; Counseling; Country; Coupled; Data; Data Collection; Diagnostic; Diagnostic Reagent Kits; Diagnostic tests; Dose; Dropout; Enrollment; Epidemic; Evidence based program; Exposure to; Face; Family Planning; Female; Female Adolescents; HIV; HIV risk; HIV-1; Health; Health Personnel; Home; Incidence; Individual; Infertility; Instruction; Intervention; Interview; Laboratories; Left; Measurement; Methods; Neisseria gonorrhoeae; Oral; Outcome; Parents; Participant; Pelvic Inflammatory Disease; Personal Autonomy; Persons; Policies; Positioning Attribute; Prevalence; Prevention; Prevention program; Procedures; Provider; Public Health; Randomized; Randomized, Controlled Trials; Recommendation; Reproductive Health; Reproductive Health Services; Research; Research Personnel; Risk; Risk Assessment; Risk Reduction; STI prevention; Schedule; Science; Self Administration; Self Assessment; Sex Behavior; Sexual Health; Sexually Transmitted Diseases; South Africa; South African; Symptoms; Target Populations; Telephone; Testing; Text; Training; Visit; Wit; age group; aged; clinical care; clinical implementation; cohort; cost; empowerment; experience; follow-up; gender disparity; high risk; home test; implementation science; infection risk; male; novel; peer; pilot trial; point of care; pre-exposure prophylaxis; primary outcome; programs; randomized trial; rapid test; recruit; self testing; standard of care; syndemic; tool; uptake; virtual; willingness; young woman

ABSTRACT Rationale. Since their initiation in 2016, oral pre-exposure prophylaxis (PrEP) HIV-1 prevention programs in South Africa (SA) have prioritized access for adolescent girls and young women (AGYW) due to their high HIV prevalence and incidence rates. Despite this effort, PrEP uptake has been low and persistence has been sub- optimal. Data are now emerging to characterize PrEP re-start as a further step in the PrEP cascade. Reasons described for PrEP restart include fluctuations in perceived HIV risk based on dynamic and shifting partnerships and sexual activity. Parallel to the HIV epidemic is a silent raging epidemic of curable but asymptomatic sexually transmitted infections (STI) which can increase risk of HIV acquisition. Recent data indicate SA AGYW as having the highest STI symptom burden nationally with gender disparity highest in the 15-19-year age-group (incidence of STI among females twice as high as males in Gauteng). We believe that targeting this younger age group to recognize and address their HIV/ STI risk during adolescence when they are developing personal autonomy, has potential to inform health seeking behavioral change needed in later years to reduce their exposure to the HIV/STI syndemics. Approach. We aim to develop a package of Neisseria gonorrhea and Chlamydia trachomatis STI kits paired with training (in-person and remote virtual methods) for at-home testing to determine whether AG can self-administer these tests and if this intervention could influence AG re-starting PrEP following receipt of a positive STI result and in clinic guided HIV self-test. The study will be conducted at the Wits Reproductive Health and HIV Institute, Johannesburg. For Aim 1, we will conduct in-depth interviews (IDI) among ~20 AGYW who have used PrEP, 20 parents of AG who have used PrEP and 20 healthcare providers to qualitatively explore barriers and facilitators to PrEP uptake, experiences with PrEP discontinuation, perspectives on re-start and willingness to self-assess STI risk using STI rapid tests and behavioral assessments. For Aim 2, we will recruit 50 AG (ages 16-17), who recently discontinued PrEP and randomize them in a 1:1 ratio to receive 1) the STI testing package coupled with self-administered behavioral risk assessments or 2) self-administered behavioral risk assessments only. Follow-up will be monthly for 6 months through a combination of remote and in-person visits. All participants will receive comprehensive sexual and reproductive health services and behavioral risk reduction counseling. Primary outcomes will include accrual, program continuation, use of STI kits for self-test, and measurement of PrEP adherence. For Aim 3, we will conduct study exit IDI with ~20 AG participating in Aim 2 to assess experiences with STI self-testing, self- administered behavioral risk assessment and re-starting PrEP. Impact. By achieving these aims, we will optimize methods and generate preliminary data to support an R01 proposal for a full trial of at-home STI testing and PrEP re-start among AG. These data will have potential to inform country policy on PrEP re-start among AG using self-identified STIs as a marker of heightened risk.

摘要 基本原理。自2016年启动以来，接触前口服预防(PrEP)艾滋病毒-1预防计划在 南非(SA)优先考虑青春期女孩和年轻妇女(AGYW)，因为她们的艾滋病毒感染程度很高 流行率和发病率。尽管做出了这些努力，PrEP的使用率一直很低，持久性一直低于 最好的。现在出现的数据表明，PrEP重新启动是PrEP级联中的进一步步骤。原因 针对PrEP重启的描述包括基于动态和变化的合作伙伴关系的感知艾滋病毒风险的波动 和性行为。与艾滋病毒流行并行的是一种无声的、肆虐的可治愈但无症状的性行为 传播感染(STI)会增加感染艾滋病毒的风险。最近的数据表明，SA AGYW拥有 全国STI症状负担最高，15-19岁年龄组性别差异最大(发病率 在豪登省，女性的性病感染率是男性的两倍)。我们认为，以这一年轻群体为目标 在青春期，当他们发展个人自主性时，认识并解决他们的艾滋病毒/性传播感染风险， 有可能为寻求健康的人提供信息，在以后的几年里需要改变行为，以减少他们对 艾滋病毒/性传播感染综合症。接近。我们的目标是开发一套奈瑟氏菌淋病和衣原体 沙眼衣原体STI试剂盒配合培训(面对面和远程虚拟方法)进行在家测试，以确定 AG是否可以自行管理这些测试，以及此干预是否会影响AG重新启动PrEP 收到阳性的性传播感染结果，并在临床指导下进行艾滋病毒自我检测。这项研究将在威茨大学进行 约翰内斯堡生殖健康和艾滋病毒研究所。对于目标1，我们将进行深入访谈(IDI) 在使用过PrEP的约20名AGYW中，有20名使用过PrEP的AG家长和20名医疗保健提供者 为了定性地探索PrEP应用的障碍和促进者，PrEP停用的经验， 重新启动和使用STI快速测试和行为自我评估性传播感染风险的意愿 评估。对于目标2，我们将招募50名AG(16-17岁)，他们最近停止了PrEP并随机化 他们以1：1的比例接受1)性传播感染测试包加上自我管理的行为风险 评估或2)仅自我管理的行为风险评估。每月跟进一次，为期6个月 通过远程访问和面对面访问相结合的方式。所有参与者都将获得全面的性行为和 生殖健康服务和行为风险降低咨询。主要结果将包括应计项目、 计划继续，使用STI试剂盒进行自检，以及测量PrEP依从性。对于目标3，我们将 在约20名AG参与目标2的情况下进行研究退出IDI，以评估STI自我测试、自我测试和 实施行为风险评估并重新启动PrEP。冲击力。通过实现这些目标，我们将优化 方法并生成初步数据，以支持R01建议的家庭STI检测和 准备在AG中重新启动。这些数据将有可能为国家关于股份公司重新启动PrEP的政策提供信息 使用自我确认的性传播感染作为高风险的标志。