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: 10256147
• 负责人: Renee A. Heffron
• 金额: $ 14.49万
• 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/10256147
• 关键词: AIDS prevention; Address; Adherence; Adolescence; Adolescent; Age; Age-Years; Behavior assessment; Behavioral; COVID-19 pandemic; Caring; Chlamydia trachomatis; Clinic; Complication; Contraceptive Agents; Counseling; Country; Coupled; Data; Data Collection; Diagnostic; Diagnostic Reagent Kits; Diagnostic tests; Dose; Dropout; Enrollment; Epidemic; Evidence based program; Exposure to; Family Planning; Female; Female Adolescents; HIV; HIV risk; HIV-1; Health; Health Personnel; Home; Incidence; Individual; Infertility; Institutes; 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; 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; Syndrome; Target Populations; Telephone; Testing; Text; Time; Training; Visit; Wit; age group; aged; base; clinical care; clinical trial implementation; cohort; cost; 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; sexual HIV transmission; standard of care; 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 理由。自2016年启动以来，口服暴露前预防（PrEP）HIV-1预防计划 南非（SA）优先考虑少女和年轻妇女（AGYW），因为她们的艾滋病毒感染率很高。 流行率和发病率。尽管做出了这一努力，PrEP的吸收率一直很低，持续性一直很低。 最佳现在出现的数据将PrEP重新启动作为PrEP级联的进一步步骤。原因 描述的PrEP重启包括基于动态和不断变化的伙伴关系的感知艾滋病毒风险波动 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传播疾病， 传播感染（STI），这可能会增加艾滋病毒感染的风险。最近的数据表明，SA AGYW 全国性传播感染症状负担最高，15-19岁年龄组的性别差异最大（发病率 在豪登，女性性传播感染率是男性的两倍）。我们认为，针对这一年轻群体， 认识到并解决他们在青春期发展个人自主能力时的艾滋病毒/性传播感染风险， 有可能告知晚年需要的健康寻求行为改变，以减少他们暴露于 艾滋病毒/性传播感染综合症。Approach.我们的目标是开发一套淋病奈瑟菌和衣原体 沙眼STI试剂盒与培训（面对面和远程虚拟方法）相结合，用于家庭检测，以确定 AG是否可以自我管理这些测试，以及这种干预是否会影响AG在以下情况下重新开始PrEP 收到阳性性传播感染结果并在诊所指导下进行艾滋病毒自我检测。该研究将在Wits进行 生殖健康和艾滋病毒研究所，约翰内斯堡。对于目标1，我们将进行深度访谈（IDI） 在约20名使用PrEP的AGYW中，20名使用PrEP的AG父母和20名医疗保健提供者 定性探讨PrEP吸收的障碍和促进因素，PrEP中断的经验， 重新开始的观点和使用STI快速测试和行为自我评估STI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并随机分配 他们以1：1的比例接受1）STI测试包加上自我管理的行为风险 评估或2）自我管理的行为风险评估。每月随访一次，持续6个月 通过远程访问和亲自访问相结合的方式。所有参与者都将获得全面的性和 生殖健康服务和减少行为风险咨询。主要结果将包括应计， 计划继续，使用STI试剂盒进行自我检测，以及测量PrEP依从性。目标3： 与约20名参与目标2的AG一起进行研究退出IDI，以评估STI自测、自测 管理行为风险评估和重新启动PrEP。影响。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R 01关于在家进行STI测试的全面试验的建议， 在AG中重新启动PrEP。这些数据将有可能为非洲集团重新启动PrEP的国家政策提供信息 使用自我认定的性传播感染作为高风险的标志。