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; 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.

抽象的 理由。自2016年启动以来，口服预防前预防（PREP）HIV-1预防计划 南非（SA）由于艾滋病毒高的艾滋病毒而优先考虑青少年女孩和年轻女性（AGYW） 患病率和发病率。尽管做出了这种努力，但预备的吸收却很低，并且持久性一直是 最佳的。现在正在出现数据以将准备重新启动描述为准备级联的进一步步骤。原因 描述用于准备重新启动的描述包括基于动态和转移伙伴关系的感知艾滋病毒风险的波动 和性活动。与艾滋病毒的流行平行是一种寂静的愤怒流行，可治愈但无症状的性行为 传播感染（STI）可以增加艾滋病毒收购风险。最近的数据表明Sa agyw具有 在全国范围内最高的性传播性传播感染症状负担，性别差异最高15-19岁的年龄段（发病率 在豪登省，女性中的性传播感染是男性的两倍。我们认为，将这个年龄段的人定位为 在建立个人自主权时，在青春期认识并解决其艾滋病毒/性传播疾病的风险， 有潜力向后来几年所需的寻求健康寻求行为改变的潜力，以减少其接触 HIV/STI Syndemics。方法。我们旨在开发一包淋病和衣原体 气管体STI套件与培训（面对面和远程虚拟方法）进行在家测试以确定 AG是否可以自我管理这些测试，并且这种干预是否会影响AG重新启动准备 在临床指导HIV自学的诊所指导的HIV自我测试中收到阳性结果。该研究将以智慧进行 约翰内斯堡生殖健康与艾滋病毒研究所。对于AIM 1，我们将进行深入的访谈（IDI） 在使用Prep的20个AGYW中，有20名使用PreP和20个医疗保健提供者的AG父母 为了定性地探索障碍和促进者以准备吸收障碍，以终止的准备经验， 关于使用STI快速测试和行为的重新启动和自我评估STI风险的意愿的观点 评估。对于AIM 2，我们将招募50 AG（16-17岁），他们最近停止准备并随机分组 他们以1：1的比率接收1）STI测试包与自我管理的行为风险相结合 评估或2）仅自我管理的行为风险评估。随访每月持续6个月 通过遥远和面对面的访问结合。所有参与者都将获得全面的性和 生殖健康服务和降低行为风险咨询。主要结果将包括应计， 程序延续，使用性传播疾病套件进行自我测试以及测量准备依从性。对于目标3，我们将 进行研究退出IDI，约有20个AG参加AIM 2，以评估STI自我测试的经验 管理行为风险评估并重新启动准备。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R01建议，以进行全面的STI测试和 准备重新开始AG。这些数据将有可能告知国家政策有关AG之间重新启动的PREP的政策 使用自我识别的性传播感染作为风险增加的标志。