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.

抽象的 理由。自 2016 年启动以来，口服暴露前预防 (PrEP) HIV-1 预防计划在 南非 (SA) 优先考虑少女和年轻女性 (AGYW)，因为她们的艾滋病毒感染率较高 患病率和发病率。尽管做出了这些努力，PrEP 的采用率仍然很低，并且持久性也较低。 最佳的。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 重新启动 PrEP 的描述包括基于动态和变化的伙伴关系所感知的 HIV 风险的波动 和性活动。与艾滋病毒流行并行的是一种可治愈但无症状的性行为的无声肆虐流行病。 传播感染（STI），这会增加感染艾滋病毒的风险。最近的数据表明 SA AGYW 具有 全国性传播感染症状负担最高，其中 15-19 岁年龄组的性别差异最大（发病率 在豪登省，女性性传播感染的发病率是男性的两倍）。我们相信，针对这个年轻群体 当他们在青春期发展个人自主权时，认识并解决他们的艾滋病毒/性传播感染风险， 有潜力告知寻求健康的人在以后几年中需要改变行为，以减少他们接触 HIV/STI 综合征。方法。我们的目标是开发淋病奈瑟菌和衣原体的套装 沙眼性传播感染套件与培训（面对面和远程虚拟方法）相结合，用于家庭测试以确定 AG 是否可以自行进行这些测试，以及这种干预是否会影响 AG 在以下情况下重新启动 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检。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） 其中约 20 名使用过 PrEP 的 AGYW、20 名使用过 PrEP 的 AG 家长以及 20 名医疗保健提供者 定性探索 PrEP 吸收的障碍和促进因素、PrEP 停止的经验， 对重新开始的看法以及使用 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 名最近停止 PrEP 的 AG（年龄 16-17 岁）并随机分组 他们以 1:1 的比例接受 1) STI 测试包以及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。随访将每月一次，持续 6 个月 通过远程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 生殖健康服务和行为风险降低咨询。主要成果将包括应计、 计划的继续、使用 STI 试剂盒进行自检以及 PrEP 依从性的测量。对于目标 3，我们将 与参与目标 2 的约 20 个 AG 进行研究退出 IDI，以评估 STI 自我测试、自我检测的经验 进行行为风险评估并重新启动 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 R01 提案，以全面试验家庭性传播感染检测和 AG 之间重新启动 PrEP。这些数据将有可能为 AG 重新启动 PrEP 的国家政策提供信息 使用自我识别的性传播感染作为高风险的标志。