A Pilot Randomized Controlled Trial to Assess a Model of Decentralised STI-Self Testing and Risk Self-Assessment Among Adolescent Girls and Young Women in South Africa to Trigger PrEP Re-start
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants that restarted PrEP
研究概览
简要总结
This is a pilot randomized trial among 50 AGYW (aged ≥16≤18 years), who discontinued PrEP use within the past 6 months, assigned in a 1:1 ratio to receive: 1) STI self-test kits (Neisseria gonorrhoea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)) with in-person instruction at enrolment and telephone/video-based instructions for home use coupled with self-administered behavioural risk assessment or 2) self-administered behavioural risk assessment only (standard of care). All participants will receive comprehensive sexual and reproductive health (SRH) services during their study visits including choice of family planning method initiation and support, and behavioural HIV/STI risk reduction counselling.
详细描述
The PALESA study aims to determine the feasibility of conducting a randomized controlled trial (RCT) to determine the impact of decentralized sexually transmitted infection (STI) point of care (POC) self-testing and risk self-assessment interventions to trigger pre-exposure prophylaxis (PrEP) re-start among adolescent girls and young women (AGYW) in South Africa at potential ongoing risk of re- acquiring STIs and HIV.
This overall study comprises two components that include a formative research study enrolling ~60 participants for qualitative in-depth interviews (IDIs) (this has been completed) and a prospective cohort study (Pilot randomized controlled trial - RCT) enrolling 50 AGYW with both clinical, diagnostic laboratory and nested qualitative methodologies.
The RCT seeks to establish the feasibility of conducting a randomized controlled trial among AGYW in South Africa to determine the impact of decentralized or at-home STI testing [(for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV)] on restarting PrEP relative to a self-administered behavioural risk assessment. Additionally qualitative interviews will be conducted to assess adolescent girls experiences of at-home STI testing, behavioural risk assessment, and re-starting PrEP while participating in the pilot trial through exit interviews.
Objective 1: To determine the feasibility and acceptability of conducting a RCT among South African AGYW to determine the impact of STI self-testing coupled with a self-administered behavioural risk assessment on restarting PrEP relative to a self-administered behavioural risk assessment only
Objective 2: To assess AGYW acceptability of and experiences with use at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP while participating in the pilot RCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For the full cohort, all participants must:
- •Be cis-gender adolescent females (16-20 years of age)
- •Be literate
- •Currently sexually active
- •Be willing to participate in in-person and virtual study visits
- •Not be pregnant or planning to be pregnant for the next 6 months
- •Be HIV-negative but not ready to initiate PrEP at the screening and enrolment visit
- •Have used PrEP with subsequent discontinuation within the last 6 months
- •Have no contraindications to oral PrEP per self-report
- •Have no indication of possible acute HIV infection, according to South African PrEP guidelines
- •Have their own personal smart phone
- •Willing to provide written informed consent/assent to participate in this study
- •For the subset invited to qualitative interviews, all participants must be:
- •Willing to participate in an IDI at/before their month 6 visit (study exit visit)
排除标准
- •Potential AGYW participants who meet any of the following criteria will be excluded from the study:
- •At Screening and Enrollment, parent/guardian (for those participants <18 years) is unwilling to provide written informed consent
- •At Screening and Enrollment, is already participating in another research study involving drugs, medical devices, or vaccines for STI prevention or treatment.
- •Is not willing to comply with study procedures
- •As determined by the PIs/designee, any current or historical physical health, mental health or social issue or condition that the site investigator or designee determines should exclude participation.
- •Has any other condition that, in the opinion of the PIs/designee, would preclude informed consent, make study participation unsafe, or otherwise interfere with achieving the study objectives.
结局指标
主要结局
Number of participants that restarted PrEP
时间窗: 1 year
There will be a dispensation form for every participant, this form will indicate if PrEP was restarted by the participant, and it will calculate include pill counts when PrEP bottles are returned to the research site
Experiences of at-home STI testing, self-administered behavioural risk assessment, and re-starting PrEP
时间窗: 1 year
In-Depth Interviews will be conducted to collect participant's experience while in the study and tools used during the study.
PrEP continuation 1 month after re-start
时间窗: 1 year
Dried Blood Spot (DBS) collected to measure tenofovir diphosphate (TFV-DP) level as an objective assessment of adherence to PrEP.
Number of participants enrolled and retained in the PALESA study
时间窗: 1 year
A recruitment target of 50 adolescent girls and young women and over 90% retention of those participants is achieved
Assessing Risk of Acquiring HIV and STIs
时间窗: 1 year
A self administered behavioural risk assessment questionnaire with 16 - 20 questions (which include questions on STI test results), which will tally up a score, will be used to measure how much counselling and guidance will the participants need to restart PrEP. A score of 0 - 7 means medium recommendation to restart PrEP. A score 8-15 means a strong recommendation to restart PrEP. Test results of STIs from the self-testing STI kit are shared on the self-administered behavioural risk assessment questionnaire.
次要结局
未报告次要终点
研究者
Thesla Palanee-Phillips
Director:Clinical Trials
Wits RHI Research Centre Clinical Research Site