Transformative Approaches to Rapidly and Efficiently Test Demand Creation Interventions to Promote HIV Retesting in Adults at Increased Risk of HIV
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40,000
- 试验地点
- 3
- 主要终点
- HIV retesting uptake
研究概览
简要总结
In this study, the investigators will test the effectiveness of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.
详细描述
HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection. The IBIS megastudy of interventions to encourage HIV retesting aims to test up to 12 different strategies aimed at encouraging repeat testing of HIV among individuals >/= 15 years old who are at increased risk of HIV infection. The different strategies are aimed at modifying individual behavior to enhance HIV testing. The study aims to enroll 30,000-40,000 individuals from 8 HIV testing sites in South West Uganda and Western Kenya. The study will then evaluate the effectiveness of the interventions by comparing HIV retesting rates 3-6 months later in the different study arms. The data collected during the study will further be used to understand which of the interventions offered worked best and for whom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 15 years of age
- •Accessing HIV testing services at study-associated hospitals or clinics
- •At increased risk of HIV infection (defined by national (Kenya or Uganda) MoH criteria)
- •Documented negative HIV antibody test at time of enrollment
- •No intent to migrate out of community in next 3 months
- •Daily access to a mobile phone (required since some of the interventions will be delivered by phone)
排除标准
- •HIV-positive at time of enrollment
研究组 & 干预措施
HIV risk assessment
A message that adheres to the following core concepts: - Emphasize that a negative test doesn't mean that previous behavior(s) weren't high-risk - Enable people to re-assess their own personal risk at a later/future date - Suggest risk behaviors to reflect on - If participant has engaged in one or more behaviors, emphasize their need to re-test
干预措施: Risk assessment messaging (Behavioral)
U=U messaging
A message that adheres to the following core concepts: Explain benefits of finding out your HIV-positive status as early after infection as possible and start treatment as soon as possible. These benefits include: -Prevent transmission of HIV to anyone -Live a normal life, with freedom in sexual choices and ability to start a family
干预措施: U=U messaging (Behavioral)
Community benefits
A message that adheres to the following core concepts: - Emphasize that regular testing keeps the participant's community safe and healthy by reducing chances of transmitting HIV unknowingly - Call for responsibility- the participant to do their part for the community; they are an integral part of the solution
干预措施: Community benefits messaging (Behavioral)
Fresh start effect
A message that adheres to the following core concepts: - Using a specific moment in time (in this case, a negative HIV test) to motivate a healthy behavior (i.e. a "fresh start" moment) - emotional unburdening of resolving uncertainty (not knowing one's status is more stressful than knowing one's status, whether positive or negative, and being able to take healthy steps after knowing if the status is negative or positive)
干预措施: Fresh start effect (Behavioral)
Education-based
A message that adheres to the following core concepts: -Increase attention to HIV re-testing reminder through interactive trivia questions -Correct or reinforce understanding about HIV prevention, transmission, and retesting
干预措施: Education-based messaging (Behavioral)
Default appointment
A message that adheres to the following core concepts: - Having a set appointment will reduce uncertainty about availability for retest visit - Having an opt-out option for the future retesting appointment - A planning prompt to be specific about the participant's future plan for retesting - Gentle/soft commitment: by picking a date, mentally agree to come back to retest
干预措施: Default appointment messaging (Behavioral)
"Reserved for you"
A message that adheres to the following core concepts: - Make participant aware that the test is available, and the clinic is welcoming the participant to receive it - "VIP status-" the participant is lucky/special to have this opportunity
干预措施: Reserved for you messaging (Behavioral)
Social norms- default messenger
A message that adheres to the following core concepts: - Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested - Leverages social pressure to participate in retesting - Uses a relatable community member to deliver the message. Message delivered by the default avatar.
干预措施: Social norms (default) messaging (Behavioral)
Social norms- varied messenger
A message that adheres to the following core concepts: - Reduce stigma and normalize retesting by explaining that it is a common practice for people to be aware of their HIV status and get tested often when they are at risk - Leverages social pressure to participate in retesting - Uses a relatable community member to deliver the message. Message delivered by avatar that approximately matches the participant's age and sex
干预措施: Social norms (varied) messaging (Behavioral)
Goal-setting
A message that adheres to the following core concepts: -Encouraging motivation of participants to set a goal for follow-up testing -Empowering individuals through promotion of HIV retesting
干预措施: Goal-setting messaging (Behavioral)
Incentive
Participants receive a small financial incentive for returning for a repeat HIV test within 3-6 months from enrollment
干预措施: Incentive (Behavioral)
Standard of care (Control)
Participants will receive standard of care messaging provided by Ministry of Health (MoH) HIV testing counselors.
结局指标
主要结局
HIV retesting uptake
时间窗: Measured 3-6 months after baseline visit
The proportion of participants in each study arm who return for repeat HIV testing within 3-6 months after the baseline visit.
次要结局
- PrEP uptake at follow up(3-6 months)