Evaluation of Unstained

Обзор

The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 22 years old who are at risk for or involved in the legal system. The primary research questions it aims to answer are: * Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months? Researchers will compare participants randomized to receive Unstained (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Подробное описание

This is an individual-level, randomized control trial to rigorously evaluate the impact of the Unstained intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at three time points: baseline (enrollment); three months post-intervention (five months after baseline); and nine months post-intervention (eleven months after baseline).

Вмешательства

• Поведенческое Unstained
  Unstained is an individual-level, virtual intervention that involves three \~60-minute sessions delivered over a 3-6 week period. Each session includes watching two videos (six videos total), followed by a discussion facilitated by study coordinators.
• Поведенческое Like
  Like is an hour-long film that discusses the impact of social media on the brain. Participants will receive a link to the film and will be asked to watch it independently. The film does not include information related to the outcomes of interest for the study.

Первичные конечные точки

• Receipt of sexually transmitted infection (STI) testing in the past four months [Срок оценки: Assessed three months after the intervention period has ended (five months post-baseline)]
• Times having vaginal and anal sex without condoms in the past four months [Срок оценки: Assessed nine months after the intervention period has ended (11 months post-baseline)]

Критерии участия

Критерии включения

• United States resident
• Owns or has regular access to a personal device with internet access
• Comfortable reading, speaking, and writing in English
• Has had vaginal or anal sex in the past 3 months
• At risk for or involved in the legal system

Критерии исключения

• Currently trying to start a pregnancy
• Currently in jail or being detained in a facility
• Enrolled in an ongoing PRG-run TPP study
• Identified as fraudulent
• Participating in another known OPA-funded research study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The Policy & Research Group — New Orleans

Идентификаторы

NCT: NCT06574139 · 1 TP2AH000085-01-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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