Evaluation of Unstained

The Policy & Research Group

Status: Enrolling

Conditions: Teen Pregnancy Prevention

Treatments: Behavioral: Unstained; Behavioral: Like

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06574139

1 TP2AH000085-01-00

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 14 to 22 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Unstained

Experimental group

Treatment:

Behavioral: Unstained

Like

Sham Comparator group

Treatment:

Behavioral: Like