Clinical trial NCT06574139: Evaluation of Unstained
Official title: Evaluation of Unstained
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Mathematica Policy Research, Inc.
name: Reproductive Health National Training Center
name: PCI Media
First posted: 2024-08-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Receipt of sexually transmitted infection (STI) testing in the past four months
timeFrame: Assessed three months after the intervention period has ended (five months post-baseline)
measure: Times having vaginal and anal sex without condoms in the past four months
timeFrame: Assessed nine months after the intervention period has ended (11 months post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Sarah Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: