Evaluation of Unstained
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 1,500
- Locations
- 3
- Primary Endpoint
- Receipt of sexually transmitted infection (STI) testing in the past four months
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Unstained
Intervention: Unstained (Behavioral)
Like
Intervention: Like (Behavioral)
Outcomes
Primary Outcomes
Receipt of sexually transmitted infection (STI) testing in the past four months
Time Frame: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.
Times having vaginal and anal sex without condoms in the past four months
Time Frame: Assessed nine months after the intervention period has ended (11 months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Receipt of sexually transmitted infection (STI) testing in the past four months
Time Frame: Assessed three months after the intervention period has ended (five months post-baseline)
Participants are asked the following item: 1\) Have you been tested for sexually transmitted infections (STIs) in the past 4 months? The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has not received STI testing in the past four months and 1 indicates a person who has received STI testing in the past four months.
Times having vaginal and anal sex without condoms in the past four months
Time Frame: Assessed nine months after the intervention period has ended (11 months post-baseline)
Participants are asked the following two items: 1. In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom? 2. In the past 4 months, how many times have you had anal sex without you or your sexual partner using a condom? The resulting variable is continuous with values that range from 0 to k, where 0 indicates that a person has not engaged in vaginal and anal sex without a condom in the past four months, and k indicates the number of times the person has engaged in vaginal and anal sex without a condom in the past four months.
Secondary Outcomes
No secondary outcomes reported