Teen Pregnancy PreventionNCT06574139
Evaluation of Unstained
A study testing Unstained and Like in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Unstained and Like
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to 14 Sep 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Policy & Research Group
New Orleans, Louisiana, 70118
About this study
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?
Read more
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.
Read the 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).
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Unstained, Like
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnstainedBehavioural
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.
LikeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Unstained | Experimental | Not described Receives: Behavioral: Unstained |
| Like | Sham comparator | Not described Receives: Behavioral: Like |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of sexually transmitted infection (STI) testing in the past four months
Participants are asked the following item:
- 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.
Measured: 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
Participants are asked the following two items:
- In the past 4 months, how many times have you had vaginal sex without you or your sexual partner using a condom?
- 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.
Measured: Assessed nine months after the intervention period has ended (11 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start16 Sep 2024
- Primary completionMar 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Why it stopped: Grant funding was unexpectedly suspended by the U.S. Department of Health \& Human Services
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Tsikbal
- Responsible party
- Sponsor
- Investigators
- Sarah Walsh, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574139
- Sponsor's protocol ID
- 1 TP2AH000085-01-00
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Unstained
- ClinicalTrials.gov ID
- NCT06574139
- Acronym / sponsor ID
- 1 TP2AH000085-01-00
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Grant funding was unexpectedly suspended by the U.S. Department of Health \& Human Services
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Tsikbal
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstained | Experimental | Behavioral: Unstained |
| Like | Sham comparator | Behavioral: Like |
Who may qualify
- Ages
- 14 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UnstainedUnstained 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. | Behavioural | Unstained |
| LikeLike 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. | Behavioural | Like |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Walsh, PhD principal investigator
The Policy & Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstained and Like in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.