HIV PreventionNCT07011563
Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health
A study testing Intervention in people with HIV Prevention and Sexual Health, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Sexual Health
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 14-17
- Assigned male
- Oral OR anal sex with an assigned male
- Live in the United States
- English-speaking
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02906
Jack Rusley, MD, MHS, 401-444-5980, jack.rusley@brownhealth.org
About this study
The goal of this study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.
- Conditions
- HIV Prevention, Sexual Health
- Being tested
- Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Youth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, b) individualized information about HIV risk reduction including PrEP, and c) use of motivational interviewing strategies to discuss barriers to PrEP.
Parents: brief (~20-30 min) web-based, interactive learning module ("module") designed to provide information about sexual health communication (SHC) best practices, HIV prevention strategies (e.g., condoms, STI testing, PrEP), as well as build practical skills around SHC using evidence-based behavior change methods (e.g., building confidence, aligning values with actions).
ControlBehavioural
Youth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, and b) didactic information about condom use, STI testing (including HIV), and PrEP (but not motivational interviewing or individualized information on HIV risk reduction).
Parent: brief written information on a digital platform (i.e., website) with advice about talking to youth about sexual health with web-links to resources about STI/HIV prevention and PrEP. This information will not be interactive or use behavior change methods.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Intervention |
| Treatment as usual + | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual health communication scale score - youth
We will administer the SHC scale to youth as a survey
Measured: 4 weeks
Sexual health communication scale score - parent
We will administer the SHC scale to parent as a survey
Measured: 4 weeks
Secondary outcomes (1)
PrEP uptake
Self-reported initiation of PrEP by youth
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2025
- Study start16 May 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jack Rusley, Rhode Island Hospital
- Investigators
- Jack Rusley, MD, MHS, Principal investigator, Brown University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011563
- Sponsor's protocol ID
- 1554023
- Other IDs
- K23MH123335
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 9 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prepping for The Talk: Helping Trusted Adults and Youth Talk About Sexual Health
- ClinicalTrials.gov ID
- NCT07011563
- Acronym / sponsor ID
- 1554023
- Conditions
- HIV Prevention, Sexual Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 9 Jun 2025 (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 study is to help young people talk to trusted adults (including their parents, but also other adults) about sexual health more openly and honestly- including how to prevent sexually transmitted diseases like HIV - while also respecting a young person's right to privacy. If youth don't have a parent they can talk to about sexual health, we want to help them find a trusted adult to talk to. We also want to help youth take control of their own health by learning about different ways to protect their health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention |
| Treatment as usual + | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 14-17
- Assigned male
- Oral OR anal sex with an assigned male
- Live in the United States
- English-speaking
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| InterventionYouth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, b) individualized information about HIV risk reduction including PrEP, and c) use of motivational interviewing strategies to discuss barriers to PrEP. Parents: brief (~20-30 min) web-based, interactive learning module ("module") designed to provide information about sexual health communication (SHC) best practices, HIV prevention strategies (e.g., condoms, STI testing, PrEP), as well as build practical skills around SHC using evidence-based behavior change methods (e.g., building confidence, aligning values with actions). | Behavioural | Intervention |
| ControlYouth: interventionist-facilitated 1:1 conversation with the youth via videoconference that includes a) brief sexual health assessment, and b) didactic information about condom use, STI testing (including HIV), and PrEP (but not motivational interviewing or individualized information on HIV risk reduction). Parent: brief written information on a digital platform (i.e., website) with advice about talking to youth about sexual health with web-links to resources about STI/HIV prevention and PrEP. This information will not be interactive or use behavior change methods. | Behavioural | Treatment as usual + |
Primary outcome
Sexual health communication scale score - youth
Time frame: 4 weeks
We will administer the SHC scale to youth as a survey
Sexual health communication scale score - parent
Time frame: 4 weeks
We will administer the SHC scale to parent as a survey
1 secondary outcome
PrEP uptake
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2025.
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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.
Jack Rusley, MD, MHS principal investigator
Brown University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with HIV Prevention and Sexual Health, run by Rhode Island Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 9 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jack Rusley, MD, MHS (401-444-5980, jack.rusley@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual health communication scale score - youth (time frame: 4 weeks). 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 9 Jun 2025.