HIVNCT06096519
Effectiveness and Implementation of Text Messaging to Improve HIV Testing in Adolescents
A study testing Information, motivation, behavioral skills treatment arm in people with HIV, run by Northwestern University at 1 site in United States.
Trial summary
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-19 year old). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Information, motivation, behavioral skills treatment arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 1 May 2027
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Have penetrative or oral sex in their lifetime
- 13-19 years old
- reads in English at a 8th grade level
- HIV negative or unknown status
- own a cell phone with an unlimited MMS plan and plan to have the same number during the study
- can provide informed assent, as shown on a capacity to consent assessment
- live in the U.S. or territories.
Who cannot join
- Previous lifetime testing for HIV or an STI OR no testing since last sexual experience
- HIV positive
- Currently on PrEP
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Adolescents
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-19 year old). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
Read the detailed description
Adolescents (ages 13-19) are disproportionately affected by HIV, accounting for 21% of all new infections in the U.S. in 2019. Although CDC and USPTF recommend HIV screening among adolescents, testing rates are very low (<10% have ever been tested). Furthermore, in the U.S., 44% of 13-24-year-olds who are HIV-positive are unaware of their status - the highest percentage of undiagnosed infections of all age groups.
As such there is a need for interventions that aim to increase HIV testing in adolescents. This study builds upon the work of a previous text-based sexual health intervention program called G2G. The G2G pilot randomized controlled trial showed adolescents in the active treatment arm were >3x more likely to report being tested for HIV at follow-up compared to those in the control arm. Given the success of HIV testing behaviors in G2G this current study will aim to update G2G with the latest HIV prevention and testing science, tailor the intervention content so it is modern and inclusive of all adolescents, and test its effectiveness on the outcome of validated HIV testing (e.g., photo of HIV test result). We will test this in a nationwide randomized controlled trial with 360 adolescents aged 13-19.
The primary efficacy outcome measure is HIV/STI testing via self report and objective evidence (e.g., photo of their test results) at 3 month and 6 month follow up surveys. Our study hypothesizes that participants assigned to the treatment arm of the intervention will have higher odds of having received an HIV test at 3 and 6 month follow up compared to those in the control arm. Ultimately, increased HIV testing in this group will mitigate transmission rates and improve the HIV prevention and care continua in this population.
- Conditions
- HIV
- Being tested
- Information, motivation, behavioral skills treatment arm, Information only control arm
- Keywords
- Human immunodeficiency virus, Adolescents, Sexually transmitted infections, Sexual health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information, motivation, behavioral skills treatment armBehavioural
Also called Guy2Guy (G2G)
Our intervention will be an updated version of (Guy2Guy) G2G, a 2014 text messaging-based healthy sexuality and HIV prevention program specifically for adolescent males. The treatment arm of G2G was guided by the Information-Motivation-Behavioral Skills (IMB) model and proved to be efficacious at increasing HIV testing in 13-18 year old adolescent males. In this updated version we will continue to utilize the IMB model, but modernize the content to include updated HIV prevention information (e.g., novel methods of HIV testing, PrEP, PEP) and tailor the text-message content to meet the needs of all adolescents.
Information only control armBehavioural
This information only control arm will consist of content and text messages focused on health behavior information, including mood, sexual health, substance use, and other health behaviors. It will be identical in length to the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Information only control | Placebo comparator | The attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content). Receives: Behavioral: Information only control arm |
| Information, motivation, behavioral skills treatment arm | Experimental | The active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition. Receives: Behavioral: Information, motivation, behavioral skills treatment arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV/STI testing
Participants asked to self-report their history of HIV testing; scale item (No, I have never been tested for HIV/Yes, I have been tested HIV/ I do not know or not sure)
Measured: Baseline, 3-months post-intervention, 6-months post-intervention
Most recent HIV test
Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I did not get the result)
Measured: Baseline, 3-months post-intervention, 6-months post-intervention
Objective proof of HIV testing
Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image)
Measured: through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention
Secondary outcomes (5)
Lifetime STI testing
Participants asked to self-report their history of STI testing; outcomes assessed via scale items (No, I have never been tested for any STI/Yes, I have been tested for at least one STI/ I do not know or not sure)
Measured: Baseline, 3-months post-intervention, 6-months post-intervention
Lifetime number of sexual partners someone has had condom-less sex with
Incidence of Condomless Sex
Measured: baseline, 3-months post-intervention, 6-months post-intervention
Ever taken PrEP
Binary-scale item (yes/no)
Measured: baseline, 3-months post-intervention, 6-months post-intervention
Currently taking PrEP
Binary-scale item (yes/no)
Measured: baseline, 3-months post-intervention, 6-months post-intervention
Sexual Health Communications Scale
This is a 7-item select all that apply question which asks participants about their communicative experiences as an adolescent receiving services from medical healthcare providers, specifically around HIV testing, PrEP, STI and HIV prevention. Question adapted from the Sexual Health Communications Scale (Fisher et al., 2018). More selected options indicate better outcomes.
Measured: baseline, 3-months post-intervention, 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start13 Jun 2024
- Primary completion2 Jul 2026
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kathryn Macapagal, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096519
- Sponsor's protocol ID
- STU00217358
- Other IDs
- 5R01MH129207
- Status last verified
- Jul 2026
- First submitted
- 18 May 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macapagal K, Alvarado Avila A, Buehler ZM, Gordon J, Knapp A, Hurtado M Jr, Lorenzo J, Foran J, Newcomb ME, Mustanski B, Li DH, Swann G, Paton MJ, Saber R, Casline E. Evaluating a Multimedia Messaging Intervention to Increase Adolescent HIV Testing: Protocol for a Hybrid Type 1 Effectiveness Implementation Study. JMIR Res Protoc. 2026 May 18;15:e88465. doi: 10.2196/88465.
PubMed 42149818
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Adolescents
- ClinicalTrials.gov ID
- NCT06096519
- Acronym / sponsor ID
- STU00217358
- Conditions
- HIV
- Keywords
- Human immunodeficiency virus, Adolescents, Sexually transmitted infections, Sexual health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Oct 2023 (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.
This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-19 year old). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
Detailed description
Adolescents (ages 13-19) are disproportionately affected by HIV, accounting for 21% of all new infections in the U.S. in 2019. Although CDC and USPTF recommend HIV screening among adolescents, testing rates are very low (<10% have ever been tested). Furthermore, in the U.S., 44% of 13-24-year-olds who are HIV-positive are unaware of their status - the highest percentage of undiagnosed infections of all age groups.
As such there is a need for interventions that aim to increase HIV testing in adolescents. This study builds upon the work of a previous text-based sexual health intervention program called G2G. The G2G pilot randomized controlled trial showed adolescents in the active treatment arm were >3x more likely to report being tested for HIV at follow-up compared to those in the control arm. Given the success of HIV testing behaviors in G2G this current study will aim to update G2G with the latest HIV prevention and testing science, tailor the intervention content so it is modern and inclusive of all adolescents, and test its effectiveness on the outcome of validated HIV testing (e.g., photo of HIV test result). We will test this in a nationwide randomized controlled trial with 360 adolescents aged 13-19.
The primary efficacy outcome measure is HIV/STI testing via self report and objective evidence (e.g., photo of their test results) at 3 month and 6 month follow up surveys. Our study hypothesizes that participants assigned to the treatment arm of the intervention will have higher odds of having received an HIV test at 3 and 6 month follow up compared to those in the control arm. Ultimately, increased HIV testing in this group will mitigate transmission rates and improve the HIV prevention and care continua in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information only control | Placebo comparator | Behavioral: Information only control armThe attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content). |
| Information, motivation, behavioral skills treatment arm | Experimental | Behavioral: Information, motivation, behavioral skills treatment armThe active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Have penetrative or oral sex in their lifetime
- 13-19 years old
- reads in English at a 8th grade level
- HIV negative or unknown status
- own a cell phone with an unlimited MMS plan and plan to have the same number during the study
Key exclusion criteria (3 listed)
- Previous lifetime testing for HIV or an STI OR no testing since last sexual experience
- HIV positive
- Currently on PrEP
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 |
|---|---|---|
| Information, motivation, behavioral skills treatment armAlso: Guy2Guy (G2G)Our intervention will be an updated version of (Guy2Guy) G2G, a 2014 text messaging-based healthy sexuality and HIV prevention program specifically for adolescent males. The treatment arm of G2G was guided by the Information-Motivation-Behavioral Skills (IMB) model and proved to be efficacious at increasing HIV testing in 13-18 year old adolescent males. In this updated version we will continue to utilize the IMB model, but modernize the content to include updated HIV prevention information (e.g., novel methods of HIV testing, PrEP, PEP) and tailor the text-message content to meet the needs of all adolescents. | Behavioural | Information, motivation, behavioral skills treatment arm |
| Information only control armThis information only control arm will consist of content and text messages focused on health behavior information, including mood, sexual health, substance use, and other health behaviors. It will be identical in length to the intervention arm. | Behavioural | Information only control |
Primary outcome
HIV/STI testing
Time frame: Baseline, 3-months post-intervention, 6-months post-intervention
Participants asked to self-report their history of HIV testing; scale item (No, I have never been tested for HIV/Yes, I have been tested HIV/ I do not know or not sure)
Most recent HIV test
Time frame: Baseline, 3-months post-intervention, 6-months post-intervention
Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I did not get the result)
Objective proof of HIV testing
Time frame: through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention
Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image)
5 secondary outcomes
Lifetime STI testing
Time frame: Baseline, 3-months post-intervention, 6-months post-intervention
Lifetime number of sexual partners someone has had condom-less sex with
Time frame: baseline, 3-months post-intervention, 6-months post-intervention
Ever taken PrEP
Time frame: baseline, 3-months post-intervention, 6-months post-intervention
Currently taking PrEP
Time frame: baseline, 3-months post-intervention, 6-months post-intervention
Sexual Health Communications Scale
Time frame: baseline, 3-months post-intervention, 6-months post-intervention
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 Jul 2026.
- Derived from this study: PubMed 42149818Macapagal K, Alvarado Avila A, Buehler ZM, Gordon J, Knapp A, Hurtado M Jr, Lorenzo J, Foran J, Newcomb ME, Mustanski B, Li DH, Swann G, Paton MJ, Saber R, Casline E. Evaluating a Multimedia Messaging Intervention to Increase Adolescent HIV Testing: Protocol for a Hybrid Type 1 Effectiveness Implementation Study. JMIR Res Protoc. 2026 May 18;15:e88465. doi: 10.2196/88465.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information, motivation, behavioral skills treatment arm in people with HIV, run by Northwestern University 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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?
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?
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?
HIV/STI testing (time frame: Baseline, 3-months post-intervention, 6-months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096519, which also lists 1 linked publication.
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 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.