HivNCT03185975
Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
A study testing at-home test kit and Motivational Interviewing and Certified Testing and Referral in people with Hiv and Transgender Youth, run by University of Michigan at 1 site in United States.
Trial summary
This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv, Transgender Youth
- What is being tested?
- at-home test kit and Motivational Interviewing and Certified Testing and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2017to 30 Sep 2019
- 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 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male sex at birth, identifies as female, trans feminine, trans woman, female
- female sex at birth, identifies as male, trans male, trans masculine, male
- agender, genderfluid, genderqueer
- between the ages of 15-24,
- negative or unknown HIV status and not having tested in the least 3 months
- willingness to have HIV test kit delivered to an address they provide
Show all 9Show fewer
- wilingness to be tested for HIV
- willingness to be randomized to either study arm
- willingness and ability to participate in video-based counseling (must have a computer or tablet with video and audio capabilities, internet access)
Who cannot join
- same sex assigned at birth and currently identifies as that same sex
- aged 14 years or younger, or 25 years or older
- reports having a positive HIV status during the baseline survey or screener survey before testing unwillingness to have HIV test kit delivered to an address they provide
- unwillingness to test for HIV
- unwillingness to be randomized
- unwillingness or inability to participate in video-based counseling
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Center for Sexuality and Health Disparities
Ann Arbor, Michigan, 49109
About this study
This research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.
- Conditions
- Hiv, Transgender Youth
- Being tested
- at-home test kit, Motivational Interviewing and Certified Testing and Referral
- Keywords
- HIV, transgender, trans, youth, home testing
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
at-home test kitBehavioural
Transgender youth in the control arm will receive test kits, but will not receive any testing intervention. Once individual results are reported, participants will be contacted via phone or email by study staff with options for referrals to services. Participants will complete follow-up surveys at 3, 6, 9, and 12 months post-testing.
Motivational Interviewing and Certified Testing and ReferralBehavioural
Also called MICTR MI/CTR
Transgender individuals randomized to the experimental group (MI/CTR) will receive HIV counseling and testing via an online, HIPPA-compliant videoconferencing service. The session will last less than one hour and focus on HIV testing, prevention strategies, and/or linkage to HIV care, depending on the individual's test results. Participants will complete follow up surveys at 3, 6, 9 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Each participant will receive an at-home test kit and will be asked to test and return results to investigator. Receives: Behavioral: at-home test kit |
| Intervention Arm | Active comparator | Each participant will receive an at-home test kit and will be asked to take the test in conjunction with an online Motivational interviewing/certified testing and referral (MI/CTR). Receives: Behavioral: Motivational Interviewing and Certified Testing and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase uptake of HIV testing for transgender youth
Assess differences and changes in TY's sexual-risk behaviors between those who receive the home-testing with video-based MI/CTR (intervention arm) compared to those who receive the home-testing alone (control arm). 200 TY (100 male: 100 female) will be randomized to either the intervention or control arm and followed for 6 months with surveys taken at baselines and months 3, 6, 9 and 12 months.
Measured: 1 year
Secondary outcomes (2)
Changes in Sexual Behavior
We measure changes in sexual behavior using behavioral measures based on information collected from the baseline survey, MI/CTR session for the intervention arm participants, and subsequent surveys each 3 months until one year from the initial survey has occurred.
Measured: 1 year.
Linkage to Care
We will measure linkage to care with the following outcomes as indicators per the recent recommendations of the Institute of Medicine and CDC: within 3 months of HIV diagnosis, attending at least one clinical care appointment, having at least one CD4 test performed and having at least one viral load test performed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start19 Jun 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Stephenson, University of Michigan
- Investigators
- Rob Stephenson, PhD, Principal investigator, University of Michigan Center for Sexuality & Health Disparities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185975
- Sponsor's protocol ID
- HUM00123412
- Status last verified
- Oct 2019
- First submitted
- 11 Jun 2017
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Stephenson R, Todd K, Kahle E, Sullivan SP, Miller-Perusse M, Sharma A, Horvath KJ. Project Moxie: Results of a Feasibility Study of a Telehealth Intervention to Increase HIV Testing Among Binary and Nonbinary Transgender Youth. AIDS Behav. 2020 May;24(5):1517-1530. doi: 10.1007/s10461-019-02741-z.
PubMed 31760536Stephenson R, Metheny N, Sharma A, Sullivan S, Riley E. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 28;6(11):e237. doi: 10.2196/resprot.8562.
PubMed 29183868
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Online Counseling for Home-Based HIV Testing With Transgender Youth
- ClinicalTrials.gov ID
- NCT03185975
- Acronym / sponsor ID
- HUM00123412
- Conditions
- Hiv, Transgender Youth
- Keywords
- HIV, transgender, trans, youth, home testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Jun 2017 (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 research study will recruit 200 transgender youths between the ages of 15-24. There are two arms to the research study: the control and the intervention arm. Each eligible participant will be randomized into either arm. The control arm participants receive an OraQuick HIV testing kit sent to an address of their choice and instructions of how to conduct the test. They will enter their results on the research study website and complete surveys at 3 month intervals until an entire year has passed. Participants in the intervention arm will receive an OraQuick HIV testing kit sent to them and will receive video-based counseling called Motivational Interviewing and Certified Testing and Referral. After this counseling session, the results from the OraQuick HIV test will be logged by study staff. Then, participants in the intervention arm will fill out surveys at 3 month intervals until a year has passed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Behavioral: at-home test kitEach participant will receive an at-home test kit and will be asked to test and return results to investigator. |
| Intervention Arm | Active comparator | Behavioral: Motivational Interviewing and Certified Testing and ReferralEach participant will receive an at-home test kit and will be asked to take the test in conjunction with an online Motivational interviewing/certified testing and referral (MI/CTR). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- male sex at birth, identifies as female, trans feminine, trans woman, female
- female sex at birth, identifies as male, trans male, trans masculine, male
- agender, genderfluid, genderqueer
- between the ages of 15-24,
- negative or unknown HIV status and not having tested in the least 3 months
Key exclusion criteria (6 listed)
- same sex assigned at birth and currently identifies as that same sex
- aged 14 years or younger, or 25 years or older
- reports having a positive HIV status during the baseline survey or screener survey before testing unwillingness to have HIV test kit delivered to an address they provide
- unwillingness to test for HIV
- unwillingness to be randomized
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 |
|---|---|---|
| at-home test kitTransgender youth in the control arm will receive test kits, but will not receive any testing intervention. Once individual results are reported, participants will be contacted via phone or email by study staff with options for referrals to services. Participants will complete follow-up surveys at 3, 6, 9, and 12 months post-testing. | Behavioural | Control arm |
| Motivational Interviewing and Certified Testing and ReferralAlso: MICTR MI/CTRTransgender individuals randomized to the experimental group (MI/CTR) will receive HIV counseling and testing via an online, HIPPA-compliant videoconferencing service. The session will last less than one hour and focus on HIV testing, prevention strategies, and/or linkage to HIV care, depending on the individual's test results. Participants will complete follow up surveys at 3, 6, 9 and 12 months. | Behavioural | Intervention Arm |
Primary outcome
Increase uptake of HIV testing for transgender youth
Time frame: 1 year
Assess differences and changes in TY's sexual-risk behaviors between those who receive the home-testing with video-based MI/CTR (intervention arm) compared to those who receive the home-testing alone (control arm). 200 TY (100 male: 100 female) will be randomized to either the intervention or control arm and followed for 6 months with surveys taken at baselines and months 3, 6, 9 and 12 months.
2 secondary outcomes
Changes in Sexual Behavior
Time frame: 1 year.
Linkage to Care
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Derived from this study: PubMed 31760536Stephenson R, Todd K, Kahle E, Sullivan SP, Miller-Perusse M, Sharma A, Horvath KJ. Project Moxie: Results of a Feasibility Study of a Telehealth Intervention to Increase HIV Testing Among Binary and Nonbinary Transgender Youth. AIDS Behav. 2020 May;24(5):1517-1530. doi: 10.1007/s10461-019-02741-z.
- Derived from this study: PubMed 29183868Stephenson R, Metheny N, Sharma A, Sullivan S, Riley E. Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2017 Nov 28;6(11):e237. doi: 10.2196/resprot.8562.
- Individual participant dataSharing planned: Yes
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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.
Rob Stephenson, PhD principal investigator
University of Michigan Center for Sexuality & Health Disparities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing at-home test kit and Motivational Interviewing and Certified Testing and Referral in people with Hiv and Transgender Youth, run by University of Michigan 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 21 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase uptake of HIV testing for transgender youth (time frame: 1 year). 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 NCT03185975, which also lists 2 linked publications.
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 21 Oct 2019.