HIV PreventionNCT03856580
Long-acting Biomedical HIV Prevention in Transgender Women
A study testing Alternative long-acting PrEP injection strategies and mHealth adherence app in people with HIV Prevention and Transgender Women, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Transgender Women
- What is being tested?
- Alternative long-acting PrEP injection strategies and mHealth adherence app
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2020to 30 Apr 2023
- 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 18 to 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-negative
- self-identified transgender woman (or woman assigned male at birth)
- at least 18 years old
- willing to complete injections
- own a smartphone that uses apps
- speak English or Spanish
Show all 9Show fewer
- willing to take an HIV test
- live in the NYC/tri-state area
- report receptive or penetrative genital-to-genital sex with another person in the last 3 months
Who cannot join
- HIV-positive
- does not identify as a transgender woman (or woman assigned male at birth)
- younger than 18
- unwilling to complete injections
- does not own a smartphone that uses apps
- does not speak English or Spanish
Show all 9Show fewer
- refuses HIV test
- lives outside of the NYC/tri-state area
- has not had receptive or penetrative genital-to-genital sex with another person in the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute/Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Developing Tailored Delivery and Adherence Interventions for Use of Long-acting Biomedical HIV Prevention Strategies by Transgender Women
Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. This study will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study to identify tailored methods to deliver injectable cabotegravir in TW, such as self-injection and injection by a healthcare provider at at "drop-in" clinic. The investigators will use qualitative methods (e.g., interviews, group discussions called "Design Sessions") to design the adherence intervention and the mHealth app. Then, investigators will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (self-injection or injection by a healthcare provider at "drop-in clinics") to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a "proof of concept" for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible).
- Conditions
- HIV Prevention, Transgender Women
- Being tested
- Alternative long-acting PrEP injection strategies, mHealth adherence app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative long-acting PrEP injection strategiesBehavioural
Participants in the two intervention groups will complete injection procedures (e.g., self-injection, injection by healthcare providers at "drop-in" clinics) to determine if this could facilitate improved adherence to an inert version of long-acting cabotegravir injections
mHealth adherence appBehavioural
Participants in the two experimental arms will be given a smartphone application, designed to facilitate adherence (this app will be developed during earlier phases of the study using in-depth interviews and "design session" groups)
| Study group | Role | What they receive |
|---|---|---|
| Self-injection | Experimental | Participants will be trained on how to self-inject (intramuscular, gluteal muscle) an inert version of injectable cabotegravir. The inert substance is intended to mimic injectable cabotegravir as closely as possible (e.g., injection equipment, location of injection, volume of injection is identical to injectable cabotegravir). Specifically, participants will self-inject their choice of 300mg vitamin B12 or saline (3ml fluid) every 2 months for a total of 6 months (for a total of 4 injections). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as instructions on how to self-inject, FAQs about self-injection, study contact information, etc.. Receives: Behavioral: Alternative long-acting PrEP injection strategies; Behavioral: mHealth adherence app |
| Injection by HCP at "drop-in" clinics | Experimental | Participants will report to a "drop-in" clinic, where a healthcare provider will inject them with an inert version of injectable cabotegravir. "Visits will take <10 minutes, and participants will be able to come whenever they want (when their injection is due) during clinic "drop-in" hours, which will be staggered in 2-hour windows during each week day. The inert substance that will be injected is intended to mimic injectable cabotegravir as closely as possible (described above). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as "drop-in" clinic hours, directions to the "drop-in" clinic site, study contact information, etc... Receives: Behavioral: Alternative long-acting PrEP injection strategies; Behavioral: mHealth adherence app |
| Control group | No intervention | Participants will make an appointment when their injection is due to report to our clinic to complete injections. Visits and the injection protocol will follow similar procedures to HPTN-083/084. Participants will not have access to the mHealth adherence app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed injections at month 6
Number of completed injections by each of the possible intervention arms (self-injection, injection by HCP at "drop-in" clinics), compared to the controls group at month 6.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start23 Oct 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: New York State Psychiatric Institution-wide research pause affecting all studies
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.
- More trials run by University of Colorado, DenverThe 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Responsible party
- Sponsor
- Investigators
- Christine Rael, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856580
- Sponsor's protocol ID
- 21-3620tx
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Tailored Delivery and Adherence Interventions for Use of Long-acting Biomedical HIV Prevention Strategies by Transgender Women
- ClinicalTrials.gov ID
- NCT03856580
- Acronym / sponsor ID
- 21-3620tx
- Conditions
- HIV Prevention, Transgender Women
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New York State Psychiatric Institution-wide research pause affecting all studies
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- New York State Psychiatric Institute
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 27 Feb 2019 (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.
Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. This study will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study to identify tailored methods to deliver injectable cabotegravir in TW, such as self-injection and injection by a healthcare provider at at "drop-in" clinic. The investigators will use qualitative methods (e.g., interviews, group discussions called "Design Sessions") to design the adherence intervention and the mHealth app. Then, investigators will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (self-injection or injection by a healthcare provider at "drop-in clinics") to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a "proof of concept" for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-injection | Experimental | Behavioral: Alternative long-acting PrEP injection strategies, Behavioral: mHealth adherence appParticipants will be trained on how to self-inject (intramuscular, gluteal muscle) an inert version of injectable cabotegravir. The inert substance is intended to mimic injectable cabotegravir as closely as possible (e.g., injection equipment, location of injection, volume of injection is identical to injectable cabotegravir). Specifically, participants will self-inject their choice of 300mg vitamin B12 or saline (3ml fluid) every 2 months for a total of 6 months (for a total of 4 injections). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as instructions on how to self-inject, FAQs about self-injection, study contact information, etc.. |
| Injection by HCP at "drop-in" clinics | Experimental | Behavioral: Alternative long-acting PrEP injection strategies, Behavioral: mHealth adherence appParticipants will report to a "drop-in" clinic, where a healthcare provider will inject them with an inert version of injectable cabotegravir. "Visits will take <10 minutes, and participants will be able to come whenever they want (when their injection is due) during clinic "drop-in" hours, which will be staggered in 2-hour windows during each week day. The inert substance that will be injected is intended to mimic injectable cabotegravir as closely as possible (described above). Participants will complete interviews and brief surveys on their experience. Additionally, they will be given access to an mHealth app to improve adherence, which will contain informational content such as "drop-in" clinic hours, directions to the "drop-in" clinic site, study contact information, etc... |
| Control group | No intervention | –Participants will make an appointment when their injection is due to report to our clinic to complete injections. Visits and the injection protocol will follow similar procedures to HPTN-083/084. Participants will not have access to the mHealth adherence app. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-negative
- self-identified transgender woman (or woman assigned male at birth)
- at least 18 years old
- willing to complete injections
- own a smartphone that uses apps
Key exclusion criteria (9 listed)
- HIV-positive
- does not identify as a transgender woman (or woman assigned male at birth)
- younger than 18
- unwilling to complete injections
- does not own a smartphone that uses apps
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 |
|---|---|---|
| Alternative long-acting PrEP injection strategiesParticipants in the two intervention groups will complete injection procedures (e.g., self-injection, injection by healthcare providers at "drop-in" clinics) to determine if this could facilitate improved adherence to an inert version of long-acting cabotegravir injections | Behavioural | Injection by HCP at "drop-in" clinics, Self-injection |
| mHealth adherence appParticipants in the two experimental arms will be given a smartphone application, designed to facilitate adherence (this app will be developed during earlier phases of the study using in-depth interviews and "design session" groups) | Behavioural | Injection by HCP at "drop-in" clinics, Self-injection |
Primary outcome
Number of completed injections at month 6
Time frame: 6 months
Number of completed injections by each of the possible intervention arms (self-injection, injection by HCP at "drop-in" clinics), compared to the controls group at month 6.
Results and safety
The study was stopped early (reason given: New York State Psychiatric Institution-wide research pause affecting all studies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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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.
Christine Rael, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative long-acting PrEP injection strategies and mHealth adherence app in people with HIV Prevention and Transgender Women, run by University of Colorado, Denver 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 9 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: stopped early, as of the sponsor's last update on 4 Oct 2024. 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?
The study was stopped early (reason given: New York State Psychiatric Institution-wide research pause affecting all studies). 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?
Number of completed injections at month 6 (time frame: 6 months). 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 4 Oct 2024.