PreventionNCT05016232
Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women
A study testing PrEP N' Shine: Strength Based Case Management (Stage 1) and PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) in people with Prevention, run by University of California, Los Angeles at 1 site in United States.
Trial summary
"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention
- What is being tested?
- PrEP N' Shine: Strength Based Case Management (Stage 1) and PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 30 Jun 2024
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Male sex at birth
- Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
- PrEP naïve
- PrEP indicated per CDC guidelines (incl. HIV negative)
- Owns a cell phone or willing to use one in the study
- Able to understand and speak English or Spanish
Who cannot join
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
- Has lived in RI for less than three months (as a means to enhance participant retention)
- Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for LGBTQ+ Advocacy, Research & Health
Los Angeles, California, 90095
About this study
Official title: Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).
Read the detailed description
The "PrEP N' Shine" package includes two behavioral intervention components:
- Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and
- A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use.
Stage 1: TGW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEP N' Shine" adherence intervention or standard of care comparison condition.
- Conditions
- Prevention
- Being tested
- PrEP N' Shine: Strength Based Case Management (Stage 1), PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)
- Keywords
- Transgender women (TGW), HIV Prevention, PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP N' Shine: Strength Based Case Management (Stage 1)Behavioural
Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)Behavioural
- Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
- Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
| Study group | Role | What they receive |
|---|---|---|
| Strength Based Case Management (SBCM) & PrEP adherence training and counseling | Experimental | Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
Stage 2: Stepped Intervention:
1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist. Receives: Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1); Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) |
| Standard of Care:Stage 1 and Stage 2 | No intervention | Stage 1: Referral to local PrEP clinic Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verified medical visit and PrEP prescription
Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.
Measured: Stage 1: one month post-baseline
Concentrations of TFV-DP in Dried Blood Spots at 3 months
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence.
Measured: Stage 2: 3 months post-baseline
Concentrations of TFV-DP in Dried Blood Spots at 6 months
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence
Measured: Stage 2: 6 months post-baseline
Secondary outcomes (1)
Change in sexual risk behavior based on self report
Change in sexual risk behavior to be measured using AIDS-Risk Behavior Assessment (ARBA), a computerized self-interview designed to assess self-reported sexual behaviors. Sexual risk questions refer to three types of sexual behavior (anal, oral, vaginal) and assess detailed sexual risk information by partner type (transactional, casual, main) and by HIV-status, whether protected or unprotected, and whether in the context of substance use in past 3 months.
Measured: Stage 2: Change from baseline sexual risk behavior at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start18 Oct 2022
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles
- Investigators
- Matthew Mimiaga, ScD, MPH, MA, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016232
- Sponsor's protocol ID
- 1R34MH122499-01A1
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing an Adaptive Intervention to Facilitate PrEP Uptake and Maximize PrEP Adherence Among At-Risk Transgender Women
- ClinicalTrials.gov ID
- NCT05016232
- Acronym / sponsor ID
- 1R34MH122499-01A1
- Conditions
- Prevention
- Keywords
- Transgender women (TGW), HIV Prevention, PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 23 Aug 2021 (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.
"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).
Detailed description
The "PrEP N' Shine" package includes two behavioral intervention components:
- Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and
- A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use.
Stage 1: TGW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.
Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEP N' Shine" adherence intervention or standard of care comparison condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Based Case Management (SBCM) & PrEP adherence training and counseling | Experimental | Behavioral: PrEP N' Shine: Strength Based Case Management (Stage 1), Behavioral: PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. Stage 2: Stepped Intervention: 1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist. |
| Standard of Care:Stage 1 and Stage 2 | No intervention | –Stage 1: Referral to local PrEP clinic Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years or older
- Male sex at birth
- Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
- PrEP naïve
- PrEP indicated per CDC guidelines (incl. HIV negative)
Key exclusion criteria (4 listed)
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
- Has lived in RI for less than three months (as a means to enhance participant retention)
- Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
- Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)
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 |
|---|---|---|
| PrEP N' Shine: Strength Based Case Management (Stage 1)Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. | Behavioural | Strength Based Case Management (SBCM) & PrEP adherence training and counseling |
| PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)1. Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and 2. Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist. | Behavioural | Strength Based Case Management (SBCM) & PrEP adherence training and counseling |
Primary outcome
Verified medical visit and PrEP prescription
Time frame: Stage 1: one month post-baseline
Linkage to care and PrEP Initiation measured through verified medical appointment at PrEP Clinic and pharmacy through medical release.
Concentrations of TFV-DP in Dried Blood Spots at 3 months
Time frame: Stage 2: 3 months post-baseline
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence.
Concentrations of TFV-DP in Dried Blood Spots at 6 months
Time frame: Stage 2: 6 months post-baseline
Dried Blood Spots (DBS) to be sent to the laboratory to test for tenofovir-diphosphate (700+ fmol/punch - corresponding to levels that are consistent with taking 4+ pills per week), which will serve as a biological measure of PrEP adherence
1 secondary outcome
Change in sexual risk behavior based on self report
Time frame: Stage 2: Change from baseline sexual risk behavior at 6 months
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 25 Jul 2024.
- Individual participant dataSharing planned: Yes. It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
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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.
Matthew Mimiaga, ScD, MPH, MA principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP N' Shine: Strength Based Case Management (Stage 1) and PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2) in people with Prevention, run by University of California, Los Angeles 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 4 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 25 Jul 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 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?
Verified medical visit and PrEP prescription (time frame: Stage 1: one month post-baseline). 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?
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 25 Jul 2024.