HIV SeronegativityNCT03191474
Linkage of Transgender Individuals to PrEP
A study testing T-POWr Intervention in people with HIV Seronegativity and Linkage, run by University of California, San Diego at 2 sites in United States.
Trial summary
CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Seronegativity, Linkage
- What is being tested?
- T-POWr Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2017to 31 Mar 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Self-identifies as a transgender or gender non-conforming person
- Self-identifies as HIV-negative or unknown status
- Ability to provide informed consent
- English or Spanish speaking
Who cannot join
- Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles Lesbian, Gay, Bisexual, and Transgender Center
Los Angeles, California, 90027
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
About this study
Official title: CCTG 602: Linkage of Transgender Individuals to PrEP, A Multicenter Trial of the California Collaborative Treatment Group (CCTG)
CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).
Read the detailed description
Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.
Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.
Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.
- Conditions
- HIV Seronegativity, Linkage
- Being tested
- T-POWr Intervention
- Keywords
- PrEP, Pre-exposure Prophylaxis, Truvada, Client-centered case management, Transgender, Gender non-conforming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-POWr InterventionBehavioural
All participants will be asked to complete a secure confidential online survey focusing on needs assessment.
Participants in the T-POWr Intervention Arm will receive a client-centered case management consultation based on how the participant responds to the online survey. The T-POWr will refer participants to assistance services based on the needs assessment, including accessing general health care, health insurance, hormone replacement therapy, housing, mental health care, domestic violence care, substance use treatment, etc. Each resource is extensively vetted to assure a trans-friendly experience and will be tailored to each geographic area across the project enrollment sites. The study facilitates referrals for services but will not provide extensive and ongoing case management.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | No intervention | Participants will receive standard of care HIV risk assessment, PrEP education, and an appointment for a PrEP evaluation visit at an affiliated clinic. |
| T-POWr Intervention Arm | Experimental | Participants will receive the same HIV risk assessment, PrEP education, and appointment for a PrEP evaluation visit as the Control Arm. Participants in the Intervention Arm will also receive a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services. Receives: Behavioral: T-POWr Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facilitated Linkage
To evaluate the effectiveness of a T-POWr intervention to effectively link transgender / gender non-conforming persons to a PrEP evaluation visit.
Measured: Baseline up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start28 Jul 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeronegativityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles LGBT Center
- Responsible party
- Principal investigator, Sheldon Morris, University of California, San Diego
- Investigators
- Sheldon Morris, MD MPH, Study chair, CCTG, UCSD AVRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191474
- Sponsor's protocol ID
- CCTG 602
- Status last verified
- Sep 2021
- First submitted
- 15 Jun 2017
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CCTG 602: Linkage of Transgender Individuals to PrEP, A Multicenter Trial of the California Collaborative Treatment Group (CCTG)
- ClinicalTrials.gov ID
- NCT03191474
- Acronym / sponsor ID
- CCTG 602
- Conditions
- HIV Seronegativity, Linkage
- Keywords
- PrEP, Pre-exposure Prophylaxis, Truvada, Client-centered case management, Transgender, Gender non-conforming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Los Angeles LGBT Center
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 19 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.
CCTG 602 is a multisite demonstration project to evaluate the effectiveness of facilitated linkage to PrEP using a community-based transgender PrEP outreach worker (T-POWr) versus standard of care (SOC).
Detailed description
Up to 500 self-identified transgender / gender non-conforming persons seeking daily Pre-Exposure Prophylaxis (PrEP) for the prevention of HIV will be enrolled into this study. Each participant will be followed up to 28 weeks after enrollment. The primary endpoint, successful linkage to a PrEP evaluation visit, will be measured after 30 days of enrollment.
Participants expressing interest in PrEP will be referred to the regional transgender PrEP outreach work (T-POWr) via phone call. Enrolled participants will be randomized (1:1) to either SOC PrEP linkage vs T-POWr facilitated PrEP linkage. Participants randomized into the SOC Arm will receive an HIV risk assessment, PrEP education, and an appointment for a linkage visit. Participants randomized into the T-POWr arm will receive SOC and a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services.
Participants will be contacted at Week 4 to verify linkage, and at Weeks 16 and 28 to assess PrEP and HIV status, and access to referred services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | No intervention | –Participants will receive standard of care HIV risk assessment, PrEP education, and an appointment for a PrEP evaluation visit at an affiliated clinic. |
| T-POWr Intervention Arm | Experimental | Behavioral: T-POWr InterventionParticipants will receive the same HIV risk assessment, PrEP education, and appointment for a PrEP evaluation visit as the Control Arm. Participants in the Intervention Arm will also receive a thorough client-centered case management evaluation that will assess needs including access to health insurance, general health care, assessment of current hormone administration, housing, mental health care, domestic violence care, substance use treatment, and other services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Self-identifies as a transgender or gender non-conforming person
- Self-identifies as HIV-negative or unknown status
- Ability to provide informed consent
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Severe active substance abuse or mental illness that the investigator feels will interfere with the ability to provide informed consent
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 |
|---|---|---|
| T-POWr InterventionAll participants will be asked to complete a secure confidential online survey focusing on needs assessment. Participants in the T-POWr Intervention Arm will receive a client-centered case management consultation based on how the participant responds to the online survey. The T-POWr will refer participants to assistance services based on the needs assessment, including accessing general health care, health insurance, hormone replacement therapy, housing, mental health care, domestic violence care, substance use treatment, etc. Each resource is extensively vetted to assure a trans-friendly experience and will be tailored to each geographic area across the project enrollment sites. The study facilitates referrals for services but will not provide extensive and ongoing case management. | Behavioural | T-POWr Intervention Arm |
Primary outcome
Facilitated Linkage
Time frame: Baseline up to Week 28
To evaluate the effectiveness of a T-POWr intervention to effectively link transgender / gender non-conforming persons to a PrEP evaluation visit.
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 13 Sep 2021.
- Individual participant dataSharing planned: No
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.
Sheldon Morris, MD MPH study chair
CCTG, UCSD AVRC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-POWr Intervention in people with HIV Seronegativity and Linkage, run by University of California, San Diego at 2 sites 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: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Facilitated Linkage (time frame: Baseline up to Week 28). 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 13 Sep 2021.