HivT'CherNCT05689281
Increasing PrEP With Trans Women in the Deep South
A study testing Peer PrEP Navigation in people with Hiv, run by CrescentCare at 1 site in United States.
Trial summary
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Peer PrEP Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to 31 Jul 2026
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Declaration of willingness to comply with all study procedures and availability during the study
- Age 18 years old or older
- Male sex designated at birth
- Identify as trans woman, woman or another gender identity not associated with being a man
- Desire to use or re-start PrEP
Show all 9Show fewer
- HIV uninfected
- Speaks English or Spanish
- Live in the New Orleans metropolitan statistical area (which includes 8 parishes)
Who cannot join
- Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
- Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
- Concurrent or planned enrollment in a research study that provides PrEP
- Unwilling to attend quarterly follow-up visits, which will include survey participation
- Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NO/AIDS Task Force d.b.a. CrescentCare
New Orleans, Louisiana, 70117
Narquis Barak, MA, 504-821-2601, narquis.barak@crescentcare.org
About this study
Official title: T'Cher, Take Charge: Increasing PrEP Awareness, Uptake and Adherence Through Health Care Empowerment and Addressing Social Determinants of Health Among Racially Diverse Trans Women in the Deep South
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
Read the detailed description
The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.
- Conditions
- Hiv
- Being tested
- Peer PrEP Navigation
- 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.
Peer PrEP NavigationBehavioural
Ecological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum.
| Study group | Role | What they receive |
|---|---|---|
| PrEP peer navigation | Experimental | Culturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors Receives: Behavioral: Peer PrEP Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP uptake
The proportion of participants enrolled in the study who begin to take PrEP
Measured: 24 months
Social determinant stressors
The proportion of participants enrolled in the study who address social determinant stressors
Measured: 24 months
Health care empowerment
The proportion of participants enrolled in the study who report improved healthcare empowerment
Measured: 24 months
Secondary outcomes (1)
Patterns and correlates of PrEP adherence
Analysis of PrEP adherence among those who begin PrEP. Patterns and correlates of adherence will be measures using data from self report surveys and urine assays
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start31 Jan 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CrescentCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narquis Barak, CrescentCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689281
- Sponsor's protocol ID
- 10275
- Acronym
- T'Cher
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2023
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T'Cher, Take Charge: Increasing PrEP Awareness, Uptake and Adherence Through Health Care Empowerment and Addressing Social Determinants of Health Among Racially Diverse Trans Women in the Deep South
- ClinicalTrials.gov ID
- NCT05689281
- Acronym / sponsor ID
- T'Cher / 10275
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CrescentCareUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Jan 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.
The goal of this to address barriers and facilitators to PrEP uptake, and encourage adherence among trans women via a single arm stepped wedge clinical trial. The main question is to compare PrEP uptake and adherence outcomes among trans women in the T'Cher intervention to the delayed study arm.
Detailed description
The intervention will also assess changes in health care empowerment and support for Social Determinants of Health (SDoH) as mediating the effect of the intervention on PrEP uptake and adherence among trans women.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be recruited on a rolling basis for a randomized, unblinded, cross-over stepped wedge study design
| Arm | Type | Receives |
|---|---|---|
| PrEP peer navigation | Experimental | Behavioral: Peer PrEP NavigationCulturally informed health care empowerment and PrEP peer navigation and support through social determinant of health stressors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Declaration of willingness to comply with all study procedures and availability during the study
- Age 18 years old or older
- Male sex designated at birth
- Identify as trans woman, woman or another gender identity not associated with being a man
Key exclusion criteria (5 listed)
- Confirmed HIV infection by rapid algorithm testing and/or laboratory testing (described above)
- Prior or current participation in the active arm of an HIV vaccine trial with evidence of vaccine-induced seropositivity
- Concurrent or planned enrollment in a research study that provides PrEP
- Unwilling to attend quarterly follow-up visits, which will include survey participation
- Has any other condition which, based on the opinion of the investigator, would preclude provision of informed consent; make participation in the project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
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 |
|---|---|---|
| Peer PrEP NavigationEcological momentary assessments to identify and address stressors related to social determinants of health (e.g., housing, substance use, mental health), and motivational interviewing to support participants' health care empowerment and progression along the PrEP continuum. | Behavioural | PrEP peer navigation |
Primary outcome
PrEP uptake
Time frame: 24 months
The proportion of participants enrolled in the study who begin to take PrEP
Social determinant stressors
Time frame: 24 months
The proportion of participants enrolled in the study who address social determinant stressors
Health care empowerment
Time frame: 24 months
The proportion of participants enrolled in the study who report improved healthcare empowerment
1 secondary outcome
Patterns and correlates of PrEP adherence
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer PrEP Navigation in people with Hiv, run by CrescentCare 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 5 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narquis Barak, MS (504.821.2601 ext. 1058, narquis.barak@crescentcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP uptake (time frame: 24 months). 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 6 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.