HIV InfectionsNCT03465852

HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention

A study testing ChiCAS in people with HIV Infections, run by Centers for Disease Control and Prevention at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: ChiCAS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2019to 30 Sep 2022
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

Self-identify as male-to-female transgender or report having been born male and identifying as female;
Self-identify as Hispanic or Latina;
Are ≥ 18 years of age;
Report sex with at least 1 man in the past 6 months;
Are HIV negative (based on self-report and verification by HIV testing);
Are fluent in Spanish; and
Provide informed consent.

Who cannot join

Having participated in any HIV prevention intervention within the past 12 months, including Chicas or other interventions co-developed by Wake Gorest University (HOLA en Grupos or HOLA).
Are ≥ 18 years of age;

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1063

Other trials in United States

About this study

Wake Forest University and its partners, Triad Health Project, and the University of North Carolina, Greensboro, will be evaluating the effectiveness of ChiCAS (Chicas Creando Acceso a la Salud or Girls Creating Access to Health), a locally developed, Spanish language small group behavioral intervention that promotes access to and participation by Hispanic/Latina transgender women who are HIV negative and who have sex with men in pre-exposure prophylaxis (PrEP), medically supervised hormone therapy, and consistent condom use.

Read the detailed description

ChiCAS will be delivered as two 4-hour group sessions over a period of two weeks to groups of about 10 participants at seven community-based organizations (CBOs) in five metropolitan locations in North Carolina (Asheville, Charlotte, Greensboro/Winston-Salem, Raleigh/Durham and Wilmington).

The intervention will be evaluated by comparing women randomized to the ChiCAS intervention group to those randomized to the delayed-intervention (waitlist) comparison group. As many as 140 participants (as many 70 participants per arm) in total will be recruited to the study. All participants will complete identical quantitative assessments at baseline and 6-month follow up. Baseline and 6-month follow-up data collection will include the following measures:

Outcome variables:

Use of PrEP and medically supervised hormone therapy and consistent condom use.

Demographics:

Age, current living situation, marital/partner status, education, country and region of origin, ethnicity/race, work and work patterns and history, financial status (including income, numbers of persons income supports), number of children and adults living in household, gender identity; time in the US and NC; Spanish-language literacy; English-language skills; health insurance; documentation status.

Mediating variables:

Knowledge about HIV and STDs: types of diseases, modes of transmission, signs, symptoms, prevention strategies, and their magnitude within communities; condom use-related attitudes, skills, self-efficacy, and intentions; adherence to traditional Latino values of masculinity and fatalism; transphobia; ethnic group pride; knowledge of available transition-related services, how to access, what to expect, and eligibility; barriers to seeking healthcare services, for HIV testing, PrEP, or transition-related services; perceived access to health care; social support; substance use; substance use during sex; communication skills with partners and providers; provider trust.

Other variables:

Religiosity; mental health, perceived discrimination; community attachment; foregoing unsafe sex/episodic abstinence HIV and sexually transmitted disease (STD) history; victimization; sexual compulsivity; sex for money, drugs or shelter, self-reported health status, acculturation, community attachment, technology use, HIV and STD history

A qualitative interview will be administered to 30 randomly selected participants after they complete the 6-month follow-up assessments. Three groups of ten participants each will be interviewed to identify factors associated with each of the following outcome patterns:

Participants who reported an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and who reported an increase in the use of medically supervised hormone therapy (n=10);
Participants who did not report an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and did not report an increase in the use of medically supervised hormone therapy (n=10), and
Participants with mixed results (n=10).

Conditions: HIV Infections
Being tested: ChiCAS
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChiCASBehavioural
Promotes access to and participation by HIV negative Hispanic/Latina transgender women who have sex with men in PrEP, medically supervised hormone therapy, and consistent condom use.

Study groups in NCT03465852
Study group	Role	What they receive
Intervention arm	Experimental	Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, and will receive the Spanish language ChiCAS intervention shortly after being randomized and will complete a follow-up assessment 6 months after completing the intervention. . Receives: Behavioral: ChiCAS
Wait list comparison (control) arm	Other	Persons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, but will not receive the Spanish language ChiCAS intervention until they complete a follow-up assessment 6 months after completing the baseline assessment. Receives: Behavioral: ChiCAS

What is being measured

The primary outcome is the main question the study is designed to answer.

Uptake of PrEP
Increased uptake of PrEP relative to baseline measures of use
Measured: Uptake compared to baseline assessed 6 months after completion of the intervention.
Uptake of medically supervised hormone therapy
Increased uptake of medically supervised hormone therapy relative to baseline use measures
Measured: Uptake compared to baseline assessed 6 months after completion of the intervention.
Consistent condom use
Increased consistent condom relative to baseline use measures
Measured: Uptake compared to baseline assessed 6 months after completion of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 201930 Sep 2022

First posted14 Mar 2018
Study start15 Jul 2019
Primary completion30 Sep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionsStudies 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: Randomised
Intervention model: Parallel groups
Model description: The intervention study uses an intervention arm and a wait list comparison (control) arm
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03465852
Sponsor's protocol ID: IRB00040441
Status last verified: Jan 2023
First submitted: 8 Mar 2018
Last updated: 28 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A plan agreed to by the Principal Investigator and the Centers for Disease Control and Prevention (CDC) will make, after approval by the CDC, the following study data available to applicants who provide detailed information on their reasons for requesting the data and plans analysis and use of the data: 1. Quantitative data from structured surveys for baseline and 6-month follow-up assessments; 2. Qualitative data from in-depth interviews with selected study participants to elucidate factors that contribute to or impede participant reports of engaging in the expected intervention outcomes following completion of the intervention (consistent condom use and use of PrEP and medically-supervised hormone therapy): 3. medical record abstractions, and data from biological markers including PrEP and HIV test results. None of the data described here will contain personal identifying information from study participants.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: HIV Prevention Among Latina Transgender Women Who Have Sex With Men: Evaluation of a Locally Developed Intervention
ClinicalTrials.gov ID: NCT03465852
Acronym / sponsor ID: IRB00040441
Conditions: HIV Infections
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Study start: 15 Jul 2019 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 14 Mar 2018 (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.

Detailed description

Outcome variables:

Use of PrEP and medically supervised hormone therapy and consistent condom use.

Demographics:

Mediating variables:

Other variables:

Participants who reported an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and who reported an increase in the use of medically supervised hormone therapy (n=10);
Participants who did not report an increase in at least one HIV prevention behavioral outcome (PrEP or condom use) and did not report an increase in the use of medically supervised hormone therapy (n=10), and
Participants with mixed results (n=10).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The intervention study uses an intervention arm and a wait list comparison (control) arm

Arm	Type	Receives
Intervention arm	Experimental	Behavioral: ChiCASPersons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, and will receive the Spanish language ChiCAS intervention shortly after being randomized and will complete a follow-up assessment 6 months after completing the intervention. .
Wait list comparison (control) arm	Other	Behavioral: ChiCASPersons randomized to this arm will have completed the study consent process (including being tested with the INSTI rapid HIV test to verify their self-reported HIV negative status and their eligibility to participate in the study) and the baseline survey, but will not receive the Spanish language ChiCAS intervention until they complete a follow-up assessment 6 months after completing the baseline assessment.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Self-identify as male-to-female transgender or report having been born male and identifying as female;
Self-identify as Hispanic or Latina;
Are ≥ 18 years of age;
Report sex with at least 1 man in the past 6 months;
Are HIV negative (based on self-report and verification by HIV testing);

Key exclusion criteria (2 listed)

Having participated in any HIV prevention intervention within the past 12 months, including Chicas or other interventions co-developed by Wake Gorest University (HOLA en Grupos or HOLA).
Are ≥ 18 years of age;

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
ChiCASPromotes access to and participation by HIV negative Hispanic/Latina transgender women who have sex with men in PrEP, medically supervised hormone therapy, and consistent condom use.	Behavioural	Intervention arm, Wait list comparison (control) arm

Primary outcome

Uptake of PrEP
Time frame: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased uptake of PrEP relative to baseline measures of use
Uptake of medically supervised hormone therapy
Time frame: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased uptake of medically supervised hormone therapy relative to baseline use measures
Consistent condom use
Time frame: Uptake compared to baseline assessed 6 months after completion of the intervention.
Increased consistent condom relative to baseline use measures

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 28 Feb 2023.
Individual participant dataSharing planned: Yes. A plan agreed to by the Principal Investigator and the Centers for Disease Control and Prevention (CDC) will make, after approval by the CDC, the following study data available to applicants who provide detailed information on their reasons for requesting the data and plans analysis and use of the data: 1. Quantitative data from structured surveys for baseline and 6-month follow-up assessments; 2. Qualitative data from in-depth interviews with selected study participants to elucidate factors that contribute to or impede participant reports of engaging in the expected intervention outcomes following completion of the intervention (consistent condom use and use of PrEP and medically-supervised hormone therapy): 3. medical record abstractions, and data from biological markers including PrEP and HIV test results. None of the data described here will contain personal identifying information from study participants.

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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.

Scott D Rhodes, PhD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ChiCAS in people with HIV Infections, run by Centers for Disease Control and Prevention 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 2 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 28 Feb 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?

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?

Uptake of PrEP (time frame: Uptake compared to baseline assessed 6 months after completion of the intervention.). 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?

On the ClinicalTrials.gov record for NCT03465852.

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 28 Feb 2023.