HIVNCT04225832

A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men

A study testing CBT Coping Intervention in people with HIV, run by RAND at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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
What is being tested?: CBT Coping Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 289 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2020to 27 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

at least 18 years-old
biologically male at birth
identify as male
identify as Latino
is an immigrant
report having sex with men in the past 12 months

Show all 9Show fewer

report HIV-negative or unknown serostatus
anticipate being available for the next 12 months to attend study visits
able to interact and communicate in spoken Spanish or English.

Who cannot join

HIV-positive
cisgender women
transgender women

Trial locations and contacts

1 site in 1 country.

United States1 site

Bienestar Human Services, Inc
Los Angeles, California, 90022

Other trials in United States

About this study

Read the detailed description

This study consists of a randomized controlled trial (RCT) of a multi-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP use among Latinx sexual minority men (SMM). We will test intervention effects on regular HIV testing and use of prevention strategies. The intervention was developed in partnership with community stakeholders at Bienestar Human Services, Inc., a Latinx-focused organization in Los Angeles County (LAC), CA. The intervention is flexible for use in community-based organizations, such as in ongoing support groups.

The Specific Aims are:

Aim 1. To conduct a randomized controlled trial of a culturally congruent cognitive behavior therapy group intervention for immigrant Latinx sexual minority men, to test intervention effects on regular HIV testing and PrEP uptake.

Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).

Aim 3. To conduct a cost-effectiveness analysis of the intervention.

Conditions: HIV
Being tested: CBT Coping Intervention
Keywords: Latino/Hispanic/Latinx, men who have sex with men
Medical subject headings: Homosexuality

What participants receive

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

CBT Coping InterventionBehavioural
A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.

Study groups in NCT04225832
Study group	Role	What they receive
CBT Coping Intervention	Experimental	The intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM). Receives: Behavioral: CBT Coping Intervention
Control	No intervention	Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.

What is being measured

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

HIV Test at Least Annually
Participants report being tested for HIV at least once in the 12 months after baseline
Measured: from baseline to 12-months
Took PrEP in the Past 12 Months
Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)
Measured: from baseline to 12-months

Secondary outcomes (1)

Level of Adaptive Coping
Participants completed the Brief COPE, a general measure of coping strategies. Items have the instruction "indicate the extent you do what the item says when you are faced with discrimination," and response options 1 = "I haven't been doing this at all," 2 = "I've been doing this a little bit," 3 = "I've been doing this a medium amount" and 4 = "I've been doing this a lot." This scale (identified by EFA) is the mean of 4 items such as "I get emotional support from others".
Higher values indicate more use of these coping strategies.
Measured: measured at 4-months, 8-months, and 12-months post baseline

Timeline

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

20 Jan 202027 Nov 2024

First posted13 Jan 2020
Study start20 Jan 2020
Primary completion27 Nov 2024
Study completion27 Nov 2024

Why it stopped: Government executive order

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04225832
Sponsor's protocol ID: R01MH121256
Status last verified: Nov 2023
First submitted: 7 Jan 2020
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Cognitive Behavioral Therapy Group Intervention to Increase HIV Testing and PrEP Use Among Latinx Sexual Minority Men
ClinicalTrials.gov ID: NCT04225832
Acronym / sponsor ID: R01MH121256
Conditions: HIV
Keywords: Latino/Hispanic/Latinx, men who have sex with men
Study type: Interventional
Recruitment status: TerminatedReason stopped: Government executive order
Enrolment: 289 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Bienestar Human Services, Inc.
Study start: 20 Jan 2020 (actual)
Primary completion: 27 Nov 2024 (actual)
Study completion: 27 Nov 2024 (actual)
First posted: 13 Jan 2020 (actual)
Results: Posted 13 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The Specific Aims are:

Aim 2. To examine mechanisms of intervention effects on regular HIV testing and PrEP uptake, including more effective coping (e.g., reduced internalized stigma).

Aim 3. To conduct a cost-effectiveness analysis of the intervention.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CBT Coping Intervention	Experimental	Behavioral: CBT Coping InterventionThe intervention is an 8-session cognitive behavior therapy (CBT) group intervention that aims to improve HIV outcomes by increasing adaptive, effective coping responses to stigma from intersectional identities related to ethnicity, immigration status, sexual minority identity, HIV status, and PrEP among Latinx sexual minority men (SMM). The intervention sessions will address topics such as: understanding and coping with intersectional stigma, multiple identities (e.g., race/ethnicity, sexual orientation), medical mistrust, social support, and structural stigma. Intervention groups will be led by a trained facilitator (with expertise in group therapy with Latinx SMM) and a trained peer co-facilitator matched in identities with participants (Latinx SMM).
Control	No intervention	–Participants who are randomized to the control condition will be referred to the standard of care program at Bienestar, which includes an ongoing weekly open wellness-oriented support group available to all clients.

Who may qualify

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

Key inclusion criteria (9 listed)

at least 18 years-old
biologically male at birth
identify as male
identify as Latino
is an immigrant

Key exclusion criteria (3 listed)

HIV-positive
cisgender women
transgender women

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
CBT Coping InterventionA cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.	Behavioural	CBT Coping Intervention

Primary outcome

HIV Test at Least Annually
Time frame: from baseline to 12-months
Participants report being tested for HIV at least once in the 12 months after baseline
Took PrEP in the Past 12 Months
Time frame: from baseline to 12-months
Participants report taking PrEP at any follow-up time-point (within the 12-month follow-up time period)

1 secondary outcome

Level of Adaptive Coping
Time frame: measured at 4-months, 8-months, and 12-months post baseline

Results and safety

Results posted to the registry on 13 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT Coping Intervention	145	103
Control	144	136

Primary outcome: HIV Test at Least Annually

Time frame: from baseline to 12-months. Count of participants. Unit: Participants

Measure	CBT Coping Intervention n = 103	Control n = 136
Value	96	114

CBT Coping Intervention vs Control: Odds Ratio (OR): 2.51 (95% CI 1.01 to 6.26), p = .049, Regression, Logistic

Primary outcome: Took PrEP in the Past 12 Months

Time frame: from baseline to 12-months. Count of participants. Unit: Participants

Measure	CBT Coping Intervention n = 103	Control n = 136
Value	56	71

CBT Coping Intervention vs Control: Odds Ratio (OR): 1.06 (95% CI 0.62 to 1.81), p = .83, Regression, Logistic

Population analysed: Of the N=289 described in Baseline Characteristics, N=50 did not complete any follow up assessments. Outcome measures are assessed for the remaining N=239

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years, 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT Coping Intervention	21 of 145 (14.5%)	0 of 145 (0%)	0 of 145
Control	3 of 144 (2.1%)	0 of 144 (0%)	0 of 144

Limitations and caveats (from the sponsor): Objective HIV testing dates and PrEP prescription data were collected (e.g., from medical records), but the US federal government (NIH) terminated the grant prematurely on March 20, 2025 before these data could be processed. These data were not fully cleaned or tabulated, and thus were not analyzed as an outcome and cannot be entered at baseline: The number of records is unknown and therefore not reported here. Thus, the primary outcomes are reported based on self-reported survey responses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Laura Bogart, PhD principal investigator

RAND

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

Questions about this trial

What is this clinical trial studying?

A study testing CBT Coping Intervention in people with HIV, run by RAND 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 3 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 13 Aug 2025. 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?

Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HIV Test at Least Annually (time frame: from baseline to 12-months). The study lists 2 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 NCT04225832.

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 Aug 2025.