ACT for HIV-Positive Men (ACT for HIV)

April 16, 2026 updated by: Nicholas C. Borgogna, University of Alabama at Birmingham

Evaluation of the Effectiveness of Acceptance and Commitment Therapy for General Mental Health Concerns in HIV-Positive Men

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the current study is to examine the feasibility and effectiveness of acceptance and commitment therapy, a specific form of cognitive-behavioral therapy, for treating general mental health concerns among HIV-positive men.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nicholas Borgogna, PhD
  • Phone Number: (205) 934-3850
  • Email: borgogna@uab.edu

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • identify as a man
  • be at least 18 years old
  • has been diagnosed with HIV by a healthcare professional

Exclusion Criteria:

  • has engaged in self-harm within the last three months
  • has attempted suicide within the last year
  • has had an active plan to attempt suicide within the last 30 days
  • is currently diagnosed with any eating disorder
  • has experienced hallucinations or delusions within the last 30 days
  • has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acceptance and commitment therapy
Trial of acceptance and commitment therapy for hiv-positive men.
Behavioral: Acceptance and commitment therapy
Acceptance and commitment therapy is a psychotherapy focused at increasing psychological flexibility and an individual's engagement in valued activities rather than focusing solely or primarily on reducing psychiatric symptoms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 Screener
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of depressive symptoms
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
PTSD Checklist-5
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of post-traumatic stress symptoms
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Yale-Brown Obsessive Compulsive Scale
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of obsessive-compulsive disorder symptoms
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Alcohol Use Disorders Identification Test
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of alcohol use
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
HIV stigma scale
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of facets of stigma experienced by individuals with HIV
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Internalized homophobia scale
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of internalized homophobia
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Brief pornography screen
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of concerning pornography use
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Life Quality Scale
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of life quality
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Experiential Avoidance Rating Scale
Time Frame: Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of experiential avoidance
Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)
National Institute of Drug Abuse Modified Alcohol, Smoking, and Substance Involvement Screening Test
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of drug use
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
High risk sexual behaviors
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
  • Frequency of sex with penetration
  • Frequency of condom use
  • Frequency of oral sex
  • Frequency of sexual partners
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Generalized Anxiety Disorder-7 Screener
Time Frame: Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of anxiety symptoms
Administered at baseline and immediately after final intervention session (8th/final session; each session is 1 hour)
PSYFLEX
Time Frame: Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of psychological flexibility
Administered at baseline, every two weeks (every second therapy session) during intervention, and immediately after final intervention session (8th/final session; each session is 1 hour)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapeutic Alliance Scale
Time Frame: Administered immediately after final intervention session (8th/final session; each session is 1 hour)
Measure of patient and therapist alliance
Administered immediately after final intervention session (8th/final session; each session is 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicholas Borgogna, PhD, University of Alabama at Birmingham
  • Principal Investigator: Drew Whittington, MS, MA, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300013506
  • Start-up (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Dataset will be shared with requesting researchers

IPD Sharing Time Frame

When results are published

IPD Sharing Access Criteria

Requesting researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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