HIV/AIDSTHRIVE+NCT05822206
Trauma Informed Intervention to Support Engagement in HIV Care Among MSM (THRIVE+)
A study testing CBT-TSC and Life Steps and Sexual Decision-Making in people with HIV/AIDS and Trauma, run by Massachusetts General Hospital at 2 sites in 2 countries.
Trial summary
This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- CBT-TSC and Life Steps and Sexual Decision-Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Aug 2016to 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected
- is a man who has sex with men
- has a history of trauma and is experiencing trauma-related distress (as operationalized by a score of >/= 20 on the Davidson Trauma Scale)
- is sub-optimally engaged in HIV care (as operationalized by missing 1 or more HIV care appointments in the past 12 months, having a detectable viral load at most recent testing, or having poor adherence - </=80% - to HIV medications)
Who cannot join
- has a significant mental health diagnosis that requires immediate treatment (e.g., acute major depression; panic disorder; any psychotic disorder)
- unable to complete the informed consent process (e.g., substantial cognitive impairment, inadequate English language skills).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Fenway Community Health
Boston, Massachusetts, 02215
About this study
Official title: Development of a Trauma Informed Intervention to Support Adaptive Engagement in Care Among MSM Living With HIV: Project THRIVE+
This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories
Read the detailed description
The proposed intervention will incorporate the most current approaches to mediating trauma responses and stressors related to experiences of HIV stigma and homonegativity with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing negative consequences of traumatic stress. This intervention intends to improve uptake of HIV care in the prevention, engagement, and care cascade while also addressing the mental health needs of HIV-positive persons in a program of research that leads to outcomes in the short-term. If found to be efficacious, this intervention can also be scalable across clinical settings.
The study will be implemented at The Fenway Institute at Fenway Health (TFI) and at Ryerson University, Toronto, Canada and Drs. O'Cleirigh and Hart will assume the responsibility of coordinating the study across sites.
Randomization will be to the 10 session intervention or to two medication adherence/engagement in care sessions.
- Being tested
- CBT-TSC, Life Steps and Sexual Decision-Making
- Keywords
- MSM, HIV/AIDS, Trauma, Engagement in care
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-TSCBehavioural
Cognitive Behavioral Therapy for Trauma and Self-Care
Life Steps and Sexual Decision-MakingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in the Treatment arm receive 2 therapy sessions on LifeSteps and sexual decision-making, as well at 8 sessions of Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC). Participants then participate in 3-, 6-, and 9-month follow-up assessments. Receives: Behavioral: CBT-TSC; Behavioral: Life Steps and Sexual Decision-Making |
| Control | Other | Participants in the Control arm receive 2 therapy sessions on LifeSteps and sexual decision-making. Participants then participate in 3-, 6-, and 9-month follow-up assessments. Receives: Behavioral: Life Steps and Sexual Decision-Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACTG Adherence Interview
HIV medication adherence is collected at all major time points (baseline, 3 month follow-up, 6 month follow-up, and 9 month follow-up) via self-report, using the AIDS Clinical Trials Group Adherence Interview. Participants are asked to give the number of doses they take of each of their HIV medications per day, and to note how many doses were missed at 4 time time points (yesterday, day before yesterday, 3 days ago, in the past 2 weeks).
Measured: up to 4 times over 9 months
Secondary outcomes (2)
Davidson Trauma Scale
The Davidson Trauma Scale measures the frequency and severity of PTSD symptoms in the past week, and is conducted at each study visit (baseline, weekly visits, and all follow-up visits). Each item on the 17-item scale is scored 0-4 on frequency (0 = not at all; 4 = every day) and severity (0 = not at all distressing; 4 = extremely distressing), yielding a total between 0 and 136.
Measured: 1 week
Viral Load
Most recent viral load is collected from each participant at baseline (first study visit) and at 9 month follow-up (final study visit) through medical record abstraction.
Measured: baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start3 Aug 2016
- Primary completionDec 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of two conditions: treatment (Cognitive Behavioral Therapy for Trauma and Self-Care; CBT-TSC) or control. The CBT-TSC condition consists of 10 therapy sessions and 3 follow-up visits. The control condition consists of 2 therapy sessions and 3 follow-up visits. The first two therapy sessions, which are received by all participants regardless of condition, employ LifeSteps and sexual decision making techniques. The remaining eight therapy sessions, which only those in the CBT-TSC condition receive, address thoughts and behaviors associated with trauma distress and poor engagement in HIV care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Fenway Institute, Toronto Metropolitan University
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Conall O'Cleirigh, PhD, Principal investigator, Fenway Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822206
- Sponsor's protocol ID
- 931482-1
- Acronym
- THRIVE+
- Status last verified
- Apr 2023
- First submitted
- 26 Jun 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Trauma Informed Intervention to Support Adaptive Engagement in Care Among MSM Living With HIV: Project THRIVE+
- ClinicalTrials.gov ID
- NCT05822206
- Acronym / sponsor ID
- THRIVE+ / 931482-1
- Keywords
- MSM, HIV/AIDS, Trauma, Engagement in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Fenway Institute, Toronto Metropolitan University
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 20 Apr 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.
This purpose of this project is to specify and provide an initial test of a 10 session, individual-based cognitive therapy intervention to address symptoms of PTSD and poor engagement in HIV care among men who have sex with men (MSM) with trauma histories
Detailed description
The proposed intervention will incorporate the most current approaches to mediating trauma responses and stressors related to experiences of HIV stigma and homonegativity with cognitive-processing therapy, an empirically validated, cognitive-behavioral intervention for reducing negative consequences of traumatic stress. This intervention intends to improve uptake of HIV care in the prevention, engagement, and care cascade while also addressing the mental health needs of HIV-positive persons in a program of research that leads to outcomes in the short-term. If found to be efficacious, this intervention can also be scalable across clinical settings.
The study will be implemented at The Fenway Institute at Fenway Health (TFI) and at Ryerson University, Toronto, Canada and Drs. O'Cleirigh and Hart will assume the responsibility of coordinating the study across sites.
Randomization will be to the 10 session intervention or to two medication adherence/engagement in care sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into one of two conditions: treatment (Cognitive Behavioral Therapy for Trauma and Self-Care; CBT-TSC) or control. The CBT-TSC condition consists of 10 therapy sessions and 3 follow-up visits. The control condition consists of 2 therapy sessions and 3 follow-up visits. The first two therapy sessions, which are received by all participants regardless of condition, employ LifeSteps and sexual decision making techniques. The remaining eight therapy sessions, which only those in the CBT-TSC condition receive, address thoughts and behaviors associated with trauma distress and poor engagement in HIV care.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: CBT-TSC, Behavioral: Life Steps and Sexual Decision-MakingParticipants in the Treatment arm receive 2 therapy sessions on LifeSteps and sexual decision-making, as well at 8 sessions of Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC). Participants then participate in 3-, 6-, and 9-month follow-up assessments. |
| Control | Other | Behavioral: Life Steps and Sexual Decision-MakingParticipants in the Control arm receive 2 therapy sessions on LifeSteps and sexual decision-making. Participants then participate in 3-, 6-, and 9-month follow-up assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-infected
- is a man who has sex with men
- has a history of trauma and is experiencing trauma-related distress (as operationalized by a score of >/= 20 on the Davidson Trauma Scale)
- is sub-optimally engaged in HIV care (as operationalized by missing 1 or more HIV care appointments in the past 12 months, having a detectable viral load at most recent testing, or having poor adherence - </=80% - to HIV medications)
Key exclusion criteria (2 listed)
- has a significant mental health diagnosis that requires immediate treatment (e.g., acute major depression; panic disorder; any psychotic disorder)
- unable to complete the informed consent process (e.g., substantial cognitive impairment, inadequate English language skills).
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-TSCCognitive Behavioral Therapy for Trauma and Self-Care | Behavioural | Treatment |
| Life Steps and Sexual Decision-Making | Behavioural | Control, Treatment |
Primary outcome
ACTG Adherence Interview
Time frame: up to 4 times over 9 months
HIV medication adherence is collected at all major time points (baseline, 3 month follow-up, 6 month follow-up, and 9 month follow-up) via self-report, using the AIDS Clinical Trials Group Adherence Interview. Participants are asked to give the number of doses they take of each of their HIV medications per day, and to note how many doses were missed at 4 time time points (yesterday, day before yesterday, 3 days ago, in the past 2 weeks).
2 secondary outcomes
Davidson Trauma Scale
Time frame: 1 week
Viral Load
Time frame: baseline and 9 months
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 20 Apr 2023.
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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.
Conall O'Cleirigh, PhD principal investigator
Fenway Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-TSC and Life Steps and Sexual Decision-Making in people with HIV/AIDS and Trauma, run by Massachusetts General Hospital at 2 sites in 2 countries.
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 4 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 20 Apr 2023. 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, Canada. 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?
ACTG Adherence Interview (time frame: up to 4 times over 9 months). 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 20 Apr 2023.