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HIV in MSMESTEEM-conneCTNCT03464422

Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas

A study testing ESTEEM conneCT in people with HIV in MSM, run by Yale University 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

The purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
HIV in MSM
What is being tested?
ESTEEM conneCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
9 Sep 2018to 1 Aug 2019
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 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must:
  • Report anticipated 6-month residential stability in New Haven county
  • Self-identify as a gay or bisexual man or report being a man who has had past-12-month sex with a man
  • Self-identify as an ethnic or racial minority, including Black, African American, Caribbean American, Hispanic, and Latinx
  • Speak fluent English

Who cannot join

  • Participants not meeting the inclusion criteria will not be eligible to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (ESTEEM-conneCT)

The purpose of this study is adapt an evidence-based intervention for stigma-related stress, mental health, and HIV risk for bay, bisexual, and other men who have sex with men (MSM) of color in small urban areas.

Read the detailed description

This study has two specific aims. Aim 1 will focus on the modification of an existing intervention manual (created by the study PI) using feedback from previous qualitative interviews with MSM in New Haven and Hartford, CT. Also incorporated will be recent qualitative research on MSM of color's resilience. Specifically, the ways in which racial minority stigma impacts the mental health of MSM in small urban areas and adaptive coping skills that MSM can use in the face of these health threats.

Aim 2, will consist of the deliver of the adapted intervention to approximately 30 young MSM (15 HIV-negative and 15 HIV-positive) to gather data on the feasibility and acceptability of the newly adapted program. The evaluation of the new program will be conducted using pre-post comparisons of quantitative assessments and from qualitative interviews hoped to provide information regarding intervention feasibility, acceptability, and any needed refinement.

This project integrates expertise in culturally-sensitive evidence-based interventions for MSM's HIV risk into a community-based HIV prevention and care context at the Fair Haven Community Health Center, where the intervention will be delivered to the existing patient population.

As of April, 2019, the study protocol was updated and approved by the Yale IRB such that the two intervention cohorts did not differ by HIV serostatus. This decision was made: (1) because of the greater number of HIV-negative men, compared to HIV-positive men, who expressed interest in the study and (2) because participants could decide whether or not to disclose their serostatus in the group, as they do in other real-life interactions with other MSM, as reviewed during the consent process. Thus, there was no group assignment based on HIV serostatus.

Conditions
HIV in MSM
Being tested
ESTEEM conneCT
Keywords
HIV, MSM

What participants receive

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

  • ESTEEM conneCTBehavioural

    The intervention adapts the ESTEEM (Pachankis et al, 2015) intervention to address the multiple-stigma stressors faced by MSM of color, including sexual orientation and racial stigma in a manualized, CBT-based intervention. Approximately thirty participants (divided between two cohorts) will complete ten group sessions will take place at regular times once per week over the course of three months. The groups will be "closed," in that no new members will be allowed to join after the first week in order to promote open self-disclosure and trust among group members.

Study groups in NCT03464422
Study groupRoleWhat they receive
Young gay and bisexual men of colorExperimentalApproximately 30 young MSM of color will take part in weekly 90-minute group treatment sessions over 10 weeks. All participants will complete outcome assessments at baseline and three months post-treatment, as well as an exit interview.
Receives: Behavioral: ESTEEM conneCT

What is being measured

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

  1. Depression

    To measure depression in participants, the Center for Epidemiological Studies - Depression Scale (CES-D) will be used. An overall depression score is computed as the sum of the 20 items, with Items 3, 11, 14, and 16 reversed. In cases with internally missing data (items not answered), the sums were computed after imputation of the missing values: # items on scale / # actually answered, multiplied by the sum obtained from the answered items. A higher score indicates more depressive symptomatology during the past week. Range is 0 - 60.

    Measured: 3 months

  2. HIV Transmission Risk

    Risk of HIV transmission was assessed through the Past-90-day Timeline Follow-back interview (TLFB; Sobell \& Sobell, 1992). HIV risk behavior was calculated as the number of past-90-day sex acts in which key harm-reduction strategies were not employed (e.g., condom, PrEP, viral load suppression) and calculated by dividing the total number of sex acts at risk for HIV transmission by the total number of sex acts. Sex acts range from 0 to (theoretically) infinite.

    Measured: 90 days

Secondary outcomes (10)
  1. Overall Depression Severity and Impairment Scale

    ODSIS (Bentley et al., 2014) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week symptoms of depression (e.g., "In the past week, when you have felt depressed, how intense or severe was your depression?) from 0 (little or none: Depression was absent or barely noticeable.) to 4 (extreme: Depression was overwhelming.). Scores range from 0-20, with higher scores indicating greater depression and associated impairment in the past week.

    Measured: 3 months

  2. Overall Anxiety Severity and Impairment Scale

    OASIS (Norman et al., 2006) is a 5-item scale that asks individuals to rate the severity and impairment associated with past-week anxiety symptoms (e.g., "In the past week, when you have felt anxious, how intense or severe was your anxiety?") from 0 (little or none: Anxiety was absent or barely noticeable.) to 4 (extreme: Anxiety was overwhelming. It was impossible to relax at all. Physical symptoms were unbearable). Scores range from 0-20, with higher scores indicating greater anxiety and associated impairment in the past week.

    Measured: 3 months

  3. Brief Symptom Inventory

    (BSI; Derogatis \& Melisarators, 1983; Meijer et al., 2011). The Global Severity Index of the 18-item BSI provides a mean score across depression, anxiety, and somatization subscales, and assesses psychological distress (e.g., "feeling nervousness or shakiness inside") on a 5-point scale from 0 (not at all) to 4 (extremely) in the past 7 days. Scores range from 0-72, with higher scores indicating worse outcomes (greater symptoms severity).

    Measured: 3 months

  4. Suicidal Ideation Attributes Scale

    SIDAS (van Spijker et al., 2014) is a 5-item scale that assesses past-month frequency and controllability of suicidal thoughts, how close one has come to making an attempt, and distress and impairment associated with thoughts of suicide (e.g., "In the past month, how often have you had thoughts about suicide?"). Responses range from 0 (never or not at all) to 10 (always or extremely) on each item, with item 2 reverse scored. Scale scores range from 0-50, with higher scores indicating more (worse) suicidal ideation

    Measured: 3 months

  5. Alcohol Use Disorders Identification Test

    The AUDIT (Saunders et al.,1993) assesses past-3-month alcohol and related problems across 10 items (e.g., "How often did you have a drink containing alcohol?") with varying numeric response options. A score of 8 or greater serves as a clinical cut-off indicating hazardous drinking. Scores range from 0-40 with higher scores indicating more hazardous drinking (worse outcome)

    Measured: 3 months

  6. Condom-use Self-Efficacy Questionnaire

    The SSSEQ assesses respondents' confidence in condom use during sex in different scenarios. Example items include, "How confident are you that you could avoid having anal sex without a condom when you are with someone who is really hot?" and "How confident are you that you could avoid having anal sex without a condom when you are drink or high on drugs?". Response options range from 1 (Not at all confident) to 5 (extremely confident). Scores range from 1 - 65 with higher scores indicating greater self-efficacy around practicing safe sex (better outcome)

    Measured: 3 months

  7. Sexual Compulsivity Scale

    The SCS (Kalichman \& Rompa, 2011) assesses respondents' compulsivity around sex. Example items include "My desires to have sex have disrupted my daily life" and "My sexual thoughts and behaviors are causing problems in my life", with response options ranging from 1 (Not at all like me) to 4 (Very much like me). Scores range from 1 - 40 with higher scores indicating greater sexual compulsivity (worse outcome)

    Measured: 3 months

  8. Gay-Related Rejection Sensitivity Scale

    The GRRS (Pachankis, Goldfried \& Ramrattan, 2008) asks respondents to rate 14 vignettes in terms of how concerned or anxious each would make them about being rejected because of their sexual orientation, and their likelihood of attributing the rejection to their sexual orientation. For example, one item states, "You've been dating someone for a few years now and you receive a wedding invitation to a straight friend's wedding. The invite was addressed only to you, not you and a guest". Responses to the anxiety and likelihood stems range from 1 (very unconcerned/very unlikely) to 6 (very concerned/very likely). Total score is the sum of the products of anxiety and likelihood scores of all items and ranges from 0-504 with higher scores indicating greater rejection sensitivity (worse outcome).

    Measured: 3 months

  9. Self-concealment Scale

    The SCS (Larson \& Chastain, 1990; Schrimshaw, Siegel, Downing \& Parsons, 2013) assesses the respondents' concealment of their sexual orientation. Example items include, "I haven't shared with anyone that I have sex with men" and "When I have sex with men, I keep it to myself". Response options range from 1 (strongly disagree) to 5 (strongly agree). Scale scores range from 7-35 with higher scores indicating greater concealment of one's sexual orientation.

    Measured: 3 months

  10. Internalized Homophobia Scale

    The IHS assesses internalized stigma related to respondents' sexual orientation, asking them to rate thoughts and feelings related to their LGBTQ identity (e.g., "You have wished you weren't gay, bisexual, or queer). Responses range from 1 (never) to 4 (often). Scale scores range from 9 - 36 with higher scores indicating greater internalized stigma (worse outcome).

    Measured: 3 months

Timeline

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

  1. First posted14 Mar 2018
  2. Study start9 Sep 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

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
Adaptation of the Effective Skills to Empower Effect Men (ESTEEM; Pachankis, 2014; Pachankis et al, 2015) intervention that addresses young gay and bisexual men's occurring maladaptive behavioral patterns, including HIV-transmission risk behavior and mental health concerns, to address multiple stigma-related stressors for young gay and bisexual men of color in a group therapy format. All participants were part of the same intervention (no randomization) to assess the feasibility and acceptability of this adapted intervention (protocol update 4.24.2019; please see attached protocol). Two cohorts were formed to retain ideal group size for group therapy (10-15 participants per group).
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03464422
Sponsor's protocol ID
2000022422
Other IDs
P30MH062294-11
Acronym
ESTEEM-conneCT
Status last verified
Jul 2021
First submitted
7 Mar 2018
Last updated
4 Aug 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ESTEEM conneCT in people with HIV in MSM, run by Yale University 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 5 inclusion and 1 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 4 Aug 2021. 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 4 Aug 2021). 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?

Depression (time frame: 3 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?
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 4 Aug 2021.

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