Trial Outcomes & Findings for Adapting an Evidence-based Intervention for Stigma-related Stress, Mental Health, and HIV Risk for MSM of Color in Small Urban Areas (NCT NCT03464422)

NCT ID: NCT03464422

Last Updated: 2021-08-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-08-04

Participant Flow

Participants were recruited for the study between September 2018 and February 2019 through local community organizations (e.g., flyers poster at community health clinics, LGBTQ community organizations, university LGBTQ centers) and online (i.e., advertisements posted to Grindr and LGNTQ Facebook groups). Potential participants received a link to a secure online eligibility survey.

Participants (n = 468) completed an online screener and were contacted for a phone screening (n = 139). Participants who met study inclusion criteria and consented to participate were invited to complete the baseline assessment prior to group assignment (n = 21).

Participant milestones

Measure	ESTEEM conneCT ESTEEM conneCT group therapy intervention
Overall Study STARTED	21
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	ESTEEM conneCT ESTEEM conneCT group therapy intervention
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Age, Continuous	27.00 years STANDARD_DEVIATION 4.80 • n=5 Participants
Sex/Gender, Customized Gender Identity · Cisgender Man	20 Participants n=5 Participants
Sex/Gender, Customized Gender Identity · Transgender Man	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Latino/Latinx (Hispanic)	7 Participants n=5 Participants
Race/Ethnicity, Customized White (Hispanic)	5 Participants n=5 Participants
Race/Ethnicity, Customized Black (Hispanic)	5 Participants n=5 Participants
Race/Ethnicity, Customized Black (Non-Hispanic)	4 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants
Sexual Orientation Gay	16 Participants n=5 Participants
Sexual Orientation Bisexual	3 Participants n=5 Participants
Sexual Orientation Queer	2 Participants n=5 Participants
HIV Status Negative	19 Participants n=5 Participants
HIV Status Positive	2 Participants n=5 Participants
Income Less than $10,000	10 Participants n=5 Participants
Income $10,000 - $19,999	2 Participants n=5 Participants
Income $20,000 - $29,999	2 Participants n=5 Participants
Income $30,000 - $39,999	3 Participants n=5 Participants
Income $40,000 - $49,999	3 Participants n=5 Participants
Income $50,000 - $74,999	1 Participants n=5 Participants
Education level High school diploma or GED	2 Participants n=5 Participants
Education level Some college or Associates degree	5 Participants n=5 Participants
Education level Currently enrolled in college	2 Participants n=5 Participants
Education level 4-year college degree (BA, BS, BFA)	6 Participants n=5 Participants
Education level Currently enrolled in graduate school	3 Participants n=5 Participants
Education level Graduate degree	2 Participants n=5 Participants
Education level Some high school	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Depression Baseline	22.10 score on a scale Standard Deviation 11.89
Depression 3-month follow-up	20.35 score on a scale Standard Deviation 12.01

PRIMARY outcome

Timeframe: 90 days

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
HIV Transmission Risk Baseline	4.10 Number of sex acts conferring HIV risk Standard Deviation 10.12
HIV Transmission Risk 3-month follow-up	8.29 Number of sex acts conferring HIV risk Standard Deviation 11.38

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Overall Depression Severity and Impairment Scale Baseline	11.00 score on a scale Standard Deviation 4.79
Overall Depression Severity and Impairment Scale 3-month follow-up	10.53 score on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Overall Anxiety Severity and Impairment Scale Baseline	12.05 score on a scale Standard Deviation 3.54
Overall Anxiety Severity and Impairment Scale 3-month follow-up	11.88 score on a scale Standard Deviation 6.07

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

(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).

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Brief Symptom Inventory Baseline	2.12 score on a scale Standard Deviation 0.87
Brief Symptom Inventory 3-month follow-up	2.05 score on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Suicidal Ideation Attributes Scale Baseline	4.33 score on a scale Standard Deviation 9.63
Suicidal Ideation Attributes Scale Post-treatment	3.41 score on a scale Standard Deviation 8.20

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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)

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Alcohol Use Disorders Identification Test Baseline	16.90 score on a scale Standard Deviation 6.57
Alcohol Use Disorders Identification Test Post-treatment	17.53 score on a scale Standard Deviation 8.77

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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)

Outcome measures

Measure	ESTEEM ConneCT n=12 Participants ESTEEM ConneCT group therapy intervention
Condom-use Self-Efficacy Questionnaire Baseline	48.05 score on a scale Standard Deviation 16.33
Condom-use Self-Efficacy Questionnaire Post-treatment	49.24 score on a scale Standard Deviation 14.32

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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)

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Sexual Compulsivity Scale Baseline	18.38 score on a scale Standard Deviation 7.11
Sexual Compulsivity Scale 3-month follow-up	18.18 score on a scale Standard Deviation 8.89

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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).

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Gay-Related Rejection Sensitivity Scale Baseline	10.73 score on a scale Standard Deviation 5.66
Gay-Related Rejection Sensitivity Scale 3-month follow-up	9.92 score on a scale Standard Deviation 5.97

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Self-concealment Scale Baseline	2.15 score on a scale Standard Deviation 0.97
Self-concealment Scale 3-month follow-up	2.01 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

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).

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
Internalized Homophobia Scale Baseline	1.53 score on a scale Standard Deviation 0.68
Internalized Homophobia Scale 3-month follow-up	1.53 score on a scale Standard Deviation 0.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: Analysis population for 3-month follow-up (n = 17) due to drop out.

Participants indicated whether they had been adherent to PrEP in the past three months.

Outcome measures

Measure	ESTEEM ConneCT n=21 Participants ESTEEM ConneCT group therapy intervention
PrEP Use Baseline	6 Participants
PrEP Use 3-month follow-up	5 Participants

Adverse Events

ESTEEM conneCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Pachankis

Yale University

Phone: 6463444060

Email: john.pachankis@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place