Adults 18 to 35, any sex, with HIV in MSM. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
DepressionPrimary· 3 months
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.
Baseline
Group
Value
95% CI
ESTEEM ConneCT
22.10
± 11.89
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
20.35
± 12.01
HIV Transmission RiskPrimary· 90 days
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.
Baseline
Group
Value
95% CI
ESTEEM ConneCT
4.10
± 10.12
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
8.29
± 11.38
Overall Depression Severity and Impairment ScaleSecondary· 3 months
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.
Baseline
Group
Value
95% CI
ESTEEM conneCT
11.00
± 4.79
3-month follow-up
Group
Value
95% CI
ESTEEM conneCT
10.53
± 6.07
Overall Anxiety Severity and Impairment ScaleSecondary· 3 months
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.
Baseline
Group
Value
95% CI
ESTEEM ConneCT
12.05
± 3.54
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
11.88
± 6.07
Brief Symptom InventorySecondary· 3 months
(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).
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
Baseline
Group
Value
95% CI
ESTEEM ConneCT
4.33
± 9.63
Post-treatment
Group
Value
95% CI
ESTEEM ConneCT
3.41
± 8.20
Alcohol Use Disorders Identification TestSecondary· 3 months
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)
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)
Baseline
Group
Value
95% CI
ESTEEM ConneCT
48.05
± 16.33
Post-treatment
Group
Value
95% CI
ESTEEM ConneCT
49.24
± 14.32
Sexual Compulsivity ScaleSecondary· 3 months
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)
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 concer
Baseline
Group
Value
95% CI
ESTEEM ConneCT
10.73
± 5.66
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
9.92
± 5.97
Self-concealment ScaleSecondary· 3 months
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.
Baseline
Group
Value
95% CI
ESTEEM ConneCT
2.15
± 0.97
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
2.01
± 0.95
Internalized Homophobia ScaleSecondary· 3 months
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).
Baseline
Group
Value
95% CI
ESTEEM ConneCT
1.53
± 0.68
3-month follow-up
Group
Value
95% CI
ESTEEM ConneCT
1.53
± 0.78
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking
· Phase 2
· not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing
· NA
· not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S
· NA
· not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa
· Phase 1, PHASE2
· not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 4 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03464422.