HIV, Acquired Immunodeficiency Syndrome
Conditions
Keywords
Minority Stress
Brief summary
The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.
Detailed description
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM. Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.
Interventions
BEHAVIORALESTEEM
ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.
BEHAVIORALCMHT
CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.
BEHAVIORALVCT
Voluntary Counselling and Testing (VCT).
Sponsors
National Institute of Mental Health (NIMH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* self-identification as a gay, bisexual or queer man; * HIV-negative status confirmed through in-office testing; * diagnosis of any DSM-5 depressive, anxiety, or trauma-/stress-related disorder; * risk of HIV transmission through sexual activity (≥ 1 act of past-90-day-condomless anal sex involving a flesh penis with a partner with an unknown HIV status or an HIV-positive status, unless with an HIV-positive primary or main partner with known undetectable viral load or an HIV-negative primary or main partner who is known to be adherent to PrEP); * not themselves currently adherent to PrEP (defined as taking PrEP on ≥ 4 days/week); * NYC or Miami residential stability and planned availability for 12 months; * English-language proficiency; and (9) provision of informed consent.
Exclusion criteria
* current active suicidality or homicidality (but not passive suicidality); * evidence of active untreated mania, psychosis, or gross cognitive impairment; * current enrollment in another intervention study; * currently receiving 1 or more mental health treatment sessions/month or 8 or more CBT sessions within the past year; * HIV-positive status (confirmed through in-office testing).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any Condomless Anal Sex Acts | 8 Months | Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minority Stress: Rathus Assertiveness Schedule | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness. |
| Depression: BSI GSI | Baseline | The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (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). |
| Substance Use: SIP-AD | Baseline | Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of yes responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., I have failed to do what is expected of me because of my drinking/drug use). Higher scores indicate greater substance use with a range of 0-15. |
| Any Pre-Exposure Prophylaxis (PrEP) Use | Baseline | Participants will be asked if they had used PrEP in the last 3 months. |
| Minority Stress: GRRS | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress. |
| Minority Stress: IHS | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress. |
| Minority Stress: SOCS | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment. |
| Minority Stress: DERS | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty. |
| Minority Stress: Brooding | Baseline | Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity. |
| Any Condomless Anal Sex Acts | Baseline | This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months. |
| Safer Sex Self-Efficacy | Baseline | HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed. |
| Decisional Balance | Baseline | HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., sex without a condom is more spontaneous) are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., I could get infected with HIV if I have sex without a condom) are rate as important when making the decision to use condoms during anal sex. |
| Depression: HAM-D | Baseline | To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chlamydia Test | Baseline | Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline. |
| Gonorrhea Test | Baseline | Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline. |
| HIV Test | Baseline | Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ESTEEM Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive ESTEEM. ESTEEM is a 10-session intervention based on the Unified Protocol,an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.
ESTEEM: ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.
VCT: Voluntary Counselling and Testing (VCT). | 100 |
| Voluntary Counselling and Testing (VCT) Participants randomized to the VCT only arm will not receive any further intervention. VCT will be based on on CDC guidelines and the control arms of large community-based RCTs (e.g., Projects RESPECT, EXPLORE, AWARE). VCT will consist of one 45-minute session given that 1-session VCT is as effective as 2-session VCT for GBM.
VCT: Voluntary Counselling and Testing (VCT). | 52 |
| Community Mental Health Treatment (CMHT) Participants in all arms will receive Voluntary Counselling and Testing (VCT). Participants randomized to this arm will receive Community Mental Health Treatment (CMHT). CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy. The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.
One participant in this arm did not complete baseline measures and is thus excluded in the baseline measures section.
CMHT: CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.
VCT: Voluntary Counselling and Testing (VCT). | 101 |
| Total | 253 |
Baseline characteristics
| Characteristic | Voluntary Counselling and Testing (VCT) | Community Mental Health Treatment (CMHT) | ESTEEM | Total |
|---|---|---|---|---|
| Age, Continuous | 26.88 years STANDARD_DEVIATION 3.43 | 26.6 years STANDARD_DEVIATION 4.23 | 26.31 years STANDARD_DEVIATION 4.47 | 26.55 years STANDARD_DEVIATION 4.17 |
| Diagnoses Agoraphobia | 11 Participants | 25 Participants | 24 Participants | 60 Participants |
| Diagnoses Alcohol-Use Disorder | 13 Participants | 22 Participants | 27 Participants | 62 Participants |
| Diagnoses Depression | 37 Participants | 79 Participants | 79 Participants | 195 Participants |
| Diagnoses Dysthymia | 9 Participants | 40 Participants | 33 Participants | 82 Participants |
| Diagnoses Generalized Anxiety Disorder | 20 Participants | 51 Participants | 53 Participants | 124 Participants |
| Diagnoses Obsessive Compulsive Disorder | 7 Participants | 20 Participants | 23 Participants | 50 Participants |
| Diagnoses Panic Disorder | 12 Participants | 25 Participants | 16 Participants | 53 Participants |
| Diagnoses Post-Traumatic Stress Disorder | 5 Participants | 14 Participants | 18 Participants | 37 Participants |
| Diagnoses Social Anxiety Disorder | 20 Participants | 49 Participants | 37 Participants | 106 Participants |
| Diagnoses Substance-Use Disorder | 28 Participants | 53 Participants | 55 Participants | 136 Participants |
| Education College Degree | 46 Participants | 91 Participants | 94 Participants | 231 Participants |
| Education Less than College | 6 Participants | 10 Participants | 6 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants | 41 Participants | 43 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 60 Participants | 57 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gender Identity Gender non-conforming/-binary | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Gender Identity Genderqueer | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Gender Identity Man | 51 Participants | 99 Participants | 100 Participants | 250 Participants |
| Gender Identity Other | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Gender Identity Transgender Man | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Gender Identity Two-spirit | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Gender Identity Woman | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian /Alaskan Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 21 Participants | 20 Participants | 43 Participants |
| Race/Ethnicity, Customized Multiracial | 12 Participants | 14 Participants | 12 Participants | 38 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 6 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 56 Participants | 53 Participants | 141 Participants |
| Region of Enrollment United States | 52 participants | 101 participants | 100 participants | 253 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 52 Participants | 100 Participants | 98 Participants | 250 Participants |
| Sexual Orientation Bisexual | 9 Participants | 19 Participants | 25 Participants | 53 Participants |
| Sexual Orientation Gay | 39 Participants | 78 Participants | 69 Participants | 186 Participants |
| Sexual Orientation Queer | 4 Participants | 3 Participants | 6 Participants | 13 Participants |
| Sexual Orientation Uncertain | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 52 | 0 / 102 |
| other Total, other adverse events | 0 / 100 | 0 / 52 | 0 / 102 |
| serious Total, serious adverse events | 4 / 100 | 0 / 52 | 1 / 102 |
Outcome results
Primary
Any Condomless Anal Sex Acts
Our primary outcome is the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time frame: 8 Months
Population: Intention to Treat. One participant in each condition did not provide data for this outcome measure; overall number of participants analyzed does not include these participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Condomless Anal Sex Acts | CAS = No | 38 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | CAS = Yes | 43 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | CAS = No | 29 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | CAS = Yes | 47 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | CAS = Yes | 17 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | CAS = No | 18 Participants |
p-value: 0.5295% CI: [0.52, 1.25]Regression, Logistic
Secondary
Any Condomless Anal Sex Acts
This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Condomless Anal Sex Acts | MISSING | 0 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | No | 0 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | Yes | 100 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | MISSING | 0 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | Yes | 52 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | No | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | MISSING | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | No | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | Yes | 101 Participants |
Secondary
Any Condomless Anal Sex Acts
This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time frame: 12 Months
Population: Participants with completed follow up visits.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Condomless Anal Sex Acts | No | 41 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | Yes | 39 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 1 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | No | 15 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | Yes | 26 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | Yes | 44 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | No | 36 Participants |
Secondary
Any Condomless Anal Sex Acts
This measure presents the presence (yes/no) of any condomless anal sex (CAS) in the absence of either PrEP or known undetectable viral load of HIV+ primary partners.The Time-Line Follow-Back Interview (TLFB) will be used to assess frequency of HIV risk behavior, including CAS, sex while under the influence of drugs or alcohol, and number of sexual partners, during the previous 3 months.
Time frame: 4 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Condomless Anal Sex Acts | No | 35 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | Yes | 47 Participants |
| ESTEEM | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 0 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | No | 17 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | Yes | 24 Participants |
| Community Mental Health Treatment (CMHT) | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | Yes | 53 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | MISSING ASSESSMENT | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Any Condomless Anal Sex Acts | No | 21 Participants |
Secondary
Any Pre-Exposure Prophylaxis (PrEP) Use
Participants will be asked if they had used PrEP in the last 3 months.
Time frame: 8 Months
Population: Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 56 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 18 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 11 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 8 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 7 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 4 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 16 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 21 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 9 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 20 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 25 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 11 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 44 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 2 Participants |
Secondary
Any Pre-Exposure Prophylaxis (PrEP) Use
Participants will be asked if they had used PrEP in the last 3 months.
Time frame: 4 Months
Population: Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 7 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 2 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 63 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 10 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING ASSESSMENT | 0 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 0 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 25 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 13 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 4 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING ASSESSMENT | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING ASSESSMENT | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 9 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 54 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 10 Participants |
Secondary
Any Pre-Exposure Prophylaxis (PrEP) Use
Participants will be asked if they had used PrEP in the last 3 months.
Time frame: Baseline
Population: Participants that either completed or partially completed the interview.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 0 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 15 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 82 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 3 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 0 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 41 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 8 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 3 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 10 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 3 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 87 Participants |
Secondary
Any Pre-Exposure Prophylaxis (PrEP) Use
Participants will be asked if they had used PrEP in the last 3 months.
Time frame: 12 Months
Population: Participants that either completed or partially completed the interview, MISSING used for those that either dropped our or partially completed the interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 13 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 7 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 50 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 11 Participants |
| ESTEEM | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 19 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 5 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 22 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 7 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 8 Participants |
| Community Mental Health Treatment (CMHT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 10 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | MISSING | 21 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP more than 3 months ago | 14 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | No, I have never taken HIV PrEP | 44 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | I am not currently taking HIV PrEP, but I have taken PrEP within the past 3 months | 3 Participants |
| Voluntary Counselling and Testing (VCT) | Any Pre-Exposure Prophylaxis (PrEP) Use | Yes, I am currently taking HIV PrEP | 20 Participants |
Secondary
Decisional Balance
HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., sex without a condom is more spontaneous) are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., I could get infected with HIV if I have sex without a condom) are rate as important when making the decision to use condoms during anal sex.
Time frame: 4 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESTEEM | Decisional Balance | Cons Subscale | 3.17 units on a scale | Standard Deviation 0.85 |
| ESTEEM | Decisional Balance | Pros Subscale | 2.45 units on a scale | Standard Deviation 0.83 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Cons Subscale | 3.19 units on a scale | Standard Deviation 0.83 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Pros Subscale | 2.71 units on a scale | Standard Deviation 0.7 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Pros Subscale | 2.65 units on a scale | Standard Deviation 0.85 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Cons Subscale | 3.19 units on a scale | Standard Deviation 0.84 |
Secondary
Decisional Balance
HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., sex without a condom is more spontaneous) are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., I could get infected with HIV if I have sex without a condom) are rate as important when making the decision to use condoms during anal sex.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESTEEM | Decisional Balance | Pros Subscale | 2.62 units on a scale | Standard Deviation 0.81 |
| ESTEEM | Decisional Balance | Cons Subscale | 3.26 units on a scale | Standard Deviation 0.81 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Cons Subscale | 3.16 units on a scale | Standard Deviation 0.81 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Pros Subscale | 2.8 units on a scale | Standard Deviation 0.74 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Pros Subscale | 2.66 units on a scale | Standard Deviation 0.77 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Cons Subscale | 3.24 units on a scale | Standard Deviation 0.8 |
Secondary
Decisional Balance
HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., sex without a condom is more spontaneous) are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., I could get infected with HIV if I have sex without a condom) are rate as important when making the decision to use condoms during anal sex.
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESTEEM | Decisional Balance | Pros Subscale | 2.46 units on a scale | Standard Deviation 0.88 |
| ESTEEM | Decisional Balance | Cons Subscale | 3.17 units on a scale | Standard Deviation 0.9 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Pros Subscale | 2.71 units on a scale | Standard Deviation 0.77 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Cons Subscale | 3.26 units on a scale | Standard Deviation 0.83 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Pros Subscale | 2.46 units on a scale | Standard Deviation 0.68 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Cons Subscale | 3.0 units on a scale | Standard Deviation 0.85 |
Secondary
Decisional Balance
HIV-relevant information, motivation, and behavioral skills will also be assessed using The Decisional Balance Questionnaire has been used in numerous studies of HIV risk behavior. On this 10-item scale, respondents rate the importance of each of five advantages and disadvantages in their decisions about condom use. Range: 1-5. Interpretation: Scores indicate the importance of each statement upon respondents' decisions to have anal sex with or without condoms. Higher scores on the Pros subscale indicate that pros of having anal sex without a condom (e.g., sex without a condom is more spontaneous) are rated as important when making the decision to use condoms during anal sex. Higher scores on the Cons subscale indicate that cons of having anal sex without a condom (e.g., I could get infected with HIV if I have sex without a condom) are rate as important when making the decision to use condoms during anal sex.
Time frame: 8 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ESTEEM | Decisional Balance | Pros Subscale | 2.31 units on a scale | Standard Deviation 0.83 |
| ESTEEM | Decisional Balance | Cons Subscale | 3.12 units on a scale | Standard Deviation 0.9 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Pros Subscale | 2.83 units on a scale | Standard Deviation 0.65 |
| Community Mental Health Treatment (CMHT) | Decisional Balance | Cons Subscale | 3.08 units on a scale | Standard Deviation 0.82 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Pros Subscale | 2.44 units on a scale | Standard Deviation 0.68 |
| Voluntary Counselling and Testing (VCT) | Decisional Balance | Cons Subscale | 3.02 units on a scale | Standard Deviation 0.84 |
Secondary
Depression: BSI GSI
The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (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).
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: BSI GSI | 0.60 score on a scale | Standard Deviation 0.54 |
| Community Mental Health Treatment (CMHT) | Depression: BSI GSI | 0.69 score on a scale | Standard Deviation 0.61 |
| Voluntary Counselling and Testing (VCT) | Depression: BSI GSI | 0.80 score on a scale | Standard Deviation 0.6 |
Secondary
Depression: BSI GSI
The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: BSI GSI | 1.23 score on a scale | Standard Deviation 0.62 |
| Community Mental Health Treatment (CMHT) | Depression: BSI GSI | 1.29 score on a scale | Standard Deviation 0.62 |
| Voluntary Counselling and Testing (VCT) | Depression: BSI GSI | 1.31 score on a scale | Standard Deviation 0.67 |
Secondary
Depression: BSI GSI
The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (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).
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: BSI GSI | 0.65 score on a scale | Standard Deviation 0.63 |
| Community Mental Health Treatment (CMHT) | Depression: BSI GSI | 0.70 score on a scale | Standard Deviation 0.69 |
| Voluntary Counselling and Testing (VCT) | Depression: BSI GSI | 0.76 score on a scale | Standard Deviation 0.64 |
Secondary
Depression: BSI GSI
The Global Severity Index (GSI) of the 18-item Brief Symptom Inventory (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).
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: BSI GSI | 0.66 score on a scale | Standard Deviation 0.6 |
| Community Mental Health Treatment (CMHT) | Depression: BSI GSI | 0.86 score on a scale | Standard Deviation 0.73 |
| Voluntary Counselling and Testing (VCT) | Depression: BSI GSI | 0.77 score on a scale | Standard Deviation 0.66 |
Secondary
Depression: HAM-D
To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: HAM-D | 9.95 units on a scale | Standard Deviation 6.34 |
| Community Mental Health Treatment (CMHT) | Depression: HAM-D | 11.49 units on a scale | Standard Deviation 8.86 |
| Voluntary Counselling and Testing (VCT) | Depression: HAM-D | 10.73 units on a scale | Standard Deviation 6.68 |
Secondary
Depression: HAM-D
To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: HAM-D | 16.13 units on a scale | Standard Deviation 6.26 |
| Community Mental Health Treatment (CMHT) | Depression: HAM-D | 15.87 units on a scale | Standard Deviation 6.75 |
| Voluntary Counselling and Testing (VCT) | Depression: HAM-D | 15.25 units on a scale | Standard Deviation 6.83 |
Secondary
Depression: HAM-D
To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: HAM-D | 10.20 units on a scale | Standard Deviation 6.13 |
| Community Mental Health Treatment (CMHT) | Depression: HAM-D | 9.93 units on a scale | Standard Deviation 6.82 |
| Voluntary Counselling and Testing (VCT) | Depression: HAM-D | 10.51 units on a scale | Standard Deviation 7.02 |
Secondary
Depression: HAM-D
To determine depression symptom severity, interviewers will complete the Hamilton Rating Scale for Depression (HAM-D). The HAM-D has a range of 0-32 where higher scores indicate greater levels of depression.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Depression: HAM-D | 9.81 units on a scale | Standard Deviation 6.04 |
| Community Mental Health Treatment (CMHT) | Depression: HAM-D | 9.57 units on a scale | Standard Deviation 6.2 |
| Voluntary Counselling and Testing (VCT) | Depression: HAM-D | 11.72 units on a scale | Standard Deviation 6.39 |
Secondary
Minority Stress: Brooding
Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Brooding | 12.36 units on a scale | Standard Deviation 3.21 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Brooding | 13.20 units on a scale | Standard Deviation 3.57 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Brooding | 13.38 units on a scale | Standard Deviation 3.15 |
Secondary
Minority Stress: Brooding
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Brooding | 12.02 units on a scale | Standard Deviation 3.53 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Brooding | 12.19 units on a scale | Standard Deviation 3.45 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Brooding | 13.14 units on a scale | Standard Deviation 3.72 |
Secondary
Minority Stress: Brooding
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Brooding | 11.55 units on a scale | Standard Deviation 3.36 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Brooding | 12.55 units on a scale | Standard Deviation 3.44 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Brooding | 12.09 units on a scale | Standard Deviation 3.5 |
Secondary
Minority Stress: Brooding
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Brooding Subscale of the Ruminative Response Scale. This scale has a range of 5 to 20 with the higher score indicating greater severity.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Brooding | 13.91 units on a scale | Standard Deviation 3.08 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Brooding | 14.25 units on a scale | Standard Deviation 3.49 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Brooding | 13.47 units on a scale | Standard Deviation 3.64 |
Secondary
Minority Stress: DERS
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: DERS | 95.39 units on a scale | Standard Deviation 20.53 |
| Community Mental Health Treatment (CMHT) | Minority Stress: DERS | 98.61 units on a scale | Standard Deviation 21.2 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: DERS | 94.41 units on a scale | Standard Deviation 25.2 |
Secondary
Minority Stress: DERS
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: DERS | 85.33 units on a scale | Standard Deviation 20.75 |
| Community Mental Health Treatment (CMHT) | Minority Stress: DERS | 86.73 units on a scale | Standard Deviation 21.21 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: DERS | 86.09 units on a scale | Standard Deviation 20.94 |
Secondary
Minority Stress: DERS
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: DERS | 87.14 units on a scale | Standard Deviation 24.29 |
| Community Mental Health Treatment (CMHT) | Minority Stress: DERS | 89.34 units on a scale | Standard Deviation 21.89 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: DERS | 86.87 units on a scale | Standard Deviation 21.91 |
Secondary
Minority Stress: DERS
Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Difficulties of Emotion Regulation Scale (DERS). The DERS has a range of 36 to 172 with higher scores indicating greater difficulty.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: DERS | 84.84 units on a scale | Standard Deviation 21.48 |
| Community Mental Health Treatment (CMHT) | Minority Stress: DERS | 94.53 units on a scale | Standard Deviation 24.16 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: DERS | 86.46 units on a scale | Standard Deviation 19.62 |
Secondary
Minority Stress: GRRS
Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: GRRS | 11.29 units on a scale | Standard Deviation 7.05 |
| Community Mental Health Treatment (CMHT) | Minority Stress: GRRS | 11.33 units on a scale | Standard Deviation 7.2 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: GRRS | 11.53 units on a scale | Standard Deviation 6.94 |
Secondary
Minority Stress: GRRS
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: GRRS | 10.01 units on a scale | Standard Deviation 6.79 |
| Community Mental Health Treatment (CMHT) | Minority Stress: GRRS | 11.07 units on a scale | Standard Deviation 7.29 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: GRRS | 10.53 units on a scale | Standard Deviation 7.32 |
Secondary
Minority Stress: GRRS
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: GRRS | 13.34 units on a scale | Standard Deviation 7.08 |
| Community Mental Health Treatment (CMHT) | Minority Stress: GRRS | 14.34 units on a scale | Standard Deviation 8.38 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: GRRS | 14.48 units on a scale | Standard Deviation 7.73 |
Secondary
Minority Stress: GRRS
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Gay-Related Rejection Sensitivity Scale (GRRS). Scores range from 1 to 36 where higher scores indicate higher stress.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: GRRS | 10.14 units on a scale | Standard Deviation 6.14 |
| Community Mental Health Treatment (CMHT) | Minority Stress: GRRS | 10.51 units on a scale | Standard Deviation 7.05 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: GRRS | 11.58 units on a scale | Standard Deviation 7.49 |
Secondary
Minority Stress: IHS
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: IHS | 1.67 units on a scale | Standard Deviation 0.75 |
| Community Mental Health Treatment (CMHT) | Minority Stress: IHS | 1.38 units on a scale | Standard Deviation 0.42 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: IHS | 1.53 units on a scale | Standard Deviation 0.59 |
Secondary
Minority Stress: IHS
Assessments at baseline, 4, 8, and 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: IHS | 1.73 units on a scale | Standard Deviation 0.72 |
| Community Mental Health Treatment (CMHT) | Minority Stress: IHS | 1.49 units on a scale | Standard Deviation 0.46 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: IHS | 1.66 units on a scale | Standard Deviation 0.62 |
Secondary
Minority Stress: IHS
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: IHS | 1.90 units on a scale | Standard Deviation 0.78 |
| Community Mental Health Treatment (CMHT) | Minority Stress: IHS | 1.78 units on a scale | Standard Deviation 0.75 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: IHS | 1.81 units on a scale | Standard Deviation 0.7 |
Secondary
Minority Stress: IHS
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Internalized Homonegativity Scale (IHS). The IHS has a range of 1 to 4 with higher scores indicating higher stress.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: IHS | 1.69 units on a scale | Standard Deviation 0.67 |
| Community Mental Health Treatment (CMHT) | Minority Stress: IHS | 1.44 units on a scale | Standard Deviation 0.44 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: IHS | 1.66 units on a scale | Standard Deviation 0.66 |
Secondary
Minority Stress: Rathus Assertiveness Schedule
Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Rathus Assertiveness Schedule | 101.87 units on a scale | Standard Deviation 15.31 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Rathus Assertiveness Schedule | 105.13 units on a scale | Standard Deviation 16.94 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Rathus Assertiveness Schedule | 108.23 units on a scale | Standard Deviation 19.62 |
Secondary
Minority Stress: Rathus Assertiveness Schedule
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Rathus Assertiveness Schedule | 104.02 units on a scale | Standard Deviation 17.07 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Rathus Assertiveness Schedule | 106.85 units on a scale | Standard Deviation 14.94 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Rathus Assertiveness Schedule | 106.47 units on a scale | Standard Deviation 18.97 |
Secondary
Minority Stress: Rathus Assertiveness Schedule
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Rathus Assertiveness Schedule | 103.26 units on a scale | Standard Deviation 15.32 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Rathus Assertiveness Schedule | 107.47 units on a scale | Standard Deviation 15.81 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Rathus Assertiveness Schedule | 108.61 units on a scale | Standard Deviation 16.01 |
Secondary
Minority Stress: Rathus Assertiveness Schedule
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Rathus Assertiveness Schedule. The measure has a range of 39-161 where greater values indicate higher levels of assertiveness.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: Rathus Assertiveness Schedule | 99.44 units on a scale | Standard Deviation 18.77 |
| Community Mental Health Treatment (CMHT) | Minority Stress: Rathus Assertiveness Schedule | 101.39 units on a scale | Standard Deviation 20.35 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: Rathus Assertiveness Schedule | 99.98 units on a scale | Standard Deviation 19.1 |
Secondary
Minority Stress: SOCS
Assessments at 12 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: SOCS | 1.87 units on a scale | Standard Deviation 0.79 |
| Community Mental Health Treatment (CMHT) | Minority Stress: SOCS | 1.57 units on a scale | Standard Deviation 0.73 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: SOCS | 1.83 units on a scale | Standard Deviation 0.81 |
Secondary
Minority Stress: SOCS
Assessments at 8 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: SOCS | 1.94 units on a scale | Standard Deviation 0.82 |
| Community Mental Health Treatment (CMHT) | Minority Stress: SOCS | 1.73 units on a scale | Standard Deviation 0.75 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: SOCS | 1.83 units on a scale | Standard Deviation 0.76 |
Secondary
Minority Stress: SOCS
Assessments at baseline will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: SOCS | 1.84 units on a scale | Standard Deviation 0.69 |
| Community Mental Health Treatment (CMHT) | Minority Stress: SOCS | 1.73 units on a scale | Standard Deviation 0.74 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: SOCS | 1.83 units on a scale | Standard Deviation 0.76 |
Secondary
Minority Stress: SOCS
Assessments at 4 months will be collected to test whether changes in minority stress and mental health precede and statistically mediate the efficacy of ESTEEM. One measurement will come from the Sexual Orientation Concealment Scale (SOCS). The SOCS has a range of 1-4 with higher scores indicating higher concealment.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Minority Stress: SOCS | 1.90 units on a scale | Standard Deviation 0.7 |
| Community Mental Health Treatment (CMHT) | Minority Stress: SOCS | 1.79 units on a scale | Standard Deviation 0.75 |
| Voluntary Counselling and Testing (VCT) | Minority Stress: SOCS | 1.87 units on a scale | Standard Deviation 0.74 |
Secondary
Safer Sex Self-Efficacy
HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Safer Sex Self-Efficacy | 44.68 units on a scale | Standard Deviation 12.32 |
| Community Mental Health Treatment (CMHT) | Safer Sex Self-Efficacy | 38.55 units on a scale | Standard Deviation 13.33 |
| Voluntary Counselling and Testing (VCT) | Safer Sex Self-Efficacy | 41.53 units on a scale | Standard Deviation 11.76 |
Secondary
Safer Sex Self-Efficacy
HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Safer Sex Self-Efficacy | 42.73 units on a scale | Standard Deviation 13.77 |
| Community Mental Health Treatment (CMHT) | Safer Sex Self-Efficacy | 36.44 units on a scale | Standard Deviation 13.11 |
| Voluntary Counselling and Testing (VCT) | Safer Sex Self-Efficacy | 40.32 units on a scale | Standard Deviation 10.89 |
Secondary
Safer Sex Self-Efficacy
HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Safer Sex Self-Efficacy | 42.83 units on a scale | Standard Deviation 12.83 |
| Community Mental Health Treatment (CMHT) | Safer Sex Self-Efficacy | 37.4 units on a scale | Standard Deviation 12.08 |
| Voluntary Counselling and Testing (VCT) | Safer Sex Self-Efficacy | 41.8 units on a scale | Standard Deviation 12.69 |
Secondary
Safer Sex Self-Efficacy
HIV-relevant information, motivation, and behavioral skills will be assessed using The Safer Sex Self-Efficacy Questionnaire. It is a 13-item measure assessing self-efficacy (confidence) for practicing safer sex. It has demonstrated strong reliability in previous research. Range of scores: 13 - 65. Interpretation: higher scores indicate greater confidence for using condoms during anal sex in the 13 situations listed.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Safer Sex Self-Efficacy | 38.92 units on a scale | Standard Deviation 11.73 |
| Community Mental Health Treatment (CMHT) | Safer Sex Self-Efficacy | 36.69 units on a scale | Standard Deviation 12.02 |
| Voluntary Counselling and Testing (VCT) | Safer Sex Self-Efficacy | 38.72 units on a scale | Standard Deviation 12.73 |
Secondary
Substance Use: SIP-AD
Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of yes responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., I have failed to do what is expected of me because of my drinking/drug use). Higher scores indicate greater substance use with a range of 0-15.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Substance Use: SIP-AD | 4.95 units on a scale | Standard Deviation 4.42 |
| Community Mental Health Treatment (CMHT) | Substance Use: SIP-AD | 4.71 units on a scale | Standard Deviation 4.06 |
| Voluntary Counselling and Testing (VCT) | Substance Use: SIP-AD | 4.52 units on a scale | Standard Deviation 4.41 |
Secondary
Substance Use: SIP-AD
Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of yes responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., I have failed to do what is expected of me because of my drinking/drug use). Higher scores indicate greater substance use with a range of 0-15.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Substance Use: SIP-AD | 3.21 units on a scale | Standard Deviation 4.19 |
| Community Mental Health Treatment (CMHT) | Substance Use: SIP-AD | 4.29 units on a scale | Standard Deviation 3.98 |
| Voluntary Counselling and Testing (VCT) | Substance Use: SIP-AD | 3.34 units on a scale | Standard Deviation 3.94 |
Secondary
Substance Use: SIP-AD
Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of yes responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., I have failed to do what is expected of me because of my drinking/drug use). Higher scores indicate greater substance use with a range of 0-15.
Time frame: 8 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Substance Use: SIP-AD | 2.72 units on a scale | Standard Deviation 3.33 |
| Community Mental Health Treatment (CMHT) | Substance Use: SIP-AD | 3.75 units on a scale | Standard Deviation 4.17 |
| Voluntary Counselling and Testing (VCT) | Substance Use: SIP-AD | 3.38 units on a scale | Standard Deviation 4.07 |
Secondary
Substance Use: SIP-AD
Short Inventory of Problems - Alcohol and Drugs (SIP-AD; Allensworth-Davies et al., 2012; Blanchard et al., 2003). SIP-AD is a 15-item scale in which the sum of yes responses indicates participants' past-3-month consequences of alcohol and drug use (e.g., I have failed to do what is expected of me because of my drinking/drug use). Higher scores indicate greater substance use with a range of 0-15.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ESTEEM | Substance Use: SIP-AD | 2.51 units on a scale | Standard Deviation 3.54 |
| Community Mental Health Treatment (CMHT) | Substance Use: SIP-AD | 3.83 units on a scale | Standard Deviation 4.18 |
| Voluntary Counselling and Testing (VCT) | Substance Use: SIP-AD | 2.79 units on a scale | Standard Deviation 3.61 |
Other Pre-specified
Chlamydia Test
Oral, rectal and urine samples will be collected to test participants for Chlamydia at Baseline.
Time frame: Baseline
Population: Participants with complete and valid data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ESTEEM | Chlamydia Test | Throat | Non-reactive | 97 Participants |
| ESTEEM | Chlamydia Test | Throat | Reactive | 2 Participants |
| ESTEEM | Chlamydia Test | Throat | Inconclusive | 0 Participants |
| ESTEEM | Chlamydia Test | Throat | Not assessed | 1 Participants |
| ESTEEM | Chlamydia Test | Rectal | Non-reactive | 97 Participants |
| ESTEEM | Chlamydia Test | Rectal | Reactive | 3 Participants |
| ESTEEM | Chlamydia Test | Rectal | Inconclusive | 0 Participants |
| ESTEEM | Chlamydia Test | Rectal | Not assessed | 0 Participants |
| ESTEEM | Chlamydia Test | Urine | Non-reactive | 99 Participants |
| ESTEEM | Chlamydia Test | Urine | Reactive | 1 Participants |
| ESTEEM | Chlamydia Test | Urine | Inconclusive | 0 Participants |
| ESTEEM | Chlamydia Test | Urine | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Non-reactive | 50 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Non-reactive | 51 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Reactive | 2 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Reactive | 4 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Non-reactive | 48 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Reactive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Non-reactive | 90 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Reactive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Reactive | 10 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Inconclusive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Not assessed | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Non-reactive | 96 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Reactive | 5 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Non-reactive | 101 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Inconclusive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Not assessed | 0 Participants |
Other Pre-specified
Chlamydia Test
Oral, rectal and urine samples will be collected to test participants for Chlamydia at 12 months.
Time frame: 12 Months
Population: Participants with complete and valid data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ESTEEM | Chlamydia Test | Urine | Non-reactive | 74 Participants |
| ESTEEM | Chlamydia Test | Rectal | Non-reactive | 69 Participants |
| ESTEEM | Chlamydia Test | Urine | Reactive | 0 Participants |
| ESTEEM | Chlamydia Test | Throat | Reactive | 1 Participants |
| ESTEEM | Chlamydia Test | Rectal | Reactive | 3 Participants |
| ESTEEM | Chlamydia Test | Urine | Not assessed | 0 Participants |
| ESTEEM | Chlamydia Test | Throat | Not assessed | 1 Participants |
| ESTEEM | Chlamydia Test | Rectal | Inconclusive | 0 Participants |
| ESTEEM | Chlamydia Test | Urine | Inconclusive | 0 Participants |
| ESTEEM | Chlamydia Test | Throat | Non-reactive | 72 Participants |
| ESTEEM | Chlamydia Test | Rectal | Not assessed | 2 Participants |
| ESTEEM | Chlamydia Test | Throat | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Non-reactive | 38 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Non-reactive | 38 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Urine | Reactive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Non-reactive | 34 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Reactive | 4 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Throat | Reactive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Chlamydia Test | Rectal | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Non-reactive | 75 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Throat | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Non-reactive | 74 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Reactive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Rectal | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Non-reactive | 75 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Chlamydia Test | Urine | Inconclusive | 0 Participants |
Other Pre-specified
Gonorrhea Test
Oral, rectal and urine samples will be collected to test participants for Gonorrhea at Baseline.
Time frame: Baseline
Population: Participants with complete and valid data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ESTEEM | Gonorrhea Test | Throat | Non-reactive | 94 Participants |
| ESTEEM | Gonorrhea Test | Throat | Reactive | 5 Participants |
| ESTEEM | Gonorrhea Test | Throat | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Throat | Not Assessed | 1 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Non-reactive | 95 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Reactive | 5 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Not Assessed | 0 Participants |
| ESTEEM | Gonorrhea Test | Urine | Non-reactive | 100 Participants |
| ESTEEM | Gonorrhea Test | Urine | Reactive | 0 Participants |
| ESTEEM | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Urine | Not Assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Not Assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Non-reactive | 48 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Non-reactive | 52 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Reactive | 4 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Reactive | 3 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Not Assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Non-reactive | 49 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Not Assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Not Assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Non-reactive | 99 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Reactive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Inconclusive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Not Assessed | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Non-reactive | 97 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Reactive | 4 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Non-reactive | 102 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Inconclusive | 1 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Not Assessed | 0 Participants |
Other Pre-specified
Gonorrhea Test
Oral, rectal and urine samples will be collected to test participants for Gonorrhea at 12 months.
Time frame: 12 Months
Population: Participants with complete and valid data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ESTEEM | Gonorrhea Test | Throat | Non-reactive | 71 Participants |
| ESTEEM | Gonorrhea Test | Throat | Reactive | 2 Participants |
| ESTEEM | Gonorrhea Test | Throat | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Throat | Not assessed | 1 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Non-reactive | 67 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Reactive | 5 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Rectal | Not assessed | 2 Participants |
| ESTEEM | Gonorrhea Test | Urine | Non-reactive | 74 Participants |
| ESTEEM | Gonorrhea Test | Urine | Reactive | 0 Participants |
| ESTEEM | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| ESTEEM | Gonorrhea Test | Urine | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Non-reactive | 36 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Non-reactive | 38 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Reactive | 2 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Reactive | 3 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Inconclusive | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Rectal | Non-reactive | 35 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Throat | Not assessed | 0 Participants |
| Community Mental Health Treatment (CMHT) | Gonorrhea Test | Urine | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Non-reactive | 73 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Reactive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Reactive | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Rectal | Not assessed | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Non-reactive | 73 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Reactive | 2 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Non-reactive | 75 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Throat | Inconclusive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | Gonorrhea Test | Urine | Not assessed | 0 Participants |
Other Pre-specified
HIV Test
Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at 12 months.
Time frame: 12 Months
Population: Participants with complete and valid data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | HIV Test | Negative | 73 Participants |
| ESTEEM | HIV Test | Preliminary Positive | 3 Participants |
| Community Mental Health Treatment (CMHT) | HIV Test | Negative | 39 Participants |
| Community Mental Health Treatment (CMHT) | HIV Test | Preliminary Positive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | HIV Test | Negative | 75 Participants |
| Voluntary Counselling and Testing (VCT) | HIV Test | Preliminary Positive | 1 Participants |
Other Pre-specified
HIV Test
Orasure Rapid HIV-1/2 Antibody Test will be used to test participants for HIV at Baseline.
Time frame: Baseline
Population: Participants with complete and valid data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ESTEEM | HIV Test | Negative | 100 Participants |
| ESTEEM | HIV Test | Preliminary Positive | 0 Participants |
| Community Mental Health Treatment (CMHT) | HIV Test | Negative | 52 Participants |
| Community Mental Health Treatment (CMHT) | HIV Test | Preliminary Positive | 0 Participants |
| Voluntary Counselling and Testing (VCT) | HIV Test | Negative | 102 Participants |
| Voluntary Counselling and Testing (VCT) | HIV Test | Preliminary Positive | 0 Participants |