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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH119968-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| The University of Akron | OTHER |
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The purpose of this clinical trial is to evaluate and test a newly developed gender-affirming intervention that addresses the dual and interconnected risks of HIV and intimate partner victimization (IPV) among transgender women (TW). The main questions it aims to answer are: (1) will the study intervention reduce HIV risk within the context of IPV and related risk factors (e.g., substance use and PTSD); (2) will STARS improve primary prevention behaviors, such as condom use, pre-exposure prophylaxis (PrEP) use, and repeat HIV testing; and (3) what are the mechanisms of change relevant to the theoretical foundations of the intervention, including gender affirmation, empowerment, and self-efficacy. The findings from this study will provide the necessary groundwork to examine the efficacy of this combined HIV-IPV intervention in a future, large-scale clinical trial.
There are several components to this research study:
The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.
Transgender women (TW) are among the populations most heavily affected by HIV in the United States (US), with nearly 1 in 5 TW living with HIV. The risk for HIV in TW often occurs in the context of intimate partner relationships. Moreover, in the context of these partnerships, TW are at elevated risk for intimate partner victimization (IPV). There is a strong link between IPV and HIV risk. IPV risk is amplified in TW who have a history of IPV or are in an abusive primary relationship. Thus, IPV and HIV as well as other sexually transmitted infections (STIs) are interconnected public health problems facing TW. Despite the dual and interconnected risks of HIV and IPV among TW, there are few empirically based HIV prevention interventions that target TW and none that target HIV risks related to IPV in this population.
This overall research study is a 3-phase project (NIH R34MH119968). In Phase 1, researchers conducted focus groups with TW and community-based service providers to identify specific strategies for a brief health educational counseling intervention to support safety and HIV risk reduction among TW who have experienced recent IPV and HIV risk. Phase 1 data collection activities and preliminary analyses have been completed, and a full draft intervention protocol was produced based on Phase 1 findings.
Phase 2 of this study involved conducting an open pilot trail (OP) of the full draft intervention protocol with 5 participants, using quantitative (i.e. surveys) and qualitative (i.e. individual interviews) methods to gain experience delivering the protocol and obtaining critical feedback on the intervention protocol, procedures and assessments. This knowledge has informed finalizing the intervention and assessment protocols, which will be used in the subsequent and final Phase 3 of the study.
Phase 3 (the clinical trial registered here), involves conducting a pilot, two-arm Randomized Control Trial (RCT) to evaluate the program's ability to increase knowledge of HIV and HIV risk factors and reduce risk of intimate partner victimization among participants. The two treatment conditions used in this clinical trial are: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) - detailed below and (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group).
Participants will first complete a multi-step screening process to determine eligibility. If eligible, enrolled participants will then complete a 2-3 hour baseline assessment that can be conducted in-person or over Zoom. Assessments consist of interviewer administered safety measures as well as self-report online questionnaires. After completing the baseline assessment, participants will be randomly assigned to one of the two intervention arms. Assessments will also be conducted post-intervention as well as at 4-months and 6-months follow up. Participants who were randomized to the study intervention arm (i.e., the STARS Program) will also be invited to complete a 60-90 minute semi-structured exit interview via Zoom to provide qualitative feedback on the program.
The overall purpose of this study is to develop a brief intervention that concurrently targets HIV and IPV risk, as well as addresses inter-related risks of HIV and IPV (e.g., substance use and PTSD) for TW - referred to as Supporting Transwomen Affirmation, Relationships and Sex (STARS). Program STARS will:
The aims of this treatment development research are to:
Researchers are primarily interested in exploring the pattern of results for any evidence of support for the intervention's influence on the primary and secondary outcomes, which are listed below.
Primary Outcomes:
Composite Risk for HIV (CR-HIV) is a binary indicator of any HIV risk (e.g., yes=1 vs. no=0), which is an algorithm based on whether the participant:
IPV frequency will be assessed with:
IPV safety will be assessed with the:
Secondary Outcomes:
Long-term aim: The findings from this R34 intervention development study will provide the groundwork to examine the efficacy of STARS in a future, large-scale clinical trial, which can be readily implemented in real-world settings.
Dissemination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program STARS (Supporting Trans Affirmation, relationships, and Sex) | Experimental | STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions. |
|
| Relaxation and Stress Reduction | Active Comparator | The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program STARS (Supporting Trans Affirmation, relationships, and Sex) | Behavioral | See description to the left. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Risk for HIV (CR-HIV) | Composite Risk for HIV (CR-HIV) calculates a binary indicator (0=No, 1=Yes) of a participant's risk for HIV acquisition using an algorithm based on the following questions:
The total number of participants at risk for HIV acquisition for each arm is reported. | Post-intervention, 4-month follow-up, and 6-month follow-up |
| Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) | Intimate Partner Violence (IPV) Frequency was measured using the Composite Abuse Scale Revised-Short Form (CASr-SF), a 15-item scale. For each item, participants answer if the type of abuse occurred and how often from, "Not in the past 2 months (0)" to "Daily/ almost daily (5)." Total score was calculated by summing all items, which could range from 0 to 75 with higher scores indicate higher frequency and severity of IPV. | Post-intervention, 4-month follow-up, and 6-month follow-up |
| Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale | IPV frequency is assessed using the trans-specific IPV scale (T-IPV), a 4-item scale that screens for IPV among transgender individuals. Participants reponsded to statements covering the presence of controlling behaviors and psychological abuse tactics (No=0; Yes=1). Scores range from 0 to 4, with higher scores indicating higher frequency of recent T-IPV. | Post-intervention, 4-month follow-up, and 6-month follow-up |
| Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk | The total number of receptive condomless anal sex acts with any HIV transmission risk was calculated by summing the number of receptive anal sex acts in which no prevention method (i.e., condom, PrEP) was used over the last 60 days. | Post-intervention, 4-months follow-up, 6-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Reporting Instances of IPV | Post-intervention, 4-month follow-up, 6-month follow-up | |
| Depressive Symptoms | Depressive symptoms were evaluated using the Center of Epidemiologic Studies Depression Scale-10 (CESD-10). The measure consists of 10 items that asked about feelings or behaviors related to depressive symptoms on a four-point Likert scale (0-3). Items 5 and 8 were first reverse coded, and all points were summed to create a total score ranging from 0 to 30, with higher scores representing greater degrees of depressed mood. |
Inclusion Criteria:
Exclusion Criteria:
Assigned male at birth and identify as female, transgender, or transfeminine
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| Name | Affiliation | Role |
|---|---|---|
| Shufang Sun, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41196739 | Derived | Guy AA, Chen CA, McCarthy-Belash N, Kang TK, Kolbasov LA, Gregory R, Scott T, Garcia J, Banson J, Zlotnick C, Operario D, Johnson DM, Sun S. Mixed methods trial of a peer intervention for HIV and partner victimization in transgender women. J Couns Psychol. 2026 Mar;73(2):246-262. doi: 10.1037/cou0000832. Epub 2025 Nov 6. |
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Following data collection, cleaning, and analysis, we plan to publish deidentified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.
Data will become available sometime in during Summer 2024 and will be available for the duration of staff funding.
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| ID | Title | Description |
|---|---|---|
| FG000 | Program STARS (Supporting Trans Affirmation, relationships, and Sex) | STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions. |
| FG001 | Relaxation and Stress Reduction | The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Program STARS (Supporting Trans Affirmation, Relationships, and Sex) | STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Risk for HIV (CR-HIV) | Composite Risk for HIV (CR-HIV) calculates a binary indicator (0=No, 1=Yes) of a participant's risk for HIV acquisition using an algorithm based on the following questions:
The total number of participants at risk for HIV acquisition for each arm is reported. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Count of Participants | Participants | Post-intervention, 4-month follow-up, and 6-month follow-up |
From enrollment until end of follow-up, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Program STARS (Supporting Trans Affirmation, relationships, and Sex) | STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious/life threatening IPV | Social circumstances | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sexual assault other than rape or attempted rape | Social circumstances | Systematic Assessment | Indicated by items 3, 6, 7 on CAS-SF or any increase in DA-5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arryn Guy | Illinois Institute of Technology | 312-567-6467 | aguy1@iit.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2023 | Sep 9, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2025 | Sep 9, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 13, 2023 | Jul 31, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001244 | Association |
| D012723 | Sex |
| ID | Term |
|---|---|
| D013811 | Psychotherapeutic Processes |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D055703 | Reproductive Physiological Phenomena |
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The methodological approach includes a 2-arm trial of Project STARS vs. a time matched, attention-controlled comparison group, with up to n=20 per arm (total Phase 3 sample size = up to 40 participants enrolled and randomized). The study is intended to evaluate the impacts of STARS on the specified outcomes.
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All research staff conducting participant assessments will remain blinded to group assignment. Randomization procedures will be conducted by a high level researcher (co-investigator responsible for clinical supervision).
| Relaxation and Stress Reduction | Behavioral | See description to the left. |
|
MOVERS is a 13-item scale designed to assess empowerment related to safety among IPV survivors. Participants rate each item on a five-point Likert scale (1 = Never true to 5 = Always true). For each participant, the mean score across all 13 items was calculated (score range: 1-5). The scale includes 3 subscales: Internal Tools, Expectations of Support, and Trade-Offs. Scores for each subscale were computed as the mean score of the items corresponding to that subscale (score range: 1-5 for all subscales). For both the composite scale and subscales, higher scores indicate greater empowerment. |
| Post-intervention, 4-month follow-up, and 6-month follow-up |
| Feasibility of Online STARS as Measured by Recruitment Rates | One measure of feasibility will be participant recruitment rates. | During recruitment period of study, up to 4 months |
| Feasibility of Online STARS as Measured by Retention Rates. | One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions. | Post-intervention, 4-month follow-up, and 6-month follow-up |
| Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire | One measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. For each participant, the mean score across all 8 items was calculated (score range: 1-4), with higher values indicating higher satisfaction. | Post-intervention |
| Post-intervention, 4-month follow-up, 6-month follow-up |
| PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5) | PTSD symptoms were evaluated using the PTSD Checklist for DSM-5, a 20-item measure that assesses symptom frequency in the past month on a five-point Likert scale (0 = "Not at all" to 4 = "Extremely"). The total score is calculated by summing the responses for all 20 items, resulting in a score between 0 and 80. A higher total score indicates more severe PTSD symptoms. | Post-intervention, 4-month follow-up, and 6-month follow-up |
| BG001 | Relaxation and Stress Reduction | The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Multiracial participants were able to select multiple race/ethnicity | Count of Participants | Participants |
|
| Frequency of past-year IPV | Mean | Standard Deviation | Events |
|
| PTSD symptoms | PTSD symptoms were evaluated using the PTSD Checklist for DSM-5, a 20-item measure that assesses symptom frequency in the past month on a five-point Likert scale (0 = "Not at all" to 4 = "Extremely"). The total score is calculated by summing the responses for all 20 items, resulting in a score between 0 and 80. A higher total score indicates more severe PTSD symptoms. | Mean | Standard Deviation | Scores on a scale |
|
| Depressive Symptoms | Depressive symptoms were evaluated using the Center of Epidemiologic Studies Depression Scale-10 (CESD-10). The measure consists of 10 items that asked about feelings or behaviors related to depressive symptoms on a four-point Likert scale (0-3). Items 5 and 8 were first reverse coded, and all points were summed to create a total score ranging from 0 to 30, with higher scores representing greater degrees of depressed mood. | Mean | Standard Deviation | Scores on a scale |
|
| Total number of receptive condomless anal sex acts with any HIV transmission risk | The total number of receptive condomless anal sex acts with any HIV transmission risk was calculated by summing the number of receptive anal sex acts in which no prevention method (i.e., condom, PrEP) was used over the last 60 days. | Mean | Standard Deviation | Events |
|
| Composite Risk for HIV (CR-HIV) | Composite Risk for HIV calculates a binary indicator (0=No, 1=Yes) of risk for HIV acquisition based on the following questions:
| Count of Participants | Participants |
|
| Intimate Partner Violence (IPV) Frequency | Intimate Partner Violence (IPV) Frequency was measured using the Composite Abuse Scale Revised-Short Form (CASr-SF), a 15-item scale. For each item, participants answer if the type of abuse occurred and how often from, "Not in the past 2 months (0)" to "Daily/ almost daily (5)." Total score was calculated by summing all items, which could range from 0 to 75 with higher scores indicate higher frequency and severity of IPV. | Mean | Standard Deviation | Scores on a scale |
|
| Intimate Partner Violence Frequency: Transgender-specific IPV scale (T-IPV) | IPV frequency is assessed using the trans-specific IPV scale (T-IPV), a 4-item scale that screens for IPV among transgender individuals. Participants reponsded to statements covering the presence of controlling behaviors and psychological abuse tactics (No=0; Yes=1). Scores range from 0 to 4, with higher scores indicating higher frequency of recent T-IPV. | Mean | Standard Deviation | Scores on a scale |
|
| Intimate Partner Violence Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) | MOVERS is a 13-item scale designed to assess empowerment related to safety among IPV survivors. Participants rate each item on a five-point Likert scale (1 = Never true to 5 = Always true). For each participant, the mean score across all 13 items was calculated (score range: 1-5). The scale includes 3 subscales: Internal Tools, Expectations of Support, and Trade-Offs. Scores for each subscale were computed as the mean score of the items corresponding to that subscale (score range: 1-5 for all subscales). For both the composite scale and subscales, higher scores indicate greater empowerment. | Mean | Standard Deviation | Scores on a scale |
|
|
|
|
| Primary | Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) | Intimate Partner Violence (IPV) Frequency was measured using the Composite Abuse Scale Revised-Short Form (CASr-SF), a 15-item scale. For each item, participants answer if the type of abuse occurred and how often from, "Not in the past 2 months (0)" to "Daily/ almost daily (5)." Total score was calculated by summing all items, which could range from 0 to 75 with higher scores indicate higher frequency and severity of IPV. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention, 4-month follow-up, and 6-month follow-up |
|
|
|
| Primary | Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale | IPV frequency is assessed using the trans-specific IPV scale (T-IPV), a 4-item scale that screens for IPV among transgender individuals. Participants reponsded to statements covering the presence of controlling behaviors and psychological abuse tactics (No=0; Yes=1). Scores range from 0 to 4, with higher scores indicating higher frequency of recent T-IPV. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention, 4-month follow-up, and 6-month follow-up |
|
|
|
| Primary | Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) | MOVERS is a 13-item scale designed to assess empowerment related to safety among IPV survivors. Participants rate each item on a five-point Likert scale (1 = Never true to 5 = Always true). For each participant, the mean score across all 13 items was calculated (score range: 1-5). The scale includes 3 subscales: Internal Tools, Expectations of Support, and Trade-Offs. Scores for each subscale were computed as the mean score of the items corresponding to that subscale (score range: 1-5 for all subscales). For both the composite scale and subscales, higher scores indicate greater empowerment. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Scores on scale | Post-intervention, 4-month follow-up, and 6-month follow-up |
|
|
|
| Primary | Feasibility of Online STARS as Measured by Recruitment Rates | One measure of feasibility will be participant recruitment rates. | Overall Number of Participants Analyzed represents number of participants screened for study interest prior to enrollment. | Posted | Count of Participants | Participants | During recruitment period of study, up to 4 months |
|
|
|
| Primary | Feasibility of Online STARS as Measured by Retention Rates. | One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions. | Posted | Count of Participants | Participants | Post-intervention, 4-month follow-up, and 6-month follow-up |
|
|
|
| Primary | Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire | One measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. For each participant, the mean score across all 8 items was calculated (score range: 1-4), with higher values indicating higher satisfaction. | In the control arm, 1 participant was lost to follow-up after the baseline assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention |
|
|
|
| Other Pre-specified | Participants Reporting Instances of IPV | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Count of Participants | Participants | Post-intervention, 4-month follow-up, 6-month follow-up |
|
|
|
| Other Pre-specified | Depressive Symptoms | Depressive symptoms were evaluated using the Center of Epidemiologic Studies Depression Scale-10 (CESD-10). The measure consists of 10 items that asked about feelings or behaviors related to depressive symptoms on a four-point Likert scale (0-3). Items 5 and 8 were first reverse coded, and all points were summed to create a total score ranging from 0 to 30, with higher scores representing greater degrees of depressed mood. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention, 4-month follow-up, 6-month follow-up |
|
|
|
| Other Pre-specified | PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5) | PTSD symptoms were evaluated using the PTSD Checklist for DSM-5, a 20-item measure that assesses symptom frequency in the past month on a five-point Likert scale (0 = "Not at all" to 4 = "Extremely"). The total score is calculated by summing the responses for all 20 items, resulting in a score between 0 and 80. A higher total score indicates more severe PTSD symptoms. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention, 4-month follow-up, and 6-month follow-up |
|
|
|
| Secondary | Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk | The total number of receptive condomless anal sex acts with any HIV transmission risk was calculated by summing the number of receptive anal sex acts in which no prevention method (i.e., condom, PrEP) was used over the last 60 days. | 3 participants were lost to attrition. In the STARS arm, 1 participant was lost after the post-intervention assessment. In the control arm, 1 participant was lost after the baseline assessment, and 1 participant was lost after the post-intervention assessment. At 4-month follow-up, 1 participant in the STARS arm and 5 in the control arm missed the assessment window. However, these participants still completed the 6-month follow-up assessment and were included in the analysis. | Posted | Mean | Standard Deviation | Events | Post-intervention, 4-months follow-up, 6-months follow-up |
|
|
|
| 0 |
| 19 |
| 5 |
| 19 |
| 1 |
| 19 |
| EG001 | Relaxation and Stress Reduction | The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies. | 0 | 18 | 0 | 18 | 0 | 18 |
| Rape or attempted rape | Social circumstances | Systematic Assessment | Indicated by item 8 on CAS-SF |
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| Hospitalization | Psychiatric disorders | Systematic Assessment | Mental Health |
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Not provided
Not provided
| D012101 | Reproductive and Urinary Physiological Phenomena |
| 4-month follow-up |
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| 6-month follow-up |
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| 4-month follow-up |
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| 6-month follow-up |
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| 4-month follow-up (Composite) |
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| 6-month follow-up (Composite) |
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| Post-intervention (Internal Tools subscale) |
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| 4-month follow-up (Internal Tools subscale) |
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| 6-month follow-up (Internal Tools subscale) |
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| Post-intervention (Expectations of Support subscale) |
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| 4-month follow-up (Expectations of Support subscale) |
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| 6-month follow-up (Expectations of Support subscale) |
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| Post-intervention (Trade-Offs subscale) |
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| 4-month follow-up (Trade-Offs subscale) |
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| 6-month follow-up (Trade-Offs subscale) |
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| 6-month follow-up |
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| 4-month follow-up |
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| 6-month follow-up |
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| 4-month follow-up |
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| 6-month follow-up |
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| 4-month follow-up |
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| 6-month follow-up |
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| 4-month follow-up |
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| 6-month follow-up |
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