Trial Outcomes & Findings for Supporting Trans Affirmation, Relationships, and Sex, Phase 3 (NCT NCT06001307)

Last Updated: 2025-11-19

Results Overview

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: 1. Do they report condomless anal sex with a HIV serodiscordant or status-unknown primary or other partner in the past 6 months? (If yes, move on to question #2; If no, 0) 2. Is the participant using PrEP? (If yes, 0; If no, move onto question #3) 3. Is the participant in a monogamous partnership with an HIV-uninfected partner or an HIV-infected partner who is virally suppressed? (If yes, 0; If no, 1) \*If participants are not certain about their partner's HIV status or viral suppression status in the last question, they are coded as having HIV risk according to this algorithm. The total number of participants at risk for HIV acquisition for each arm is reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

Post-intervention, 4-month follow-up, and 6-month follow-up

Results posted on

2025-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	18
Overall Study Post-intervention Assessment	19	17
Overall Study 4-month Follow-up Assessment	17	11
Overall Study 6-month Follow-up Assessment	18	16
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Supporting Trans Affirmation, Relationships, and Sex, Phase 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Program STARS (Supporting Trans Affirmation, Relationships, and Sex) n=19 Participants 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 n=18 Participants 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.	Total n=37 Participants Total of all reporting groups
Age, Continuous	32.42 Years STANDARD_DEVIATION 8.88	35.28 Years STANDARD_DEVIATION 9.20 • n=4 Participants	33.81 Years STANDARD_DEVIATION 9.02 • n=8 Participants
Sex/Gender, Customized Feminine/femme or transfeminine	4 Participants	6 Participants n=4 Participants	10 Participants n=8 Participants
Sex/Gender, Customized Māhū, or muxe, or two spirit	2 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants
Sex/Gender, Customized Non-binary	1 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants
Sex/Gender, Customized Woman or Transgender Woman	10 Participants	11 Participants n=4 Participants	21 Participants n=8 Participants
Sex/Gender, Customized None of these describe me	2 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants	1 Participants n=4 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Asian American and Pacific Islander	0 Participants	3 Participants n=4 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Black/African American	2 Participants	0 Participants n=4 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized White/Caucasian	16 Participants	16 Participants n=4 Participants	32 Participants n=8 Participants
Race/Ethnicity, Customized Other	3 Participants	0 Participants n=4 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latina	3 Participants	4 Participants n=4 Participants	7 Participants n=8 Participants
Frequency of past-year IPV	14.32 Events STANDARD_DEVIATION 11.09	9.67 Events STANDARD_DEVIATION 10.26 • n=4 Participants	12.06 Events STANDARD_DEVIATION 10.81 • n=8 Participants
PTSD symptoms	41.32 Scores on a scale STANDARD_DEVIATION 12.29	33.94 Scores on a scale STANDARD_DEVIATION 13.87 • n=4 Participants	37.73 Scores on a scale STANDARD_DEVIATION 13.43 • n=8 Participants
Depressive Symptoms	15.53 Scores on a scale STANDARD_DEVIATION 4.83	12.90 Scores on a scale STANDARD_DEVIATION 5.79 • n=4 Participants	14.26 Scores on a scale STANDARD_DEVIATION 5.41 • n=8 Participants
Total number of receptive condomless anal sex acts with any HIV transmission risk	0.16 Events STANDARD_DEVIATION 0.69	0.83 Events STANDARD_DEVIATION 2.36 • n=4 Participants	0.49 Events STANDARD_DEVIATION 1.73 • n=8 Participants
Composite Risk for HIV (CR-HIV)	1 Participants	3 Participants n=4 Participants	4 Participants n=8 Participants
Intimate Partner Violence (IPV) Frequency	4.16 Scores on a scale STANDARD_DEVIATION 4.73	3.06 Scores on a scale STANDARD_DEVIATION 4.21 • n=4 Participants	3.63 Scores on a scale STANDARD_DEVIATION 4.46 • n=8 Participants
Intimate Partner Violence Frequency: Transgender-specific IPV scale (T-IPV) Past year	1.16 Scores on a scale STANDARD_DEVIATION 1.74	0.67 Scores on a scale STANDARD_DEVIATION 1.14 • n=4 Participants	0.92 Scores on a scale STANDARD_DEVIATION 1.48 • n=8 Participants
Intimate Partner Violence Frequency: Transgender-specific IPV scale (T-IPV) Past two months	0.16 Scores on a scale STANDARD_DEVIATION 0.50	0.28 Scores on a scale STANDARD_DEVIATION 0.83 • n=4 Participants	0.22 Scores on a scale STANDARD_DEVIATION 0.67 • n=8 Participants
Intimate Partner Violence Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Composite score	3.55 Scores on a scale STANDARD_DEVIATION 0.48	3.59 Scores on a scale STANDARD_DEVIATION 0.60 • n=4 Participants	3.57 Scores on a scale STANDARD_DEVIATION 0.54 • n=8 Participants
Intimate Partner Violence Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Internal Tools subscale	3.47 Scores on a scale STANDARD_DEVIATION 0.68	3.53 Scores on a scale STANDARD_DEVIATION 0.60 • n=4 Participants	3.50 Scores on a scale STANDARD_DEVIATION 0.63 • n=8 Participants
Intimate Partner Violence Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Expectations of Support subscale	3.28 Scores on a scale STANDARD_DEVIATION 0.75	3.38 Scores on a scale STANDARD_DEVIATION 0.92 • n=4 Participants	3.33 Scores on a scale STANDARD_DEVIATION 0.83 • n=8 Participants
Intimate Partner Violence Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Trade-Offs subscale	3.91 Scores on a scale STANDARD_DEVIATION 0.70	3.87 Scores on a scale STANDARD_DEVIATION 0.67 • n=4 Participants	3.89 Scores on a scale STANDARD_DEVIATION 0.68 • n=8 Participants

PRIMARY outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

Population: 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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Composite Risk for HIV (CR-HIV) Post-intervention	0 Participants	1 Participants
Composite Risk for HIV (CR-HIV) 4-month follow-up	9 Participants	1 Participants
Composite Risk for HIV (CR-HIV) 6-month follow-up	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) Post-intervention	2.37 Scores on a scale Standard Deviation 4.27	1.18 Scores on a scale Standard Deviation 2.38
Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) 4-month follow-up	1.06 Scores on a scale Standard Deviation 2.93	0.82 Scores on a scale Standard Deviation 2.09
Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF) 6-month follow-up	0.22 Scores on a scale Standard Deviation 0.65	0.63 Scores on a scale Standard Deviation 1.62

PRIMARY outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale Post-intervention	0 Scores on a scale Standard Deviation 0	0 Scores on a scale Standard Deviation 0
Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale 4-month follow-up	0 Scores on a scale Standard Deviation 0	0 Scores on a scale Standard Deviation 0
Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale 6-month follow-up	0 Scores on a scale Standard Deviation 0	0.06 Scores on a scale Standard Deviation 0.25

PRIMARY outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 6-month follow-up (Composite)	3.77 Scores on scale Standard Deviation .57	3.73 Scores on scale Standard Deviation .49
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Post-intervention (Internal Tools subscale)	3.69 Scores on scale Standard Deviation 0.74	3.43 Scores on scale Standard Deviation 0.85
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 4-month follow-up (Internal Tools subscale)	3.94 Scores on scale Standard Deviation 0.69	3.76 Scores on scale Standard Deviation 0.70
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Post-intervention (Expectations of Support subscale)	3.45 Scores on scale Standard Deviation 1.03	3.35 Scores on scale Standard Deviation 1.03
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 6-month follow-up (Expectations of Support subscale)	3.51 Scores on scale Standard Deviation 0.95	3.66 Scores on scale Standard Deviation 0.83
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Post-intervention (Composite)	3.65 Scores on scale Standard Deviation 0.63	3.46 Scores on scale Standard Deviation 0.74
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 4-month follow-up (Composite)	3.82 Scores on scale Standard Deviation 0.51	3.61 Scores on scale Standard Deviation 0.51
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 6-month follow-up (Internal Tools subscale)	3.95 Scores on scale Standard Deviation 0.52	3.65 Scores on scale Standard Deviation 0.75
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 4-month follow-up (Expectations of Support subscale)	3.63 Scores on scale Standard Deviation 0.82	3.57 Scores on scale Standard Deviation 0.66
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) Post-intervention (Trade-Offs subscale)	3.81 Scores on scale Standard Deviation 0.75	3.61 Scores on scale Standard Deviation 0.76
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 4-month follow-up (Trade-Offs subscale)	3.88 Scores on scale Standard Deviation 0.95	3.52 Scores on scale Standard Deviation 0.90
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS) 6-month follow-up (Trade-Offs subscale)	3.85 Scores on scale Standard Deviation 0.91	3.88 Scores on scale Standard Deviation 0.75

PRIMARY outcome

Timeframe: During recruitment period of study, up to 4 months

Population: Overall Number of Participants Analyzed represents number of participants screened for study interest prior to enrollment.

One measure of feasibility will be participant recruitment rates.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=98 Participants 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 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.
Feasibility of Online STARS as Measured by Recruitment Rates	37 Participants	—

PRIMARY outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

One measure of feasibility will be participant retention rates, as measured by engagement/completion of the interventions.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Feasibility of Online STARS as Measured by Retention Rates. 4-month follow-up	17 Participants	11 Participants
Feasibility of Online STARS as Measured by Retention Rates. 6-month follow-up	18 Participants	16 Participants
Feasibility of Online STARS as Measured by Retention Rates. Post-intervention	19 Participants	17 Participants

PRIMARY outcome

Timeframe: Post-intervention

Population: In the control arm, 1 participant was lost to follow-up after the baseline assessment.

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=17 Participants 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.
Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire	3.29 Scores on a scale Standard Deviation .48	2.95 Scores on a scale Standard Deviation .8

SECONDARY outcome

Timeframe: Post-intervention, 4-months follow-up, 6-months follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk Post-intervention	0 Events Standard Deviation 0	0.5 Events Standard Deviation .24
Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk 4-month follow-up	0 Events Standard Deviation 0	1.45 Events Standard Deviation 4.82
Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk 6-month follow-up	0 Events Standard Deviation 0	.25 Events Standard Deviation 1

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention, 4-month follow-up, 6-month follow-up

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Participants Reporting Instances of IPV Post-intervention	7 Participants	5 Participants
Participants Reporting Instances of IPV 4-month follow-up	5 Participants	3 Participants
Participants Reporting Instances of IPV 6-month follow-up	2 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention, 4-month follow-up, 6-month follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
Depressive Symptoms 6-month follow-up	13.11 Scores on a scale Standard Deviation 5.88	13.19 Scores on a scale Standard Deviation 7.58
Depressive Symptoms Post-intervention	13.63 Scores on a scale Standard Deviation 6.32	12.47 Scores on a scale Standard Deviation 5.54
Depressive Symptoms 4-month follow-up	12.29 Scores on a scale Standard Deviation 5.60	13.27 Scores on a scale Standard Deviation 6.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention, 4-month follow-up, and 6-month follow-up

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.

Outcome measures

Outcome measures
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 Participants 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 n=18 Participants 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.
PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5) Post-intervention	32.68 Scores on a scale Standard Deviation 16.13	26.59 Scores on a scale Standard Deviation 10.74
PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5) 4-month follow-up	30.76 Scores on a scale Standard Deviation 16.04	27.91 Scores on a scale Standard Deviation 16.91
PTSD Symptoms: PTSD Checklist for DSM-5 (PCL-5) 6-month follow-up	26.83 Scores on a scale Standard Deviation 14.86	31.31 Scores on a scale Standard Deviation 19.57

Adverse Events

Program STARS (Supporting Trans Affirmation, relationships, and Sex)

Serious events: 5 serious events

Other events: 1 other events

Deaths: 0 deaths

Relaxation and Stress Reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 participants at risk 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 n=18 participants at risk 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.
Social circumstances Serious/life threatening IPV	15.8% 3/19 • From enrollment until end of follow-up, up to 6 months	0.00% 0/18 • From enrollment until end of follow-up, up to 6 months
Social circumstances Rape or attempted rape	21.1% 4/19 • From enrollment until end of follow-up, up to 6 months	0.00% 0/18 • From enrollment until end of follow-up, up to 6 months
Psychiatric disorders Hospitalization	5.3% 1/19 • From enrollment until end of follow-up, up to 6 months	0.00% 0/18 • From enrollment until end of follow-up, up to 6 months

Other adverse events

Other adverse events
Measure	Program STARS (Supporting Trans Affirmation, relationships, and Sex) n=19 participants at risk 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 n=18 participants at risk 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.
Social circumstances Sexual assault other than rape or attempted rape	5.3% 1/19 • From enrollment until end of follow-up, up to 6 months	0.00% 0/18 • From enrollment until end of follow-up, up to 6 months

Additional Information

Arryn Guy

Illinois Institute of Technology

Phone: 312-567-6467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place