HIV Risk Reduction Intervention for Transwomen With Intimate Partner Victimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire
研究概览
简要总结
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:
- First, participants will be asked to complete a series of screening interviews/questionnaires to determine eligibility, including completing a HIV test.
- If eligible, participants will then take part in a 2-3 hour baseline assessment consisting of both interviewer administered questionnaires as well as self-administered surveys.
- Participants will then be randomly assigned to one of two treatment conditions: (1) a newly developed gender affirming intervention, known as Program STARS (Supporting Trans Affirmation, relationships, and Sex) or (2) a time-matched, attention-controlled program that offers free training in relaxation and stress reduction techniques (a.k.a., the comparison group). Both interventions offer unique components and the researchers do not yet know the impact the programs may have on participants' overall well-being.
- Participants randomized to Project STARS, will be invited to complete a semi-structured exit interview (lasting 60-90 min.) after the completion of the program.
- This clinical trial has three follow-up assessments: (1) post-intervention (i.e., after the peer-counseling programs are complete); (2) at 4-months follow-up; and (3) at 6-months follow-up. The follow-up assessments are structured the same way as the baseline assessment and are estimated to take around 1-2 hours.
The total study involvement for this clinical trial is estimated to take approximately 10 to 12 hours over the course of six months.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18+ years old;
- •Assigned male at birth but identify as female, transgender, or transfeminine;
- •Endorse at least one IPV incident during the previous 12 months based on the trans-specific IPV Scale (T-IPV Scale; Peitzmeier et al, in press);
- •Report at least one instance of condomless anal sex in the last 6 months.
排除标准
- •Have been diagnosed with HIV or test positive for HIV.
结局指标
主要结局
Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire
时间窗: Post-intervention
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.
Composite Risk for HIV (CR-HIV)
时间窗: Post-intervention, 4-month follow-up, and 6-month follow-up
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.
Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF)
时间窗: 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.
Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale
时间窗: 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.
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS)
时间窗: 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.
Feasibility of Online STARS as Measured by Recruitment Rates
时间窗: During recruitment period of study, up to 4 months
One measure of feasibility will be participant recruitment rates.
Feasibility of Online STARS as Measured by Retention Rates.
时间窗: 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.
Composite Risk for HIV (CR-HIV)
时间窗: Post-intervention, 4-month follow-up, and 6-month follow-up
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.
Intimate Partner Violence (IPV) Frequency: Composite Abuse Scale Revised Short Form (CASr-SF)
时间窗: 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.
Intimate Partner Violence (IPV) Frequency: Transgender-Specific Intimate Partner Violence (T-IPV) Scale
时间窗: 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.
Intimate Partner Violence (IPV) Safety: Measure Of Victim Empowerment Related to Safety (MOVERS)
时间窗: 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.
Feasibility of Online STARS as Measured by Recruitment Rates
时间窗: During recruitment period of study, up to 4 months
One measure of feasibility will be participant recruitment rates.
Feasibility of Online STARS as Measured by Retention Rates.
时间窗: 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.
Acceptability of Online STARS as Measured by the Client Satisfaction Questionnaire
时间窗: Post-intervention
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.
次要结局
- Total Number of Receptive Condomless Anal Sex Acts With Any HIV Transmission Risk(Post-intervention, 4-months follow-up, 6-months follow-up)