Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking
Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sexual Trafficking
The goal of this clinical trial is to learn if the CONNECT program helps women with a history of sex trafficking get connected to substance use, HIV/STI, and mental health services. It will also learn whether the program is practical to deliver and acceptable to participants. The main questions it aims to answer are:
Does CONNECT increase participants' engagement in substance use treatment (such as starting medication for opioid use disorder or therapy for alcohol use), HIV and STI prevention and treatment services (such as starting PrEP or getting tested for STIs), and mental health treatment (such as treatment for PTSD)? Is CONNECT feasible and acceptable for women with a history of sex trafficking?
Researchers will compare CONNECT to usual care to see if CONNECT increases engagement in these health services. The program will be delivered in partnership with a Street Medicine team that provides care directly to unhoused women, with support from a trained care navigator.
Participants will:
Complete the CONNECT program or receive usual care Work 1:1 with a care navigator who helps with referrals to substance use, HIV/STI, and mental health services (CONNECT group) Complete assessments at the start of the study and at a 2-month follow-up Answer questions about their substance use, health behaviors, mental health, and use of health services
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 초기 1단계
연락처 및 위치
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02904
- Rhode Island Hospital
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연락하다:
- Lindsay Orchowski, PhD
- 전화번호: 401-444-7021
- 이메일: lindsay_orchowski@brown.edu
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연락하다:
- Prachi Bhuptani, PhD
- 이메일: prachi_bhuptani@brown.edu
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
- Age 18 years and above at enrollment
- Woman
- Screen positive for lifetime sexual trafficking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: CONNECT Program: Screening
Screening, intervention, referral, care navigation
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CONNECT intervention provides screening for sex trafficking with the goal of increasing treatment engagement for substance use, HIV/STI, and psychological distress among victims of sex trafficking.
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간섭 없음: Control Group
Wait List Control
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment engagement
기간: Measured at baseline and at 2-month follow-up
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Number of Participants Who Initiate Substance Use or Mental Health Treatment Description: Treatment initiation, defined as attending at least one treatment appointment, verified by [self-report / record review].
This is a binary variable (yes/no), with the positive outcome being "yes" (treatment initiated)
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Measured at baseline and at 2-month follow-up
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Treatment Utilization
기간: Total session attendance measured at baseline and at 2-month follow-up
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Number of Treatment Sessions Attended (Treatment Utilization) [self-report and record review).
This is a count variable, with the positive outcome being a greater number of sessions attended.
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Total session attendance measured at baseline and at 2-month follow-up
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Alcohol Use
기간: Assessed at baseline and 2-month follow-up
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Change From Baseline in Alcohol Use Disorders Identification Test (AUDIT) Score at 2 Months.
Scores range from 0 to 40; higher scores indicate more hazardous alcohol use.
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Assessed at baseline and 2-month follow-up
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Drug Use
기간: Assessed at baseline and 2-month follow-up
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Change From Baseline in Drug Use Disorders Identification Test (DUDIT) Score at 2 Months.
Scores range from 0 to 44; higher scores indicate more problematic drug use.
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Assessed at baseline and 2-month follow-up
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HIV Risk Behavior
기간: Assessed at baseline and 2-month follow-up
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Change From Baseline in HIV Risk Behavior Scale Score at 2 Months (Darke et al., 1990; HIV Risk-taking Behavior Scale ranges 0-55; higher scores indicate greater HIV risk behavior)
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Assessed at baseline and 2-month follow-up
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PTSD Symptoms
기간: Assessed at baseline and 2-month follow-up
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Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score at 2 Months; Scores range from 17 to 85; higher scores indicate greater PTSD symptom severity.
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Assessed at baseline and 2-month follow-up
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Overall Health Symptoms (Depression)
기간: Assessed at baseline and 2-month follow-up
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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) to score at 2 Months, scores range from 0 to 27; higher scores indicate more severe depressive symptoms.
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Assessed at baseline and 2-month follow-up
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Anxiety Symptoms
기간: Assessed as change from baseline to 2-months
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Change From Baseline to 2-months in Generalized Anxiety Disorder-7 (GAD-7), Scores range from 0 to 21; higher scores indicate more severe anxiety symptoms.
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Assessed as change from baseline to 2-months
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Satisfaction with Program
기간: Assessed immediate post program as a descriptive measure (no comparison group)
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Client Satisfaction Questionnaire - 8 will assess overall satisfaction with the intervention, scored from 8 to 32, with higher scores indicating greater satisfaction.
Assessed after each session.
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Assessed immediate post program as a descriptive measure (no comparison group)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 1R34DA063037-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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