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Digital Intervention Delivered Via Street Medicine to Increase HIV and Substance Use Care Among Survivors of Sex Trafficking

2026년 7월 7일 업데이트: Lindsay Orchowski Ph.D., Lifespan

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

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Consistent with the goals of RFA-DA-25-018 Engaging Survivors of Sexual Violence and Trafficking in HIV and Substance Use Disorder Services, the objective of this R34 application is to develop and evaluate the CONNECT program for use in a sample of women with a history of sex trafficking to evaluate its feasibility, acceptability, and preliminary efficacy. CONNECT will be delivered in collaboration with the Street Medicine team, which provides health and social services directly to unhoused women in their own environment; who are at high risk for sex trafficking. CONNECT will also be administered with the support of a trained care navigator to provide 1:1 assistance in completing CONNECT and navigating referrals to substance use, HIV/STI, and mental health care. Following (ADAPT-ITT) framework and informed by a Community-Based Participatory Research approach, information from informant interviews (N = 9), focus groups (N = 30), stakeholder interviews (N = 6), and the Community Advisory Board will be leveraged to adapt the intervention. An open trial (N = 12) with a 2-month follow-up will be conducted to demonstrate program feasibility, acceptability, satisfaction, and utility of CONNECT. A randomized pilot trial (N = 60) with a 2-month follow-up will be conducted to examine whether women randomized to CONNECT, relative to control, show change in: treatment engagement outcomes for substance use (e.g., MOUD initiation, therapy for alcohol use), HIV and STI treatment/prevention services (e.g., uptake of PrEP, testing for STI), and/or mental health treatment (e.g., treatment for PTSD). Secondary outcomes of domains relating to motivation to seek treatment aligned with the theory of planned behavior (i.e., attitudes, intentions, self-efficacy, subjective norms, and stigma will be explored. Behavioral outcomes of changes in substance use outcomes (e.g., reduced substance use), HIV and STI risk behaviors, and mental health outcomes (e.g., improvements in PTSD) will also be examined. Mediators (i.e., readiness to change) and moderators (i.e., trauma history) will be examined (exploratory). To prepare for Hybrid Type I efficacy trial, exit interviews will be conducted with participants (N = 20), and practitioners (N = 9) to describe contextual factors that might influence subsequent implementation.

연구 유형

중재적

등록 (추정된)

60

단계

  • 초기 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

  1. Age 18 years and above at enrollment
  2. Woman
  3. Screen positive for lifetime sexual trafficking

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: CONNECT Program: Screening
Screening, intervention, referral, care navigation
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.
간섭 없음: Control Group
Wait List Control

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment engagement
기간: Measured at baseline and at 2-month follow-up
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)
Measured at baseline and at 2-month follow-up
Treatment Utilization
기간: Total session attendance measured at baseline and at 2-month follow-up
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.
Total session attendance measured at baseline and at 2-month follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
Alcohol Use
기간: Assessed at baseline and 2-month follow-up
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.
Assessed at baseline and 2-month follow-up
Drug Use
기간: Assessed at baseline and 2-month follow-up
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.
Assessed at baseline and 2-month follow-up
HIV Risk Behavior
기간: Assessed at baseline and 2-month follow-up
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)
Assessed at baseline and 2-month follow-up
PTSD Symptoms
기간: Assessed at baseline and 2-month follow-up
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.
Assessed at baseline and 2-month follow-up
Overall Health Symptoms (Depression)
기간: Assessed at baseline and 2-month follow-up
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.
Assessed at baseline and 2-month follow-up
Anxiety Symptoms
기간: Assessed as change from baseline to 2-months
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.
Assessed as change from baseline to 2-months

기타 결과 측정

결과 측정
측정값 설명
기간
Satisfaction with Program
기간: Assessed immediate post program as a descriptive measure (no comparison group)
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.
Assessed immediate post program as a descriptive measure (no comparison group)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 5일

기본 완료 (추정된)

2028년 6월 15일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2026년 7월 1일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 1R34DA063037-01 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

We will follow data sharing plans as required by NIDA and specified in the data management and sharing plan.

IPD 공유 기간

Materials will be shared as available at the completion of the study.

IPD 공유 액세스 기준

Data will be publicly available, and interested parties can contact the PI for support in accessing data.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .