Theory-based Text Messaging to Reduce Methamphetamine Use and HIV Risks Among MSM
2017년 6월 16일 업데이트: Friends Research Institute, Inc.
Participants receive culturally relevant and specifically tailored text messages based on the behavioral change theoretical constructs of Social Support Theory, Health Belief Model, and Social Cognitive Theory.
Participants are randomized into one of three conditions for an 8-week intervention period: Group 1: culturally relevant theory-based text messages interactively transmitted by peer health educators (TXT-PHE); or, Group 2: the same culturally relevant theory-based text messages transmitted by automation (TXT-Auto); or, Group 3: assessment-only (AO) control with no theoretically based text messages.
연구 개요
상태
완전한
상세 설명
The randomized three-group design uses repeated assessments at baseline, at the end of the 8-week intervention period, and at 3-, 6-, and 9-month post randomization follow-up.
Participants in all three conditions receive brief weekly text-message assessments on their methamphetamine use and HIV sexual behaviors in the previous seven days.
This study will determine the differential immediate and sustained effects of transmitting theory-based text messages by PHE (TXT-PHE) versus by automation (TXT-Auto), compared to an assessment-only (AO) control condition among out-of-treatment, methamphetamine-using MSM for reductions of methamphetamine use and HIV sexual risk behaviors.
It is hypothesized that there will be significantly greater reductions in methamphetamine use and HIV sexual risk behaviors from text messages transmitted by PHE than by text messages transmitted by automation, which in turn will produce significantly greater reductions than the AO condition (PHE > TXT > AO).
In addition, this study will determine the cost-effectiveness of TXT-PHE vs. TXT-Auto compared to AO for reducing methamphetamine use and HIV sexual risk behaviors.
The investigators hypothesize that the TXT-PHE intervention will prove more cost-effective than TXT-Auto in reducing methamphetamine use and HIV sexual risk behaviors, while the TXT-Auto condition will prove more cost effective than the AO condition in reducing these same outcomes (PHE > TXT > AO).
연구 유형
중재적
등록 (실제)
286
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
California
-
Los Angeles, California, 미국, 90028
- Friends Community Center, a division of Friends Research Institute, Inc., Los Angeles, CA 90028
-
-
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
Inclusion Criteria:
- Self-identified MSM
- Between the ages of 18 and 65 years
- Methamphetamine use within the previous 3 months
- Unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
- Not currently in treatment or seeking methamphetamine abuse treatment
- Able and willing to fully charge a cellular phone daily
- Able and willing to provide informed consent
- Able and willing to comply with study requirements
Exclusion Criteria:
- Does not identify as a MSM
- Not between the ages of 18 and 65 years
- Has not used methamphetamine in the previous 3 months
- Has not had unprotected anal intercourse (insertive or receptive) with a non-primary male partner in the previous 6 months
- Currently in treatment or seeking methamphetamine abuse treatment
- Unable or unwilling to fully charge a cellular phone daily
- Unable or unwilling to provide informed consent
- Unable or unwilling to comply with study requirements
- Unable to understand the Informed Consent Form
- Determined to have a more serious psychiatric condition (SCID verified) that is beyond the safe enrollment of study procedures
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: TXT-PHE
Gay-specific, Theory-based Text Messages Transmitted by Peer Health Educators (TXT-PHE) This condition is interactive and tailored to the needs of the individual participant. PHEs initiate (i.e., "push") text messages to participants and also respond to participant-initiated queries and participant responses to the PHE messages (i.e., "pull"). Participants receive five pre-written messages per day sent on a predetermined schedule. Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days. |
Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule.
Participants who respond to the pre-written text messages or initiate queries or requests for support ("pull") are sent additional real-time messages back from the PHE.
Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities.
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
|
|
실험적: TXT-Auto
Group 2: Gay-specific, Theory-based Text Messages Transmitted by Automation (TXT-Auto) Participants assigned to this group receive automatic text-messages. Following the initial welcome message, participants receive five pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days. |
Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule.
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
|
|
간섭 없음: Assessment Only (AO)
During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Methamphetamine Use
기간: 9-months post randomization
|
Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.
|
9-months post randomization
|
|
HIV Sexual Risk Behavior
기간: 9-months post randomization
|
Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.
|
9-months post randomization
|
|
Cost Effectiveness
기간: up to 36 months
|
Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.
|
up to 36 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV Primary Care
기간: 8-weeks post randomization, 3-/6-/9-months post randomization
|
HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.
|
8-weeks post randomization, 3-/6-/9-months post randomization
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Reback CJ, Ling D, Shoptaw S, Rohde J. Developing a Text Messaging Risk Reduction Intervention for Methamphetamine-Using MSM: Research Note. Open AIDS J. 2010 May 14;4:116-22. doi: 10.2174/1874613601004030116.
- Reback CJ, Grant DL, Fletcher JB, Branson CM, Shoptaw S, Bowers JR, Charania M, Mansergh G. Text messaging reduces HIV risk behaviors among methamphetamine-using men who have sex with men. AIDS Behav. 2012 Oct;16(7):1993-2002. doi: 10.1007/s10461-012-0200-7. Erratum In: AIDS Behav. 2012 Oct;16(7):2003.
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
2014년 1월 1일
기본 완료 (실제)
2017년 1월 1일
연구 완료 (실제)
2017년 1월 1일
연구 등록 날짜
최초 제출
2013년 12월 3일
QC 기준을 충족하는 최초 제출
2013년 12월 10일
처음 게시됨 (추정)
2013년 12월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 6월 16일
마지막으로 확인됨
2017년 6월 1일
추가 정보
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. .
에이즈에 대한 임상 시험
-
Hospital Clinic of Barcelona완전한
-
CDC FoundationGilead Sciences알려지지 않은
-
University of WashingtonNational Institute of Mental Health (NIMH)모병
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
-
Erasmus Medical Center모집하지 않고 적극적으로