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临床试验/NCT03144336
NCT03144336已完成不适用

Using Mobile Technology and Incentives With Men Who Have Sex With Men and Transgender Women for HIV Prevention (MOTIVES)

RAND1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2017年5月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
217
试验地点
1
主要终点
HIV knowledge

研究概览

简要总结

This project called Mobile Technology and Incentives (MOTIVES) aims to increase engagement with HIV prevention information and improve testing frequency among Latino/a men who have sex with men (MSM) and transgender women (TGW). Its primary goal is to develop and test the feasibility and acceptability of an HIV prevention intervention that uses text messages in combination with prizes to improve HIV prevention information retention and HIV testing frequency. The project will be conducted in collaboration with Bienestar Human Services, Inc. (Bienestar) in Los Angeles County. Phase 1 consists of formative research (focus groups n=9) with MSM (n=52) and TGW (n=39) to complement the previously collected pilot data (2014-2015) to finalize the planned intervention. In Phase 2, the intervention will be piloted among 5 individuals, implemented, and tested in a small, randomized controlled trial (RCT) among 200 Latino MSM and TGW from Bienestar's HIV testing sites. Interested individuals will be screened for eligibility upon testing HIV-negative (those testing positive will be linked to HIV services as required by Bienestar's standard of care). Eligible participants will be randomized into either the intervention or control group that will both receive study information weekly and will be invited to get tested for HIV every three months. Participants in the intervention group will be able to accumulate rewards points for correctly answering weekly quizzes regarding the HIV prevention information; these reward incentives aim to encourage retention in the study and improve HIV prevention knowledge engagement and recollection. Every three months those in the intervention group can win a prize based on testing HIV-negative at least once during that time period. The chance of winning will increase based on the number of reward points a participant accumulates by correctly answering questions on the weekly quizzes. The primary outcome measures will include HIV-preventive knowledge and frequency of HIV testing (at least once every 3 months). In Phase 3 of the study, the investigators will conduct 6 focus groups with approximately 5-8 participants each among MSM (n=3) and TGW (n=1) study participants, testing site staff (n=1), and administrative staff (n=1) to identify implementation challenges and areas for improvement; and estimate mission-critical design parameters with point and confidence interval estimates to inform a subsequent, fully-powered R01 application.

详细描述

This project entails a 3-phase mobile technology based and behavioral economics supported HIV prevention intervention - called Mobile Technology and Incentives (MOTIVES) - to increase engagement with HIV prevention information and improve testing frequency among Latino men who have sex with men (MSM) and transgender women (TGW). The study is conducted in collaboration with Bienestar Human Services, Inc. (Bienestar); a non-profit community-based service organization established in 1989 with sites located across Los Angeles County that primarily serves Latino populations. Specific Aim 1 included focus groups with MSM and TGW to finalize the planned intervention based on the insights from a preliminary study. Specific Aim 2 will enroll 200 HIV-negative MSM and TGW in a 12-month, two-arm randomized controlled trial (RCT). Those in the intervention group will receive weekly text messages with HIV prevention information and can win reward points for correctly answering weekly quizzes to keep them engaged and improve their retention of the HIV prevention information. Those who continue to test negative for HIV at least once every three months can enter a prize drawing to win prizes, with larger chances for those correctly answering the weekly quizzes. The control group will receive the same HIV prevention information but without the incentives. The secondary outcomes include sexual risk behaviors and HIV infection. Specific Aim 3 includes 6 exit focus groups (with 5-8 participants per group) to evaluate areas for study improvement and estimate parameters for future scale up. The Specific Aims are to 1) develop MOTIVES and finalize the weekly text message information content and the types of incentives; 2) implement and evaluate the impact of MOTIVES; and 3) evaluate areas of improvement for MOTIVES through focus groups and estimate mission-critical design parameters with point and confidence interval estimates for a subsequent, fully-powered R01 application.

SUMMARY OF PHASE 1 Phase 1 developed the intervention parameters to inform the implementation of MOTIVES. The focus groups built on the preliminary study information and gathered data regarding specific barriers to receiving HIV prevention information, frequent testing, type of information, incentive and prize drawing parameters from MSM and TGW clients. The focus groups took between 60 to 90 minutes and were conducted by Dr. MacCarthy and Study Coordinator, Joanna Barreras in English or Spanish as preferred by the participants. Clients were provided a copy of the informed consent and received an overview of the study, the purpose of Phase 1, procedures, potential risks and discomforts, anticipated benefits, alternatives to participation, payment for participation, privacy and confidentiality. All focus groups were digitally recorded and translated into English when needed. All focus groups content was synthesized to produce summary memos on specific topics describing each theme, presenting segments of text as exemplars.

SUMMARY OF PHASE 2 Phase 2 will conduct a small RCT among 200 Bienestar clients that will be piloted with five participants. Quantitative data on primary (e.g., HIV knowledge and frequency of testing behavior) and secondary outcomes (e.g., self-reported sexual risk behavior - to determine how well participants translated their HIV prevention knowledge into behavior over the study period, and HIV status) will be collected.

Clients who express interest and are eligible will undergo the consent process. At enrollment, several steps will be taken to increase the confidentiality of participants related to text message communication. For example, HIV testers will instruct participants how to maintain privacy on their device, and delete SMS messages from their mobile device. At recruitment, HIV testers will ask the participant to save the number from which the messages will be sentas 'MOTIVES' so that the respondent easily recognizes the sender without increasing the chance of accidental disclosure of study participation. Further, participants will be reminded that they will receive texts on the same day every week (e.g., Wednesday and Friday) and at the same times of the week (e.g., 2 pm PST) to help them anticipate the arrival of study-related communication. The text message database will be secured by password protection, anonymized data, and managed onsite. The participant will then participate the baseline survey (details of the survey described later). The participant will then be randomized into either intervention or control group. The randomization of TGW will be performed separately from MSM to ensure equal distribution of TGW in both arms (approximately 90 MSM and 10 TGW in each arm). This is important because our pilot data suggests TGW experience much higher levels of risk and vulnerability to HIV compared to MSM and will represent a smaller percentage of the overall study population.

Follow-up surveys at 6 months and 12 months after enrollment: Our pilot data suggests that most participants will have access to the Internet and accommodations will be made for participants who are not able to access the Internet. The month 12 follow-up survey will have a reduced number of questions to complete. Participants will be asked to complete their final survey 12 months after enrollment. Thus the final survey will be conducted when the intervention period has ended and therefore completing the questions at a Bienestar testing location will not confound the outcome of interest. Those who do not complete their HIV test for that period can complete the final survey at Bienestar. The survey measures used have been successfully applied in our prior research among MSM and TGW. All measures described below will be assessed at baseline and 12 months, whereas a select few will be assessed at month six to keep the survey burden of the online surveys at the interim month survey low.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The statistician will clean the data and compile the analysis dataset. Before sending on to the principal investigator for the outcome analysis, any information allowing inferring treatment assignment will be removed, in particular the two intervention arms will receive a non-descriptive label such as group A and group B. This way, the analysis can be performed without knowing which group corresponds to the intervention group, and which to control.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •own or have regular access to a smartphone
  • •self-identify as a Latino
  • •fluent in English or Spanish
  • •able to provide contact information for at least three tracking mechanisms (e.g., cell phone, email, address, friend's contact)
  • •HIV-negative

排除标准

  • 未提供

研究组 & 干预措施

Control group

Active Comparator

Intervention: Information provision: Participants in the control group will receive weekly information by SMS to encourage retention in the study and improve HIV prevention knowledge engagement and recollection. They are encouraged to come to the clinic every three months to test for HIV but do not receive any incentives for answering messages or for the HIV tests.

干预措施: Information provision (Behavioral)

Intervention group

Experimental

Participants in the intervention group will be able to accumulate rewards points for correctly answering weekly quizzes regarding the HIV prevention information; these reward incentives aim to encourage retention in the study and improve HIV prevention knowledge engagement and recollection.

Intervention 'Rewards for testing HIV-negative' Every three months those in the intervention group can win a prize based on testing HIV-negative at least once during that time period. The chance of winning will increase based on the number of reward points a participant accumulates by correctly answering questions on the weekly quizzes.

干预措施: Information provision (Behavioral)

Intervention group

Experimental

Participants in the intervention group will be able to accumulate rewards points for correctly answering weekly quizzes regarding the HIV prevention information; these reward incentives aim to encourage retention in the study and improve HIV prevention knowledge engagement and recollection.

Intervention 'Rewards for testing HIV-negative' Every three months those in the intervention group can win a prize based on testing HIV-negative at least once during that time period. The chance of winning will increase based on the number of reward points a participant accumulates by correctly answering questions on the weekly quizzes.

干预措施: Weekly quizzes (Behavioral)

Intervention group

Experimental

Participants in the intervention group will be able to accumulate rewards points for correctly answering weekly quizzes regarding the HIV prevention information; these reward incentives aim to encourage retention in the study and improve HIV prevention knowledge engagement and recollection.

Intervention 'Rewards for testing HIV-negative' Every three months those in the intervention group can win a prize based on testing HIV-negative at least once during that time period. The chance of winning will increase based on the number of reward points a participant accumulates by correctly answering questions on the weekly quizzes.

干预措施: Rewards for testing HIV-negative (Behavioral)

结局指标

主要结局

HIV knowledge

时间窗: 12 months

HIV knowledge using the 18 items in Carey, M. P., \& Schroder, K. E. E. (2002). Development and psychometric evaluation of the brief HIV knowledge questionnaire (HIV-KQ-18). AIDS Education and Prevention, 14, 174-184.

HIV testing frequency

时间窗: 12 months

Whether a participant tests HIV-negative within a given 3-month window

次要结局

  • HIV seroconversion(12 months)
  • Sexual risk behavior(12 months)

研究者

发起方
RAND
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sebastian Linnemayr

Principal Investigator

RAND

研究点 (1)

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