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Trial record 1 of 1 for:    NCT03144336
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Using Mobile Technology and Incentives With Men Who Have Sex With Men and Transgender Women for HIV Prevention (MOTIVES)

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ClinicalTrials.gov Identifier: NCT03144336
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
Columbia University
Bienestar Human Services, Inc.
Information provided by (Responsible Party):
Sebastian Linnemayr, RAND

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections HIV Behavioral: Information provision Behavioral: Weekly quizzes Behavioral: Rewards for testing HIV-negative Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Using Mobile Technology and Incentives With Men Who Have Sex With Men and Transgender Women for HIV Prevention (MOTIVES)
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group

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.

Behavioral: Information provision
All study participants will receive weekly messages with HIV prevention information.

Behavioral: Weekly quizzes
Those in the intervention group receive a weekly quiz by text message that gains them points increasing their chances of winning a prize if answered correctly

Behavioral: Rewards for testing HIV-negative
Those in the intervention group are entered into a prize drawing if they test HIV-negative at least once in a three-month period.

Active Comparator: Control group
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.
Behavioral: Information provision
All study participants will receive weekly messages with HIV prevention information.




Primary Outcome Measures :
  1. HIV knowledge [ Time Frame: 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.

  2. HIV testing frequency [ Time Frame: 12 months ]
    Whether a participant tests HIV-negative within a given 3-month window


Secondary Outcome Measures :
  1. HIV seroconversion [ Time Frame: 12 months ]
    Participant testing HIV-positive

  2. Sexual risk behavior [ Time Frame: 12 months ]
    Self-reported sexual behaviors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identify as MSM (men who have sex with men) or TGW (transgender women)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144336


Locations
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United States, California
Bienestar Human Services, Inc.
Los Angeles, California, United States, 90022
Sponsors and Collaborators
RAND
Columbia University
Bienestar Human Services, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sebastian Linnemayr, Principal Investigator, RAND
ClinicalTrials.gov Identifier: NCT03144336    
Other Study ID Numbers: RAND
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases