NCT03144336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

April 27, 2017

Last Update Submit

September 7, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • HIV knowledge

    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.

    12 months

  • HIV testing frequency

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

    12 months

Secondary Outcomes (2)

  • HIV seroconversion

    12 months

  • Sexual risk behavior

    12 months

Study Arms (2)

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.

Behavioral: Information provisionBehavioral: Weekly quizzesBehavioral: Rewards for testing HIV-negative

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.

Behavioral: Information provision

Interventions

All study participants will receive weekly messages with HIV prevention information.

Control groupIntervention group
Weekly quizzesBEHAVIORAL

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

Intervention group

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as MSM (men who have sex with men) or TGW (transgender women)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bienestar Human Services, Inc.

Los Angeles, California, 90022, United States

Location

Related Publications (2)

  • MacCarthy S, Mendoza-Graf A, Wagner Z, L Barreras J, Kim A, Giguere R, Carballo-Dieguez A, Linnemayr S. The acceptability and feasibility of a pilot study examining the impact of a mobile technology-based intervention informed by behavioral economics to improve HIV knowledge and testing frequency among Latinx sexual minority men and transgender women. BMC Public Health. 2021 Feb 12;21(1):341. doi: 10.1186/s12889-021-10335-5.

  • Linnemayr S, MacCarthy S, Kim A, Giguere R, Carballo-Dieguez A, Barreras JL. Behavioral economics-based incentives supported by mobile technology on HIV knowledge and testing frequency among Latino/a men who have sex with men and transgender women: Protocol for a randomized pilot study to test intervention feasibility and acceptability. Trials. 2018 Oct 5;19(1):540. doi: 10.1186/s13063-018-2867-1.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 8, 2017

Study Start

May 24, 2017

Primary Completion

August 23, 2019

Study Completion

August 23, 2019

Last Updated

September 10, 2019

Record last verified: 2019-09

Locations