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



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:May 24, 2017
End Date:December 2019

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

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.

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.

Participants will be invited to return to one of the Bienestar testing sites at least once
every three months to be re-tested for HIV (for the intervention group, this will be the
eligibility criterion for entering the prize drawings). The participants will received a text
message reminder 2.5 months after their last HIV test to get their HIV test again and remind
them to make sure the study staff knows that they have completed their HIV test and that they
continue to be negative to qualify for additional gift cards. Individuals who test HIV
positive will be given referrals to Bienestar's HIV linkage to care programs.

Text messaging that addresses the unique needs of Latino MSM and TGW clients will be sent in
Spanish or English (based on the preference of the participant) weekly. Based on feedback
from our focus groups, the initial information will likely be sent on Wednesday and then
followed up on Friday. The study team will include ways to access additional information, if
participants wish to do so after receiving a text message, by sending an additional link, as
well as a phone number that the participant can call. The phone number will connect clients
to study staff that have the same information available via the link and they will be
prepared to relay this information over the phone. The structure of these weekly information
messages could be of the following format: "Hi [name of participant], did you know that
[information content]? Use this link [hyperlink] or call [number] for more information."
These messages will be sent to both control and intervention groups.

The analysis for phase two aims to obtain estimates of the intervention's acceptance and
feasibility by determining enrollment and retention rates in the study. This will be
determined by using the number of clients screening positive for eligibility in the survey,
the number of clients enrolling in the study per month, and percentage of enrolled clients
who respond to the weekly quizzes and are eligible to participate in the testing-based prize
drawings, and participants retained in the study. The focus groups in Phase 3 will also
provide valuable feedback about the acceptability of the program to clients and clinic
personnel.

A brief questionnaire module for participants in the intervention group will assess their
experience at the last assessment. Items will assess level of satisfaction with the
intervention, perception of its fairness and transparency, whether they perceive the
intervention to have influenced their behavior and which HIV prevention strategy that they
learned during the intervention have they been most likely to employ. Participants will be
asked to indicate whether more or less frequent awarding of prizes or a different prize value
would have influenced their adherence to more frequent HIV testing and other behaviors of
interest. These items will use a 5-point Likert scale to rate level of agreement with
statements. Finally, participants will be asked open-ended questions to elicit feedback on
aspects of the program that they liked or did not like, and any suggestions for how the
program could be improved.

SUMMARY OF PHASE 3 In Phase 3 of the study, focus groups discussion will identify
implementation challenges and areas for improvement in preparation for a R01 submission for
an intervention at scale. There will be three types of focus groups: (1) MSM and TGW clients
from the intervention group and (2) testing staff and administrators. Focus groups will
separately be run for MSM (n=3) and TGW (n=1) clients to broadly assess their experience
participating in the intervention and for testing staff (n=1) to examine perception of study
procedures, and identify areas for improvement. All of the groups will discuss how to best
adapt the study for future scale up and implementation. Specially, the client focus groups
will cover barriers and facilitators to obtaining HIV prevention information through the
intervention messaging and ask about how information receipt did (or did not) translate into
healthy behavior change. Ultimately these findings will guide the scale up and implementation
of a large scale R01 RCT.

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:
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Los Angeles, California 90022
Phone: 866-590-6411
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