Text Messaging Intervention to Improve HIV Adherence in Rural Drug Users
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2018 |
| Start Date: | May 2011 |
| End Date: | December 2013 |
RCT of a Text Messaging Adherence Assessment & Intervention Tool for Rural HIV+ Drug Users
The investigators will develop and test the feasibility and promise of a combined HIV
adherence assessment and intervention application for rural drug users using an available,
familiar technology whose reach will grow exponentially: text messaging via mobile phones. By
2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration
projected by 2013. While technology adoption is often slower in under-served communities, the
trend is different with mobile phone technology. African-Americans are using more mobile
phone minutes per capita and increasing their use at a higher rate compared with other ethnic
groups. This technology has great potential to reduce health disparities. In this project,
the investigators will develop and test the feasibility and promise of a text messaging
application and system using Ecological Momentary Assessment methods to detect nonadherence
and drug use and immediately intervene to improve HIV treatment adherence in drug users
living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a
project in the Stage Model of Behavioral Therapy Development that will develop novel
interventions and methods, and generate preliminary estimates of effect sizes that will
determine whether a larger clinical trial with extended follow-up and cost-effectiveness
evaluation is warranted.
The specific aims of this project are:
1. To identify assessment and intervention features relevant to the adherence barriers and
drug use patterns of rural and non-urban HIV+ drug users using formative methods
including:
- structured interviews and focus groups to identify specific barriers to adherence
and engagement in care and needs related to drug craving and drug use that should
be addressed by the intervention
- iterative usability testing of components and drafts of the intervention
2. To create a text messaging mobile phone application and system (Treatment Extension by
Texting, Text) to assess and improve HIV treatment adherence and drug use in real time
--Text will be built upon a piloted unidirectional personalized text phone application
and system, STeM, and will include pre- and post-programming usability testing
3. To test the feasibility and promise of the assessment and intervention tool in a
randomized pilot trial of rural HIV+ drug users with detectable viral load (VL)
comparing Text to usual care
- Feasibility: Identify recruitment rates, consent rates, participant flow,
completion rates, and variance of key covariates and outcome variables
- Promise: determine point estimates and the precision of effects for primary and
secondary adherence outcomes including pharmacy refills and unannounced pill counts
(medication adherence), missed visit percentage (treatment engagement), VL, and
drug craving and drug use.
adherence assessment and intervention application for rural drug users using an available,
familiar technology whose reach will grow exponentially: text messaging via mobile phones. By
2007, 84% of U.S. residents had mobile phones, with near 100% mobile phone penetration
projected by 2013. While technology adoption is often slower in under-served communities, the
trend is different with mobile phone technology. African-Americans are using more mobile
phone minutes per capita and increasing their use at a higher rate compared with other ethnic
groups. This technology has great potential to reduce health disparities. In this project,
the investigators will develop and test the feasibility and promise of a text messaging
application and system using Ecological Momentary Assessment methods to detect nonadherence
and drug use and immediately intervene to improve HIV treatment adherence in drug users
living with HIV/AIDS who reside outside major metropolitan areas. This R34 is a Stage 1b/2a
project in the Stage Model of Behavioral Therapy Development that will develop novel
interventions and methods, and generate preliminary estimates of effect sizes that will
determine whether a larger clinical trial with extended follow-up and cost-effectiveness
evaluation is warranted.
The specific aims of this project are:
1. To identify assessment and intervention features relevant to the adherence barriers and
drug use patterns of rural and non-urban HIV+ drug users using formative methods
including:
- structured interviews and focus groups to identify specific barriers to adherence
and engagement in care and needs related to drug craving and drug use that should
be addressed by the intervention
- iterative usability testing of components and drafts of the intervention
2. To create a text messaging mobile phone application and system (Treatment Extension by
Texting, Text) to assess and improve HIV treatment adherence and drug use in real time
--Text will be built upon a piloted unidirectional personalized text phone application
and system, STeM, and will include pre- and post-programming usability testing
3. To test the feasibility and promise of the assessment and intervention tool in a
randomized pilot trial of rural HIV+ drug users with detectable viral load (VL)
comparing Text to usual care
- Feasibility: Identify recruitment rates, consent rates, participant flow,
completion rates, and variance of key covariates and outcome variables
- Promise: determine point estimates and the precision of effects for primary and
secondary adherence outcomes including pharmacy refills and unannounced pill counts
(medication adherence), missed visit percentage (treatment engagement), VL, and
drug craving and drug use.
Active illicit drug use, regardless of diagnostic category (i.e., abuse or dependence), along
with medication non-adherence, are the problematic behaviors targeted for change in this
study. The investigators will develop and test an innovative mobile-phone delivered text
messaging intervention designed to reduce drug use and increase HIV medication adherence.
In the first phase of our work (quarters 1-2), the investigators will use qualitative,
formative methods with user input to develop the assessment and intervention contents, while
our technology partner develops the mobile phone application shell with which the
investigators will conduct initial pre-coding usability testing. Focus groups will be used to
inform the final design of the text messaging application, and participant input will provide
important information to help us determine the number and rate of messages.
The investigators plan to recruit 1-2 focus groups from three participating clinics and will
spend a day to two days in each location to conduct the groups and to conduct individual
interviews with participants who prefer a private interview. In the past, the investigators
have succeeded in recruiting groups of 5-8 participants by using flyers, word of mouth, and
reminders from providers to prompt participants to call our study staff to arrange
participation. The investigators also have typically scheduled groups with several weeks'
notice, in both daytime and evening hours, to accommodate the schedules of employed and
unemployed participants. The investigators plan to provide lunch or snacks, and to compensate
participants for their time.
The purpose of the focus groups and individual interviews is to develop the content of the
phone application, and to address their adherence barriers and drug use patterns, so that the
investigators can program messages (queries) that are the most appropriate for this
population. Other topics to be covered in focus groups and individual interviews will include
preferred rate of messaging, types of messages desired, use of language and terms that
participants understand for random and scheduled queries, followed by iterative user testing
of the pre-programming shell of the program to determine whether they understand the flow,
understand all terms and symbols, etc. The investigators will gather quantitative (count)
data as well as qualitative (free response) data, which the investigators will analyze for
rates and themes, respectively. Themes will be derived by analysis of transcripts of
interviews and focus group sessions, then grouped into related categories to determine common
and unusual concerns of participants. The investigators will ensure that the program
addresses all common issues, and the investigators will decide on a case by case basis
whether and how to incorporate unusual issues. However, unusual issues may be important ones,
representing likely crisis intervention topics to plan for. The count data will provide raw
numbers in which to anchor the thematic data. Given that people who text may send and receive
50 or more messages per day routinely, it does not seem overly burdensome to request that
they respond to the system 5 times per day, but this issue will be addressed directly in the
focus groups. This formative work will be used to generate appropriate content and structure
for the intervention that best fits the needs of this unique rural, HIV+, drug using
population.
The revision of our existing text messaging tool, Stem, will take approximately 6 months,
proceeding iteratively. The investigators will iteratively test the acceptability and
usability of components of the tool with the target population before finalizing its
programming by conducting guided sessions with participants who will review the program via
screenshots. The resulting product will be the novel mobile phone application, Text, which
the investigators will test with users on the phones in their homes for a 2 week period in
quarter 2 to identify any remaining programming needs to finalize the system for the pilot
trial.
There are three distinct types of messaging events planned Random queries will be sent at a
rate of 4 per day during normal waking hours for that participant, as recommended by the
leading Ecological Momentary Assessment (EMA) researchers. The second type is a medication
dose reminder, which for most patients will occur once or twice per day with current ART
medication regimens. The third type is an event-contingent message, which the PARTICIPANT
initiates, for events like drug craving, drug use, etc. Therefore, most participants will
receive 5 or maybe 6 messages per day from the system, and may send 1-2 messages confirming
taking their medications, or may send us more messages if they report a critical event.
The current Stem system is programmed on a web-based application. A staff member interviews
the participant to determine which kinds of messages they want to have sent with emphasis on
personal meaning and concerns for confidentiality. The staff member then types the message
into the web-based program while the patient is present. The investigators have an archive of
previously used personal messages that new participants could review and reuse or create
their own messages. For the enhanced TEXT application proposed here, the investigators will
use the same procedure to develop messages. Staff members will also assist the participants
in programming the cell phone with appropriate numbers and reviewing its relevant features.
Therefore, staff members will do all of the programming, with the participant's guidance
about what messages will be helpful to them. When literacy is an issue, the investigators
will use a combination of simple textable icons along with a few words to assist the
participant in understanding the message.
The finalized intervention will be compared to usual care in a small pilot randomized trial
that will demonstrate the feasibility of the approach, and yield evidence of promise
(estimates of effect sizes) as recommended by recent publications on conducting pilot work.
In this phase, the investigators will test the new Text intervention in the field with real
participants who will be assessed at baseline, then randomized to receive the phones and Text
intervention or usual care over a 12 week period (quarters 3-6). The investigators will
assess participants again at 3 and 6 months as a post-treatment follow-up, and complete data
cleaning, analyses, and reporting during the final months of the project (quarters 5-8). The
investigators plan to begin enrollment of participants in the pilot trial in quarter 3,
enrolling 8-12 participants per month until the investigators have enrolled 70 people, which
will occur during quarter 5 or 6. This will permit a 6 month follow-up of all participants.
Hypotheses: Based on the rates of change the investigators saw in the two pilot studies, the
investigators expect that: 1).The intervention will result in a 20% decrease in Missed Visit
Proportion (MVP) compared to usual care. 2).The intervention will result in a 20% increase in
adherence by pharmacy refill data compared to usual care. 3).The intervention will result in
a 25% decrease in drug use over 30 days compared to usual care. Lastly, while not a formal
hypothesis, the investigators expect that the intervention will be feasible and acceptable
for participants, and the investigators will measure this using an exit interview.
with medication non-adherence, are the problematic behaviors targeted for change in this
study. The investigators will develop and test an innovative mobile-phone delivered text
messaging intervention designed to reduce drug use and increase HIV medication adherence.
In the first phase of our work (quarters 1-2), the investigators will use qualitative,
formative methods with user input to develop the assessment and intervention contents, while
our technology partner develops the mobile phone application shell with which the
investigators will conduct initial pre-coding usability testing. Focus groups will be used to
inform the final design of the text messaging application, and participant input will provide
important information to help us determine the number and rate of messages.
The investigators plan to recruit 1-2 focus groups from three participating clinics and will
spend a day to two days in each location to conduct the groups and to conduct individual
interviews with participants who prefer a private interview. In the past, the investigators
have succeeded in recruiting groups of 5-8 participants by using flyers, word of mouth, and
reminders from providers to prompt participants to call our study staff to arrange
participation. The investigators also have typically scheduled groups with several weeks'
notice, in both daytime and evening hours, to accommodate the schedules of employed and
unemployed participants. The investigators plan to provide lunch or snacks, and to compensate
participants for their time.
The purpose of the focus groups and individual interviews is to develop the content of the
phone application, and to address their adherence barriers and drug use patterns, so that the
investigators can program messages (queries) that are the most appropriate for this
population. Other topics to be covered in focus groups and individual interviews will include
preferred rate of messaging, types of messages desired, use of language and terms that
participants understand for random and scheduled queries, followed by iterative user testing
of the pre-programming shell of the program to determine whether they understand the flow,
understand all terms and symbols, etc. The investigators will gather quantitative (count)
data as well as qualitative (free response) data, which the investigators will analyze for
rates and themes, respectively. Themes will be derived by analysis of transcripts of
interviews and focus group sessions, then grouped into related categories to determine common
and unusual concerns of participants. The investigators will ensure that the program
addresses all common issues, and the investigators will decide on a case by case basis
whether and how to incorporate unusual issues. However, unusual issues may be important ones,
representing likely crisis intervention topics to plan for. The count data will provide raw
numbers in which to anchor the thematic data. Given that people who text may send and receive
50 or more messages per day routinely, it does not seem overly burdensome to request that
they respond to the system 5 times per day, but this issue will be addressed directly in the
focus groups. This formative work will be used to generate appropriate content and structure
for the intervention that best fits the needs of this unique rural, HIV+, drug using
population.
The revision of our existing text messaging tool, Stem, will take approximately 6 months,
proceeding iteratively. The investigators will iteratively test the acceptability and
usability of components of the tool with the target population before finalizing its
programming by conducting guided sessions with participants who will review the program via
screenshots. The resulting product will be the novel mobile phone application, Text, which
the investigators will test with users on the phones in their homes for a 2 week period in
quarter 2 to identify any remaining programming needs to finalize the system for the pilot
trial.
There are three distinct types of messaging events planned Random queries will be sent at a
rate of 4 per day during normal waking hours for that participant, as recommended by the
leading Ecological Momentary Assessment (EMA) researchers. The second type is a medication
dose reminder, which for most patients will occur once or twice per day with current ART
medication regimens. The third type is an event-contingent message, which the PARTICIPANT
initiates, for events like drug craving, drug use, etc. Therefore, most participants will
receive 5 or maybe 6 messages per day from the system, and may send 1-2 messages confirming
taking their medications, or may send us more messages if they report a critical event.
The current Stem system is programmed on a web-based application. A staff member interviews
the participant to determine which kinds of messages they want to have sent with emphasis on
personal meaning and concerns for confidentiality. The staff member then types the message
into the web-based program while the patient is present. The investigators have an archive of
previously used personal messages that new participants could review and reuse or create
their own messages. For the enhanced TEXT application proposed here, the investigators will
use the same procedure to develop messages. Staff members will also assist the participants
in programming the cell phone with appropriate numbers and reviewing its relevant features.
Therefore, staff members will do all of the programming, with the participant's guidance
about what messages will be helpful to them. When literacy is an issue, the investigators
will use a combination of simple textable icons along with a few words to assist the
participant in understanding the message.
The finalized intervention will be compared to usual care in a small pilot randomized trial
that will demonstrate the feasibility of the approach, and yield evidence of promise
(estimates of effect sizes) as recommended by recent publications on conducting pilot work.
In this phase, the investigators will test the new Text intervention in the field with real
participants who will be assessed at baseline, then randomized to receive the phones and Text
intervention or usual care over a 12 week period (quarters 3-6). The investigators will
assess participants again at 3 and 6 months as a post-treatment follow-up, and complete data
cleaning, analyses, and reporting during the final months of the project (quarters 5-8). The
investigators plan to begin enrollment of participants in the pilot trial in quarter 3,
enrolling 8-12 participants per month until the investigators have enrolled 70 people, which
will occur during quarter 5 or 6. This will permit a 6 month follow-up of all participants.
Hypotheses: Based on the rates of change the investigators saw in the two pilot studies, the
investigators expect that: 1).The intervention will result in a 20% decrease in Missed Visit
Proportion (MVP) compared to usual care. 2).The intervention will result in a 20% increase in
adherence by pharmacy refill data compared to usual care. 3).The intervention will result in
a 25% decrease in drug use over 30 days compared to usual care. Lastly, while not a formal
hypothesis, the investigators expect that the intervention will be feasible and acceptable
for participants, and the investigators will measure this using an exit interview.
Inclusion Criteria:
- 18 or older
- has a detectable viral load
- reports use of at least one illicit drug in last 30 days
- requires ART
- able to receive mobile phone service at home address
Exclusion Criteria:
- lack of English proficiency
- planning to move out of area in the next six months
- inability to provide consent.
Note regarding "inability to provide consent": Traditionally, some patients with HIV whom
we evaluate for potential participation in research studies are not able to provide
informed consent, either due to significant cognitive decline, or their designation of
someone else as their legal proxy. When this occurs, we do not offer them study
participation because legally, they are unable to consent, even if currently, their
cognitive capacities seem intact. We have generally assessed this through a series of
branching questions to determine their legal and cognitive capacity for consent.
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