mHealth Intervention Supporting HIV Treatment Adherence and Retention
Study Details
Study Description
Brief Summary
Despite advances in antiretroviral treatment (ART) over the past 10 years, the incidence of HIV in the United States remains stagnant with over 50,000 new cases annually. HIV-infected individuals inconsistently engaged with care are less likely to receive ART which is associated with correspondingly adverse clinical outcomes in the long term and increased risk of transmission. Mobile health (mHealth) strategies including cell phone and text messaging have shown success in the developing world for medication adherence, yet mHealth interventions have not been developed to improve retention in HIV care. This strategy needs to be tested to demonstrate feasibility, acceptability and preliminary effectiveness in supporting HIV treatment adherence in Rhode Island.
The Miriam Hospital Immunology Center is an urban HIV-clinic that provides comprehensive primary and specialty care for over 1400 HIV-infected patients. It is the largest HIV clinic in Rhode Island with patients also referred from eastern Connecticut and southern Massachusetts. In 2010, there were 165 new patients in clinic, 70 of whom were diagnosed within 1 year of entering care. In this environment, we propose a pilot study with the following specific aims:
Specific Aim 1: To pilot a bidirectional mHealth intervention among individuals at high risk of loss to follow-up, including those with a recent HIV diagnosis or those re-engaging in HIV care. HIV-infected persons (n=30) with a recent diagnosis or re-engaging in care at the Immunology Center at TMH will be recruited to participate in a bidirectional mHealth intervention that delivers automated, regularly scheduled appointment and medication adherence reminders in an individualized format, and also allows individuals to request motivational enhancement and problem-solving support to address barriers to care.
Specific Aim 2: To assess the impact and acceptability of the pilot intervention through qualitative interviews. All participants will also be invited to complete individual in-depth interviews which will assess acceptability and effectiveness of the pilot mHealth intervention, such as content and frequency of automatic messages, for retention and medication adherence for HIV-infected individuals in RI.
The results of this study will provide preliminary data to inform an R21 or R34 application to determine efficacy of an mHealth intervention among HIV-infected persons at high-risk for loss to follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm intervention study All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. |
Other: Text messaging
|
Outcome Measures
Primary Outcome Measures
- Number of Particpatns Who Considered the Intervention Feasible and Acceptable [6 months]
A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.
Secondary Outcome Measures
- Efficacy [6 months]
Exploratory end point of PVL <200 copies at the end of the study
Eligibility Criteria
Criteria
Inclusion Criteria:
-
HIV infected
-
age >/= 18
-
patient at The Miriam Hospital Immunology Center
-
has cell phone that can send and receive text messages
-
English speaking only
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Miriam Hospital Immunology Center | Providence | Rhode Island | United States | 02906 |
Sponsors and Collaborators
- The Miriam Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Lifespan Dev Grant Rana-2012
Study Results
Participant Flow
| Recruitment Details | Patients at the Immunology Center in Providence RI who were either 1) newly diagnosed, 2) returning to care after a gap, 3) or with difficulties with adherence to care were eligible for enrollment in this pilot study. Participants were recruited from January 2013 through July 2013 and followed for 6 months. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm Intervention Study |
|---|---|
| Arm/Group Description | All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. Text messaging |
| Period Title: Overall Study | |
| STARTED | 32 |
| COMPLETED | 20 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | Single Arm Intervention Study |
|---|---|
| Arm/Group Description | All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. |
| Overall Participants | 32 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
36
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
31.3%
|
| Male |
22
68.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
3.1%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
21.9%
|
| White |
20
62.5%
|
| More than one race |
2
6.3%
|
| Unknown or Not Reported |
2
6.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
32
100%
|
| Participants with HIV PVL <200 copies/mL (participants) [Number] | |
| Number [participants] |
18
56.3%
|
Outcome Measures
| Title | Number of Particpatns Who Considered the Intervention Feasible and Acceptable |
|---|---|
| Description | A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable. |
| Arm/Group Title | Single Arm Intervention Study |
|---|---|
| Arm/Group Description | All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. |
| Measure Participants | 20 |
| Number [participants] |
20
62.5%
|
| Title | Efficacy |
|---|---|
| Description | Exploratory end point of PVL <200 copies at the end of the study |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Arm Intervention Study |
|---|---|
| Arm/Group Description | All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. |
| Measure Participants | 32 |
| Number [participants] |
32
100%
|
Adverse Events
| Time Frame | 6 months (during participation in the study) | |
|---|---|---|
| Adverse Event Reporting Description | Primary adverse events evaluated for would be loss of confidentiality due to text messaging. None were reported in this study. | |
| Arm/Group Title | Single Arm Intervention Study | |
| Arm/Group Description | All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview. | |
All Cause Mortality |
||
| Single Arm Intervention Study | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Single Arm Intervention Study | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Single Arm Intervention Study | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Aadia Rana, MD |
|---|---|
| Organization | Alpert Medical School of Brown University/The Miriam Hospital |
| Phone | 401-793-4680 |
| arana@lifespan.org |
- Lifespan Dev Grant Rana-2012