Trial Outcomes & Findings for mHealth Intervention Supporting HIV Treatment Adherence and Retention (NCT NCT01951092)

NCT ID: NCT01951092

Last Updated: 2016-04-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

6 months

Results posted on

2016-04-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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. Text messaging
Overall Study STARTED	32
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Text messaging
Overall Study Lost to Follow-up	10
Overall Study Incarceration	1
Overall Study Transfer of Care	1

Baseline Characteristics

mHealth Intervention Supporting HIV Treatment Adherence and Retention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Intervention Study n=32 Participants 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.
Age, Continuous	36 years n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	22 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants
Race (NIH/OMB) White	20 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Region of Enrollment United States	32 participants n=99 Participants
Participants with HIV PVL <200 copies/mL	18 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.

Outcome measures

Outcome measures
Measure	Single Arm Intervention Study n=20 Participants 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.
Number of Particpatns Who Considered the Intervention Feasible and Acceptable	20 participants

SECONDARY outcome

Timeframe: 6 months

Exploratory end point of PVL \<200 copies at the end of the study

Outcome measures

Outcome measures
Measure	Single Arm Intervention Study n=32 Participants 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.
Efficacy	32 participants

Adverse Events

Single Arm Intervention Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aadia Rana, MD

Alpert Medical School of Brown University/The Miriam Hospital

Phone: 401-793-4680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place