Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01641380 |
| Other study ID # |
NA_00043284 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2011 |
| Est. completion date |
September 1, 2017 |
Study information
| Verified date |
January 2019 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
While there have been major declines in teenage pregnancy around the country, Baltimore,
Maryland has continued to experience increases over the last several years. Access and
adherence to contraception has been found to be a major contributor to declines in teen
pregnancy worldwide. The aim of this proof of concept pilot project is to determine
preliminary efficacy of the DepoText Intervention. We will randomize urban adolescent girls
who have elected Depo-Provera for ongoing contraception to receive either standard counseling
and clinic appointment reminders or a text messaging (DepoTEXT) follow-up intervention.
Participants in the DepoTEXT intervention will receive reminders for clinic visits and
encouraging messages each month for STI prevention. The primary outcome is the preliminary
efficacy for improving appointment adherence.
Description:
Aims:
The aim of this proof of concept pilot project is to determine the feasibility and
acceptability of a text messaging reminder system for communicating with urban adolescents
using Depo-Provera for long-acting contraception. We will randomize urban adolescent girls
who have elected Depo-Provera for ongoing contraception to receive either standard counseling
and clinic appointment reminders or a text messaging (DepoTEXT) follow-up intervention.
Participants in the DepoTEXT intervention will receive reminders for clinic visits and
encouraging messages each month for STI prevention. The primary outcome is the preliminary
efficacy for improving appointment adherence. Secondary measures include patient
responsiveness to text messages and acceptability/satisfaction with this approach.
Setting and Participants:
This research study will be conducted in the Johns Hopkins Harriet Lane Clinic located
Baltimore, Maryland. As noted above, Baltimore currently has rates of teen pregnancy that are
significantly higher than statewide rates.5, 6 The United States Census estimates that there
are 47,710 adolescents between the ages of 15-19 years in Baltimore. 7 Using 2007 Youth Risk
Behavior Survey estimates, approximately 35,829 youth in this age group are having sexual
intercourse and 13,302 are not using condoms for either STI or pregnancy prevention. 20 The
current rise in birth rates to teens in urban Baltimore has prompted a joint initiative
involving the mayor's office, Baltimore City Health Department, Urban Health Institute, and
Healthy Teen Network.21
The Harriet Lane Clinic located in East Baltimore primarily serves low-income African
American families from the neighboring communities. Adolescents and young adults in East
Baltimore have high rates of pregnancy and STIs. During the 1st 12-months of funding of the
Johns Hopkins Harriet Lane Teen Clinic's Title X Program, the majority of clients were
females aged 15 to 25 years (83%), uninsured (52%), and minors seeking confidential services
(50%). The program provides sexual/reproductive health services to young persons who are
uninsured, underinsured and seeking confidential services. More than 80% of patients served
by the clinic participate in a Medicaid Managed Care Organization. While there are
approximately 250 individuals on the Depo-Provera logs, the Harriet Lane Clinic currently has
more than 100 active users, but adherence to scheduled Depo-Provera appointments remains a
problem despite access to care through our clinical site.
Recruitment:
Adolescent girls 13-21 who have 1) elected Depo-Provera for long-acting contraception and 2)
have an active cell phone for their personal use will be asked by the adolescent nurse case
manager and/or research staff at 1) routine clinical visits and 2) through telephone outreach
if they would be willing to participate in a quality improvement intervention that involved
random assignment to the text messaging intervention that reminds them of their next
Depo-Provera visit via text message or the standard clinic reminders via phone.
All recruitment will take place in the confines of their private room during their routine
clinical visits for family planning or via phone at the preferred contact number listed by
the patient. The same degree of privacy will be afforded as during the clinical visit or
during routine follow-up phone calls.
Randomization & Blinding As noted in the above schematic, adolescents who agree to
participate will be randomized to the intervention or control arms at the time of enrollment.
A computer-generated randomization sequence for block randomization (5 units) will be
employed. Ordered envelopes will be generated for each enrollment packet to guide the
research staff regarding group assignment.
Interventions All adolescents will receive care from the Harriet Lane Adolescent Medicine
Clinic according to the existing clinical protocol. During "Depo visits" patients receive a
nursing assessment, medical assessment if indicated, counseling, and if all is well their
next injection, an appointment card with the date of the next injection. Patients are also
offered automatic clinic reminders via their home phone. All adolescents in the study will
complete a baseline interview and brief follow-up interview at each visit based on the
standard interviews conducted by staff at each Depo-Provera visit. Adolescents who are
enrolled by phone will be asked the questions via phone and then interviewed at the next
visit.
In addition to standard of care and brief study interviews, adolescents in the Depo-TEXT
intervention will be provided with online enrollment in the Compliance for Life® (CFL) system
through iReminder) to receive a welcome Message 24 hrs after enrollment, appointment
reminders prior to 3 month injection cycles, monthly health reminders (condom use, weight
control on Depo-Provera, side effect management, 6-month STD testing reminder, call for text
replies to reschedule missed appointments.) Intervention participants will receive standard
of care for those enrolled in the Depo-Provera clinical program through which a nurse case
manager responds to self-activated queries for assistance and missed clinic appointments.
Patients will be followed for adherence for 2-3 Depo-Provera injection cycles depending on
the time of enrollment.
Human subjects Protections:
All participants will provide informed oral consent and/or via phone and will be informed
that their participation in the study will have no effect on subsequent medical care. All
patient data will be kept confidential and secure by using subject ID numbers, electronic
collection of survey information and storage on secure servers with password protection for
access. All research team members on this project have been educated in the protection of
human research participants and the treatment of protected health information as evidenced by
completion of their institutional compliance courses. Research assistants have completed the
compliance courses as a part of their staff training. We are also using an established
provider of global, secure and regulatory HIPAA compliant patient communication solutions to
healthcare and biopharmaceutical research sectors to engage adolescents using SMS technology.
