NCT02301507

Brief Summary

There has been increasing use of technology in delivery of healthcare and increasing use of cellular phone and text messaging services to help with various healthcare related issues including but not limited to medication adherence and clinic attendance. Mobile phones technology has been used for healthcare delivery and prevention strategies such as smoking cessation. In the present era, cell phones have become part of daily life for most people even among those in lower economic groups. There have also been several studies looking at cell phone text messaging services to improve adherence to ART among HIV infected subjects but no studies have so far been done in HIV infected young women to help retention and adherence to care. The overall goal of this study is to evaluation of the impact of texting intervention to improve adherence to care and treatment in HIV infected young women. Study Hypothesis: Text message intervention will improve adherence to ART in HIV infected young women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

November 18, 2014

Last Update Submit

May 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improve adherence to care and treatment in HIV infected young women. The outcome measure will be assessed by capturing kept medical appointments.

    6 months

Secondary Outcomes (1)

  • assess improvements in stigma and depression in HIV infected women. The outcome measure will be assessed by questionaires.

    3 months

Study Arms (1)

SMS (texting) Arm

EXPERIMENTAL

texts received

Behavioral: cell phone SMS text messaging

Interventions

This study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare).

SMS (texting) Arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV-infected women who have been newly diagnosed within the past 1 year or who are just entering into care at Thomas Street Health Center.
  • Subjects must be 18 years or older.
  • Subjects must have cell phones with texting capability.
  • Ability to speak, read, or understand English or Spanish.
  • Must be willing and able to respond to text messages.

You may not qualify if:

  • \. Women who are unable to speak, read, or understand English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 26, 2014

Study Start

November 1, 2014

Primary Completion

August 1, 2015

Study Completion

July 1, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations