NCT01359280

Brief Summary

Persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. The proposed research will test a theory-based behavioral intervention that includes objectively monitoring HIV treatment adherence with corrective feedback delivered by cell phone. The study will also test the independent effects of an automated text message reminder system for sustaining adherence improvements. The intervention under study has utility for people living with HIV/AIDS In resource limited rural and urban settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.1 years

First QC Date

May 20, 2011

Last Update Submit

December 2, 2014

Conditions

Medication Adherence

Keywords

HIVAIDSMedicationAdherence

Outcome Measures

Primary Outcomes (1)

  • Chart Abstracted Viral Load

    Patient HIV viral load is abstracted from medical records at baseline and at 12-month retrospective follow-up.

    12 months retrospective

Secondary Outcomes (1)

  • Unannounced Pill Count Adherence

    Monthly

Study Arms (4)

Adherence Counseling + Text Messages

EXPERIMENTAL

Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone.

Behavioral: Adherence CounselingBehavioral: Text Messages

Adherence Counseling Only

EXPERIMENTAL

Participants receive one office-based adherence counseling session and 4 phone-delivered counseling sessions focused on antiretroviral adherence strategies using a model of behavioral self regulation skills building.

Behavioral: Adherence Counseling

General Health Counseling Only

PLACEBO COMPARATOR

Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building.

Behavioral: General Health Counseling

General Health Messages + Text Messages

PLACEBO COMPARATOR

Participants receive one office-based counseling session and 4 phone-delivered counseling sessions focused on general health and nutrition strategies using a model of behavioral self regulation skills building. Participants also receive follow-up medication reminder text messages delivered by cell phone.

Behavioral: General Health CounselingBehavioral: Text Messages

Interventions

Adherence CounselingBEHAVIORAL

5 Sessions of theory-based medication adherence counseling

Adherence Counseling + Text MessagesAdherence Counseling Only
General Health CounselingBEHAVIORAL

5 sessions of health improvement counseling

General Health Counseling OnlyGeneral Health Messages + Text Messages
Text MessagesBEHAVIORAL

Daily medication regimen tailored adherence reminders delivered by cell phone

Adherence Counseling + Text MessagesGeneral Health Messages + Text Messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Currently taking HIV treatment medication with non-adherence

You may not qualify if:

  • Under age 18
  • Not HIV positive
  • Not taking HIV treatment medications
  • Adherent to HIV Medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Medication AdherenceAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Seth C Kalichman, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)