NCT00273780

Brief Summary

This study proposes a 4-armed factorial randomized clinical trial in Nairobi, Kenya to determine the effect of cognitive and behavioral interventions on HAART adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started May 2006

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

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

January 5, 2006

Last Update Submit

August 23, 2012

Conditions

HIV Infections

Keywords

Patient compliance

Outcome Measures

Primary Outcomes (1)

  • Pill count

    18 months

Secondary Outcomes (2)

  • CD4 count

    18 months

  • HIV-1 viral load

    18 months

Study Arms (4)

Adherence counseling

ACTIVE COMPARATOR
Behavioral: Adherence counseling

Alarm device

ACTIVE COMPARATOR
Device: Alarm device

Counseling and alarm

ACTIVE COMPARATOR

Participants in this arm will receive both education counseling and a pocket alarm device.

Behavioral: Adherence counselingDevice: Alarm device

Control

NO INTERVENTION

Interventions

Adherence counselingBEHAVIORAL

Three adherence counseling sessions will be given to participants in the trial. Two sessions will occur prior to initiation of antiretroviral medications and one session will be given one month after drug administration.

Adherence counselingCounseling and alarm
Alarm deviceDEVICE

This pocket alarm device will be set to ring at designated times during the day that the participant should take their antiretroviral medication.

Also known as: ALRT Med Reminder PC200
Alarm deviceCounseling and alarm

Eligibility Criteria

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

You may qualify if:

  • Individuals must qualify for HAART treatment by World Health Organization (WHO) criteria (Clinical Stage IV disease) and/or CD4 count of less than 200 and plan to start HAART therapy.
  • Must be above 18 years of age
  • Must be HAART treatment-naïve
  • Must agree to home visits, and plan to live in Kenya for at least two years.

You may not qualify if:

  • Individuals who are mentally incompetent or are pregnant are excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hope Center for Infectious Diseases

Nairobi, Kenya

Location

Related Publications (2)

  • Marson KG, Tapia K, Kohler P, McGrath CJ, John-Stewart GC, Richardson BA, Njoroge JW, Kiarie JN, Sakr SR, Chung MH. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic. PLoS One. 2013 Oct 24;8(10):e78900. doi: 10.1371/journal.pone.0078900. eCollection 2013.

    PMID: 24205345DERIVED

  • Chung MH, Richardson BA, Tapia K, Benki-Nugent S, Kiarie JN, Simoni JM, Overbaugh J, Attwa M, John-Stewart GC. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes. PLoS Med. 2011 Mar;8(3):e1000422. doi: 10.1371/journal.pmed.1000422. Epub 2011 Mar 1.

    PMID: 21390262DERIVED

MeSH Terms

Conditions

HIV InfectionsPatient Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michael H Chung, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

KE(1)