NCT01015989

Brief Summary

The purpose of this study is to see if a computerized counseling tool helps patients reduce their sexual transmission risk and improve their antiretroviral adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

2 active sites

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

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 28, 2022

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

November 17, 2009

Last Update Submit

October 26, 2022

Conditions

HIV Infections

Keywords

HIV treatmentART adherenceUsing new technology to improve adherenceCARE+HIV-1 viral loads

Outcome Measures

Primary Outcomes (3)

  • ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance

    Every 3 months up to 9 months

  • HIV transmission risk will be measured by self-reported unprotected sex with HIV negative/unknown partner, and trends in Chlamydia trachomatis, Neisseria gonorrhoeae, and T. vaginalis.

    Every 3 months up to 9 months

  • We will conduct economic evaluation to compare CARE+ Kenya vs. standard of care.

    9 months

Secondary Outcomes (2)

  • Qualitative exit interviews with patients

    At end of study

  • Two focus groups with providers

    At end of study

Study Arms (2)

CARE+ Kenya brief computer risk assessment session (control)

ACTIVE COMPARATOR
Other: CARE+ Kenya brief computer risk assessment session

Full CARE+ Spanish computer-counseling group

ACTIVE COMPARATOR
Other: CARE+ Kenya computer counseling session

Interventions

CARE+ Kenya brief computer risk assessment sessionOTHER

The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. We will repeat the session every 3 months up to 9 months total.

CARE+ Kenya brief computer risk assessment session (control)
CARE+ Kenya computer counseling sessionOTHER

The computer will ask patients questions about taking HIV medicine. The computer will also ask patients questions about sexual and substance use activities. The computer will let patients look at short videos on various HIV medicine and HIV risk reduction topics and will then help patients create a health plan. Patients will get an anonymous print out at the end of the session and can choose to share with health care provider. There are questions about depression, suicide, or domestic violence. If a patient's answers indicate that they may be depressed, suicidal, or currently in an abusive relationship, we will refer them to a health worker at the clinic. We will repeat the session every 3 months up to 9 months total.

Full CARE+ Spanish computer-counseling group

Eligibility Criteria

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

You may qualify if:

  • Seen for care including ART at the clinics
  • Able to understand spoken Kiswahili or English
  • Reported less than "perfect" ART adherence/any missed dose or pill counts that indicate non-adherence with medication or delay in pharmacy refill; unprotected sex in the last 6 months, or \>1 sex partner in last year, or any STI diagnosis in last 3 years
  • Able to give consent (i.e., no evidence of inebriation or psychosis)

You may not qualify if:

  • Not fluent in Kiswahili or English
  • Has a thought disorder that precludes participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AMPATH at Burnt Forest Health Centre

Burnt Forest, Rift Valley, Kenya

Location

AMPATH Module 1

Eldoret, Kenya

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 Officials

  • Ann Kurth, PhD

    NYU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The CARE Kenya counseling tool software randomizes the participant automatically to the control or intervention arms when the user first logs into the program, using a quasi-random number algorithm.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

June 1, 2014

Last Updated

October 28, 2022

Record last verified: 2018-09

Locations

KE(2)