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HIV InfectionsCARE+ KenyaNCT01015989

Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya

A study testing CARE+ Kenya brief computer risk assessment session and CARE+ Kenya computer counseling session in people with HIV Infections, run by New York University at 2 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
CARE+ Kenya brief computer risk assessment session and CARE+ Kenya computer counseling session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
2 sitesKenya
Study dates
Sep 2011to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites
  • AMPATH at Burnt Forest Health Centre

    Burnt Forest, Rift Valley

  • AMPATH Module 1

    Eldoret

Other trials in Kenya

About this study

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.

Read the detailed description

Helping people living with HIV to remain healthy and reduce transmission to sexual partners ('positive prevention') can be accomplished by behavioral counseling and supporting adherence to infectivity-reducing antiretroviral therapy (ART). Positive prevention and ART adherence approaches that are not staff-dependent are urgently needed in Africa, the region hardest hit by HIV and decimated health workforce. Interactive health communication tools offer one approach. We will adapt a computerized counseling intervention found to be efficacious in reducing HIV-1 viral load and risk behaviors in the US ('CARE+') with the largest HIV provider in Kenya, the Academic Model for the Prevention and Treatment of HIV/AIDS (AMPATH). Aim 1: Adapt a theoretically driven computerized counseling intervention for use in Kenya ('CARE+_Kenya'). Conduct in-depth interviews with n≤ 50 urban and rural AMPATH patients to understand HIV support needs, and two staff focus groups to assess counseling practices and beliefs about computer use. Modify intervention content; translate and record audio into local Kiswahili. Adapt skill-building videos (e.g., on secondary prevention, HIV disclosure, ART adherence, reproductive health). Conduct software usability testing with n=20 patients and n=8 staff. Perform 3-day test-retest reliability assessment to establish psychometric performance of measures.

Aim 2: Establish biological and behavioral efficacy of CARE+_Kenya. Longitudinal randomized controlled trial (RCT) in one urban and one rural AMAPATH clinic. Randomly assign HIV-positive adults with any missed ART or unprotected sex in last 6 months, >1 sex partner in last year, or sexually transmitted infection (STI)diagnosis in last 3 years, to intervention (n=125) or risk-assessment control (n=125) for baseline, 3, 6, and 9 month sessions. 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. ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance. Aim 3: Establish cost-effectiveness of CARE+_Kenya. At baseline, follow 100 patients at each of the two clinics to evaluate standard of care counseling, and collect time-spent and facility data to determine costs and unmet counseling need. Conduct economic evaluation to compare CARE+_Kenya vs. standard of care. If the RCT shows that the intervention reduces viral load and transmission risk behaviors, we will use a Bernoulli transmission dynamics model to estimate number of secondary HIV infections prevented; then create a cost-effectiveness model to calculate 2 incremental cost-effectiveness ratios: 1) cost per HIV infection averted, and 2) cost per daily adjusted life year saved. If CARE+_Kenya is efficacious and efficient, we will develop a proposal for a cluster-randomized trial to assess translational effectiveness of CARE+_Kenya throughout the AMPATH system. This is directly responsive to PA-08-107's call for innovative, integrated interventions that leverage ART roll-out infrastructure in international settings to benefit people living with HIV.

Conditions
HIV Infections
Being tested
CARE+ Kenya brief computer risk assessment session, CARE+ Kenya computer counseling session
Keywords
HIV treatment, ART adherence, Using new technology to improve adherence, CARE+, HIV-1 viral loads
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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.

Study groups in NCT01015989
Study groupRoleWhat they receive
CARE+ Kenya brief computer risk assessment session (control)Active comparatorNot described
Receives: Other: CARE+ Kenya brief computer risk assessment session
Full CARE+ Spanish computer-counseling groupActive comparatorNot described
Receives: Other: CARE+ Kenya computer counseling session

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Every 3 months up to 9 months

  2. 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.

    Measured: Every 3 months up to 9 months

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

    Measured: 9 months

Secondary outcomes (2)
  1. Qualitative exit interviews with patients

    Measured: At end of study

  2. Two focus groups with providers

    Measured: At end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2009 (estimated)
  2. Study startSep 2011
  3. Primary completionJul 2012
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01015989
Sponsor's protocol ID
1R01MH085577
Acronym
CARE+ Kenya
Status last verified
Sep 2018
First submitted
17 Nov 2009
Last updated
28 Oct 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing CARE+ Kenya brief computer risk assessment session and CARE+ Kenya computer counseling session in people with HIV Infections, run by New York University at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance (time frame: Every 3 months up to 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.

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