Clinical trial NCT01015989: Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya
Official title: Computerized Counseling to Promote Positive Prevention and HIV Health in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV treatment
ART adherence
Using new technology to improve adherence
CARE+
HIV-1 viral loads
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Moi University
First posted: 2009-11-18
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: ART adherence will be measured by HIV-1 viral load, electronic monitoring, pharmacy refill, self-report, and clinic attendance
timeFrame: Every 3 months up to 9 months
measure: 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.
timeFrame: Every 3 months up to 9 months
measure: We will conduct economic evaluation to compare CARE+ Kenya vs. standard of care.
timeFrame: 9 months
Secondary outcomes:
measure: Qualitative exit interviews with patients
timeFrame: At end of study
measure: Two focus groups with providers
timeFrame: At end of study
Other outcomes:
Locations:
city: Burnt Forest
country: Kenya
facility: AMPATH at Burnt Forest Health Centre
state: Rift Valley
city: Eldoret
country: Kenya
facility: AMPATH Module 1
Study officials:
affiliation: NYU
name: Ann Kurth, PhD
role: PRINCIPAL_INVESTIGATOR
References: