Preliminary Findings From the CDC/HRSA

Retention in Care Project

HIV/AIDS Bureau

Health Services and Resources Administration

Division of HIV/AIDS Prevention

Centers for Disease Control and Prevention

The findings and conclusions in this presentation are those of the presenters and do not necessarily represent the view of CDC or HRSA

Faye Malitz, HRSA

Lytt Gardner, CDC

Mollie Jenckes, Johns Hopkins

Angie McCray, Johns Hopkins

Melissa Otterbein, Johns Hopkins

Elana Desrivieres, SUNY-Downstate

6 HIV Clinics InvestigatorsBoston University Medical Center, Center for Infectious Diseases

Meg SullivanMari-Lynn Drainoni

STAR Health Center, SUNY Downstate Medical Center, Brooklyn, NY

Tracey Wilson

Moore HIV Clinic, Johns Hopkins University, Baltimore, MD

Richard MooreJeanne Keruly

Jackson Memorial Hospital Adult HIV Clinic, Miami, FL

Allan RodriguezLisa Metsch

1917 HIV Clinic, University of Alabama, Birmingham, AL

Michael MugaveroMichael Saag

Thomas Street Health Center, Baylor College of Medicine, Houston, TX

Tom GiordanoJessica Davila

Objective• To identify clinic-based interventions to promote regular

attendance for primary care and prevent loss to care

Two Studies Conducted in Two Phases

Characteristics of Intervention

Study 1 / Phase 1: low-dose, low effort, clinic-wide intervention

• Provider messages, brochures, visual cues (posters)

Study 2 / Phase 2: 3-arm randomized controlled trial (~300 patients per clinic)

• Enhanced contact with patients across time

• Improvement/reinforcement of patient skills relevant for clinic attendance

• The talk today will concern Year 1 of the Phase 2 trial.

Timeline For The Two Phases

6/09 6/10 6/11 6/12 |------------|------------|------------|-------------|-------------|------------|------------| ▼ PHASE 1 clinic-wide intervention

▼ PHASE 2 RCT enrollment

▼ 12-month intervention period begins, per enrollee, and monitoring of attendance

▼ After intervention ends, monitor

attendance for 12 months, per enrollee

Focus of The Talk

Phase 2• Brief description of RCT design & intervention

components

• Findings during the 12-month intervention period

• Future analyses

Overview of Phase 2 Study

• Phase 2 Intervention delivered by trained interventionists hired for the study

• Involves ~ 300 patients per clinic

• Enrolled at a primary care visit

• Enrollees did not have “perfect” attendance in prior 12 months

• Within each clinic, patients randomized to 3-arm trial

Research Questions

1. Does attendance for primary care improve through enhanced contact with patients across time?

2. Does attendance improve even more when we add a behavioral skills component relevant to attending clinic?

Standard of Care (n ~ 100 per clinic)

Enhanced Contact (n ~ 100 per clinic)

Enhanced Contact + Skills(n ~ 100 per clinic)

Patients continue to receive standard services offered to all patients

Standard services +

Enhanced contact with patients across time

Standard services +

Enhanced contact with patients across time +Modules to improve skills relevant to clinic attendance Problem solving Communication Organization

Note: patients in these two arms also received HIV education from interventionist on importance of regular care and association with CD4/VL

Enhanced Contact

Conducted by Interventionist

• Reminder calls 7 and 2 days before appointments

• Interim visit call (~half way between appointments)

• Missed visit call

• Brief face-to-face when patient returned to clinic for primary care visit

Skills Component

Retention Risk Screener

• Administered by interventionist in semi-structured, conversational manner (probes, specific questions, checkboxes)

• Identify barriers to clinic attendance

• Identify skill areas that need attention

• Prioritize skill modules

• Unmet/continuing needs, referral to case manager

Skill Modules

• Three ~ 20 minute modules Problem solving skills for overcoming barriers to clinic

attendance Communication skills with providers Organizational skills

• Patients worked interactively with interventionist

• Not all patients needed all three modules

• Received a pocket guide summarizing essentials of all three skill areas

Enrollment at clinic

2-week Interv. visit

Interim phone call

Attend primary care visit

Interim phone call

Miss primary care appt

Phone call to patient who missed appt.

Reminder calls at 7 & 2 days before primary care appt.

-Eligibility screen -ACASI (all enrollees) -Randomized -Session 1 (EC, EC+) Intro; HIV educ; locator info.

Phase 2 Timeline of Intervention Activities

Session 2 (EC+ only; 97% received) -Retention scrn -Skill modules

Brief F-to-F w/ interventionist (EC, EC+)

EC : Enhanced contact arm

EC+ : Enhanced contact + skills arm

Phase 2 TrialEligibility Criteria

Attendance Criteria

I. Established patients met ONE of the following two clinic attendance criteria: At least one no-show for an HIV primary care

appointment in the prior 12 months

Not seen for HIV primary care at least once in each of two consecutive 6-month periods

(Based on electronic attendance data already in hand)

II. All New patients were eligible.

•In addition, eligibility required meeting ALL of the following criteria:

18 years of age or older (at least 19 years of age in Alabama)

Currently receiving care at the clinic Able to speak English or Spanish No plans to move out of area in next 12 months Able to provide informed consent

Additional Criteria

N Percent

Number approached 2671 100.0

Number screened 2090 78.2

Number eligible 2015 96.4

Number enrolled 1838 91.2

Enrollment Data

Data Sources

Visit + Lab(EMR)

Intervention delivery dataACASI

Analysis Database

Baseline Demographics (N=1,838)

Demographics N PercentStudy Site Houston Baltimore Boston Brooklyn Miami Birmingham

330308299302299300

17.916.816.316.416.316.3

Study Arm Enhanced contact + Skills Enhanced contact Standard of care

 610615613

 33.233.533.3

Patient Type New Patients Established Patients

 526

1312

 28.671.4

Baseline Demographics (2)Demographics N Percent

Sex Males Females Transgender

 115866515

 63.036.20.8

Race/ethnicity Black/African American Hispanic/Latino White Other (Asian, NH/PI, AI/AN, multi-race)

 126228823553

 68.715.712.82.9

Age at time of enrollment 

1,835 Mean (median)44.6 (45)

Age, categorical 18-29 30-39 40-49 50+

 199361624651

 10.819.734.035.5

Baseline Demographics (3)

Demographics N PercentHIV Risk Factor MSM+ MSM/IDU IDU Heterosexual Other (e.g., perinatal, blood transfusion)

Unknown/Undetermined

 52630985435114

 28.616.846.51.9 6.2

Baseline Clinical Variables

Clinical N Percent

Taking ART medication Self-report (ACASI) Medical records

 13931437

 76.078.2

Undetectable viral load ≤200 copies/mL 980 56.5

COMPARABILITY AMONG STUDY ARMS

Variable Chi Square Result (df)

p-value

Demographics and BehavioralSite 0.50 (10) 0.99Sex 4.57 (2) 0.10Race/Ethnicity 7.58 (6) 0.27HIV Risk Factor 4.00 (6) 0.68Insurance Type (n=1780) 5.43 (6) 0.49Age Category 3.09 (6) 0.80Education level 2.71 (10) 0.99Housing type 7.19 (8) 0.52Employment status 2.79 (6) 0.84Quality of health, self-report 6.58 (8) 0.58Incarcerated in past 6 months 0.16 (2) 0.92Alcohol binge drinking 0.55 (2) 0.76Any drug use in past 3 months 1.74 (2) 0.42

Comparability Among 3 Study Arms

Unmet needs/barriers Chi Square (df) p-value Any unmet needs (1+ vs. 0), past 6 months 2.68 (2) 0.26 Unmet needs (categorical): 0, 1, 2+ 3.69 (4) 0.45Structural and Financial barriers: payment 0.90 (2) 0.64 barriers: transportation 1.40 (2) 0.50Clinical Data Baseline CD4 (<350 vs. ≥ 350 cells/mL) 2.06 (2) 0.36 Baseline VL (≤200 vs. >200 copies/mL) 3.81 (2) 0.15 Taking ART at baseline 2.05 (2) 0.36Attendance in prior year (**established patients only**)

4-month visit constancy 1.48 (2) 0.48 No missed visits 0.66 (2) 0.72 >6 month gap in care 0.07 (2) 0.97 Appointment adherence (≥0.75 vs. <0.75) 0.18 (2) 0.92

Comparability among Study Arms

Outcomes

Three PC outcomes assessed over the 12-month intervention period:

• 4-Month constancy : at least one visit in each of three 4-month periods (yes/no)

• Appointment Adherence: each participant’s proportion of kept appts divided by scheduled appts (mean of the proportions)

4-Month Constancy Result Outcome Arm Percent

Success Prevalence Ratio

p-value*

4-Month Constancy

Enhanced Contact 55.7

1.22 0.0006Standard of Care 45.8

Enhanced Contact+ Skills

55.5

1.21 0.0008Standard of Care 45.8

* Log binomial

Appointment AdherenceOutcome Arm Mean

Proportion of Kept Appts

Prevalence Ratio

p-value

Appt Adherence

Enhanced Contact

.718

1.08 0.0002Standard of Care .662

Enhanced Contact + Skills

.702

1.06 0.008Standard of Care .662

EC vs. EC+Skills ComparisonsOutcome Arms Adjusted

Percent successEC vs.EC+Skills

Prevalence Ratio

p-value

4-Month Constancy

EC 55.71.00 0.94EC + Skills 55.5

Appt Adherence

EC .7181.02 0.29EC + Skills .702

Dose of Intervention Contacts

Telephone Contacts

• Telephone Calls (EC and EC+skills arms pooled)– Number of appointment reminders– Number of Interim calls (half-way between PC visits)

Mean Appt Adherence

(p-value*)

4-Month Visit Constancy

(p-value*)

# of Successful Interim Phone Contacts

0 (n=234) 0.614 (<0.0001) 42.7% (<0.0001)1 – 2 (n=547) 0.733 57.2%3 or more (n=439) 0.753 60.4%

# of Successful Appt Reminder Contacts

0 (n=181) 0.545 (<0.0001) 30.3% (<0.0001)1 – 2 (n=320) 0.702 42.2%3 – 6 (n=423) 0.764 62.1%7 or more (n=300) 0.770 77.0%

Telephone Contacts

* Linear trend from log-binomial model

Skill Modules DeliveredEC+Skills Arm Only

Differences in retention by type of module and number of modules

received?

Type and Number of Skills Modules Received

  Mean Appt Adherence

4-Month Visit Constancy

Organization Module (n=550) 0.724 57.3%

Problem-solving Module(n=232) 0.706 60.3%

Commun. Module (n=199) 0.684 54.8%

1 module (n=300) 0.750 54.7%

2 modules (n=189) 0.713 56.6%

All 3 modules (n=101) 0.672 61.4%

     

Preliminary Conclusions

• Enhanced contact improved clinic attendance for PC when compared to SOC practices at clinics

• As number of successful telephone reminders and interim calls increased, attendance increased

• Skills modules delivered in the context of enhanced contact activities did not further improve attendance

Future Analyses

• Looking at clinics in more detail taking into account their SOC activities

• Examining whether other variables modified the EC intervention effect

• Examining whether we had an effect on viral load of patients

• Analysis of longer-term effects in the 12-month period after the intervention ended

END