1. Research design for implementation studies: Finding a comparison group when you have no resources
CIIS Implementation in Progress
Mari-Lynn Drainoni, PhD, MEd
Michael Silverstein, MD
 February 21, 2017

2. Improving Access to Care: Using Community Health Workers to Improve Linkage and Retention in HIV Care
Funder: HRSA HIV/AIDS Bureau PI: Sally Bachman Co-PIs: Mari-Lynn Drainoni, Serena Rajabiun, Jane Fox Program Manager: Allyson Baughman Evaluation Team: Mari-Lynn Drainoni, Haley Falkenberry, Alex de Groot, Caitlin Allen

3. Project Goals
Increase utilization of CHWs to improve access, retention & outcomes among PLWH
Strengthen HIV health care workforce & build capacity of RWHAP recipients to integrate CHWs into care team
Evaluate implementation & effectiveness of models

4. Background & Rationale
PLWH not well-engaged in care account for large proportion of those with detectable VL
Evidence that clinical programs integrating CHWs improve care across HIV care continuum
Patients who received CHW services, including case management, concrete supports, MH & SUD services more likely to receive medical care, have more visits & be retained in care
Regular, frequent visits with CHWs improve treatment adherence rates
PLWH who had been tested but were not well-engaged in care accounted for a large proportion of patients with detectable viral loads (Gardener et al, 2011)
Evidence that clinical programs that integrate CHWs improve care across the HIV care continuum – from linkage to retention, adherence and suppression (Maulsby, 2015, Genberg, 2016).
CHWs are able to help reduce patient barriers and improve access to HIV primary care (Koester, 2014).
Patients who received CHW services, including case management, transportation, mental health and chemical dependency are more likely to receive care and have more visits than those with no services, and are more likely to be retained in care (Sherer, 2002).
Regular, frequent visits with CHWs improve treatment adherence rates (Bradford et al, 2007).

5. This is a Contract! Project Structure
10 clinical sites across US to be funded to:
Implement program ($75K/year), limited staffing
Receive training
Participate in evaluation
3 year project
12 months: BU team planning: program, curriculum, training development, evaluation design
18 months: program implementation & evaluation, ongoing training, collect & provide data
6 months: complete evaluation
Evaluation:
Small % of data person in $75K, no additional for data
No funding for control/comparison sites

7. Evaluation
Hybrid 3 implementation-effectiveness evaluation
Primary focus: Experience implementing the programs from multiple staff/organizational perspectives
Primarily qualitative, assessed through:
Client, CHW, and site experience with intervention
Integration of CHW program into setting
Intervention fidelity
Primarily qualitative
HRSA not mandating effectiveness component – we would like some rigor
Question: how can we create rigor with no funding for comparator/control sites?

8. Comparison Group Options
Control group not possible:
All sites must get intervention
Cannot randomize individual clients within a site
Evaluation team ideas for comparison group:
Obtain clinical/outcome data from 10 matched non-intervention sites - would require time & effort from sites
Obtain pre-post data from funded CHW sites for intervention clients 
Obtain pre-post data from funded CHW sites for intervention & non- intervention clients
Obtain data for 10 matched non-intervention sites from HRSA 
Compare our client outcomes to publicly available aggregate HRSA data 

9. Other Options. What Should we Do
Other Options? What Should we Do? How do we get rigor with no additional funds?