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

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

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

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).

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

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?

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 

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