Online Program

CHWs as clinical trial staff: Strategies used and lessons learned from a study in rural Uganda

Tuesday, November 5, 2013

Monique Mueller, MSPH, Social and Behavioral Health Sciences, FHI 360, Durham, NC
Holly Burke, PhD, MPH, Reproductive, Maternal, Newborn, and Child Health, FHI 360, Durham, NC
Leonard Bufumbo, MSc, FHI 360/Uganda, Kampala, Uganda
Anja Lendvay, MPH, Clinical Sciences, FHI 360, Durham, NC
Brian Perry, MPH, Social and Behavioral Health Sciences, FHI 360, Durham, NC
Anthony Mbonye, MD, PhD, Ministry of Health / Makerere University School of Public Health, Kampala, Uganda
In rural Uganda there is a growing trend of CHW participation in health services. Since 2005 CHWs have been administering the injectable contraception depot medroxyprogesterone acetate (DMPA) to clients. As the responsibilities of CHWs expands, their exposure to and role in clinical trials will increase. However, CHWs with previous research experience is rare. Clinical trials traditionally take place in clinic settings and adhere to stringent guidelines called Good Clinical Practice (GCP) to protect human subjects involved in trials. Thirty-eight CHWs from Mubende and Nakasongola districts were trained to be staff family planning (FP) providers in a clinical trial studying the acceptability of depo-subQ in Uniject. The study assessed FP provider and DMPA client acceptability of this new injectable contraceptive method. To assess acceptability, the study was designed to maintain CHW current working practices as close as possible. CHWs routinely collect FP supplies from local clinics, transport and store the supplies in their home, and provide FP counseling and services to clients in a variety of community settings including their home. In this presentation, we will discuss the challenges faced and strategies used to meet GCP guidelines in this non-clinic setting, with a focus on CHW training and oversight, and CHWs' role in meeting documentation requirements, client participant recruitment and consent, and study product storage and accountability. As CHW participation in health services continues to grow, the challenges and lessons learned from this example will help inform future research strategies considering engaging CHWs as researchers.

Learning Areas:

Clinical medicine applied in public health
Public health or related research
Social and behavioral sciences

Learning Objectives:
Discuss three key GCP guidelines that may require special consideration when CHWs serve as research staff.

Keyword(s): Clinical Trials, Lay Health Workers

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Depot medroxyprogesterone acetate for subcutaneous injection (104 mg/0.65 mL suspension for injection) in the Uniject™ injection system is manufactured by Pfizer, Inc. as SAYANA PRESS®, approved by the UK MHRA, but not yet registered in Uganda or Senegal

Qualified on the content I am responsible for because: I am the project manager on this study. I have also been the project manager/coordinator for multiple social and behavioral health science research (SBHS) in HIV prevention and contraception since 2006. Among the projects were two multi-site phase III clinical trials with significant SBHS components. I received Good Clinical Practice certification in 2006.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.