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Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya (PrIYA-SP)

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ClinicalTrials.gov Identifier: NCT03875950
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Pamela Kohler, University of Washington

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 15, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
Quality of PrEP counseling provided by health care workers delivering PrEP to adolescent girls and young women for HIV prevention in Kenya [ Time Frame: Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months. ]
Quality is assessed as total score from a checklist provided by the SPs after each unannounced visit including domains of communication skills and adherence to national guidelines. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guideline adherence is assessed in a scoring system adapted from the Kenyan National AIDS & STI Control Programme guidelines; scores range from 0-13 with higher scores indicating higher PrEP competency. The total quality score will be a combined continuous score per unannounced SP visit. Mean scores among all SP encounters taking place in facilities randomized to the clinical intervention will be compared to mean scores among those randomized to standard of care.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
Competency score measuring quality of PrEP counseling provided by health care workers during clinical training intervention [among intervention arm only] [ Time Frame: Standardized patient actor training interactions take approximately 15 minutes each and will occur during a two-day training intervention. Trainings will be conducted over a period of 2-3 months. ]
The secondary outcome is PrEP competency among HCWs in interactions with SPs during the clinical training intervention, assessed as sub-scores for interpersonal skills, communication quality, and guideline adherence. Interpersonal skills are assessed using the Interpersonal skills (IPS) assessment tool (Van Zanten 2007); scores range from 1-16 with higher scores indicating better interpersonal skills. Communication quality is assessed in an adapted version of the Bayer-Fetzer Kalamazoo Consensus Statement; scores range from 7-28 with higher scores indicating higher quality communication. Guideline adherence is assessed in a scoring system adapted from the Kenyan National AIDS & STI Control Programme guidelines; scores range from 0-13 with higher scores indicating higher competency. The total competency score will be a combined continuous score per SP interaction during the clinical training intervention.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
Official Title  ICMJE Standardized Patient Encounters to Improve Counseling for Pre-Exposure Prophylaxis (PrEP) for HIV Prevention to Adolescent Girls and Young Women (AGYW) in Kenya
Brief Summary The goal of this study is to facilitate uptake of and adherence to HIV pre-exposure prophylaxis (PrEP) among adolescent girls and young women (AGYW) in Kenya. The investigators will conduct a cluster randomized controlled trial at 24 health facilities in Kisumu, Kenya of a clinical training intervention using standardized patient actors. The hypothesis is that the training will improve quality of PrEP service delivery, defined as adherence to national guidelines and non-judgmental communication.
Detailed Description

Despite global gains in female-controlled HIV prevention strategies, the incidence of HIV in adolescent girls and young women (AGYW) continues to rise. Pre-exposure prophylaxis (PrEP) has been shown to reduce the risk of HIV acquisition in trial settings, however real-world effectiveness at scale is limited by poor adherence.

An important barrier to uptake and adherence to HIV prevention services among AGYW is the experience of judgmental, and non-empathetic interactions with health care workers (HCWs). New strategies are needed to improve provider counseling and communication skills to support PrEP adherence among AGYW. Standardized patient actors (SPs) have been used in a variety of settings to improve clinical assessment and care skills, as well as patient outcomes.

The "PrIYA-SP" study aims to improve HCW communication skills and adherence to PrEP guidelines through a cluster randomized trial of a SP actor training intervention. Twenty-four facilities that currently offer PrEP to AGYW in Kisumu County, Kenya will be selected. The first phase will include a cross-sectional assessment by unannounced SPs who will present to clinics portraying AGYW seeking PrEP, according to case scripts. Following the baseline assessment, 12 facilities will be randomized to the SP training intervention. The two-day intervention consists of didactic sessions covering national guidelines and communication skills, values clarification exercises, role playing sessions with SPs, and a group debriefing with HCW participants. Following the intervention, unannounced SPs will repeat the cross-sectional assessment.

The primary outcome is quality of counseling, defined as adherence to national guidelines for PrEP delivery and use of non-judgmental communication skills. An intention-to-treat (ITT) analysis will be used to evaluate whether the SP training intervention resulted in higher quality counseling at intervention compared to control facilities, adjusted for relevant baseline characteristics and quality measures. The investigators hypothesize that this SP training intervention will improve quality delivery of PrEP to AGYW compared to standard of care.

Results from this study will directly inform operational guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve PrEP service delivery and adherence among AGYW.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Behavioral: Clinician training intervention
This intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care workers delivering PrEP to adolescent girls and young women to prevent HIV in Kenya.
Study Arms  ICMJE
  • Experimental: Training intervention
    In this cluster randomized control trial design, the experimental arm refers to the 12 study sites that are randomly assigned to receive the clinician training intervention. The intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care workers who deliver PrEP to adolescent girls and young women to prevent HIV.
    Intervention: Behavioral: Clinician training intervention
  • No Intervention: Standard of care control
    In this randomized cluster randomized control trial design, the no intervention arm refers to the 12 study sites that are randomly assigned not to receive the clinician training intervention. Instead, these study sites will receive the standard of care, which is no standardized patient actor training, for health care workers who deliver PrEP to adolescent girls and young women to prevent HIV.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Listed by population

Facilities:

  • Facilities located in a county in Western Kenya
  • Currently offering PrEP services to adolescent girls and young women

Health care workers:

  • Age 18 or older
  • Current employee of one of the 24 study sites
  • Able to provide consent

Exclusion Criteria: Listed by population

Facilities:

  • Health facilities where PrEP services are staffed by contract workers, program, or study staff

Health care workers:

  • Study staff seconded to the site as part of a trial or intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Katherine S Wilson, PhD 206-685-0583 ksw@uw.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875950
Other Study ID Numbers  ICMJE STUDY00005595
R01HD094630 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The study investigators are prepared to share data with other researchers in accordance with NIH policies and other local regulations.
Supporting Materials: Study Protocol
Time Frame: Summary data may be shared or otherwise made available to interested parties starting 6 months after publication of trial results
Access Criteria: Access to data will be determined on a case-by-base basis in agreement with the Kenyan Ministry of Health. De-identified data will be made available for secondary analyses. Any data sharing will be performed through secure servers and/or encrypted external drives.
Responsible Party Pamela Kohler, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Pamela K Kohler, RN, MPH, PhD University of Washington
PRS Account University of Washington
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP