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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

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Clinician training intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Standardized Patient Encounters to Improve Counseling for Pre-Exposure Prophylaxis (PrEP) for HIV Prevention to Adolescent Girls and Young Women (AGYW) in Kenya
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875950


Contacts
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Contact: Katherine S Wilson, PhD 206-685-0583 ksw@uw.edu

Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Pamela K Kohler, RN, MPH, PhD University of Washington

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Responsible Party: Pamela Kohler, Associate Professor, School of Nursing: Department Of Psychosocial And Community Health, University of Washington
ClinicalTrials.gov Identifier: NCT03875950     History of Changes
Other Study ID Numbers: STUDY00005595
R01HD094630 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela Kohler, University of Washington:
Adolescents
Young women
HIV care and treatment
Clinical training
Africa
Kenya