Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya

NCT ID: NCT03875950

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-02
• Study Completion Date: 2021-12-02

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Clinician training intervention

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Pamela Kohler

Associate Professor, School of Nursing: Department Of Psychosocial And Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela K Kohler, RN, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Kenyatta National Hospital

Nairobi, , Kenya

Countries

Kenya

References

Larsen A, Wilson KS, Kinuthia J, John-Stewart G, Richardson BA, Pintye J, Abuna F, Lagat H, Owens T, Kohler P. Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial. BMJ Open. 2020 Jun 21;10(6):e035689. doi: 10.1136/bmjopen-2019-035689.

Reference Type: DERIVED

PMID: 32565464 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01HD094630

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005595

Identifier Type: -

Identifier Source: org_study_id