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

HIV/AIDS Clinical Trial

— PrIYA-SP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875950
• Other study ID #: STUDY00005595
• Secondary ID: R01HD094630
• Status: Completed
• Phase: N/A
• Start date: March 2, 2019
• Est. completion date: December 2, 2021

Study information

• Verified date: October 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 2, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital	Nairobi

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya	Quality is assessed as total score from a checklist provided by the SPs after each unannounced visit (n=71 SP visits in each arm) 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. Each measure is computed as a percent of total score possible. The total quality score will be a combined continuous score and rescaled out of 100 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.	Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.
Secondary	Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only]	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 (range 8-57) per SP interaction during the clinical training intervention. All scores are rescaled as a percent of total points possible.	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.