Clinical trial NCT03875950: Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Adolescents
Young women
HIV care and treatment
Clinical training
Africa
Kenya
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-03-15
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya
timeFrame: Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.
Secondary outcomes:
measure: Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only]
timeFrame: 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.
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
Study officials:
affiliation: University of Washington
name: Pamela K Kohler, RN, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.