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

NCT03875950 | Completed Results DMC

• 2 other identifiers: STUDY00005595R01HD094630
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Adolescents; Young women; HIV care and treatment; Clinical training; Africa; Kenya

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only]

  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.

Study Arms (2)

Training intervention

EXPERIMENTAL

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

Standard of care control

NO INTERVENTION

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.

Interventions

Clinician training intervention 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.

Training intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Kenyatta National Hospital

Nairobi, Kenya

Location

Related Publications (1)

• 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.

  PMID: 32565464 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Intervention roll-out was delayed during the COVID-19 pandemic.

Results Point of Contact

• Title: Pamela Kohler
• Organization: University of Washington

pkohler2@uw.edu

206.221.5746

Study Officials

• Pamela K Kohler, RN, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Nursing: Department Of Psychosocial And Community Health

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 15, 2019
• Study Start: March 2, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 2, 2021
• Last Updated: October 12, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

KE (1)