Trial Outcomes & Findings for Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya (NCT NCT03875950)

Last Updated: 2022-10-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

232 participants

Primary outcome timeframe

Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.

Results posted on

2022-10-12

Participant Flow

232 providers consented to unannounced patient actor visits (125 at invention sites and 107 at control sites). The number of providers at intervention sites is higher than the number of providers trained, because all newly hired staff at health facilities provided consent during the outcome assessments which took place after the training.

Participant milestones

Participant milestones
Measure	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. 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.	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.
Overall Study STARTED	125	107
Overall Study COMPLETED	125	107
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Training Intervention n=125 Participants 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. 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.	Standard of Care Control n=107 Participants 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.	Total n=232 Participants Total of all reporting groups
Age, Continuous	31 years n=93 Participants	31 years n=4 Participants	31 years n=27 Participants
Sex: Female, Male Female	75 Participants n=93 Participants	59 Participants n=4 Participants	134 Participants n=27 Participants
Sex: Female, Male Male	50 Participants n=93 Participants	48 Participants n=4 Participants	98 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	125 Participants n=93 Participants	107 Participants n=4 Participants	232 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Kenya	125 participants n=93 Participants	107 participants n=4 Participants	232 participants n=27 Participants
Number of years providing HIV prevention services	4 years n=93 Participants	3 years n=4 Participants	4 years n=27 Participants
Prior receipt of HIV prevention training	54 Participants n=93 Participants	52 Participants n=4 Participants	106 Participants n=27 Participants

PRIMARY outcome

Timeframe: Unannounced standardized patient actor visits take approximately 15 minutes each, taking place over 3-4 months.

Population: Outcomes were assessed by unannounced patient actors who portrayed patients seeking PrEP services. There were 71 patient actor visits at control, and 71 patient actor visits at intervention sites. Visits were not matched to specific providers and some providers may have been seen twice, so the total number of providers evaluated is unknown.

Outcome measures

Outcome measures
Measure	Training Intervention n=71 USP visits 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. 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. Outcome measures are assessed through 71 unannounced patient actor visits.	Standard of Care Control n=71 USP visits 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. Outcome measures are assessed through 71 unannounced patient actor visits.
Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya Overall quality	73.6 percentage of total score possible Standard Deviation 16.3	58.4 percentage of total score possible Standard Deviation 16.7
Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya Guideline adherence	57.2 percentage of total score possible Standard Deviation 25.4	36.2 percentage of total score possible Standard Deviation 26.9
Quality of PrEP Counseling Provided by Health Care Workers Delivering PrEP to Adolescent Girls and Young Women for HIV Prevention in Kenya Communication skills	90.0 percentage of total score possible Standard Deviation 10.9	80.5 percentage of total score possible Standard Deviation 11.4

SECONDARY outcome

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.

Population: The 94 health providers who participated in the training intervention

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.

Outcome measures

Outcome measures
Measure	Training Intervention n=94 Participants 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. 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. Outcome measures are assessed through 71 unannounced patient actor visits.	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. Outcome measures are assessed through 71 unannounced patient actor visits.
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only] Overall quality (sum of adherence and communication)	83.1 percentage of total score possible Standard Deviation 10.1	—
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only] Guideline adherence	66.1 percentage of total score possible Standard Deviation 20.7	—
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only] Communication skills	96.2 percentage of total score possible Standard Deviation 8.1	—
Competency Score Measuring Quality of PrEP Counseling Provided by Health Care Workers During Clinical Training Intervention [Among Intervention Arm Only] Interpersonal skills	86.9 percentage of total score possible Standard Deviation 8.7	—

Adverse Events

Training Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Kohler

University of Washington

Phone: 206.221.5746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place