HIV/AIDSSPEEDNCT02928900

Patient Actor Training to Improve HIV Services for Adolescents in Kenya

A study testing Clinician training intervention in people with HIV/AIDS, run by University of Washington at 6 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to develop and evaluate a clinical training intervention utilizing standardized patient actors to improve communication and interpersonal skills of health care workers who serve HIV-infected adolescents and youth in Kenya, resulting in increased engagement in HIV care. Read more about this study

Who is it for?: Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for: HIV/AIDS
What is being tested?: Clinician training intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 6 sitesKenya
Study dates: 26 Sep 2016to 31 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Facilities:
HIV care and treatment facilities in Kenya with ≥40 adolescents currently in HIV care
EMR data systems
No concurrent adolescent interventions
Adolescent patient records:
Records of adolescents and youth ages 10-24

Show all 16Show fewer

Enrollment in HIV care and treatment at one of the study facilities
Adolescent satisfaction surveys:
Patients ages 10-24 seeking counseling or treatment services at trial site who are HIV-infected
Willing and able to provide informed consent or assent based on age and presence of a caregiver.
Reside in Kenya
Health care workers:
>18 years of age
Employed at trial site in clinical care for at least three months and/or have a 1 year contract (i.e. not temporary staff)
Provide clinical services to adolescents
Reside in Kenya

Who cannot join

Facilities:
If inclusion criteria are not met
If anything would prevent the complete conduct of the training intervention at that site and/or the collection of outcome measures
Adolescents and health care worker surveys:
If an individual has conditions that would place them at increased risk or preclude the individual's full compliance with or completion of the study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Kenya6 sites

HIV care facility 6
Homa Bay
HIV care facility 3
Kiambu
HIV care facility 4
Kiambu
HIV care facility 5
Kisumu
HIV care facility 1
Nairobi
HIV care facility 2
Nairobi

Other trials in Kenya

About this study

Official title: Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents

Read the detailed description

Adolescents and youth have the highest HIV incidence rates compared to any other age strata. Inadequate provision of accessible and acceptable HIV testing, counseling, and treatment services has been cited as a barrier to uptake of and retention in HIV care in this population.

The "SPEED" study aims to develop and evaluate a clinical training intervention utilizing Standardized Patient (SP) actors to improve communication and interpersonal skills of health care workers (HCWs) who work with adolescents and youth (ages 10-24), resulting in increased engagement in HIV care in Kenya. This intervention includes a series of role plays between HCW participants and professional Kenyan actors, followed by feedback and debriefing sessions. The hypothesis is that SP encounters will increase HCW confidence and capacity to facilitate HIV status disclosure and provide supportive interactions with HIV-infected youth, which will in turn increase uptake and improve retention in HIV services among adolescents and youth.

The pilot phase (Aim 1) will consist of developing patient case scripts specific to adolescent HIV-related care and counseling needs and establishing HCW competency scores. To evaluate the intervention, a cluster randomized controlled stepped-wedge trial will be conducted in 24 HIV care and treatment facilities to assess the impact of SP encounters on the proportion of adolescents and youth patients retained in care at HIV treatment facilities in Kenya (Aim 2). Finally, the cost effectiveness and cost utility of the SP intervention will be determined (Aim 3). The estimated study duration is five years.

The primary outcomes from Aim 1 are final scripts and pass/fail scores for use in SP encounters. The primary outcome for the randomized controlled trial (RCT) (Aim 2) is retention in care among HIV-positive adolescents and youth, based on electronic medical records data. Secondary outcomes will include satisfaction (patients and HCWs), HCW competency in youth- friendly counseling, antiretroviral therapy adherence, and viral suppression. For the cost effectiveness and cost utility analyses (Aim 3), the cost per additional HIV-infected adolescent/youth retained in care and the cost per additional life year saved and disability-adjusted life averted will be estimated.

Conditions: HIV/AIDS
Being tested: Clinician training intervention
Keywords: Adolescents, Clinical training, HIV care and treatment, Africa
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinician training interventionBehavioural
This intervention is a clinician training using SP actors to improve communication and empathy skills of HIV care providers who serve HIV-positive adolescents and youth in Kenya.

Study groups in NCT02928900
Study group	Role	What they receive
Intervention period	Experimental	In this stepped-wedge trial design, the experimental arm refers to the time period when the study sites receive the clinician training intervention. The intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care providers who serve HIV-positive adolescents and youth. Receives: Behavioral: Clinician training intervention
Control period	No intervention	In this stepped-wedge trial design, the no intervention arm refers to the time period before the study sites receive the clinician training intervention, during which standard of care is provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention in HIV Care
The primary outcome is change in retention in HIV care between the intervention and control periods, where retention is defined as return for first follow-up visit within 3 months among newly enrolled adolescent clients OR follow-up visit after 're-engagement visit' (after lost-to-follow-up for >90 days since last visit, with no record of death or transfer).
Measured: Up to four years after baseline

Secondary outcomes (6)

Proportion of HCWs With Pass/Fail Scores
The proportion of HCW participants who achieved competency upon completion of the training.
Measured: Up to one month after last day of training
Numeric Scores From SP Actors
All SP actors will complete a check-list to provide non-technical feedback to each HCW participant. Scores will be used to compute the overall pass/fail score at completion of the training.
Measured: Up to one week after last day of training
Health Care Worker Competency
This outcome is measured as change in mean competency score between intervention and control periods using a structured survey.
Measured: Baseline and every nine months for up to four years
Health Care Workers' Satisfaction With Skills
This outcome is measured as change in mean satisfaction scores between intervention (post-training) and control periods (pre-training), using a structured survey. These surveys will be conducted at baseline, and every nine months at the end of the training in each wave. Exit interviews among trained participants will be conducted about one year after each training wave for up to four waves to complement the quantitative results.
Measured: Baseline and every nine months for up to four years
Adolescent Patients' Satisfaction With Care
This outcome is defined as mean change in satisfaction score between intervention and control periods, using a structured survey.
Measured: Baseline and every nine months for up to four years
Retention in HIV Care (Secondary)
A secondary measure of retention in HIV care is return for any follow-up visit within 3 months (90 days) among currently enrolled HIV-positive adolescent patients
Measured: Baseline and every nine months for up to four years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201631 Mar 2021

First posted10 Oct 2016 (estimated)
Study start26 Sep 2016
Primary completion2 Nov 2020
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Stepped wedge cluster RCT
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02928900
Sponsor's protocol ID: STUDY00002035
Acronym: SPEED
Status last verified: Oct 2024
First submitted: 26 Sep 2016
Last updated: 9 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: The study investigators are prepared to share data with other researchers in accordance with NIH policies and other local regulations.

Publications

Kohler PK, Mugo C, Wilson KS, Moraa H, Onyango A, Tapia K, Pike K, Mburu C, Nduati M, Guthrie B, Richardson BA, Owens T, Bukusi D, Inwani I, John-Stewart G, Wamalwa D. Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial. PLOS Glob Public Health. 2023 Apr 19;3(4):e0001765. doi: 10.1371/journal.pgph.0001765. eCollection 2023.
PubMed 37074998
Wilson K, Onyango A, Mugo C, Guthrie B, Slyker J, Richardson B, John-Stewart G, Inwani I, Bukusi D, Wamalwa D, Kohler P. Kenyan HIV Clinics With Youth-Friendly Services and Trained Providers Have a Higher Prevalence of Viral Suppression Among Adolescents and Young Adults: Results From an Observational Study. J Assoc Nurses AIDS Care. 2022 Jan-Feb 01;33(1):45-53. doi: 10.1097/JNC.0000000000000302.
PubMed 34939987
Wilson KS, Mugo C, Bukusi D, Inwani I, Wagner AD, Moraa H, Owens T, Babigumira JB, Richardson BA, John-Stewart GC, Slyker JA, Wamalwa DC, Kohler PK. Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial. Trials. 2017 Dec 28;18(1):619. doi: 10.1186/s13063-017-2266-z.
PubMed 29282109

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Simulated Patient Encounters to Promote Early Detection and Engagement in HIV Care for Adolescents
ClinicalTrials.gov ID: NCT02928900
Acronym / sponsor ID: SPEED / STUDY00002035
Conditions: HIV/AIDS
Keywords: Adolescents, Clinical training, HIV care and treatment, Africa
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: University of Nairobi
Study start: 26 Sep 2016 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 10 Oct 2016 (estimated)
Results: Posted 9 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Stepped wedge cluster RCT

Arm	Type	Receives
Intervention period	Experimental	Behavioral: Clinician training interventionIn this stepped-wedge trial design, the experimental arm refers to the time period when the study sites receive the clinician training intervention. The intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care providers who serve HIV-positive adolescents and youth.
Control period	No intervention	–In this stepped-wedge trial design, the no intervention arm refers to the time period before the study sites receive the clinician training intervention, during which standard of care is provided.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (16 listed)

HIV care and treatment facilities in Kenya with ≥40 adolescents currently in HIV care
EMR data systems
No concurrent adolescent interventions
Records of adolescents and youth ages 10-24
Enrollment in HIV care and treatment at one of the study facilities

Key exclusion criteria (5 listed)

If inclusion criteria are not met
If anything would prevent the complete conduct of the training intervention at that site and/or the collection of outcome measures
If an individual has conditions that would place them at increased risk or preclude the individual's full compliance with or completion of the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinician training interventionThis intervention is a clinician training using SP actors to improve communication and empathy skills of HIV care providers who serve HIV-positive adolescents and youth in Kenya.	Behavioural	Intervention period

Primary outcome

Retention in HIV Care
Time frame: Up to four years after baseline
The primary outcome is change in retention in HIV care between the intervention and control periods, where retention is defined as return for first follow-up visit within 3 months among newly enrolled adolescent clients OR follow-up visit after 're-engagement visit' (after lost-to-follow-up for >90 days since last visit, with no record of death or transfer).

6 secondary outcomes

Proportion of HCWs With Pass/Fail Scores
Time frame: Up to one month after last day of training
Numeric Scores From SP Actors
Time frame: Up to one week after last day of training
Health Care Worker Competency
Time frame: Baseline and every nine months for up to four years
Health Care Workers' Satisfaction With Skills
Time frame: Baseline and every nine months for up to four years
Adolescent Patients' Satisfaction With Care
Time frame: Baseline and every nine months for up to four years
Retention in HIV Care (Secondary)
Time frame: Baseline and every nine months for up to four years

Results and safety

Results posted to the registry on 9 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standardized Patient Training	–	–
Control	–	–

Primary outcome: Retention in HIV Care

Time frame: Up to four years after baseline. Count of participants. Unit: Participants

Measure	Adolescent Records - Intervention Exposed n = 2123	Adolescent Records - Unexposed n = 2472
Value	1570	1855

Population analysed: Medical record review. Final analysis accounts for clustering by facility, time (stepped wedge design), and newly enrolled in care status.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years following the first intervention training.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SP Training Intervention	0 of 2,123 (0%)	0 of 2,123 (0%)	0 of 2,123
No Training Intervention	0 of 2,472 (0%)	0 of 2,472 (0%)	0 of 2,472

Limitations and caveats (from the sponsor): Data collection was suspended after Wave 4 training in March 2020 due to the COVID-19 pandemic

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37074998Kohler PK, Mugo C, Wilson KS, Moraa H, Onyango A, Tapia K, Pike K, Mburu C, Nduati M, Guthrie B, Richardson BA, Owens T, Bukusi D, Inwani I, John-Stewart G, Wamalwa D. Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial. PLOS Glob Public Health. 2023 Apr 19;3(4):e0001765. doi: 10.1371/journal.pgph.0001765. eCollection 2023.
Derived from this study: PubMed 34939987Wilson K, Onyango A, Mugo C, Guthrie B, Slyker J, Richardson B, John-Stewart G, Inwani I, Bukusi D, Wamalwa D, Kohler P. Kenyan HIV Clinics With Youth-Friendly Services and Trained Providers Have a Higher Prevalence of Viral Suppression Among Adolescents and Young Adults: Results From an Observational Study. J Assoc Nurses AIDS Care. 2022 Jan-Feb 01;33(1):45-53. doi: 10.1097/JNC.0000000000000302.
Derived from this study: PubMed 29282109Wilson KS, Mugo C, Bukusi D, Inwani I, Wagner AD, Moraa H, Owens T, Babigumira JB, Richardson BA, John-Stewart GC, Slyker JA, Wamalwa DC, Kohler PK. Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial. Trials. 2017 Dec 28;18(1):619. doi: 10.1186/s13063-017-2266-z.
Individual participant dataSharing planned: Yes. The study investigators are prepared to share data with other researchers in accordance with NIH policies and other local regulations.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela Kohler, PhD, MPH, RN principal investigator

University of Washington

Dalton Wamalwa, MMed, MPH study director

University of Nairobi

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clinician training intervention in people with HIV/AIDS, run by University of Washington at 6 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention in HIV Care (time frame: Up to four years after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02928900, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.