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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05482360
Other study ID # STUDY00008392-A
Secondary ID K01MH121124
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date July 31, 2024

Study information

Verified date August 2023
Source University of Washington
Contact Anjuli Wagner, PhD
Phone 9784602331
Email anjuliw@uw.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.


Description:

This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include three packages of strategies identified by stakeholders.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 100 Years
Eligibility Inclusion Criteria: - Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys Exclusion Criteria: - Unwilling or unable to provide informed consent

Study Design


Intervention

Other:
PrEP Optimization Interventions
There will be three strategies or bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders and are unknown at this time.

Locations

Country Name City State
Kenya Ober Health Center Homa Bay

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PrEP penetration Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services 6 months
Primary Change in PrEP fidelity Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling 6 months
Primary Change in timeliness of services Time (minutes) spent receiving services from health care works 6 months
Primary Change in time waiting Time (minutes) spent waiting to receive services 6 months
Primary Change in HCW acceptability Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale 6 months
Primary Change in health care worker (HCW) appropriateness Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale 6 months
Primary Change in client satisfaction Exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale 6 months
Secondary Change in PrEP uptake Proportion of women who accept PrEP among those offered 6 months
Secondary Change in PrEP continuation Proportion of women who present for a refill among those initially prescribed PrEP 6 months
Secondary Change in PrEP adherence Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP 6 months
Secondary Change in PrEP efficiency Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers 6 months
Secondary Change client PrEP knowledge Average score of PrEP information questions based on content covered in counseling sessions 6 months
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