PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

HIV Infections Clinical Trial

Official title:

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712994
• Other study ID #: STUDY00008392
• Secondary ID: R01HD094630R01AI
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

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 a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1958
• Est. completion date: January 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

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

Related Conditions & MeSH terms

• HIV Infections
• Pre-Exposure Prophylaxis
• Pregnancy Related

Intervention

Other:
• PrEP Optimization Interventions
A bundle of strategies (video-based PrEP counselling, HIV Self-Testing [HIVST] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.

Locations

Country	Name	City	State
Kenya	Kendu Sub-District Hospital	Homa Bay
Kenya	Ober Health Center	Homa Bay
Kenya	Masogo Sub-County Hospital	Kisumu
Kenya	Nyahera Sub Sub County Hospital	Kisumu
Kenya	Bondo County Referral Hospital	Siaya
Kenya	Madiany Sub County Hospital	Siaya
Kenya	Malanga Health Center	Siaya
Kenya	Uyawi Sub County Hospital	Siaya

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), 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