Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya

NCT05482360 | Completed Results DMC

• 2 other identifiers: STUDY00008392-AK01MH121124
• Study Type: interventional
• Target: 5,173
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pre-Exposure Prophylaxis; HIV Infections; Pregnancy Related

Outcome Measures

Primary Outcomes (7)

• Change in PrEP Penetration

  Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services

  6 months

• Change in PrEP Fidelity

  Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.

  6 months

• Timeliness of Services

  Time (minutes) spent receiving services from health care workers

  6 months

• Waiting Time

  Time (minutes) spent waiting to receive services

  6 months

• HCW Acceptability

  Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.

  6 months

• Health Care Worker (HCW) Appropriateness

  Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.

  6 months

• Client Satisfaction

  Total on 7 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.

  6 months

Secondary Outcomes (5)

• PrEP Uptake

  6 months

• PrEP Continuation

  6 months

• Client PrEP Knowledge

  6 months

• PrEP Adherence

  6 months

• PrEP Efficiency

  6 months

Study Arms (6)

Package 1

EXPERIMENTAL

Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH

Other: PrEP Optimization Interventions

Comparator for Package 1

NO INTERVENTION

4 facilities were assigned to the comparator group and never received any implementation strategy.

Package 2

EXPERIMENTAL

Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH

Other: PrEP Optimization Interventions

Package 3

EXPERIMENTAL

Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH

Other: PrEP Optimization Interventions

Comparison for Package 2

NO INTERVENTION

4 facilities were assigned to the comparator group and never received any implementation strategy.

Comparison for Package 3

NO INTERVENTION

4 facilities were assigned to the comparator group and never received any implementation strategy.

Interventions

PrEP Optimization Interventions OTHER

There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders

Package 1; Package 2; Package 3

Eligibility Criteria

• Age: 15 Years - 100 Years
• Gender Eligibility Details: Anyone presenting for maternal child health services can be included in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

You may not qualify if:

• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ober Health Center

Homa Bay, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Anjuli Wagner, PI
• Organization: University of Washington

anjuliw@uw.edu

978 460 2331

Study Officials

• Anjuli Wagner, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Global Health

Model Details: A difference-in-difference design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced and compares that with the expected change before and after in comparison clinics. Three rounds of difference-in-differences tests will be used to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three rounds will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Locations

KE (1)