PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

NCT04712994 | Completed Results DMC

• 3 other identifiers: STUDY00008392R01HD094630R01AI125498
• Study Type: interventional
• Target: 1,958
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Pre-Exposure Prophylaxis; HIV Infections; Pregnancy Related

Outcome Measures

Primary Outcomes (7)

• PrEP Penetration

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

  6 months

• PrEP Fidelity

  Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling

  6 months

• Timeliness of Services

  Time (minutes) spent receiving services from health care works

  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 6 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 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 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

• PrEP Adherence

  6 months

• PrEP Efficiency

  6 months

• Client PrEP Knowledge

  6 months

Study Arms (2)

PrEP Optimization Strategies

EXPERIMENTAL

Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).

Other: PrEP Optimization Interventions

Comparator

NO INTERVENTION

Four facilities will be assigned to the comparator group.

Interventions

PrEP Optimization Interventions OTHER

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.

PrEP Optimization Strategies

Eligibility Criteria

• 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
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (8)

Kendu Sub-District Hospital

Homa Bay, Kenya

Location

Ober Health Center

Homa Bay, Kenya

Location

Masogo Sub-County Hospital

Kisumu, Kenya

Location

Nyahera Sub Sub County Hospital

Kisumu, Kenya

Location

Bondo County Referral Hospital

Siaya, Kenya

Location

Madiany Sub County Hospital

Siaya, Kenya

Location

Malanga Health Center

Siaya, Kenya

Location

Uyawi Sub County Hospital

Siaya, Kenya

Location

Related Publications (1)

• Sila J, Wagner AD, Abuna F, Dettinger JC, Odhiambo B, Ngumbau N, Oketch G, Sifuna E, Gomez L, Hicks S, John-Stewart G, Kinuthia J. An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya. Front Reprod Health. 2023 Nov 17;5:1205503. doi: 10.3389/frph.2023.1205503. eCollection 2023.

  PMID: 38045529 DERIVED

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
• Organization: University of Washington

anjuliw@uw.edu

9784602331

Study Officials

• Grace John-Stewart, MD, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor, School of Medicine: 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. One package of interventions (video-based PrEP counseling, HIV Self-Testing \[HIVST\], and optimized PrEP delivery) will be implemented at four intervention facilities and here will be 4 comparison facilities will undergo the same data collection procedures.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 19, 2021
• Study Start: May 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: January 31, 2022
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Locations

KE (8)