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Completed

NCT Number: NCT04712994

PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

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

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Key information

Conditions

Pre-exposure Prophylaxis Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pregnancy Related RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kendu Sub-District Hospital, Homa Bay, Kenya

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unwilling or unable to provide informed consent

Treatment and study plan

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.

Primary outcomes

  1. PrEP Penetration

    Time frame: 6 months

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

  2. PrEP Fidelity

    Time frame: 6 months

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

  3. Timeliness of Services

    Time frame: 6 months

    Time (minutes) spent receiving services from health care works

  4. Waiting Time

    Time frame: 6 months

    Time (minutes) spent waiting to receive services

  5. HCW Acceptability

    Time frame: 6 months

    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. Health Care Worker (HCW) Appropriateness

    Time frame: 6 months

    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.

  7. Client Satisfaction

    Time frame: 6 months

    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.

Secondary outcomes

  1. PrEP Uptake

    Time frame: 6 months

    Proportion of women who accept PrEP among those offered

  2. PrEP Continuation

    Time frame: 6 months

    Proportion of women who present for a refill among those initially prescribed PrEP

  3. PrEP Adherence

    Time frame: 6 months

    Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP

  4. PrEP Efficiency

    Time frame: 6 months

    Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers

  5. Client PrEP Knowledge

    Time frame: 6 months

    Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 19, 2021
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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