PathToScale: An Implementation Evaluation

Summary

The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels.

Conditions

• Oral Pre-exposure Prophylaxis (PrEP)
• Long-acting Injectable Cabotegravir for PrEP

Interventions

OTHER

Standard intervention: Offer PrEP choice

This hybrid observational-implementation study will observe the implementation of a choice of oral pre-exposure prophylaxis or long-acting injectable cabotegravir for pre-exposure prophylaxis for all participants.

Sponsors & Collaborators

• AIDS Vaccine Advocacy Coalition

  collaborator UNKNOWN

• Centers for Disease Control and Prevention

  collaborator FED

• Center for the Development of People

  collaborator UNKNOWN

• Cooper/Smith

  collaborator UNKNOWN

• Elizabeth Glaser Pediatric AIDS Foundation

  collaborator OTHER

• Family Health Services

  collaborator UNKNOWN

• Healthqual

  collaborator UNKNOWN

• Johns Hopkins Research Project, Malawi

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• Blantyre District Health Office, Malawi

  collaborator UNKNOWN

• Lilongwe District Health Office, Malawi

  collaborator UNKNOWN

• Lighthouse Trust

  collaborator OTHER

• Ministry of Health, Malawi

  collaborator OTHER_GOV

• National AIDS Commission, Malawi

  collaborator UNKNOWN

• Pakachere Institute of Health and Development Communication

  collaborator UNKNOWN

• Partners in Hope, Inc.

  collaborator INDUSTRY

• Population Services International

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• United States President's Emergency Plan for AIDS Relief

  collaborator FED

• Quantitative Engineering Design

  collaborator UNKNOWN

• Clinton Health Access Initiative-Malawi

  collaborator UNKNOWN

• Georgetown University

  lead OTHER

Principal Investigators

• Charles Holmes, MD, MPH · Georgetown University

Eligibility

Min Age

15 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-26

Primary Completion

2026-04-01

Completion

2026-04-01

FDA Drug

Yes

Countries

• Malawi

Study Locations