PathToScale: An Implementation Evaluation

NCT06319105 | Recruiting DMC FDA Drug

• 1 other identifier: 775736
• Study Type: observational
• Target: 9,900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV; pre-exposure prophylaxis (PrEP); Implementation Science; Long-acting injectable cabotegravir for PrEP; Oral pre-exposure prophylaxis (PrEP)

Outcome Measures

Primary Outcomes (7)

• Pre-exposure prophylaxis uptake by modality

  Comparison of pre-exposure prophylaxis uptake by modality (injectable vs. oral) between months 7-12

  12 months after enrollment

• Pre-exposure prophylaxis uptake by delivery channel

  Comparison of oral and injectable pre-exposure prophylaxis uptake by service delivery channel (e.g. HIV counseling and testing, postnatal care, family planning, sexually transmitted infection clinics, drop-in centers, youth-friendly services, etc.)

  12 months after enrollment

• Pre-exposure prophylaxis uptake by population

  Comparison of oral and injectable pre-exposure prophylaxis uptake by pre-exposure prophylaxis client population (e.g. female sex workers, breastfeeding women, adolescent girls and young women/women at high risk for HIV infection, men who have sex with men, transgender persons, men at high risk for HIV acquisition).

  12 months after enrollment

• Pre-exposure prophylaxis continuation by modality

  Comparison of pre-exposure prophylaxis continuation by modality (injectable vs. oral)

  12 months after enrollment

• Pre-exposure prophylaxis continuation by delivery channel

  Comparison of pre-exposure prophylaxis continuation by channel (e.g. HIV counseling and testing, post-natal care, family planning, sexually transmitted infection clinics, drop-in centers, youth-friendly services, etc.)

  12 months after enrollment

• Pre-exposure prophylaxis continuation by population

  Comparison of pre-exposure prophylaxis continuation by pre-exposure prophylaxis client population (e.g. female sex workers, breastfeeding women, adolescent girls and young women/women at high risk for HIV acquisition, men who have sex with men, transgender persons, men at high risk for HIV acquisition).

  12 months after enrollment

• Rates of switching between oral and injectable pre-exposure prophylaxis

  Describe rates of switching between oral and injectable pre-exposure prophylaxis among pre-exposure prophylaxis users

  18 months after enrollment

Secondary Outcomes (3)

• Implementation readiness

  6 months after enrollment

• Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users

  18 months after enrollment

• Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users

  18 months after enrollment

Study Arms (1)

Standard intervention: Offer PrEP choice

Offer pre-exposure prophylaxis choice between oral and long-acting injectable cabotegravir for pre-exposure prophylaxis across 36 study sites.

Other: Standard intervention: Offer PrEP choice

Interventions

Standard intervention: Offer PrEP choice OTHER

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.

Standard intervention: Offer PrEP choice

Eligibility Criteria

• Age: 15 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active participants will be pre-exposure prophylaxis providers and clients from the 36 implementation facilities and key stakeholders (e.g. governmental and non-governmental stakeholders), who are invited to participate in study activities about their perspectives, prescribing and use of pre-exposure prophylaxis across the 36 PathToScale sites.

You may qualify if:

• Individuals who are 15+ years old AND either
• Female sex workers (FSW) OR
• Men who have sex with men (MSM) OR
• Transgender individuals (TG) OR
• Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR
• Breastfeeding women (BFW) OR
• Male partners of female sex workers and/or Men at high risk for HIV and/or men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.

You may not qualify if:

• Those living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.

Sponsors & Collaborators

• Georgetown University: lead
• AIDS Vaccine Advocacy Coalition: collaborator
• Centers for Disease Control and Prevention: collaborator
• Center for the Development of People: collaborator
• Cooper/Smith: collaborator
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator
• Family Health Services: collaborator
• Healthqual: collaborator
• Johns Hopkins Research Project, Malawi: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Kamuzu University of Health Sciences: collaborator
• Blantyre District Health Office, Malawi: collaborator
• Lilongwe District Health Office, Malawi: collaborator
• Lighthouse Trust: collaborator
• Ministry of Health, Malawi: collaborator
• National AIDS Commission, Malawi: collaborator
• Pakachere Institute of Health and Development Communication: collaborator
• Partners in Hope, Inc.: collaborator
• Population Services International: collaborator
• University of North Carolina: collaborator
• United States Agency for International Development (USAID): collaborator
• United States President's Emergency Plan for AIDS Relief: collaborator
• Quantitative Engineering Design: collaborator
• Clinton Health Access Initiative-Malawi: collaborator

Study Sites (1)

Community Health Science Unit

Lilongwe, Malawi

RECRUITING

Study Officials

• Charles Holmes, MD, MPH

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Holmes, MD, MPH

CONTACT

+1 (202) 662-9000; charles.holmes@georgetown.edu

Deborah Hoege, MPH

CONTACT

+1 (202) 662-9000; dh1107@georgetown.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Innovation in Global Health

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 19, 2024
• Study Start: March 26, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)