- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319105
PathToScale: An Implementation Evaluation
Accelerating the Path To Scale for Injectable PrEP in Malawi: An Implementation Evaluation
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will assess client uptake, equitable reach, and continuation of oral and injectable pre-exposure prophylaxis implementation across priority populations and service delivery channels in real-world settings. The study will also evaluate long-acting injectable cabotegravir for pre-exposure prophylaxis implementation readiness and implementation outcomes across these delivery channels and priority populations from the perspectives of providers and clients. Demand generation activities will also be evaluated. Lastly, the study will conduct clinical surveillance of long-acting injectable cabotegravir outcomes at scale, including pregnancy outcomes among clients who become pregnant or are pregnant on long-acting injectable cabotegravir, and seroconversion and resistance outcomes of long-acting injectable cabotegravir users.
This study takes a hybrid observational-implementation approach, which will leverage routine programmatic data from pre-exposure prophylaxis implementation from national registries and tools from the real-world roll-out of long-acting injectable cabotegravir and will complement these routine data with targeted collection of implementation outcomes and barriers and facilitators to implementation with a subset of stakeholders. Research staff will not implement long-acting injectable cabotegravir, but rather long-acting injectable cabotegravir will be implemented by the Ministry of Health and implementing partners under routine care and following the Ministry of Health pre-exposure prophylaxis guidelines.
Per the Ministry of Health eligibility guidelines, we anticipate the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution nationally, following individual risk assessment.
- Female sex workers (FSW)
- Men who have sex with men (MSM)
- Transgender individuals (TG)
- Women and adolescent girls and young women (AGYW) presenting at sexually transmitted infection (STI) services
- Breastfeeding women
- Male partners of female sex workers (FSW)
- Men at high risk, presenting with a syndromic or lab-confirmed sexually transmitted infection (STI)
Pre-exposure prophylaxis users will be passively enrolled into the evaluation. Routine, de-identified programmatic data will be utilized from Ministry of Health pre-exposure prophylaxis ScanForms to identify the number and demographic characteristics (gender, age, indication for pre-exposure prophylaxis) of oral and long-acting injectable cabotegravir for pre-exposure prophylaxis users initiating pre-exposure prophylaxis modalities by site, switching from oral to long-acting injectable cabotegravir for pre-exposure prophylaxis (and vice versa), and continuation rates.
Additional data collection activities will be conducted to evaluate the process of implementation and its fidelity, including facility context assessments, a long-acting injectable cabotegravir for pre-exposure prophylaxis provision readiness assessment with providers across implementing facilities, qualitative interviews with providers, observational assessments of providers across facilities, and client exit interviews.
Primary Outcomes
Outcome 1 Title: Pre-exposure prophylaxis uptake by modality Description: Comparison of pre-exposure prophylaxis uptake by modality (injectable vs. oral) between months 7-12 Timeframe: 12 months after enrollment Analysis: Pre-exposure prophylaxis uptake across modalities will be described overall as the average proportion taking up injectable vs. oral pre-exposure prophylaxis per site, and compared across sites using proportion-tests.
Outcome 2 Title: Pre-exposure prophylaxis uptake by delivery channel Description: 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.) Timeframe: 12 months after enrollment Analysis: Monthly counts of pre-exposure prophylaxis uptake by delivery channel will be described and compared using Poisson regression adjusting for HIV testing service eligible-site volume and available supply; clustering within sites will be included.
Outcome 3 Title: Pre-exposure prophylaxis uptake by population Description: 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).
Timeframe: 12 months after enrollment Analysis: Monthly counts of pre-exposure prophylaxis uptake by population will be described and compared using Poisson regression adjusting for HIV testing service eligible-site volume and available supply; clustering within sites will be included.
Outcome 4 Title: Pre-exposure prophylaxis continuation by modality Description: Comparison of pre-exposure prophylaxis continuation by modality (injectable vs. oral) Timeframe: 12 months after enrollment Analysis: Proportion of clients persisting on pre-exposure prophylaxis across each time point will be described and compared by modality using log-binomial regression adjusting for number of pre-exposure prophylaxis clients at the site by modality; clustering within sites will be included.
Outcome 5 Title: Pre-exposure prophylaxis continuation by delivery channel Description: 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.) Timeframe: 12 months after enrollment Analysis: Proportion of clients persisting on pre-exposure prophylaxis across each time point will be described and compared by delivery channel using log-binomial regression adjusting for number of pre-exposure prophylaxis clients at the site by modality; clustering within sites will be included.
Outcome 6 Title: Pre-exposure prophylaxis continuation by population Description: 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).
Timeframe: 12 months after enrollment Analysis: Proportion of clients persisting on pre-exposure prophylaxis across each time point will be described and compared by population using log-binomial regression adjusting for number of pre-exposure prophylaxis clients at the site by modality; clustering within sites will be included.
Outcome 7 Title: Rates of switching between oral and injectable pre-exposure prophylaxis Description: Describe rates of switching between oral and injectable pre-exposure prophylaxis among pre-exposure prophylaxis users Timeframe: 18 months after enrollment Analysis: Describe overall switching proportion to oral and injectable pre-exposure prophylaxis at 18-months and compare proportions of those switching using proportions testing clustered on site
Secondary Outcomes Outcome 8 Title: Implementation readiness Description: Implementation readiness across sites and service delivery channels using Normalisation MeAsurement Development questionnaire (NoMAD) scores Timeframe: 6 months after enrollment Analysis: Describe mean implementation readiness scores across sites and compare across service delivery channels using analysis of variance (ANOVA) testing.
Outcome 9 Title: Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users Description: Incidence of pregnancy among long-acting injectable cabotegravir for pre-exposure prophylaxis users Timeframe: 18 months after enrollment Analysis: Describe pregnancies per 100-woman years of follow-up among cisgender women on long-acting injectable cabotegravir
Outcome 10 Title: Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users Description: Describe birth registry outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users Timeframe: 18 months after enrollment Analysis: Proportion of pregnancy abnormalities will be described overall amongst cisgender women with incident long-acting injectable cabotegravir pregnancies and compared to women with oral pre-exposure prophylaxis pregnancies using comparison of proportions.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charles Holmes, MD, MPH
- Phone Number: +1 (202) 662-9000
- Email: charles.holmes@georgetown.edu
Study Contact Backup
- Name: Deborah Hoege, MPH
- Phone Number: +1 (202) 662-9000
- Email: dh1107@georgetown.edu
Study Locations
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-
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Lilongwe, Malawi
- Recruiting
- Community Health Science Unit
-
Contact:
- W Ozituosauka
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:
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.
Exclusion Criteria:
- Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre-exposure prophylaxis uptake by modality
Time Frame: 12 months after enrollment
|
Comparison of pre-exposure prophylaxis uptake by modality (injectable vs. oral) between months 7-12
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12 months after enrollment
|
Pre-exposure prophylaxis uptake by delivery channel
Time Frame: 12 months after enrollment
|
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
Time Frame: 12 months after enrollment
|
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
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Pre-exposure prophylaxis continuation by modality
Time Frame: 12 months after enrollment
|
Comparison of pre-exposure prophylaxis continuation by modality (injectable vs. oral)
|
12 months after enrollment
|
Pre-exposure prophylaxis continuation by delivery channel
Time Frame: 12 months after enrollment
|
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
Time Frame: 12 months after enrollment
|
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
Time Frame: 18 months after enrollment
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Describe rates of switching between oral and injectable pre-exposure prophylaxis among pre-exposure prophylaxis users
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18 months after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation readiness
Time Frame: 6 months after enrollment
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Implementation readiness across sites and service delivery channels using Normalisation MeAsurement Development questionnaire (NoMAD) scores
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6 months after enrollment
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Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Time Frame: 18 months after enrollment
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Incidence of pregnancy among long-acting injectable cabotegravir for pre-exposure prophylaxis users
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18 months after enrollment
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Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Time Frame: 18 months after enrollment
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Describe birth registry outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users
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18 months after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Holmes, MD, MPH, Georgetown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 775736
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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