An observational study in Oral Pre-exposure Prophylaxis (PrEP) and Long-acting Injectable Cabotegravir for PrEP, sponsored by Georgetown University. Recruiting at 1 site in Malawi. Open to participants aged 15 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Georgetown University · Observational
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.
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.
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.
Georgetown University is the lead sponsor of 292 studies on the registry; 40 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals who are 15+ years old AND either
Exclusion Criteria:
Those living with -1 or evidence of possible acute HIV infection OR Those with a prior 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Pre-exposure prophylaxis uptake by modality
Comparison of pre-exposure prophylaxis uptake by modality (injectable vs. oral) between months 7-12
Time frame: 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.)
Time frame: 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).
Time frame: 12 months after enrollment
Pre-exposure prophylaxis continuation by modality
Comparison of pre-exposure prophylaxis continuation by modality (injectable vs. oral)
Time frame: 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.)
Time frame: 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).
Time frame: 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
Time frame: 18 months after enrollment
Implementation readiness
Implementation readiness across sites and service delivery channels using Normalisation MeAsurement Development questionnaire (NoMAD) scores
Time frame: 6 months after enrollment
Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Incidence of pregnancy among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Time frame: 18 months after enrollment
Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Describe birth registry outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users
Time frame: 18 months after enrollment
Plan to share: No — There is not a plan to make IPD available. We are working with vulnerable populations and can make aggregate data available by request. Approval from principal investigators will be necessary to release de-identified data.
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