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.
