Accelerating the Path To Scale for Injectable PrEP in Malawi: An Implementation Evaluation

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.