Table 1 Scale-up and delivery strategies for long-acting cabotegravir for PrEP using an adaptation of the Intervention Sscalability Assessment Tool (ISAT)
Adapted ISAT Category | Operationalized Definition | Codes | Major Themes | Supporting Quote |
|---|---|---|---|---|
Part A: Rationale and setting for CAB scale-up | ||||
The problem | Describes the problem and gap in HIV prevention, who it impacts, and how the shortcomings are currently being addressed | ■ HIV acquisition and transmission ■ Oral PrEP gap | ■ Daily oral PrEP does not adequately address HIV prevention needs of all people and context | “We saw that in a number of people [who] were initiating oral PrEP, however, the follow-up was kind of winding down, and this was mostly because of stigma or mostly because of pill burden or people not wanting to have daily pills. So, introduction of an injectable long-acting would kind of be a solace to such populations that are [at] substantial risk and would want to prevent HIV.” -Participant #17 |
The intervention | Describes how CAB can address the problem | ■ Benefits ■ Challenges | ■ Intramuscular injection given once every two months with some concerns for drug resistance and need to attend in-person appointments ■ Good safety profile and efficacy | “I’m wondering if the initial potential attractiveness of injectable PrEP will diminish when people realize that it’s not just a shot in the arm every two months.” -Participant #20 |
Strategic/political context | Strategic, political, or environmental contextual factors that are potentially important influences on scale-up of CAB | ■ Community and cultural ■ Political | ■ Guideline development across world is ongoing and US FDA approval will encourage this further, but cost-effectiveness and demonstration studies will be crucial for product positioning and prioritization | “I think it’s farther along than any other product has been at the moment of launch […] and implementing partners are ready to deliver this product, all based on how much does the product cost and can they get access to it. So, once those two questions get answered, then we’ll be able to say whether we’re ready.” -Participant #19 |
Evidence of effectiveness | The level of evidence available to support the scale-up of CAB, such as scientific literature and/or other known evaluations | ■ Available data ■ Missing data | ■ Highly efficacious compared to daily oral PrEP in clinical trials, less concerns for adherence ■ More data are needed on use during pregnancy/breastfeeding, and among transgender women, transgender men, and non-binary persons | “For Cabotegravir I think we need those data [during pregnancy and breastfeeding] really, really quick and really fast before it even gets to the market so when it rolls out, it rolls out that it’s safe for everybody rather than holding some populations back and saying, ‘You know, let’s first figure this out.’” -Participant #10 |
Intervention cost and benefits | Consideration of the known costs of CAB implementation | ■ Direct cost ■ Indirect cost | ■ Direct cost is a primary concern and will be a significant barrier to product rollout ■ Indirect costs include provider training and supply chain management | “Even if they make it accessible through purchase through PEPFAR or Global Fund for low- and middle- income countries, they’re still price gouging wealthier countries. In the U.S., $22 thousand dollars a year with no generic PrEP. Who’s gonna even – why would anyone use that? So, I don’t see it as an elephant in the room. I see it as the major barrier to universal rollout of Cabotegravir.” -Participant #29 |
Part B: Strategies for CAB scale-up | ||||
Fidelity and adaptation | Proposed changes to CAB implementation required or helpful for scale-up | ■ Consistent ■ Inconsistent | ■ Consideration of the CAB tail and how discontinuation/late doses will render users vulnerable to drug resistant HIV ■ HIV RNA testing is not feasible in many settings | “CDC guidance has come out that requires viral load or NAT testing before initiation and at every two month intervals. That’s obviously going to be very complicated –if not impossible – to implement in resource limited settings.” -Participant #11 |
Reach and acceptability | The likely reach and acceptability of CAB for the target population | ■ Provider counseling and messaging ■ Community counseling and messaging ■ Stigma | ■ Implement with population-level approach centered around product choice, led by potential end-users ■ Discrete and less product-related stigma | “And if we work with the local communities, they’ll tell us what is the best way to disseminate information and how is it going to be acceptable. It has to be socially and culturally acceptable wording and delivery” -Participant #27 |
Delivery setting, workforce, and implementation infrastructure | The setting within which CAB is delivered, and details implementation infrastructure required for scale-up | ■ Integration into health behaviors ■ Integration into medical care ■ Social support ■ Health system ■ Subsidizing or incentivizing | ■ Train healthcare workers and peers from community-based programs with the goal of normalizing PrEP use ■ De-medicalization and integration into sexual and reproductive health services will increase access but likely needs a medical setting to start | “With CAB, at least at the beginning, I don’t think we’re gonna see that differentiation in terms of the delivery of the product […] I think there is huge opportunity to differentiate the elements of the program, even if the product is all given from a particular place.” -Participant #19 |
Sustainability | Longer-term outcomes of the scale-up and how, once scaled up, CAB could be made sustainable over the medium to longer term | ■ Sustainability | ■ Ensure adequate supply chain ■ Development of newer PrEP formulations should not overshadow delivery of existing programs and products (i.e., oral PrEP) | “And then when we think about not only that cost, we think about also sustainability. That’s my biggest, biggest concern is that if we started to have long acting Cabotegravir, will we have an issue with oral PrEP being available? When you introduce many, many options, we’ve had very good experiences with ART, but you have to be careful to ensure that all of those options are available” -Participant #9 |