The direct implementation costs of HIV pre-exposure prophylaxis in Lesotho and Zimbabwe: a costing study of PrEP choice involving oral pills, the dapivirine ring, and long-acting injectable cabotegravir to inform policy setting

This study provides the first comparative analysis of direct implementation costs for oral pills, the dapivirine ring, and long-acting injectable cabotegravir PrEP in Lesotho and Zimbabwe, revealing that while injectable CAB PrEP is the most expensive option, these findings offer critical client-level data to guide HIV prevention budgeting and policy decisions amidst decreasing international funding.

The Gist

Imagine you are the manager of a busy community health center. Your job is to help people stay healthy and avoid getting HIV. For years, your main tool has been a daily pill (Oral PrEP). It works well, but some people find it hard to remember to take every single day, or they don't like the idea of taking a pill every day.

Recently, two new "tools" have arrived in your toolbox:

1. The Ring: A small device women insert once a month (like a tampon, but for HIV prevention).
2. The Shot: A long-acting injection given every two months (like a flu shot, but it lasts much longer).

Now, you have a choice: Do you offer just the pill? Or do you offer all three so people can pick what fits their life best?

The Problem:
While we know these new tools work medically, no one knew exactly how much they would cost the health center to actually give out. It's like buying a new car: you know the price of the car, but you don't know how much it costs to fill it with gas, change the oil, and pay the mechanic for every trip to the store.

This paper is a "receipt" from two countries, Lesotho and Zimbabwe, that tried offering all three options to see what the real-world costs were.

The "Price Tag" Breakdown

The researchers acted like accountants, timing every second of a patient's visit and adding up the cost of the staff's time, the paper forms, the gloves, and the medicine itself. Here is what they found, using simple analogies:

1. The Daily Pill (Oral PrEP)

• The Cost: This is the "budget-friendly" option.
• The Analogy: Think of this like buying a weekly grocery pass. It's cheap to start, and refilling it is easy.
• The Numbers: In Zimbabwe, starting someone on the pill cost about $13. In Lesotho, it was about $22. Refills were slightly more expensive because you are giving them a bigger supply (3 months worth).

2. The Monthly Ring (Dapivirine Ring)

• The Cost: This is the "mid-range" option.
• The Analogy: This is like a monthly gym membership. It costs more upfront than the grocery pass, but you don't have to go there every day.
• The Numbers: In Lesotho, starting someone on the ring cost about $34. However, in Zimbabwe, almost no one chose the ring during the study, so they couldn't get a good "starting price" for it there.

3. The Long-Acting Shot (CAB PrEP)

• The Cost: This is the "premium" option.
• The Analogy: This is like buying a luxury car. The car itself (the medicine) is expensive, and you have to visit the dealership (the clinic) more often to get the special fuel (the injection).
• The Numbers: This was the most expensive to provide. In Lesotho, the first visit cost $57, and a refill cost $54. In Zimbabwe, it was slightly cheaper but still the priciest at around $48 per visit.

Why Does the Shot Cost So Much More?

You might wonder, "If the shot is only given every two months, why is it so expensive?"

Think of it this way:

• The Pill: You give it to someone, and they leave. They come back in 3 months.
• The Shot: The staff has to do a lot of extra work. They have to mix the medicine, give the injection, and monitor the patient more closely. Plus, because the shot lasts longer, the patient has to come back more often (every 2 months) compared to the ring (every 3 months) or the pill (every 3 months). More visits = more staff time = higher cost.

The Big Picture: What This Means for the Future

The study found that while the new methods (Ring and Shot) are more expensive for the clinic to run, they offer something priceless: Choice.

Imagine a restaurant. If you only serve burgers, you might lose customers who are vegetarian. If you serve burgers, salads, and steaks, you keep everyone happy, even if the salad costs a bit more to prepare.

• The Challenge: The countries are running out of money from big international donors. They have to pay for this themselves now.
• The Lesson: If a country wants to offer the "premium shot" to everyone, they need a much bigger budget than if they just offer the "budget pill."
• The Reality Check: The study also noted that many people stop taking PrEP after a few months (just like people cancel gym memberships). So, the real cost per person might be lower than the "perfect world" math, but the health centers still need to be ready to pay for the expensive start-up costs.

The Bottom Line

This paper is a map for governments. It says: "If you want to offer the new, fancy HIV prevention shots and rings, you need to know they cost more to run than the old pills. But if you want to help more people stay healthy by giving them choices, you need to plan your budget accordingly."

It's not just about buying the medicine; it's about paying for the time, the staff, and the system to deliver it.

Technical Summary

1. Problem Statement

• Context: Sub-Saharan African nations like Lesotho and Zimbabwe have long utilized oral PrEP (Pre-Exposure Prophylaxis) for HIV prevention. However, adherence barriers have led to the introduction of novel methods: the dapivirine vaginal ring (monthly) and long-acting injectable cabotegravir (CAB PrEP) (bi-monthly).
• The Gap: While regulatory approvals for these new methods have been granted recently (Zimbabwe in 2021/2022; Lesotho in 2023/2024), there is a lack of empirical data regarding the direct service delivery costs of implementing a "PrEP choice" model where clients can select between multiple methods.
• Urgency: With a shift in global health funding (from donors like PEPFAR and the Global Fund to domestic governments), accurate cost data is critical for national budgeting and policy planning. Previous studies often lacked the granularity to compare costs across different modalities in routine or near-routine settings.

2. Methodology

• Study Design: A cross-sectional costing study conducted within the CATALYST study framework (funded by PEPFAR/USAID).
• Setting: Public health facilities in Lesotho (3 facilities) and Zimbabwe (6 facilities).
• Data Collection Period: September 9 – November 8, 2024.
• Perspective: Healthcare provider perspective, focusing strictly on direct service delivery costs (personnel time, equipment, consumables, commodities).
• Sampling:
  • Time-Motion Study: Data collectors observed 166 clients in Lesotho and 188 clients in Zimbabwe.
  • Method: Direct observation of client visits (excluding confidential counseling) combined with provider self-reporting for non-observable steps.
  • Scope: Data covered initiation and refill visits for Oral PrEP, Dapivirine Ring, and CAB PrEP.
• Analytical Approach:
  • Cost Calculation: Personnel costs were derived from annual salaries converted to per-minute rates. Equipment and consumables were allocated based on time spent and normative standards.
  • Annualization: Costs were extrapolated to an annual basis based on national guidelines:
    • Oral PrEP/Ring: 1 initiation + 4 refills (3-month supply).
    • CAB PrEP: 1 initiation + 6 refills (2-month interval).
  • Currency: All figures presented in 2024 USD.
• Limitations Addressed: The study excluded observations with missing data or unclear visit types (7 in Lesotho, 16 in Zimbabwe). It noted that initiation visits for the dapivirine ring were not observed in Zimbabwe due to low uptake during the data collection window.

3. Key Results

The study provided the first comparative direct cost data for three PrEP modalities in these settings.

A. Per-Visit Direct Costs (2024 USD)

Country	Method	Initiation Visit	Refill Visit
Lesotho	Oral PrEP	$22.47 |$31.98
	Dapivirine Ring	$34.27 |$50.70
	CAB PrEP	$57.22 |$54.20
Zimbabwe	Oral PrEP	$13.47 |$21.78
	Dapivirine Ring	Not Observed	$42.56
	CAB PrEP	$48.26 |$47.40

• Cost Drivers:
  • In Zimbabwe, PrEP products accounted for 35–85% of total direct costs.
  • In Lesotho, PrEP products were the primary driver for CAB PrEP and refill visits, but "other consumables" (HIV tests, gloves, forms) drove costs for initiation visits of Oral PrEP and the Ring.
  • Generally, initiation visits were more expensive than refills, except for Oral PrEP in Lesotho where they were nearly identical.

B. Estimated Annual Direct Costs

Assuming full adherence to guidelines (continuous use):

• Lesotho:
  • Oral PrEP: $150.39 (Range: $117.87 –$226.15)
  • Dapivirine Ring: $237.07 (Range: $220.59 –$251.86)
  • CAB PrEP: $382.41 (Range: $326.21 –$498.50)
• Zimbabwe:
  • Oral PrEP: $100.59 (Range: $84.71 –$120.70)
  • CAB PrEP: $332.66 (Range: $110.80 –$607.50)
  • Note: Annual Ring costs could not be calculated in Zimbabwe due to lack of initiation data.

C. Impact of Real-World Adherence

The study highlighted a critical discrepancy between "normative" annual costs (assuming perfect adherence) and real-world costs. When applying observed discontinuation rates:

• The estimated annual cost per person initiated dropped significantly to $43 in Lesotho and $29 in Zimbabwe for Oral PrEP.
• This suggests that while the potential cost of a full year of PrEP is high, the actual resource utilization per enrolled client is much lower due to early discontinuation.

4. Key Contributions

1. First Comparative Costing: This is the first study to compare the direct implementation costs of oral PrEP, the dapivirine ring, and CAB PrEP within the same facilities where clients had a choice of method.
2. Granular Cost Breakdown: It distinguishes between initiation and refill visits, revealing that initiation costs are often driven by consumables (testing/screening) while refill costs are driven by product costs and visit frequency.
3. Policy-Relevant Data: Provides specific cost inputs for Lesotho and Zimbabwe to help ministries of health budget for the transition from donor-funded pilot programs to domestic routine implementation.
4. Adherence Adjustment: Demonstrates the importance of factoring in discontinuation rates when budgeting, showing that "per-user" costs are significantly lower than "per-visit" normative estimates.

5. Significance and Implications

• Budget Planning: As donor funding recedes, governments must understand that CAB PrEP is the most expensive modality annually (approx. 2.5x Oral PrEP in Lesotho) primarily due to the higher frequency of required visits (6 refills/year vs. 4 for oral/ring) and product costs.
• Strategic Allocation: The data suggests that while CAB PrEP is clinically superior for certain populations, its high service delivery costs require careful targeting. Oral PrEP remains the most cost-effective option for broad population coverage.
• Future Research Needs: The authors recommend that future studies must account for non-client-facing provider time (e.g., charting, lab review), which was not captured here and likely leads to an underestimation of personnel costs. Additionally, future models must integrate real-world continuation rates to avoid overestimating annual budget requirements.

Conclusion: The study confirms that while novel PrEP methods offer vital choice and potentially higher efficacy, they come with significantly higher direct service delivery costs. Policymakers in Lesotho and Zimbabwe must balance the clinical benefits of CAB PrEP and the Ring against their higher operational costs, particularly as they transition to domestic financing.