Article Text

Lessons learnt from daily oral PrEP delivery to inform national planning for PrEP ring introduction for women in low-income and middle-income countries: a qualitative inquiry of international stakeholders
  1. Craig J Heck1,2,
  2. Anita Dam3,
  3. Kibret Yohannes4,
  4. Justine Deacon5,
  5. Katharine Kripke6,
  6. Kathrine Meyers2,
  7. Ohemaa Poku7,
  8. Christopher Obermeyer8,
  9. Sarah Wiant2,
  10. Daniela Quigee2,
  11. Martha Larson9,
  12. Christine Malati3,
  13. Magdalena E Sobieszczyk2,
  14. Sergio Torres-Rueda10,
  15. Delivette Castor1,2
  1. 1Columbia University Mailman School of Public Health, New York, New York, USA
  2. 2Columbia University Irving Medical Center, New York, New York, USA
  3. 3United States Agency for International Development, Washington, District of Columbia, USA
  4. 4University of Virginia School of Medicine, Charlottesville, Virginia, USA
  5. 5CDC Foundation Inc, Atlanta, Georgia, USA
  6. 6Avenir Health, Takoma Park, Maryland, USA
  7. 7New York State Psychiatric Institute, New York, New York, USA
  8. 8The Global Fund to Fight AIDS Tuberculosis and Malaria, Grand-Saconnex, Switzerland
  9. 9FHI 360, Durham, North Carolina, USA
  10. 10London School of Hygiene & Tropical Medicine, London, UK
  1. Correspondence to Mr Craig J Heck; cjh2204{at}cumc.columbia.edu

Abstract

Introduction Some African countries plan to introduce and scale-up new long-acting pre-exposure prophylaxis methods (LA-PrEP), like the monthly dapivirine vaginal ring (PrEP ring) and injectable cabotegravir. National costed implementation plans, roadmaps for successful product implementation, are often overlooked. International stakeholders engaged in oral PrEP planning, introduction and scale-up are an information resource of lessons learned to advise LA-PrEP planning. We consulted such international stakeholders and synthesised oral PrEP lessons to inform the development of a costed rollout plan template for LA-PrEP.

Methods From selected global health organisations (five international nongovernmental, four donor, four university/research and two multilateral), we interviewed 27 representatives based in America, Europe, Asia and Africa about strategic content and approaches for LA-PrEP policy, programming and implementation. We conducted a thematic analysis of the interview data for implementation considerations.

Results From the consultations, we identified six implementation themes for LA-PrEP introduction and scale-up: (1) ethically increasing choice and avoiding coercion; (2) de-stigmatising PrEP by focusing on preference rather than risk-based eligibility; (3) integrating LA-PrEP into services that are more woman-oriented, couple-oriented and family-oriented, and providing private spaces for LA-PrEP delivery; (4) de-medicalising delivery of relatively safe products (eg, PrEP ring); (5) constructing multilevel, nuanced communication strategies to address measured and perceived product efficacy and effectiveness; and (6) devising product-agnostic, modular approaches to service delivery. Despite the widespread emphasis on integration, few stakeholders offered empirical examples of successful integration approaches and frameworks.

Conclusions Lessons learnt from stakeholder participants suggest standardised and modular processes can improve efficiencies in LA-PrEP planning and implementation. Tiered communication strategies addressing product efficacy and effectiveness will improve clients’ and providers’ efficacy in making informed decisions. Integration is important for LA-PrEP delivery, but data on empirical integration approaches and frameworks is minimal: further research in this discipline is needed.

  • HIV
  • Prevention strategies
  • Health services research
  • Public Health
  • Health policy

Data availability statement

We can provide aggregate summaries of the data upon reasonable request. Please contact cjh2204@cumc.columbia.edu or dc2022@cumc.columbia.edu for any inquiries.

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WHAT IS ALREADY KNOWN ON THIS TOPIC

  • Long-acting pre-exposure prophylaxis (LA-PrEP) methods, including the monthly vaginal ring and bimonthly injectables, are undergoing global and national regulatory review and approval in low-income and middle-income countries; systematic plans for their introduction and scale-up are needed to redress product-specific considerations and challenges encountered in oral PrEP implementation.

WHAT THIS STUDY ADDS

  • In the absence of other empirical data, international stakeholders involved in oral PrEP planning and implementation provide key information that we summarised into six themes to inform LA-PrEP implementation plans.

  • Stakeholders believed LA-PrEP availability could increase women’s choice and effective use and reduce stigma of HIV prevention by offering based on values and preference rather than risk.

  • Providers and end users could benefit from tiered communication strategies with clear messaging about each method’s efficacy and effectiveness.

  • Plans would benefit from a product-agnostic, modular approach to integrating current and future LA-PrEP into HIV and non-HIV services (eg, family planning, sexual and reproductive health) and de-medicalised PrEP service delivery.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

  • LA-PrEP introduction planning is underway in several settings; these actionable findings can inform systematic planning and execution of LA-PrEP implementation.

Introduction

Countries are striving towards the Joint United Nations Programme on HIV/AIDS 2030 goals to end the HIV/AIDS pandemic.1 2 Global HIV prevention fell far behind achievements in access to treatment.3 Cisgender women and girls (WAGs, aged 15–49 years) and adolescent girls and young women (AGYW, aged 15–24 years) bear a disproportionate HIV burden, as their global share of annual seroconversions (42% and 18%, respectively) are approximately 2.5-times their population distributions. Notably, most of this transmission occurs in sub-Saharan Africa (SSA).4 5 Global HIV prevention goals will remain unattainable until WAGs’ HIV risk is reduced.6 7

The WHO’s recommendation of daily oral pre-exposure prophylaxis (PrEP) as part of combination HIV prevention for all populations in 2015 represented the first non-barrier HIV prevention method available to WAGs. Oral PrEP rollout strategies have had variable success. Exclusive delivery through HIV treatment clinics engendered stigma, limiting reach and uptake.8 9 Community-based delivery (eg, mobile clinics, pharmacies, safe spaces) aims to reduce facility-related access barriers.10–12 Other system-level, provider-level and user-level barriers have also impeded oral PrEP initiation, adherence and continuation among WAGs.13–20

In 2021 and 2022, respectively, WHO conditionally recommended the monthly dapivirine vaginal ring (PrEP ring) and long-acting injectable cabotegravir (CAB-PrEP), marking the first time WAGs could choose among PrEP regimens.21–23 As of February 2024, 11 low-income and middle-income countries, predominantly in SSA, have approved the PrEP ring and 11 have approved CAB-PrEP.24–27 The PrEP ring confers month-long protection by locally releasing dapivirine from a silicone ring inserted in the vagina; CAB-PrEP provides bimonthly systemic protection on administering cabotegravir.28–31 Long-acting PrEP (LA-PrEP) methods challenge health systems with specific infrastructural requirements, messaging, counselling practices and service delivery approaches.32 33 Robust planning activities is necessary to ensure that LA-PrEP population impact is moderated by addressing persisting and emerging implementation challenges with oral and LA-PrEP.3 9 34–36

Prior reports of lessons learnt from oral PrEP implementation included reviews, commentaries and/or viewpoints.9 32 33 37–40 We report on interviews with diverse international stakeholders from various sectors associated with oral PrEP policy, programming and research to synthesise their collective experiences into actionable considerations for planning national LA-PrEP implementation.

Methods

Reflexivity

We acknowledge our positionality relative to the scientific process. Online supplemental material 1 summarises the research teams’ demographic characteristics, credentials and professional relationships, highlighting how these factors may have affected our sampling frame, research approach, stakeholder interactions, analysis and interpretation of findings.

Supplemental material

Study context

The data were initially collected within the Preparing for Ring Opportunities through Market Introduction Support and Knowledge Exchange collaboration, an activity funded by The US President’s Emergency Plan for AIDS Relief (PEPFAR)/United States Agency for International Development (USAID) that aimed to facilitate PrEP ring roll out in SSA.41 Within this consortium, Columbia University was funded to develop a costed rollout plan template (CRPT) to support national operational plans for PrEP ring introduction and scale-up. To do so, we planned consultations across sectors and organisations described in the Participants section.

Stakeholder outreach occurred from 27 January to 22 April 2021. We started with international stakeholders, assuming they would provide cross-cutting views on implementation barriers, facilitators and cost considerations. We intended to interview national and local stakeholders; however, our ability to do so was limited by funding changes.

Participants

We purposively sampled representatives of public, governmental and private donor organisations, multilateral organisations, research and academic institutions, and international non-governmental organisations (INGOs). We identified representatives by reviewing publicly available participant lists from international and USAID-supported PrEP ring meetings, yielding 138 index stakeholders from 47 organisations. Along with participant lists, we identified informants through collaborator and stakeholder referrals. Participants were recruited via email. Eligibility criteria included experience developing PrEP policy or implementing and/or supporting national or global PrEP programmes. Stakeholders from the same organisation were interviewed in sessions ranging from 1 to 5 participants.

Methodological orientation

We framed our study using interpretive phenomenology because it implicitly orients researchers’ perspectives within the scientific method of collecting and analysing data.42 This orientation enabled maximisation of the rich, varied professional experience of the research team, especially regarding HIV prevention interventions and programming.

Data collection

At minimum, three researchers attended each interview to facilitate, take notes or manage audiovisuals. Interviews were approximately 60 min and conducted via Zoom. Stakeholders were interviewed once. Two interviews were not recorded due to technical errors. External professionals transcribed the audio files. The data collection team edited the transcripts for unintelligible or misunderstood transcriptions. Participants were not provided the transcripts.

The interview guide (online supplemental material 2) included open-ended questions covering product introduction, scale-up approaches and systematic planning recommendations, with a particular framing of how oral PrEP lessons could inform PrEP ring implementation plans.

Supplemental material

We adapted questions to better align with stakeholders’ role, organisation and/or sector. Also, when several participants offered similar responses, we interpreted this recurrence as saturation and adapted the question to probe deeper into the topical area. Throughout data collection, we conducted a rapid synthesis of interviews and adapted the guide using the Delphi method, an iterative approach of analysing and revising structured interview questions to deal with complex communication on multifaceted problems from diverse sources typically used for consensus building.43 Discourse on the PrEP ring has been contentious; the Delphi approach capitalises on the insights, knowledge, and authority of international stakeholders while avoiding the dominance of individual responses.

Analysis

Deductive framing

Shortly following the interviews, the lead interviewer (DC) rapidly identified themes based on interview facilitation, personal reflection, postinterview debriefs, transcript review and examination of the team’s notes. The preliminary themes were categorised into two main categories: (1) strategic approaches and (2) costing and financing. The lead interviewer and other data collection leads (CJH, JD) iteratively reviewed the initially identified themes, yielding minimal changes.

Coding and analytic approach

Data were attributed to stakeholders by their initials, organisation, interview date and number, and organisational sector. Two analysts (CJH, KY) independently identified and sorted quotes from the professional transcripts into the deductive themes. Stakeholders often responded with examples about CAB-PrEP to contrast the PrEP ring; however, CAB-PrEP was not consistently discussed in all themes to distinguish both products in the results. After, the team (DC, CJH, KY, OP) examined response patterns to decide which themes should be condensed, separated or dropped. We dropped the theme ‘COVID-19 mitigation plans’ due to lack of data.

All data management, coding and analysis were performed using word processor software.

Patient and public involvement

Patients and the public were not involved in the design or conduct of this study.

Results

Of the initial 34 stakeholders, 27 consented to the use of their data for research, representing five INGOs (n=10 participants), four university/research partners (n=4), four donors (n=11) and two multilateral (n=2) organisations. Of the 10 INGO participants, 8 were implementers. Stakeholders were based in the USA, western Europe, southeast Asia, and eastern and southern Africa. Sixteen participants reviewed study results: one requested minor changes to ensure anonymisation.

All non-consenting stakeholders (N=7) were due to non-response; 86% (6/7) were from organisations represented in our sample, and their redacted data did not meaningfully change the content. One non-consenting stakeholder was from a unique academic institution, and their input overlapped extensively with responses from other stakeholders.

Here, we report insights on implementation only. Although presented discretely, the six thematic areas intersect.

Theme 1: improving choice in prevention

Stakeholders unanimously agreed that adding long-acting, woman-initiated options could improve HIV prevention coverage and effective use (ie, PrEP use aligned with HIV exposure risk) by offering WAGs alternative options if they decline daily oral PrEP. One implementer noted, ‘We know from contraception that having a bunch of options increases uptake’. A researcher theorised, ‘Perhaps more people will use PrEP because you’ve got a menu’. This ‘menu’ can increase a woman’s autonomy to use HIV prevention methods in unsafe environments: ‘[Y]ou want [a] toolbox because for a woman [experiencing violence], CAB-[PrEP] might be worth it … she gets that shot, and he doesn’t know. She can be completely discreet’ (INGO). Effective use of oral PrEP was observed ‘[When] immigrant miners come home for holidays, women [use] oral PrEP for just one or two weeks. After that they are no longer at risk, so they might not prefer [LA-PrEP]’ (INGO).

Stakeholders underscored that increasing HIV prevention choices must be free of provider bias, coercion or logistical limitations: ‘[I]n a lot of cases, [contraceptive] menus are pretty small based on procurement and pricing and not so much demand’ (Donor). Choice is evident only when women can make informed, coercion-free decisions regarding the full breadth of available PrEP options.

Theme 2: stigma reduction

Stakeholders discussed how initial oral PrEP delivery and communication approaches unintentionally stigmatised PrEP users. Using HIV treatment clinics and ARV supply chains for early oral PrEP delivery was logistically helpful but resulted in unintended stigma. Community members viewed anyone entering ARV clinics as someone living with HIV, discouraging service access: ‘[W]e stigmatised [oral PrEP] at the outset [by not disassociating it from] ARVs’ (Multilateral). Delivery channels for new prevention products should be expanded at the beginning, and programmes should avoid exclusively offering LA-PrEP in HIV treatment clinics.

Delivering PrEP at treatment sites also led to the conflation of oral PrEP and treatment. One researcher noted that users still ‘don’t want to take a box [saying] PrEP or ARVs because then [people assume] they are HIV positive’. A multilateral stakeholder suggested ‘creating the basic knowledge, getting people comfortable with just the concept of [PrEP]’ might disrupt this cycle of stigma because conceptual knowledge of PrEP is still limited.

Unintended stigma also resulted from prioritising higher-incidence populations through risk-based assessments and communication strategies to reach this group. The targeting ‘ended up slightly stigmatising the product [because] we confuse[d] epidemiology and public health with how to successfully communicate with the public and run a program’ (INGO). The risk-based strategy also failed to generate interest among the general population because the drug appeared to be exclusively for high-incidence populations. The programmes ‘[didn’t] reach lots of people, [yielding minimal] population-level impact’ (INGO). Further, community disapproval can negatively affect PrEP use: ‘[W]e got over 900 girls [on] PrEP in two months. Then, we started getting community backlash and realised [girls] may have agency but still want [their] community to support [their] choice’ (INGO). The implementer recommended ‘creat[ing] an environment where we address misconceptions [and] support girls to have the agency to make choices’.

Overall, stakeholders were optimistic about the PrEP ring’s neutrality: ‘I think we have a good shot at making the ring the cool new thing [that] doesn’t have the stigma attached to oral PrEP’ (University/Researcher). An implementer believed the PrEP ring fills the need for ‘prevention options that aren’t so loaded, so that we don’t worry someone might be using it who’s not [high-risk]’. Doing so will ‘build social acceptability and desirability and lend a lot of credibility to the brand’.

Theme 3: integration into existing services

Subtheme 3A: integration into HIV services

We asked how new PrEP products could complement existing HIV prevention and PrEP services. Stakeholders emphasised moving away from risk-based eligibility to options best fitting lifestyle needs. ‘We [positioned] PrEP within a broader integrated HIV prevention approach that focused on people taking control of their chosen prevention methods … PrEP being one of them’ (INGO). One researcher suggested that a country explored hierarchical integration approaches, but details substantiating this approach could not be found.

Another researcher said that currently, HIV clinics ‘are for HIV-positive people’, recommending that they become ‘more family-oriented, couples-oriented [to enable] a razor focus on seronegative members of discordant pairs’, and integrating women’s and children’s HIV services. They noted, ‘it’s sadistic to have a woman come for HIV care and then go to another clinic for her child’s HIV care’.

One donor, and other less optimistic stakeholders, said the PrEP ring required a different level of capacitation, although it would conceivably be easier to self-administer. Other stakeholders wondered if HIV clinics had the infrastructure, such as adequate private space, to facilitate PrEP ring insertion. The same donor postulated HIV providers would be comfortable with CAB-PrEP because many already know how to administer injections. Others discussed HIV providers’ capacity to deliver LA-PrEP.

Subtheme 3B: integration into non-HIV services

Figure 1 presents stakeholder insights on potential best practices for integrating LA-PrEP into non-HIV services. PrEP integration into family planning (FP) was most often mentioned. A stakeholder said that in many contexts, young women are more concerned about preventing pregnancy than HIV acquisition and are more likely to access FP than HIV prevention services (figure 1, Multilateral). Furthermore, FP providers deliver products with similar administration routes, reducing training needs and streamlining introduction (figure 1, Donor). Co-delivery of injectable contraception and PrEP was a popular prospect among stakeholders, with many highlighting the threat of discontinuation because of asynchronous regimens (3 months for injectable contraception, 2 months for CAB-PrEP). Other frequently suggested integration points were sexual and reproductive health (SRH), primary healthcare (PHC), antenatal care (ANC), sexually transmitted infection (STI) services and one-stop shops (figure 1, Implementer and University/Researcher).

Figure 1

Integration into non-HIV services.

Stakeholders discussed the need for patient-centred integration rather than co-localised services. ‘Sometimes [AGYW] access [PrEP and contraception] at clinics/adolescent-friendly-specific clinics, safe spaces’ (Donor). A donor highlighted the added nuance of ring delivery, ‘It’s not as easy as [writing] a prescription, like oral PrEP. [AGYW] will have to understand how to insert it and they’ll have to have privacy’. One INGO respondent pondered country-specific requirements for ARV-based delivery that could preclude service integration, such as South Africa’s nurse-initiated management of antiretroviral therapy, ‘Would [PrEP rings] sit within HIV clinics due to the regulatory requirements of a given country?’.

Few stakeholders described frameworks for integration: ‘[W]e’ve been talking about integrating [FP] and HIV for a [quarter-century], and it hasn’t happened, so I don’t know whether the addition of [PrEP] products in [FP] services will make a difference in terms of promotion by [FP] people’ (Donor). Stakeholders perceived HIV services as having greater political interest, creating an ‘orphan’ effect for the other services. Convening leadership meetings across service sectors can also be organisationally and bureaucratically challenging. Finally, with many FP, SRH and ANC services currently operating at or beyond capacity, adding HIV prevention services could negatively affect staff and clients.

Theme 4: de-medicalisation

Stakeholders suggested applying oral PrEP de-medicalisation efforts to the PrEP ring early in the introduction phase given the PrEP ring’s safety profile—non-systemic drug release, lack of required laboratory assessments, and low likelihood of resistance. Proposed de-medicalised channels were pharmacy-based and community-based distribution through drop-in centres or peer groups. De-medicalised service points could reach the most marginalised, disenfranchised populations and potentially reduce PrEP-related stigma.

Figure 2 shows potential de-medicalisation strategies for PrEP ring mentioned by stakeholders; PrEP ring could be incorporated into WHO’s self-care guidelines (Donor) or accessible via vending machines or in-home insertion (Implementer). One researcher cautioned that de-medicalisation of PrEP methods, especially the PrEP ring, must not decouple from other PrEP choices (eg, oral PrEP) to maintain the moral and ethical obligation of providing holistic, comprehensive care (University/Researcher).

In addition to increasing end-users’ access to PrEP, stakeholders noted de-medicalisation would reduce the burden on the health system. ‘[Providers] can talk about different available options, but the policies would be simplified so that providers wouldn’t spend lots of time seeing clients … monitoring them can be done in the community’ (INGO). De-medicalised delivery could also minimise the effect of provider bias, which can ‘gatekeep’ PrEP.

One implementer reflected that ‘[policymakers and providers] are hesitant to push services out to communities and pharmacies. [W]e will have to address this [when] de-medicalising and differentiating [PrEP] delivery’. They clarified this hesitation was because ‘lot[s] of data run through health facilities to health information systems, so monitoring is why things are continuously linked to facilities’.

Theme 5: measurement and perception of efficacy and effectiveness

Respondents compared the efficacy and effectiveness of oral PrEP to LA-PrEP methods, inferring the potential for real-world incidence reduction and prioritised implementation. Many stakeholders based real-world effectiveness and delivery on clinical trial efficacy and implementation, an issue compounded by their consistent knowledge of oral PrEP and CAB-PrEP trials yet varying understanding of PrEP ring trial findings. These perceptions shaped stakeholders’ views on each method’s positioning and availability in the market and whether a hierarchy of products should be offered to clients.

Varying impressions of LA-PrEP methods led stakeholders to evaluate each method differently. Some stakeholders cautioned against delaying PrEP ring introduction amid the inevitability of CAB-PrEP (figure 3, Multilateral), while other stakeholders regarded the PrEP ring as a bridge/‘stop gap’ until CAB-PrEP or concurrent PrEP regimens are available. Optimistically, one donor viewed the current PrEP ring as a stepping stone to more effective rings (figure 3, Donor). One implementer reflected on the complexity of managing scientific and policy decisions about end-user choice amid varying efficacy and utility; they also compared CAB-PrEP and the PrEP ring in the context of efficacy, sexual behaviour patterns and user control (figure 3, Implementer).

Figure 3

Measurement and perception of efficacy and effectiveness.

Stakeholders held conflicting views on how to consider effectiveness during counselling. One donor representative was hesitant about effectiveness-based prioritisation: ‘[I] can imagine scenarios where providers [believe] oral PrEP is more effective, so [they’ll] counsel towards that as opposed to something not as effective’ (Donor). Alternatively, another donor respondent encouraged it: ‘[I]f someone was equally enthusiastic about oral PrEP and the ring … happy to try to use either one correctly, we would encourage oral PrEP’. An implementer reflected on the danger of avertable seroconversions occurring with use of less effective products and advocated that each method’s protectiveness be communicated simply, clearly, accurately and directly so women and providers can make informed decisions. ‘[W]e have concerns about a product with lower efficacy, effectiveness, being offered without appropriate context and communication around pros and cons, and that is sort of diluting the impact of HIV prevention interventions. Real choice for women needs to be among highly effective products’. One researcher further problematised these contentions by cautiously stating the PrEP ring might be slightly more effective than oral PrEP based on preliminary analyses (figure 3, University/Researcher).

Stakeholders underscored that further study of end-users’ wants, needs, preferences and enabling environments would help improve the effectiveness of all PrEP methods. They requested additional information on comparisons between PrEP methods, effectiveness when pairing PrEP methods with non-biomedical prevention, and how to accurately define effective use and discontinuation amid concurrent and/or crossover use of PrEP products.

Theme 6: product-agnostic approach to future HIV prevention efforts

Stakeholders said that given the considerable time and effort needed to incorporate oral PrEP into national and programmatic planning, implementation and systems, HIV prevention efforts should account for current and future methods, including multipurpose technologies. Wherever possible, frameworks, training, monitoring and evaluation systems, and national guidelines should be product-agnostic and modular, meaning implementation, counselling, and communication strategies are interchangeable across methods, while method-specific considerations are independent and compartmentalised. This approach would streamline product introduction processes by requiring fewer adaptations, structural changes, and health system augmentations.

One donor representative elaborated on modular guidance, highlighting similarities and dissimilarities between LA-PrEP methods. ‘[G]uidance around the ring and [CAB-PrEP], it’s written broadly because they have a lot of shared aspects—HIV prevention for one, but the delivery frameworks are likely to be different’. Similarly, an implementer said modular PrEP frameworks will facilitate planning activities that are sensitive to considerations and contexts within specific operating environments:

[Provide a] more generic framework, which then goes to say what are the core issues from a regulatory authority, vigilance, training of healthcare workers, the M&E system, the service delivery … [what do] you need in place if you’re going to have this framework that can allow for broader integration? It’s general but can be customizable and sensitive to the nuances within a particular country.

An INGO representative said building modularity into combination HIV prevention frameworks should expedite product introduction and avoid service and/or programming changes. The INGO representative stated that ‘the combination HIV prevention frame of mind … is important because it allows for addition of or adjustment to current options without reframing the way a programme is approached’.

A researcher stressed that future PrEP methods should be emphasised in formative procedures. ‘I think it’s very much about how we set up the whole training, supply chain, guideline development … While we’re doing this, we can … be quite clear with the [trainers] that we are doing this for a range of prevention options’. Because it is the newest method to debut in some settings, stakeholders noted PrEP ring planning and trainings should ‘prime’ people’s understanding of other PrEP methods:

[A]s we’re planning for the ring, talking to populations and providers, this is an opportunity to introduce other products in the pipeline[.] (Multilateral)

[A]s you’re training about the ring, start preparing providers for the idea that other ARV-based prevention modalities are coming and will be given in different ways and with different efficacies … all in a package and depending on patient’s needs. (Donor)

However, an INGO representative said discussions regarding future methods should be minimal to avoid wasted efforts: ‘I think it’s useful to have [future PrEP methods] in context, [but] I don’t know that we will get anything done if we’re always [spending] too much time on things that may or may not get approved’.

Discussion

Ultimately, international stakeholders believed LA-PrEP methods could increase choice, autonomy, effective use, and coverage. Stakeholders mentioned de-stigmatisation approaches, including avoiding risk-based messaging and eligibility in lieu of preference-based and lifestyle-based needs assessments, capacitating providers, and person-centred, couple-centred and family-centred care. Stakeholders also discussed expanding PrEP service delivery beyond HIV treatment clinics for ethical, equitable access through integration in FP, SRH and ANC services, and into communities. Some stakeholders expressed that de-medicalised PrEP ring delivery may improve reach marginalised communities. They also underscored communication campaigns confronting objective and relative efficacy and effectiveness of PrEP method would increase awareness, knowledge, and autonomy among end-users and providers. Systematic introduction and scale-up processes will require robust, complex and nuanced planning to ensure each LA-PrEP method builds on oral PrEP’s lessons while simultaneously capitalising on their strengths and potential (a modular approach).

Based on common impressions from successes in FP, stakeholders were optimistic that PrEP uptake and continuation would increase with LA-PrEP availability.44 45 Emerging evidence supports the benefits of choice offered to WAGs. In two cohorts assessing choice among AGYW in Zimbabwe, 76.9% selected PrEP ring—with a higher propensity among rural versus urban residents (97.5% vs 61.0%). Also, PrEP ring continuation was higher.46 In HPTN 084’s open-label extension, 67% of women assigned to oral PrEP switched to CAB-PrEP; recent physical intimate partner violence was higher among CAB-PrEP choosers.47 An ancillary HPTN 084 study found AGYW viewed CAB-PrEP positively because it was discreet, like injectable contraceptives, and helped with adherence, although injection pain, reactions and fears were potential acceptability barriers.48 During the crossover period of MTN-034, two-thirds of AGYW chose the PrEP ring over oral PrEP.49 FP literature underscores that providers must remain product-neutral and avoid guiding towards products that are easier to administer and manage, rather than user preferences.50–52 FP studies also highlight averting stock-outs is vital to preserving choice, as consistent inventory enables WAG to make informed decisions regarding all approved HIV prevention methods.53–57

Previous literature support stakeholders’ insights about LA-PrEP augmenting service and training to reduce stigma. One review showed that increasing hospitability in HIV treatment clinics was a key stigma-reducing strategy, and a trial found integrating oral PrEP into treatment clinics reached a high proportion of partners without HIV.58 59 Aligned with stakeholders, a recent review showed that HIV services benefited from mirroring the infrastructural dynamics of contraceptive services given their history of providing similar products.32 During early oral PrEP implementation, inadequate training and supportive supervision engendered low self-efficacy and PrEP prescribing among some providers.19 However, interventional evidence from Kenya highlights evidence-based approaches, like standardised patient actors, can improve providers’ confidence, quality of care and provider–client relations.60

For non-HIV service integration, stakeholders posited commonly researched integration points: FP, SRH, ANC and PHC.61–64 Preliminary evidence supports that in addition to potentially improving access, initiation, adherence and continuation, oral PrEP integration is appropriate, feasible and acceptable.65–67 The current evidence supports HIV and primary care outcomes improve with HIV-PHC integration, highlighting the potential benefit of sustainable development goal strategies focused on one health initiatives. Integrating HIV into PHC’s multi-service model may increase confidentiality, as visit reasons are less apparent than SRH, FP or HIV services; PHC may also have a broader reach than specialised services. Despite enthusiasm, stakeholders offered no frameworks on how to integrate HIV into other services, an oversight likely caused by the absence of evidence on empirical large-scale oral PrEP integration.66

Stakeholders purported potential reasons for the lack of empirical integration models: one leading explanation was power imbalance resulting from historical investment structures. PEPFAR, which began in 2003, did not authorise funding for HIV–FP integration until 2012.68 Furthermore, PEPFAR funds cannot be used to directly procure contraceptive commodities,69 offering little help to alleviate persistent stock-outs globally.53–55 The Global Fund to Fight AIDS, Tuberculosis and Malaria, another key funder of HIV programming, currently does not have a distinct focus on FP.70 71 These narrow funding approaches have bifurcated complementary service sectors, a divide further compounded by the underfunding and politicisation of reproductive health.72–75 PrEP’s integration into non-HIV services will require collaborative and political activities to dissolve long-standing bureaucratic and financial barriers. A potential catalyst for that reconciliation is the advent of multipurpose prevention technologies against pregnancy and HIV acquisition.76 In addition to strengthening policy, programme planning and implementation, intersectoral partnerships will increase the availability, accessibility, and quality of services for WAGs.

De-medicalisation discussions focused on oral PrEP and PrEP ring, likely because CAB-PrEP’s mode of administration, risk of resistance, and expectations about laboratory monitoring.23 De-medicalised delivery can expand PrEP access and reach, especially for marginalised populations.12 77 78 This delivery model may also reduce health system burden and leverage or establish self-care pathways. Secondarily, de-medicalisation could also decrease the levels of stigmatising products and populations by increasing anonymity.12 Accessing community-based services may reduce stigmatising assumptions if complementary services are offered at the same location. Few—if any—stakeholders reflected on barriers and facilitators of wraparound HIV testing services in the context of de-medicalised delivery channels. Since repeat HIV testing is required for PrEP initiation and continuation, this warrants further investigation.79 Also, shifting services from clinics to communities complicates monitoring and evaluation of use, adherence and continuation,80 necessitating measurement innovations to ensure accurate reporting and data utilisation of performance and inventory metrics.81

Stakeholders provided differing insights on the role of product efficacy and effectiveness in real-world delivery. Stakeholders spoke favourably of oral PrEP despite varying efficaciousness, clinical effectiveness and programme effectiveness. Oral PrEP in WAGs was approximately 49%–79% efficacious in trials, 85% effective in highly adherent trial participants, and 95% effective in an open-label extension study.82 83 Real-world studies report lower adherence and continuation, especially among AGYW, which could result in lower programme effectiveness.84 A recent clinical trial of CAB-PrEP in women exhibited 88% efficacy compared with daily oral PrEP.31 Compared with placebo, PrEP ring trials showed 27%–31% efficacy, and age-stratified analyses elucidated efficacy was higher in older women and lower in younger women; open-label extension studies suggest effectiveness is 39%–62%.28 29 85 86 Stakeholders’ responses reflected variability in understanding this evidence base: most preferred oral PrEP over the ring based on trial data, while some thought the ring might outperform oral PrEP in real-world settings. Tiered, nuanced communication and counselling strategies, based on current evidence, will be critical to address varied understanding of the PrEP ring’s measured efficacy and effectiveness and perceived real-world effectiveness. As policymakers grapple with PrEP ring evidence, advocates demand decisions be driven by choice.87 HIV prevention remains a delicate balance between protectiveness, choice and demand, suggesting the most effective product is one WAGs will use properly and consistently.

Strengths and limitations

Our study has several strengths. The interviews co-occurred with HPTN 084’s reported results and release of WHO’s recommendation on PrEP ring, enabling us to capture the contemporaneous zeitgeist.21 88 Although only half accepted, we invited stakeholders to review and confirm the results, strengthening the methodological approach and ethics of this study. Our analysis also has some limitations. First, our sample disproportionately included US-based and UK-based stakeholders, which limits representativeness of responses. Second, interviews occurred before the PrEP ring’s application was withdrawn from the US Food and Drug Administration, which could impact perceptions.89 Third, we could have missed valuable data by prematurely adjusting questions using the Delphi method. Fourth, we synthesised two stakeholders’ viewpoints using notes due to lack of recordings; thus, some themes might be under-reported. Fifth, because we could not interview all stakeholders (eg, national MoH, advocates and potential beneficiaries) as planned due to funding changes, our responses do not represent certain sectors. Sixth, very few participants responded to the preinterview questionnaire on individual-level professional and demographic data, precluding us from offering detailed insights into participant characteristics. Seventh, we did not interview non-English speaking stakeholders, meaning certain insights could have been overlooked.

Conclusion

The imminent introduction and scale-up of LA-PrEP necessitate systematic planning to facilitate product accessibility and availability. We can capitalise on stakeholders’ oral PrEP experiences by maximising achievements and re-purposing lessons learnt into opportunities. Stakeholders emphasised LA-PrEP would increase choice, but these methods must avoid targeting and service delivery practices that increase stigma, which continues to undermine oral PrEP. Service integration and de-medicalised delivery were considered the ‘next steps’, potentially expanding PrEP’s reach and coverage, especially among marginalised populations. No PrEP method was unanimously preferred by stakeholders, amplifying the importance of informed choice. Other PrEP methods in advanced stages of research and development may enter the market in the near future, highlighting the importance of a product agnostic HIV prevention implementation plan. Acting on these lessons will offer a robust foundation for LA-PrEP introduction and scale-up activities.

Data availability statement

We can provide aggregate summaries of the data upon reasonable request. Please contact cjh2204@cumc.columbia.edu or dc2022@cumc.columbia.edu for any inquiries.

Ethics statements

Patient consent for publication

Ethics approval

This study involves human participants. We originally interviewed stakeholders for programmatic purposes to develop a CRPT. All 34 stakeholders, representing 16 organisations, were asked to provide written informed consent to use their responses for research. Participants who consented to this analysis were invited to review the results to confirm anonymisation. Columbia University’s review board approved all research procedures (#AAAU1602).

Acknowledgments

We would like to acknowledge and thank the stakeholders who participated in the interviews. Without their time, effort and knowledge, many of the lessons and recommendations provided within this manuscript would be unknown. Due to the breadth, depth and quality of their contributions, we, and the HIV prevention field, are indebted to them. We also would like to thank Bridger Trap for his assistance in creating the figures. Preliminary findings regarding this analysis were presented at Fast-Track Cities 2022 and the 12th IAS Conference on HIV Science.

References

Supplementary materials

  • Supplementary Data

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Footnotes

  • Handling editor Seema Biswas

  • X @DelivetteC

  • CJH and DC contributed equally.

  • Correction notice This article has been corrected since it first published. The author 'Ohemma Poku' has been corrected to 'Ohemaa Poku'.

  • Contributors CJH and DC conceptualised this study. CJH, DC, JD, KK and KM participated in the interviews, providing support ranging from facilitation, note-taking, question generation and audio/visual support. ML and CM provided technical support and assistance. DC created the initial set of themes, with input from CJH and JD; CJH and KY analysed the transcripts. AD, KM, OP, CO, SW, DQ, MES and ST-R provided support with synthesising and interpreting the qualitative data. CJH and DC wrote the first draft of this manuscript. DC secured funding. CJH and DC accept full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish. The corresponding author confirms all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. All authors read and approved the final manuscript.

  • Funding This article was conducted as part of the Preparing for Ring Opportunities through Market Introduction Support and Knowledge Exchange (PROMISE) and Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC) projects. PROMISE and MOSAIC were made possible by the generous support of the American people through the US Agency for International Development (USAID) under the US President's Emergency Plan for AIDS Relief (PEPFAR) via the terms of cooperative agreements AID-OAA-A-15-00045 (PROMISE) and 7200AA21CA00011 (MOSAIC). Research reported in this publication was also supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Numbers T32AI114398 (CJH) and National Institute of Allergy and Infectious Diseases UM1AI069470 (DC, MES). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The contents of this article are the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health, USAID, PEPFAR or the United States Government.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.