Abstract
Background
While recognized as a key HIV prevention strategy, pre-exposure prophylaxis (PrEP) availability and accessibility are not well documented globally. We aimed to describe PrEP drug registration status and the availability of PrEP services across HIV care sites participating in the International epidemiology Databases to Evaluate AIDS (IeDEA) research consortium.
Methods
We used country-level PrEP drug registration status from the AIDS Vaccine Advocacy Coalition and data from IeDEA surveys conducted in 2014, 2017 and 2020 among participating HIV clinics in seven global regions. We used descriptive statistics to assess PrEP availability across IeDEA sites serving adult patients in 2020 and examined trends in PrEP availability among sites that responded to all three surveys.
Results
Of 199 sites that completed the 2020 survey, PrEP was available in 161 (81%). PrEP availability was highest at sites in North America (29/30; 97%) and East Africa (70/74; 95%) and lowest at sites in Central (10/20; 50%) and West Africa (1/6; 17%). PrEP availability was higher among sites in countries where PrEP was officially registered (146/161; 91%) than where it was not (14/32; 44%). Availability was higher at health centers (109/120; 90%) and district hospitals (14/16; 88%) compared to regional/teaching hospitals (36/63). Among the 94 sites that responded to all three surveys, PrEP availability increased from 47% in 2014 to 60% in 2017 and 76% in 2020.
Conclusion
PrEP availability has substantially increased since 2014 and is now available at most IeDEA sites. However, PrEP service provision varies markedly across global regions.
Keywords: Pre-exposure prophylaxis (PrEP), HIV prevention, availability
Introduction
Pre-Exposure Prophylaxis (PrEP) may be an important biomedical method to prevent new HIV infections in populations at substantial risk for HIV.1–3 Key studies among serodiscordant couples, adolescent girls and young women, female sex workers (FSW) and men who have sex with men (MSM) have provided evidence on the effectiveness of PrEP programs.4–6
Since the World Health Organization’s (WHO) 2015 recommendation that PrEP be offered to people at substantial risk of HIV acquisition, PrEP availability and uptake have increased considerably in low- and middle-income countries, with large programs launched in high -HIV prevalence settings such as Kenya, South Africa, Brazil, and Thailand.6–11 Globally, more than 3 million people have initiated PrEP since 2015.9,12
Despite the rapid and widescale implementation of PrEP, there are limited data describing the settings in which PrEP is being delivered.13 Most reports in the literature present country-level data, describe general approaches to PrEP delivery or report data from controlled trials.13,14 Data on the settings in which PrEP is delivered across diverse country income, HIV prevalence and country-level PrEP registration status are crucial for examining PrEP effectiveness at a population level.13 Using data from periodic site assessment surveys conducted by the International epidemiology Database to Evaluate AIDS (IeDEA) research consortium, the objective of the current study is to provide a descriptive analysis of PrEP availability and service delivery across a geographically diverse group of HIV clinics that participate in IeDEA.
Methods
Data Source and Collection
Established in 2006, IeDEA is a global research consortium of HIV clinical centers and research groups. IeDEA harmonizes routine, clinical data from HIV clinics in 42 countries across seven geographic regions: Asia-Pacific; North America; Caribbean, Central and South America; Central Africa; East Africa; Southern Africa; and West Africa. 15 Sites participating in IeDEA are primarily public-sector health facilities providing HIV care and comprise a heterogenous mix of academic and community programs, ranging from rural health centers to tertiary referral hospitals.
Every three to five years, IeDEA administers a site assessment survey among all sites to collect data on site characteristics and services available to patients.16 Survey questions include: patient populations served (e.g. adults, children or both), available staffing for HIV care, routine screening and care for HIV patients, and preventive services offered, including PrEP. Surveys are completed in either online or paper-based formats by clinical or record-keeping staff with in-depth knowledge of services provided at their clinic. For the current analysis, we included data from all IeDEA sites serving adult patients in 2020 (i.e., excluding those providing care to only pediatric patients), as well as all sites that had completed similar surveys in 2014, 2017 and 2020.
Variables and Analysis
Sites were asked whether PrEP was available to patients within the HIV clinic, onsite but not in the HIV clinic, or offsite (i.e., via referral). The survey did not specify specific formulation of PrEP (e.g. oral, vaginal ring, injectable). Other variables included clinic location, facility type, availability of HIV counseling testing services at the clinic and in the site’s catchment area, types of providers available onsite and provision of services to special populations (e.g., female sex workers etc.).
We assessed PrEP availability for all sites that participated in the 2020 IeDEA site assessment survey. Descriptive statistics related to PrEP availability were calculated overall, and by country setting (e.g., PrEP registration status, country level income and national HIV incidence) and site characteristics. In addition, we examined changes in PrEP availability over time among the subset of sites that had completed IeDEA’s site assessment surveys in 2014, 2017 and 2020.
To determine whether PrEP medications were registered in each country, we used 2019 data (the most recent available at the time of analysis) from the AIDS Vaccine Advocacy Coalition (AVAC).9 Registration status was defined as local regulatory approval of either generic or brand name Tenofovir Disoproxil Fumerate/Emtricitabine (TDF/FTC) and categorized as unregistered, under review, or registered. Additional country-level data included income category, based on World Bank classifications.17
Results
Of 210 sites serving adult HIV patients in 42 countries across all IeDEA regions, 199 completed the 2020 site assessment survey (Table 1). More than half of sites responding were in the East Africa (n=74, 37%) and Asia-Pacific (n=37, 19%) regions of IeDEA, with 15% from North America (n=30), 13% from Southern Africa (n=25), and the remainder from Central Africa (n=20, 10%), the Caribbean, Central and South America (n=7, 4%) and West Africa (n=6, 3%). PrEP registration was lowest among countries in the Central Africa (0/5; 0%) and West Africa (3/7; 43%) regions of IeDEA, whereas all countries in North America, Southern Africa and East Africa regions had at least one PrEP formulation registered (Table S1).
Table 1:
Characteristics of Health Centers that Provide PrEP Services in 2020
| Sites with PrEP Available N=161 | |||||
|---|---|---|---|---|---|
| Setting and Site Characteristics | IeDEA sites | PrEP availability either on or off site n (%)† | PrEP provided in HIV clinic n (%) | PrEP provided in health facility but not in HIV clinic n (%) | PrEP provided only offsite* n (%) |
| N=199 | 161 (81%) | 131 (81%) | 20 (12%) | 10 (6.2%) | |
| IeDEA region δ | |||||
| Asia-Pacific | 37 | 30 (81%) | 24 (80%) | 4 (13%) | 2 (7%) |
| North America | 30 | 29 (97%) | 18 (62%) | 10 (35%) | 1 (3%) |
| Central Africa | 20 | 10 (50%) | 10 (100%) | 0 (0%) | 0 (0%) |
| Caribbean, Central and South America | 7 | 4 (57%) | 1 (25%) | 1 (25%) | 2 (50%) |
| East Africa | 74 | 70 (95%) | 64 (91%) | 4 (6%) | 2 (3%) |
| Southern Africa | 25 | 17 (68%) | 13 (77%) | 1 (6%) | 3 (18%) |
| West Africa | 6 | 1 (17%) | 1 (100%) | 0 (0%) | 0 (0%) |
| National PrEP registration status | |||||
| Not registered or under review | 32 | 14 (44%) | 12 (86%) | 1 (7%) | 1 (7%) |
| Registered | 161 | 146 (91%) | 118 (81%) | 19 (13%) | 9 (6%) |
| Unknown registration status | 6 | 1 (16.7%) | 1 (100%) | 0 (0%) | 0 (0%) |
| National HIV incidence level | |||||
| Low (<1 per 1000) | 96 | 72 (75%) | 52 (72%) | 15 (21%) | 5 (7%) |
| Medium (1–4.9 per 1000) | 83 | 76 (92%) | 68 (90%) | 4 (5%) | 4 (5%) |
| High (≥5 per 1000) | 18 | 11 (61%) | 9 (82%) | 1 (9%) | 1 (9%) |
| No national data | 2 | 2 (100%) | 2 (100%) | 0 (0%) | 0 (0%) |
| Country income category | |||||
| Low income | 53 | 39 (74%) | 36 (92%) | 2 (5.1%) | 1 (3%) |
| Lower-middle income | 70 | 61 (87%) | 54 (89%) | 3 (5%) | 4 (7%) |
| Upper-middle income | 24 | 11 (46%) | 8 (73%) | 1 (9%) | 2 (18%) |
| High income | 52 | 50 (96%) | 33 (66%) | 14 (28%) | 3 (6%) |
| Facility type | |||||
| Health center | 120 | 109 (91%) | 89 (82%) | 14 (13%) | 6 (6%) |
| District hospital | 16 | 14 (88%) | 13 (93%) | 1 (7%) | 0 (0%) |
| Regional, provincial, or teaching hospital | 63 | 38 (60%) | 29 (76%) | 5 (13%) | 4 (11%) |
| Population served (urban vs rural) | |||||
| Urban | 71 | 56 (79%) | 36 (64%) | 14 (25%) | 6 (11%) |
| Rural | 44 | 41 (93%) | 38 (93%) | 2 (5%) | 1 (2%) |
| Mixed | 84 | 64 (77%) | 57 (89%) | 4 (6%) | 3 (5%) |
| Availability/provision of services to special populations ** | |||||
| Adolescents (10 –24 years) | 166 | 130 (78%) | 107 (82%) | 14 (11%) | 9 (7%) |
| Female sex workers (FSW) | 103 | 80 (78%) | 67 (84%) | 9 (11%) | 4 (5%) |
| Men who have sex with Men (MSM) | 87 | 66 (76%) | 54 (82%) | 8 (12%) | 4 (6%) |
| Transgender Individuals | 77 | 61 (79%) | 50 (82%) | 7 (12%) | 4 (7%) |
| People with substance use disorders (SUDs) | 89 | 74 (83%) | 61 (82%) | 9 (12%) | 4 (5%) |
| People who inject drugs (PWID) | 80 | 66 (83%) | 53 (80%) | 9 (14%) | 4 (6%) |
| People with mental health disorders (MHDs) | 115 | 94 (82%) | 78 (83%) | 11 (12%) | 5 (5%) |
| Mobile Populations | 107 | 87 (81%) | 74 (85%) | 7 (8%) | 6 (7%) |
| Incarcerated population/prisoners | 60 | 42 (70%) | 37 (88%) | 1 (2%) | 4 (10%) |
| People living with disabilities | 123 | 95 (77%) | 80 (84%) | 9 (10%) | 6 (6%) |
| Staffing availability *** | |||||
| Internist, family practitioner, generalist physician | 120 | 87 (73%) | 67 (77%) | 15 (17%) | 5 (6%) |
| Infectious disease or HIV specialist | 112 | 88 (79%) | 65 (74%) | 17 (19%) | 6 (7%) |
| Mid-level provider | 192 | 154 (80%) | 129 (84%) | 15 (10%) | 10 (7%) |
| Outreach worker | 132 | 106 (80%) | 83 (78%) | 14 (13%) | 9 (9%) |
| Availability of HIV counseling and testing services | |||||
| Daily | 190 | 153 (81%) | 124 (81%) | 19 (12%) | 10 (7%) |
| Some days | 4 | 3 (75%) | 3 (100%) | 0 (0%) | 0 (0%) |
| Never | 5 | 5 (100%) | 4 (80%) | 1 (20%) | 0 (0%) |
| Availability of services in site catchment area | |||||
| VCT testing | 142 | 120 (85%) | 99 (83%) | 14 (12%) | 7 (6%) |
| Mobile VCT testing | 83 | 69 (83%) | 62 (90%) | 3 (4%) | 4 (6%) |
% of sites
E.g., via referral
Services available every day or on special/dedicated days
Staff availability every day or on some days
Asia-Pacific: Australia, Cambodia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, Taiwan, Thailand, Vietnam
North America: Canada, United States of America
Central Africa: Burundi, Cameroon, Democratic Republic of Congo, Republic of Congo, Rwanda
Caribbean, Central and South America: Argentina, Brazil, Chile, Honduras, Haiti, Mexico, Peru
East Africa: Kenya, Tanzania, Uganda
Southern Africa: Lesotho, Malawi, Mozambique, South Africa, Zambia, Zimbabwe
West Africa: Benin, Burkina Faso, Côte d'Ivoire, Ghana, Mali, Senegal, Togo
Out of 199 sites, 161 (81%) reported that PrEP was available either on-site or off-site. PrEP availability was highest at IeDEA sites in North America (29/30; 97%) and East Africa (70/74; 95%), whereas only 17% (1/6) of sites in West Africa reported that PrEP was available. Most sites with PrEP availability reported that it was provided within the HIV clinic (131/161; 81%).
We observed differences in PrEP availability by country and site characteristics. PrEP availability was substantially higher among sites in countries where PrEP was registered (146/161; 91%) than in countries where it was not registered (14/32; 44%)). PrEP availability was lower in countries with high HIV incidence (11/18; 61%) than in countries with low (72/76; 75%) and medium (76/83; 96%) HIV incidence. Almost all sites in the seven high-income countries (50/52; 96%) reported PrEP availability, along with most sites in 12 low-income (39/53; 74%) and 14 lower-middle-income (61/70; 87%) countries, versus only 46% (11/24) of sites in the nine upper-middle income countries. On-site PrEP provision either in the HIV clinic or elsewhere within the health facility (as opposed to offsite, via referral) was more common in low, lower-middle- and high-income countries compared with sites in upper-middle income countries. PrEP availability was more commonly reported by sites serving rural patient populations (93%) than by sites serving urban or mixed urban/rural populations (79% and 76%, respectively) (Table S2). Nearly all (40/41; 98%) rural sites reported on-site provision of PrEP.
Most sites reporting that they served at least one key population group at substantial risk of HIV acquisition reported PrEP availability. Of 166 sites (83%) reporting that they served adolescents and young adults (ages 10–24 years), 78% (n=130) reported PrEP availability. Similarly, more than three-quarters of sites serving other key populations (e.g., female sex workers, men who have sex with men, people who inject drugs, etc.) reported PrEP availability.
Among a subset of 94 sites participating in IeDEA’s 2014, 2017 and 2020 consortium-wide site surveys, PrEP availability increased from 47% in 2014 to 76% in 2020. Increases in PrEP availability were observed in all IeDEA regions other than West Africa, where PrEP availability (25%) did not change, and North America, where 100% of sites reported PrEP availability in each survey.
Discussion
We found that PrEP availability has increased substantially among a diverse group of HIV clinics, with 76% of sites across 42 countries reporting availability in 2020. However, PrEP availability varied across geographic regions, country income, and clinic urbanicity.
The findings from our study highlight the need to address barriers that limit PrEP availability and to accelerate PrEP scale-up efforts to ensure global access. We observed that PrEP was not yet registered for HIV prevention in 17 of the 42 countries reflected in IeDEA’s 2020 site survey, and PrEP availability was markedly lower among sites in countries where it was not yet registered. Our results accord with other research showing that even among countries that have formally adopted WHO recommendations on PrEP into national guidelines, the availability of PrEP varies considerably by country. 11,12 Furthermore, PrEP registration alone may not be sufficient to create access and thus efforts to expand PrEP availability need to address barriers to access, such as cost, distance to services and perceived stigma that may be felt by those seeking PrEP.18–21
We observed that PrEP availability was higher in clinics serving rural populations compared with those serving urban or mixed populations. These findings are in contrast to findings from predominantly high-resource areas,22–23 but may be a reflection of our sample, rather than real-world availability of PrEP services across urban and rural settings. Many of the urban sites participating in IeDEA are tertiary-level hospitals that focus on specialized HIV care rather than HIV preventions services. In contrast, IeDEA sites serving rural populations are largely concentrated in the East Africa region of IeDEA and are predominantly primary health centers– sites that are more likely to provide both HIV prevention and treatment services delivered within the same facility.
A strength of our study is our longitudinal data from diverse HIV clinics from a broad range of clinical programs across different world regions and setting characteristics. This strength notwithstanding, clinics participating in the IeDEA research consortium comprise a small subset of the health facilities providing PrEP- sites that may not be fully representative of PrEP service provision and expansion within countries, primarily because the IeDEA is largely focused on HIV treatment, rather than prevention, and it comprises many high-volume clinics focused on specialized HIV care rather than primary health services. Representativeness may further be impacted by the variation in site participation from year to year.16,24,25 Additionally, it should be noted that IeDEA site assessment surveys rely on self-report by respondents, which could result in bias due to recall errors and/or social desirability bias.16
Conclusion
In conclusion, using data from global surveys of HIV clinics across 42 countries, we observed a substantial increase in PrEP availability from 2014 to 2020. However, gaps persist, particularly in geographical regions and in countries where PrEP has not been officially registered. Expansion of PrEP in areas with lower availability is imperative, as are efforts to identify and address barriers to PrEP access and uptake.
Supplementary Material
Figure 1.
Temporal Changes in PrEP Availability Among IeDEA Sites, 2014 to 2020
Funding:
The International Epidemiology Databases to Evaluate AIDS (IeDEA) is supported by the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute of Mental Health, the National Institute on Drug Abuse, the National Heart, Lung, and Blood Institute, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Diabetes and Digestive and Kidney Diseases, the Fogarty International Center, and the National Library of Medicine: Asia-Pacific, U01AI069907; CCASAnet, U01AI069923; Central Africa, U01AI096299; East Africa, U01AI069911; NA-ACCORD, U01AI069918; Southern Africa, U01AI069924; West Africa, U01AI069919. Informatics resources are supported by the Harmonist project, R24AI24872. This work is solely the responsibility of the authors and does not necessarily represent the official views of any of the institutions mentioned above.
Footnotes
Conflicts of Interest:
The authors declare that the research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest.
Data Availability Statement:
All data relevant to the study are included in the article.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
All data relevant to the study are included in the article.