Abstract
Keywords
Introduction
HIV is still a significant health issue in India with a 0.21% adult prevalence and 63,000 new infections in 2021. 1 Although the estimated adult HIV prevalence is apparently low in India, there is heterogeneity in terms of its distribution by population, as well as by geographical area. The estimated HIV prevalence in India among drug users is 9.03%, transgender persons (TG) 3.78%, men who have sex with men (MSM) 3.26%, and female sex workers (FSW) is 1.85%. 1 The estimated prevalence and incidence also varies widely by states, and districts in India. 2
New biomedical interventions, including pre-exposure prophylaxis (PrEP), have been added to HIV prevention methods. PrEP has been proven safe and effective in reducing HIV incidence among key populations.3,4 The National AIDS Control Organization (NACO) of India recommends oral PrEP as part of a combination HIV prevention approach for those at substantial risk of HIV infection, such as people who have had unprotected anal sex with multiple partners in the last 6 months. 5 Although daily oral PrEP was approved in India in 2016, the provision presently is very limited. 6 It is provided at discounted prices in some cities, including Delhi, by non-government organisations. 7 PrEP delivery through the government programme is not being done in Delhi, but is being carried out on a pilot basis in some other states. 8 Success of PrEP implementation for MSM and TG is yet to be seen, and depends on its acceptability, which is influenced by knowledge about the intervention.9,10
Studies reported low HIV PrEP awareness among Indian MSM and TG, but the respondents in these studies expressed an interest to use PrEP when explained and informed about PrEP; most of these studies recruited participants from South India (including Tamil Nadu, Telangana, Andhra Pradesh and Karnataka), so information is limited for North India.11–14
Given the regional heterogeneity of the HIV epidemic in India, key populations in Northern India face unique issues. Delhi, in Northern India, has much higher HIV incidence than the Southern States. 1 MSM and TG in the Northern states have higher literacy than those in the Southern states, while TG in the Northern states have lower knowledge of HIV than those in the Southern states.15,16 Hence, up-to-date, locally relevant information is crucial for PrEP policy and strategizing PrEP implementation.
Our aim was to determine awareness of HIV PrEP and willingness-to-use it among MSM and TG enrolled at the targeted intervention (TI) projects in Delhi. We also identified the socio-demographic and behavioural determinants of PrEP awareness and willingness to use.
Methods
Study setting and design
The study was a cross-sectional study conducted among MSM and TG enrolled at TI projects run by the Delhi State AIDS Control Society (DSACS) and non-governmental organizations. The projects provided HIV preventive services to around 1500 persons from key populations and included a drop-in centre, clinics for medical advice and referral for HIV testing, and peer educators for health promotion and condom distribution.17,18 Each project had a drop-in centre, where enrolled persons could gather for social interaction and educational activities. The study was conducted from December 2021 to June 2022, and PrEP was not available during the study period.
Sampling strategy
At the time of the study, there were a total of 17 TI projects serving MSM and TG under DSACS.
19
Five of these were selected purposively, to have a geographical representation of Delhi (Figure 1). The overall sample size was distributed equally among these five TI projects. On the day of the visit of the investigator, all individuals visiting the drop-in centre of that site were invited for participation. Recruitment at a site continued until the desired sample size for that site was achieved. This required multiple visits (about ten) per site. (a). Sampling strategy; (b). Map showing locations of MSM and TG TI projects within the districts of Delhi. The sites selected for this study are marked in blue. (The map is adapted from the work of Heinz OSM, shared under a CC BY-SA 4.0 license [https://creativecommons.org/licenses/by-sa/4.0], via Wikimedia Commons [https://commons.wikimedia.org/wiki/File:Dehli_districts.png]. The map is indicative only and may not accurately represent scales of distance or administrative boundaries).
Study participants
The study participants were MSM or TG aged 18 years or older, enrolled in selected TI projects, with self-reported negative or unknown HIV status. Individuals who reported a positive HIV test, were unwilling to disclose HIV status, or were unable to communicate in Hindi, were excluded.
Study tool
The participants were interviewed using a Hindi self-designed, structured interview schedule covering socio-demographics, PrEP awareness, acceptability and willingness, behavioural practices, stigma and violence experiences (Supplementary File 1). The schedule was created through literature review, expert discussions, and input from formative qualitative research conducted from October–November 2021. It was pre-tested among five eligible individuals in a TI project other than those selected for the study.
Socio-demographic variables, sexual behaviour and stigma
Education was assessed by asking participants how many years of formal education they had completed, including school, college and university, and excluding pre-school and kindergarten. Participants’ current main occupation was recorded as per the revised Kuppuswamy Socioeconomic Status scale, a widely used measure of socio-economic status for urban populations in India. 20 It consists of three components: education, occupation and household income. The ‘occupation’ component classifies occupations, based on the training required and complexity, into professional work, skilled work, unemployed, etc. We included additional options—begging/badhai, sex work, student and retired—to cover other occupations relevant to the study population. A regular, non-commercial partner was defined as a regular sexual partner with whom no monetary transaction was done in exchange for sexual intercourse. Experience of stigma was assessed by asking participants about any perceived bad behaviour they had faced, from friends, family, neighbours, or healthcare providers, on account of their gender or sexuality.
Outcome variables
Awareness of PrEP was determined by asking participants if they had heard of a medication taken by HIV-negative individuals to prevent HIV infection. Participants were then asked to explain the timing of starting the medication (before or after sexual activity) to differentiate between PrEP and post-exposure prophylaxis (PEP). Those who correctly identified that PrEP is started before sexual activity were considered “aware” of PrEP. Additional questions were asked about the sources of information and whether they had ever used PrEP.
Before assessing willingness, all participants were given information about PrEP. Willingness was assessed by asking if participants would take it for free, with a “yes, definitely” or “yes, probably” response considered as “willing to use PrEP”.
Further exploration of willingness to use
Participants who indicated willingness to use PrEP were further asked about their preferred regimen, intention to adhere to PrEP, willingness to pay for PrEP, willingness to continue use despite mild side effects, and possible expected risk compensation. Preferred regimen was assessed by asking participants to rank daily oral PrEP, event-driven oral PrEP and long-acting injectable PrEP in order of their preference. Intention to adhere was measured by asking, ‘Would you be able to take PrEP regularly?’, with responses on a five-point Likert scale from ‘yes, definitely’ to ‘no, definitely not’. The first two responses on the scale (‘yes, definitely’ and ‘yes, probably’) were categorised as ‘able to take PrEP regularly’. Willingness to pay for PrEP was measured by asking the amount (in INR) the person would be willing to pay per month for PrEP. Willingness to continue use despite mild side effects was assessed on a five-point Likert scale from ‘yes, definitely’ to ‘no, definitely not’. The risk compensation items were meant to capture information on changes in sexual behaviour while taking PrEP, in terms of frequency of condom use, number of sexual partners, and ability to convince partners or clients for condom use.
Participants who were not willing to use PrEP, i.e., answered ‘uncertain’, ‘no, probably not’ or ‘no, definitely not’, were asked their reasons for the same. Options included not adding anything to HIV prevention, lack of protection against other STIs, side effects, etc.; multiple responses were allowed.
In addition, all participants were asked their overall feeling about PrEP (on a five-point Likert scale from ‘very positive’ to ‘very negative’) and their willingness to tell friends about PrEP (on a five-point Likert scale from ‘yes, definitely’ to ‘no, definitely not’).
Sample size
We aimed to determine the proportions aware of and willing to use PrEP with 95% confidence and an absolute precision of 5%. To estimate the prevalence of awareness and willingness to use PrEP, we used results from a previous meta-analysis of studies among MSM in low- and middle-income countries, as we expected the true prevalence in India to be close to this value. Taking the prevalence of PrEP awareness as 29.7% and prevalence of willingness to use PrEP as 64.4%, we needed to interview 353 participants. 21 To account for non-response (anticipated to be 10%), we needed to approach 400 eligible individuals.
Statistical analysis
The data was collected using a mobile application (Epicollect5, Centre for Genomic Pathogen Surveillance, South Cambridgeshire, UK), and summarized as numbers, proportions, means and standard deviations, or medians and interquartile ranges for skewed distributions. The primary outcomes of awareness of and willingness to use PrEP were reported as prevalence and its 95% confidence interval. The amount that a participant was willing to pay for PrEP every month was expressed as a proportion of that participant’s monthly household income. Logistic regression was used to identify factors associated with awareness and willingness, with results reported as odds ratios and adjusted odds ratios (AORs) with 95% confidence intervals. Variables that were associated at p < .25 were included in multivariable logistic regression models. A p-value of less than 0.05 in the multivariable model was considered statistically significant. In a sensitivity analysis, individuals with unknown HIV serostatus were excluded.
Statistical analysis was done on Stata/MP 17.0 (StataCorp LLC, College Station, Texas, USA).
Ethical considerations
Ethical approval was sought and obtained from the Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi, India (vide letter number IECPG-423/28.07.2021, RT-16/25.08.2021; dated 28 August 2021). Persons invited for participation were informed about the nature and purposes of the study, and written informed consent for participation was sought. Care was taken to ensure privacy during the interviews. Confidentiality of HIV status was maintained as per the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017. Individual details were de-identified before running the analysis, so as not to trace back an individual.
Results
Participant characteristics
A total of 509 potential participants were contacted, of whom 451 were eligible. 400 persons responded in the interview, giving a response rate of 88.7% (Figure 2). The respondents included 224 (56.0%) MSM and 176 (44.0%) TG with a median age of 23 years (IQR 21–29 years; Table 1). Around one-tenth of the participants reported begging as their main occupation, and around one-tenth reported sex work as their main occupation. Flow chart showing recruitment of participants. DIC, drop-in centre. Socio-demographic characteristics and HIV testing among study participants (n = 400).
Sexual behaviour, injecting drug use, risk perception, and experience of stigma and violence, among study participants who responded to the relevant section of the interview (n = 380).
Values are expressed as n (%), unless specified otherwise.
Awareness of and willingness to use PrEP
The prevalence of awareness of PrEP was 14.5% (58/400; 95% CI 11.0%, 18.0%). None of the participants interviewed had ever used PrEP. Non-governmental organisations, friends and the internet were the most common sources of information about PrEP (Figure 3). Sources of information about PrEP among study participants who were aware of it. Multiple responses were allowed.
Overall, 252 of 398 participants (63.3%, 95% CI 58.6%, 68.1%) were willing to use PrEP. Most participants (135/252, 53.6%) preferred long-acting injectable PrEP.
Among 252 participants willing to take PrEP, 225 (89.3%) believed that they would be able to take PrEP regularly, while 78 (31.0%) were willing to continue its use despite mild side effects. Participants were willing to pay a median (IQR) of INR 500 (200–1000) per month, or 2.0% (IQR 0.7%, 5.6%; range 0.0%, 150.0%) of their monthly household income, to purchase PrEP if required to do so.
Most participants reported their overall feeling about PrEP as ‘very positive’ (154/400, 38.5%) or ‘somewhat positive’ (156/400, 39.0%), and 87.0% (348/400) said that they would ‘definitely’ or ‘probably’ tell their friends about PrEP.
Potential risk compensation while using PrEP
Most participants stated that use of PrEP would not affect the number of their sexual partners (208/252, 82.5%) or frequency of condom use (235/252, 93.3%). Most participants (208/252, 82.5%) were confident that they could convince their partners for condom use along with PrEP.
Reasons for not taking PrEP
Among persons who were not willing to use PrEP, the most common reasons for not taking PrEP were perception that it would not add to HIV prevention (69/146, 47.3%), concerns about side effects (60/146, 41.1%), not being sexually active (27/146, 18.5%), having only one sexual partner (12/146, 8.2%), and medical comorbidities (5/146, 3.4%).
Determinants of awareness and willingness to use
Factors associated with PrEP awareness among MSM and TG at targeted intervention projects in Delhi.
A total of 306 participants (178 MSM and 128 TG) contributed to the multivariable analysis. Percentages in columns add up to 100. AOR, adjusted odds ratio; CI, confidence interval; OR, odds ratio; SD, standard deviation.
Factors associated with willingness to use PrEP among MSM and TG at targeted intervention projects in Delhi.
A total of 343 participants (194 MSM and 149 TG) contributed to the multivariable analysis. Percentages in columns add up to 100. AOR, adjusted odds ratio; CI, confidence interval; OR, odds ratio; SD, standard deviation.
Anal sex with a male partner in the last 3 months (AOR = 2.29, p = .011), use of condom at last anal sex (AOR = 2.09, p = .017), and experience of physical violence in the last 3 months (AOR 3.65, p = .014) were found to be positively associated with willingness to use PrEP.
Results by key population
MSM and TG participants were similar in their age, education, income, and HIV testing. MSM were more likely to be living with their relatives, while TG were more likely to be living alone, or with male partners, peers or gurus (Table S4). TG also reported a greater number of sexual partners, engagement in transactional sex and injecting drug use (Table S5). MSM and TG had similar PrEP awareness and willingness to use (Table S6). The determinants of awareness and willingness were also similar to the overall findings (Tables S7–S10), although analyses were limited by the sample size for each group.
Sensitivity analysis
Results were essentially unchanged on excluding participants with unknown HIV status (Supplementary File 2, Tables S1–S3).
Discussion
Summary of results
In our cross-sectional study, less than one in five MSM and TG, recruited from the targeted intervention projects in Delhi, India, were aware of HIV PrEP. After being provided detailed information on PrEP, including its advantages and side effects, the majority of the participants expressed willingness to use PrEP. They also showed confidence to regularly adhere to their PrEP regimen. Our study also found that awareness of PrEP was less likely among MSM and TG who had lower education, were living with their families, had a non-professional job, and who did not use condom at last anal sex. Willingness to use PrEP was more likely among MSM and TG who engaged in anal sex, had used condoms at last anal intercourse, or have had an experience of physical violence in the previous 3 months.
Awareness of HIV PrEP
Our results are in line with other studies from India, which show that PrEP awareness among MSM and TG ranges from 7.0% to 36.5%.11–14 Compared to ours, two studies, one among MSM (in Chennai and Mumbai), and one among TG (across six cities of India), have shown relatively higher awareness of PrEP.13,14 Participants in these studies were asked whether they had heard or read about antiretroviral drugs for HIV prevention, without differentiating between PrEP and post-exposure prophylaxis (PEP) drugs, which could have led to overestimate of awareness. Confusion among participants between PrEP and PEP has been reported previously among MSM. 22 To remove such ambiguity in our study, we followed up our initial question of having heard about PrEP, by specifically asking participants when the medication should be started in relation to sexual activity, to have its effect. The two questions in series would have improved the specificity of the response.
The low awareness observed in our study can further be explained by the fact that TI projects, which are the most important source of HIV prevention information for participants, are not involved in promoting PrEP at present. Even globally, the awareness of PrEP among MSM has been found to be lower in South-East Asia, compared to that in the Americas and Europe. 10 This contrast could be due to the fact that in the Americas and Europe, information regarding PrEP has been disseminated, and also implementation is being scaled up.23–25 This implies that targeted dissemination of PrEP-related information to this population needs to be considered using the existing channels of the targeted intervention projects in India and specifically in Delhi.
Determinants of PrEP awareness
Determinants of PrEP awareness help to understand differentials in access to HIV prevention information, and will be useful for targeting communication. However, unlike our study, not many in India that assessed PrEP awareness had looked into its determinants. We found that awareness of PrEP did not differ by perceived risk of HIV infection, which is in line with Uthappa et al. 11 We observed a positive association of PrEP awareness with education, as seen previously among MSM and TG in China.26,27 Additionally, we observed use of condoms during last anal sex act to be positively associated with PrEP awareness, which has not been reported in previous studies.26,27 Given the greater gap in awareness among those with lower education and non-professional jobs, educational messages about PrEP should be simple and easily comprehensible. Also, they should be able to reach key population members with inconsistent condom use. Peer education could be an effective way of delivering such messages. 17
Willingness to use PrEP
The high willingness to use and intention to adhere to a PrEP regimen among MSM and TG, as seen in our study, are similar to those noted previously by studies done in India and elsewhere.10–13 The acceptability of PrEP likely stems from the importance placed on HIV prevention, as well as product characteristics: effectiveness, privacy of use, and utility where condoms cannot be used.22,28,29 In our study, the most common reasons for not taking PrEP were perceived low efficacy and fear of adverse effects. Only 2% cited inconvenience of regular use. Adverse effects 12 and requirements for HIV testing 13 were also cited as major deterrents in previous studies among Indian MSM and TG. However, participants in our study did not report requirement for HIV testing as a deterrent, a reason for which might be that the targeted intervention sites where these individuals are enrolled have provisions for six-monthly HIV testing. These findings indicate that to improve the willingness to use PrEP, it will be important to specifically address the concerns related to its adverse effects, efficacy, requirements for HIV testing prior to starting PrEP, and the need for frequent HIV testing while on PrEP regimen.
Preferences regarding PrEP formulation
Participants in our study preferred long-acting injectable PrEP over daily oral PrEP. In India, such a preference for less frequent dosing has been seen in some,30,31 but not all,12,13 studies among MSM and TG. The preference for injectable PrEP could be due to challenges with adherence to daily oral PrEP. Previous work has shown that PrEP dosing at longer time intervals is considered more user-friendly. 22
Determinants of willingness to use PrEP
Our study, like others, found that willingness to use PrEP is higher among individuals who used condom at last anal intercourse. 30 Although we did not consider type of partner for condom use, this could reflect the higher felt need of these individuals for HIV preventive interventions. Results for association of anal sex with willingness to use PrEP have been mixed.13,14,30 Our results are consistent with the information–motivation–behavioural skills model for PrEP uptake: being sexually active predisposes to HIV acquisition, and thus leads to higher motivation for HIV prevention. 32
Our study did not find differences in willingness to use PrEP based on living arrangement, sexual partner type, or experience of gender-related stigma. Willingness to use PrEP has been shown to be influenced by interpersonal relationships and experiences of stigma. 22 Transgender women who experienced discrimination by family members and healthcare providers were less likely to be willing for PrEP use. 13 In our study, individuals who reported experiencing physical violence in the past 3 months were more willing to use PrEP. It has been shown that individuals belonging to key populations who face physical violence are also at risk of condomless sex, particularly in the context of sex work.33,34 This could motivate PrEP use, as PrEP could provide an additional layer of protection.
Willingness to pay for PrEP
In our study, participants were unlikely to pay more than $12 per month for PrEP, if they had to buy it themselves. While this could amount to a significant proportion of their earnings (up to 5%), it is much lower than market prices, i.e., $18-$24 for 30 tablets. Almost one in ten (14.7%) participants were not willing to spend any money to procure PrEP themselves. Other studies in India and the Asia–Pacific have shown that willingness to use PrEP decreases if it needs to be paid for,11,30,35 and is higher if the individual has insurance cover. 36 Given this difficulty in purchasing PrEP in the free market, appropriate financing arrangements will be required so that disadvantaged groups can access it.
Implications of this study
PrEP is an important HIV prevention tool for MSM and TG in India. The Joint United Nations Programme on HIV/AIDS (UNAIDS) aims for PrEP to be accessible to all those at high risk of HIV infection by 2025. 37 However, PrEP implementation has been slow, especially in Asia-Pacific, mainly owing to unavailability of a PrEP policy and issues related to its delivery to MSM and TG. Despite inclusion in HIV prevention policy, implementation is lacking in some countries. 38 There are concerns about risk compensation and increased risk of STIs. 39 A successful PrEP rollout requires awareness, acceptability, community participation, and avoiding risk compensation. 40 The information provided in our study is crucial for the rollout. High willingness to use shows potential for large-scale uptake of this intervention. High intention to adhere, and low possibility of risk compensation, are reassuring, and suggest that these issues can be addressed by appropriate communication. Indian guidelines recommend daily oral PrEP, but long-acting injectable PrEP may improve user choice as was evident in our study.
Strengths and limitations
Recruitment at multiple sites, comprehensive interview schedule developed based on literature review and formative research, capture of different dimensions of PrEP acceptability (willingness to pay, regimen preferences, willingness to use despite side effects), and determinants of awareness and willingness to use were major strengths of our study.
Our work has some limitations. The study recruited consecutive participants visiting drop-in centers and may have selected a subgroup with higher motivation for HIV prevention, leading to potential overestimation of awareness and acceptability of PrEP. However, a random sampling methodology was not feasible in our setting. In our study, assessment of PrEP acceptability and sexual behaviour could have been affected by reporting bias due to social desirability. We did not collect information linking frequency of anal sex and condom use to specific partners. Our sample size, though sufficient for estimating overall awareness and willingness to use, did not allow precise estimation separately for MSM and TG. The measurement of willingness to use was based on hypothetical availability. The actual acceptance and usage of PrEP might differ when it becomes available, as was demonstrated in the Princess PrEP programme in Thailand, which recorded low initiation rates and high losses to follow-up. 41
In conclusion, low PrEP awareness but high willingness to use once described among MSM and TG was evident in our study. Future work should focus on demonstration projects for these groups and impact assessment with PrEP implementation. Strategic communication is needed to increase awareness and PrEP uptake.
Supplemental Material
Supplemental Material - Low awareness but high acceptability of pre-exposure prophylaxis for HIV among men who have sex with men and transgender persons in Delhi, India
Supplemental Material for Low awareness but high acceptability of pre-exposure prophylaxis for HIV among MSM and transgender persons in Delhi, India by Adhish Kumar Sethi, Partha Haldar, Sanjay Kumar Rai, Shashi Kant, Shobini Rajan, Parveen Kumar, Jitendra Kumar Mishra and Bhawani Singh in International Journal of STD & AIDS
Supplemental Material
Supplemental Material - Low awareness but high acceptability of pre-exposure prophylaxis for HIV among men who have sex with men and transgender persons in Delhi, India
Supplemental Material for Low awareness but high acceptability of pre-exposure prophylaxis for HIV among MSM and transgender persons in Delhi, India by Adhish Kumar Sethi, Partha Haldar, Sanjay Kumar Rai, Shashi Kant, Shobini Rajan, Parveen Kumar, Jitendra Kumar Mishra and Bhawani Singh in International Journal of STD & AIDS
Footnotes
Acknowledgements
We acknowledge the support received from the Targeted Intervention Programme Officers, community-based organisations, and peer educators. We also thank the participants, for contributing their valuable time to this research.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
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References
Supplementary Material
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