Preference for daily versus on‐demand pre‐exposure prophylaxis for HIV and correlates among men who have sex with men: the China Real‐world Oral PrEP Demonstration study

IntroductionThis study explores the preference for daily versus on‐demand pre‐exposure prophylaxis (PrEP) among men who have sex with men (MSM) in developing countries when both regimens are available.MethodsFrom 11 December 2018 to 19 October 2019, we recruited MSM for an open‐label real‐world PrEP demonstration study in four major cities in China. Subjects selected their preferred PrEP (oral tenofovir/emtricitabine) regimen (daily vs. on‐demand) at recruitment and underwent on‐site screening before initiation of PrEP. We used logistic regression to assess preference for daily PrEP and correlates.ResultsOf 1933 recruited MSM, the median age was 29 years, 7.6% was currently married to or living with a female; the median number of male sexual partners was four and 6.1% had used post‐exposure prophylaxis (PEP) in the previous six months. HIV infection risk was subjectively determined as very high (>75%) in 7.0% of subjects, high (50% to 75%) in 13.3%, moderate (25% to 49%) in 31.5% and low or none (0% to 24%) in 48.1%. On average, participants preferred on‐demand PrEP over daily PrEP (1104 (57.1%) versus 829 (42.9%)) at recruitment. In multivariable analysis, currently being married to or living with a female was associated with 14.6 percentage points lower preference for daily PrEP (marginal effect = −0.146 [95% CI: −0.230, −0.062], p = 0.001); whereas the number of male sexual partners (marginal effect = 0.003 [95% CI: 0.000, 0.005], p = 0.034) and a subjective assessment of being very high risk of HIV infection (vs. low and no risk, marginal effect size = 0.105 [95% CI: 0.012, 0.198], p = 0.027) were associated with increased preference for daily versus on‐demand PrEP. Among the 1933 potential participants, 721 (37.3%) did not attend the subsequent on‐site screening. Lower‐income, lower education level, lower subjective expected risk of HIV infection risk and younger age positively correlated with the absence of on‐site screening.ConclusionsMSM in China prefer both daily and on‐demand PrEP when both regimens are provided free. Social structural factors and subjective risk of HIV infection have significant impacts on PrEP preference and use. The upcoming national PrEP guideline should consider incorporating both regimens and the correlates to help implement PrEP in China.     

Association between HIV PrEP indications and use in a national sexual network study of US men who have sex with men

IntroductionHIV pre‐exposure prophylaxis (PrEP) is effective in preventing HIV transmission. United States Public Health Service (USPHS) clinical practice guidelines define biobehavioral indications for initiation. To assess guideline implementation, it is critical to quantify PrEP nonusers who are indicated and PrEP users who are not indicated. We sought to estimate current PrEP use among US men who have sex with men (MSM), characterize whether their PrEP use aligned with their current indications for PrEP, and assess whether the association between PrEP indications and PrEP use differed by demography or geography.MethodsUsing data from a US web‐based sexual network study of MSM between 2017 and 2019, we measured PrEP usage and assessed whether respondents met indications for PrEP. Log‐binomial regression was used to estimate the relationship between PrEP indications and PrEP use, with adjustment for geography, age and race/ethnicity.ResultsOf 3508 sexually active, HIV‐negative MSM, 34% met indications for PrEP. The proportion with current PrEP use was 32% among MSM meeting indications and 11% among those without indications. Nearly 40% of those currently using PrEP did not meet indications for PrEP, and 68% of MSM with indications for PrEP were not currently using PrEP. After adjusting for geography and demographics, MSM with PrEP indications were about three times as likely to be currently using PrEP. This association varied slightly, but not significantly, by geographic region, age and race/ethnicity.ConclusionsIndications for PrEP strongly predicted current PrEP use among US MSM. However, we identified substantial misalignment between indications and use in both directions (indicated MSM who were not benefitting from PrEP, and MSM taking PrEP while not presently being indicated). PrEP underuse by those at greatest risk for HIV acquisition may limit the projected impact of PrEP implementation, despite reported increases in PrEP provision. This calls for further implementation efforts to improve PrEP delivery to those most in need during periods of elevated sexual risk and to close the gap between indications and uptake.     

Imperfect adherence in real life: a prevention‐effective perspective on adherence to daily and event‐driven HIV pre‐exposure prophylaxis among men who have sex with men – a prospective cohort study in Taiwan

IntroductionBoth daily and event‐driven (ED) pre‐exposure prophylaxis (PrEP) have been demonstrated to be highly effective among men who have sex with men (MSM). Prevention‐effective adherence proposes that PrEP adherence should be aligned with the risk of HIV, which could be applied to both daily and ED PrEP adherence measurement. The objective of this study was to describe the relationship between the use of PrEP and sex events among the MSM PrEP users and identify factors associated with adherence among daily and ED MSM PrEP users.MethodsA multicentre, observational, prospective cohort study was conducted at three hospital‐based clinics in three urban cities of Taiwan from January 2018 to December 2019. MSM ages 18 years or older – at high risk of HIV acquisition and taking PrEP during the study period – were included in the analysis. MSM PrEP users were allowed to choose between daily and ED PrEP based on their preference. Data on sociodemographic characteristics, mental health, sexual behaviours, substance use and PrEP‐taking behaviours were collected at each visit.ResultsA total of 374 MSM were included in the analysis with 1,054 visits. More than half (56%) of the PrEP users chose ED at the baseline and 150 regimen switches were reported by 21% of the participants. There was only one seroconversion documented during the study period. Most (84.2%) of the MSM PrEP users were able to adhere to PrEP during the most recent anal intercourse in the past one month. Among ED PrEP users with suboptimal adherence, the majority (81.9%) missed the pre‐coital dose. In the multivariable analysis, we found that participants who switched from daily to an ED dosing regimen were associated with poorer adherence to PrEP.ConclusionsA high level of PrEP adherence was observed among the majority of MSM in a real‐world setting. On the other hand, Taiwanese MSM switching from daily to ED dosing regimens were less likely to adhere to PrEP, suggesting that novel approaches focusing on a dosing switch would be necessary for MSM to improve their adherence to PrEP.     

Adherence to event‐driven HIV PrEP among men who have sex with men in Amsterdam,the Netherlands: analysis based on online diary data, 3‐monthly questionnaires and intracellular TFV‐DP

IntroductionEvent‐driven pre‐exposure prophylaxis (edPrEP) with oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is highly effective for preventing HIV acquisition in men who have sex with men (MSM) and is preferred over daily PrEP by some MSM. However, it is largely unknown how well MSM adhere to edPrEP. We then aimed to assess PrEP protection during CAS among MSM using edPrEP and participating in the Amsterdam PrEP demonstration project (AMPrEP).MethodsWe analysed data from participants enrolled in AMPrEP who were taking edPrEP. We measured adherence through (1) a mobile application in which sexual behaviour and PrEP‐use were recorded daily, (2) three‐monthly self‐completed questionnaires and (3) dried blood spot (DBS) samples collected around six, twelve and twenty‐four months after PrEP initiation. We assessed the proportion of days with condomless anal sex (CAS) acts that were protected by PrEP, per partner type (i.e. steady partners, known casual partners, unknown casual partners), and the proportion of three‐month periods during which PrEP was correctly used. Intracellular TFV‐diphosphate (TFV‐DP) concentrations were determined from DBS. Good adherence was defined as at least one tablet before and one tablet within 48 hours after a CAS act.ResultsBetween 11 September 2015 and 6 October 2019, 182 of 376 MSM (48.4%) used edPrEP for at least one three‐month period. Of the 8224 CAS days that were reported in the app during edPrEP‐use, we observed good protection for most CAS days involving steady partners (n = 1625/2455, 66.9%), known casual partners (n = 3216/3472, 92.6%) and unknown casual partners (n = 2074/2297, 90.3%). Men reported consistently correct PrEP‐use in 851 (81.4%) of the 1046 three‐month periods of edPrEP‐use. The median TFV‐DP concentration was 591 fmol/sample (interquartile range = 270 to 896).ConclusionsAdherence to edPrEP was high as determined from the online app and questionnaire. DBS measurements were consistent with two to three tablets per week on average.     

HIV self‐testing partially filled the HIV testing gap among men who have sex with men in China during the COVID‐19 pandemic: results from an online survey

IntroductionHIV self‐testing (HIVST) is a useful strategy to promote HIV testing among key populations. This study aimed to understand HIV testing behaviours among men who have sex with men (MSM) and specifically how HIVST was used during the coronavirus disease 2019 (COVID‐19) measures in China when access to facility‐based testing was limited.MethodsAn online cross‐sectional study was conducted to recruit men who have sex with men (MSM) in China from May to June of 2020, a period when COVID‐19 measures were easing. Data on socio‐demographic characteristics, sexual behaviours and HIV testing in the three months before and during COVID‐19 measures (23 January 2020) were collected. Chi‐square test and logistic regression were used for analyses.ResultsOverall, 685 MSM were recruited from 135 cities in 30 provinces of China, whose mean age was 28.8 (SD: 6.9) years old. The majority of participants self‐identified as gay (81.9%) and had disclosed their sexual orientation (66.7%). In the last three months, 69.6% ever had sex with men, nearly half of whom had multiple sexual partners (47.2%). Although the overall HIV testing rates before and during COVID‐19 measures were comparable, more MSM self‐tested for HIV during COVID‐19 measures (52.1%) compared to before COVID‐19 measures (41.6%, p = 0.038). Fewer MSM used facility‐based HIV testing during COVID‐19 measures (42.9%) compared to before COVID‐19 measures (54.1%, p = 0.038). Among 138 facility‐based testers before COVID‐19 measures, 59.4% stopped facility‐based testing during COVID‐19 measures. Among 136 self‐testers during COVID‐19 measures, 58.1% had no HIV self‐testing before COVID‐19 measures. Multivariable logistic regression showed that having sex with other men in the last three months (adjusted odds ratio, aOR = 2.04, 95% CI: 1.38 to 3.03), self‐identifying as gay (aOR = 2.03, 95% CI: 1.31 to 3.13), ever disclosing their sexual orientation (aOR = 1.72, 95% CI: 1.19 to 2.50) and tested for HIV in three months before COVID‐19 measures (aOR = 4.74, 95% CI: 3.35 to 6.70) were associated with HIV testing during COVID‐19 measures.ConclusionsFacility‐based HIV testing decreased and HIVST increased among MSM during COVID‐19 measures in China. MSM successfully accessed HIVST as substitute for facility‐based testing, with no overall decrease in HIV testing rates.     

Choosing event‐driven and daily HIV pre‐exposure prophylaxis – data from two European PrEP demonstration projects among men who have sex with men

IntroductionDaily and event‐driven PrEP are both efficacious in reducing the risk for HIV infection. However, the practice of event‐driven PrEP (edPrEP) is less well studied, in particular when provided as an alternative to daily PrEP. We studied regimen preferences and switches, and sexually transmitted infection (STI) incidence.MethodsWe analysed pooled data from two prospective cohort studies among MSM: Be‐PrEP‐ared, Belgium and AMPrEP, the Netherlands. In both projects, participants could choose between daily and edPrEP at three‐monthly study visits, when they were also screened for sexually transmitted infections including hepatitis C (HCV). We assessed the proportion choosing each regimen, and the determinants of choosing edPrEP at baseline. Additionally, we compared the incidence rates (IRs) of HCV, syphilis and chlamydia or gonorrhoea between regimens using Poisson regression. The study period was from 3 August 2015 until 24 September 2018.Results and discussionWe included 571 MSM, of whom 148 (25.9%) chose edPrEP at baseline. 31.7% of participants switched regimen at least once. After 28 months, 23.5% used edPrEP. Older participants (adjusted odds ratio (aOR) = 1.38 per 10 years, 95% confidence interval (CI) = 1.15 to 1.64) and those unemployed (aOR = 1.68, 95% CI = 1.03 to 1.75) were more likely to initially choose edPrEP. IR of HCV and syphilis did not differ between regimens, but the IR of chlamydia/gonorrhoea was higher among daily users (adjusted incidence rate ratio = 1.61, 95% CI = 1.35 to 1.94).ConclusionsA quarter of participants chose edPrEP at baseline and at 28 months this proportion was similar. Although the IR of HCV and syphilis were similar in the two regimens, the lower incidence of chlamydia and gonorrhoea among edPrEP users may suggest that less frequent STI testing of this group could be considered.     

Comparing recruitment strategies to engage hard‐to‐reach men who have sex with men living with HIV with unsuppressed viral loads in four US cities: Results from HPTN 078

IntroductionThere is an urgent need to identify men who have sex with men (MSM) living with HIV with unsuppressed viral loads to prevent transmission. Though respondent‐driven sampling (RDS) is traditionally used for hard‐to‐reach populations, we compare how RDS and direct recruitment (DR) perform in identifying MSM living with HIV with unsuppressed viral loads and identifying MSM with socio‐demographics characteristic of hard‐to‐reach populations.MethodsThis is a cross‐sectional analysis among 1305 MSM who were recruited from March 2016 to December 2017 for a case management intervention trial (HPTN 078). We recruited participants across four cities using RDS and DR methods: Birmingham, AL; Atlanta, GA; Baltimore, MD; and Boston, MA. Participants completed a socio‐demographic questionnaire and underwent HIV testing. We compare the proportion of MSM with HIV and unsuppressed viral loads (HIV RNA ≥ 1000 copies/ml) based on recruitment method using Pearson chi‐square tests. We also compare differences in race, income, healthcare coverage, education, sexual orientation, hidden sexuality and comfort with participating in the LGBT community between recruitment methods and perform non‐parametric trend tests to see how demographics change across RDS recruitment waves.ResultsRDS recruited 721 men (55.2%) and DR yielded 584 men (44.8%). Overall, 69% were living with HIV, of whom 18% were not virally suppressed. HIV prevalence was higher among those recruited via DR (84%) compared to RDS (58%), p < 0.0001. Twenty per cent of DR recruits were not virally suppressed compared to 15% of RDS, though this was not significant. DR yielded a significantly higher proportion of Black participants and those with less than a high school diploma. The prevalence of low income, no healthcare coverage, bisexuality and hidden sexuality increased across RDS waves.ConclusionsDR was more efficient in identifying MSM living with HIV with unsuppressed viral loads; however, there was a higher proportion of hard‐to‐reach MSM who were low income, lacked health coverage, were bisexual and were not open with their sexuality in deeper waves of RDS. Researchers should consider supplementing RDS recruitment with DR efforts if aiming to identify MSM with unsuppressed viral loads via RDS.     

Assessing the performance of international pre‐exposure prophylaxis (PrEP) eligibility guidelines in a cohort of Chinese MSM,Beijing, China 2009 to 2016

IntroductionPrEP is a powerful HIV prevention tool, and locally relevant eligibility criteria are necessary to optimize the prevention impact of PrEP. We assessed performance of existing national and international PrEP eligibility criteria to predict future HIV seroconversion among MSM in Beijing, China.MethodsParticipants were MSM aged ≥18 years who enrolled in a cohort study between July 2009 and March 2016. Participants completed HIV testing, syphilis testing, and a questionnaire on recent sexual health behaviours at each follow‐up visit and were followed until HIV seroconversion or dropout. We assessed PrEP eligibility at the most recent follow‐up visit prior to the final study visit. Participants were classified as indicated for PrEP (or not) based on criteria from guidelines from Europe, Korea, South Africa, Taiwan, the United Kingdom, United States and the World Health Organization. To compare guideline performance, we calculated sensitivity, specificity, Youden’s Index (YI), Matthew’s Correlation Coefficient (MCC), F1 scores and diagnostic odds ratios. For each guideline, performance measures were compared to random allocation of PrEP by randomly selecting a proportion of participants equal to the proportion indicated.ResultsThere were 287 (17∙3%) incident HIV seroconversions among 1663 MSM. The number of men indicated for PrEP from different guidelines ranged from 556 (33∙4%) to 1569 (94∙2%). Compared to random allocation, sensitivity of algorithms to predict seroconversion ranged from slightly worse (−4∙7%) to 30∙2% better than random. However, in absolute terms, none of the sensitivity values increased by more than 11% when compared to random allocation. For all guidelines, specificity was not meaningfully better than random allocation. No guidelines had high binary classification performance measures.ConclusionsThe performance of international indication guidelines in this sample was only slightly better than random allocation. Using such guidelines to screen out MSM self‐identifying as interested in PrEP could lead to misallocation of resources and to good candidates for PrEP being denied access. For settings in which international guidelines perform poorly, alternative indication approaches should be considered.     

A multi‐country cross‐sectional study to assess predictors of daily versus on‐demand oral pre‐exposure prophylaxis in youth from South Africa,Uganda and Zimbabwe

IntroductionSub‐Saharan Africa (SSA) carries the burden of the HIV epidemic, especially among adolescents and young people (AYP). Little is known about pre‐exposure prophylaxis (PrEP) uptake and preferences among AYP in SSA. We describe preferences for daily and on‐demand PrEP among AYP in South Africa, Uganda and Zimbabwe.MethodsA cross‐sectional survey was conducted in 2019 among 13‐ to 24‐year olds, capturing socio‐demographics, HIV risk behaviours and preferences for daily or on‐demand PrEP. Logistic regression models were used to estimate odds ratios, adjusting for site, sex and age.Results and discussionA total of 1330 participants from Cape Town (n = 239), Johannesburg (n = 200), Entebbe (n = 491) and Chitungwiza (n = 400) were enrolled; 673 (51%) were male, and the median age was 19 years (interquartile range 17–22 years). Of 1287 participants expressing a preference, 60% indicated a preference for on‐demand PrEP with differences by site (p < 0.001), sex (p < 0.001) and age group (p = 0.003). On‐demand PrEP was most preferred in Entebbe (75%), among males (65%) versus females (54%) and in older participants (62% in 18‐ to 24‐year‐olds vs. 47% in 13‐ to 15‐year‐olds). After adjusting for site, sex and age group, preference for on‐demand PrEP decreased as sex frequency over the past month increased (p‐trend = 0.004) and varied with the number of partners in the last 6 months, being least popular among those reporting four or more partners (p = 0.02). Participants knowing further in advance that they were likely to have sex were more likely to prefer on‐demand PrEP (p‐trend = 0.02). Participants having a larger age gap with their most recent partner and participants whose last partner was a transactional sex partner or client were both less likely to prefer on‐demand compared to daily PrEP (p = 0.05 and p = 0.09, respectively). Participants who knew their most recent partner was living with HIV or who did not know the HIV status of their most recent partner were less likely to prefer on‐demand PrEP (p = 0.05).ConclusionsOur data show that AYP in four SSA communities prefer on‐demand over daily PrEP options, with differences seen by site, age and sex. PrEP demand creation needs to be reviewed, optimized and tailored to socio‐demographic differences and designed in conjunction with AYP.     

A comparison of the effectiveness of respondent‐driven and venue‐based sampling for identifying undiagnosed HIV infection among cisgender men who have sex with men and transgender women in Tijuana,Mexico

BackgroundEfforts to increase HIV testing, diagnosis and care are critical to curbing HIV epidemics among cisgender men who have sex with men (MSM) and transgender women (TW) in low‐ and middle‐income countries (LMIC). We compared the effectiveness of respondent‐driven sampling (RDS) and venue‐based sampling (VBS) for identifying previously undiagnosed HIV infection among MSM and TW in Tijuana, Mexico.MethodsBetween March 2015 and December 2018, we conducted RDS within the social networks of MSM and TW and VBS at venues frequented by MSM and TW to socialize and meet sexual partners. Those reached by RDS/VBS who reported at least 18 years of age, anal sex with MSM or TW, and no previous HIV diagnosis were eligible for HIV testing.ResultsOf those screened following recruitment via RDS (N = 1232; 98.6% MSM; 1.3% TW), 60.8% (749/1232) were eligible for HIV testing and 97.5% (730/749) were tested for HIV infection, which led to the identification of 36 newly diagnosed HIV infections (4.9%). Of those screened following recruitment via VBS (N = 2560; 95.2% MSM; 4.6% TW), 56.5% (1446/2560) were eligible for HIV testing and 92.8% (1342/1446) were tested for HIV infection, which led to the identification of 82 newly diagnosed HIV infections (6.1%). The proportion of new HIV diagnoses did not differ by recruitment method (ratio = 0.81, 95% confidence interval: 0.55 to 1.18). Compared to those recruited via RDS, those tested following recruitment via VBS were younger, more likely to identify as gay, and more likely to identify as TW. Compared to those recruited via VBS, those newly diagnosed with HIV infection following recruitment via RDS reported higher levels of internalized stigma and were more likely to report injection drug use and a history of deportation from the United States.ConclusionsDespite RDS and VBS being equally effective for identifying undiagnosed HIV infection, each recruitment method reached different subgroups of MSM and TW in Tijuana. Our findings suggest that there may be benefits to using both RDS and VBS to increase the identification of previously undiagnosed HIV infection and ultimately support HIV care engagement among MSM and TW in Mexico and other similar LMIC.     

The impact of disruptions due to COVID‐19 on HIV transmission and control among men who have sex with men in China

IntroductionThe COVID‐19 pandemic is impacting HIV care globally, with gaps in HIV treatment expected to increase HIV transmission and HIV‐related mortality. We estimated how COVID‐19‐related disruptions could impact HIV transmission and mortality among men who have sex with men (MSM) in four cities in China, over a one‐ and five‐year time horizon.MethodsRegional data from China indicated that the number of MSM undergoing facility‐based HIV testing reduced by 59% during the COVID‐19 pandemic, alongside reductions in ART initiation (34%), numbers of all sexual partners (62%) and consistency of condom use (25%), but initial data indicated no change in viral suppression. A mathematical model of HIV transmission/treatment among MSM was used to estimate the impact of disruptions on HIV infections/HIV‐related deaths. Disruption scenarios were assessed for their individual and combined impact over one and five years for 3/4/6‐month disruption periods, starting from 1 January 2020.ResultsOur model predicted new HIV infections and HIV‐related deaths would be increased most by disruptions to viral suppression, with 25% reductions (25% virally suppressed MSM stop taking ART) for a three‐month period increasing HIV infections by 5% to 14% over one year and deaths by 7% to 12%. Observed reductions in condom use increased HIV infections by 5% to 14% but had minimal impact (<1%) on deaths. Smaller impacts on infections and deaths (<3%) were seen for disruptions to facility HIV testing and ART initiation, but reduced partner numbers resulted in 11% to 23% fewer infections and 0.4% to 1.0% fewer deaths. Longer disruption periods (4/6 months) amplified the impact of disruption scenarios. When realistic disruptions were modelled simultaneously, an overall decrease in new HIV infections occurred over one year (3% to 17%), but not for five years (1% increase to 4% decrease), whereas deaths mostly increased over one year (1% to 2%) and five years (1.2 increase to 0.3 decrease).ConclusionsThe overall impact of COVID‐19 on new HIV infections and HIV‐related deaths is dependent on the nature, scale and length of the various disruptions. Resources should be directed to ensuring levels of viral suppression and condom use are maintained to mitigate any adverse effects of COVID‐19‐related disruption on HIV transmission and control among MSM in China.     

Comparison between daily and on‐demand PrEP (pre‐exposure prophylaxis) regimen in covering condomless anal intercourse for men who have sex with men in Hong Kong: A randomized,controlled, open‐label,crossover trial

IntroductionBoth daily and on‐demand regimens have been proven effective for pre‐exposure prophylaxis (PrEP) against HIV in men who have sex with men (MSM). We aimed to compare the two regimens on their coverage of condomless anal intercourse (CLAI) in MSM.MethodsA randomized, controlled, open‐label, crossover trial was conducted in a teaching hospital in Hong Kong. Participants were sexually active HIV‐negative MSM aged 18 years or above with normal renal function and without chronic hepatitis B infection. Oral tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) tablets were prescribed for PrEP. After a 2‐week lead‐in with daily TDF/FTC for treatment‐naïve MSM for tolerance assessment, participants were randomly assigned in a 1:1 ratio with a block size of four to either daily‐first or on‐demand‐first arm based on the IPERGAY study, for receiving PrEP for 16 weeks, then crossed‐over to the alternative regimen for another 16 weeks. The primary outcome was the proportion of days with PrEP‐covered CLAI by intention‐to‐treat analysis. The trial is registered with the CCRB Clinical Trials Registry, CUHK, CUHK_CCRB00606, and is closed to accrual.ResultsBetween 25 August 2018 and 23 March 2019, 119 eligible participants were assigned to daily‐first arm (n = 59) and on‐demand‐first arm (n = 60) with an 87% overall completion rate (n = 103). With 96% and 54% of days on PrEP during daily and on‐demand periods, respectively, the proportion of days with PrEP‐covered CLAI between two arms were not statistically different (92% vs. 92%, p = 0.93). About half (47%) were diagnosed with at least one episode of incident sexually transmitted infection. Mild and time‐limited adverse events, including diarrhoea, headache, nausea and dizziness, were reported in 37 (31%) and 10 (8%) during the daily and on‐demand periods, respectively. At the end of the study, a similar proportion favoured daily or on‐demand regimen.ConclusionsHigh prevention‐effective adherence, as reflected from the coverage of CLAI, was achievable by either daily or on‐demand PrEP among MSM, albeit a higher number of tablets taken for daily PrEP. As both regimens were well accepted, a flexible approach adopting either or both regimens with possible switching is warranted in order to suit individual health needs.     

Impact of the COVID‐19 pandemic on HIV prevention and care services among key populations across 15 cities in India: a longitudinal assessment of clinic‐based data

IntroductionThe COVID‐19 pandemic has threatened to diminish gains in HIV epidemic control and impacts are likely most profound among key populations in resource‐limited settings. We aimed to understand the pandemic''s impact on HIV‐related service utilization among men who have sex with men (MSM) and people who inject drugs (PWID) across India.MethodsBeginning in 2013, we established integrated care centres (ICCs) which provide HIV preventive and treatment services to MSM and PWID across 15 Indian sites. We examined utilization patterns for an 18‐month period covering 2 months preceding the pandemic (January–February 2020) and over the first and second COVID‐19 waves in India (March 2020–June 2021). We assessed: (1) unique clients accessing any ICC service, (2) ICC services provided, (3) unique clients tested for HIV and (4) HIV diagnoses and test positivity. Among an established cohort of PWID/MSM living with HIV (PLHIV), we administered a survey on the pandemic''s impact on HIV care and treatment (June–August 2020).ResultsOverall, 13,854 unique clients visited an ICC from January 2020 to June 2021. In January/February 2020, the average monthly number of clients was 3761. Compared to pre‐pandemic levels, the number of clients receiving services declined sharply in March 2020, dropping to 25% of pre‐pandemic levels in April/May 2020 (first wave), followed by a slow rebound until April/May 2021 (second wave), when there was a 57% decline. HIV testing followed a similar trajectory. HIV test positivity changed over time, declining in the first wave and reaching its nadir around July 2020 at ∼50% of pre‐pandemic levels. Positivity then increased steadily, eventually becoming higher than pre‐pandemic periods. The second wave was associated with a decline in positivity for MSM but was relatively unchanged for PWID. Among 1650 PLHIV surveyed, 52% of PWID and 45% of MSM reported the pandemic impacted their ability to see an HIV provider. MSM had barriers accessing sexually transmitted infection testing and partner HIV testing.ConclusionsThe COVID‐19 pandemic led to significant decreases in HIV‐related service utilization among key populations in India. This presents an opportunity for increased transmission and patients presenting with advanced disease among groups already disproportionately impacted by HIV.     

The likelihood of severe COVID‐19 outcomes among PLHIV with various comorbidities: a comparative frequentist and Bayesian meta‐analysis approach

IntroductionThe SARS‐CoV‐2 virus can currently pose a serious health threat and can lead to severe COVID‐19 outcomes, especially for populations suffering from comorbidities. Currently, the data available on the risk for severe COVID‐19 outcomes due to an HIV infection with or without comorbidities paint a heterogenous picture. In this meta‐analysis, we summarized the likelihood for severe COVID‐19 outcomes among people living with HIV (PLHIV) with or without comorbidities.MethodsFollowing PRISMA guidelines, we utilized PubMed, Web of Science and medRxiv to search for studies describing COVID‐19 outcomes in PLHIV with or without comorbidities up to 25 June 2021. Consequently, we conducted two meta‐analyses, based on a classic frequentist and Bayesian perspective of higher quality studies.Results and discussionWe identified 2580 studies (search period: January 2020–25 June 2021, data extraction period: 1 January 2021–25 June 2021) and included nine in the meta‐analysis. Based on the frequentist meta‐analytical model, PLHIV with diabetes had a seven times higher risk of severe COVID‐19 outcomes (odd ratio, OR = 6.69, 95% CI: 3.03–19.30), PLHIV with hypertension a four times higher risk (OR = 4.14, 95% CI: 2.12–8.17), PLHIV with cardiovascular disease an odds ratio of 4.75 (95% CI: 1.89–11.94), PLHIV with respiratory disease an odds ratio of 3.67 (95% CI: 1.79–7.54) and PLHIV with chronic kidney disease an OR of 9.02 (95% CI: 2.53–32.14) compared to PLHIV without comorbidities. Both meta‐analytic models converged, thereby providing robust summative evidence. The Bayesian meta‐analysis produced similar effects overall, with the exclusion of PLHIV with respiratory diseases who showed a non‐significant higher risk to develop severe COVID‐19 outcomes compared to PLHIV without comorbidities.ConclusionsOur meta‐analyses show that people with HIV, PLHIV with coexisting diabetes, hypertension, cardiovascular disease, respiratory disease and chronic kidney disease are at a higher likelihood of developing severe COVID‐19 outcomes. Bayesian analysis helped to estimate small sample biases and provided predictive likelihoods. Clinical practice should take these risks due to comorbidities into account and not only focus on the HIV status alone, vaccination priorities should be adjusted accordingly.     

PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project

IntroductionHIV incidence remains high among African adolescent girls and young women (AGYW). The primary objective of this study is to assess pre‐exposure prophylaxis (PrEP) initiation, use, persistence and HIV acquisition among African AGYW offered PrEP in order to inform PrEP scale‐up.MethodsPOWER was a prospective implementation science evaluation of PrEP delivery for sexually active HIV‐negative AGYW ages 16–25 in family planning clinics in Kisumu, Kenya and youth and primary healthcare clinics in Cape Town and Johannesburg, South Africa. Follow‐up visits occurred at month 1 and quarterly for up to 36 months. PrEP users were defined based on the month 1 refill. PrEP persistence through month 6 was assessed using Kaplan–Meier survival analysis among AGYW with a month 1 visit, defining non‐persistence as an ≥15 day gap in PrEP availability for daily dosing. PrEP execution was evaluated in a subset with PrEP supply from the prior visit sufficient for daily dosing by measuring blood tenofovir diphosphate (TFV‐DP) levels.ResultsFrom June 2017 to September 2020, 2550 AGYW were enrolled (1000 in Kisumu, 787 in Cape Town and 763 in Johannesburg). Median age was 21 years, 66% had a sexual partner of unknown HIV status, and 29% had chlamydia and 10% gonorrhoea. Overall, 2397 (94%) initiated PrEP and 749 (31%) had a refill at 1 month. Of AGYW who could reach 6 months of post‐PrEP initiation follow‐up, 128/646 (20%) persisted with PrEP for 6 months and an additional 92/646 (14%) had a gap and restarted PrEP. TFV‐DP levels indicated that 47% (91/193) took an average of ≥4 doses/week. Sixteen HIV seroconversions were observed (incidence 2.2 per 100 person‐years, 95% CI 1.2, 3.5); 13 (81%) seroconverters either did not have PrEP dispensed in the study interval prior to seroconversion or TFV‐DP levels indicated <4 doses/week in the prior 6 weeks.ConclusionsIn this study of PrEP integration with primary care and reproductive health services for African AGYW, demand for PrEP was high. Although PrEP use decreased in the first months, an important fraction used PrEP through 6 months.  Strategies are needed to simplify PrEP delivery, support adherence and offer long‐acting PrEP options to improve persistence and HIV protection.