HIV testing and linkage to ART following secondary distribution of HIV self‐test kits to male partners of women living with HIV: a pilot randomized control trial in Mpumalanga,South Africa

IntroductionSouth African men are underrepresented in HIV testing and treatment services. Secondary distribution of oral HIV self‐test (HIVST) kits by women living with HIV (WLHIV) to their male partners (i.e. index partner HIVST) may increase men''s testing and treatment but has been understudied.MethodsBetween March and July 2021, we evaluated the effectiveness of index partner HIVST versus the standard of care (SOC) (invitations for men''s facility‐based testing) on men''s testing in a 1:1 randomized control trial. Eligibility criteria included: WLHIV; ≥18 years of age; attending one of four high‐density rural clinics; have a working cell phone; and self‐reported having a primary male partner of unknown serostatus. The primary outcome was the proportion of WLHIV reporting that her partner tested for HIV within 3 months after enrolment.ResultsWe enrolled 180 WLHIV and 176 completed an endline survey (mean age = 35 years, 15% pregnant, 47% unmarried or non‐cohabiting). In the HIVST arm, 78% of male partners were reported to have tested for HIV versus 55% in SOC (RR = 1.41; 95% CI = 1.14–1.76). In the HIVST arm, nine men were reactive with HIVST (14% positivity), six were confirmed HIV positive with standard testing (67%) and all of those started antiretroviral therapy (ART), and four HIV‐negative men started pre‐exposure prophylaxis (PrEP) (5%). In SOC, six men were diagnosed with HIV (12% positivity), 100% started ART and seven HIV‐negative men started PrEP (16%). One case of verbal intimate partner violence was reported in the HIVST arm.ConclusionsSecondary distribution of HIVST to partners of WLHIV was acceptable and effective for improving HIV testing among men in rural South Africa in our pilot study. Interventions are needed to link reactive HIVST users to confirmatory testing and ART.     

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.     

Improving ART initiation among men who use HIV self‐testing in Malawi: a qualitative study

IntroductionHIV self‐testing (HIVST) increases HIV testing uptake among men; however, the linkage to antiretroviral therapy (ART) among HIVST users is low. Innovative strategies for ART initiation are needed, yet little is known about the unique barriers to care experienced by male HIVST users, and what ART‐related interventions men desire.MethodsWe conducted semi‐structured in‐depth interviews with cisgender men (≥15 years) in Malawi who tested HIV positive using HIVST between 2018 and 2020, as well as interviews with their female partners (≥15 years) who distributed the HIVST kits. Medical records from seven facilities were used to identify respondents. We included men who received HIVST from a health facility (primary distribution) and from sexual partners (secondary distribution). Interview guides focused on unique barriers to ART initiation following HIVST and desired interventions to improve linkage and initiation. Interviews were audio recorded, translated and transcribed to English, and analysed using constant comparison methods in Atlas.ti v.8.4. Themes were compared by HIVST distribution strategy. Data were collected between 2019 and 2020.ResultsTwenty‐seven respondents were interviewed: eight male/female dyads (16 respondents), eight men without a female partner and three women who represented men who did not participate in the study. Among the 19 men represented (16 men interviewed in person, three represented by secondary report from female partners), seven received HIVST through primary distribution, 12 through secondary distribution. Six men never initiated ART (all secondary HIVST distribution). Barriers to ART initiation centred on the absence of healthcare workers at the time of diagnosis and included lack of external motivation for linkage to care (men had to motivate themselves) and lack of counselling before and after testing (leaving ART‐related fears and misconceptions unaddressed)––the latter was especially true for secondary HIVST distribution. Desired interventions were similar across distribution strategies and included ongoing peer mentorship for normalizing treatment adherence, counselling messages tailored to men, outside‐facility services for convenience and privacy, and facility navigation to help men understand how to navigate ART clinics.ConclusionsMale HIVST users face unique challenges to ART initiation, especially those receiving HIVST through secondary distribution. Male‐tailored interventions are desired by men and may help overcome barriers to care.     

Towards the first 90: impact of the national HIV self‐test program on case finding and factors associated with linkage to confirmatory diagnosis in Taiwan

IntroductionBeing aware of one''s HIV‐positive status can help reduce unprotected sex and promote early treatment seeking. Therefore, HIV self‐test (HIVST) programs may help control the HIV epidemic by case finding. The aims of this study were to determine the effect of HIVST programs on HIV case finding, time to confirmatory diagnosis and factors associated with linkage to confirmatory diagnosis in Taiwan.MethodsThe Centers for Disease Control in Taiwan initiated HIVST programs and imported 78,000 self‐test kits in 2017 and 2019. Clients paid 7 US dollars for a self‐test kit at facilities, vending machines or online. The programs set up an HIVST logistics management system; each kit had a unique barcode for monitoring the programs because purchases were anonymous. When clients provided their test results with photo barcodes online or at HIV/AIDS‐designated hospitals, they received full monetary reimbursement. We conducted a quasi‐experimental interrupted time‐series (ITS) analysis that covered a period of 60 months from 2015 to 2019. We enrolled a retrospective cohort of reported HIV cases with initial positive results from HIVST programs between March 2017 and July 2020.ResultsThe ITS analysis included data from 10,976 reported HIV cases from 2015 to 2019. The HIVST‐positive cohort included 386 reported HIV cases, of whom 99.7% were males and 97% were men who have sex with men (MSM); the median age was 28 years. The ITS analysis showed a positive slope change in the number of reported HIV cases immediately in the beginning implementation month (coefficient: 51.09 in 2017 and 3.62 in 2019), but there was a significant decrease over time. It was a negative slope change by 9.52 cases per month in 2017 and 5.56 cases per month in 2019. In the HIVST‐positive cohort, three of five individuals linked to HIV confirmatory diagnosis within 1 month after a positive self‐test result, and an early linkage to confirmatory diagnosis was associated with HIVST disclosure (adjusted OR = 6.5; 95% CI: 3.9–10.6).ConclusionsHIVST programs were associated with an increase in HIV case finding. Our findings suggest that countries with a high incidence of HIV among MSM populations should offer multichannel HIVST services.     

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.     

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.     

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.     

Home‐Based Intervention to Test and Start (HITS): a community‐randomized controlled trial to increase HIV testing uptake among men in rural South Africa

IntroductionThe uptake of HIV testing and linkage to care remains low among men, contributing to high HIV incidence in women in South Africa. We conducted the “Home‐Based Intervention to Test and Start” (HITS) in a 2x2 factorial cluster randomized controlled trial in one of the World’s largest ongoing HIV cohorts in rural South Africa aimed at enhancing both intrinsic and extrinsic motivations for HIV testing.MethodsBetween February and December 2018, in the uMkhanyakude district of KwaZulu‐Natal, we randomly assigned 45 communities (clusters) (n = 13,838 residents) to one of the four arms: (i) financial incentives for home‐based HIV testing and linkage to care (R50 [$3] food voucher each); (ii) male‐targeted HIV‐specific decision support application, called EPIC‐HIV; (iii) both financial incentives and male‐targeted HIV‐specific decision support application and (iv) standard of care (SoC). EPIC‐HIV was developed to encourage and serve as an intrinsic motivator for HIV testing and linkage to care, and individually offered to men via a tablet device. Financial incentives were offered to both men and women. Here we report the effect of the interventions on uptake of home‐based HIV testing among men. Intention‐to‐treat (ITT) analysis was performed using modified Poisson regression with adjustment for clustering of standard errors at the cluster levels.ResultsAmong all 13,838 men ≥ 15 years living in the 45 communities, the overall population coverage during a single round of home‐based HIV testing was 20.7%. The uptake of HIV testing was 27.5% (683/2481) in the financial incentives arm, 17.1% (433/2534) in the EPIC‐HIV arm, 26.8% (568/2120) in the arm receiving both interventions and 17.8% in the SoC arm. The probability of HIV testing increased substantially by 55% in the financial incentives arm (risk ratio (RR)=1.55, 95% CI: 1.31 to 1.82, p < 0.001) and 51% in the arm receiving both interventions (RR = 1.51, 95% CI: 1.21 to 1.87 p < 0.001), compared to men in the SoC arm. The probability of HIV testing did not significantly differ in the EPIC‐HIV arm (RR = 0.96, 95% CI: 0.76 to 1.20, p = 0.70).ConclusionsThe provision of a small financial incentive acted as a powerful extrinsic motivator substantially increasing the uptake of home‐based HIV testing among men in rural South Africa. In contrast, the counselling and testing application which was designed to encourage and serve as an intrinsic motivator to test for HIV did not increase the uptake of home‐based testing.     

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.     

Intersecting stigma and HIV testing practices among urban refugee adolescents and youth in Kampala,Uganda: qualitative findings

IntroductionHIV‐related risks may be exacerbated in humanitarian contexts. Uganda hosts 1.3 million refugees, of which 60% are aged under 18. There are knowledge gaps regarding HIV testing facilitators and barriers, including HIV and intersecting stigmas, among urban refugee youth. In response, we explored experiences and perspectives towards HIV testing strategies, including HIV self‐testing, with urban refugee youth in Kampala, Uganda.MethodsWe implemented a qualitative study with refugee cisgender youth aged 16 to 24 living in Kampala''s informal settlements from February‐April 2019. We conducted five focus groups with refugee youth, including two with adolescent boys and young men, two with adolescent girls and young women and one with female sex workers. We also conducted five key informant (KI) interviews with government, non‐government and community refugee agencies and HIV service providers. We conducted thematic analyses to understand HIV testing experiences, perspectives and recommendations.ResultsParticipants (n = 49) included young men (n = 17) and young women (n = 27) originally from the Democratic Republic of Congo [DRC] (n = 29), Rwanda (n = 11), Burundi (n = 3) and Sudan (n = 1), in addition to five KI (gender: n = 3 women, n = 2 men; country of origin: n = 2 Rwanda, n = 2 Uganda, n = 1 DRC). Participant narratives revealed stigma drivers included fear of HIV infection; misinformation that HIV is a “Ugandan disease”; and blame and shame for sexual activity. Stigma facilitators included legal precarity regarding sex work, same‐sex practices and immigration status, alongside healthcare mistreatment and confidentiality concerns. Stigma experiences were attributed to the social devaluation of intersecting identities (sex work, youth, refugees, sexual minorities, people living with HIV, women). Participants expressed high interest in HIV self‐testing. They recommended HIV self‐testing implementation strategies to be peer supported and expressed concerns regarding sexual‐ and gender‐based violence with partner testing.ConclusionsIntersecting stigma rooted in fear, misinformation, blame and shame, legal precarity and healthcare mistreatment constrain current HIV testing strategies with urban refugee youth. Findings align with the Health Stigma and Discrimination Framework that conceptualizes stigma drivers and facilitators that devalue intersecting health conditions and social identities. Findings can inform multi‐level strategies to foster enabling HIV testing environments with urban refugee youth, including tackling intersecting stigma and leveraging refugee youth peer support.     

Annual home‐based HIV testing in the Chókwè Health Demographic Surveillance System,Mozambique, 2014 to 2019: serial population‐based survey evaluation

IntroductionWHO recommends implementing a mix of community and facility testing strategies to diagnose 95% of persons living with HIV (PLHIV). In Mozambique, a country with an estimated 506,000 undiagnosed PLHIV, use of home‐based HIV testing services (HBHTS) to help achieve the 95% target has not been evaluated.MethodsHBHTS was provided at 20,000 households in the Chókwè Health Demographic Surveillance System (CHDSS), Mozambique, in annual rounds (R) during 2014 to 2019. Trends in prevalence of HIV infection, prior HIV diagnosis among PLHIV (diagnostic coverage), and undiagnosed HIV infection were assessed with three population‐based surveys conducted in R1 (04/2014 to 04/2015), R3 (03/2016 to 12/2016), and R5 (04/2018 to 03/2019) of residents aged 15 to 59 years. Counts of patients aged ≥15 years tested for HIV in CHDSS healthcare facilities were obtained from routine reports.ResultsDuring 2014 to 2019, counsellors conducted 92,512 home‐based HIV tests and newly diagnosed 3711 residents aged 15 to 59 years. Prevalence of HIV infection was stable (R1, 25.1%; R3 23.6%; R5 22.9%; p‐value, 0.19). After the first two rounds (44,825 home‐based tests; 31,717 facility‐based tests), diagnostic coverage increased from 73.8% (95% CI 70.3 to 77.2) in R1 to 93.0% (95% CI 91.3 to 94.7) in R3, and prevalence of undiagnosed HIV infection decreased from 6.6% (95% CI 5.6 to 7.5) in R1 to 1.7% (95% CI 1.2 to 2.1) in R3. After two more rounds (32,226 home‐based tests; 46,003 facility‐based tests), diagnostic coverage was 95.4% (95% CI 93.7 to 97.1) and prevalence of undiagnosed HIV infection was 1.1% (95% CI 0.7 to 1.5) in R5. Prevalence of having last tested at home was 12.7% (95% CI 11.3 to 14.0) in R1, 45.2% (95% CI 43.4 to 47.0) in R3, and 41.4% (95% CI 39.5 to 43.2) in R5, and prevalence of having last tested at a healthcare facility was 45.3% (95% CI 43.3 to 47.3) in R1, 40.1% (95% CI 38.4 to 41.8) in R3, and 45.2% (95% CI 43.3 to 47.0) in R5.ConclusionsHBHTS successfully augmented facility‐based testing to achieve HIV diagnostic coverage in a high‐burden community of Mozambique. HBHTS should be considered in sub‐Saharan Africa communities striving to diagnose 95% of persons living with HIV.     

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.     

Timing of HIV testing among pregnant and breastfeeding women and risk of mother‐to‐child HIV transmission in Malawi: a sampling‐based cohort study

IntroductionPregnant women living with HIV can achieve viral suppression and prevent HIV mother‐to‐child transmission (MTCT) with timely HIV testing and early ART initiation and maintenance. Although it is recommended that pregnant women undergo HIV testing early in antenatal care in Malawi, many women test positive during breastfeeding because they did not have their HIV status ascertained during pregnancy, or they tested negative during pregnancy but seroconverted postpartum. We sought to estimate the association between the timing of last positive HIV test (during pregnancy vs. breastfeeding) and outcomes of maternal viral suppression and MTCT in Malawi’s PMTCT programme.MethodsWe conducted a two‐stage cohort study among mother–infant pairs in 30 randomly selected high‐volume health facilities across five nationally representative districts of Malawi between 1 July 2016 and 30 June 2017. Log‐binomial regression was used to estimate prevalence ratios (PR) and risk ratios (RR) for associations between timing of last positive HIV test (i.e. breastfeeding vs. pregnancy) and maternal viral suppression and MTCT, controlling for confounding using inverse probability weighting.ResultsOf 822 mother–infant pairs who had available information on the timing of the last positive HIV test, 102 mothers (12.4%) had their last positive test during breastfeeding. Women who lived one to two hours (PR = 2.15; 95% CI: 1.29 to 3.58) or >2 hours (PR = 2.36; 95% CI: 1.37 to 4.10) travel time to the nearest health facility were more likely to have had their last positive HIV test during breastfeeding compared to women living <1 hour travel time to the nearest health facility. The risk of unsuppressed VL did not differ between women who had their last positive HIV test during breastfeeding versus pregnancy (adjusted RR [aRR] = 0.87; 95% CI: 0.48 to 1.57). MTCT risk was higher among women who had their last positive HIV test during breastfeeding compared to women who had it during pregnancy (aRR = 6.57; 95% CI: 3.37 to 12.81).ConclusionsMTCT in Malawi occurred disproportionately among women with a last positive HIV test during breastfeeding. Testing delayed until the postpartum period may lead to higher MTCT. To optimize maternal and child health outcomes, PMTCT programmes should focus on early ART initiation and providing targeted testing, prevention, treatment and support to breastfeeding women.     

Closing the gap: did delivery approaches complementary to home‐based testing reach men with HIV testing services during and after the HPTN 071 (PopART) trial in Zambia?

IntroductionThe HPTN 071 (PopART) trial demonstrated that universal HIV testing‐and‐treatment reduced community‐level HIV incidence. Door‐to‐door delivery of HIV testing services (HTS) was one of the main components of the intervention. From an early stage, men were less likely to know their HIV status than women, primarily because they were not home during service delivery. To reach more men, different strategies were implemented during the trial. We present the relative contribution of these strategies to coverage of HTS and the impact of community hubs implemented after completion of the trial among men.MethodsBetween 2013 and 2017, three intervention rounds (IRs) of door‐to‐door HTS delivery were conducted in eight PopART communities in Zambia. Additional strategies implemented in parallel, included: community‐wide “Man‐up” campaigns (IR1), smaller HTS campaigns at work/social places (IR2) and revisits to households with the option of HIV self‐testing (HIVST) (IR3). In 2018, community “hubs” offering HTS were implemented for 7 months in all eight communities. Population enumeration data for each round of HTS provided the denominator, allowing for calculation of the proportion of men tested as a result of each strategy during different time periods.ResultsBy the end of the three IRs, 65–75% of men were reached with HTS, primarily through door‐to‐door service delivery. In IR1 and IR2, “Man‐up” and work/social place campaigns accounted for ∼1 percentage point each and in IR3, revisits with the option of self‐testing for ∼15 percentage points of this total coverage per IR. The yield of newly diagnosed HIV‐positive men ranged from 2.2% for HIVST revisits to 9.9% in work/social places. At community hubs, the majority of visitors accepting services were men (62.8%). In total, we estimated that ∼36% (2.2% tested HIV positive) of men resident but not found at their household during IR3 of PopART accessed HTS provided at the hubs after trial completion.ConclusionsAchieving high coverage of HTS among men requires universal, home‐based service delivery combined with an option of HIVST and delivery of HTS through community‐based hubs. When men are reached, they are willing to test for HIV. Reaching men thus requires implementers to adapt their HTS delivery strategies to meet men''s needs.Clinical Trial Number{"type":"clinical-trial","attrs":{"text":"NCT01900977","term_id":"NCT01900977"}}NCT01900977     

Preference for using a variety of future HIV pre‐exposure prophylaxis products among men who have sex with men in three US cities

BackgroundDaily oral pre‐exposure prophylaxis (PrEP) is available and recommended for men who have sex with men (MSM) at risk for HIV infection. Other HIV prevention products are being developed, including long‐acting injectable (LAI) and event‐based oral and topical formulations. Understanding preferences for potential products by MSM can help direct further development of prevention messaging.MethodsWe present baseline data from HIV‐negative participants enrolled in the US Mobile Messaging for Men (M‐cubed) Study. Participants were asked their likelihood of and rank order preference for using daily oral PrEP and various potential prevention products (one‐ to ‐three‐month injections, 2‐1‐1 sexual event oral dosing, anal or penile gel, or anal suppository), and their sociodemographic characteristics. Bivariate and multivariable logistics regression assessed demographic associations with likelihood of use and rank order preference.ResultsOverall, most MSM reported a likelihood of using LAI (74%), sexual event‐based pills (67%) and penile gel (64%). Men who reported recent unprotected (condomless and PrEPless) anal sex most preferred a penile gel formulation (74%), followed closely by LAI and event‐based pills (73% each). Current PrEP users (vs. non‐users) had greater odds of reporting likelihood to use LAI (AOR = 3.29, 95% CI = 2.12 to 5.11), whereas men reporting recent unprotected anal sex had a greater odds of likelihood to use a penile gel (AOR = 1.79, 95% CI = 1.27 to 2.52) and an anal suppository (AOR = 1.48, 95% CI = 1.08 to 2.02). Hispanic/Latino (vs. White) MSM (AOR = 2.29, 95% CI = 1.40 to 3.73) and, marginally, Black MSM (AOR = 1.54, 95% CI = 1.00 to 2.38) had greater odds of reporting likelihood to use penile gel. Similar patterns were found for rank ordering preference of products, including condoms.ConclusionsMost MSM were interested in using various potential future HIV prevention products, especially LAI. However, two typologies of potential users emerged: men who prefer sexual event‐based methods (condoms, event‐based pill, sexual gels and suppositories) and men who prefer non‐sexual event‐based methods (daily pill, LAI). Men who reported recent unprotected anal sex preferred a penile gel product most, followed closely by sexual event‐based pills and LAI. Racial/ethnic differences were noted as well. These findings on product preferences can help in formulation development and messaging.