Articles tagged as "Blood / body fluids and HIV prevention"

HIV Self-testing acceptable to vocational students in South Africa

High acceptability of HIV self-testing among technical vocational education and training college students in Gauteng and North West province: what are the implications for the scale up in South Africa?

Mokgatle MM, Madiba S. PLoS One. 2017 Jan 31;12(1):e0169765. doi: 10.1371/journal.pone.0169765. eCollection 2017.

Background: Although HIV self-testing (HIVST) is globally accepted as an important complement to existing HIV testing approaches, South Africa has lagged behind in its adoption. As a result, data on the acceptability and uptake of HIVST is limited. The study investigated the acceptability of HIVST among students in Technical Vocational Education and Training (TVET) colleges in two provinces in South Africa.

Methods: A cross-sectional survey using a self-administered structured questionnaire was used to collect data among 3662 students recruited from 13 TVET colleges.

Results: The mean age of the students was 21.9 years. The majority (80.9%) were sexually active; while 66.1% reported that they had one sexual partner, and 33.9% had two or more sexual partners in the past year, and 66.5% used condoms during the last sexual act. Three-quarters tested for HIV in the past year but less than half knew about HIVST prior to the survey. The acceptability of HIVST was high; about three-quarters showed a willingness to purchase a self-test kit and a majority would self-test with partners. Acceptability of HIVST was associated with being sexually active (OR = 1.73, p = 0.02, confidence interval (CI): 1.08-2.75), having ever been tested for HIV (OR = 1.74, p = 0.001, CI: 1.26-2.38), and having multiple sexual partners (OR = 0.61, p = 0.01, CI: 0.42-0.88). Three-quarters would confirm test results at a local health facility. In terms of counselling, telephone hotlines were acceptable to only 39.9%, and less than half felt that test-kit leaflets would provide sufficient information to self-test.

Interpretations: The high acceptability of HIVST among the students calls for extensive planning and preparation for the scaling up of HIVST in South Africa. In addition, campaigns similar to those conducted to promote HIV counselling and testing (HCT) should be considered to educate communities about HIVST.

Abstract  Full-text [free] access  

Editor’s notes: The percentage of people living with HIV who know their status (the first 90 of the UNAIDS 90:90:90 treatment target) has been consistently well below the stated target in national HIV treatment cascades. HIV self-testing is an exciting strategy being used to increase the uptake of testing, and has recently been adopted in South Africa. This study had two aims; firstly to assess the participants attitudes to currently available HIV counselling and testing services and secondly to assess the level of acceptability of HIV self-testing. The study population were students in technical and vocational education and training colleges in South Africa.

Among people who had not tested for HIV in the past year, reasons given for non-uptake of testing (other than a low perception of risk) included a fear of stigma associated with a positive test or a lack of comfort with testing in a hospital setting. Less than half of participants had heard of HIV self-testing, but when the concept was explained to them, around 80% expressed a willingness to use it if it was available, and 70% were willing to purchase the self-test kit. These results are consistent with other studies of HIV self-testing uptake and acceptability in sub-Saharan Africa.

The stated willingness of participants to present at a clinic for a confirmatory test is encouraging. However, this may not reflect actual behaviour, especially in a setting where there is currently no plan or system to link people with positive HIV self-test results to a clinic for confirmatory testing. However, the drive to improve counselling and linkage around self-testing needs to be balanced against the fundamental principle for HIV self-testing to allow choice for users to test without the need for a health worker to be present, and the privacy associated with this. Further work may include assessing acceptability of using remote services to complement HIV self-testing such as telephone hotlines or other counselling strategies. 

Africa
South Africa
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Mixed methods in biomedical intervention trials yield rich data – the VOICE-D qualitative study

How presentation of drug detection results changed reports of product adherence in South Africa, Uganda and Zimbabwe.

Musara P, Montgomery ET, Mgodi NM, Woeber K, Akello CA, Hartmann M, Cheng H, Levy L, Katz A, Grossman CI, Chirenje ZM, van der Straten A, Mensch B. AIDS Behav. 2017 Jan 21. doi: 10.1007/s10461-017-1685-x. [Epub ahead of print]

Accurate estimates of study product use are critical to understanding and addressing adherence challenges in HIV prevention trials. The VOICE trial exposed a significant gap between self-reported adherence and drug detection. The VOICE-D qualitative study was designed to better understand non-adherence during VOICE, and was conducted in 2 stages: before (stage 1) and after (stage 2) drug detection results were provided to participants. Transcripts from 44 women who participated in both stages were analysed to understand the effect of presenting drug detection data on narratives of product use. Thirty-six women reported high adherence in stage 1, yet admitted non-use in stage 2, three reported high adherence in both stages (contrary to their drug detection results) and five had consistent responses across both stages and drug results. Presenting objective measures of use may facilitate more accurate product use reporting and should be evaluated in future prevention trials.

Abstract access  

Editor’s notes: The VOICE trial looked at the effectiveness of PrEP and vaginal microbicides in women in three African countries. One of the findings of the study was low product adherence among some women, based on retrospective drug level testing. In this paper, the authors compare data on product adherence from before and after participants were given plasma drug detection results. The findings are revealing, not least because many of women interviewed explained why they had claimed to be adhering to the drug, when they were not. Women gave many reasons for not being open about taking their medicines/use of the microbicide. It is interesting that a few women continued to say that they were good adherers, even when presented with drug plasma data, which suggested otherwise. This, the authors note, requires further investigation. 

The findings provide valuable evidence of the shortcomings of collecting self-reported adherence data. The use of biomedical markers to reveal drug plasma levels is important. However, the qualitative research, which documented the discussion around those findings, is both fascinating and extremely useful. Perhaps in future there will be an even greater willingness to fund good qualitative research as a key component of trials?

Africa
South Africa, Uganda, Zimbabwe
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Benefits of including males living with HIV in voluntary medical male circumcision - modelling analysis

Could circumcision of HIV-positive males benefit voluntary medical male circumcision programs in Africa? Mathematical modeling analysis.

Awad SF, Sgaier SK, Lau FK, Mohamoud YA, Tambatamba BC, Kripke KE, Thomas AG, Bock N, Reed JB, Njeuhmeli E, Abu-Raddad LJ. PLoS One. 2017 Jan 24;12(1):e0170641. doi: 10.1371/journal.pone.0170641. eCollection 2017.

Background: The epidemiological and programmatic implications of inclusivity of HIV-positive males in voluntary medical male circumcision (VMMC) programs are uncertain. We modeled these implications using Zambia as an illustrative example.

Methods and findings: We used the Age-Structured Mathematical (ASM) model to evaluate, over an intermediate horizon (2010-2025), the effectiveness (number of VMMCs needed to avert one HIV infection) of VMMC scale-up scenarios with varying proportions of HIV-positive males. The model was calibrated by fitting to HIV prevalence time trend data from 1990 to 2014. We assumed that inclusivity of HIV positive males may benefit VMMC programs by increasing VMMC uptake among higher risk males, or by circumcision reducing HIV male-to-female transmission risk. All analyses were generated assuming no further antiretroviral therapy (ART) scale-up. The number of VMMCs needed to avert one HIV infection was projected to increase from 12.2 VMMCs per HIV infection averted, in a program that circumcises only HIV-negative males, to 14.0, in a program that includes HIV-positive males. The proportion of HIV-positive males was based on their representation in the population (e.g. 12.6% of those circumcised in 2010 would be HIV-positive based on HIV prevalence among males of 12.6% in 2010). However, if a program that only reaches out to HIV-negative males is associated with 20% lower uptake among higher-risk males, the effectiveness would be 13.2 VMMCs per infection averted. If improved inclusivity of HIV-positive males is associated with 20% higher uptake among higher-risk males, the effectiveness would be 12.4. As the assumed VMMC efficacy against male-to-female HIV transmission was increased from 0% to 20% and 46%, the effectiveness of circumcising regardless of HIV status improved from 14.0 to 11.5 and 9.1, respectively. The reduction in the HIV incidence rate among females increased accordingly, from 24.7% to 34.8% and 50.4%, respectively.

Conclusion: Improving inclusivity of males in VMMC programs regardless of HIV status increases VMMC effectiveness, if there is moderate increase in VMMC uptake among higher-risk males and/or if there is moderate efficacy for VMMC against male-to-female transmission. In these circumstances, VMMC programs can reduce the HIV incidence rate in males by nearly as much as expected by some ART programs, and additionally, females can benefit from the intervention nearly as much as males.

Abstract  Full-text [free] access

Editor’s notes: Evidence from randomised control trials and modelling studies suggest that voluntary male medical circumcision (VMMC) is a cost-effective HIV prevention programme. A deterministic compartmental age structured HIV model was used to assess benefits of including HIV positive males in VMMC programmes. The HIV model was parameterized using HIV biological and behavioural data for sub-Saharan Africa.  The model was fit to HIV prevalence for Zambia in the years between 1990 and 2014. The model used baseline circumcision coverages from Zambia Demographic and Health Survey 2007. The authors analysed the model for three VMMC programme scenarios; circumcising HIV negative males only, circumcising both HIV negative and HIV positive males, and circumcising males regardless of their HIV status. Sensitivity analysis was conducted to ascertain the robustness of key model assumptions on the study findings. The findings from the study suggest that, improving the inclusivity of all males is likely to improve the effectiveness of VMMC programmes.  This will be the case if there is moderate increase in uptake among higher-risk males and/or moderate VMMC efficacy in preventing male-to-female transmission. This is a very interesting modelling study which gives insights to policymakers on factors to consider in designing VMMC programmes. 

Africa
Zambia
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HIV incidence halved among injecting drugs users in network outreach programme - Ukraine

HIV incidence among people who inject drugs (PWIDs) in Ukraine: results from a clustered randomised trial.

Booth RE, Davis JM, Dvoryak S, Brewster JT, Lisovska O, Strathdee SA, Latkin CA. Lancet HIV. 2016 Oct;3(10):e482-9. doi: 10.1016/S2352-3018(16)30040-6. Epub 2016 Jul 29.

Background: HIV prevalence among people who inject drugs (PWID) in Ukraine is among the highest in the world. In this study, we aimed to assess whether a social network intervention was superior to HIV testing and counselling in affecting HIV incidence among PWID. Although this was not the primary aim of the study, it is associated with reducing drug and sex risk behaviours, which were primary aims.

Methods: In this clustered randomised trial, PWID who were 16 years of age or older, had used self-reported drug injection in the past 30 days, were willing to be interviewed for about 1 hour and tested for HIV, were not too impaired to comprehend and provide informed consent, and, for this paper, who tested HIV negative at baseline were recruited from the streets by project outreach workers in three cities in southern and eastern Ukraine: Odessa, Donetsk, and Nikolayev. Index or peer leaders, along with two of their network members, were randomly assigned (1:1) by the study statistician to the testing and counselling block (control group) or the testing and counselling plus a social network intervention block (intervention group). No stratification or minimisation was done. Participants in the network intervention received five sessions to train their network members in risk reduction. Those participants assigned to the control group received no further intervention after counselling. The main outcome of this study was HIV seroconversion in the intent-to-treat population as estimated with Cox regression and incorporating a gamma frailty term to account for clustering. This trial is registered with ClinicalTrial.gov, number NCT01159704.

Findings: Between July 12, 2010, and Nov 23, 2012, 2304 PWIDs were recruited, 1200 of whom were HIV negative and are included in the present study. 589 index or peer leaders were randomly assigned to the control group and 611 were assigned to the intervention group. Of the 1200 HIV-negative participants, 1085 (90%) were retained at 12 months. In 553.0 person-years in the intervention group, 102 participants had seroconversion (incidence density 18.45 per 100 person-years; 95% CI 14.87-22.03); in 497.1 person-years in the control group 158 participants seroconverted (31.78 per 100 person-years; 26.83-36.74). This corresponded to a reduced hazard in the intervention group (hazard ratio 0.53, 95% CI 0.38-0.76, p=0.0003). No study-related adverse events were reported.

Interpretation: These data provide strong support for integrating peer education into comprehensive HIV prevention programmes for PWID and suggest the value in developing and testing peer-led interventions to improve access and adherence to pre-exposure prophylaxis and antiretroviral therapy.

Abstract  Full-text [free] access 

Editor’s notes: People who inject drugs are at high risk of HIV infection, and, in many settings, are unlikely to have appropriate access to HIV prevention programmes. This study is a secondary, subgroup analysis of a randomised control of a social network programme for people who inject drugs in Ukraine (the primary outcome was HIV risk taking behaviour). The investigators recruited 256 index users, who subsequently recruited fellow members of their injection network to the study. Half (n=128) of the index participants were randomized to a two-week training programme in risk reduction education. These “peer leaders” were trained with the intention that they would disseminate these skills within their injection networks. The HIV incidence was alarmingly high. After 12 months, for the sub-group of participants who were initially HIV-negative, the incidence of seroconversion was 31.9/100 person-years in the control networks and 18.4/100 person-years in the programme networks, representing a 47% reduction in incidence associated with the programme. This study is notable for its randomized design, low attrition, close collaboration with local non-governmental organizations, a study protocol adaptation process which engaged drugs users and dealers, and a biological outcome measure. Further research can consider the economic costs for each averted HIV infection, whether the programme effects varied by other factors, and assessment of the extent to which the risk reduction skills were shared beyond study participants. The very high incidence, even among those receiving the intervention, emphasize the need for much greater investment in harm reduction approaches.

Europe
Ukraine
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HIV-exposed uninfected children – why the increased mortality risk?

HIV-exposed children account for more than half of 24-month mortality in Botswana.

Zash R, Souda S, Leidner J, Ribaudo H, Binda K, Moyo S, Powis KM, Petlo C, Mmalane M, Makhema J, Essex M, Lockman S, Shapiro R. BMC Pediatr. 2016 Jul 21;16:103. doi: 10.1186/s12887-016-0635-5.

Background: The contribution of HIV-exposure to childhood mortality in a setting with widespread antiretroviral treatment (ART) availability has not been determined.

Methods: From January 2012 to March 2013, mothers were enrolled within 48 h of delivery at 5 government postpartum wards in Botswana. Participants were followed by phone 1-3 monthly for 24 months. Risk factors for 24-month survival were assessed by Cox proportional hazards modeling.

Results: Three thousand mothers (1499 HIV-infected) and their 3033 children (1515 HIV-exposed) were enrolled. During pregnancy 58% received three-drug ART, 23% received zidovudine alone, 11% received no antiretrovirals (8% unknown); 2.1% of children were HIV-infected by 24 months. Vital status at 24 months was known for 3018 (99.5%) children; 106 (3.5%) died including 12 (38%) HIV-infected, 70 (4.7%) HIV-exposed uninfected, and 24 (1.6%) HIV-unexposed. Risk factors for mortality were child HIV-infection (aHR 22.6, 95% CI 10.7, 47.5), child HIV-exposure (aHR 2.7, 95% CI 1.7, 4.5) and maternal death (aHR 8.9, 95% CI 2.1, 37.1). Replacement feeding predicted mortality when modeled separately from HIV-exposure (aHR 2.3, 95% CI 1.5, 3.6), but colinearity with HIV-exposure status precluded investigation of its independent effect. Applied at the population level (26% maternal HIV prevalence), an estimated 52% of child mortality occurs among HIV-exposed or HIV-infected children.

Conclusions: In a programmatic setting with high maternal HIV prevalence and widespread maternal and child ART availability, HIV-exposed and HIV-infected children still account for most deaths at 24 months. Lack of breastfeeding was a likely contributor to excess mortality among HIV-exposed children.

Abstract  Full-text [free] access 

Editor’s notes: It has been known for some time that HIV-exposed but uninfected children have a higher risk of death than HIV-unexposed children. There is now a need for prospective studies to explore the mechanisms underlying this observation. In this study from Botswana, one of every 20 HIV-exposed but uninfected children had died by 24 months. Four in every five deaths in the HIV-exposed but uninfected children were attributed to infectious diseases, most commonly diarrhoeal illness and respiratory infections.

The analysis was unfortunately not able to unpick the effect of infant feeding on mortality in the HIV-exposed uninfected children. Only 16% of HIV-exposed children were breastfed. This is consistent with national guidelines at the time, where formula feeding was recommended for mothers living with HIV. It is reassuring that in recently updated national guidelines, exclusive breastfeeding for six months is now recommended for mothers living with HIV on ART with virologic suppression.

Mother-to-child HIV transmission at 24 months was still around 2%, and further infections may have been undiagnosed in children who died before being tested. More than one in three children living with HIV died within 24 months. This reminds us that while there is increasing interest in HIV-exposed uninfected children, our priority for now should still be achieving elimination of mother-to-child HIV transmission.

Africa
Botswana
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Fishing, injection drug use and HIV risk

The association between psychosocial and structural-level stressors and HIV injection drug risk behavior among Malaysian fishermen: a cross-sectional study.

Michalopoulos LM, Jiwatram-Negron T, Choo MK, Kamarulzaman A, El-Bassel N. BMC Public Health. 2016 Jun 2;16(1):464. doi: 10.1186/s12889-016-3125-7.

Background: Malaysian fishermen have been identified as a key-affected HIV population with HIV rates 10 times higher than national rates. A number of studies have identified that psychosocial and structural-level stressors increase HIV injection drug risk behaviors. The purpose of this paper is to examine psychosocial and structural-level stressors of injection drug use and HIV injection drug risk behaviors among Malaysian fishermen.

Methods: The study employs a cross-sectional design using respondent driven sampling methods. The sample includes 406 fishermen from Pahang state, Malaysia. Using multivariate logistic regressions, we examined the relationship between individual (depression), social (adverse interactions with the police), and structural (poverty-related) stressors and injection drug use and risky injection drug use (e.g.., receptive and non-receptive needle sharing, frontloading and back-loading, or sharing drugs from a common container).

Results: Participants below the poverty line had significantly lower odds of injection drug use (OR 0.52, 95 % CI: 0.27-0.99, p = 0.047) and risky injection drug use behavior (OR 0.48, 95 % CI: 0.25-0.93, p = 0.030). In addition, participants with an arrest history had higher odds of injection use (OR 19.58, 95 % CI: 9.81-39.10, p < 0.001) and risky injection drug use (OR 16.25, 95 % CI: 4.73-55.85, p < 0.001). Participants with depression had significantly higher odds of engaging in risky injection drug use behavior (OR 3.26, 95 % 1.39-7.67, p = 0.007). Focusing on participants with a history of injection drug use, we found that participants with depression were significantly more likely to engage in risky drug use compared to participants below the depression cutoff (OR 3.45, 95 % CI: 1.23-9.66, p < 0.02).

Conclusions: Findings underscore the need to address psychosocial and structural-level stressors among Malaysian fishermen to reduce HIV injection drug risk behaviors.

Abstract  Full-text [free] access 

Editor’s notes: There is an increasing amount of research on high rates of HIV infection among people living in fishing communities in parts of Africa and Asia. There is also a lot of information on factors which put people in these fishing communities at risk of HIV infection. This paper is, however, the first study to look in detail at the association between risky injection drug use behaviours and HIV among fishermen. The authors of this fascinating and important paper provide a detailed analysis on the association between, what they call, individual, social and structural factors which contribute to risk. Interestingly, poorer fishermen were at less risk than fishermen who were better off, perhaps because poorer men could not afford the costs of injection drugs. However, the fear of the police, and the risk of arrest, resulted in injection practices which increased the risk of HIV infection. The authors note that the association between symptoms of depression and risky injection drug use may be an outcome of this behaviour rather than the cause. The authors highlight how fishermen using injection drugs to manage stress and risk in their lives, may compound the stress they face by this behaviour. The paper illustrates, very clearly, the complex relationship there often is between individual behaviours and the structural and social context. The authors provide very useful pointers for unpacking risk and HIV-infection in other similar populations. 

Asia
Malaysia
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HIV and injecting ‘krokodile’

Krokodile Injectors in Ukraine: fueling the HIV Epidemic?

Booth RE, Davis JM, Brewster JT, Lisovska O, Dvoryak S. AIDS Behav. 2016 Feb;20(2):369-76. doi: 10.1007/s10461-015-1008-z.

This study was designed to assess the characteristics of krokodile injectors, a recent phenomenon in Ukraine, and HIV-related risk factors among people who inject drugs (PWID). In three Ukraine cities, Odessa, Donetsk and Nikolayev, 550 PWID were recruited between December 2012 and October 2013 using modified targeted sampling methods. The sample averaged 31 years of age and they had been injecting for over 12 years. Overall, 39% tested positive for HIV, including 45% of krokodile injectors. In the past 30 days, 25% reported injecting krokodile. Those who injected krokodile injected more frequently (p < 0.001) and they injected more often with others (p = 0.005). Despite knowing their HIV status to be positive, krokodile users did not reduce their injection frequency, indeed, they injected as much as 85% (p = 0.016) more frequently than those who did not know their HIV status or thought they were negative. This behavior was not seen in non-krokodile using PWID. Although only a small sample of knowledgeable HIV positive krokodile users was available (N = 12), this suggests that krokodile users may disregard their HIV status more so than non-krokodile users. In spite of widespread knowledge of its harmful physical consequences, a growing number of PWID are turning to injecting krokodile in Ukraine. Given the recency of krokodile use in the country, the associated higher frequency of injecting, a propensity to inject more often with others, and what could be a unique level of disregard of HIV among krokodile users, HIV incidence could increase in future years.

Abstract access

Editor’s notes: This is an important study among a highly vulnerable population of people who inject drugs where HIV prevalence has been consistently high over the last decade. This is one of the first empirical studies to examine the role of krokodile use on HIV risk acquisition. Krokodile is a home produced drug that has become more popular among people who inject drugs in Ukraine and the Russian Federation over the last five years. There is a long history of injection with home-produced opioids and amphetamines in these countries. The key component of krokodile is codeine, an opioid, but severe side effects have been associated with its injection including tissue damage, gangrene and organ failure. This study highlights some of the characteristics and HIV risk behaviours associated with krokodile injection to inform appropriate HIV prevention programming. Findings note that people who inject krokodile are more likely to inject with others. This reflects the home-produced nature of the drug that facilitates more group injecting as people congregate at places where it is produced to buy and inject. Programmes need to focus on strategies to avoid injecting with other people’s used injecting equipment, such as marking equipment, as can happen in group injecting scenarios. This programme would ensure there are sufficient numbers of clean needles/syringes in circulation. Worryingly, a higher prevalence of HIV was observed among people who inject krokodile, most likely associated with their older age and more frequent injecting. Targeted harm reduction information is urgently needed for krokodile users to prevent further HIV transmission and prevent soft tissue damage. There is already a large network of needle-syringe programmes and opioid substitution therapy available for people who inject drugs in Ukraine. However, access is often reduced since people who inject drugs are concerned about being arrested. Registration as a person who injects drugs causes problems with employment, families and police. Collaboration with the police is necessary to increase access to opioid substitution and needle and syringe programmes. Programmes are also required to reduce the stigma associated with injection in order to address the health needs of this population. 

Europe
Ukraine
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Condomless sex + viral suppression = ‘safe(r)’ sex? Challenging the laws that criminalise HIV transmission

HIV transmission law in the age of treatment-as-prevention.

Haire B, Kaldor J. J Med Ethics. 2015 Dec;41(12):982-6. doi: 10.1136/medethics-2014-102122. Epub 2015 Sep 29.

Evidence that treating people with HIV early in infection prevents transmission to sexual partners has reframed HIV prevention paradigms. The resulting emphasis on HIV testing as part of prevention strategies has rekindled the debate as to whether laws that criminalise HIV transmission are counterproductive to the human rights-based public health response. It also raises normative questions about what constitutes 'safe(r) sex' if a person with HIV has undetectable viral load, which has significant implications for sexual practice and health promotion. This paper discusses a recent high-profile Australian case where HIV transmission or exposure has been prosecuted, and considers how the interpretation of law in these instances impacts on HIV prevention paradigms. In addition, we consider the implications of an evolving medical understanding of HIV transmission, and particularly the ability to determine infectiousness through viral load tests, for laws that relate to HIV exposure (as distinct from transmission) offences. We conclude that defensible laws must relate to appreciable risk. Given the evidence that the transmissibility of HIV is reduced to negligible level where viral load is suppressed, this needs to be recognised in the framing, implementation and enforcement of the law. In addition, normative concepts of 'safe(r) sex' need to be expanded to include sex that is 'protected' by means of the positive person being virally suppressed. In jurisdictions where use of a condom has previously mitigated the duty of the person with HIV to disclose to a partner, this might logically also apply to sex that is 'protected' by undetectable viral load.

Abstract access

Editor’s notes: The changing landscape of HIV treatment challenges assumptions about the HIV epidemic based on past knowledge and understanding. The authors of this paper set out why laws that criminalise HIV transmission may now need to change. This change is required because of the impact of antiretroviral therapy on the viral load of someone living with HIV and taking their treatment regularly. As the authors note ‘it is no longer reasonable to classify condomless sex as ‘unsafe’ if the partner with HIV has an undetectable viral load’ (p. 985).  What the authors do not discuss is whether someone on antiretroviral therapy does indeed have a suppressed viral load.  Indeed, whether the person’s viral load suppression may change between the act for which they are prosecuted, and the time of the prosecution, is not discussed. The viral load of someone living with HIV on treatment may not stay suppressed if there is a break in adherence. That said, this paper does very effectively highlight how the evolution of the HIV epidemic affects many areas of life and institutions; including laws that may be slow to adapt and change.

Oceania
Australia, New Zealand
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PrEP is effective in a real world setting

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial.

McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, Sullivan AK, Clarke A, Reeves I, Schembri G, Mackie N, Bowman C, Lacey CJ, Apea V, Brady M, Fox J, Taylor S, Antonucci S, Khoo SH, Rooney J, Nardone A, Fisher M, McOwan A, Phillips AN, Johnson AM, Gazzard B, Gill ON. Lancet. 2015 Sep 9. pii: S0140-6736(15)00056-2. doi: 10.1016/S0140-6736(15)00056-2. [Epub ahead of print]

Background: Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir-emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect.

Methods: PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986).

Findings: We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1.2/100 person-years) versus 20 in the deferred group (9.0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64-96, p=0.0001; absolute difference 7.8/100 person-years, 90% CI 4.3-11.3). 13 men (90% CI 9-23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEP. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients.

Interpretation: In this high incidence population, daily tenofovir-emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection.

Abstract  Full-text [free] access

Editor’s notes: The PROUD study was an open label pragmatic randomised controlled trial designed to assess the effectiveness of pre-exposure prophylaxis (PrEP) in gay men and other men who have sex with men and whether the benefits are counteracted by risk compensation in users of PrEP. During the pilot phase of the study to test the feasibility of a large-scale trial the investigators found an unexpectedly high incidence of HIV infections. It was seven times higher than the national estimate reported for gay men and other men who have sex with men in the UK. The incidence of HIV infection was significantly lower in the group assigned to receive PrEP immediately, compared with the group assigned to receive it after a deferral period of one year. Moreover the reduction in HIV incidence was greater than has been observed in placebo-controlled trials. As a result the trial was stopped early on the recommendation of the trial steering committee. The high incidence of HIV suggests that, despite the broad eligibility criteria, the study population was highly selective and that the offer of PrEP attracted men who were at high risk of HIV and most likely to benefit from it. Despite some limitations, for example, lack of data on adherence and sexual behaviour, the results of this study are encouraging and have important implication for HIV prevention. They indicate that PrEP is effective in a real world setting, particularly in a population that is aware of its risk of HIV infection. Furthermore, there was no evidence of risk compensation among PrEP recipients. 

Europe
United Kingdom
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Sexual risk reduction and behavioural programme increases uptake of circumcision in hard-to-reach men

A cluster randomized controlled trial to increase the availability and acceptability of voluntary medical male circumcision in Zambia: the Spear and Shield Project.

Weiss SM, Zulu R, Jones DL, Redding CA, Cook R, Chitalu N. Lancet HIV. 2015 May 1;2(5):e181-e189.

Background: Widespread voluntary medical male circumcision in Africa could avert an estimated 3.436 million HIV infections and 300 000 deaths over the next 10 years. Most Zambian men have expressed little interest in the procedure. We tested the effect of the Spear and Shield intervention designed to increase demand for voluntary medical male circumcision among these hard-to-reach men.

Methods: This cluster randomised controlled trial was done between Feb 1, 2012, and Oct 31, 2014, in Lusaka, Zambia, where HIV prevalence is 20.8%. 13 community health centres were stratified by HIV voluntary counselling and testing rates and patient census, and randomly assigned (5:5:3) to experimental (the intervention), control, or observation-only conditions. Community health centre health-care providers at all 13 sites received training in voluntary medical male circumcision. Eligible participants were aged at least 18 years, HIV-negative, uncircumcised, and had not proactively requested or planned for voluntary medical male circumcision at the time of enrolment. Trial statisticians did not participate in randomisation. After voluntary counselling and HIV testing, participants were recruited; female partners were invited to participate. The primary outcomes at the individual level were the likelihood of voluntary medical male circumcision by 12 months post intervention, and condom use after voluntary medical male circumcision among participants receiving the intervention. The trial is registered with ClinicalTrials.gov, number NCT01688167.

Findings: 800 uncircumcised HIV-negative men (400 in the experimental group, 400 in the control group) were enrolled. 161 participants in the experimental group and 96 in the control group had voluntary medical male circumcision (adjusted odds ratio 2.45, 95% CI 1.24–4.90; p=0.02). Condom use was examined in participants who had voluntary medical male circumcision and reported sexual activity within 1 month of a post-circumcision assessment (88 in the experimental group and 64 in the control group). Condom use over time increased in the experimental group (p=0.03) but not in the control group (p=0.2). One patient died in each group; no adverse events related to study participation were reported.

Interpretation: Comprehensive HIV prevention programmes can increase the demand for and uptake of voluntary medical male circumcision services.

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Editor’s notes: Voluntary medical male circumcision reduces the risk of HIV acquisition in men by approximately 60%, yet in some high-prevalence countries uptake is low. This presents challenges in meeting WHO targets of 80% coverage. In Zambia, only 37% of the national target has been achieved. In this cluster randomised trial, 13 community health centres were randomised to receive training in the “Spear and Shield” programme, control (training for an equivalent period of time on general disease prevention strategies) or observation only. The Spear and Shield programme consisted of four weekly 90 minute group sessions. Men in the programme group had about 2.5 times the odds of having male circumcision, compared to the control group participants. This increase in uptake of male circumcision was not associated with an increase in sexual risk behaviours. In fact there was an increase in condom use in the programme group. According to WHO, demand creation continues to be the major challenge in meeting male circumcision coverage goals. The authors propose that scaling up an evidence-informed programme such as Spear and Shield, while training community health care workers to perform circumcisions, might be one of the best and most cost-effective ways to significantly reduce HIV rates in high-incidence settings.

Africa
Zambia
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