Articles tagged as "Sexual transmission and prevention"

Risky young love

Perspectives on intimate relationships among young people in rural South Africa: the logic of risk. 

Edin K, Nilsson B, Ivarsson A, Kinsman J, Norris SA, Kahn K. Cult Health Sex. 2016 Mar 17:1-15. [Epub ahead of print]

This paper explores how young people in rural South Africa understand gender, dating, sexuality and risk-taking in adolescence. The empirical material drawn upon consists of 20 interviews with young men and women (aged 18-19) and reflects normative gender patterns characterised by compulsory heterosexuality and dating as obligatory, and representing key symbols of normality. However, different meanings of heterosexual relationships are articulated in the interviews, for example in the recurring concept of 'passing time', and these meanings show that a relationship can be something arbitrary: a way to reduce boredom and have casual sex. Such a rationale for engaging in a relationship reflects one of several other normative gender patterns, which relate to the trivialisation of dating and sexual risk-taking, and which entail making compromises and legitimising deviations from the 'ideal' life-script and the hope of a better future. However, risks do not exclusively represent something bad, dangerous or immoral, because they are also used as excuses to avoid sex, HIV acquisition and early pregnancy. In conclusion, various interrelated issues can both undermine and/or reinforce risk awareness and subsequent risk behaviour. Recognition of this tension is essential when framing policies to support young people to reduce sexual risk-taking behaviour.

Abstract access

Editor’s notes: This article explores how young people in a poor, rural area in South Africa articulate and understand gender, dating, sexuality, and risk-taking.  Twenty young people (10 female, 10 male) aged between 18 and 19 years of age were randomly selected from three villages that participate in the Health and Socio-Demographic Surveillance System in Mpumalanga Province in north-eastern South Africa. 

Participants’ narratives highlight how normative gender patterns characterised by compulsory heterosexuality and dating as obligatory represent key symbols of normality. The authors highlight how two themes, early pregnancy and HIV, are central to understanding practices of dating and heterosexual relationships. They are also important for understanding ideas about the consequences of a dissolute lifestyle and the risk it exerts on plans and hopes for a better future. This risk was perceived to be particularly acute by, and for, young women who are seen to bear the brunt of negative outcomes, particularly relating to early school dropout.

The findings of this study have important implications for HIV prevention programmes, particularly for adolescent girls and young women. Where intimate relationships are trivialised as guided by normative gender patterns and pressure to have heterosexual relationships, young people risk becoming infected with HIV, becoming parents too early, and interrupting their education. The findings highlight the potential for context-sensitive programmes which play careful attention to local norms and young people’s internalised relationship discourses. These could usefully include opportunities for critical reflection in order to support young people to reduce their exposure to risks.  It is also important to recognise young people’s aspirations, and the perceived benefits they derive from relationships.

Africa
South Africa
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Couples programme illustrates benefits in effecting change in drinking and HIV risk behaviours among men

The male factor: outcomes from a cluster randomized field experiment with a couples-based HIV prevention intervention in a South African township.

Wechsberg WM, Zule WA, El-Bassel N, Doherty IA, Minnis AM, Novak SD, Myers B, Carney T. Drug Alcohol Depend. 2016 Apr 1;161:307-15. doi: 10.1016/j.drugalcdep.2016.02.017. Epub 2016 Feb 18.

Background: This study examined the effects of the Couples Health CoOp intervention on heavy drinking, condom use, and HIV incidence.

Methods: Thirty neighborhoods from one South African township were cluster randomized into three intervention arms: Couples Health CoOp (CHC), Women's Health CoOp/Men's Health CoOp (WHC/MHC), or a comparison arm. We recruited 290 men from informal drinking establishments who reported drinking alcohol regularly. We also recruited their main heterosexual sex partners.

Results: At 6-month follow-up, men in the CHC arm were less likely to report heavy drinking (OR 0.47, 95% CI: 0.25, 0.90) and were more likely to report consistent condom use during the past month (OR 2.66, 95% CI: 1.23, 5.76) than men in the comparison arm. At baseline, 26% of women and 13% of men were HIV-infected; at 6-month follow-up, 16 females and 5 males had seroconverted. HIV incidence was significantly lower among women in the CHC arm (IRR 0.22, 95% CI: 0.04, 1.01) than in the WHC/MHC arm.

Conclusions: A couples-based intervention focusing on intersecting risks for HIV can improve bio-behavioral outcomes, underscoring the importance of engaging couples together in HIV prevention.

Abstract access

Editor’s notes: This study describes the benefits of a novel couples-based programme that addresses key drivers of HIV incidence in South Africa. It focuses on the intersection of alcohol use, relationship contexts, and gender norms. Heavy drinking among men in South Africa is associated with HIV risks including multiple concurrent sexual partnerships and low rates of condom use. In addition, heavy drinking alongside gender norms that disempower women can lead to increased HIV risk for female partners. For example, women may seek sexual partners outside of their main relationship for money, due to male regular partners spending household income on alcohol instead. The study extends the Women’s Health CoOp (an evidence-based programme to reduce substance use, violence, and sexual risks among vulnerable women) to include both partners. The hypothesis is that a programme addressing both partners together (the Couples Health CoOp [CHC] arm) would be more effective than the original female-focused programme at reducing alcohol use and risk behaviors. They found that men reported reduced heavy drinking in all three arms including the control arm after six months (compared to baseline) and the reduction in heavy drinking was greatest in the CHC arm. This highlights the role of couples-based programmes for HIV prevention in women. The high HIV incidence in this setting (16 per 100 person-years in women; 4 per 100 person-years in men) is a reminder that innovative activities are necessary. Future work should continue to include exploration of the effectiveness of adapting of single-gender programmes to be couple-based. 

Africa
South Africa
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Tackling taboos and preventing HIV: family programmes to prevent HIV in adolescence

Developing family interventions for adolescent HIV prevention in South Africa. 

Kuo C, Atujuna M, Mathews C, Stein DJ, Hoare J, Beardslee W, Operario D, Cluver L, L KB. AIDS Care. 2016 Mar;28 Suppl 1:106-10. doi: 10.1080/09540121.2016.1146396. Epub 2016 Feb 26.

Adolescents and young people account for 40% of all new HIV infections each year, with South Africa one of the hardest hit countries, and having the largest population of people living with HIV. Although adolescent HIV prevention has been delivered through diverse modalities in South Africa, and although family-based approaches for adolescent HIV prevention have great potential for highly affected settings such as South Africa, there is a scarcity of empirically tested family-based adolescent HIV preventive interventions in this setting. We therefore conducted focus groups and in-depth interviews with key informants including clinicians, researchers, and other individuals representing organizations providing HIV and related health services to adolescents and parents (N = 82). We explored family perspectives and interactions around topics such as communication about sex, HIV, and relationships. Participants described aspects of family interactions that presented both challenges and opportunities for family-based adolescent HIV prevention. Parent-child communication on sexual topics were taboo, with these conversations perceived by some adults as an invitation for children to engage in HIV risk behavior. Parents experienced social sanctions for discussing sex and adolescents who asked about sex were often viewed as disrespectful and needing discipline. However, participants also identified context-appropriate strategies for addressing family challenges around HIV prevention including family meetings, communal parenting, building efficacy around parent-adolescent communication around sexual topics, and the need to strengthen family bonding and positive parenting. Findings indicate the need for a family intervention and identify strategies for development of family-based interventions for adolescent HIV prevention. These findings will inform design of a family intervention to be tested in a randomized pilot trial.

Abstract  Full-text [free] access

Editor’s notes: This short paper presents a qualitative study about family discussions about HIV and sex in Khayelitsha, South Africa. The results illustrate that sex is considered by many adults a taboo subject with adolescents younger than 18 years old. Young people who initiate discussion about sex, HIV risk or pregnancy can be scolded for being disrespectful. Sex is often discussed as a problem after young people have already started being sexually active. Study participants identified ‘family conferences’, with parents but also relatives more broadly, as promising settings for programmes. The activities should facilitate discussions that frame communication about sex and HIV prevention as positive. 

Africa
South Africa
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Tenofovir resistance – need for caution but not panic

Global epidemiology of drug resistance after failure of WHO recommended first-line regimens for adult HIV-1 infection: a multicentre retrospective cohort study.

TenoRes Study Group. Lancet Infect Dis. 2016 Jan 28. pii: S1473-3099(15)00536-8. doi: 10.1016/S1473-3099(15)00536-8. [Epub ahead of print]

Background: Antiretroviral therapy (ART) is crucial for controlling HIV-1 infection through wide-scale treatment as prevention and pre-exposure prophylaxis (PrEP). Potent tenofovir disoproxil fumarate-containing regimens are increasingly used to treat and prevent HIV, although few data exist for frequency and risk factors of acquired drug resistance in regions hardest hit by the HIV pandemic. We aimed to do a global assessment of drug resistance after virological failure with first-line tenofovir-containing ART.

Methods: The TenoRes collaboration comprises adult HIV treatment cohorts and clinical trials of HIV drug resistance testing in Europe, Latin and North America, sub-Saharan Africa, and Asia. We extracted and harmonised data for patients undergoing genotypic resistance testing after virological failure with a first-line regimen containing tenofovir plus a cytosine analogue (lamivudine or emtricitabine) plus a non-nucleotide reverse-transcriptase inhibitor (NNRTI; efavirenz or nevirapine). We used an individual participant-level meta-analysis and multiple logistic regression to identify covariates associated with drug resistance. Our primary outcome was tenofovir resistance, defined as presence of K65R/N or K70E/G/Q mutations in the reverse transcriptase (RT) gene.

Findings: We included 1926 patients from 36 countries with treatment failure between 1998 and 2015. Prevalence of tenofovir resistance was highest in sub-Saharan Africa (370/654 [57%]). Pre-ART CD4 cell count was the covariate most strongly associated with the development of tenofovir resistance (odds ratio [OR] 1.50, 95% CI 1.27-1.77 for CD4 cell count <100 cells per µL). Use of lamivudine versus emtricitabine increased the risk of tenofovir resistance across regions (OR 1.48, 95% CI 1.20-1.82). Of 700 individuals with tenofovir resistance, 578 (83%) had cytosine analogue resistance (M184V/I mutation), 543 (78%) had major NNRTI resistance, and 457 (65%) had both. The mean plasma viral load at virological failure was similar in individuals with and without tenofovir resistance (145 700 copies per mL [SE 12 480] versus 133 900 copies per mL [SE 16 650; p=0.626]).

Interpretation: We recorded drug resistance in a high proportion of patients after virological failure on a tenofovir-containing first-line regimen across low-income and middle-income regions. Effective surveillance for transmission of drug resistance is crucial.

Abstract  Full-text [free] access 

Editor’s notes: Global surveillance for tenofovir (TDF) resistance is important at a time of expanding use of TDF-containing regimens for treatment and prevention. This collaborative analysis used data collated from several small studies in different settings. Overall, around one in three people who had failed on TDF-containing treatment had evidence of TDF resistance, although this frequency varied between 20% in Europe to almost 60% in Africa. Mutations associated with NNRTIs and lamivudine/emtricitabine resistance were more common overall and were present in most people with TDF resistance.

The regional variation probably reflects differences in clinical practice and study inclusion criteria. All European studies involved cohorts with frequent viral load monitoring, whereas half of the African cohorts had no routine viral load monitoring. All European studies included people with virologic failure but with low-level viraemia (viral load <1000 copies/ml) whereas almost all African studies included only people with viral load >1000 copies/ml.

While these data provide useful estimates of the frequency of drug resistance mutations in people with virologic failure on first-line ART, there should be caution about extrapolating beyond this. Reports from cohort studies with an accurate denominator of all people starting TDF-containing first-line ART would be useful to give more reliable estimates of overall incidence of acquired TDF resistance. Moreover, there remains a need for representative population-based surveillance for acquired and transmitted drug resistance. So far, global surveillance has detected limited evidence of transmitted TDF-associated mutations, but this needs to be monitored closely, especially in high incidence settings.

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The dapivirine ring confers moderate efficacy, but hope for a new prevention option

Use of a vaginal ring containing dapivirine for HIV-1 prevention in women.

Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, Mgodi NM, Matovu Kiweewa F, Nair G, Mhlanga F, Siva S, Bekker LG, Jeenarain N, Gaffoor Z, Martinson F, Makanani B, Pather A, Naidoo L, Husnik M, Richardson BA, Parikh UM, Mellors JW, Marzinke MA, Hendrix CW, van der Straten A, Ramjee G, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Mayo A, Scheckter R, Berthiaume J, Livant E, Jacobson C, Ndase P, White R, Patterson K, Germuga D, Galaska B, Bunge K, Singh D, Szydlo DW, Montgomery ET, Mensch BS, Torjesen K, Grossman CI, Chakhtoura N, Nel A, Rosenberg Z, McGowan I, Hillier S, Team M-AS N Engl J Med. 2016 Feb 22. [Epub ahead of print]

Background: Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection.

Methods: We conducted a phase 3, randomized, double-blind, placebo-controlled trial of a monthly vaginal ring containing dapivirine, a non-nucleoside HIV-1 reverse-transcriptase inhibitor, involving women between the ages of 18 and 45 years in Malawi, South Africa, Uganda, and Zimbabwe.

Results: Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively). The incidence of HIV-1 infection in the dapivirine group was lower by 27% (95% confidence interval [CI], 1 to 46; P=0.05) than that in the placebo group. In an analysis that excluded data from two sites that had reduced rates of retention and adherence, the incidence of HIV-1 infection in the dapivirine group was lower by 37% (95% CI, 12 to 56; P=0.007) than that in the placebo group. In a post hoc analysis, higher rates of HIV-1 protection were observed among women over the age of 21 years (56%; 95% CI, 31 to 71; P<0.001) but not among those 21 years of age or younger (-27%; 95% CI, -133 to 31; P=0.45), a difference that was correlated with reduced adherence. The rates of adverse medical events and antiretroviral resistance among women who acquired HIV-1 infection were similar in the two groups.

Conclusions: A monthly vaginal ring containing dapivirine reduced the risk of HIV-1 infection among African women, with increased efficacy in subgroups with evidence of increased adherence.

 Abstract  Full-text [free] access 

Editor’s notes: Women bear a larger proportion of the HIV burden worldwide due to biological and behavioural factors. As a result, the HIV prevention field has focused research over the past couple of decades to identify new prevention options especially for women, to reduce this burden. The study presented in this paper is the first to publish phase III efficacy trial results for a vaginal ring containing the antiretroviral drug dapivirine for HIV prevention. The ring is designed to prevent HIV acquisition locally within the vagina in HIV negative women and kept in the body for a period of four weeks. This strategy is meant to address two components of adherence and side effects. A longer-acting product and local application is contrasted with the daily and systemic use of oral pre-exposure prophylaxis, a regimen which can be difficult to maintain. This study found that the dapivirine ring did not protect women with a high rate of efficacy, 27% overall. Interestingly, the sub-analyses of the data illustrated that there was better protection in women with better adherence, and in women who were over the age of 21. Further explorations of the data along with the qualitative findings from the study will surely provide more valuable insights into the low overall rate of efficacy, and perhaps most importantly into why age made such a difference in rates of protection. As mentioned in the paper, a second study on the ring, which was presented at CROI 2016, publishing similar results, and those results combined with the data from this study will further our knowledge regarding the viability of this HIV prevention option.  

Africa
Malawi, South Africa, Uganda, Zimbabwe
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The effects of trauma follow people on the move

A systematic review of HIV risk behaviors and trauma among forced and unforced migrant populations from low and middle-income countries: state of the literature and future directions.

Michalopoulos LM, Aifah A, El-Bassel N. AIDS Behav. 2016 Feb;20(2):243-61. doi: 10.1007/s10461-015-1014-1.

The aim of the current systematic review is to examine the relationship between trauma and HIV risk behaviors among both forced and unforced migrant populations from low and middle income countries (LMIC). We conducted a review of studies published from 1995 to 2014. Data were extracted related to (1) the relationship between trauma and HIV risk behaviors, (2) methodological approach, (3) assessment methods, and (4) differences noted between forced and unforced migrants. A total of 340 records were retrieved with 24 studies meeting inclusion criteria. Our review demonstrated an overall relationship between trauma and HIV risk behaviors among migrant populations in LMIC, specifically with sexual violence and sexual risk behavior. However, findings from 10 studies were not in full support of the relationship. Findings from the review suggest that additional research using more rigorous methods is critically needed to understand the nature of the relationship experienced by this key-affected population.

Abstract access

Editor’s notes: The number of forced and unforced migrants is growing globally. Refugees, asylum seekers, and internally displaced persons (IDP) are forced migrants who often migrate due to political violence or conflict. Labour migrants are seen as unforced migrants who choose to emigrate for economic reasons. About half of labour migrants worldwide are women who are increasingly migrating on their own being the sole income provider for their families. With respect to trauma exposure and HIV risk in settings of long-term political violence and conflict, the distinction between war migrant, non-war migrant, and long-term resident is blurred. This in-depth review of 24 studies related to low-and middle-income countries (LMIC), mostly from sub-Saharan Africa, found findings similar to those from non-migrant populations in high-income countries. These linked traumatic experiences among migrant populations with HIV risk behaviours. Sexual violence was consistently associated with HIV sexual risk behaviours and HIV infection across the studies. But there are big gaps in the scientific literature. For example, the relationship between trauma and HIV risks has been explored for female labour migrants who are sex workers but not among women who have other occupations. Most studies addressed sexual risk and alcohol dependence, but injecting drug risk behaviours and use of any illicit drugs were virtually ignored by most studies. Few studies examined a possible link for trauma that occurred pre-migration and post-migration. Three qualitative studies examined male migrants who have sex with men, finding that violent experiences and discrimination and stigma associated with homophobia, combined with other migrant-associated traumas, can compound their mental health outcomes and subsequent HIV risk behaviours – but all were only conducted in the last four years. No studies were found that focused on HIV prevention programmes to address trauma and HIV risks among migrant workers in LMIC. However, the studies do reveal important factors that prevention programmes would have to consider. For example, concerns among labour migrants about dangerous working conditions may take precedence over HIV risk perceptions and the need for safer sex. This systematic review presents a wealth of information while highlighting the need to improve the quality of scientific research examining the link between HIV and trauma among both forced and unforced migrants in LMIC. 

Africa, Asia, Europe, Latin America
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Sex and drugs: cost-effectiveness of risk reduction programmes for female sex workers who inject drugs in Mexico

Cost-effectiveness of combined sexual and injection risk reduction interventions among female sex workers who inject drugs in two very distinct Mexican border cities.

Burgos JL, Patterson TL, Graff-Zivin JS, Kahn JG, Rangel MG, Lozada MR, Staines H, Strathdee SA. PLoS One. 2016 Feb 18;11(2):e0147719. doi: 10.1371/journal.pone.0147719. eCollection 2016.

Background: We evaluated the cost-effectiveness of combined single session brief behavioral intervention, either didactic or interactive (Mujer Mas Segura, MMS) to promote safer-sex and safer-injection practices among female sex workers who inject drugs (FSW-IDUs) in Tijuana (TJ) and Ciudad-Juarez (CJ) Mexico. Data for this analysis was obtained from a factorial RCT in 2008-2010 coinciding with expansion of needle exchange programs (NEP) in TJ, but not in CJ.

Methods: A Markov model was developed to estimate the incremental cost per quality adjusted life year gained (QALY) over a lifetime time frame among a hypothetical cohort of 1000 FSW-IDUs comparing a less intensive didactic vs. a more intensive interactive format of the MMS, separately for safer sex and safer injection combined behavioral interventions. The cost for antiretroviral therapy was not included in the model. We applied a societal perspective, a discount rate of 3% per year and currency adjusted to US$2014. A multivariate sensitivity analysis was performed. The combined and individual components of the MMS interactive behavioral intervention were compared with the didactic formats by calculating the incremental cost-effectiveness ratios (ICER), defined as incremental unit of cost per additional health benefit (e.g., HIV/STI cases averted, QALYs) compared to the next least costly strategy. Following guidelines from the World Health Organization, a combined strategy was considered highly cost-effective if the incremental cost per QALY gained fell below the gross domestic product per capita (GDP) in Mexico (equivalent to US$ 10 300).

Findings: For CJ, the mixed intervention approach of interactive safer sex/didactic safer injection had an incremental cost-effectiveness ratio (ICER) of US$4360 ($310-$7200) per QALY gained compared with a dually didactic strategy. Using the dually interactive strategy had an ICER of US$5874 ($310-$7200) compared with the mixed approach. For TJ, the combination of interactive safer sex/didactic safer injection had an ICER of US$5921 ($104-$9500) per QALY compared with dually didactic. Strategies using the interactive safe injection intervention were dominated due to lack of efficacy advantage. The multivariate sensitivity analysis showed a 95% certainty that in both CJ and TJ the ICER for the mixed approach (interactive safer sex didactic safer injection intervention) was less than the GDP per capita for Mexico. The dual interactive approach met this threshold consistently in CJ, but not in TJ.

Interpretation: In the absence of an expanded NEP in CJ, the combined-interactive formats of the MMS behavioral intervention is highly cost-effective. In contrast, in TJ where NEP expansion suggests that improved access to sterile syringes significantly reduced injection-related risks, the interactive safer-sex combined didactic safer-injection was highly cost-effective compared with the combined didactic versions of the safer-sex and safer-injection formats of the MMS, with no added benefit from the interactive safer-injection component.

Abstract  Full-text [free] access 

Editor’s notes: Female sex workers who inject drugs are a particularly vulnerable group with potential risks of HIV infection stemming from both condomless sex and use of contaminated injecting equipment. In the northern border towns of Mexico, which are on major drug trafficking routes into the United States, the prevalence of HIV among female sex workers who inject drugs is 12%. This is in comparison with 6% among female sex workers who do not inject drugs and 0.3% among the general population. In this context, the authors conducted a cost-effectiveness analysis of a combined single-session brief behavioural programme. It was either didactic or interactive, to promote safer sexual and injection practices among female sex workers who inject drugs in two Mexican cities: Ciudad Juarez and Tijuana.

The authors found that the programme can be highly cost-effective in reducing HIV risky behaviours, although with varying results. Sensitivity analyses suggested that in both cities, the mixed approach (interactive safer sex/didactic safer injection intervention) was highly cost-effective. The dual interactive approach was highly cost-effective in Ciudad Juarez but not in Tijuana.

This article illustrates the importance of targeting programmes that take into consideration city-level contexts. Although the cities are similar in many ways, the double interactive approach was not highly cost-effective in the Tijuana setting. This is likely to be due to the fact that needle syringe distribution at the community level expanded at the same time, making the interactive safer injection practice component redundant. This supports previous research that community-level programmes, such as needle-exchange programmes, could be potentially more cost-effective than individual-level activities. Individual-level activities may then be best suited for settings where needle-syringe programmes are not available, such as in prisons. 

Latin America
Mexico
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High adherence to on-demand PrEP and no increase in sexual risk behaviours

Uptake of PrEP and condom and sexual risk behavior among MSM during the ANRS IPERGAY trial.

Sagaon-Teyssier L, Suzan-Monti M, Demoulin B, Capitant C, Lorente N, Preau M, Mora M, Rojas Castro D, Chidiac C, Chas J, Meyer L, Molina JM, Spire B, Group AIS. AIDS Care. 2016 Feb 17:1-8. [Epub ahead of print]

The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40-98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate-emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants' adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0-M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1-max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9-35.6%) reported both PrEP and condom use; 11.7% (7.2-18.9%) reported condom-use only, and 16.7% (10.8-29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2-68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3-79.4%) and 69.3% (58.3-75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4-max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM.

Abstract access

Editor’s notes: HIV pre-exposure prophylaxis (PrEP) is an effective method of HIV prevention, and it is now recognised as a key element of combination prevention strategies in key populations. The IPERGAY trial evaluated the intermittent use of oral PrEP, timed around sexual activity, in gay men and other men who have sex with men. The investigators hypothesised that taking PrEP ‘on demand’, i.e. at the time of sexual activity rather than daily, would improve adherence and therefore its effectiveness. The reduction in HIV incidence in the trial is one of the highest reported at 86%.

This analysis of trial participants in the double-blind phase of the trial demonstrated that PrEP and/or condom use at the most recent sexual intercourse was reported at 80% of visits, and there was no evidence of a change over time. Adherence remained quite high over the 24 months of follow-up, with 60% reporting correct use of PrEP at each visit, although numbers were small owing to early stopping of the placebo arm. As with other studies of PrEP, there was no evidence of an increase in reported sexual risk behaviours over time. In addition, there was some suggestion of a trend towards a decreased number of partners. However, as trial participants were offered a comprehensive care package (including regular adherence and risk reduction counselling), it is difficult to separate the effects of the intensive support from the effects of the PrEP regimen itself.

The successful integration of PrEP into HIV combination prevention programmes will require an understanding of factors that facilitate its uptake and who is most likely to benefit from its use, as well as ensuring regular HIV testing and adequate support services are available.

Europe, Northern America
Canada, France
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Treating vaginal infections lowers risk of sexually transmitted bacterial infections

Periodic presumptive treatment for vaginal infections may reduce the incidence of bacterial sexually transmitted infections.

Balkus JE, Manhart LE, Lee J, Anzala O, Kimani J, Schwebke J, Shafi J, Rivers C, Kabare E, McClelland RS. J Infect Dis. 2016 Feb 4. pii: jiw043. [Epub ahead of print]

Background: Bacterial vaginosis (BV) may increase women's susceptibility to sexually transmitted infections (STIs). In a randomized trial of periodic presumptive treatment (PPT) to reduce vaginal infections, we observed a significant reduction in BV. We further assessed the intervention effect on incident Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Mycoplasma genitalium (MG).

Methods: Non-pregnant, HIV-uninfected women from the US and Kenya received intravaginal metronidazole 750mg plus miconazole 200mg or placebo for 5 consecutive nights each month for 12 months. Genital fluid specimens were collected every other month. Poisson regression models were used to assess the intervention effect on STI acquisition.

Results: Of 234 women enrolled, 221 had specimens available for analysis. Incidence of any bacterial STI (CT, GC, or MG) was lower in the intervention arm compared to placebo (incidence rate ratio [IRR]=0.54, 95% CI 0.32-0.91). When assessed individually, reductions in STIs were similar but not statistically significant (CT:IRR=0.50, 95% CI 0.20-1.23; GC:IRR=0.56, 95% CI 0.19-1.67; MG:IRR=0.66, 95% CI 0.38-1.15).

Conclusions: In addition to reducing BV, this PPT intervention may also reduce women's bacterial STI risk. Because BV is highly prevalent, often persists, and frequently recurs after treatment, interventions that reduce BV over extended periods could play a role in decreasing STI incidence globally.

Abstract access

Editor’s notes: Increasing attention is being paid to the health of vaginal microbiota. Disruption of the vaginal microbiota i.e. dysbiosis, is thought to increase susceptibility to other sexually transmitted infections, including HIV. While considerable observational data support the hypothesis of vaginal dysbiosis being a risk factor for sexually transmitted infection, the hypothesis has not been confirmed through randomized control trials. Women in the programme arm of this randomized control trial were presumptively treated for bacterial vaginosis and vulvovaginal candidiasis on a monthly basis. Relative to the control arm, the women in the programme arm had approximately half the risk of infection by Chlamydia trachomatis, Neisseria gonorrhoea or Mycoplasma genitalium. The findings provide strong evidence for considering healthy vaginal flora as a protective factor from sexually transmitted bacterial infections. Further research must consider whether the protection extends to sexually transmitted viruses and protozoa, and for adolescents and women who are not of African heritage.

Africa, Northern America
Kenya, United States of America
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We need to listen to people living with HIV who refuse or delay starting ART: lessons from Australia

On the margins of pharmaceutical citizenship: not taking HIV medication in the "treatment revolution" era.

Persson A, Newman CE, Mao L, de Wit J. Med Anthropol Q. 2016 Jan 12. doi: 10.1111/maq.12274. [Epub ahead of print]

With the expanding pharmaceuticalization of public health, anthropologists have begun to examine how biomedicine's promissory discourses of normalization and demarginalization give rise to new practices of and criteria for citizenship. Much of this work focuses on the biomedicine-citizenship nexus in less-developed, resource-poor contexts. But how do we understand this relationship in resource-rich settings where medicines are readily available, often affordable, and a highly commonplace response to illness? In particular, what does it mean to not use pharmaceuticals for a treatable infectious disease in this context? We are interested in these questions in relation to the recent push for early and universal treatment for HIV infection in Australia for the twin purposes of individual and community health. Drawing on Ecks's concept of pharmaceutical citizenship, we examine the implications for citizenship among people with HIV who refuse or delay recommended medication. We find that moral and normative expectations emerging in the new HIV "treatment revolution" have the capacity to both demarginalize and marginalize people with HIV.

Abstract 

Editor’s notes: Following the release of WHO ‘Guidelines on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV’ at the end of September 2015, there has been growing momentum to roll out treatment to all people living with HIV. This important paper highlights an important issue affecting the provision of antiretroviral therapy (ART) to all people living with HIV, regardless of CD4 cell count. Not everyone wants to start treatment promptly. The authors interviewed 27 people in Australia who had declined to start ART. Ten of these people had never used ART, while the remaining 17 had started and then stopped therapy. There were many reasons why these people chose not to start or continue with ART. These reasons included fears over side-effects and the commitment to life-long therapy. Some doubted that they needed ‘treatment’ because they were well. A few were sceptical about the efficacy of the drugs.  These reasons for delaying treatment are being echoed in research from other parts of the world. The authors of this paper note that if treatment is promoted as ‘normal’, then people who decline ART risk marginalisation for ‘not doing the right thing’. This, they suggest, is particularly the case in places where ART are readily and freely available, like Australia. The authors conclude by highlighting the importance of listening to people who do not want to start ART, and understanding their reservations, while ensuring they do not become marginalised.

Oceania
Australia
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