Articles tagged as "Latin America"

Stigma and sex work

Editor’s notes: Two interesting studies this month looked at aspects of stigma.  There are big methodological challenges to the study of stigma.  Stigma comprises several different domains and few studies use standardized approaches to measurement that can be translated easily into other contexts.  A systematic review and meta-analysis concludes that people who feel more stigmatized are twice as likely to delay presenting for HIV care.  Gesesew HA and colleagues found only ten studies that met their pre-specified inclusion criteria, and five of these came from Ethiopia.  They acknowledge many of the challenges in combining the results of these ten studies into a single conclusion.  They recommend engagement of health care workers to try to reduce perceived stigma among people living with HIV.

The Nyblade L et al. study from Kenya emphasizes the perception of stigma among sex workers.  In a large sample of 497 females and 232 males, most reported experiencing stigma both verbal and measured from health care workers. For female sex workers, the anticipation of such stigma led to avoidance of health services for both HIV and non-HIV related conditions. In order to provide effective services for key populations, health care workers must be trained to be non-judgemental.  HIV services need to be provided in the context of an overall package of health care.

A study from Europe used ecological data to explore structural risks for HIV among sex workers.  Reeves A and colleagues used regression modelling with data on sex work policies from 27 countries.  They showed a strong correlation between criminalisation of sex work and higher prevalence of HIV among sex workers.  Although they included other factors such as the level of economic development and using drugs, the relatively small number of data points does mean that there may be other confounding factors that could not be measured or adjusted for.

Significant association between perceived HIV related stigma and late presentation for HIV/AIDS care in low and middle-income countries: A systematic review and meta-analysis.

Gesesew HA, Tesfay Gebremedhin A, Demissie TD, Kerie MW, Sudhakar M, Mwanri L. PLoS One. 2017 Mar 30;12(3):e0173928. doi: 10.1371/journal.pone.0173928.eCollection 2017.

Background: Late presentation for human immunodeficiency virus (HIV) care is a major impediment for the success of antiretroviral therapy (ART) outcomes. The role that stigma plays as a potential barrier to timely diagnosis and treatment of HIV among people living with HIV/AIDS (acquired immunodeficiency syndrome) is ambivalent. This review aimed to assess the best available evidence regarding the association between perceived HIV related stigma and time to present for HIV/AIDS care.

Methods: Quantitative studies conducted in English language between 2002 and 2016 that evaluated the association between HIV related stigma and late presentation for HIV care were sought across four major databases. This review considered studies that included the following outcome: 'late HIV testing', 'late HIV diagnosis' and 'late presentation for HIV care after testing'. Data were extracted using a standardized Joanna Briggs Institute (JBI) data extraction tool. Meta- analysis was undertaken using Revman-5 software. I2 and chi-square test were used to assess heterogeneity. Summary statistics were expressed as pooled odds ratio with 95% confidence intervals and corresponding p-value.

Results: Ten studies from low- and middle- income countries met the search criteria, including six (6) and four (4) case control studies and cross-sectional studies respectively. The total sample size in the included studies was 3788 participants. Half (5) of the studies reported a significant association between stigma and late presentation for HIV care. The meta-analytical association showed that people who perceived high HIV related stigma had two times more probability of late presentation for HIV care than who perceived low stigma (pooled odds ratio = 2.4; 95%CI: 1.6-3.6, I2 = 79%).

Conclusions: High perceptions of HIV related stigma influenced timely presentation for HIV care. In order to avoid late HIV care presentation due the fear of stigma among patients, health professionals should play a key role in informing and counselling patients on the benefits of early HIV testing or early entry to HIV care. Additionally, linking the systems and positive case tracing after HIV testing should be strengthened.

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The relationship between health worker stigma and uptake of HIV counseling and testing and utilization of non-HIV health services: the experience of male and female sex workers in Kenya.

Nyblade L, Reddy A, Mbote D, Kraemer J, Stockton M, Kemunto C, Krotki K, Morla J, Njuguna S, Dutta A, Barker C. AIDS Care. 2017 Mar 22:1-9. doi: 10.1080/09540121.2017.1307922. [Epub ahead of print]

The barrier HIV-stigma presents to the HIV treatment cascade is increasingly documented; however less is known about female and male sex worker engagement in and the influence of sex-work stigma on the HIV care continuum. While stigma occurs in all spheres of life, stigma within health services may be particularly detrimental to health seeking behaviors. Therefore, we present levels of sex-work stigma from healthcare workers (HCW) among male and female sex workers in Kenya, and explore the relationship between sex-work stigma and HIV counseling and testing. We also examine the relationship between sex-work stigma and utilization of non-HIV health services. A snowball sample of 497 female sex workers (FSW) and 232 male sex workers (MSW) across four sites was recruited through a modified respondent-driven sampling process. About 50% of both male and female sex workers reported anticipating verbal stigma from HCW while 72% of FSW and 54% of MSW reported experiencing at least one of seven measured forms of stigma from HCW. In general, stigma led to higher odds of reporting delay or avoidance of counseling and testing, as well as non-HIV specific services. Statistical significance of relationships varied across type of health service, type of stigma and gender. For example, anticipated stigma was not a significant predictor of delay or avoidance of health services for MSW; however, FSW who anticipated HCW stigma had significantly higher odds of avoiding (OR = 2.11) non-HIV services, compared to FSW who did not. This paper adds to the growing evidence of stigma as a roadblock in the HIV treatment cascade, as well as its undermining of the human right to health. While more attention is being paid to addressing HIV-stigma, it is equally important to address the key population stigma that often intersects with HIV-stigma.

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National sex work policy and HIV prevalence among sex workers: an ecological regression analysis of 27 European countries.

Reeves A, Steele S, Stuckler D, McKee M, Amato-Gauci A, Semenza JC. Lancet HIV. 2017 Mar;4(3):e134-e140. doi: 10.1016/S2352-3018(16)30217-X. Epub2017 Jan 25.

Background: Sex workers are disproportionately affected by HIV compared with the general population. Most studies of HIV risk among sex workers have focused on individual-level risk factors, with few studies assessing potential structural determinants of HIV risk. In this Article, we examine whether criminal laws around sex work are associated with HIV prevalence among female sex workers.

Method: We estimate cross-sectional, ecological regression models with data from 27 European countries on HIV prevalence among sex workers from the European Centre for Disease Control; sex-work legislation from the US State Department's Country Reports on Human Rights Practices and country-specific legal documents; the rule of law and gross-domestic product per capita, adjusted for purchasing power, from the World Bank; and the prevalence of injecting drug use among sex workers. Although data from two countries include male sex workers, the numbers are so small that the findings here essentially pertain to prevalence in female sex workers.

Findings: Countries that have legalised some aspects of sex work (n=17) have significantly lower HIV prevalence among sex workers than countries that criminalise all aspects of sex work (n=10; β=-2·09, 95% CI -0·80 to -3·37;p=0·003), even after controlling for the level of economic development (β=-1·86; p=0·038) and the proportion of sex workers who are injecting drug users (-1·93;p=0·026). We found that the relation between sex work policy and HIV among sex workers might be partly moderated by the effectiveness and fairness of enforcement, suggesting legalisation of some aspects of sex work could reduce HIV among sex workers to the greatest extent in countries where enforcement is fair and effective.

Interpretation: Our findings suggest that the legalisation of some aspects of sex work might help reduce HIV prevalence in this high-risk group, particularly in countries where the judiciary is effective and fair.

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HIV testing for all

HIV self-testing in Peru: questionable availability, high acceptability but potential low linkage to care among men who have sex with men and transgender women.

Bustamante MJ, Konda KA, Joseph Davey D, Leon SR, Calvo GM, Salvatierra J, Brown B, Caceres CF, Klausner JD. Int J STD AIDS. 2017 Feb;28(2):133-137. doi: 10.1177/0956462416630674. Epub 2016 Jul 10.

HIV status awareness is key to prevention, linkage-to-care and treatment. Our study evaluated the accessibility and potential willingness of HIV self-testing among men who have sex with men (MSM) and transgender women in Peru. We surveyed four pharmacy chains in Peru to ascertain the commercial availability of the oral HIV self-test. The pharmacies surveyed confirmed that HIV self-test kits were available; however, those available were not intended for individual use, but for clinician use. We interviewed 147 MSM and 45 transgender women; nearly all (82%) reported willingness to perform the oral HIV self-test. However, only 55% of participants would definitely seek a confirmatory test in a clinic after an HIV-positive test result. Further, price may be a barrier, as HIV self-test kits were available for 18 USD, and MSM and transgender women were only willing to pay an average of 5 USD. HIV self-testing may facilitate increased access to HIV testing among some MSM/transgender women in Peru. However, price may prevent use, and poor uptake of confirmatory testing may limit linkage to HIV treatment and care.

Abstract access  

Editor’s notes: One of the key ways to reduce stigma around HIV is to increase uptake of HIV testing, making it more acceptable and widely available. The authors of this paper sought to understand the barriers to the use of oral self-testing HIV kits. Evidence illustrates that awareness of HIV status leads to safer sexual and injecting risk behaviours and reduced HIV prevalence. Gay men and other men who have sex with men and transgender women are often marginalized populations. They can experience increased prevalence of HIV and have poorer access to HIV testing and treatment. This descriptive study provides important information illustrating that the use of oral self-testing HIV kits are acceptable to gay men and other men who have sex with men and transgender women. On average, respondents said they would undergo testing four times a year. While test kits were available at pharmacies, the higher price prohibits frequent use. Following diagnosis with a self-test, two thirds of transgender women and 71% of gay men and other men who have sex with men said they would follow up with a confirmatory test. Strategies are necessary to encourage everyone to access services to receive confirmatory testing, counselling and referral to treatment and care as necessary. Prices of HIV self-testing kits need to be lowered to increase accessibility.

Latin America
Peru
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Peer led activities increase HIV testing uptake among MSM

Effectiveness of peer-led interventions to increase HIV testing among men who have sex with men: a systematic review and meta-analysis.

Shangani S, Escudero D, Kirwa K, Harrison A, Marshall B, Operario D. AIDS Care. 2017 Feb 2:1-11. doi: 10.1080/09540121.2017.1282105. [Epub ahead of print]

HIV testing constitutes a key step along the continuum of HIV care. Men who have sex with men (MSM) have low HIV testing rates and delayed diagnosis, especially in low-resource settings. Peer-led interventions offer a strategy to increase testing rates in this population. This systematic review and meta-analysis summarizes evidence on the effectiveness of peer-led interventions to increase the uptake of HIV testing among MSM. Using a systematic review protocol that was developed a priori, we searched PubMed, PsycINFO and CINAHL for articles reporting original results of randomized or non-randomized controlled trials (RCTs), quasi-experimental interventions, and pre- and post-intervention studies. Studies were eligible if they targeted MSM and utilized peers to increase HIV testing. We included studies published in or after 1996 to focus on HIV testing during the era of combination antiretroviral therapy. Seven studies encompassing a total of 6205 participants met eligibility criteria, including two quasi-experimental studies, four non-randomized pre- and-post intervention studies, and one cluster randomized trial. Four studies were from high-income countries, two were from Asia and only one from sub-Saharan Africa. We assigned four studies a "moderate" methodological rigor rating and three a "strong" rating. Meta-analysis of the seven studies found HIV testing rates were statistically significantly higher in the peer-led intervention groups versus control groups (pooled OR 2.00, 95% CI 1.74-2.31). Among randomized trials, HIV testing rates were significantly higher in the peer-led intervention versus control groups (pooled OR: 2.48, 95% CI 1.99-3.08). Among the non-randomized pre- and post-intervention studies, the overall pooled OR for intervention versus control groups was 1.71 (95% CI 1.42-2.06), with substantial heterogeneity among studies (I2 = 70%, p < 0.02). Overall, peer-led interventions increased HIV testing among MSM but more data from high-quality studies are needed to evaluate effects of peer-led interventions on HIV testing among MSM in low- and middle-income countries.

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Editor’s notes: A key driver of the HIV epidemic is low uptake of HIV testing in many settings. This leads to a high proportion of individuals living with HIV being unaware of their status, failing to engage with care and treatment and hence being at risk of transmitting HIV to others. Recent reviews have illustrated that programmes led by members of the same peer group can be effective in promoting HIV-associated behavioural change and improving clinical outcomes. Gay men and other men who have sex with men can experience specific challenges associated with engagement with HIV care. This problem is particularly acute in resource poor regions due to very high levels of stigma.

This systematic review is the first to look specifically at the effectiveness of peer-led activities among gay men and other men who have sex with men. Seven studies were found which fulfilled the inclusion criteria of assessing the impact of peer-led activities on HIV testing uptake among gay men and other men who have sex with men. Four of these were in high income settings, and the others in Peru, Taiwan and Kenya. Each study illustrated a positive effect of peer-led activities on increasing HIV testing rates, and meta-analyses illustrated consistent effects when data were stratified by sub-groups (study methodology, study quality or setting). However, the generalizability of these studies to the entire population of gay men and other men who have sex with men is a concern recognized by the authors as the majority used gay-centric community venues to recruit participants. This is likely to exclude individuals who do not self-identify as being part of this community. Two studies, one in Taiwan and the other in Peru, used social-media as a mechanism of recruitment. This approach may lead to a wider recruitment, although not accessible to people without access to the internet.

Overall, this review emphasizes the potential of peer-led activities to overcome barriers to engage with testing and treatment experienced by gay men and other men who have sex with men and other hard to reach and high-risk sub-populations. It also illustrated the very limited current evidence available to assess such programmes.

 

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Transwomen: high time to act

Unveiling of HIV dynamics among transgender women: a respondent-driven sampling study in Rio de Janeiro, Brazil.

Grinsztejn B, Jalil EM, Monteiro L, Velasque L, Moreira RI, Garcia AC, Castro CV, Kruger A, Luz PM, Liu AY, McFarland W, Buchbinder S, Veloso VG, Wilson EC , for the Transcender Study Team. Lancet HIV. 2017 Feb 7. pii: S2352-3018(17)30015-2. doi: 10.1016/S2352-3018(17)30015-2. [Epub ahead of print]

Background: The burden of HIV in transgender women (transwomen) in Brazil remains unknown. We aimed to estimate HIV prevalence among transwomen in Rio de Janeiro and to identify predictors of newly diagnosed HIV infections.

Methods: We recruited transwomen from Rio de Janeiro, Brazil, by respondent-driven sampling. Eligibility criteria were self-identification as transwomen, being 18 years of age or older, living in Rio de Janeiro or its metropolitan area, and having a valid peer recruitment coupon. We recruited 12 seed participants from social movements and formative focus groups who then used peer recruitment coupons to refer subsequent peers to the study. We categorised participants as HIV negative, known HIV infected, or newly diagnosed as HIV infected. We assessed predictors of newly diagnosed HIV infections by comparing newly diagnosed with HIV-negative participants. We derived population estimates with the Respondent-Driven Sampling II estimator.

Findings: Between Aug 1, 2015, and Jan 29, 2016, we enrolled 345 eligible transwomen. 29.1% (95% CI 23.2-35.4) of participants had no previous HIV testing (adjusted from 60 participants), 31.2% (18.8-43.6) had HIV infections (adjusted from 141 participants), and 7.0% (0.0-15.9) were newly diagnosed as HIV infected (adjusted from 40 participants). We diagnosed syphilis in 28.9% (18.0-39.8) of participants, rectal chlamydia in 14.6% (5.4-23.8), and gonorrhoea in 13.5% (3.2-23.8). Newly diagnosed HIV infections were associated with black race (odds ratio 22.8 [95% CI 2.9-178.9]; p=0.003), travesti (34.1 [5.8-200.2]; p=0.0001) or transsexual woman (41.3 [6.3-271.2]; p=0.0001) gender identity, history of sex work (30.7 [3.5-267.3]; p=0.002), and history of sniffing cocaine (4.4 [1.4-14.1]; p=0.01).

Interpretation: Our results suggest that transwomen bear the largest burden of HIV among any population at risk in Brazil. The high proportion of HIV diagnosis among young participants points to the need for tailored long-term health-care and prevention services to curb the HIV epidemic and improve the quality of life of transwomen in Brazil.

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Editor’s notes: This is a must-read paper for anyone interested in good participatory practices (GPP) in research and/or gender identity and HIV risk, and/or respondent driven sampling (RDS) research techniques. The researchers engaged the transwomen community from the outset in the very apt naming of the project – Transcender – and the study design – appropriate language and participant-sensitive procedures. Three community members were part of the study implementation team and the analyses were refined and written with trans community input. Although eligibility criteria included self-identification as transwomen, study participants included 131 travesti (transvestites), 107 transsexual women, 96 women, and 11 people with other gender identities. Transwomen who self-identified as women had the lowest odds of newly diagnosed HIV infection. This underscores the importance of exploring whether and how greater internal or external gender identity acceptance might confer a protective effect for HIV acquisition, perhaps through ability to use medical services through to transition, which might reduce the risk of violence. The RDS-weighted characteristics of the study participants are striking: 97% had ever experienced discrimination, 49% had ever been subjected to physical violence, and 42% had ever been raped. As for the RDS methodology itself, recruitment began with 12 seeds generating 3.6 (range two to seven) recruitment waves over a period of 26 weeks, with one seed generating 23% of the study sample. Although confidence intervals are wide, detected associations are of high magnitude and significant. With respect to homophily (the tendency to recruit others like oneself), it was moderate for HIV status and race and strong for history of sex work. Further, what are the immediate implications of the findings? Among the 29% of participants who were newly diagnosed as having HIV, nearly half reported no previous HIV testing and 44% reported a negative HIV test in the previous year. Offering pre-exposure prophylaxis (PrEP) to the latter transwomen could have prevented them from acquiring HIV. In addition to addressing the social exclusion and marginalization that creates the structural context of HIV risk for transwomen, it is critical to achieving the UNAIDS 90-90-90 treatment target that we move effectively to remove barriers to health care access. These include fighting stigma and discrimination, tackling transphobia, penalizing and preventing physical and sexual violence, and offering immediate antiretroviral therapy to people living with HIV and to offer immediate PrEP to people found to be HIV-negative.   

 

Latin America
Brazil
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Outcomes on ART among children and adolescents in Latin America

Mortality in children with human immunodeficiency virus initiating treatment: a six-cohort study in Latin America.

Luque MT, Jenkins CA, Shepherd BE, Padgett D, Rouzier V, Succi RC, Machado DM, McGowan CC, Vermund SH, Pinto JA. J Pediatr. 2017 Jan 9. pii: S0022-3476(16)31433-0. doi: 10.1016/j.jpeds.2016.12.034. [Epub ahead of print]

Objectives: To assess the risks of and factors associated with mortality, loss to follow-up, and changing regimens after children with HIV infected perinatally initiate combination antiretroviral therapy (cART) in Latin America and the Caribbean.

Study design: This 1997-2013 retrospective cohort study included 1174 antiretroviral therapy-naive, perinatally infected children who started cART when they were younger than 18 years of age (median 4.7 years; IQR 1.7-8.8) at 1 of 6 cohorts from Argentina, Brazil, Haiti, and Honduras, within the Caribbean, Central and South America Network for HIV Epidemiology. Median follow-up was 5.6 years (IQR 2.3-9.3). Study outcomes were all-cause mortality, loss to follow-up, and major changes/interruption/stopping of cART. We used Cox proportional hazards models stratified by site to examine the association between predictors and times to death or changing regimens.

Results: Only 52% started cART at younger than 5 years of age; 19% began a protease inhibitor. At cART initiation, median CD4 count was 472 cells/mm3 (IQR 201-902); median CD4% was 16% (IQR 10-23). Probability of death was high in the first year of cART: 0.06 (95% CI 0.04-0.07). Five years after cART initiation, the cumulative mortality incidence was 0.12 (95% CI 0.10-0.14). Cumulative incidences for loss to follow-up and regimen change after 5 years were 0.16 (95% 0.14-0.18) and 0.30 (95% 0.26-0.34), respectively. Younger children had the greatest risk of mortality, whereas older children had the greatest risk of being lost to follow-up or changing regimens.

Conclusions: Innovative clinical and community approaches are needed for quality improvement in the pediatric care of HIV in the Americas.

Abstract access

Editor’s notes: Despite the dramatic declines in mortality with antiretroviral therapy (ART), mortality rates among children living with HIV still remain substantially higher than in the general paediatric population in high-income settings, such as in the United States of America. Mortality rates after ART initiation are even higher in sub-Saharan Africa, likely because children initiate ART at older ages and at more advanced stages of disease. There are, however, no data available for Latin America and the Caribbean, which has had a mostly stable epidemic with a slowly declining adult HIV incidence over the past decade.

In this retrospective cohort study, the authors investigate mortality, loss-to-follow-up (LTFU) and regimen change among children who acquired HIV in the perinatal period from Argentina, Haiti, Honduras and Brazil. They initiated ART aged below 18 years. About half of all children started ART aged over five years, and a third had clinical AIDS by the time they initiated ART. This would suggest that paediatric HIV programmes in this region face similar challenges to those seen in African programmes, including failure of prevention of mother-to-child HIV transmission (PMTCT) programmes and late diagnosis of children.

As expected, a low baseline CD4 count and clinical AIDS at baseline were both associated with an increased risk of mortality. Importantly, younger age at starting ART was also associated with an increased hazard of death, as was being an adolescent (although the association was weaker). The most likely reason for this is that the youngest children placed on ART may have been initiated following presentation with fast-progressing disease, and would therefore have a higher risk of death than comparatively healthier and stable older children. The higher risk of death among the adolescents likely reflects delayed diagnosis of slow-progressors in adolescence.   

Another important finding was the significantly higher risk of LTFU and regimen change in adolescents compared to younger children. This finding, also noted in African and high-income setting cohorts, highlights the challenges of retaining adolescents in care, addressing treatment fatigue, and possibly increased risk of attrition from care during transitioning from paediatric to adult services. 

In summary, HIV care outcomes in children in Latin America and the Caribbean appear to be similar to those reported in other settings. Together, they highlight the pressing need for strengthening prevention of mother-to-child HIV transmission programmes, particularly follow-up and prompt testing of HIV-exposed infants. It also emphasizes the need for innovative approaches to support children to stay in care and maintain long-term adherence. 

Latin America
Argentina, Brazil, Haiti, Honduras
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Peer support: not a panacea for poor adherence

Use of peers to improve adherence to antiretroviral therapy: a global network meta-analysis.

Kanters S, Park JJ, Chan K, Ford N, Forrest J, Thorlund K, Nachega JB, Mills EJ. J Int AIDS Soc. 2016 Nov 30;19(1):21141. doi: 10.7448/IAS.19.1.21141. eCollection 2016.

Introduction: It is unclear whether using peers can improve adherence to antiretroviral therapy (ART). To construct the World Health Organization's global guidance on adherence interventions, we conducted a systematic review and network meta-analysis to determine the effectiveness of using peers for achieving adequate adherence and viral suppression.

Methods: We searched for randomized clinical trials of peer-based interventions to promote adherence to ART in HIV populations. We searched six electronic databases from inception to July 2015 and major conference abstracts within the last three years. We examined the outcomes of adherence and viral suppression among trials done worldwide and those specific to low- and middle-income countries (LMIC) using pairwise and network meta-analyses.

Results and discussion: Twenty-two trials met the inclusion criteria. We found similar results between pairwise and network meta-analyses, and between the global and LMIC settings. Peer supporter+Telephone was superior in improving adherence than standard-of-care in both the global network (odds-ratio [OR]=4.79, 95% credible intervals [CrI]: 1.02, 23.57) and the LMIC settings (OR=4.83, 95% CrI: 1.88, 13.55). Peer support alone, however, did not lead to improvement in ART adherence in both settings. For viral suppression, we found no difference of effects among interventions due to limited trials.

Conclusions: Our analysis showed that peer support leads to modest improvement in adherence. These modest effects may be due to the fact that in many settings, particularly in LMICs, programmes already include peer supporters, adherence clubs and family disclosures for treatment support. Rather than introducing new interventions, a focus on improving the quality in the delivery of existing services may be a more practical and effective way to improve adherence to ART.

Abstract  Full-text [free] access 

Editor’s notes: Sustained adherence to antiretroviral therapy (ART) is critical to ensure successful treatment outcomes and prevent drug resistance, AIDS-associated illness, death and onward transmission of HIV infection. In recent years, there has been much enthusiasm for use of peer support as a programme to improve adherence. Most high HIV prevalence settings have limited resources. Stigma influences adherence to treatment, and peer-based support may be a practical solution both in terms of being low cost and a mechanism for addressing stigma.

In this systematic review, the authors evaluated the effectiveness of peer-supporter programmes alone or in combination with other activities, namely telephone calls, device reminders or cognitive behavioural therapy (CBT), globally and in low and middle-income countries (LMIC). The systematic review findings were used to inform the 2015 World Health Organization HIV treatment guidelines.

The study demonstrates that peer support alone did not have any impact on adherence or on viral suppression. It did demonstrate modest improvements on adherence when combined with telephone activities. Several factors need to be considered in interpreting these findings. Firstly, adherence was assessed using a variety of methods including pill counts and the Medication Event Monitoring System (MEMS), which may have introduced heterogeneity. Secondly, few trials (particularly in LMICs) used HIV viral load as an outcome and therefore there may not have been adequate statistical power to detect an effect. Thirdly, populations included in the review were heterogeneous e.g. ART-naïve and experienced, people who inject drugs, non-adherent individuals. Notably, only one trial included children and adolescents among whom adherence is typically poorer. 

Importantly, in many settings particularly in LMICs, programmes already include treatment supporters and adherence clubs and therefore additional peer support would likely not add additional impact. The findings of this study suggest that programmes should focus on improving the quality of existing services rather than introduce new programmes. The review also highlights the need to standardise adherence measures and the need for robust research on adherence, particularly among children.         

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Study finds rectal gel to be safe in men, but not as acceptable for daily use

MTN-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel.

Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, Patterson KB, Leu CS, Galaska B, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I; MTN-017 Protocol Team. Clin Infect Dis. 2016 Dec 16. pii: ciw832. [Epub ahead of print]

Background: HIV disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed.

Methods: MTN-017 was a Phase 2, three-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily; or RG-TFV rectal gel before and after receptive anal intercourse (RAI) (or at least twice weekly in the event of no RAI); or daily oral FTC/TDF.

Results: MSM and TGW (n=195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in Grade 2 or higher adverse event rates in participants using daily gel (Incidence Rate Ratio (IRR): 1.09, p=0.59) or RAI gel (IRR: 0.90, p=0.51) compared to FTC/TDF. High adherence (≥80% of prescribed doses as assessed by unused product return and SMS reports) was less likely in the daily gel regimen (Odds Ratio (OR): 0.35, p<0.001) and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR: 0.38, p<0.001).

Conclusions: Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.

Abstract access  

Editor’s notes: While microbicide gel to prevent HIV in women has not been consistently shown to be effective, scientific efforts to develop a rectal microbicide gel have continued in the hopes of finding a safe and effective product for HIV prevention in men. This paper presents a phase II clinical trial in which gay men and other men who have sex with men across four different countries were randomly assigned to one of three arms: oral pre-exposure prophylaxis (‘daily oral’), topical gel administered before and after receptive anal intercourse (‘RAI’), and topical gel administered daily (‘daily rectal’). The authors found that the rectal gel was safe to use, and was acceptable to participants, although the daily rectal application had lower acceptability and lower adherence than daily oral or the RAI.  This safety, adherence, and acceptability seen in this Phase II study supports further development of the gel as a rectal microbicide candidate, although consideration will need to be given to dosing regimens to maximize adherence. 

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Is universal antenatal HIV testing still cost-effective?

Should HIV testing for all pregnant women continue? Cost-effectiveness of universal antenatal testing compared to focused approaches across high to very low HIV prevalence settings.

Ishikawa N, Dalal S, Johnson C, Hogan DR, Shimbo T, Shaffer N, Pendse RN, Lo YR, Ghidinelli MN, Baggaley R. J Int AIDS Soc. 2016 Dec 14;19(1):21212. doi: 10.7448/IAS.19.1.21212. eCollection 2016.

Introduction: HIV testing is the entry point for the elimination of mother-to-child transmission of HIV. Decreasing external funding for the HIV response in some low- and middle-income countries has triggered the question of whether a focused approach to HIV testing targeting pregnant women in high-burden areas should be considered. This study aimed at determining and comparing the cost-effectiveness of universal and focused HIV testing approaches for pregnant women across high to very low HIV prevalence settings.

Methods: We conducted a modelling analysis on health and cost outcomes of HIV testing for pregnant women using four country-based case scenarios (Namibia, Kenya, Haiti and Viet Nam) to illustrate high, intermediate, low and very low HIV prevalence settings. We used subnational prevalence data to divide each country into high-, medium- and low-burden areas, and modelled different antenatal and testing coverage in each.

Results: When HIV testing services were only focused in high-burden areas within a country, mother-to-child transmission rates remained high ranging from 18 to 23%, resulting in a 25 to 69% increase in new paediatric HIV infections and increased future treatment costs for children. Universal HIV testing was found to be dominant (i.e. more QALYs gained with less cost) compared to focused approaches in the Namibia, Kenya and Haiti scenarios. The universal approach was also very cost-effective compared to focused approaches, with $ 125 per quality-adjusted life years gained in the Viet Nam-based scenario of very low HIV prevalence. Sensitivity analysis further supported the findings.

Conclusions: Universal approach to antenatal HIV testing achieves the best health outcomes and is cost-saving or cost-effective in the long term across the range of HIV prevalence settings. It is further a prerequisite for quality maternal and child healthcare and for the elimination of mother-to-child transmission of HIV.

Abstract  Full-text [free] access 

Editor’s notes: This paper describes research undertaken to support the consolidated guidelines on HIV testing services, published by World Health Organization in 2015. This analysis was conducted in response to growing questions as to whether focused HIV testing in high prevalence areas can improve value for money in investment for HIV testing.

A model was parameterized to represent four scenarios with high, intermediate, low, and very low HIV prevalence settings (Namibia, Kenya, Haiti, and Viet Nam). Three approaches to HIV testing in antenatal care are considered in comparison with current coverage in each setting. These three approaches were: a very focused approach, a targeted approach, and a universal testing approach for all pregnant women.  The authors estimate the costs and effects of each scenario, including the future costs of treating paediatric HIV for 20 years. Universal testing was found to be cost-saving in Namibia, Kenya and Haiti and was found to be cost-effective in Viet Nam ($125 per QALY gained).  The targeted testing approach was also more cost-effective than current coverage in all settings.

The clear policy implication from this analysis is that HIV testing for pregnant women saves both money and lives in the long term. Universal HIV testing in antenatal care can be regarded as a good investment in almost any HIV prevalence setting. However, it is also important to note that targeted testing was more cost-effective than current coverage in all settings. Countries that are currently struggling to provide testing in antenatal care may need to consider factors other than cost-effectiveness in their planning and strategy for scaling up. This is important in order to address HIV at a national scale.  

Africa, Asia, Latin America
Haiti, Kenya, Namibia, Viet Nam
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Improving ART adherence: what works?

Interventions to improve adherence to antiretroviral therapy: a systematic review and network meta-analysis.

Kanters S, Park JJ, Chan K, Socias ME, Ford N, Forrest JI, Thorlund K, Nachega JB, Mills EJ. Lancet HIV. 2017 Jan;4(1):e31-e40. doi: 10.1016/S2352-3018(16)30206-5. Epub 2016 Nov 16.

Background: High adherence to antiretroviral therapy is crucial to the success of HIV treatment. We evaluated comparative effectiveness of adherence interventions with the aim of informing the WHO's global guidance on interventions to increase adherence.

Methods: For this systematic review and network meta-analysis, we searched for randomised controlled trials of interventions that aimed to improve adherence to antiretroviral therapy regimens in populations with HIV. We searched Cochrane Central Register of Controlled Trials, Embase, and MEDLINE for reports published up to July 16, 2015, and searched major conference abstracts from Jan 1, 2013, to July 16, 2015. We extracted data from eligible studies for study characteristics, interventions, patients' characteristics at baseline, and outcomes for the study populations of interest. We used network meta-analyses to compare adherence and viral suppression for all study settings (global network) and for studies in low-income and middle-income countries only (LMIC network).

Findings: We obtained data from 85 trials with 16 271 participants. Short message service (SMS; text message) interventions were superior to standard of care in improving adherence in both the global network (odds ratio [OR] 1.48, 95% credible interval [CrI] 1.00-2.16) and in the LMIC network (1.49, 1.04-2.09). Multiple interventions showed generally superior adherence to single interventions, indicating additive effects. For viral suppression, only cognitive behavioural therapy (1.46, 1.05-2.12) and supporter interventions (1.28, 1.01-1.71) were superior to standard of care in the global network; none of the interventions improved viral response in the LMIC network. For the global network, the time discrepancy (whether the study outcome was measured during or after intervention was withdrawn) was an effect modifier for both adherence to antiretroviral therapy (coefficient estimate -0.43, 95% CrI -0.75 to -0.11) and viral suppression (-0.48; -0.84 to -0.12), suggesting that the effects of interventions wane over time.

Interpretation: Several interventions can improve adherence and viral suppression; generally, their estimated effects were modest and waned over time.

Abstract access  

Editor’s notes: Maintaining adherence to self-administered medications is difficult. On average, people who are prescribed medications for chronic diseases take fewer than half the prescribed doses. Evidence suggests that in most settings adherence to antiretroviral therapy (ART) is better than this, but there will always be people that struggle to maintain the high levels of adherence required for durable virologic suppression. In this analysis, there was some evidence that specific activities or combinations of activities improved virologic suppression. However, the effect sizes were small and when the analysis was confined to studies in low-income and middle-income countries, there was no evidence to suggest an effect on virologic suppression. Overall the evidence to support any particular activity or combination of activities was not compelling.     

Findings from this analysis have been incorporated into most recent consolidated ART guidelines from the World Health Organization. Trying to summarize complex evidence in this way creates many challenges. Trials were conducted in different populations. Some with all people starting ART, others with people considered to have high risk of suboptimal adherence, and others with people who already had adherence problems. The trials also naturally would have differed in content and quality of the usual package of care to support adherence (the comparator for most programme). 60% of the trials were conducted exclusively in the United States, while others were conducted across different settings.

These are just some of the things that make it difficult to synthesize this evidence into guidance that can be applicable to people living with HIV worldwide. HIV programmes in countries have to decide whether or not to adopt any of these activities that are recommended by WHO on the basis of relatively weak evidence. Would we expect activities aimed at improving adherence to be generalizable across different settings? One might argue probably not. Adherence is a multifactorial, dynamic process and there is unlikely to be a ‘one size fits all’ approach to supporting adherence. In the absence of better evidence for any specific activity, we should perhaps focus on improving the quality of the basic package of adherence support offered to all people receiving ART, while also developing better ways to identify when certain people might benefit from enhanced support.        

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School-based HIV prevention programmes appear ineffective

School-based interventions for preventing HIV, sexually transmitted infections, and pregnancy in adolescents.

Mason-Jones AJ, Sinclair D, Mathews C, Kagee A, Hillman A, Lombard C. Cochrane Database Syst Rev. 2016 Nov 8;11:CD006417.

Background: School-based sexual and reproductive health programmes are widely accepted as an approach to reducing high-risk sexual behaviour among adolescents. Many studies and systematic reviews have concentrated on measuring effects on knowledge or self-reported behaviour rather than biological outcomes, such as pregnancy or prevalence of sexually transmitted infections (STIs).

Objectives: To evaluate the effects of school-based sexual and reproductive health programmes on sexually transmitted infections (such as HIV, herpes simplex virus, and syphilis), and pregnancy among adolescents.

Search methods: We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for published peer-reviewed journal articles; and ClinicalTrials.gov and the World Health Organization's (WHO) International Clinical Trials Registry Platform for prospective trials; AIDS Education and Global Information System (AEGIS) and National Library of Medicine (NLM) gateway for conference presentations; and the Centers for Disease Control and Prevention (CDC), UNAIDS, the WHO and the National Health Service (NHS) centre for Reviews and Dissemination (CRD) websites from 1990 to 7 April 2016. We hand searched the reference lists of all relevant papers.

Selection criteria: We included randomized controlled trials (RCTs), both individually randomized and cluster-randomized, that evaluated school-based programmes aimed at improving the sexual and reproductive health of adolescents.

Data collection and analysis: Two review authors independently assessed trials for inclusion, evaluated risk of bias, and extracted data. When appropriate, we obtained summary measures of treatment effect through a random-effects meta-analysis and we reported them using risk ratios (RR) with 95% confidence intervals (CIs). We assessed the certainty of the evidence using the GRADE approach.

Main results: We included eight cluster-RCTs that enrolled 55,157 participants. Five trials were conducted in sub-Saharan Africa (Malawi, South Africa, Tanzania, Zimbabwe, and Kenya), one in Latin America (Chile), and two in Europe (England and Scotland). Sexual and reproductive health educational programmes. Six trials evaluated school-based educational interventions. In these trials, the educational programmes evaluated had no demonstrable effect on the prevalence of HIV (RR 1.03, 95% CI 0.80 to 1.32, three trials; 14 163 participants; low certainty evidence), or other STIs (herpes simplex virus prevalence: RR 1.04, 95% CI 0.94 to 1.15; three trials, 17 445 participants; moderate certainty evidence; syphilis prevalence: RR 0.81, 95% CI 0.47 to 1.39; one trial, 6977 participants; low certainty evidence). There was also no apparent effect on the number of young women who were pregnant at the end of the trial (RR 0.99, 95% CI 0.84 to 1.16; three trials, 8280 participants; moderate certainty evidence). Material or monetary incentive-based programmes to promote school attendance. Two trials evaluated incentive-based programmes to promote school attendance. In these two trials, the incentives used had no demonstrable effect on HIV prevalence (RR 1.23, 95% CI 0.51 to 2.96; two trials, 3805 participants; low certainty evidence). Compared to controls, the prevalence of herpes simplex virus infection was lower in young women receiving a monthly cash incentive to stay in school (RR 0.30, 95% CI 0.11 to 0.85), but not in young people given free school uniforms (data not pooled, two trials, 7229 participants; very low certainty evidence). One trial evaluated the effects on syphilis and the prevalence was too low to detect or exclude effects confidently (RR 0.41, 95% CI 0.05 to 3.27; one trial, 1291 participants; very low certainty evidence). However, the number of young women who were pregnant at the end of the trial was lower among those who received incentives (RR 0.76, 95% CI 0.58 to 0.99; two trials, 4200 participants; low certainty evidence). Combined educational and incentive-based programmes. The single trial that evaluated free school uniforms also included a trial arm in which participants received both uniforms and a programme of sexual and reproductive education. In this trial arm herpes simplex virus infection was reduced (RR 0.82, 95% CI 0.68 to 0.99; one trial, 5899 participants; low certainty evidence), predominantly in young women, but no effect was detected for HIV or pregnancy (low certainty evidence).

Authors' conclusions: There is a continued need to provide health services to adolescents that include contraceptive choices and condoms and that involve them in the design of services. Schools may be a good place in which to provide these services. There is little evidence that educational curriculum-based programmes alone are effective in improving sexual and reproductive health outcomes for adolescents. Incentive-based interventions that focus on keeping young people in secondary school may reduce adolescent pregnancy but further trials are needed to confirm this.

Abstract  Full-text [free] access 

Editor’s notes: School-based HIV prevention programmes are widespread worldwide. These programmes use educational institutions as a venue to reach a population that is entering sexual maturity. Several systematic reviews have found beneficial effects of these programmes on HIV-associated knowledge and behaviours, though a subsequent effect of reduced HIV incidence remains unconfirmed. In this systematic review and meta-analysis, the authors included eight randomized controlled trials from sub-Saharan Africa, Europe, and Latin America. Whether using a curriculum- or incentive-based programme, the trials did not provide evidence of an effect of school-based programmes on reducing HIV infection. Nor was there compelling evidence of an effect of these programmes on reducing sexually transmitted infection or pregnancy. This paper highlights the difficulty of translating knowledge and reported behaviors into reductions in HIV infection and other biological outcomes. Further thought is necessary to deliver effective sexual and reproductive health programmes in schools – possibly including incentives, which show some promise but need further evidence on effectiveness. 

Africa, Europe, Latin America
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