Articles tagged as "HIV testing"

Comparing different methods to measure HIV incidence in a sub-Saharan African population

Estimating HIV incidence using a cross-sectional survey: comparison of three approaches in a hyperendemic setting, Ndhiwa sub-county, Kenya, 2012.

Blaizot S, Kim AA, Zeh C, Riche B, Maman D, DeCock K, Etard JF, Ecochard R. AIDS Res Hum Retroviruses. 2016 Dec 13. [Epub ahead of print]

Objectives: Estimating HIV incidence is critical for identifying groups at risk for HIV infection, planning and targeting interventions, and evaluating these interventions over time. The use of reliable estimation methods for HIV incidence is thus of high importance. The aim of this study was to compare methods for estimating HIV incidence in a population-based cross-sectional survey.

Design/methods: The incidence estimation methods evaluated included assay-derived methods, a testing history-derived method, and a probability-based method applied to data from the Ndhiwa HIV Impact in Population Survey (NHIPS). Incidence rates by sex and age and cumulative incidence as a function of age were presented.

Results: HIV incidence ranged from 1.38 [95% confidence interval (CI) 0.67-2.09] to 3.30 [95% CI 2.78-3.82] per 100 persons-years overall; 0.59 [95% CI 0.00-1.34] to 2.89 [95% CI 0.11-5.68] in men; and 1.62 [95% CI 0.16-6.04] to 4.03 [95% CI 3.30-4.77] per 100 persons-years in women. Women had higher incidence rates than men for all methods. Incidence rates were highest among women aged 15-24 and 25-34 years and highest among men aged 25-34 years.

Conclusion: Comparison of different methods showed variations in incidence estimates, but they were in agreement to identify most-at-risk groups. The use and comparison of several distinct approaches for estimating incidence are important to provide the best-supported estimate of HIV incidence in the population.

Abstract access

Editor’s notes: The estimation of HIV incidence is important both for planning effective HIV prevention strategies, and also to provide a proximal measure of changes in HIV epidemics both in general populations and in higher risk sub-groups. Further development of methods for accurately measuring HIV incidence that can be applied in routine monitoring settings is necessary.

This study compares three assay-based incidence estimation methods with approaches using self-reported testing history and a probabilistic technique on age and sex stratified sero-prevalence data. Two of the assays, BioRad and Lag, use antibody markers and a recent infection testing algorithm (RITA). The BioRad assay allowed for a longer time window for detection post-infection than the Lag. Recent infections were reclassified using results from HIV viral load tests and self-reported ART use, as appropriate. The other assay detected trace levels of HIV RNA in HIV seronegative individuals. The results for the two RITA assays were very similar at 1.38 [95% CI 0.67 – 2.09] infections per 100 person years (PY) for the BioRad and 1.46 [95% CI 0.71 – 2.22] per 100 PY for Lag. Combining these with HIV-RNA results led to small increases in each incidence estimate. The results for the probability-based incidence assays were very close to those derived from the combination of the RITA and HIV-RNA assays. However, the testing history-derived approach estimated incidence as almost double that from the other methods and this is likely to be in large part due to reporting/recall bias.

Despite the limitations of the methods, it was possible to identify population sub-groups defined by age and sex at higher risk of HIV infection. 

Africa
Kenya
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How to keep HIV prevalence low in refugee populations

Predictors of HIV infection: a prospective HIV screening study in a Ugandan refugee settlement.

O'Laughlin KN, Rabideau DJ, Kasozi J, Parker RA, Bustamante ND, Faustin ZM, Greenwald KE, Walensky RP, Bassett IV. BMC Infect Dis. 2016 Nov 23;16(1):695.

Background: The instability faced by refugees may place them at increased risk of exposure to HIV infection. Nakivale Refugee Settlement in southwestern Uganda hosts  68 000 refugees from 11 countries, many with high HIV prevalence. We implemented an HIV screening program in Nakivale and examined factors associated with new HIV diagnosis.

Methods: From March 2013-November 2014, we offered free HIV screening to all clients in the Nakivale Health Center while they waited for their outpatient clinic visit. Clients included refugees and Ugandan nationals accessing services in the settlement. Prior to receiving the HIV test result, participants were surveyed to obtain demographic information including gender, marital status, travel time to reach clinic, refugee status, and history of prior HIV testing. We compared variables for HIV-infected and non-infected clients using Pearson's chi-square test, and used multivariable binomial regression models to identify predictors of HIV infection.

Results: During the HIV screening intervention period, 330 (4%) of 7766 individuals tested were identified as HIV-infected. Refugees were one quarter as likely as Ugandan nationals to be HIV-infected (aRR 0.27 [0.21, 0.34], p < 0.0001). Additionally, being female (aRR 1.43 [1.14, 1.80], p = 0.002) and traveling more than 1 h to the clinic (aRR 1.39 [1.11, 1.74], p = 0.003) increased the likelihood of being HIV-infected. Compared to individuals who were married or in a stable relationship, being divorced/separated/widowed increased the risk of being HIV-infected (aRR 2.41 [1.88, 3.08], p < 0.0001), while being single reduced the risk (aRR 0.60 [0.41, 0.86], p < 0.0001). Having been previously tested for HIV (aRR 0.59 [0.47, 0.74], p < 0.0001) also lowered the likelihood of being HIV-infected.

Conclusions: In an HIV screening program in a refugee settlement in Uganda, Ugandan nationals are at higher risk of having HIV than refugees. The high HIV prevalence among clients seeking outpatient care, including Ugandan nationals and refugees, warrants enhanced HIV screening services in Nakivale and in the surrounding region. Findings from this research may be relevant for other refugee settlements in sub-Saharan Africa hosting populations with similar demographics, including the 9 other refugee settlements in Uganda.

Abstract  Full-text [free] access 

Editor’s notes: The 4% prevalence seen among refugees in this study warrants the introduction of a routine offer of HIV testing and counselling, provider-initiated testing and counselling (PITC), in the outpatient services provided at this refugee settlement in Uganda. Although 7766 people accepted the offer of HIV testing and counselling (HTC), the real extent of the acceptability of this service is unclear because routine service delivery records document simply encounters (23 016 during the study period) rather than unique individuals. There may be challenges in defining and using unique identifiers in refugee settlement health care services but this is one example of their potential utility in helping understand the true burden of disease in these settings. HIV prevalence in refugees accepting testing was not significantly different from that in the general population in their countries of origin. For example, Rwanda 2.3% versus 2.9% and Burundi 1.4% versus 1.0%. The exception was the Democratic Republic of Congo (DRC) with 1.9% of Congolese refugees being HIV-positive compared to 0.8% in the DRC general population, warranting further study to understand this increased HIV risk.

This study reveals lower HIV prevalence among refugees (2%) than among Ugandan nationals availing themselves of the settlement health services (9%). The Ugandans included both refugees and people living in surrounding communities. Ugandans freely come and go from the settlement for job-associated or personal reasons. People testing positive for HIV were more likely to live outside the settlement. The extent of sexual mixing between local Ugandans and refugees from other countries in Nakivale is unknown but providing prevention and treatment services to both populations could help reduce the risk of HIV transmission within the settlement. This study was conducted when the 2010 WHO guidelines of 350 cells/mm3 or WHO stage III/IV for treatment initiation were in effect and antiretroviral therapy was free of charge. However, data are not presented in this paper on the important question of the extent of linkage to care and antiretroviral therapy. These data are now being used worldwide to track progress towards the UNAIDS 90-90-90 treatment target. Refugee settlements in sub-Saharan Africa provide fertile settings for a routine offer of HIV testing and immediate offer of antiretroviral therapy to people found to be HIV-positive, as per current WHO guidelines. This would benefit not only these individuals clinically but would help keep HIV transmission as low as possible in refugee settlements.

Africa
Uganda
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Using HIV testing infrastructure for other diseases can be very low cost

Implementation and operational research: cost and efficiency of a hybrid mobile multidisease testing approach with high HIV testing coverage in east Africa.

Chang W, Chamie G, Mwai D, Clark TD, Thirumurthy H, Charlebois ED, Petersen M, Kabami J, Ssemmondo E, Kadede K, Kwarisiima D, Sang N, Bukusi EA, Cohen CR, Kamya M, Havlir DV, Kahn JG. J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):e39-e45.

Background: In 2013-2014, we achieved 89% adult HIV testing coverage using a hybrid testing approach in 32 communities in Uganda and Kenya (SEARCH: NCT01864603). To inform scalability, we sought to determine: (1) overall cost and efficiency of this approach; and (2) costs associated with point-of-care (POC) CD4 testing, multidisease services, and community mobilization.

Methods: We applied microcosting methods to estimate costs of population-wide HIV testing in 12 SEARCH trial communities. Main intervention components of the hybrid approach are census, multidisease community health campaigns (CHC), and home-based testing for CHC nonattendees. POC CD4 tests were provided for all HIV-infected participants. Data were extracted from expenditure records, activity registers, staff interviews, and time and motion logs.

Results: The mean cost per adult tested for HIV was $20.5 (range: $17.1-$32.1) (2014 US$), including a POC CD4 test at $16 per HIV+ person identified. Cost per adult tested for HIV was $13.8 at CHC vs. $31.7 by home-based testing. The cost per HIV+ adult identified was $231 ($87-$1245), with variability due mainly to HIV prevalence among persons tested (ie, HIV positivity rate). The marginal costs of multidisease testing at CHCs were $1.16/person for hypertension and diabetes, and $0.90 for malaria. Community mobilization constituted 15.3% of total costs.

Conclusions: The hybrid testing approach achieved very high HIV testing coverage, with POC CD4, at costs similar to previously reported mobile, home-based, or venue-based HIV testing approaches in sub-Saharan Africa. By leveraging HIV infrastructure, multidisease services were offered at low marginal costs.

Abstract access  

Editor’s notes: The scale up of HIV testing services over recent years has meant that infrastructure for HIV testing is, in many places, much stronger than that of other diseases. This study assessed the costs and cost-effectiveness of both HIV testing services and additional multi disease testing in 32 communities of Uganda and Kenya. As has been found in other studies, testing people through community health campaigns cost less than home-based testing. However, the cost per HIV positive person identified varied widely according to the underlying HIV prevalence. The costs of including additional disease testing services – for hypertension, diabetes and malaria – were low. A more holistic approach to health testing could lead to substantial health benefits for relatively low cost.

Africa
Kenya, Uganda
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Longitudinal HIV viral load measures give insights into disease burden and transmission risk in the USA

Durable viral suppression and transmission risk potential among persons with diagnosed HIV infection: United States, 2012-2013.

Crepaz N, Tang T, Marks G, Mugavero MJ, Espinoza L, Hall HI. Clin Infect Dis. 2016 Oct 1;63(7):976-83. doi: 10.1093/cid/ciw418. Epub 2016 Jun 29.

Background: We examined durable viral suppression, cumulative viral load (VL) burden, and transmission risk potential among human immunodeficiency virus (HIV)-diagnosed persons in care.

Methods: Using data from the National HIV Surveillance System from 17 jurisdictions with complete reporting of VL test results, we determined the percentage of persons in HIV care who achieved durable viral suppression (all VL results <200 copies/mL) and examined viremia copy-years and time spent above VL levels that increase the risk of HIV transmission during 2012-2013.

Results: Of 265 264 persons in HIV care in 2011, 238 641 had at least 2 VLs in 2012-2013. The median number of VLs per individual during the 2-year period was 5. Approximately 62% had durable viral suppression. The remaining 38% had high VL burden (geometric mean of viremia copy-years, 7261) and spent an average of 438 days, 316 days, and 215 days (60%, 43.2%, and 29.5% of the 2-year period) above 200, 1500, and 10 000 copies/mL. Women, blacks/African Americans, Hispanics/Latinos, persons with HIV infection attributed to transmission other than male-to-male sexual contact, younger age groups, and persons with gaps in care had higher viral burden and transmission risk potential.

Conclusions: Two-thirds of persons in HIV care had durable viral suppression during a 2-year period. One-third had high VL burden and spent substantial time above VL levels with increased risk of onward transmission. More intervention efforts are needed to improve retention in care and medication adherence so that more persons in HIV care achieve durable viral suppression.

Abstract access  

Editor’s notes: Virologic suppression is the ultimate goal of HIV care. It determines health outcomes and transmission risk. Most analyses assess viral suppression by considering a single viral load measure. However, adherence to antiretroviral therapy and engagement in HIV care are often not straightforward, but rather complex and dynamic. People living with HIV may transition in and out of treatment and care throughout their lifetime. Therefore, a single undetectable viral load may not equate to true virologic suppression in an individual, but rather only a snapshot. This has the potential for an inaccurate picture of HIV burden and transmission risk in a population.

Within this study, researchers used the longitudinal measures of durable viral suppression, viraemia copy years and time without viral load suppression to assess disease burden and HIV transmission risk in the United States of America. The analysis involved people ages 13 years or older diagnosed with HIV before 2011 and in care in one of 17 jurisdictions that reported complete CD4 and viral load data to the Centers for Disease Control and Prevention’s National HIV Surveillance System. Everyone had at least one viral load test in 2011 and at least two between 2012-2013, and all were alive at the end of 2013.

Of the 251 649 persons included, two thirds had durable viral suppression with all viral load values being <200 copies/mL over the two-year period. Of note, during the same time period an additional 20% (total 83%) of the cohort had a suppressed viral load on their latest test. This would have potentially underestimated disease burden if analysed in isolation. The remaining one-third, without durable viral suppression, had high plasma burden and spent substantial time without virologic suppression, increasing the risk of HIV transmission.  As would be expected, the percentages of persons with durable viral suppression were lower among people with gaps in care. Disparities in disease burden and transmission risk potential were seen in several other subgroups.

The use of longitudinal measures broadens insight into disease burden and transmission risk in this population. Of further interest would have been people that had no evidence of being in care in 2011 but had an unsuppressed viral load between 2012-13, thus contributing to the population disease burden. These people were unfortunately not included in the analyses but may increase overall population transmission risk over the two years.

The findings underscore the recognised need for focused care and treatment efforts to address these disparities in virologic suppression and improve retention in care in the United States of America. The study also encourages the use of longitudinal markers in informing public health planning and resource allocation.

Northern America
United States of America
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Engaging men in antenatal care: a win-win for healthy families

Male partner participation in antenatal clinic services is associated with improved HIV-free survival among infants in Nairobi, Kenya: a prospective cohort study.

Aluisio AR, Bosire R, Bourke B, Gatuguta A, Kiarie JN, Nduati R, John-Stewart G, Farquhar C. J Acquir Immune Defic Syndr. 2016 Oct 1;73(2):169-76. doi: 10.1097/QAI.0000000000001038.

Objective: This prospective study investigated the relationship between male antenatal clinic (ANC) involvement and infant HIV-free survival.

Methods: From 2009 to 2013, HIV-infected pregnant women were enrolled from 6 ANCs in Nairobi, Kenya and followed with their infants until 6 weeks postpartum. Male partners were encouraged to attend antenatally through invitation letters. Men who failed to attend had questionnaires sent for self-completion postnatally. Multivariate regression was used to identify correlates of male attendance. The role of male involvement in infant outcomes of HIV infection, mortality, and HIV-free survival was examined.

Results: Among 830 enrolled women, 519 (62.5%) consented to male participation and 136 (26.2%) men attended the ANC. For the 383 (73.8%) women whose partners failed to attend, 63 (16.4%) were surveyed through outreach. In multivariate analysis, male report of previous HIV testing was associated with maternal ANC attendance (adjusted odds ratio = 3.7; 95% CI: 1.5 to 8.9, P = 0.003). Thirty-five (6.6%) of 501 infants acquired HIV or died by 6 weeks of life. HIV-free survival was significantly greater among infants born to women with partner attendance (97.7%) than those without (91.3%) (P = 0.01). Infants lacking male ANC engagement had an approximately 4-fold higher risk of death or infection compared with those born to women with partner attendance (HR = 3.95, 95% CI: 1.21 to 12.89, P = 0.023). Adjusting for antiretroviral use, the risk of death or infection remained significantly greater for infants born to mothers without male participation (adjusted hazards ratio = 3.79, 95% CI: 1.15 to 12.42, P = 0.028).

Conclusions: Male ANC attendance was associated with improved infant HIV-free survival. Promotion of male HIV testing and engagement in ANC/prevention of mother-to-child transmission services may improve infant outcomes.

Abstract access

Editor’s notes: Although new HIV infections among children have declined by a striking 50% since 2010, 150 000 children [110 000–190 000] worldwide became newly infected with HIV in 2015. Getting to zero and achieving virtual elimination of mother-to-child HIV transmission will require all hands on deck – and that includes fathers. This study has several limitations but its findings stand: lack of involvement by fathers in the antenatal care (ANC) of their HIV-positive pregnant partner increased four-fold their offspring’s risk of death or HIV infection by six weeks of life. How exactly ANC involvement of fathers might increase the HIV-free survival of their babies is unclear. In multivariate analysis, only male report of previous HIV testing was associated with men’s ANC engagement. However, factors found significant in univariate analysis were: disclosure of HIV-positive status by women, mutual discussion of mother-to-child transmission, having undergone couples voluntary counselling and testing, and being in a monogamous partnership. There was no difference between men who attended and men who did not in terms of age, employment status, or level of education – all of which one might think could be associated with male engagement in ANC. These results beg more questions. Given the HIV-survival benefits for children, how can we enhance male HIV testing and ANC involvement? In country after country, men living with HIV are less likely to know their serostatus than are women. They are therefore less likely to start antiretroviral treatment in a timely manner to reap its clinical benefits for themselves and reduce the risk of HIV transmission for others. Trials are necessary to test innovative strategies to reach men with HIV testing, on their own or through couples testing and by location such as at work sites, in community service settings, at sporting and other special events, through home-based testing, and in the context of antenatal care. Mixed methods studies are necessary to better understand beneficial partnership characteristics and individual barriers and facilitators of male involvement in antenatal care. The results would inform the design of effective programmes and approaches. The benefits for the father, mother, and baby of enhanced male engagement in ANC might go well beyond HIV to encompass the health of all family members. 

 

Africa
Kenya
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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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Weekends off ART: a strategy to maintain adherence in children and adolescents?

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial.

The BREATHER (PENTA 16) Trial Group. Lancet HIV. 2016 Sep;3(9):e421-30. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

Background: For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).

Methods: In this open-label, non-inferiority trial (BREATHER), eligible participants were aged 8-24 years, were stable on first-line efavirenz with two nucleoside reverse transcriptase inhibitors, and had HIV-1 RNA viral load less than 50 copies per mL for 12 months or longer. Patients were randomly assigned (1:1) to remain on continuous therapy or change to short cycle therapy according to a computer-generated randomisation list, with permuted blocks of varying size, stratified by age and African versus non-African sites; the list was prepared by the trial statistician and randomisation was done via a web service accessed by site clinician or one of the three coordinating trials units. The primary outcome was the proportion of participants with confirmed viral load 50 copies per mL or higher at any time up to the 48 week assessment, estimated with the Kaplan-Meier method. The trial was powered to exclude a non-inferiority margin of 12%. Analyses were intention to treat. The trial was registered with EudraCT, number 2009-012947-40, ISRCTN, number 97755073, and CTA, number 27505/0005/001-0001.

Findings: Between April 1, 2011, and June 28, 2013, 199 participants from 11 countries worldwide were randomly assigned, 99 to the short cycle therapy and 100 to continuous therapy, and were followed up until the last patient reached 48 weeks. 105 (53%) were men, median age was 14 years (IQR 12-18), and median CD4 cell count was 735 cells per µL (IQR 576-968). Six percent (6%) patients assigned to the short cycle therapy versus seven percent (7%) assigned to continuous therapy had confirmed viral load 50 copies per mL or higher (difference -1.2%, 90% CI -7.3 to 4.9, non-inferiority shown). 13 grade 3 or 4 events occurred in the short cycle therapy group and 14 in the continuous therapy group (p=0.89). Two ART-related adverse events (one gynaecomastia and one spontaneous abortion) occurred in the short cycle therapy group compared with 14 (p=0.02) in the continuous therapy group (five lipodystrophy, two gynaecomastia, one suicidal ideation, one dizziness, one headache and syncope, one spontaneous abortion, one neutropenia, and two raised transaminases).

Interpretation: Non-inferiority of maintaining virological suppression in children, adolescents, and young adults was shown for short cycle therapy versus continuous therapy at 48 weeks, with similar resistance and a better safety profile. This short cycle therapy strategy is a viable option for adherent HIV-infected young people who are stable on efavirenz-based ART.

Abstract  Full-text [free] access 

Editor’s notes: Increasing number of children born with HIV infection, who would otherwise have died in infancy, are now reaching adolescence because of the scale-up of antiretroviral therapy (ART). Adherence to treatment for chronic illnesses often drops as children approach adolescence, and unfortunately HIV is no exception.  

BREATHER is an open-label, non-inferiority trial comparing continuous daily ART (CT) with short cycle treatment (SCT) enabling two days off treatment every week. The participants were aged 8 to 24 years and had to have been virally suppressed for at least one year prior to enrolment on an ART regimen containing efavirenz. At 48 weeks, 6.1% of children in the SCT arm versus 7.3% in the CT arm had virologic rebound (defined as an HIV viral load > 50 copies/ml), demonstrating that SCT is non-inferior to CT. There was no statistical difference between arms in the proportion who developed major resistance mutations or in proportion of adverse events.

This is the first trial to demonstrate that controlled interruption appears to be safe in terms of maintaining viral suppression and lack of emergence of drug resistance mutations. Notably, the trial was conducted in geographically diverse settings (11 countries) and achieved an impressive retention rate with only one participant being lost to follow-up. In addition, the strategy was highly acceptable to participants, particularly as it provided a legitimate way of missing doses. Children are expected to take ART for 20 years longer on average than adults and strategies that enable time off ART may be an effective way to reduce treatment fatigue. In addition, reduced ART usage may provide potential cost savings. 

A concern, however, is that such a strategy may give out the detrimental message that missing doses is acceptable and may not affect the viral load. Therefore, appropriate counselling is important to ensure that people understand that there is a maximum break in treatment of two designated days per week. It is also important to note that the findings of this study are only generalisable to people who are stable on ART, who have not experienced treatment failure and who are taking efavirenz-based regimens. The trial was carried out with intensive viral load monitoring and further research is required to work out how such a strategy could be safely implemented in settings where routine viral load monitoring may not be available.

Viral suppression is the ultimate goal to improve health outcomes and reduce HIV transmission. Consistent adherence to ART is critical to ensure sustained virologic suppression. Children and adolescents face multiple challenges to adhere to treatment and a number of different approaches to address this are required- this trial now provides an innovative and promising option to offer to children.

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Improving retention in HIV care

Barriers and facilitators to interventions improving retention in HIV care: a qualitative evidence meta-synthesis.

Hall BJ, Sou KL, Beanland R, Lacky M, Tso LS, Ma Q, Doherty M, Tucker JD. AIDS Behav. 2016 Aug 31. [Epub ahead of print]

Retention in HIV care is vital to the HIV care continuum. The current review aimed to synthesize qualitative research to identify facilitators and barriers to HIV retention in care interventions. A qualitative evidence meta-synthesis utilizing thematic analysis. Prospective review registration was made in PROSPERO and review procedures adhered to PRISMA guidelines. Nineteen databases were searched to identify qualitative research conducted with individuals living with HIV and their caregivers. Quality assessment was conducted using CASP and the certainty of the evidence was evaluated using CERQual. A total of 4419 citations were evaluated and 11 were included in the final meta-synthesis. Two studies were from high-income countries, 3 from middle-income countries, and 6 from low-income countries. A total of eight themes were identified as facilitators or barriers for retention in HIV care intervention: (1) stigma and discrimination, (2) fear of HIV status disclosure, (3) task shifting to lay health workers, (4) human resource and institutional challenges, (5) mobile health (mHealth), (6) family and friend support, (7) intensive case management, and, (8) relationships with caregivers. The current review suggests that task shifting interventions with lay health workers were feasible and acceptable. mHealth interventions and stigma reduction interventions appear to be promising interventions aimed at improving retention in HIV care. Future studies should focus on improving the evidence base for these interventions. Additional research is needed among women and adolescents who were under-represented in retention interventions.

Abstract access 

Editor’s notes: Retention in HIV care is defined as the continued engagement in health services from enrolment in care to discharge or death of an individual living with HIV. There is strong evidence for the clinical and public health benefits of early antiretroviral therapy initiation. Individuals retained in care have lower mortality and a higher likelihood of viral suppression. Universal test and treat strategies are dependent on successful retention in HIV care.

A qualitative evidence meta-synthesis utilising thematic analysis was conducted. Some 11 studies were ultimately included in the review. Task shifting to non-specialist community caregivers was the most common activity identified in the review. Other programmes included home-based care, case management, primary HIV medical care, counselling, and mHealth.

The findings of the meta-synthesis highlight eight themes that were identified as facilitators or barriers for retention in HIV care programmes. This offers important insights for improving retention in care. However, more research is necessary to understand the experience of important sub populations including pregnant women, children and adolescents and key populations including gay men and other men who have sex with men.  The authors also emphasise the need for studies to provide particular emphasis on the perspectives of individuals living with HIV and providers involved in programme delivery. This, they argue, would greatly enhance subsequent implementation and development of tailored programmes to retain individuals living with HIV in care.

Africa, Northern America
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Changes in sexual risk behaviour and sustained HIV incidence among MSM in the UK

Sexual behaviours, HIV testing, and the proportion of men at risk of transmitting and acquiring HIV in London, UK, 2000-13: a serial cross-sectional study.

Aghaizu A, Wayal S, Nardone A, Parsons V, Copas A, Mercey D, Hart G, Gilson R, Johnson AM. Lancet HIV. 2016 Sep;3(9):e431-40. doi: 10.1016/S2352-3018(16)30037-6. Epub 2016 Jul 14.

Background: HIV incidence in men who have sex with men (MSM) in the UK has remained unchanged over the past decade despite increases in HIV testing and antiretroviral therapy (ART) coverage. In this study, we examine trends in sexual behaviours and HIV testing in MSM and explore the risk of transmitting and acquiring HIV.

Methods: In this serial cross-sectional study, we obtained data from ten cross-sectional surveys done between 2000 and 2013, consisting of anonymous self-administered questionnaires and oral HIV antibody testing in MSM recruited in gay social venues in London, UK. Data were collected between October and January for all survey years up to 2008 and between February and August thereafter. All men older than 16 years were eligible to take part and fieldworkers attempted to approach all MSM in each venue and recorded refusal rates. Data were collected on demographic and sexual behavioural characteristics. We analysed trends over time using linear, logistic, and quantile regression.

Findings: Of 13 861 questionnaires collected between 2000 and 2013, we excluded 1985 (124 had completed the survey previously or were heterosexual reporting no anal intercourse in the past year, and 1861 did not provide samples for antibody testing). Of the 11 876 eligible MSM recruited, 1512 (13%) were HIV positive, with no significant trend in HIV positivity over time. 35% (531 of 1505) of HIV-positive MSM had undiagnosed infection, which decreased non-linearly over time from 34% (45 of 131) to 24% (25 of 106; p=0.01), while recent HIV testing (ie, in the past year) increased from 26% (263 of 997) to 60% (467 of 777; p<0.0001). The increase in recent testing in undiagnosed men (from 29% to 67%, p<0.0001) and HIV-negative men (from 26% to 62%, p<0.0001) suggests that undiagnosed infection might increasingly be recently acquired infection. The proportion of MSM reporting unprotected anal intercourse (UAI) in the past year increased from 43% (513 of 1187) to 53% (394 of 749; p<0.0001) and serosorting (exclusively) increased from 18% (207 of 1132) to 28% (177 of 6369; p<0.0001). 268 (2%) of 11 570 participants had undiagnosed HIV and reported UAI in the past year were at risk of transmitting HIV. Additionally 259 (2%) had diagnosed infection and reported UAI and non-exclusive serosorting in the past year. Although we did not collect data on antiretroviral therapy or viral load, surveillance data suggests that a small proportion of men with diagnosed infection will have detectable viral load and hence might also be at risk of transmitting HIV. 2633 (25%) of 10 364 participants were at high risk of acquiring HIV (defined as HIV-negative MSM either reporting one or more casual UAI partners in the past year or not exclusively serosorting). The proportions of MSM at risk of transmission or acquisition changed little over time (p=0.96 for MSM potentially at risk of transmission and p=0.275 for MSM at high risk of acquiring HIV). Undiagnosed men reporting UAI and diagnosed men not exclusively serosorting had consistently higher partner numbers than did other MSM over the period (median ranged from one to three across surveys in undiagnosed men reporting UAI, two to ten in diagnosed men not exclusively serosorting, and none to two in other men).

Interpretation: An increasing proportion of undiagnosed HIV infections in MSM in London might have been recently acquired, which is when people are likely to be most infectious. High UAI partner numbers of MSM at risk of transmitting HIV and the absence of a significant decrease in the proportion of men at high risk of acquiring the infection might explain the sustained HIV incidence. Implementation of combination prevention interventions comprising both behavioural and biological interventions to reduce community-wide risk is crucial to move towards eradication of HIV.

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Editor’s notes: Despite wide-scale ART coverage, HIV incidence among gay men and other men who have sex with men remains high in many high-income countries, and is increasing in some locations. Although expanded testing and treatment are expected to lower HIV incidence, there are concerns that changes in risk behaviour may offset the impact of ART on HIV transmission. In this paper, the authors illustrate that among gay men and other men who have sex with men in London, the proportion who had tested for HIV in the past year increased considerably over the period 2000 and 2013, with a corresponding decrease in the numbers with undiagnosed HIV.  However, there were increasing rates of condomless anal intercourse in both HIV-negative and HIV-positive men.  Furthermore, men living with HIV who were undiagnosed, and men who were not exclusively serosorting (having sex with partners of the presumed same HIV status), reported increased numbers of sexual partners over the period of the surveys. Despite the increases in recent HIV testing, three percent of men in 2013 incorrectly perceived themselves to be HIV negative. This suggests that many men who are undiagnosed may be recent infections, so could be at high risk of transmission. Previous modelling studies have illustrated that increased sexual risk behaviour, particular among people who are unaware that they are HIV positive, could account for the observed increase in incidence in gay men and other men who have sex with men. The findings of this study demonstrate the importance of core groups to the continued transmission of HIV. Test and treat programmes alone may not be sufficient to reduce HIV incidence in gay men and other men who have sex with men populations. There is the need for appropriately tailored combination prevention programmes in order to make real gains against HIV among gay men and other men who have sex with men.

Europe
United Kingdom
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Couples learning from couples: now is the time to test together

Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial.

Matovu JK, Todd J, Wanyenze RK, Kairania R, Serwadda D, Wabwire-Mangen F. BMC Infect Dis. 2016 Aug 8;16:379. doi: 10.1186/s12879-016-1720-y.

Background: Uptake of couples' HIV counseling and testing (couples' HCT) services remains largely low in most settings. We report the effect of a demand-creation intervention trial on couples' HCT uptake among married or cohabiting individuals who had never received couples' HCT.

Methods: This was a cluster-randomized intervention trial implemented in three study regions with differing HIV prevalence levels (range: 9-43 %) in Rakai district, southwestern Uganda, between February and September 2014. We randomly assigned six clusters (1:1) to receive the intervention or serve as the comparison arm using computer-generated random numbers. In the intervention clusters, individuals attended small group, couple and male-focused interactive sessions, reinforced with testimonies from 'expert couples', and received invitation coupons to test together with their partners at designated health facilities. In the comparison clusters, participants attended general adult health education sessions but received no invitation coupons. The primary outcome was couples' HCT uptake, measured 12 months post-baseline. Baseline data were collected between November 2013 and February 2014 while follow-up data were collected between March and April 2015. We conducted intention-to-treat analysis using a mixed effects Poisson regression model to assess for differences in couples' HCT uptake between the intervention and comparison clusters. Data analysis was conducted using STATA statistical software, version 14.1.

Results: Of 2135 married or cohabiting individuals interviewed at baseline, 42% (n = 846) had ever received couples' HCT. Of those who had never received couples' HCT (n = 1174), 697 were interviewed in the intervention clusters while 477 were interviewed in the comparison clusters. 73.6% (n = 513) of those interviewed in the intervention and 82.6% (n = 394) of those interviewed in the comparison cluster were interviewed at follow-up. Of those interviewed, 72.3% (n = 371) in the intervention and 65.2% (n = 257) in the comparison clusters received HCT. Couples' HCT uptake was higher in the intervention than in the comparison clusters (20.3% versus 13.7%; adjusted prevalence ratio (aPR) = 1.43, 95% CI: 1.02, 2.01, P = 0.04).

Conclusion: Our findings show that a small group, couple and male-focused, demand-creation intervention reinforced with testimonies from 'expert couples', improved uptake of couples' HCT in this rural setting.

Trial registration: ClinicalTrials.gov, NCT02492061. Date of registration: June 14, 2015.

Abstract  Full-text [free] access

Editor’s notes: Effective programmes to increase HIV testing uptake are necessary, given new guidance from WHO recommending an immediate offer of antiretroviral therapy (ART) to all people who test HIV-positive regardless of CD4 count. This HIV testing demand creation trial involving married or cohabiting couples residing in Rakai, Uganda sheds light on strategies for achieving 90% knowledge of HIV-positive serostatus among all people living with HIV. In reality, HIV-serodiscordant couples have a striking 50% HIV prevalence from their partnership. Knowledge of serostatus is therefore critical to preventing HIV transmission to the HIV-negative partner and to an offspring. Such knowledge is also the doorway to early initiation of ART with its proven clinical benefits for the HIV-positive partner and reduced risk of HIV transmission to the HIV-negative partner. This intervention trial contributes to the literature on couples’ testing uptake generated through studies in Rwanda and Zambia in which influential network agents invited couples to take up HIV testing and counselling together. This trial was conducted in a highly studied population that has undergone annual sero-surveillance for over 20 years. At baseline 94.6% of individuals interviewed had already had an HIV test, 42% had a history of previous couples’ HIV testing and counselling (HTC), and 62.3% had had tested for HIV in the past year. People who had never received couples’ HTC formed the study populations. Couples in the programme clusters participated in couple- and male-focused demand creation small groups in which ‘expert couples’ shared their couple testing experiences. It is not possible to know which components of this relatively expensive programme were most effective. Uptake of couples HTC was modest at 20.3% compared with 13.7% in the control arm. Since this trial was conducted, new promising technologies have come on the horizon, including self-testing and point of care testing. Combining these with concerted efforts to reduce stigma and discrimination while increasing access to ART should see steady increases in uptake of couples’ HCT. Further, there is enough evidence now to suggest that engaging men and encouraging couple-to-couple conversations about testing can influence couples’ decisions to have an HIV test.

Africa
Uganda
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