Articles tagged as "HIV testing"

Women are successful in promoting HIV self-testing in Kenyan men

Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study.

Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.

Background: Increased uptake of HIV testing by men in sub-Saharan Africa is essential for the success of combination prevention. Self-testing is an emerging approach with high acceptability, but little evidence exists on the best strategies for test distribution. We assessed an approach of providing multiple self-tests to women at high risk of HIV acquisition to promote partner HIV testing and to facilitate safer sexual decision making.

Methods: In this cohort study, HIV-negative women aged 18-39 years were recruited at two sites in Kisumu, Kenya: a health facility with antenatal and post-partum clinics and a drop-in centre for female sex workers. Participants gave informed consent and were instructed on use of oral fluid based rapid HIV tests. Participants enrolled at the health facility received three self-tests and those at the drop-in centre received five self-tests. Structured interviews were conducted with participants at enrolment and over 3 months to determine how self-tests were used. Outcomes included the number of self-tests distributed by participants, the proportion of participants whose sexual partners used a self-test, couples testing, and sexual behaviour after self-testing.

Findings: Between Jan 14, 2015, and March 13, 2015, 280 participants were enrolled (61 in antenatal care, 117 in post-partum care, and 102 female sex workers); follow-up interviews were completed for 265 (96%). Most participants with primary sexual partners distributed self-tests to partners: 53 (91%) of 58 participants in antenatal care, 91 (86%) of 106 in post-partum care, and 64 (75%) of 85 female sex workers. 82 (81%) of 101 female sex workers distributed more than one self-test to commercial sex clients. Among self-tests distributed to and used by primary sexual partners of participants, couples testing occurred in 27 (51%) of 53 in antenatal care, 62 (68%) of 91 from post-partum care, and 53 (83%) of 64 female sex workers. Among tests received by primary and non-primary sexual partners, two (4%) of 53 tests from participants in antenatal care, two (2%) of 91 in post-partum care, and 41 (14%) of 298 from female sex workers had positive results. Participants reported sexual intercourse with 235 (62%) of 380 sexual partners who tested HIV-negative, compared with eight (18%) of 45 who tested HIV-positive (p<0.0001); condoms were used in all eight intercourse events after positive results compared with 104 (44%) after of negative results (p<0.0018). Four participants reported intimate partner violence as a result of self-test distribution: two in the post-partum care group and two female sex workers. No other adverse events were reported.

Interpretation: Provision of multiple HIV self-tests to women at high risk of HIV infection was successful in promoting HIV testing among their sexual partners and in facilitating safer sexual decisions. This novel strategy warrants further consideration as countries develop self-testing policies and programmes.

Abstract access

Editor’s notes: This paper presents a novel approach to promoting HIV self-testing strategies among men and couples, by distributing self-tests through social and sexual networks of women. Women attending antenatal clinics, post-partum care, and sex workers were briefly trained on how to use the Ora-Quick self-test kit, and then given five kits to take with them and give to people in their networks. This strategy allowed women and their partners to choose when and where they tested, often together and in the comfort of their own environments. The majority of women reported having distributed self-test kits to partners/clients and undertaking couples testing. Further, according to participant’s report, 58% of people testing positive linked to HIV care (and linkage was unknown in 35%). Interestingly, the on-the-spot, or point-of-sex testing allowed individuals to decide whether to continue with sexual encounters according to status, which reportedly proved to be especially useful to the female sex workers. There were four reported cases of violence resulting from test use, and this should be closely watched in future research. This is the first study to assess the potential for secondary distribution of HIV self-test kits by multiple populations of women to promote HIV testing in their male partners, and overall, the results indicate that this model is a promising strategy for promoting further HIV-testing, leading the field closer to the UNAIDS 90-90-90 treatment target and improved HIV prevention as well. 

Africa
Kenya
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Increased adolescent testing

Increased adolescent HIV testing with a hybrid mobile strategy in Uganda and Kenya.

Kadede K, Ruel T, Kabami J, Ssemmondo E, Sang N, Kwarisiima D, Bukusi E, Cohen CR, Liegler T, Clark TD, Charlebois ED, Petersen ML, Kamya MR, Havlir DV, Chamie G, SEARCH team. AIDS. 2016 Jun 1. [Epub ahead of print]

Objective: We sought to increase adolescent HIV testing across rural communities in east Africa and identify predictors of undiagnosed HIV.

Design: Hybrid mobile testing.

Methods: We enumerated 116 326 adolescents (10-24 years) in 32 communities of Uganda and Kenya (SEARCH: NCT01864603): 98 694 (85%) reported stable (≥6 months of prior year) residence. In each community we performed hybrid testing: 2- week multi-disease community health campaign (CHC) that included HIV testing, followed by home-based testing of CHC non-participants. We measured adolescent HIV testing coverage and prevalence, and determined predictors of newly-diagnosed HIV among HIV+ adolescents using multivariable logistic regression.

Results: 86 421 (88%) stable adolescents tested for HIV; coverage was 86%, 90%, and 88% in early (10-14), mid (15-17) and late (18-24) adolescents, respectively. Self- reported prior testing was 9%, 26%, and 55% in early, mid and late adolescents tested, respectively. HIV prevalence among adolescents tested was 1.6% and 0.6% in Ugandan women and men, and 7.1% and 1.5% in Kenyan women and men, respectively. Prevalence increased in mid-adolescence for women, and late adolescence for men. Among HIV+ adolescents, 58% reported newly-diagnosed HIV. In multivariate analysis of HIV+ adolescents, predictors of newly-diagnosed HIV included male gender (OR = 1.97 [95%CI: 1.42-2.73]), Ugandan residence (OR = 2.63 [95%CI: 2.08-3.31]), and single status (OR = 1.62 [95%CI: 1.23-2.14] vs. married).

Conclusions: The SEARCH hybrid strategy tested 88% of stable adolescents for HIV, a substantial increase over the 28% reporting prior testing. The majority (57%) of HIV+ adolescents were new diagnoses. Mobile HIV testing for adults should be leveraged to reach adolescents for HIV treatment and prevention.

Abstract access 

Editor’s notes: Ending the AIDS epidemic requires much greater focus on adolescents, among whom HIV associated deaths is a leading cause of death in sub-Saharan Africa. Critical behaviours that are likely to impact on future health, such as risky sexual behaviour, often begin in adolescence. However, it is estimated that less than a third of adolescents in sub-Saharan Africa have been tested for HIV. In this paper, the authors report the impact of a hybrid community-based mobile testing approach to increase HIV testing among adolescents in rural communities in East Africa. This model, which does not rely on accessing schools or clinics, is very suitable for this age group, given the low rates of school attendance among female adolescents and the low use of clinic-based services by adolescents. A high rate of HIV testing was achieved, and testing for HIV in a multi-disease context may have enabled adolescents to access testing without fear of being stigmatised. However, uptake of testing is only the first stage in the HIV prevention and treatment cascade, and further data on the proportion of people testing positive who link to care and start treatment, and people testing negative who link to prevention services, are necessary. 

Africa
Kenya, Uganda
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Unique needs of gay men in sub-Saharan Africa identified with respondent-driven sampling

Respondent-driven sampling as a recruitment method for men who have sex with men in southern sub-Saharan Africa: a cross-sectional analysis by wave.

Stahlman S, Johnston LG, Yah C, Ketende S, Maziya S, Trapence G, Jumbe V, Sithole B, Mothopeng T, Mnisi Z, Baral S. Sex Transm Infect. 2016 Jun;92(4):292-8. doi: 10.1136/sextrans-2015-052184. Epub 2015 Sep 30.

Objectives: Respondent-driven sampling (RDS) is a popular method for recruiting men who have sex with men (MSM). Our objective is to describe the ability of RDS to reach MSM for HIV testing in three southern African nations.

Methods: Data collected via RDS among MSM in Lesotho (N=318), Swaziland (N=310) and Malawi (N=334) were analysed by wave in order to characterise differences in sample characteristics. Seeds were recruited from MSM-affiliated community-based organisations. Men were interviewed during a single study visit and tested for HIV. X2 tests for trend were used to examine differences in the proportions across wave category.

Results: A maximum of 13-19 recruitment waves were achieved in each study site. The percentage of those who identified as gay/homosexual decreased as waves increased in Lesotho (49% to 27%, p<0.01). In Swaziland and Lesotho, knowledge that anal sex was the riskiest type of sex for HIV transmission decreased across waves (39% to 23%, p<0.05, and 37% to 19%, p<0.05). The percentage of participants who had ever received more than one HIV test decreased across waves in Malawi (31% to 12%, p<0.01). In Lesotho and Malawi, the prevalence of testing positive for HIV decreased across waves (48% to 15%, p<0.01 and 23% to 11%, p<0.05). Among those living with HIV, the proportion of those unaware of their status increased across waves in all study sites although this finding was not statistically significant.

Conclusions: RDS that extends deeper into recruitment waves may be a promising method of reaching MSM with varying levels of HIV prevention needs.

Abstract access  

Editor’s notes: The HIV risk profile of gay men and other men who have sex with men have not been well-characterised within sub-Saharan African countries. These key populations are traditionally difficult to reach for purposes of estimating the prevalence of HIV and of behavioural risk factors, and for prevention outreach. This study enrolled recruiters from community based organizations which served gay men and other men who have sex with men in Malawi, Lesotho and Swaziland. Each of these ‘seeds’ could recruit up to three participants. Each subsequent participant could recruit another three participants into a new ‘wave’. The profiles of participants changed in each setting with each additional recruitment wave. Men in Swaziland were less likely to know that anal sex was the riskiest type of sex, men in Malawi were less likely to have ever tested for HIV, and men in Lesotho were less likely to have disclosed their sexual orientation to family members. This type of respondent-driven sampling can be replicated to identify men who are removed from community-based organisations, and to identify their unique service needs. Future research can consider whether the hardest-to-reach men are also people at highest risk of HIV infection.

Africa
Lesotho, Malawi, Swaziland
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Ending deaths in people with TB and HIV – still some way to go

High mortality in tuberculosis patients despite HIV interventions in Swaziland.

Mchunu G, van Griensven J, Hinderaker SG, Kizito W, Sikhondze W, Manzi M, Dlamini T, Harries AD. Public Health Action. 2016 Jun 21;6(2):105-10. doi: 10.5588/pha.15.0081.

Setting: All health facilities providing tuberculosis (TB) care in Swaziland.

Objective: To describe the impact of human immunodeficiency virus (HIV) interventions on the trend of TB treatment outcomes during 2010-2013 in Swaziland; and to describe the evolution in TB case notification, the uptake of HIV testing, antiretroviral therapy (ART) and cotrimoxazole preventive therapy (CPT), and the proportion of TB-HIV co-infected patients with adverse treatment outcomes, including mortality, loss to follow-up and treatment failure.

Design: A retrospective descriptive study using aggregated national TB programme data.

Results: Between 2010 and 2013, TB case notifications in Swaziland decreased by 40%, HIV testing increased from 86% to 96%, CPT uptake increased from 93% to 99% and ART uptake among TB patients increased from 35% to 75%. The TB-HIV co-infection rate remained around 70% and the proportion of TB-HIV cases with adverse outcomes decreased from 36% to 30%. Mortality remained high, at 14-16%, over the study period, and anti-tuberculosis treatment failure rates were stable over time (<5%).

Conclusion: Despite high CPT and ART uptake in TB-HIV patients, mortality remained high. Further studies are required to better define high-risk patient groups, understand the reasons for death and design appropriate interventions.

Abstract  Full-text [free] access 

Editor’s notes: This article adds to the body of evidence describing a reduction in TB case notifications at national level at a time of increasing coverage of antiretroviral therapy. Despite the apparent strengthening of the HIV treatment cascade in people with TB, mortality remained high. Around one in seven people with TB and HIV died during TB treatment, and additional deaths may have occurred in people lost to follow-up or with no outcome evaluation.

This analysis using aggregated data does not allow for detailed understanding of why people with TB and HIV died. The authors raise a number of important questions arising from these results. To achieve World Health Organization End TB target of reducing TB deaths by 90% by 2030, we need to understand where to focus resources for maximum impact.

Although not the focus of this paper, it is notable that there appeared to be a relatively stable TB case notification rate in HIV negative people across the four-year study period. This is a reminder that although TB/HIV programmes may be the key to reducing TB mortality, broader population-level programmes to interrupt TB transmission will be required to drive down TB incidence rates.           

Africa
Swaziland
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Taking account of the human factor when introducing new technology – a cautionary tale

Unintended adverse consequences of electronic health record introduction to a mature universal HIV screening program.

Medford-Davis LN, Yang K, Pasalar S, Pillow MT, Miertschin NP, Peacock WF, Giordano TP, Hoxhaj S. AIDS Care. 2016 May;28(5):566-73. doi: 10.1080/09540121.2015.1127319. Epub 2016 Jan 5.

Early HIV detection and treatment decreases morbidity and mortality and reduces high-risk behaviors. Many Emergency Departments (EDs) have HIV screening programs as recommended by the Centers for Disease Control and Prevention. Recent federal legislation includes incentives for electronic health record (EHR) adoption. Our objective was to analyze the impact of conversion to EHR on a mature ED-based HIV screening program. A retrospective pre- and post-EHR implementation cohort study was conducted in a large urban, academic ED. Medical records were reviewed for HIV screening rates from August 2008 through October 2013. On 1 November 2010, a comprehensive EHR system was implemented throughout the hospital. Before EHR implementation, labs were requested by providers by paper orders with HIV-1/2 automatically pre-selected on every form. This universal ordering protocol was not duplicated in the new EHR; rather it required a provider to manually enter the order. Using a chi-squared test, we compared HIV testing in the 6 months before and after EHR implementation; 55 054 patients presented before, and 50 576 after EHR implementation. Age, sex, race, acuity of presenting condition, and HIV seropositivity rates were similar pre- and post-EHR, and there were no major patient or provider changes during this period. Average HIV testing rate was 37.7% of all ED patients pre-, and 22.3% post-EHR, a 41% decline (p < 0.0001), leading to 167 missed new diagnoses after EHR. The rate of HIV screening in the ED decreased after EHR implementation, and could have been improved with more thoughtful inclusion of existing human processes in its design.

Abstract access

Editor’s notes: The introduction of Electronic Health Records is beneficial for sharing patient information between health care providers in large health care settings. However, as the authors of this paper illustrate with this thoughtful case study, the introduction of electronic health records in some settings may worsen rather than improve care. In this case, the electronic health record system which was introduced did not faithfully mimic the manual system it replaced. HIV-screening which had previously been an ‘opt out’ option for laboratory testing, became an ‘opt-in’ option in the new system.  As a result, testing rates went down. Interestingly, a similar electronic system was introduced in another hospital nearby. The effect on testing rates was noticed there and a manual workaround put in place. The nursing director in that institution ‘was a very strong personal advocate and champion for the HIV screening programme there’.  The authors point to the importance of testing new systems carefully and checking for unintended consequences on patient care.

Northern America
United States of America
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Substantial morbidity despite preserved CD4 count in children with slow-progressing HIV

Chronic morbidity among older children and adolescents at diagnosis of HIV infection.

McHugh G, Rylance J, Mujuru H, Nathoo K, Chonzi P, Dauya E, Bandason T, Simms V, Kranzer K, Ferrand RA. J Acquir Immune Defic Syndr. 2016 May 11. [Epub ahead of print]. doi: 10.1097/QAI.0000000000001073

Background: Substantial numbers of children with HIV present to health care services in older childhood and adolescence, previously undiagnosed. These "slow-progressors" may experience considerable chronic ill-health, which is not well-characterised. We investigated the prevalence of chronic morbidity among children aged 6-15 years at diagnosis of HIV infection.

Methods: A cross sectional study was performed at seven primary care clinics in Harare, Zimbabwe. Children aged 6-15 years who tested HIV positive following provider-initiated HIV testing and counselling were recruited. A detailed clinical history and standardised clinical examination was undertaken. The association between chronic disease and CD4 count was investigated using multivariate logistic regression.

Results: Of the 385 participants recruited (52% female, median age 11 years (IQR 8-13)), 95% were perinatally HIV-infected. The median CD4 count was 375 (IQR 215-599) cells/mm3. Although 78% had previous contact with health care services, HIV testing had not been performed. There was a high burden of chronic morbidity: 23% were stunted, 21% had pubertal delay, 25% had chronic skin disease, 54% had a chronic cough of more than 1 month's duration, 28% had abnormal lung function and 12% reported hearing impairment. There was no association between CD4 count of <500cells/mm3 or <350 cells/mm3 with WHO stage or these chronic conditions.

Conclusion: In children with slow-progressing HIV, there is a substantial burden of chronic morbidity even when CD4 count is relatively preserved. Timely HIV testing and prompt ART initiation are urgently needed to prevent development of chronic complications.

Abstract  Full-text [free] access

Editor’s notes: Substantial numbers of infants who have perinatally acquired HIV are presenting with HIV infection in later childhood or adolescence. It is estimated that a third of infants living with HIV are ‘slow-progressors’ with a median survival of 16 years. This study found a large burden of chronic morbidity among older children and adolescent at the time of HIV diagnosis.   Interestingly, no association between CD4 count and WHO HIV disease stage was seen. Children with slow-progressing disease still appear go on to develop poor growth and chronic lung and skin disease despite preserved CD4 counts. Up until recently many of these children would not have been eligible to start ART based on the WHO 2013 HIV treatment guidelines. Recent changes to WHO guidelines recommending immediate ART for all, including older children, will hopefully reduce the risk of development of chronic complications in this population. Improved outcomes will only occur with timely diagnosis which requires increasing awareness of the burden of undiagnosed HIV disease, strengthening provider-initiated HIV testing and counselling and improving retention in ART care in this vulnerable age group.

Africa
Zimbabwe
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Routine programmatic data used to estimate HIV incidence and service uptake among female sex workers in Zimbabwe

Implementation and operational research: cohort analysis of program data to estimate HIV incidence and uptake of HIV-related services among female sex workers in Zimbabwe, 2009-2014.

Hargreaves JR, Mtetwa S, Davey C, Dirawo J, Chidiya S, Benedikt C, Naperiela Mavedzenge S, Wong-Gruenwald R, Hanisch D, Magure T, Mugurungi O, Cowan FM. J Acquir Immune Defic Syndr. 2016 May 1;72(1):e1-8. doi: 10.1097/QAI.0000000000000920.

Background: HIV epidemiology and intervention uptake among female sex workers (FSW) in sub-Saharan Africa remain poorly understood. Data from outreach programs are a neglected resource.

Methods: Analysis of data from FSW consultations with Zimbabwe's National Sex Work program, 2009-2014. At each visit, data were collected on sociodemographic characteristics, HIV testing history, HIV tests conducted by the program and antiretroviral (ARV) history. Characteristics at first visit and longitudinal data on program engagement, repeat HIV testing, and HIV seroconversion were analyzed using a cohort approach.

Results: Data were available for 13 360 women, 31 389 visits, 14 579 reported HIV tests, 2750 tests undertaken by the program, and 2387 reported ARV treatment initiations. At first visit, 72% of FSW had tested for HIV; 50% of these reported being HIV positive. Among HIV-positive women, 41% reported being on ARV. 56% of FSW attended the program only once. FSW who had not previously had an HIV-positive test had been tested within the last 6 months 27% of the time during follow-up. After testing HIV positive, women started on ARV at a rate of 23/100 person years of follow-up. Among those with 2 or more HIV tests, the HIV seroconversion rate was 9.8/100 person years of follow-up (95% confidence interval: 7.1 to 15.9).

Conclusions: Individual-level outreach program data can be used to estimate HIV incidence and intervention uptake among FSW in Zimbabwe. Current data suggest very high HIV prevalence and incidence among this group and help identify areas for program improvement. Further methodological validation is required.

Abstract access

Editor’s notes: Female sex workers in resource poor regions have been shown to have higher levels of HIV incidence and prevalence than people in the general population. Due to the highly stigmatised and often illegal nature of their work, these individuals are often marginalised in society. This can lead to poor engagement with the HIV testing and treatment programmes provided for the general population. Targeted outreach programmes for female sex workers such as the “Sisters for Change” programme in Zimbabwe described in this paper, aim to improve the engagement with testing and care for this group.

Collecting reliable data from female sex workers using a convenience sampling approach in order to estimate the prevalence of HIV is challenging due to the difficulty in ensuring the survey sample is representative of the wider female sex worker population. An alternative approach is respondent driven sampling (RDS) in which respondents recruit their peers to produce a generally representative sample of hard-to-reach populations. The results from RDS are however complex to analyse and interpret.

This paper presents an alternative approach using routinely collected data. Using the dates of programme visits, HIV tests (conducted both within and outside of the programme) and dates of antiretroviral initiation, the researchers generated estimates of HIV prevalence (number of positive tests/total number of tests) and HIV incidence (time at risk calculated from the first visit to an imputed date of seroconversion). They also identified risk factors associated with socio-demographic parameters or HIV testing history that were associated with a failure to continue engagement with the programme after a first visit. The prevalence and incidence results are consistent with results from a series of RDS surveys previously conducted in Zimbabwe by this research team.

A difficulty highlighted by the authors is that while this method improves on convenience sampling, it is still difficult to know how HIV incidence and prevalence among programme participants compares to that in the wider female sex worker population. 

In summary this paper presents an approach by which similar programmes elsewhere could make better use of routinely collected data in order to generate estimates of impact and also identify sub-groups of female sex workers with poorer engagement with care. This in turn could lead to a more effective targeting of limited resources.

Africa
Zimbabwe
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Role for LAM test in TB diagnosis among the sickest people living with HIV

Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in HIV-positive adults.

Shah M, Hanrahan C, Wang ZY, Dendukuri N, Lawn SD, Denkinger CM, Steingart KR. Cochrane Database Syst Rev. 2016 May 10;5:CD011420. doi: 10.1002/14651858.CD011420.pub2.

Background: Rapid detection of tuberculosis (TB) among people living with human immunodeficiency virus (HIV) is a global health priority. HIV-associated TB may have different clinical presentations and is challenging to diagnose. Conventional sputum tests have reduced sensitivity in HIV-positive individuals, who have higher rates of extrapulmonary TB compared with HIV-negative individuals. The lateral flow urine lipoarabinomannan assay (LF-LAM) is a new, commercially available point-of-care test that detects lipoarabinomannan (LAM), a lipopolysaccharide present in mycobacterial cell walls, in people with active TB disease.

Objectives: To assess the accuracy of LF-LAM for the diagnosis of active TB disease in HIV-positive adults who have signs and symptoms suggestive of TB (TB diagnosis). To assess the accuracy of LF-LAM as a screening test for active TB disease in HIV-positive adults irrespective of signs and symptoms suggestive of TB (TB screening).

Search methods: We searched the following databases without language restriction on 5 February 2015: the Cochrane Infectious Diseases Group Specialized Register; MEDLINE (PubMed,1966); EMBASE (OVID, from 1980); Science Citation Index Expanded (SCI-EXPANDED, from 1900), Conference Proceedings Citation Index-Science (CPCI-S, from 1900), and BIOSIS Previews (from 1926) (all three using the Web of Science platform; MEDION; LILACS (BIREME, from 1982); SCOPUS (from 1995); the metaRegister of Controlled Trials (mRCT); the search portal of the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); and ProQuest Dissertations & Theses A&l (from 1861).

Selection criteria: Eligible study types included randomized controlled trials, cross-sectional studies, and cohort studies that determined LF-LAM accuracy for TB against a microbiological reference standard (culture or nucleic acid amplification test from any body site). A higher quality reference standard was one in which two or more specimen types were evaluated for TB, and a lower quality reference standard was one in which only one specimen type was evaluated for TB. Participants were HIV-positive people aged 15 years and older.

Data collection and analysis: Two review authors independently extracted data from each included study using a standardized form. We appraised the quality of studies using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We evaluated the test at two different cut-offs: (grade 1 or 2, based on the reference card scale of five intensity bands). Most analyses used grade 2, the manufacturer's currently recommended cut-off for positivity. We carried out meta-analyses to estimate pooled sensitivity and specificity using a bivariate random-effects model and estimated the models using a Bayesian approach. We determined accuracy of LF-LAM combined with sputum microscopy or Xpert(R) MTB/RIF. In addition, we explored the influence of CD4 count on the accuracy estimates. We assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: We included 12 studies: six studies evaluated LF-LAM for TB diagnosis and six studies evaluated the test for TB screening. All studies were cross-sectional or cohort studies. Studies for TB diagnosis were largely conducted among inpatients (median CD4 range 71 to 210 cells per µL) and studies for TB screening were largely conducted among outpatients (median CD4 range 127 to 437 cells per µL). All studies were conducted in low- or middle-income countries. Only two studies for TB diagnosis (33%) and one study for TB screening (17%) used a higher quality reference standard LF-LAM for TB diagnosis (grade 2 cut-off): meta-analyses showed median pooled sensitivity and specificity (95% credible interval (CrI)) of 45% (29% to 63%) and 92% (80% to 97%), (five studies, 2313 participants, 35% with TB, low quality evidence). The pooled sensitivity of a combination of LF-LAM and sputum microscopy (either test positive) was 59% (47% to 70%), which represented a 19% (4% to 36%) increase over sputum microscopy alone, while the pooled specificity was 92% (73% to 97%), which represented a 6% (1% to 24%) decrease from sputum microscopy alone (four studies, 1876 participants, 38% with TB). The pooled sensitivity of a combination of LF-LAM and sputum Xpert(R) MTB/RIF (either test positive) was 75% (61% to 87%) and represented a 13% (1% to 37%) increase over Xpert(R) MTB/RIF alone. The pooled specificity was 93% (81% to 97%) and represented a 4% (1% to 16%) decrease from Xpert(R) MTB/RIF alone (three studies, 909 participants, 36% with TB). Pooled sensitivity and specificity of LF-LAM were 56% (41% to 70%) and 90% (81% to 95%) in participants with a CD4 count of less than or equal to 100 cells per µL (five studies, 859 participants, 47% with TB) versus 26% (16% to 46%) and 92% (78% to 97%) in participants with a CD4 count greater than 100 cells per µL (five studies, 1410 participants, 30% with TB). LF-LAM for TB screening (grade 2 cut-off): for individual studies, sensitivity estimates (95% CrI) were 44% (30% to 58%), 28% (16% to 42%), and 0% (0% to 71%) and corresponding specificity estimates were 95% (92% to 97%), 94% (90% to 97%), and 95% (92% to 97%) (three studies, 1055 participants, 11% with TB, very low quality evidence). There were limited data for additional analyses. The main limitations of the review were the use of a lower quality reference standard in most included studies, and the small number of studies and participants included in the analyses. The results should, therefore, be interpreted with caution.

Authors' conclusions: We found that LF-LAM has low sensitivity to detect TB in adults living with HIV whether the test is used for diagnosis or screening. For TB diagnosis, the combination of LF-LAM with sputum microscopy suggests an increase in sensitivity for TB compared to either test alone, but with a decrease in specificity. In HIV-positive individuals with low CD4 counts who are seriously ill, LF-LAM may help with the diagnosis of TB.

Abstract  Full-text [free] access

Editor’s notes: Tuberculosis (TB) remains a leading cause of death among people living with HIV. Diagnostic tests for TB are suboptimal, and a test for TB with adequate performance which could be used by nurses in primary care clinics would be a great advance. Lipoarabinomannam (LAM) is a component of mycobacterial cell wall which can be found in urine. A lateral flow assay to detect LAM in urine is commercially available at low cost, and can be used in primary care settings without the need for laboratory equipment. However the test is insensitive, such that it has no useful role among HIV-negative people, but has better sensitivity among people living with HIV, leading to questions concerning its role in TB diagnostic pathways.

This systematic review puts together data concerning the performance of the LAM lateral flow assay when used either as a screening test or for diagnosis of TB among people living with HIV. Assessment is made more complicated because the recommended reference cut-off for the test has been changed, with relatively few studies performed after the recommended cut off became what is referred to here as the “higher quality” reference standard (grade two test band intensity, rather than grade one as was previously recommended). Based on the grade two cut–off, the pooled estimate of sensitivity of the test was 45%. As expected, sensitivity was better for individuals with low CD4 counts.

This review informed WHO recommendations on the use of the LAM assay, suggesting that its use should be restricted to assisting with TB diagnosis in people living with HIV with low CD4 counts who are seriously ill. This is consistent with the results of the recent trial (PMID: 26970721) comparing management of hospitalised HIV-positive people reporting one or more TB symptoms with routine testing of urine for LAM compared to standard diagnostic tests, which found that the addition of LAM testing resulted in a small reduction in eight-week mortality.

Overall, LAM is inadequate as a single test for TB, and an accurate diagnostic test that could be used in-session for TB diagnosis in primary care clinics remains a pressing priority.

Comorbidity, HIV testing
Africa
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Botswana within reach of UNAIDS 90-90-90 treatment target

Botswana's progress toward achieving the 2020 UNAIDS 90-90-90 antiretroviral therapy and virological suppression goals: a population-based survey.

Gaolathe T, Wirth KE, Holme MP, Makhema J, Moyo S, Chakalisa U, Yankinda EK, Lei Q, Mmalane M, Novitsky V, Okui L, van Widenfelt E, Powis KM, Khan N, Bennett K, Bussmann H, Dryden-Peterson S, Lebelonyane R, El-Halabi S, Mills LA, Marukutira T, Wang R, Tchetgen EJ, DeGruttola V, Essex M, Lockman S, Botswana Combination Prevention Project study team. Lancet HIV. 2016 May;3(5):e221-30. doi: 10.1016/S2352-3018(16)00037-0. Epub 2016 Mar 24.

Background: HIV programmes face challenges achieving high rates of HIV testing and treatment needed to optimise health and to reduce transmission. We used data from the Botswana Combination Prevention Project study survey to assess Botswana's progress toward achieving UNAIDS targets for 2020: 90% of all people living with HIV knowing their status, 90% of these receiving sustained antiretroviral therapy (ART), and 90% of those having virological suppression (90-90-90).

Methods: A population-based sample of individuals was recruited and interviewed in 30 rural and periurban communities from Oct 30, 2013, to Nov 24, 2015, as part of a large, ongoing community-randomised trial designed to assess the effect of a combination prevention package on HIV incidence. A random sample of about 20% of households in each community was selected. Consenting household residents aged 16-64 years who were Botswana citizens or spouses of citizens responded to a questionnaire and had blood drawn for HIV testing in the absence of documentation of positive HIV status. Viral load testing was done in all HIV-infected participants, irrespective of treatment status. We used modified Poisson generalised estimating equations to obtain prevalence ratios, corresponding Huber robust SEs, and 95% Wald CIs to examine associations between individual sociodemographic factors and a binary outcome indicating achievement of the three individual and combined overall 90-90-90 targets. The study is registered at ClinicalTrials.gov, number NCT01965470.

Findings: 81% of enumerated eligible household members took part in the survey (10% refused and 9% were absent). Among 12 610 participants surveyed, 3596 (29%) were infected with HIV, and 2995 (83.3%, 95% CI 81.4-85.2) of these individuals already knew their HIV status. Among those who knew their HIV status, 2617 (87.4%, 95% CI 85.8-89.0) were receiving ART (95% of those eligible by national guidelines, and 73% of all infected people). Of the 2609 individuals receiving ART with a viral load measurement, 2517 (96.5%, 95% CI 96.0-97.0) had viral load of 400 copies per mL or less. Overall, 70.2% (95% CI 67.5-73.0) of HIV-infected people had virological suppression, close to the UNAIDS target of 73%.

Interpretation: UNAIDS 90-90-90 targets are achievable even in resource-constrained settings with high HIV burden.

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Editor’s notes: The UNAIDS treatment target set for 2020 aim for at least 90 percent of all people living with HIV to be diagnosed, at least 90 percent of people diagnosed to receive antiretroviral therapy, and for treatment to be effective and consistent enough in at least 90 percent of those people on treatment to suppress the virus. This would result in about 73% of all HIV-positive people being virally suppressed. 

This study estimated coverage of HIV diagnosis, antiretroviral therapy and viral suppression among 30 communities in Botswana, a country with a high HIV prevalence (~ 25%), to assess the country’s progress towards the UNAIDS treatment target. They found that overall, about 70% of people living with HIV had viral suppression (defined in this analysis as having a viral load of less than HIV RNA 400 copies per mL), close to the UNAIDS target of 73%. However, there is still substantial ongoing transmission (demonstrated by an HIV incidence of 1.4% per year in 2013). The authors attribute this mainly to the 30% of people living with HIV that remain unsuppressed (undiagnosed, or not on treatment, or not virally suppressed because of poor adherence or drug resistance). They also acknowledge that other factors such as the complexities of sexual networks, risk behaviour patterns, and biological factors may play a role.

Interestingly the authors found very high proportions of viral suppression. Nearly 97% of people on ART were virally suppressed. The authors also found that younger age was the strongest predictor of not reaching the ultimate target (diagnosed, on treatment and being virally suppressed). People living with HIV aged 20-29 years old were about 50% less likely to be virally suppressed compared with people 60 years and older. Young people living with HIV aged between 16-19 years old were 60% less likely to be virally suppressed. This emphasizes again the need for focussed programmes for adolescents and young people.

Botswana has reached this level of coverage even when the criterion for initiating antiretroviral therapy was a CD4 cell count below 350 cells per μL, even before moving to providing treatment for everyone diagnosed with HIV. The authors conclude that the high proportions of HIV testing, antiretroviral therapy and viral suppression provide good evidence that the UNAIDS treatment target is achievable.

Africa
Botswana
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HIV testing in South Africa: on track to reach the first “90”?

Changes in self-reported HIV testing during South Africa's 2010/2011 national testing campaign: gains and shortfalls.

Maughan-Brown B, Lloyd N, Bor J, Venkataramani AS. J Int AIDS Soc. 2016; 19(1): 20658.

Objectives: HIV counselling and testing is critical to HIV prevention and treatment efforts. Mass campaigns may be an effective strategy to increase HIV testing in countries with generalized HIV epidemics. We assessed the self-reported uptake of HIV testing among individuals who had never previously tested for HIV, particularly those in high-risk populations, during the period of a national, multisector testing campaign in South Africa (April 2010 and June 2011).

Design: This study was a prospective cohort study.

Methods: We analyzed data from two waves (2010/2011, n=16 893; 2012, n=18 707) of the National Income Dynamics Study, a nationally representative cohort that enabled prospective identification of first-time testers. We quantified the number of adults (15 years and older) testing for the first time nationally. To assess whether the campaign reached previously underserved populations, we examined changes in HIV testing coverage by age, gender, race and province sub-groups. We also estimated multivariable logistic regression models to identify socio-economic and demographic predictors of first-time testing.

Results: Overall, the proportion of adults ever tested for HIV increased from 43.7% (95% confidence interval (CI): 41.48, 45.96) to 65.2% (95% CI: 63.28, 67.10) over the study period, with approximately 7.6 million (95% CI: 6,387,910; 8,782,986) first-time testers. Among black South Africans, the country's highest HIV prevalence sub-group, HIV testing coverage improved among poorer and healthier individuals, thus reducing gradients in testing by wealth and health. In contrast, HIV testing coverage remained lower for men, younger individuals and the less educated, indicating persistent if not widening disparities by gender, age and education. Large geographic disparities in coverage also remained as of 2012.

Conclusions: Mass provision of HIV testing services can be effective in increasing population coverage of HIV testing. The geographic and socio-economic disparities in programme impacts can help guide best practices for future efforts. These efforts should focus on hard-to-reach populations, including men and less-educated individuals.

Abstract Full-text [free] access

Editor’s notes: In South Africa, around one in eight people are living with HIV yet around half of these people do not know that they are HIV positive. To meet the 90-90-90 treatment target by 2020, there needs to be considerable expansion of HIV testing coverage. This analysis used independent nationally representative data on self-reported HIV testing to demonstrate that coverage of HIV testing increased substantially following the national multi-sector HIV testing campaign in 2010/11. Despite the expansion in coverage, in the 2012 survey one in three people aged >15 years reported never having received an HIV test. There was marked gender disparity, some 72% of women versus 57% men reported ever having tested in the 2012 survey. There were also prominent gaps among certain socio-economic groups, suggesting persistent inequities in access to HIV testing. 

Although South Africa performs around 10 million HIV tests per year, the number of people tested falls substantially below the target of 30 million tests set for 2016 in the National Strategic Plan. In September, South Africa will implement the “test and treat” approach where all people living with HIV will be offered antiretroviral therapy. In addition, demonstration projects are underway of pre-exposure prophylaxis (PrEP) for HIV prevention. HIV testing services  is the gateway to all treatment and prevention services. The national campaign for HIV testing will clearly need to be revitalised in order to maximise the impact of these public health activities. At the same time, the data reported here would suggest that more innovative and focused approaches may be necessary for difficult to reach population groups.

Africa
South Africa
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