Articles tagged as "HIV testing and treatment"

Getting to 90-90-90 in China: where are the gaps?

Disparities in HIV care along the path from infection to viral suppression: a cross-sectional study of HIV/AIDS patient records in 2013, Shandong province, China.

Zhang N, Bussell S, Wang G, Zhu X, Yang X, Huang T, Qian Y, Tao X, Kang D, Wang N. Clin Infect Dis. 2016 Jul 1;63(1):115-21. doi: 10.1093/cid/ciw190. Epub 2016 Mar 29.

Background: The 90-90-90 targets recommended by the Joint United Nations Programme on HIV/AIDS require strengthening human immunodeficiency virus (HIV) care, which includes diagnosis, linkage to and retention in care, assessment for treatment suitability, and optimization of HIV treatment. We sought to quantify patient engagement along the continuum, 10 years after introduction of Chinese HIV care policies.

Methods: We included patients from Shandong, China, who were diagnosed with HIV from 1992 to 2013. Records were obtained from the HIV/AIDS Comprehensive Response Information Management System to populate a 7-step HIV care continuum. Pearson chi2 test and multivariate logistic regression were used for analysis.

Results: Of 6500 estimated HIV-infected persons, 60.1% were diagnosed, of whom 41.9% received highly active antiretroviral therapy (HAART). Only 59.6% of patients on HAART and 15% of all infected persons achieved viral suppression. Children infected by mother-to-child transmission (MTCT) and persons infected by intravenous drug use were less likely to be linked to and retained in care (odds ratio [OR], 0.33 [95% confidence interval {CI}, .14-.80] and OR, 0.58 [95% CI, .40-.90], respectively). Persons tested in custodial institutions were substantially less likely to be on HAART (OR, 0.22 [95% CI, .09-.59]) compared with those tested in medical facilities. Patients on HAART infected by homosexual or heterosexual transmission and those infected by MTCT were less likely to achieve viral suppression (OR, 0.18 [95% CI, .09-.34]; OR, 0.12 [95% CI, .06-.22]; OR, 0.07 [95% CI, .02-.20], respectively).

Conclusions: Our report suggests, at the current rate, Shandong Province has to accelerate HIV care efforts to close disparities in HIV care and achieve the 90-90-90 goals equitably.

Abstract access

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 people living with HIV being virally suppressed.

This study estimated coverage of HIV diagnosis, antiretroviral treatment and viral suppression in Shandong Province in 2013, 10 years after the introduction of a Chinese HIV care policy.

The authors found that overall, only about 60% of people on ART and 15% of all people living with HIV achieved viral suppression (defined in this analysis as having a viral load of less than HIV RNA 50 copies per mL). This is in sharp contrast with recently published figures from Botswana where 97% of people on ART, and about 70% of persons living with HIV were virally suppressed (there defined as having a viral load of less than 400 copies per mL).

With only 15% of persons with HIV being virally suppressed in Shandong Province, a big gap remains for reaching the UNAIDS target of 73%. The authors demonstrate that despite a free, inclusive, nationwide HIV care policy, significant inequalities in HIV testing and treatment exist in Shandong Province. For example people who inject drugs and people in custodial institutions were much less likely to be initiated on ART.

The authors conclude that to achieve the 90-90-90 UNAIDS treatment target, Shandong Province needs to close these disparities in HIV care. 

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Showing they care: lay-counsellors, home-based testing and the value of follow-up support

How home HIV testing and counselling with follow-up support achieves high testing coverage and linkage to treatment and prevention: a qualitative analysis from Uganda.

Ware NC, Wyatt MA, Asiimwe S, Turyamureeba B, Tumwesigye E, van Rooyen H, Barnabas RV, Celum CL. J Int AIDS Soc. 2016 Jun 28;19(1):20929. doi: 10.7448/IAS.19.1.20929. eCollection 2016.

Introduction: The successes of HIV treatment scale-up and the availability of new prevention tools have raised hopes that the epidemic can finally be controlled and ended. Reduction in HIV incidence and control of the epidemic requires high testing rates at population levels, followed by linkage to treatment or prevention. As effective linkage strategies are identified, it becomes important to understand how these strategies work. We use qualitative data from The Linkages Study, a recent community intervention trial of community-based testing with linkage interventions in sub-Saharan Africa, to show how lay counsellor home HIV testing and counselling (home HTC) with follow-up support leads to linkage to clinic-based HIV treatment and medical male circumcision services.

Methods: We conducted 99 semi-structured individual interviews with study participants and three focus groups with 16 lay counsellors in Kabwohe, Sheema District, Uganda. The participant sample included both HIV+ men and women (N=47) and HIV-uncircumcised men (N=52). Interview and focus group audio-recordings were translated and transcribed. Each transcript was summarized. The summaries were analyzed inductively to identify emergent themes. Thematic concepts were grouped to develop general constructs and framing propositional statements.

Results: Trial participants expressed interest in linking to clinic-based services at testing, but faced obstacles that eroded their initial enthusiasm. Follow-up support by lay counsellors intervened to restore interest and inspire action. Together, home HTC and follow-up support improved morale, created a desire to reciprocate, and provided reassurance that services were trustworthy. In different ways, these functions built links to the health service system. They worked to strengthen individuals' general sense of capability, while making the idea of accessing services more manageable and familiar, thus reducing linkage barriers.

Conclusions: Home HTC with follow-up support leads to linkage by building "social bridges," interpersonal connections established and developed through repeated face-to-face contact between counsellors and prospective users of HIV treatment and male circumcision services. Social bridges link communities to the service system, inspiring individuals to overcome obstacles and access care.

Abstract  Full-text [free] access 

Editor’s notes: How can people be encouraged once they have received a positive HIV-test result to link and stay in treatment? This is a crucial question as the momentum for everyone living with HIV to be on antiretroviral therapy grows.  The authors of this paper demonstrate clearly and succinctly the value of personal contact in supporting people to test and the link to care. Lay-counsellors paying visits to people’s homes provided the encouragement to help some people to link to care. The home visits were seen by people visited as a sign that ‘someone cared’.  The personal attention and information provided promoted trust. The visits also created a sense of obligation: the person visited felt they should do something in return to please the counsellor.

Increasing numbers of people living with HIV does not necessarily mean that it is easier for someone coping with a positive-test result to link to care. We should not underestimate the continued burden that an HIV-positive test result places on individuals.  Many barriers remain both to testing and sustaining a link to care. The authors of this paper provide examples of how to overcome some of those barriers. However, while this paper provides encouraging findings on the value of the home-based activity, the findings also pose a challenge. Can such follow-up support services, which demand more than a single visit, be provided widely enough to benefit all people who need such attention and support? 

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Patient navigators and financial incentives have no effect on HIV viral suppression in people with substance use disorders

Effect of patient navigation with or without financial incentives on viral suppression among hospitalized patients with HIV infection and substance use: a randomized clinical trial.  

Metsch LR, Feaster DJ, Gooden L, Matheson T, Stitzer M, Das M, Jain MK, Rodriguez AE, Armstrong WS, Lucas GM, Nijhawan AE, Drainoni ML, Herrera P, Vergara-Rodriguez P, Jacobson JM, Mugavero MJ, Sullivan M, Daar ES, McMahon DK, Ferris DC, Lindblad R, VanVeldhuisen P, Oden N, Castellon PC, Tross S, Haynes LF, Douaihy A, Sorensen JL, Metzger DS, Mandler RN, Colfax GN, del Rio C. JAMA. 2016 Jul 12;316(2):156-70. doi: 10.1001/jama.2016.8914.

Importance: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates.

Objective: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients.

Design, setting, and participants: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months.

Interventions: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment.

Main outcomes and measures: The primary outcome was HIV viral suppression (200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up.

Results: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68).

Conclusions and relevance: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: Identifier: NCT01612169.

Abstract access

Editor’s notes: Substance use in people living with HIV has consistently been shown to be associated with poor clinical outcomes. Within this population, management often requires a combination of treatment for both HIV and substance use disorders. It is evident that it is the poor engagement in one or both of these treatment approaches that contributes significantly to poor clinical outcomes. The author’s group aimed to fill a gap in current evidence and explore whether two activities, patient navigation and financial incentives, could potentially motivate engagement with both treatment approaches and ultimately improve HIV viral suppression.

This study tested, among people living with HIV in hospital,  with substance use disorders, six months of patient navigation alone (care co-ordination and case management), or six months of patient navigation alongside a financial incentive plan. While overall uptake and retention to the programme schedules were high, no differences in HIV-1 viral suppression rates (which were generally poor) or death by 12 months were noted.

One factor that must be highlighted is that the participation in actual substance use treatment programmes post hospital discharge was low across all groups (average 24.8%), primarily due to a lack of available services in the regions. It may be that the programme may have been more effective in a different population of people already established in substance use treatment programmes, or if treatment had been more easily accessible.

The study serves as a reminder that such key populations are extremely vulnerable with a number of comorbidities and competing priorities. While not supporting health care navigation or financial incentives in their defined setting, the study findings emphasise a need to develop and tailor, cost-effective activities to improve health outcomes in this group.

Northern America
United States of America
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Less than half of HIV-positive people identified through HBTC link to care in large community study in KwaZulu-Natal

 Access to HIV care in the context of universal test and treat: challenges within the ANRS 12249 TasP cluster-randomized trial in rural South Africa.

Plazy M, Farouki KE, Iwuji C, Okesola N, Orne-Gliemann J, Larmarange J, Lert F, Newell ML, Dabis F, Dray-Spira R. J Int AIDS Soc. 2016 Jun 1;19(1):20913. doi: 10.7448/IAS.19.1.20913. eCollection 2016.

Introduction: We aimed to quantify and identify associated factors of linkage to HIV care following home-based HIV counselling and testing (HBHCT) in the ongoing ANRS 12249 treatment-as-prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa.

Methods: Individuals ≥16 years were offered HBHCT; those who were identified HIV positive were referred to cluster-based TasP clinics and offered antiretroviral treatment (ART) immediately (five clusters) or according to national guidelines (five clusters). HIV care was also available in the local Department of Health (DoH) clinics. Linkage to HIV care was defined as TasP or DoH clinic attendance within three months of referral among adults not in HIV care at referral. Associated factors were identified using multivariable logistic regression adjusted for trial arm.

Results: Overall, 1323 HIV-positive adults (72.9% women) not in HIV care at referral were included, of whom 36.9% (n=488) linked to care <3 months of referral (similar by sex). In adjusted analyses (n=1222), individuals who had never been in HIV care before referral were significantly less likely to link to care than those who had previously been in care (<33% vs. >42%, p<0.001). Linkage to care was lower in students (adjusted odds-ratio [aOR]=0.47; 95% confidence interval [CI] 0.24-0.92) than in employed adults, in adults who completed secondary school (aOR=0.68; CI 0.49-0.96) or at least some secondary school (aOR=0.59; CI 0.41-0.84) versus ≤ primary school, in those who lived at 1 to 2 km (aOR=0.58; CI 0.44-0.78) or 2-5 km from the nearest TasP clinic (aOR=0.57; CI 0.41-0.77) versus <1 km, and in those who were referred to clinic after ≥2 contacts (aOR=0.75; CI 0.58-0.97) versus those referred at the first contact. Linkage to care was higher in adults who reported knowing an HIV-positive family member (aOR=1.45; CI 1.12-1.86) versus not, and in those who said that they would take ART as soon as possible if they were diagnosed HIV positive (aOR=2.16; CI 1.13-4.10) versus not.

Conclusions: Fewer than 40% of HIV-positive adults not in care at referral were linked to HIV care within three months of HBHCT in the TasP trial. Achieving universal test and treat coverage will require innovative interventions to support linkage to HIV care.

Abstract  Full-text [free] access 

Editor’s notes: The UNAIDS treatment target set for 2020 aims 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 people on treatment to suppress the virus. This would result in about 73% of all HIV-positive people being virally suppressed. 

This manuscript describes the linkage to care after being diagnosed HIV- positive during home based testing and counselling (HBTC) in a Treatment as Prevention trial in Kwazulu-Natal, South Africa. About 30% of consenting participants were HIV-positive. Some 43% of these participants were new diagnoses, 26% had previously been diagnosed but never accessed care, and about 31% had already accessed HIV care but dropped out of care. The authors found disappointingly low linkage proportions: fewer than 40% of participants diagnosed through HBTC accessed an HIV clinic within three months of referral. 

Although stigma is a commonly cited barrier to adherence, the authors did not find an association between perceived stigma and linkage to care. They did find that people with HIV-positive family members were more likely to access HIV care than people who did not, and suggest that this might be because they are more confident in disclosing their status and more likely to receive family support.

These findings are particularly relevant in the context of the results of the parent Treatment as Prevention trial, which were reported at the AIDS2016 conference in Durban. The trial found no effect on HIV incidence of offering immediate ART, mainly due to the low rates of linkage to care following HIV diagnosis. This underscores that while HBTC is useful to ensure that HIV-positive people know their status, further programmes are necessary to maximise the number of people linked to care and initiating ART.

South Africa
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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. 

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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. 

Kenya, Uganda
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Antiretroviral therapy: being reborn into uncertainty

What will become of me if they take this away? Zimbabwean women's perceptions of "free" ART.

Gona CM, McGee E, DeMarco R. J Assoc Nurses AIDS Care. 2016 May 13. pii: S1055-3290(16)30040-1. doi: 10.1016/j.jana.2016.05.001. [Epub ahead of print]

The evolution of antiretroviral therapies (ART) has redefined HIV infection from a life-threatening disease to a chronic manageable condition. Despite ART, HIV infection remains a serious health burden in Zimbabwe, particularly among women of reproductive age. In this interpretive phenomenology study, we interviewed 17 women with advanced HIV infection to uncover and understand their experiences of living with HIV infection in the ART era. Two themes (knowing the restorative power of ART and the heavy burden of being infected with HIV) reflected the women's experiences. ART brought physical and mental relief, but did not change the sobering reality of poverty or the challenges posed by the infective nature of HIV. The heavily donor-funded Zimbabwean ART program has been a success story, but there is uncertainty over its long-term sustainability. In resource-limited countries, clinicians and other stakeholders should continue to focus on HIV prevention as the cornerstone of HIV programming.

Abstract access

Editor’s notes: In Zimbabwe, as in much of sub-Saharan Africa, women are disproportionately affected by HIV infection. In 2013, women comprised 59% of adults living with HIV. Between 2007 and 2010, women accounted for 64% of people enrolled on ART in the country. Currently only 77% of women in clinical need of ART have access to it with most accessing it through a government and donor-funded ‘cost-free’ programme.  For women in Zimbabwe, living with HIV infection, normal life not only depends on the assurance of uninterrupted access to ART, but also the ability to get married and bear children.

The authors of this paper report on Zimbabwean women’s experiences of living with HIV infection while on ART. The study was nested within an ongoing clinical trial. Women were interviewed through in-depth, individual, face-to-face, open-ended interviews. 

The authors identify a number of important implications of the findings of this study. First, many women, in addition to concerns about their health, also had to contend with the effects of extreme poverty and gender inequality. For HIV treatment programmes to be successful, health care providers and policy makers should incorporate poverty reduction and gender equity components. Second, funding provisions should be put in place to ensure continued supplies of medications in order to reduce the reliance on external donor funding. Third, there is a need to clarify and strengthen policies regarding the continuation of treatment after the completion of a clinical trial to ensure participants’ continued access. Fourth, given the ability of ART to transform HIV into a chronic disease, reproductive health service provision should be prioritized to enable people living with HIV to have children if they wish. Further, and particularly in the light of these challenges, HIV prevention should be centralised as a focal point of HIV programming in order to reduce HIV incidence.

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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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Minimal evidence for serious adverse events resulting from in utero ARV exposure

The PHACS SMARTT Study: assessment of the safety of in utero exposure to antiretroviral drugs.

Van Dyke RB, Chadwick EG, Hazra R, Williams PL, Seage GR, 3rd. Front Immunol. 2016 May 23;7:199. doi: 10.3389/fimmu.2016.00199. eCollection 2016.

The Surveillance Monitoring for ART Toxicities (SMARTT) cohort of the Pediatric HIV/AIDS Cohort Study includes over 3500 HIV-exposed but uninfected infants and children at 22 sites in the US, including Puerto Rico. The goal of the study is to determine the safety of in utero exposure to antiretrovirals (ARVs) and to estimate the incidence of adverse events. Domains being assessed include metabolic, growth and development, cardiac, neurological, neurodevelopmental (ND), behavior, language, and hearing. SMARTT employs an innovative trigger-based design as an efficient means to identify and evaluate adverse events. Participants who met a predefined clinical or laboratory threshold (trigger) undergo additional evaluations to define their case status. After adjusting for birth cohort and other factors, there was no significant increase in the likelihood of meeting overall case status (case in any domain) with exposure to combination ARVs (cARVs), any ARV class, or any specific ARV. However, several individual ARVs were significantly associated with case status in individual domains, including zidovudine for a metabolic case, first trimester stavudine for a language case, and didanosine plus stavudine for a ND case. We found an increased rate of preterm birth with first trimester exposure to protease inhibitor-based cARV. Although there was no overall increase in congenital anomalies with first trimester cARV, a significant increase was seen with exposure to atazanavir, ritonavir, and didanosine plus stavudine. Tenofovir exposure was associated with significantly lower mean whole-body bone mineral content in the newborn period and a lower length and head circumference at 1 year of age. With ND testing at 1 year of age, specific ARVs (atazanavir, ritonavir-boosted lopinavir, nelfinavir, and tenofovir) were associated with lower performance, although all groups were within the normal range. No ARVs or classes were associated with lower performance between 5 and 13 years of age. Atazanavir and saquinavir exposure were associated with late language emergence at 1 year, but not at 2 years of age. The results of the SMARTT study are generally reassuring, with little evidence for serious adverse events resulting from in utero ARV exposure. However, several findings of concern warrant further evaluation, and new ARVs used in pregnancy need to be evaluated.

Abstract  Full-text [free] access 

Editor’s notes: The SMARTT study set out to determine the safety of in utero exposure to antiretroviral (ARV) therapy using a trigger-based surveillance design to identify adverse events in a cohort of HIV-positive mothers and their HIV-exposed but HIV-negative children in the United States of America and Puerto Rico. A ‘trigger’ was set off if participants met a predefined clinical or laboratory threshold, with additional specified evaluations to determine if they met a predefined adverse event “case” definition.  After adjusting for birth cohort and other factors, there was no significant increase in the likelihood of meeting overall case status (case in any domain, such as growth and development or language etc.) with exposure to combination ARVs or any ARV class. No single ARV prophylaxis was associated with an increased risk of overall case status on adjusted analysis. However, several ARVs had significant associations in unadjusted analysis, namely between (1) maternal PI-based ARV prophylaxis during pregnancy and premature delivery and low birth weight; and (2) exposure to atazanavir and a twofold-higher risk of congenital anomalies. Overall the results from this study are reassuring, but some of the findings warrant further evaluation.

Latin America, Northern 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.

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