Articles tagged as "Health care delivery"

Health care navigators do not improve early outcomes on ART in South Africa

Sizanani: a randomized trial of health system navigators to improve linkage to HIV and TB care in South Africa.

Bassett IV, Coleman SM, Giddy J, Bogart LM, Chaisson CE, Ross D, Jacobsen MM, Robine M, Govender T, Freedberg KA, Katz JN, Walensky RP, Losina E. J Acquir Immune Defic Syndr. 2016 Oct 1;73(2):154-60. doi: 10.1097/QAI.0000000000001025.

Background: A fraction of HIV-diagnosed individuals promptly initiate antiretroviral therapy (ART). We evaluated the efficacy of health system navigators for improving linkage to HIV and tuberculosis (TB) care among newly diagnosed HIV-infected outpatients in Durban, South Africa.

Methods: We conducted a randomized controlled trial (Sizanani Trial, NCT01188941) among adults (≥18 years) at 4 sites. Participants underwent TB screening and randomization into a health system navigator intervention or usual care. Intervention participants had an in-person interview at enrollment and received phone calls and text messages over 4 months. We assessed 9-month outcomes via medical records and the National Population Registry. Primary outcome was completion of at least 3 months of ART or 6 months of TB treatment for coinfected participants.

Results: Four thousand nine hundred three participants were enrolled and randomized; 1899 (39%) were HIV-infected, with 1146 (60%) ART-eligible and 523 (28%) TB coinfected at baseline. In the intervention, 212 (39% of outcome-eligible) reached primary outcome compared to 197 (42%) in usual care (RR 0.93, 95% CI: 0.80 to 1.08). One hundred thirty-one (14%) HIV-infected intervention participants died compared to 119 (13%) in usual care; death rates did not differ between arms (RR 1.06, 95% CI: 0.84 to 1.34). In the as-treated analysis, participants reached for ≥5 navigator calls were more likely to achieve study outcome.

Conclusions: approximately 40% of ART-eligible participants in both study arms reached the primary outcome 9 months after HIV diagnosis. Low rates of engagement in care, high death rates, and lack of navigator efficacy highlight the urgency of identifying more effective strategies for improving HIV and TB care outcomes.

Abstract access  

Editor’s notes: Early mortality remains high among people starting antiretroviral therapy (ART) in low- and middle-income countries, and tuberculosis is consistently identified as a leading cause. In KwaZulu-Natal province, South Africa, where this study was conducted, tuberculosis incidence is very high, and around two-thirds of people starting tuberculosis treatment are HIV-positive. Previous studies have illustrated gaps between positive test results and linkage to HIV and tuberculosis care. For HIV-positive people with tuberculosis, accessing treatment for both HIV and tuberculosis is made more difficult by a lack of integrated care in many settings. Health care navigators have helped people with HIV link to care in the United States.

This study tested a programme whereby health care navigators helped newly-diagnosed HIV-positive people to link to HIV care, and if necessary also to tuberculosis treatment. The navigators had a counselling role, and also contacted patients by phone or text message reminders. Disappointingly, the programme did not improve outcomes at nine months after enrolment. All-cause mortality was high at around 14% by nine months, and was not reduced by the programme. This is an important result, contrasting with findings from other studies. The SEARCH trial in Uganda illustrated more rapid ART initiation resulting from a complex programme, primarily targeting health system rather than individual barriers. However, the primary outcome of the SEARCH analysis was ART initiation; there was no detectable effect on mortality, which was very low, suggesting a lower-risk study population. In the REMSTART study, a programme including point-of-care testing for cryptococcal antigen plus adherence support from community counsellors (along with routine tuberculosis investigation in both arms) was associated with a reduction in early mortality; the “active ingredient” of this programme was not clearly defined. Ideally, people with HIV need to start ART before they reach the stage of advanced disease. However, given the reality that many people do present with advanced disease, more work is necessary to define which programme could reduce their risk of mortality.

Africa
South Africa
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It’s hard to tell: healthcare workers experiences of telling children of their HIV positive status.

Experiences with disclosure of HIV-positive status to the infected child: perspectives of healthcare providers in Dar es Salaam, Tanzania.

Sariah A, Rugemalila J, Somba M, Minja A, Makuchilo M, Tarimo E, Urassa D, Siril H. BMC Public Health. 2016 Oct 13;16(1):1083.

Background: The specific age to which an HIV infected child can be disclosed to is stipulated to begin between ages 4 and 6 years. It has also been documented that before disclosure of HIV positive status to the infected child. Health care providers should consider children's cognitive-developmental ability. However, observation and situation analysis show that, health care providers still feel uncomfortable disclosing the HIV positive status to the infected child. The aim of the study was to explore healthcare providers' experiences in disclosure of HIV-positive status to the infected child.

Methods: A qualitative study involving 20 health care providers who attend HIV-positive children was conducted in September, 2014 in Dar es Salaam, Tanzania. Participants were selected from ten HIV care and treatment clinics (CTC) by purposive sampling. An interview guide, translated into participants' national language (Kiswahili) was used during in-depth interviews. Sampling followed the principle of data saturation. The interviews focused on perspectives of health-care providers regarding their experience with paediatric HIV disclosure. Data from in-depth interviews were transcribed into text; data analysis followed qualitative content analysis.

Results: The results show how complex the process of disclosure to children living with HIV can be to healthcare providers. Confusion was noted among healthcare providers about their role and responsibility in the process of disclosing to the HIV infected child. This was reported to be largely due to unclear guidelines and lack of standardized training in paediatric HIV disclosure. Furthermore, healthcare providers were concerned about parental hesitancy to disclose early to the child due to lack of disclosure skills and fear of stigma. In order to improve the disclosure process in HIV infected children, healthcare providers recommended further standardized training on paediatric HIV disclosure with more emphasis on practical skills and inclusion of disclosure content that is age appropriate for children with HIV.

Discussion: The disclosure process was found to be a complex process. Perspectives regarding disclosure in children infected with HIV varied among healthcare providers in terms of their role in the process, clear national guidelines and appropriate standardized training for paediatric disclosure. Consistent with other studies, healthcare providers reported difficulties during disclosure because parents /guardians largely fear blame, social stigma, child's negative emotional reaction when disclosed to and have concerns about the child being too young and immature to understand the HIV condition.

Conclusions: In order to prevent inconsistencies during the disclosure process, it is important to have in place clear guidelines and standardized paediatric HIV disclosure training for healthcare providers. This would help improve their skills in paediatric disclosure, leading to positive health outcomes for children infected with HIV.

Abstract  Full-text [free] access 

Editor’s notes: This valuable paper explores the experiences of healthcare providers who are disclosing to children and young people living with HIV. It focusses on a clinical setting in a district of Dar es Salaam in the United Republic of Tanzania. The authors examine factors that hinder and facilitate the process of disclosing to children and young people living with HIV through interviews with healthcare workers. Disclosure is understood to be pivotal in supporting children and young people’s adaptation to the realities of living with HIV and in managing their treatment and care effectively. While this topic has been the subject of much policy and research attention, this paper presents valuable insights into how disclosure is practised in reality. The authors point to the gap between what is in the guidelines and healthcare workers’ ability to deliver these principles within the context of the clinic. They note that disclosure is often with parental resistance and/ or concern. Another significant feature hindering healthcare workers’ ability to follow the disclosure guidelines was their limited training on disclosure, as well as in some cases their limited awareness of the guidelines. The authors present a stark picture of the distance between what ‘should’ be being done and what ‘is’ being done. The primary conclusion the authors draw is the significant need for improved training for healthcare workers. The provision of such training across clinics would enable healthcare workers to respond to the various dynamics. For example, parental reticence and lack of support, which currently result in disclosure being delayed or being done ineffectively.  

Africa
United Republic of Tanzania
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Success in accelerating ART initiation in Uganda

Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial.

Amanyire G, Semitala FC, Namusobya J, Katuramu R, Kampiire L, Wallenta J, Charlebois E, Camlin C, Kahn J, Chang W, Glidden D, Kamya M, Havlir D, Geng E. Lancet HIV. 2016 Nov;3(11):e539-e548. pii: S2352-3018(16)30090-X. doi: 10.1016/S2352-3018(16)30090-X. [Epub 2016 Aug 27]

Background: In Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the effects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation.

Methods: In this stepped-wedge, non-blinded, cluster-randomised controlled trial, 20 clinics in southwestern Uganda were randomly assigned in groups of five clinics every 6 months to the intervention by a computerised random number generator. This procedure continued until all clinics had crossed over from control (standard of care) to the intervention, which consisted of opinion-leader-led training and coaching of front-line health workers, a point-of-care CD4 cell count testing platform, a revised counselling approach without mandatory multiple pre-initiation sessions, and feedback to the facilities on their ART initiation rates and how they compared with other facilities. Treatment-naive, HIV-infected adults (aged ≥18 years) who were clinically eligible for ART during the study period were included in the study population. The primary outcome was ART initiation 14 days after first clinical eligibility for ART. This study is registered with ClinicalTrials.gov, number NCT01810289.

Findings: Between April 11, 2013, and Feb 2, 2015, 12 024 eligible patients visited one of the 20 participating clinics. Median CD4 count was 310 cells per µL (IQR 179-424). 3753 of 4747 patients (weighted proportion 80%) in the intervention group had started ART by 2 weeks after eligibility compared with 2585 of 7066 patients (38%) in the control group (risk difference 41.9%, 95% CI 40.1-43.8). Vital status was ascertained in a random sample of 208 patients in the intervention group and 199 patients in the control group. Four deaths (2%) occurred in the intervention group and five (3%) occurred in the control group.

Interpretation: A multicomponent intervention targeting health-care worker behaviour increased the probability of ART initiation 14 days after eligibility. This intervention consists of widely accessible components and has been tested in a real-world setting, and is therefore well positioned for use at scale.

Abstract access  

Editor’s notes: As noted in another article in this month’s digest, early mortality remains high among people starting antiretroviral therapy (ART). People with advanced disease are at particularly high risk. Previous research has illustrated that mortality was even higher during the period between entering care and starting ART. ART start may be delayed for many reasons, some attributable to the person and others to the health system. Some of the health system delays date from practice early in ART roll-out. Great emphasis was placed on ART counselling, usually requiring people to attend several counselling sessions prior to initiating treatment, because of concerns about poor adherence. This practice has persisted despite evidence that treatment outcomes are no worse if ART is initiated rapidly with concurrent counselling rather than delaying ART initiation until after counselling has been completed.

In this study, the investigators tested a complex activity aiming to accelerate ART initiation in primary health care clinics in Uganda. This was developed based on health promotion literature, and was a combination of training led by opinion-leaders to counter the widespread belief that delays to ART initiation are not harmful. There was also a more flexible approach to ART counselling and the need for treatment supporters; introduction of point of care CD4 machines so that ART eligibility could be assessed in-session; and feedback to facilities concerning their performance compared to other clinics. The programme was successful in accelerating ART initiation. This approach holds promise as an effective method to implement change in health facilities. However, as more countries adopt the WHO guidance to offer ART regardless of CD4 count, the contribution of point of care CD4 machines in similar approaches may diminish.  This is a common challenge for generalisability from randomised trials at a time of rapid policy changes. Cost and cost-effectiveness analyses will be reported later. The study was not primarily designed to determine the effect of the activity on patient-relevant outcomes, which were measured in a small subset of people, and illustrated no difference in mortality after one year. Of note, mortality was very low in both groups (2% programme versus 3% control), which may be partly explained by the relatively high median CD4 count at enrolment, and around one-quarter of participants being pregnant women. It would be very interesting to see whether this programme has an effect on early mortality in settings and populations where early survival is less good.  

Africa
Uganda
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High mortality persists among people presenting with advanced HIV disease

Mortality in the first 3 months on antiretroviral therapy among HIV-positive adults in low- and middle-income countries: a meta-analysis.

Brennan AT, Long L, Useem J, Garrison L, Fox MP. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):1-10. doi: 10.1097/QAI.0000000000001112.

Previous meta-analyses reported mortality estimates of 12-month post-antiretroviral therapy (ART) initiation; however, 40%-60% of deaths occur in the first 3 months on ART, a more sensitive measure of averted deaths through early ART initiation. To determine whether early mortality is dropping as treatment thresholds have increased, we reviewed studies of 3 months on ART initiation in low- to middle-income countries. Studies of 3-month mortality from January 2003 to April 2016 were searched in 5 databases. Articles were included that reported 3-month mortality from a low- to middle-income country; nontrial setting and participants were ≥15. We assessed overall mortality and stratified by year using random effects models. Among 58 included studies, although not significant, pooled estimates show a decline in mortality when comparing studies whose enrollment of patients ended before 2010 (7.0%; 95% CI: 6.0 to 8.0) with the studies during or after 2010 (4.0%; 95% CI: 3.0 to 5.0). To continue to reduce early HIV-related mortality at the population level, intensified efforts to increase demand for ART through active testing and facilitated referral should be a priority. Continued financial investments by multinational partners and the implementation of creative interventions to mitigate multidimensional complex barriers of accessing care and treatment for HIV are needed.

Abstract access  

Editor’s notes: Early mortality among people initiating antiretroviral therapy (ART) remains high, presumed to be because many people living with HIV present when already very sick with advanced HIV disease. This systematic review included 43 studies from Africa and 13 from Asia. Its main aim was to see whether the evolution of guidelines recommending ART initiation at progressively higher CD4 counts over this period had reduced early mortality (defined as death within three months of ART start) and, by implication, the proportion of people starting ART who had advanced disease. To investigate this, the authors compared studies where enrolment ended before 2010 with studies that had started later.

Overall early mortality was six percent.  Because of the large numbers lost to follow up this will be an underestimate. The authors attempted to compensate for this, and calculated an adjusted overall figure of more than 10%. There was a fall in early mortality from seven percent to four percent (unadjusted) between the early and late periods but although the trend was consistent the difference was not significant.

In only four of the 58 studies was the median CD4 count at ART initiation above 200x106/l. It seems likely that even when policies to initiate ART at high CD4 counts are adopted, additional efforts will be necessary to promote initiation of ART and retention in care for people who feel well.  This is in order to reduce the number of people starting ART with advanced disease and consequently at very high risk of early death.   

Africa, Asia, Latin America
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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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The limits of HIV disclosure for women in 27 countries

The association between HIV disclosure status and perceived barriers to care faced by women living with HIV in Latin America, China, central/eastern Europe, and western Europe/Canada.

Loutfy M, Johnson M, Walmsley S, Samarina A, Vasquez P, Hao-Lan H, Madihlaba T, Martinez-Tristani M, van Wyk J. AIDS Patient Care STDS. 2016 Sep;30(9):435-44. doi: 10.1089/apc.2016.0049. Epub 2016 Aug 23.

Generally, women are less likely than men to disclose their HIV status. This analysis examined the relationship between HIV disclosure and (1) perceived barriers to care and (2) quality of life (QoL) for women with HIV. The ELLA (EpidemioLogical study to investigate the popuLation and disease characteristics, barriers to care, and quAlity of life for women living with HIV) study enrolled HIV-positive women aged ≥18 years. Women completed the 12-item Barriers to Care Scale (BACS) questionnaire. QoL was assessed using the Health Status Assessment. BACS and QoL were stratified by dichotomized HIV disclosure status (to anyone outside the healthcare system). Multilevel logistic regression analysis was used to identify factors associated with disclosure. Of 1945 patients enrolled from Latin America, China, central/eastern Europe, and western Europe/Canada between July 2012 and September 2013, 1929 were included in the analysis (disclosed, n = 1724; nondisclosed, n = 205). Overall, 55% of patients lived with a husband/partner, 53% were employed, and 88% were receiving antiretroviral therapy. Patients who were with a serodiscordant partner were more likely to disclose (p = 0.0003). China had a disproportionately higher percentage of participants who did not disclose at all (nearly 30% vs. <15% for other regions). Mean BACS severity scores for medical/psychological service barriers and most personal resource barriers were significantly lower for the disclosed group compared with the nondisclosed group (p ≤ 0.02 for all). Compared with the disclosed group, the nondisclosed group reported statistically significantly higher (p ≤ 0.03) BACS item severity scores for 8 of the 12 potential barriers to care. The disclosed group reported better QoL. Overall, HIV nondisclosure was associated with more severe barriers to accessing healthcare by women with HIV.

Abstract Full-text [free] access

Editor’s notes: This study drew women participants from Latin America, China, central and eastern Europe and from western Europe and Canada.  China was the only Asian country included and no African countries were included. This is important background information since the first sentence of the abstract ‘women are less likely than men to disclose HIV status’ is less likely to be true for, for example, parts of Africa. The study did not include men. So, no comparison can therefore be made with men’s disclosure behaviour. Nevertheless, the paper draws on data from 27 countries. Most women in the study did have access to ‘efficacious, well-tolerated’ antiretroviral therapy. A number of women, most notably in China, did not disclose their HIV status outside the health care system. Many women disclosed their status to a limited extent (only to some family and close friends). Non-disclosure affected access to health care as well as more general support. This pattern of non- or limited disclosure and barriers to access to care is replicated in many other places. The findings in this paper point to the importance globally of tackling stigma and providing a supportive health care and social setting for people living with HIV, so they can benefit fully from the treatment and care that is available.

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South Africa’s major cascade gap is between testing and treatment

Level of viral suppression and the cascade of HIV care in a South African semi-urban setting in 2012.

Jean K, Puren A, Cutler E, Singh B, Bouscaillou J, Rain-Taljaard R, Taljaard D, Gouws E, Lissouba P, Lewis DA, Peytavin G, Auvert B. AIDS. 2016 Aug 24;30(13):2107-16. doi: 10.1097/QAD.0000000000001155.

Objective: In 2012, 7 years after the introduction of antiretroviral treatment (ART) in the South African township of Orange Farm, we measured the proportion of HIV-positive people who were virally suppressed, especially among high-risk groups (women 18-29 years and men 25-34 years).

Design: A community-based cross-sectional representative survey was conducted among 3293 men and 3473 women.

Methods: Study procedures included a face-to-face interview and collection of blood samples that were tested for HIV, 11 antiretroviral drugs and HIV-viral load.

Results: HIV prevalence was 17.0% [95% confidence interval: 15.7-18.3%] among men and 30.1% [28.5-31.6%] among women. Overall, 59.1% [57.4-60.8%] of men and 79.5% [78.2-80.9%] of women had previously been tested for HIV. When controlling for age, circumcised men were more likely to have been tested compared with uncircumcised men (66.1 vs 53.6%; P < 0.001). Among HIV+, 21.0% [17.7-24.6%] of men and 30.5% [27.7-33.3%] of women tested positive for one or more antiretroviral drugs. Using basic calculations, we estimated that, between 2005 and 2012, ART programs prevented between 46 and 63% of AIDS-related deaths in the community. Among antiretroviral-positive, 91.9% [88.7-94.3%] had viral suppression (viral load <400 copies/ml). The proportion of viral suppression among HIV+ was 27.0% [24.3-29.9%] among women and 17.5% [14.4-20.9%] among men. These proportions were lower among the high-risk groups: 15.6% [12.1-19.7%] among women and 8.4% [5.0-13.1%] among men.

Conclusion: In Orange Farm, between 2005 and 2012, ART programs were suboptimal and, among those living with HIV, the proportion with viral suppression was still low, especially among the young age groups. However, our study showed that, in reality, antiretroviral drugs are highly effective in viral suppression at an individual level.

Abstract access  

Editor’s notes: The efficacy of antiretroviral treatment (ART) in preventing HIV transmission from HIV-positive to HIV-negative people is clearly established. However, HIV incidence remains stubbornly high in many settings, and the challenge is to find ways to implement ART at sufficient scale, in combination with other effective programmes, to make an impact on HIV incidence at community level.

In this study, the authors surveyed a representative sample of adults in a community near Johannesburg, South Africa, where HIV prevalence is high and ART has been widely available since 2005. A trial of voluntary male medical circumcision (VMMC) was run in this location between 2002 to 2004, and a programme of incentivised VMMC and community mobilisation have been in place since 2008. The proportion of adults who had ever tested for HIV was nearly 80% among women and 60% among men, similar to that reported at national level in South Africa. Among survey participants with detectable ART agents in their blood, 94% had an HIV viral load below 1000 copies per ml, 92% below 400 copies per ml and 78% below 50 copies per ml. However, because ART programmes were sub-optimal at the time of the study, only 24% of all HIV-positive people in the survey had an HIV viral load below 400 copies per ml.

This study presents data from a real-world setting in South Africa. During the time of the study (2005-2012) treatment programmes were still sub-optimal (using the WHO 2006 treatment guidelines) but it shows that for all people on ART, significant levels of viral suppression were obtained. Of critical importance for treatment programmes will be to make sure that people have access to testing services and that testing and treatment programmes are linked. 

Africa
South Africa
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Near elimination of HIV transmission with combined ART and PrEP

Integrated delivery of antiretroviral treatment and pre-exposure prophylaxis to HIV-1-serodiscordant couples: a prospective implementation study in Kenya and Uganda.

Baeten JM, Heffron R, Kidoguchi L, Mugo NR, Katabira E, Bukusi EA, Asiimwe S, Haberer JE, Morton J, Ngure K, Bulya N, Odoyo J, Tindimwebwa E, Hendrix C, Marzinke MA, Ware NC, Wyatt MA, Morrison S, Haugen H, Mujugira A, Donnell D, Celum C. PLoS Med. 2016 Aug 23;13(8):e1002099. doi: 10.1371/journal.pmed.1002099. eCollection 2016.

Background: Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings.

Methods and findings: Between November 5, 2012, and January 5, 2015, we enrolled and followed 1013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (≥85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP.

Conclusions: Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Abstract  Full-text [free] access 

Editor’s notes: Long-term follow-up of the landmark HPTN-052 trial of ART for prevention of HIV transmission between HIV serodiscordant couples was covered in a recent issue of HIV This Month. In that trial, of the few transmission events that did occur, half were during the first few months of ART use in the HIV-positive partner, before viral load suppression. This study from Kenya and Uganda now suggests that offering pre-exposure prophylaxis (PrEP) to the HIV-negative partner to bridge the gap until virologic suppression may be an effective way to almost eliminate the risk of transmission.

In this study there were significant delays in ART initiation in the HIV-positive partner. At the start of the study the recommendation for ART initiation was a CD4+ cell count <350, and only half of the HIV-positive partners had initiated ART by six months. PrEP uptake by the HIV-negative partner was high during this time period and high levels of adherence were sustained, suggesting that this was a feasible and acceptable strategy for discordant couples.

The activities were delivered using specific clinical research facilities and staff, so the logical next step would be to demonstrate scalability with delivery through routine health systems and through more innovative community-based systems.  

Africa
Kenya, Uganda
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Challenges in assessing quality in HIV outpatient care

Structure and quality of outpatient care for people living with an HIV infection.

Engelhard EA, Smit C, Nieuwkerk PT, Reiss P, Kroon FP, Brinkman K, Geerlings SE. AIDS Care. 2016 Aug;28(8):1062-72. doi: 10.1080/09540121.2016.1153590. Epub 2016 Mar 13.

Policy-makers and clinicians are faced with a gap of evidence to guide policy on standards for HIV outpatient care. Ongoing debates include which settings of care improve health outcomes, and how many HIV-infected patients a health-care provider should treat to gain and maintain expertise. In this article, we evaluate the studies that link health-care facility and care provider characteristics (i.e., structural factors) to health outcomes in HIV-infected patients. We searched the electronic databases MEDLINE, PUBMED, and EMBASE from inception until 1 January 2015. We included a total of 28 observational studies that were conducted after the introduction of combination antiretroviral therapy in 1996. Three aspects of the available research linking the structure to quality of HIV outpatient care were evaluated: (1) assessed structural characteristics (i.e., health-care facility and care provider characteristics); (2) measures of quality of HIV outpatient care; and (3) reported associations between structural characteristics and quality of care. Rather than scarcity of data, it is the diversity in methodology in the identified studies and the inconsistency of their results that led us to the conclusion that the scientific evidence is too weak to guide policy in HIV outpatient care. We provide recommendations on how to address this heterogeneity in future studies and offer specific suggestions for further reading that could be of interest for clinicians and researchers.

Abstract access

Editor’s notes: The availability of antiretroviral therapy has resulted in remarkable decreases in HIV-associated mortality.  Complexity in the management of HIV infection has however grown along with these advances in treatment. Health-care providers are confronted with challenges associated with antiretroviral therapy including toxicities; drug-drug interactions and drug resistance; and comorbidities and aging among the population living with HIV. In order to achieve optimal health outcomes, care for people living with HIV should be provided at health-care facilities and by care providers with sufficient expertise. A variety of different delivery models have been attempted to achieve this. There are a growing number of studies assessing care delivery models and programmes in outpatient HIV care.  In this article the authors provide an overview of the scientific literature linking health-care facility and care provider characteristics to the quality of HIV outpatient care.

The authors conducted a systematic review of articles that reported an original observational research study with an adult population living with HIV, were conducted after 1996, and that did not focus exclusively on interventions.

The authors acknowledge the limitations of their research. These included a disproportionate number of studies based in the USA and sub-Saharan Africa (thus limited generalisability); diversity in the definition of structural variables; a wide scope of measures of quality of care used in studies; and limited inclusion of peoples’ healthcare experiences. The authors summarise two main implications of their research.  First, they note that their findings suggest that health-care provider experience improves outcomes among people living with HIV although they are unable to make recommendations regarding facility volume requirements for outpatient care. Second, they advocate for the need for research to extend to regions outside the USA and sub-Saharan Africa.  They also note the need for researchers to align their methods of measuring quality including by going beyond HIV-associated morbidity in the evaluation of health outcomes.  Peoples’ preferences and retention in care should also play an important role in the evaluation of the quality of care.

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