Articles tagged as "15 million accessing treatment"

Simplified pathway to ART reduces mortality in China

Simplified HIV testing and treatment in China: analysis of mortality rates before and after a structural intervention.

Wu Z, Zhao Y, Ge X, Mao Y, Tang Z, Shi CX, Chen C, Li Y, Qiu X, Nong G, Huang S, Luo S, Wu S, He W, Zhang M, Shen Z, Jin X, Li J, Brookmeyer R, Detels R, Montaner J, Wang Y. PLoS Med. 2015 Sep 8;12(9):e1001874. doi: 10.1371/journal.pmed.1001874. eCollection 2015.

Background: Multistage stepwise HIV testing and treatment initiation procedures can result in lost opportunities to provide timely antiretroviral therapy (ART). Incomplete patient engagement along the continuum of HIV care translates into high levels of preventable mortality. We aimed to evaluate the ability of a simplified test and treat structural intervention to reduce mortality.

Methods and findings: In the "pre-intervention 2010" (from January 2010 to December 2010) and "pre-intervention 2011" (from January 2011 to December 2011) phases, patients who screened HIV-positive at health care facilities in Zhongshan and Pubei counties in Guangxi, China, followed the standard-of-care process. In the "post-intervention 2012" (from July 2012 to June 2013) and "post-intervention 2013" (from July 2013 to June 2014) phases, patients who screened HIV-positive at the same facilities were offered a simplified test and treat intervention, i.e., concurrent HIV confirmatory and CD4 testing and immediate initiation of ART, irrespective of CD4 count. Participants were followed for 6-18 mo until the end of their study phase period. Mortality rates in the pre-intervention and post-intervention phases were compared for all HIV cases and for treatment-eligible HIV cases. A total of 1034 HIV-positive participants (281 and 339 in the two pre-intervention phases respectively, and 215 and 199 in the two post-intervention phases respectively) were enrolled. Following the structural intervention, receipt of baseline CD4 testing within 30 d of HIV confirmation increased from 67%/61% (pre-intervention 2010/pre-intervention 2011) to 98%/97% (post-intervention 2012/post-intervention 2013) (all p < 0.001 [i.e., for all comparisons between a pre- and post-intervention phase]), and the time from HIV confirmation to ART initiation decreased from 53 d (interquartile range [IQR] 27-141)/43 d (IQR 15-113) to 5 d (IQR 2-12)/5 d (IQR 2-13) (all p < 0.001). Initiation of ART increased from 27%/49% to 91%/89% among all cases (all p < 0.001) and from 39%/62% to 94%/90% among individuals with CD4 count ≤350 cells/mm3 or AIDS (all p < 0.001). Mortality decreased from 27%/27% to 10%/10% for all cases (all p < 0.001) and from 40%/35% to 13%/13% for cases with CD4 count ≤ 350 cells/mm3 or AIDS (all p < 0.001). The simplified test and treat intervention was significantly associated with decreased mortality rates compared to pre-intervention 2011 (adjusted hazard ratio [aHR] 0.385 [95% CI 0.239-0.620] and 0.380 [95% CI 0.233-0.618] for the two post-intervention phases, respectively, for all newly diagnosed HIV cases [both p < 0.001], and aHR 0.369 [95% CI 0.226-0.603] and 0.361 [95% CI 0.221-0.590] for newly diagnosed treatment-eligible HIV cases [both p < 0.001]). The unit cost of an additional patient receiving ART attributable to the intervention was US$83.80. The unit cost of a death prevented because of the intervention was US$234.52.

Conclusions: Our results demonstrate that the simplified HIV test and treat intervention promoted successful engagement in care and was associated with a 62% reduction in mortality. Our findings support the implementation of integrated HIV testing and immediate access to ART irrespective of CD4 count, in order to optimize the impact of ART.

Abstract  Full-text [free] access

Editor’s notes: The pathway from testing HIV positive to initiation of antiretroviral therapy (ART) can be complicated to navigate. The pathway may involve multiple visits, with delays and potential for losses at each step. These delays and losses are particularly hazardous for people with low CD4 counts, for whom delay in starting ART increases the risk of early mortality.

In this study from China, the pathway from an HIV-positive test result to starting treatment prior to the study programme was complex. It required people to have a confirmatory HIV test, which had a turn-around time of 7-18 days, before blood was sent for a CD4 count, with a further 7-18 day delay before the CD4 result became available. People eligible for ART, based on a CD4 count below 350 cells/mm3, would be asked to attend a different facility, usually the county general hospital. Eligible individuals would have to attend education sessions and have further blood tests for assessment prior to starting ART.

The programme simplified the pathway to ART start substantially by starting ART educational sessions at the same visit as the first HIV-positive test result. A second visit, to the county general hospital, was required to have blood taken for a CD4 count and pre-ART assessments, along with further education and counselling. The county general hospital was responsible for all subsequent care, and providers were responsible for following up if people did not attend scheduled visits. ART was initiated regardless of CD4 count. Mortality prior to the programme was 27% overall; in the programme period it was 10%.

Although a before-after evaluation is less robust than a randomised design, this study illustrates the potential for major improvement in patient-relevant outcomes following a health system programme to simplify the patient pathway. The pathway prior to the programme was particularly complex and similar impacts may not be achievable in other systems. Nonetheless this is an impressive achievement, which should encourage programme managers to consider how systems could be modified to make them work more effectively for people.

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High uptake of HIV self-testing among adolescents

Uptake, accuracy, safety, and linkage into care over two years of promoting annual self-testing for HIV in Blantyre, Malawi: a community-based prospective study.

Choko AT, MacPherson P, Webb EL, Willey BA, Feasy H, Sambakunsi R, Mdolo A, Makombe SD, Desmond N, Hayes R, Maheswaran H, Corbett EL.  PLoS Med. 2015 Sep 8;12(9):e1001873. doi: 10.1371/journal.pmed.1001873. eCollection 2015.

Background: Home-based HIV testing and counselling (HTC) achieves high uptake, but is difficult and expensive to implement and sustain. We investigated a novel alternative based on HIV self-testing (HIVST). The aim was to evaluate the uptake of testing, accuracy, linkage into care, and health outcomes when highly convenient and flexible but supported access to HIVST kits was provided to a well-defined and closely monitored population.

Methods and findings: Following enumeration of 14 neighbourhoods in urban Blantyre, Malawi, trained resident volunteer-counsellors offered oral HIVST kits (OraQuick ADVANCE Rapid HIV-1/2 Antibody Test) to adult (≥16 y old) residents (n = 16 660) and reported community events, with all deaths investigated by verbal autopsy. Written and demonstrated instructions, pre- and post-test counselling, and facilitated HIV care assessment were provided, with a request to return kits and a self-completed questionnaire. Accuracy, residency, and a study-imposed requirement to limit HIVST to one test per year were monitored by home visits in a systematic quality assurance (QA) sample. Overall, 14 004 (crude uptake 83.8%, revised to 76.5% to account for population turnover) residents self-tested during months 1-12, with adolescents (16-19 y) most likely to test. 10 614/14 004 (75.8%) participants shared results with volunteer-counsellors. Of 1257 (11.8%) HIV-positive participants, 26.0% were already on antiretroviral therapy, and 524 (linkage 56.3%) newly accessed care with a median CD4 count of 250 cells/µl (interquartile range 159-426). HIVST uptake in months 13-24 was more rapid (70.9% uptake by 6 mo), with fewer (7.3%, 95% CI 6.8%-7.8%) positive participants. Being "forced to test", usually by a main partner, was reported by 2.9% (95% CI 2.6%-3.2%) of 10 017 questionnaire respondents in months 1-12, but satisfaction with HIVST (94.4%) remained high. No HIVST-related partner violence or suicides were reported. HIVST and repeat HTC results agreed in 1639/1649 systematically selected (1 in 20) QA participants (99.4%), giving a sensitivity of 93.6% (95% CI 88.2%-97.0%) and a specificity of 99.9% (95% CI 99.6%-100%). Key limitations included use of aggregate data to report uptake of HIVST and being unable to adjust for population turnover.

Conclusions: Community-based HIVST achieved high coverage in two successive years and was safe, accurate, and acceptable. Proactive HIVST strategies, supported and monitored by communities, could substantially complement existing approaches to providing early HIV diagnosis and periodic repeat testing to adolescents and adults in high-HIV settings.

Abstract  Full-text [free] access

Editor’s notes: The new global 90–90–90 targets call for 90% of all people with HIV to be diagnosed, 90% of people with HIV diagnosed to receive ART and 90% of people on ART to have a suppressed viral load by 2020. The first 90 (diagnosis of HIV) is essential to the second 90 (initiation of ART among people with HIV) and the ultimate outcome of the third 90 (viral load suppression among people on ART), which improves client outcomes and prevents HIV transmission.

The first 90 is also the most problematic, especially for adolescents, men and key populations, as HIV testing primarily takes place at the health care facility, which is typically underutilised by these groups.

This article reports on a prospective study on community-based oral HIV self-testing (HIVST) among adults (16 years or older) in Blantyre, Malawi. HIVST involves individuals performing and interpreting their own HIV test, in this study by using an oral HIV test kit. The high acceptability and ease of distribution of oral test kits makes HIVST of special interest in settings with high HIV prevalence, where the aim is to achieve affordable universal coverage and regular repeat testing.

The authors found high uptake among men and adolescents (two hard-to-reach groups), and a high accuracy of HIVST, but suboptimal linkage post-testing to ART services: less than 60% of HIV-positive clients not yet on ART were linked to HIV care. However, they attribute these good outcomes partially to the involvement of trained volunteers in their community-based HIV care service delivery model. They suggest re-evaluating accuracy and uptake of post-testing services when using different tests or less supportive models, for example over-the-counter or vending machine sales of oral HIV test kits.

The authors found that 35% of participants had never previously tested. Interestingly they also found that among self-testing participants, HIV prevalence was highest in the age group 40-49 years (with a pooled estimate among men and women of 23%). The authors emphasize that the high acceptability of HIVST services among adolescents and men could facilitate linkage into HIV prevention programmes, such as pre-exposure prophylaxis and voluntary medical male circumcision, as well as ensuring prompt linkage into HIV care. They conclude that HIV self-testing is complementary to existing strategies in providing early HIV diagnosis and periodic repeat testing, and that HIVST has potential to be scaled up in other low-income settings where annual repeat HIV testing is recommended. 

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Intimate partner violence and uptake and adherence of HIV treatment

Intimate partner violence and engagement in HIV care and treatment among women: a systematic review and meta-analysis.

Hatcher AM, Smout EM, Turan JM, Christofides N, Stockl H. AIDS. 2015 Sep 5. [Epub ahead of print]

Objective: We aimed to estimate the odds of engagement in HIV care and treatment among HIV-positive women reporting intimate partner violence (IPV).

Design: We systematically reviewed the literature on the association between IPV and engagement in care. Data sources included searches of electronic databases (PubMed, Web of Science, CINAHL and PsychoInfo), hand searches and citation tracking.

Methods: Two reviewers screened 757 full-text articles, extracted data and independently appraised study quality. Included studies were peer-reviewed and assessed IPV alongside engagement in care outcomes: antiretroviral treatment (ART) use; self-reported ART adherence; viral suppression; retention in HIV care. Odds ratios (ORs) were pooled using random effects meta-analysis.

Results: Thirteen cross-sectional studies among HIV-positive women were included. Measurement of IPV varied, with most studies defining a 'case' as any history of physical and/or sexual IPV. Meta-analysis of five studies showed IPV to be significantly associated with lower ART use [OR 0.79, 95% confidence interval (95% CI) 0.64-0.97]. IPV was associated with poorer self-reported ART adherence in seven studies (OR 0.48, 95% CI 0.30-0.75) and lower odds of viral load suppression in seven studies (OR 0.64, 95% CI 0.46-0.90). Lack of longitudinal data and measurement considerations should temper interpretation of these results.

Conclusion: IPV is associated with lower ART use, half the odds of self-reported ART adherence and significantly worsened viral suppression among women. To ensure the health of HIV-positive women, it is essential for clinical programmes to address conditions that impact engagement in care and treatment. IPV is one such condition, and its association with declines in ART use and adherence requires urgent attention.

Abstract access 

Editor’s notes: Intimate partner violence (IPV) is prevalent globally (30%). It has been associated with HIV infection and also with progression to AIDS among women living with HIV. However it is unclear how intimate partner violence may impact on HIV-associated health. This study examined associations between violence exposure and uptake of HIV treatment and care services. The authors conducted a systematic review and meta-analyses. From an initial search of 621 studies, 13 were included in these analyses: 12 were conducted in the United States of America and one in Haiti. All were cross-sectional. Measurement of intimate partner violence varied from a single question to validated scales. Some 11 measured lifetime IPV and two measured recent intimate partner violence, in the past 12 months.

Meta-analysis suggests intimate partner violence is associated with significantly lower odds of (i) current ART use (ii) self-reported adherence and (iii) worsened viral load suppression. There was insufficient data to measure retention in HIV care. These analyses suggest that uptake and adherence to ART is a key pathway through which intimate partner violence may negatively influence HIV-associated health of women. Further research is necessary, in low and middle income settings, and among key populations. Future studies should develop and test programmes to address intimate partner violence within HIV clinical care. 

Latin America, Northern America
Haiti, United States of America
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When to switch to second-line ART in children?

HIV-1 drug resistance and second-line treatment in children randomized to switch at low versus higher RNA thresholds.

Harrison L, Melvin A, Fiscus S, Saidi Y, Nastouli E, Harper L, Compagnucci A, Babiker A, McKinney R, Gibb D, Tudor-Williams G; PENPACT-1 (PENTA 9PACTG 390) Study Team. J Acquir Immune Defic Syndr. 2015 Sep 1;70(1):42-53. doi: 10.1097/QAI.0000000000000671.

Background: The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold.

Methods: PENPACT-1 had a 2 x 2 factorial design, randomizing HIV-infected children to start protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, and switch at a 1000 copies/mL versus 30 000 copies/mL threshold. Switch criteria were not achieving the threshold by week 24, confirmed rebound above the threshold thereafter, or Center for Disease Control and Prevention stage C event. Resistance tests were performed on samples ≥1000 copies/mL before switch, resuppression, and at 4-years/trial end.

Results: Sixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL (PI-1000), 64 PIs and 30 000 copies/mL (PI-30 000), 67 NNRTIs and 1000 copies/mL (NNRTI-1000), and 65 NNRTI and 30 000 copies/mL (NNRTI-30 000). Ninety-four (36%) children reached the 1000 copies/mL switch criteria during 5-year follow-up. In 30 000 copies/mL threshold arms, median time from 1000 to 30 000 copies/mL switch criteria was 58 (PI) versus 80 (NNRTI) weeks (P = 0.81). In NNRTI-30 000, more nucleoside reverse transcriptase inhibitor (NRTI) resistance mutations accumulated than other groups. NNRTI mutations were selected before switching at 1000 copies/mL (23% NNRTI-1000, 27% NNRTI-30 000). Sixty-two children started abacavir + lamivudine, 166 lamivudine + zidovudine or stavudine, and 35 other NRTIs. The abacavir + lamivudine group acquired fewest NRTI mutations. Of 60 switched to second-line, 79% PI-1000, 63% PI-30 000, 64% NNRTI-1000, and 100% NNRTI-30 000 were <400 copies/mL 24 weeks later.

Conclusions: Children on first-line NNRTI-based ART who were randomized to switch at a higher virologic threshold developed the most resistance, yet resuppressed on second-line. An abacavir + lamivudine NRTI combination seemed protective against development of NRTI resistance.

Abstract access 

Editor’s notes: Paediatric guidelines recommend that children living with HIV initiate ART early in life. Therefore duration of treatment is likely to be for several decades in children. Children have tended to be maintained on failing therapies longer than adults due to limited treatment options, particularly in resource-limited settings.

The PENPACT-1 trial compared two HIV viral load thresholds, <1000 and <30 000 copies/ml, for switching to second-line ART among children taking non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)-based first-line regimens. As expected, children starting NNRTIs as their first-line regimen developed more NRTI mutations than children starting on boosted PIs. Importantly, children switching to second line ART at the higher viral load threshold were much more likely to develop resistance if they were taking NNRTI as their first line regimen than if they were taking boosted PIs. The study highlights the more “forgiving” nature of the PI drug class in terms of development of drug resistance. The main implication of this finding is that delayed switching on PI-based ART is a safe option in settings where future drug options are limited, as the risk of development of clinically significant PI or NRTI mutations is low. Interestingly, use of an abacavir + lamivudine nucleoside backbone resulted in fewer thymidine analogue mutations (TAMs) than use of lamivudine + zidovudine or stavudine backbone. This finding was based on analysis of non-randomised data, but supports the current WHO recommendations to use abacavir as the first-line drug of choice in the NRTI backbone.

HIV Treatment
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Better integration of programmes against alcohol use necessary at every step of the HIV treatment cascade

The impact of alcohol use and related disorders on the HIV continuum of care: a systematic review: alcohol and the HIV continuum of care.

Vagenas P, Azar MM, Copenhaver MM, Springer SA, Molina PE, Altice FL. Curr HIV/AIDS Rep. 2015 Sep 28. [Epub ahead of print]

Alcohol use is highly prevalent globally with numerous negative consequences to human health, including HIV progression, in people living with HIV (PLH). The HIV continuum of care, or treatment cascade, represents a sequence of targets for intervention that can result in viral suppression, which ultimately benefits individuals and society. The extent to which alcohol impacts each step in the cascade, however, has not been systematically examined. International targets for HIV treatment as prevention aim for 90% of PLH to be diagnosed, 90% of them to be prescribed with antiretroviral therapy (ART), and 90% to achieve viral suppression; currently, only 20% of PLH are virally suppressed. This systematic review, from 2010 through May 2015, found 53 clinical research papers examining the impact of alcohol use on each step of the HIV treatment cascade. These studies were mostly cross-sectional or cohort studies and from all income settings. Most (77 %) found a negative association between alcohol consumption on one or more stages of the treatment cascade. Lack of consistency in measurement, however, reduced the ability to draw consistent conclusions. Nonetheless, the strong negative correlations suggest that problematic alcohol consumption should be targeted, preferably using evidence-based behavioral and pharmacological interventions, to indirectly increase the proportion of PLH achieving viral suppression, to achieve treatment as prevention mandates, and to reduce HIV transmission.

Abstract access 

Editor’s notes: This systematic review examined the impact of alcohol consumption on each step of the HIV treatment cascade. This covered HIV diagnosis, linkage to care, retention in care, ART initiation and adherence, and sustained virologic suppression. Overall, there was an association between alcohol consumption and negative consequences on various steps of the treatment cascade. The majority of studies focused on the effect of alcohol use disorders and ART adherence, and on viral suppression. There was fairly consistent evidence of reduced adherence among people with alcohol use disorders. Key findings of this review include the lack of consistency in studies of alcohol consumption. Many studies are not using standardised, validated, measures such as the AUDIT, and there is the lack of studies on the association of alcohol use with earlier stages of the cascade, including testing uptake and linkage to care. Further studies in this area would be useful, to identify whether programmes focused on problematic alcohol use are necessary at HIV testing centres.

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Optimal methods to deliver HTC in health facility out-patient settings

Strengthening HIV test access and treatment uptake study (Project STATUS): a randomized trial of HIV testing and counseling interventions.

McNaghten AD, Schilsky Mneimneh A, Farirai T, Wamai N, Ntiro M, Sabatier J, Makhunga-Ramfolo N, Mwanasalli S, Awor A, Moore J, Project SST. J Acquir Immune Defic Syndr. 2015 Aug 6. [Epub ahead of print]

Objective: To determine which of 3 HIV testing and counseling (HTC) models in outpatient departments (OPDs) increases HIV testing and entry of newly identified HIV-infected patients into care.

Design: Randomized trial of HIV testing and counseling interventions.

Methods: Thirty-six OPDs in South Africa, Tanzania and Uganda were randomly assigned to 3 different HTC models: A) health care providers referred eligible patients (aged 18-49, not tested in the past year, not known HIV positive) to on-site voluntary counseling and testing (VCT) for HTC offered and provided by VCT counselors after clinical consultation; B) health care providers offered and provided HTC to eligible patients during clinical consultation; and C) nurse or lay counselors offered and provided HTC to eligible patients before clinical consultation. Data were collected October 2011-September 2012. We describe testing eligibility and acceptance, HIV prevalence, and referral and entry into care. Chi-square analyses were conducted to examine differences by model.

Results: Of 79 910 patients, 45% were age-eligible and 16 099 (45%) age-eligibles were tested. Ten percent tested HIV positive. Significant differences were found in percent tested by model. The proportion of age eligible patients tested by Project STATUS was highest for Model C (54.1%, 95% confidence interval [CI]=42.4-65.9), followed by Model A (41.7%, 95% CI=30.7-52.8) and Model B (33.9%, 95% CI=25.7-42.1). Of the 1,596 newly identified HIV-positives, 94% were referred to care (96.1% in Model A, 94.7% in Model B, and 94.9% in Model C), and 58% entered on-site care (74.4% in Model A, 54.8% in Model B, and 55.6% in Model C) with no significant differences in referrals or care entry by model.

Conclusions: Model C resulted in the highest proportion of all age eligible patients receiving a test. Although 94% of STATUS patients with a positive test result were referred to care, only 58% entered care. We found no differences in patients entering care by HTC model. Routine HTC in OPDs is acceptable to patients and effective for identifying HIV-infected persons, but additional efforts are needed to increase entry to care.

Abstract access

Editor’s notes: While there has been much attention given in recent years to community models of HIV testing, WHO and UNAIDS guidelines continue to recommend the importance of efforts to improve access to HIV testing in health facilities. This interesting study conducted under “real world” conditions, examined different models of out-patient department based testing. It found that the model which focussed on people while they waited for their clinical consultation, achieved the highest proportion taking up testing among people who were eligible. Beyond this step, the authors report that proportions referred and entered into care did not differ significantly and the proportion who did so was low (<60%). This was despite the fact the fact that the study population consisted entirely of people already utilising services at the health care facility. The majority of participants were women. No further information on the clinical status or CD4 counts of people identified as HIV positive is provided, although that would be interesting follow-up information in future. This study highlights not only that facility based HIV testing and counselling should not be forgotten as an important means to increase access to testing, but also that linkage to care is a problem even among individuals already utilising general health services.  

HIV testing
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Patient support networks may improve long-term engagement in HIV care

Implementation and operational research: pulling the network together: quasiexperimental trial of a patient-defined support network intervention for promoting engagement in HIV care and medication adherence on Mfangano Island, Kenya.

Hickey MD, Salmen CR, Omollo D, Mattah B, Fiorella KJ, Geng EH, Bacchetti P, Blat C, Ouma GB, Zoughbie D, Tessler RA, Salmen MR, Campbell H, Gandhi M, Shade S, Njoroge B, Bukusi EA, Cohen CR. J Acquir Immune Defic Syndr. 2015 Aug 1;69(4):e127-34. doi: 10.1097/QAI.0000000000000664.

Background: Despite progress in the global scale-up of antiretroviral therapy, sustained engagement in HIV care remains challenging. Social capital is an important factor for sustained engagement, but interventions designed to harness this powerful social force are uncommon.

Methods: We conducted a quasiexperimental study evaluating the impact of the Microclinic Social Network intervention on engagement in HIV care and medication adherence on Mfangano Island, Kenya. The intervention was introduced into 1 of 4 similar communities served by this clinic; comparisons were made between communities using an intention-to-treat analysis. Microclinics, composed of patient-defined support networks, participated in 10 biweekly discussion sessions covering topics ranging from HIV biology to group support and group HIV status disclosure. Nevirapine concentrations in hair were measured before and after study.

Results: One hundred thirteen (74%) intervention community participants joined a microclinic group, 86% of whom participated in group HIV status disclosure. Over 22-month follow-up, intervention community participants experienced one-half the rate of ≥ 90-day clinic absence as those in control communities (adjusted hazard ratio: 0.48; 95% confidence interval: 0.25 to 0.92). Nevirapine hair levels declined in both study arms; in adjusted linear regression analysis, the decline was 6.7 ng/mg less severe in the intervention arm than control arm (95% confidence interval: -2.7 to 16.1).

Conclusions: The microclinic intervention is a promising and feasible community-based strategy to improve long-term engagement in HIV care and possibly medication adherence. Reducing treatment interruptions using a social network approach has important implications for individual patient virologic suppression, morbidity, and mortality and for broader community empowerment and engagement in healthcare.

Abstract access 

Editor’s notes: To maximise the impact of ART, people living with HIV should be diagnosed early, enrolled and retained in pre-ART care, initiated on ART and retained in ART care. Long-term adherence to achieve and maintain viral load suppression is the last step in the continuum of HIV care. Engagement along the complete treatment cascade will determine the long-term success of the global response to HIV.

This article reports on the results of a quasi-experimental study that assessed whether a combined stigma reduction and social network empowerment programme resulted in improved HIV treatment outcomes. The programme consisted of an adaptation of a social network-based activity known as ‘microclinics’. ‘Microclinics’ are informal social networks empowered to support chronic disease management and prevention. ‘Microclinic’ groups consisted of five to ten close family, friends or other members of the patient’s social support system, irrespective of the member’s HIV status. ‘Microclinics’ were assigned a Community Health Worker coordinator and facilitator and were guided through a series of ten discussion sessions over a period of five months. During these sessions they received health education messages to promote knowledge of HIV prevention and treatment, and group support was promoted through discussion of confidentiality, HIV status disclosure, and encouragement of group support for adherence and clinic attendance. The programme was introduced into one of four similar communities served by the main study clinic, and comparisons were made between communities. The outcomes were engagement in HIV care and medication adherence. 

Three-quarters of participants in the programme community joined a ‘microclinic’. Participants in the programme community spent a larger proportion of time adherent to clinic schedules. On average, during a year of follow-up, compared to people in the control group, people in the ‘microclinics’ group returned to care three weeks sooner after a missed visit. Work by Ware et al. describes a pathway from missing a clinic visit to disengaging from care. The pathway includes as intermediate steps, developing a reluctance to return, and subsequent feelings of decreased connectedness to care. The authors of this study hypothesise that ‘microclinic’ participation prevented the development of ‘reluctance to return’ after a missed visit.

The authors conclude that there is empiric support for ‘microclinics’ as an effective model for chronic disease management. But, given the quasi-experimental design, other factors may have contributed to improved outcomes. Data from longer term follow up would be useful to determine the durability of the programme effect, since study participants were only followed up for 22 months. 

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Integrated care: necessary but not sufficient to improve the PMTCT cascade

Implementation and operational research: effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: results from the SHAIP cluster-randomized controlled trial in Kenya.

Turan JM, Onono M, Steinfeld RL, Shade SB, Owuor K, Washington S, Bukusi EA, Ackers ML, Kioko J, Interis EC, Cohen CR. J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):e172-81. doi: 10.1097/QAI.0000000000000678.

Background: Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes.

Methods: ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or nonintegrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression.

Results: HIV care enrollment was higher in intervention compared with control clinics [69% versus 36%; odds ratio = 3.94, 95% confidence interval (CI): 1.14 to 13.63]. Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, hazard ratio = 2.20, 95% CI: 1.62 to 3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%; odds ratio = 3.22, 95% CI: 1.81 to 5.72). Infant testing was more common in the intervention arm (25% versus 18%), however, not statistically different. No significant differences were detected in postnatal service uptake or maternal retention.

Conclusions: Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions.

Abstract access 

Editor’s notes: WHO recommends a combination approach to prevention of mother-to-child transmission that includes primary prevention of HIV among women of childbearing age, prevention of unintended pregnancies among women living with HIV, prevention of HIV transmission from a woman living with HIV to her infant and the provision of appropriate treatment, care and support to mothers living with HIV, their children and families.

Prevention of mother-to-child transmission programmes in sub-Saharan Africa experience high rates of maternal and infant loss to follow-up at each step of the cascade. The largest losses occur with failure of linkage to and retention in HIV care services.

This article reports on a cluster randomized trial that assessed whether integration of HIV services into antenatal care (ANC) settings improved the uptake of prevention of mother-to-child transmission services (maternal HIV care enrolment, ART initiation, and three-month infant HIV testing) and retention in care along the prevention of mother-to-child transmission cascade.

The integration of HIV services into ANC settings improved HIV care enrolment, time to enrolment, and ART initiation among eligible women compared with control clinics. Retention in care was lower in the programme clinics.

However, even at the programme sites only 70% (and not 100%) of HIV-positive women enrolled in HIV care, indicating that women’s hesitations about initiating HIV care continue to be a barrier for a substantial proportion of women. The authors found that internalized HIV-associated stigma was a significant issue, and hypothesise that women from integrated clinics were even more at risk for unwanted disclosure and of stigmatization.

Early infant diagnosis was inadequate in both arms of the study. The inadequate systems to identify HIV exposed infants in postnatal clinics, and the continuing stigma associated with HIV were cited as the main challenges. Integrated point of care electronic maternal and child health registers that provide timely access to data on women and infants falling out of the cascade could help to address this.

The authors conclude that integration of clinical services is necessary but not sufficient to address all barriers to utilization of prevention of mother-to-child transmission services. 

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Low rates of switching to second-line treatment in children failing first-line ART

Determinants of durability of first-line antiretroviral therapy regimen and time from first-line failure to second-line antiretroviral therapy initiation.

Desmonde S, Eboua FT, Malateste K, Dicko F, Ekouevi DK, Ngbeche S, Koueta F, Sy HS, Renner L, Koumakpai SA, Leroy V, IeDEA Pediatric West African Working Group. AIDS. 2015 Jul 31;29(12):1527-36. doi: 10.1097/QAD.0000000000000707.

Background: We described reasons for switching to second-line antiretroviral treatment (ART) and time to switch in HIV-infected children failing first-line ART in West Africa.

Methods: We included all children aged 15 years or less, starting ART (at least three drugs) in the paediatric IeDEA clinical centres in five West-African countries. We estimated the incidence of switch (at least one drug class change) within 24 months of ART and associated factors were identified in a multinomial logistic regression. Among children with clinical-immunological failure, we estimated the 24-month probability of switching to a second-line and associated factors, using competing risks. Children who switched to second-line ART following the withdrawal of nelfinavir in 2007 were excluded.

Results: Overall, 2820 children initiated ART at a median age of 5 years; 144 (5%) were on nelfinavir. At 24-month post-ART initiation, 188 (7%) had switched to second-line. The most frequent reasons were drug stock outs (20%), toxicity (18%), treatment failure (16%) and poor adherence (8%). Over the 24-month follow-up period, 322 (12%) children failed first-line ART after a median time of 7 months. Of these children, 21 (7%) switched to second-line after a median time of 21 weeks in failure. This was associated with older age [subdistribution hazard ratio (sHR) 1.21, 95% confidence interval (95% CI) 1.10-1.33] and longer time on ART (sHR 1.16, 95% CI 1.07-1.25).

Conclusion: Switches for clinical failure were rare and switches after an immunological failure were insufficient. These gaps reveal that it is crucial to advocate for both sustainable access to first-line and alternative regimens to provide adequate roll-out of paediatric ART programmes.

Abstract access 

Editor’s notes: Data on the durability of first-line ART in children in low-income settings are limited. However, there is mounting evidence that children in facilities without routine viral load testing are less likely to be identified as failing on first-line therapy. This observational study by the IeDEA Paediatric West African working group illustrates that the rate of switch to second-line therapy in children on first-line treatment, monitored using clinical (with or without immunological) criteria, was low. Additionally, the majority of switches that did occur were due to ART availability issues, poor adherence and drug toxicity, rather than in response to clinically-defined treatment failure.  Some 12% of children failed first-line ART after a median of seven months, of whom only 0.8% switched to second-line ART. These findings highlight the missed opportunities and underscore the difficulties in identifying treatment failure in children within a context in which virologic monitoring is not yet available.

Health care delivery
Burkina Faso, Côte d'Ivoire, Ghana, Mali, Senegal
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Provider-perceived barriers and facilitators to viral load monitoring for HIV-positive individuals in resource-limited settings

On the front line of HIV virological monitoring: barriers and facilitators from a provider perspective in resource-limited settings.

Rutstein SE, Golin CE, Wheeler SB, Kamwendo D, Hosseinipour MC, Weinberger M, Miller WC, Biddle AK, Soko A, Mkandawire M, Mwenda R, Sarr A, Gupta S, Mataya R. AIDS Care. 2015 Aug 17:1-10. [Epub ahead of print]

Scale-up of viral load (VL) monitoring for HIV-infected patients on antiretroviral therapy (ART) is a priority in many resource-limited settings, and ART providers are critical to effective program implementation. We explored provider-perceived barriers and facilitators of VL monitoring. We interviewed all providers (n = 17) engaged in a public health evaluation of dried blood spots for VL monitoring at five ART clinics in Malawi. All ART clinics were housed within district hospitals. We grouped themes at patient, provider, facility, system, and policy levels. Providers emphasized their desire for improved ART monitoring strategies, and frustration in response to restrictive policies for determining which patients were eligible to receive VL monitoring. Although many providers pled for expansion of monitoring to include all persons on ART, regardless of time on ART, the most salient provider-perceived barrier to VL monitoring implementation was the pressure of work associated with monitoring activities. The work burden was exacerbated by inefficient data management systems, highlighting a critical interaction between provider-, facility-, and system-level factors. Lack of integration between laboratory and clinical systems complicated the process for alerting providers when results were available, and these communication gaps were intensified by poor facility connectivity. Centralized second-line ART distribution was also noted as a barrier: providers reported that the time and expenses required for patients to collect second-line ART frequently obstructed referral. However, provider empowerment emerged as an unexpected facilitator of VL monitoring. For many providers, this was the first time they used an objective marker of ART response to guide clinical management. Providers' knowledge of a patient's virological status increased confidence in adherence counselling and clinical decision-making. Results from our study provide unique insight into provider perceptions of VL monitoring and indicate the importance of policies responsive to individual and environmental challenges of VL monitoring program implementation. Findings may inform scale-up by helping policy-makers identify strategies to improve feasibility and sustainability of VL monitoring.

Abstract access 

Editor’s notes: Viral load monitoring for HIV-positive individuals is gaining prominence as a method for monitoring responses to antiretroviral therapy (ART) and for identifying treatment failure. It is considered more accurate (in terms of its sensitivity and specificity) than alternative methods (e.g., CD4 cell counts). ART providers are critical to the implementation of viral load scale-up as it tends to be resource heavy and providers are tasked with numerous responsibilities in order to achieve individual and public health benefits. Using data from in-person interviews with providers on the frontline of ART management in five ART clinics in Malawi, this study explored multi-level barriers to, and facilitators for incorporating viral load monitoring into daily clinical practice. Study results illustrated a complex set of interconnected provider–identified barriers and facilitators that occurred at multiple levels. In terms of facilitators, high patient demand for viral load testing reinforced provider-perceived benefits of viral load monitoring. In addition, placing an emphasis on provider empowerment during viral load scale-up activities was thought to increase providers’ willingness to adopt additional responsibilities. Barriers identified by providers included the additional burden associated with viral load monitoring such as the time required in completing adherence assessment forms. Related to this was a barrier identified at the facility level by providers around shortage of staff. This was in particular identified as an impediment to completing viral load monitoring activities. Furthermore, inconsistent staffing alongside reluctance of rotating staff to participate in viral load monitoring activities were cited as contributors to people’s failure to return to scheduled clinic visits. Barriers at the system level were around time and expenses required for people to collect second-line ART which then obstructed referrals to viral load monitoring. Further, providers expressed frustration over a policy in Malawi that dictates only certain time points from ART exposure in order to be eligible for viral load monitoring. Hence, they felt forced to ration a service that was considered useful for guiding clinical practice and counselling people.

In order to address some of these barriers, the authors suggest that issues around workload burden and shortage of trained staff at facilities be addressed by expanding provider-to-patient ratios at ART clinics, broadening the scope of practice and training a lower cadre of health workers to facilitate programme sustainability. Furthermore, to synchronise facility, system and policy level interfaces, shortcomings in data management systems needed to be overcome. To that end, improving coverage of mobile networks and internet connectivity to outlying clinics would help facilitate reliable clinic-laboratory communication. Also, decentralised distribution of second-line ART drugs along with improved supply chain procedures should be considered to minimise stock-outs for individuals seeking viral load monitoring in more remote areas. Further, in order to address the issue around Malawi’s strict eligibility criteria, policy-makers need to make an effort to design provider trainings and patient education materials with clarity around the criteria in order to optimise access to limited viral load monitoring opportunities for people at highest risk of ART failure. Another option to improve access is ‘catch up’ testing where every individual on ART for more than two years receives a single test and then returns to biannual eligibility. Even though the results from this study are exploratory, they do provide useful insights into the perceived barriers and facilitators faced by providers around viral load monitoring. Overall, viral load monitoring can be used as a tool to help providers improve the quality of HIV care they deliver, if certain barriers are overcome.

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