Articles tagged as "Malawi"

Improving linkage to pre-antiretroviral therapy care and antiretroviral therapy initiation

Interventions to improve or facilitate linkage to or retention in pre-ART (HIV) care and initiation of ART in low- and middle-income settings--a systematic review.

Govindasamy D, Meghij J, Kebede Negussi E, Clare Baggaley R, Ford N, Kranzer K. J Int AIDS Soc. 2014 Aug 1;17(1):19032. doi: 10.7448/IAS.17.1.19032. eCollection 2014.

Introduction: Several approaches have been taken to reduce pre-antiretroviral therapy (ART) losses between HIV testing and ART initiation in low- and middle-income countries, but a systematic assessment of the evidence has not yet been undertaken. The aim of this systematic review is to assess the potential for interventions to improve or facilitate linkage to or retention in pre-ART care and initiation of ART in low- and middle-income settings.

Methods: An electronic search was conducted on Medline, Embase, Global Health, Web of Science and conference databases to identify studies describing interventions aimed at improving linkage to or retention in pre-ART care or initiation of ART. Additional searches were conducted to identify on-going trials on this topic, and experts in the field were contacted. An assessment of the risk of bias was conducted. Interventions were categorized according to key domains in the existing literature.

Results: A total of 11 129 potentially relevant citations were identified, of which 24 were eligible for inclusion, with the majority (n=21) from sub-Saharan Africa. In addition, 15 on-going trials were identified. The most common interventions described under key domains included: health system interventions (i.e. integration in the setting of antenatal care); patient convenience and accessibility (i.e. point-of-care CD4 count (POC) testing with immediate results, home-based ART initiation); behaviour interventions and peer support (i.e. improved communication, patient referral and education) and incentives (i.e. food support). Several interventions showed favourable outcomes: integration of care and peer supporters increased enrolment into HIV care, medical incentives increased pre-ART retention, POC CD4 testing and food incentives increased completion of ART eligibility screening and ART initiation. Most studies focused on the general adult patient population or pregnant women. The majority of published studies were observational cohort studies, subject to an unclear risk of bias.

Conclusions: Findings suggest that streamlining services to minimize patient visits, providing adequate medical and peer support, and providing incentives may decrease attrition, but the quality of the current evidence base is low. Few studies have investigated combined interventions, or assessed the impact of interventions across the HIV cascade. Results from on-going trials investigating POC CD4 count testing, patient navigation, rapid ART initiation and mobile phone technology may fill the quality of evidence gap. Further high-quality studies on key population groups are required, with interventions informed by previously reported barriers to care.

 Abstract  Full-text [free] access 

Editor’s notes: To maximise the impact of antiretroviral therapy (ART), people living with HIV should be diagnosed as early as possible, after acquiring HIV infection. They should be enrolled and retained in pre-ART care, initiated on ART and retained in ART care. And at the same time ensuring long-term adherence to achieve and maintain viral load suppression.

This review focuses on the first few steps in the treatment cascade. The authors review the evidence for activities that enhance the linkage from HIV testing to pre-ART care, retain people in pre-ART care and enhance the linkage to ART initiation. Streamlining services to minimize patient visits, providing adequate medical and peer support, and providing incentives appear to decrease attrition between HIV testing and ART initiation. However, the authors point out that most of the included studies looked at the effect of a single activity on a single point, in the continuum of care. There is a gap in evidence of the effect of combined activities and programmes across the continuum of care.

With the clear trend towards the earliest possible initiation of ART, the pre-ART care period will become much shorter. However there will be need for activities to improve immediate linkage from a positive test result, to ART initiation and ART care.

Health care delivery
Africa, Asia
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How can we improve the UNAIDS modes of transmission model?

The HIV modes of transmission model: a systematic review of its findings and adherence to guidelines.

Shubber Z, Mishra S, Vesga JF, Boily MC. J Int AIDS Soc. 2014 Jun 23;17:18928. doi: 10.7448/IAS.17.1.18928. eCollection 2014.

Introduction: The HIV Modes of Transmission (MOT) model estimates the annual fraction of new HIV infections (FNI) acquired by different risk groups. It was designed to guide country-specific HIV prevention policies. To determine if the MOT produced context-specific recommendations, we analyzed MOT Results by region and epidemic type, and explored the factors (e.g. data used to estimate parameter inputs, adherence to guidelines) influencing the differences.

Methods: We systematically searched MEDLINE, EMBASE and UNAIDS reports, and contacted UNAIDS country directors for published MOT Results from MOT inception (2003) to 25 September 2012.

Results: We retrieved four journal articles and 20 UNAIDS reports covering 29 countries. In 13 countries, the largest FNI (range 26 to 63%) was acquired by the low-risk group and increased with low-risk population size. The FNI among female sex workers (FSWs) remained low (median 1.3%, range 0.04 to 14.4%), with little variability by region and epidemic type despite variability in sexual behaviour. In India and Thailand, where FSWs play an important role in transmission, the FNI among FSWs was 2 and 4%, respectively. In contrast, the FNI among men who have sex with men (MSM) varied across regions (range 0.1 to 89%) and increased with MSM population size. The FNI among people who inject drugs (PWID, range 0 to 82%) was largest in early-phase epidemics with low overall HIV prevalence. Most MOT studies were conducted and reported as per guidelines but data quality remains an issue.

Conclusions: Although countries are generally performing the MOT as per guidelines, there is little variation in the FNI (except among MSM and PWID) by region and epidemic type. Homogeneity in MOT FNI for FSWs, clients and low-risk groups may limit the utility of MOT for guiding country-specific interventions in heterosexual HIV epidemics.

 Abstract  Full-text [free] access

Editor’s notes: In 2002, the HIV Modes of Transmission model (MoT) was developed by UNAIDS to inform and focus, country-specific HIV prevention policies. The idea behind the model was to use simple mathematical modelling approaches, in combination with country specific data, to predict what the distribution of new HIV infection may look like. In this way, countries would be able to better focus their HIV response. Since its development and through 2012, the MoT has been applied in 29 countries, with the findings being used in many settings to shape priorities. In this study, the authors assess the degree to which the MoT produces different outputs in different epidemic contexts. They explore whether there are key parameters in the model that seem to drive similarities and/or differences in projections between countries. Surprisingly, across a broad range of epidemic settings, they found limited variability in the predicted annual fraction of new HIV infections (FNI) acquired by female sex workers (FSW) (0.04-14.4%). There were higher levels of variability between countries in the projected fraction of new HIV infections among men who have sex with men (0.01-89%) and people who inject drugs (0-82%).

The differences in the MoT projections were largely dependent on whether the country in question was categorised as having a concentrated / low-level epidemic, versus generalised epidemic, as defined by UNAIDS. Differences also arose depending upon whether ‘low risk groups’ were also included in the model. Indeed, for 22 of the 25 studies that included a low-risk group, this group was predicted to have a large annual fraction of new HIV infections (11.8-62.9%). This phenomenon arose, not because of high transmission rates in this group (in comparison to others such as MSM or PWIDs) but because these ‘low risk groups’ are large. They are one third of the total population. These findings may be misleading, as the projected high fraction of transmission is dependent on the assumption that everyone in this ‘low risk group’ does have some risk.

It appears that although the MoT was designed to address an important need, it is likely to have limited utility to guide programming in heterosexually driven epidemics.  To address this limitation, UNAIDS is supporting the HIV Modelling Consortium in their development of a revised MoT model that takes into better consideration risk categorization, data constraints and programmatic needs. The revised model is currently undergoing field testing and will be available for country use in 2015.

Africa, Asia, Europe, Latin America
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WHO-recommended second-line ART regimen is safe and effective in Africa

Assessment of second-line antiretroviral regimens for HIV therapy in Africa.

Paton NI, Kityo C, Hoppe A, Reid A, Kambugu A, Lugemwa A, van Oosterhout JJ, Kiconco M, Siika A, Mwebaze R, Abwola M, Abongomera G, Mweemba A, Alima H, Atwongyeire D, Nyirenda R, Boles J, Thompson J, Tumukunde D, Chidziva E, Mambule I, Arribas JR, Easterbrook PJ, Hakim J, Walker AS, Mugyenyi P, EARNEST Trial Team. N Engl J Med. 2014 Jul 17;371(3):234-47. doi: 10.1056/NEJMoa1311274.

Background: The efficacy and toxic effects of nucleoside reverse-transcriptase inhibitors (NRTIs) are uncertain when these agents are used with a protease inhibitor in second-line therapy for human immunodeficiency virus (HIV) infection in resource-limited settings. Removing the NRTIs or replacing them with raltegravir may provide a benefit.

Methods: In this open-label trial in sub-Saharan Africa, we randomly assigned 1 277 adults and adolescents with HIV infection and first-line treatment failure to receive a ritonavir-boosted protease inhibitor (lopinavir-ritonavir) plus clinician-selected NRTIs (NRTI group, 426 patients), a protease inhibitor plus raltegravir in a superiority comparison (raltegravir group, 433 patients), or protease-inhibitor monotherapy after 12 weeks of induction therapy with raltegravir in a noninferiority comparison (monotherapy group, 418 patients). The primary composite end point, good HIV disease control, was defined as survival with no new World Health Organization stage 4 events, a CD4+ count of more than 250 cells per cubic millimeter, and a viral load of less than 10 000 copies per milliliter or 10 000 copies or more with no protease resistance mutations at week 96 and was analyzed with the use of imputation of data (</=4%).

Results: Good HIV disease control was achieved in 60% of the patients (mean, 255 patients) in the NRTI group, 64% of the patients (mean, 277) in the raltegravir group (P=0.21 for the comparison with the NRTI group; superiority of raltegravir not shown), and 55% of the patients (mean, 232) in the monotherapy group (noninferiority of monotherapy not shown, based on a 10-percentage-point margin). There was no significant difference in rates of grade 3 or 4 adverse events among the three groups (P=0.82). The viral load was less than 400 copies per milliliter in 86% of patients in the NRTI group, 86% in the raltegravir group (P=0.97), and 61% in the monotherapy group (P<0.001).

Conclusions: When given with a protease inhibitor in second-line therapy, NRTIs retained substantial virologic activity without evidence of increased toxicity, and there was no advantage to replacing them with raltegravir. Virologic control was inferior with protease-inhibitor monotherapy.

Abstract  Full-text [free] access

Editor’s notes: Over the coming years, increasing numbers of individuals taking antiretroviral therapy (ART) in sub-Saharan Africa will develop treatment failure and require second-line treatment.  There is an urgent need to find the most cost-effective, tolerable and safe standardised second-line regimen for this setting.  The Europe-Africa Research Network for Evaluation of Second-Line Therapy (EARNEST) trial set out to assess whether alternative ART regimens (excluding the nucleoside reverse transcriptase inhibitor [NRTI] backbone) are more efficacious and less toxic than the WHO-recommended second-line regimen of a boosted protease inhibitor (PI) and two NRTIs.  The setting of the trial is typical of most antiretroviral programmes in Africa, with no routine viral load monitoring, and the second-line NRTI backbone selected without genotypic resistance testing. 

Participants in this study had extensive NRTI resistance. Despite this, there was substantial residual NRTI activity, and, by week  96, the WHO-recommended regimen of a boosted PI and two NRTIs was as good as the alternative regimen of a boosted PI and raltegravir, and better than PI monotherapy.  It is worth pointing out that although “good HIV disease control” was achieved in only 60% of study participants in the NRTI arm, this composite outcome required study participants to have had a CD4 count ≥250 cells per mm3 at week 96.  The 60% achieving “good HIV disease control” in the NRTI arm therefore reflects the low baseline CD4 cell counts (median CD4 count 72) at the time of switch to second-line therapy rather than treatment efficacy with regard to virologic suppression (VL<400 copies/ml), which was achieved in some 86% of people.

Further research will be needed to determine whether this second-line regimen continues to be effective in maintaining good HIV disease control through virologic suppression in the longer term.  

HIV Treatment
Africa
Kenya, Malawi, Uganda, Zambia, Zimbabwe
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Home initiation of ART may be valuable addition to services to achieve universal access to treatment

Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial

MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, Butterworth AE, van Oosterhout JJ, Desmond N, Thindwa D, Squire SB, Hayes RJ, Corbett EL Journal of the American Medical Association. 2014 Jul 23-30;312(4):372-9. doi: 10.1001/jama.2014.6493.

Importance: Self-testing for HIV infection may contribute to early diagnosis of HIV, but without necessarily increasing antiretroviral therapy (ART) initiation.

Objective: To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase demand for ART initiation, compared with HIV self-testing accompanied by facility-based services only.

Design, setting, and participants: Cluster randomized trial conducted in Blantyre, Malawi, between January 30 and November 5, 2012, using restricted 1:1 randomization of 14 community health worker catchment areas. Participants were all adult (≥16 years) residents (n = 16 660) who received access to home HIV self-testing through resident volunteers. This was a second-stage randomization of clusters allocated to the HIV self-testing group of a parent trial.

Interventions: Clusters were randomly allocated to facility-based care or optional home initiation of HIV care (including 2 weeks of ART if eligible) for participants reporting positive HIV self-test results.

Main outcomes and measures: The pre-planned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability. Secondary outcomes were uptake of HIV self-testing, reporting of positive HIV self-test results, and rates of loss from ART at 6 months.

Results: A significantly greater proportion of adults in the home group initiated ART (181/8 194, 2.2%) compared with the facility group (63/8 466, 0.7%; risk ratio [RR], 2.94, 95% CI, 2.10-4.12; P < .001). Uptake of HIV self-testing was high in both the home (5 287/8 194, 64.9%) and facility groups (4 433/8 466, 52.7%; RR, 1.23; 95% CI, 0.96-1.58; P = .10). Significantly more adults reported positive HIV self-test results in the home group (490/8 194 [6.0%] vs the facility group,   278/8 466 [3.3%]; RR, 1.86; 95% CI, 1.16-2.97; P = .006). After 6 months, 52 of 181 ART initiators (28.7%) and 15 of 63 ART initiators (23.8%) in the home and facility groups, respectively, were lost from ART (adjusted incidence rate ratio, 1.18; 95% CI, 0.62-2.25, P = .57).

Conclusions and relevance: Among Malawian adults offered HIV self-testing, optional home initiation of care compared with standard HIV care resulted in a significant increase in the proportion of adults initiating ART.

Abstract  Full-text [free] access 

Editor’s notes: This study extends the recent drive to bring HIV testing closer to individuals and away from facilities by offering the option of initiating ART at the door-step. There are many benefits of such a strategy for asymptomatic individuals, and the popularity is clear from the high uptake of self-testing in this and other studies. The higher self-report of HIV positivity in the home initiating group probably reflects favourable disclosure and low stigma related conditions for this subset of community members. It is noteworthy that a greater number of home initiators were lost-to-follow-up 6 months after initiating ART. The authors highlight that the difference was not statistically significant. Although the pooled retention across initiation groups was lower than national retention data i.e., ART retention at 6 months was 72% vs 80% in the Malawi national programme, it was still within the range seen in other programmes. Home initiation of ART may be a valuable addition to services in the drive towards universal access to treatment. 

Health care delivery
Africa
Malawi
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Increasing HIV-testing in men: what works?

Systematic review of strategies to increase men's HIV-testing in sub-Saharan Africa

Hensen B, Taoka S, Lewis JJ, Weiss HA, Hargreaves J. AIDS. 2014 Jul; DOI:10.1097/QAD.0000000000000395

Objective: This systematic review summarizes evidence on the effectiveness of strategies to increase men's HIV-testing in sub-Saharan Africa.

Methods: Medline, EmBase, Africa-Wide Information and Global Health were searched. Cluster and individually randomized trials evaluating interventions to increase the proportion of adults (≥15 years) testing for HIV were eligible if they were conducted in sub-Saharan Africa, included men in the study population, and reported HIV-testing data by sex. References were independently screened.

Findings: Of the 1 852 references, 15 papers including 16 trials were eligible. Trials were judged too heterogeneous to combine in meta-analysis. Three interventions invited men to attend antenatal care-based HIV-testing via pregnant partners, of which two showed a significant effect on partner-testing. One intervention invited men to HIV-test through pregnant partners and showed an increase in HIV-testing when it was offered in bars compared with health facilities. A trial of notification to partners of newly diagnosed HIV-positive people showed an increase in testing where notification was by healthcare providers compared with notification by the patient. Three interventions reached men already at health facilities and eight reported the effects of community-based HIV-testing. Mobile-testing had a significant effect on HIV-testing compared with standard voluntary counselling and testing. Home-based testing also had a significant effect, but reached smaller numbers of men than mobile-testing.

Discussion: Interventions to encourage HIV-testing can increase men's levels of HIV-testing. Community-based programmes in particular had a large effect on population levels of HIV-testing. More data on costs and potential population impact of these approaches over different time-horizons would aid policy-makers in planning resource allocation to increase male HIV-testing.

Abstract access 

Editor’s notes: Approaches to increase rates of HIV-testing among men are urgently needed as uptake of HIV-testing in men remains lower than in women across sub-Saharan Africa. This systematic review identified published randomised controlled trials evaluating the impact of programmes to increase HIV-testing among men in sub-Saharan Africa. Few programmes focus on men specifically but some, like mobile testing, can have a substantial effect on HIV testing compared with standard voluntary counselling and testing. In addition, to be of direct benefit to men, increased HIV-testing among men is likely to lead to increased uptake among women and improved adherence to prevention of mother-to-child transmission. To increase men’s HIV-testing at a population level, country and time-specific combinations of available strategies are likely to be required. Along with additional research to determine whether these strategies encourage repeat-testing by high-risk HIV-negative men.

HIV testing
Africa
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Violence against men – by women

Male victims of sexual violence in rural Malawi: the overlooked association with HIV infection.

Conroy AA, Chilungo A. AIDS Care. 2014 Jul 3:1-5. [Epub ahead of print]

In sub-Saharan Africa, research on intimate partner violence (IPV) has largely failed to consider men's experiences as victims by female perpetrators - particularly within ongoing heterosexual relationships such as marriage. The objectives of this study were to document the prevalence of sexual coercion among men, to describe the characteristics of male victims, and to test for an association between sexual coercion and HIV positivity. In 2010, cross-sectional data on HIV risk behaviors, HIV status, and IPV were collected from a sample of 684 mostly married men in rural Malawi. Bivariate analyses were used to examine differences in HIV risk characteristics between victims and nonvictims of sexual coercion. Multivariate logistic regression was used to determine the association between sexual coercion and HIV positivity. Over one-tenth (10.4%) of men reported being a victim of sexual coercion. Male victims of sexual coercion were more likely to be married (p < 0.05), older than 24 years (p < 0.05), physically abused by a female partner (p < 0.001), believed their partners were at higher risk for HIV (p < 0.05), and had consumed alcohol in the past month (p < 0.01). After controlling for potential confounders, the odds of being HIV positive were 7.2 times higher among men who had experienced sexual coercion (p < 0.000). In sub-Saharan Africa, research on men's experience of violence as victims is long overdue. More formative research is needed to understand the mechanisms through which men experience violence and how to appropriately measure IPV among male victims. While the data are cross-sectional and cannot evaluate causality, the strength of the association with HIV positivity merits further attention.

Abstract access

Editor’s notes: Research on intimate partner violence (IPV), in which a man is the victim, is rare in sub-Saharan Africa.  This paper, based on data collected over the course of a longitudinal study on reproduction and AIDS in Malawi, is therefore a welcome addition to the literature on IPV.  While the findings show associations between sexual coercion and alcohol use, age and HIV-status, there is much that is not known.  Might the woman also have been subject to IPV? Was she intoxicated at the time of the violence or coercion? Is IPV against a man habitual in some relationships? This is an uncomfortable topic to investigate in settings where the man is expected to be `in charge’, but given the associated risk factors, more needs to be known.  The call by the authors for more research should be heeded.

Africa
Malawi
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WHO clinical staging misses a significant proportion of antiretroviral therapy eligible individuals

Diagnostic accuracy of the WHO clinical staging system for defining eligibility for ART in sub-Saharan Africa: a systematic review and meta-analysis.

Munthali C, Taegtmeyer M, Garner PG, Lalloo DG, Squire SB, Corbett EL, Ford N, MacPherson P. J Int AIDS Soc. 2014 Jun 12;17:18932. doi: 10.7448/IAS.17.1.18932. eCollection 2014.

Introduction: The World Health Organization (WHO) recommends that HIV-positive adults with CD4 count ≤500 cells/mm3 initiate antiretroviral therapy (ART). In many countries of sub-Saharan Africa, CD4 count is not widely available or consistently used and instead the WHO clinical staging system is used to determine ART eligibility. However, concerns have been raised regarding its discriminatory ability to identify patients eligible to start ART. We therefore reviewed the accuracy of WHO stage 3 or 4 assessment in identifying ART eligibility according to CD4 count thresholds for ART initiation.

Methods: We systematically searched PubMed and Global Health databases and conference abstracts using a comprehensive strategy for studies that compared the Results of WHO clinical staging with CD4 count thresholds. Studies performed in sub-Saharan Africa and published in English between 1998 and 2013 were eligible for inclusion according to our predefined study protocol. Two authors independently extracted data and assessed methodological quality and risk of bias using the Quality Assessment Tool for Diagnostic Accuracy Studies (QUADAS-2) tool. Summary estimates of sensitivity and specificity were derived for each CD4 count threshold and hierarchical summary receiver operator characteristic curves were plotted.

Results: Fifteen studies met the inclusion criteria, including 25 032 participants from 14 countries. Most studies assessed individuals attending ART clinics prior to treatment initiation. WHO clinical stage 3 or 4 disease had a sensitivity of 60% (95% CI: 45-73%, Q=914.26, p<0.001) and specificity of 73% (95% CI: 60-83%, Q=1439.43, p<0.001) for a CD4 threshold of ≤200 cells/mm3 (11 studies); sensitivity and specificity for a threshold of CD4 count ≤350 cells/mm3 were 45% (95% CI: 26-66%, Q=1607.31, p<0.001) and 85% (95% CI: 69-93%, Q=896.70, p<0.001), respectively (six studies). For the threshold of CD4 count ≤500 cells/mm3 sensitivity was 14% (95% CI: 13-15%) and specificity was 95% (95% CI: 94-96%) (one study).

Conclusions: When used for individual treatment decisions, WHO clinical staging misses a high proportion of individuals who are ART eligible by CD4 count, with sensitivity falling as CD4 count criteria rises. Access to accurate, accessible, robust and affordable CD4 count testing methods will be a pressing need for as long as ART initiation decisions are based on criteria other than seropositivity.

Abstract  Full-text [free] access  

Editor’s notes: This study highlights the major shortcomings of WHO clinical staging when identifying antiretroviral therapy (ART) eligible individuals, with decreasing sensitivity of clinical staging for eligibility at higher CD4 thresholds. There remains limited access to CD4 count testing in many settings in sub-Saharan Africa. The individual and public health benefit of earlier ART initiation will not be achieved unless strategies other than WHO clinical staging are implemented. Access to affordable, quality assured CD4 count testing in all ART initiation clinics may never be feasible in the most resource-constrained settings. Universal treatment, removing the need for CD4 count testing, may be the way to ensure that eligible individuals are started on ART in a timely way.

Africa
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Integrating HIV, malaria and diarrhoea prevention is far more efficient than vertical programmes

Scaling up integrated prevention campaigns for global health: costs and cost-effectiveness in 70 countries. 

Marseille E, Jiwani A, Raut A, Verguet S, Walson J, Kahn JG. BMJ Open. 2014 Jun 26;4(6):e003987. doi: 10.1136/bmjopen-2013-003987.

Objective: This study estimated the health impact, cost and cost-effectiveness of an integrated prevention campaign (IPC) focused on diarrhoea, malaria and HIV in 70 countries ranked by per capita disability-adjusted life-year (DALY) burden for the three diseases.

Methods: We constructed a deterministic cost-effectiveness model portraying an IPC combining counselling and testing, cotrimoxazole prophylaxis, referral to treatment and condom distribution for HIV prevention; bed nets for malaria prevention; and provision of household water filters for diarrhoea prevention. We developed a mix of empirical and modelled cost and health impact estimates applied to all 70 countries. One-way, multiway and scenario sensitivity analyses were conducted to document the strength of our findings. We used a healthcare payer's perspective, discounted costs and DALYs at 3% per year and denominated cost in 2012 US dollars.

Primary and secondary outcomes: The primary outcome was cost-effectiveness expressed as net cost per DALY averted. Other outcomes included cost of the IPC; net IPC costs adjusted for averted and additional medical costs and DALYs averted.

Results: Implementation of the IPC in the 10 most cost-effective countries at 15% population coverage would cost US$583 million over 3 years (adjusted costs of US$398 million), averting 8.0 million DALYs. Extending IPC programmes to all 70 of the identified high-burden countries at 15% coverage would cost an adjusted US$51.3 billion and avert 78.7 million DALYs. Incremental cost-effectiveness ranged from US$49 per DALY averted for the 10 countries with the most favourable cost-effectiveness to US$119, US$181, US$335, US$1 692 and US$8 340 per DALY averted as each successive group of 10 countries is added ordered by decreasing cost-effectiveness.

Conclusions: IPC appears cost-effective in many settings, and has the potential to substantially reduce the burden of disease in resource-poor countries. This study increases confidence that IPC can be an important new approach for enhancing global health.

Abstract  Full-text [free] access

Editor’s notes: Increasingly governments and policy makers are seeking to identify how to invest resources most effectively, to achieve multiple health and development outcomes. This paper presents a cost-effectiveness analysis of an integrated campaign to prevent diarrhoea, malaria and HIV.  

They developed a model to estimate the cost per disability adjusted life year (DALY) averted by this intervention, across 70 countries with high disease burden, assuming 15% coverage. The authors categorise countries by income level and their opportunity index (i.e. the opportunity to avert DALYs by having a high disease burden). The findings suggest that an integrated prevention campaign (IPC) could cost as little as US$7 per DALY averted in Guinea-Bissau, a low income, high opportunity country. As would be expected, the contribution of the different IPC components varied by country, depending on their relative disease burdens. This suggests that further focusing of activities within countries may further improve efficiency.

The model was also used to consider potential roll out strategies across counties. For this, countries were grouped into blocks of 10, and ordered with increasing incremental-cost effectiveness. The authors suggest that reaching the top 40 countries with IPC, even at just 15% coverage, could achieve far greater health benefits, with a substantially lower budget, than requested under PEPFAR for antiretroviral therapy alone.

This paper provides further evidence of the need for a more integrated approach to improve population health across disease areas.

Africa, Asia, Europe, Latin America
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Fewer clinical events with early antiretroviral therapy in a trial among serodiscordant couples

Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial.

Grinsztejn B, Hosseinipour MC, Ribaudo HJ, Swindells S, Eron J, Chen YQ, Wang L, Ou SS, Anderson M, McCauley M, Gamble T, Kumarasamy N, Hakim JG, Kumwenda J, Pilotto JH, Godbole SV, Chariyalertsak S, de Melo MG, Mayer KH, Eshleman SH, Piwowar-Manning E, Makhema J, Mills LA, Panchia R, Sanne I, Gallant J, Hoffman I, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Havlir D, Cohen MS, HPTN 052-ACTG Study Team. Lancet Infect Dis. 2014 Apr;14(4):281-90. doi: 10.1016/S1473-3099(13)70692-3. Epub 2014 Mar 4.

Background: Use of antiretroviral treatment for HIV-1 infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-1. However, the best time to initiate antiretroviral treatment to reduce progression of HIV-1 infection or non-AIDS clinical events is unknown. We reported previously that early antiretroviral treatment reduced HIV-1 transmission by 96%. We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes.

Methods: The HPTN 052 trial is a randomised controlled trial done at 13 sites in nine countries. We enrolled HIV-1-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation, stratified by site. Random assignment was unblinded. The HIV-1-infected member of every couple initiated antiretroviral treatment either on entry into the study (early treatment group) or after a decline in CD4 count or with onset of an AIDS-related illness (delayed treatment group). Primary events were AIDS clinical events (WHO stage 4 HIV-1 disease, tuberculosis, and severe bacterial infections) and the following serious medical conditions unrelated to AIDS: serious cardiovascular or vascular disease, serious liver disease, end-stage renal disease, new-onset diabetes mellitus, and non-AIDS malignant disease. Analysis was by intention-to-treat.

Findings: 1 763 people with HIV-1 infection and a serodiscordant partner were enrolled in the study; 886 were assigned early antiretroviral treatment and 877 to the delayed treatment group (two individuals were excluded from this group after randomisation). Median CD4 counts at randomisation were 442 (IQR 373-522) cells per μL in patients assigned to the early treatment group and 428 (357-522) cells per μL in those allocated delayed antiretroviral treatment. In the delayed group, antiretroviral treatment was initiated at a median CD4 count of 230 (IQR 197-249) cells per μL. Primary clinical events were reported in 57 individuals assigned to early treatment initiation versus 77 people allocated to delayed antiretroviral treatment (hazard ratio 0.73, 95% CI 0.52-1.03; p=0.074). New-onset AIDS events were recorded in 40 participants assigned to early antiretroviral treatment versus 61 allocated delayed initiation (0.64, 0.43-0.96; p=0.031), tuberculosis developed in 17 versus 34 patients, respectively (0.49, 0.28-0.89, p=0.018), and primary non-AIDS events were rare (12 in the early group vs nine with delayed treatment). In total, 498 primary and secondary outcomes occurred in the early treatment group (incidence 24.9 per 100 person-years, 95% CI 22.5-27.5) versus 585 in the delayed treatment group (29.2 per 100 person-years, 26.5-32.1; p=0.025). 26 people died, 11 who were allocated to early antiretroviral treatment and 15 who were assigned to the delayed treatment group.

Interpretation: Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes. The clinical benefits recorded, combined with the striking reduction in HIV-1 transmission risk previously reported, provides strong support for earlier initiation of antiretroviral treatment.

Abstract access 

Editor’s notes: The HPTN 052 trial has received wide attention for its main result. This shows a large reduction in HIV transmission risk among HIV-serodiscordant couples where HIV-positive partners with CD4 counts between 350 and 550 started immediate antiretroviral therapy (ART). This was compared to deferring treatment until the CD4 count fell below 250 or an AIDS-defining illness occurred. This analysis reports on clinical events in the trial. Despite the trial population having relatively high CD4 counts at baseline, new AIDS-defining events, excluding tuberculosis, were the most common outcome. These were reduced in the early ART arm. Tuberculosis incidence was reduced by half. Non-AIDS events were rare.

For these trial results to translate into population level benefits, more people need to know their HIV status at an early stage, before they develop symptomatic disease. People with positive test results then need to link to care successfully so that treatment can be initiated. Stigma remains a key barrier to testing and accessing care in many settings. Virologic suppression among people in the intervention arm of this trial was very high, implying very good adherence to treatment. Strategies to support excellent adherence and retention are needed as ART programmes expand and include people starting ART earlier.

Comorbidity, HIV Treatment
Africa, Asia, Latin America
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Social intolerance increases risky sexual behaviour

HIV-related social intolerance and risky sexual behavior in a high HIV prevalence environment.

Delavande A, Sampaio M, Sood N. Soc Sci Med. 2014 Apr 13;111C:84-93. doi: 10.1016/j.socscimed.2014.04.011. [Epub ahead of print]

Although most countries state that fighting social intolerance against persons with HIV is part of their national HIV strategy, the impact of reducing intolerance on risky sexual behavior is largely unknown. In this paper, we estimate the effect of social intolerance against HIV+ persons on risky sexual behavior in rural Malawi using data from roughly 2 000 respondents from the 2004 and 2006 waves of the Malawi Longitudinal Study of Families and Health (MLSFH). The effect of social intolerance on risky behavior is a priori ambiguous. On the one hand, higher social intolerance or stigma can lead people to disassociate from the stigmatized group and hence promote risky behavior. On the other hand, intolerance can be viewed as a social tax on being HIV+ and thus higher intolerance may reduce risky behavior. We find that a decrease in social intolerance is associated with a decrease in risky behavior, including fewer partners and a lower likelihood of having extra-marital relations. This effect is mainly driven by the impact of social intolerance on men. Overall the results suggest that reducing social intolerance might not only benefit the HIV positive but might also forestall the spread of HIV.

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Editor’s notes: Social intolerance is the unwillingness of certain groups to tolerate ideas or behaviour different from their own. The focus of this paper on social intolerance in Malawi is timely, given the moves in certain countries to put in place legislation to sanction what are perceived to be ‘deviant behaviours’. The authors show that a greater tolerance of people living with HIV encourages safer sexual behaviour. These findings suggest that efforts to address intolerance, stigma and discrimination may have a more lasting impact than legislation, which may drive marginalised groups underground. 

Africa
Malawi
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