Articles tagged as "HIV testing"

Testing for acute HIV infection feasible but impact remains uncertain

Incorporating acute HIV screening into routine HIV testing at sexually transmitted infection clinics and HIV testing and counseling centers in Lilongwe, Malawi.

Rutstein SE, Pettifor AE, Phiri S, Kamanga G, Hoffman IF, Hosseinipour MC, Rosenberg NE, Nsona D, Pasquale D, Tegha G, Powers K, Phiri M, Tembo B, Chege W, Miller WC. J Acquir Immune Defic Syndr. 2015 Sep 29. [Epub ahead of print]

Background and objectives: Integrating acute HIV infection (AHI) testing into clinical settings is critical to prevent transmission and realize potential treatment-as-prevention benefits. We evaluated acceptability of AHI testing and compared AHI prevalence at sexually transmitted infection (STI) and HIV testing and counseling (HTC) clinics in Lilongwe, Malawi.

Methods: We conducted HIV RNA testing for HIV-seronegative patients visiting STI and HTC clinics. AHI was defined as positive RNA and negative/discordant rapid antibody tests. We evaluated demographic, behavioral, and transmission-risk differences between STI and HTC patients and assessed performance of a risk-score for targeted screening.

Results: Nearly two-thirds (62.8%, 9280/14 755) of eligible patients consented to AHI testing. We identified 59 persons with AHI (prevalence=0.64%) - a 0.9% case-identification increase. Prevalence was higher at STI (1.03% (44/4255)) than HTC clinics (0.3% (15/5025), p<0.01), accounting for 2.3% of new diagnoses, vs 0.3% at HTC. Median viral load (VL) was 758 050 copies/ml; 25% (15/59) had VL ≥10 000 000 copies/ml. Median VL was higher at STI (1 000 000 copies/ml) compared to HTC (153 125 copies/ml, p=0.2). Among persons with AHI, those tested at STI clinics were more likely to report genital sores compared to those tested at HTC (54.6% versus 6.7%, p<0.01). The risk score algorithm performed well in identifying persons with AHI at HTC (sensitivity=73%, specificity=89%).

Conclusions: The majority of patients consented to AHI testing. AHI prevalence was substantially higher in STI clinics than HTC. Remarkably high VLs and concomitant genital sores demonstrates the potential for transmission. Universal AHI screening at STI clinics, and targeted screening at HTC centers, should be considered.

Abstract access 

Editor’s notes: Acute HIV infection (AHI) is defined as the time from HIV acquisition to the appearance of detectable antibodies. Individuals with AHI are highly infectious, at least partly due to high viral load. Effective strategies to identify and treat people with AHI could increase the impact of treatment as prevention strategies, although there continues to be debate around the contribution of AHI to HIV transmission at population level.

This study in Malawi was part of a clinical trial evaluating the impact of behavioural and antiretroviral programmes during AHI. The study was done in four high-volume urban facilities. Pooled HIV RNA testing was performed on blood from participants with negative or discordant rapid HIV tests, according to the routine testing algorithm (discordant defined as one positive and two negative tests). Overall participation rates were relatively low, with only one in three individuals with negative or discordant rapid HIV tests included. Most of the loss was due to potentially eligible persons not being screened. The reasons for this are not mentioned, although more than a third that were screened did not consent. Overall, one in 150 participants had AHI. This was higher, at one in 100, at the STI clinics. The proportion with AHI was lower than previous research in Malawi, which could reflect a decline in HIV incidence at population level.

The potential risk of HIV transmission during AHI is highlighted by the characteristics of the people with AHI. Almost half had HIV RNA >6 log10 copies/ml, a similar proportion had genital ulcers, and only one in five reported condom use at last sex. The algorithm for focussing AHI testing, previously developed in the same setting, had suboptimal performance across all sites. 

This study adds to a body of evidence that suggests testing for AHI is feasible and will increase the overall yield of HIV testing by a small amount. We now need more evidence around whether programmatic implementation of AHI testing would have an impact on HIV transmission, and on the cost-effectiveness of different testing strategies. Data from treatment as prevention trials, none of which have included specific strategies to diagnose AHI, will also indirectly inform whether this should become a higher priority for public health programmes. 

Africa
Malawi
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Invitation plus tracing increases male partner testing during pregnancy

Recruiting male partners for couple HIV testing and counselling in Malawi's option B+ programme: an unblinded randomised controlled trial.

Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng'ambi W, Miller WC, Hoffman I, Hosseinipour M. Lancet HIV. 2015 Nov;2(11):e483-91. doi: 10.1016/S2352-3018(15)00182-4. Epub 2015 Oct 22.

Background: Couples HIV testing and counselling (CHTC) is encouraged but is not widely done in sub-Saharan Africa. We aimed to compare two strategies for recruiting male partners for CHTC in Malawi's option B+ prevention of mother-to-child transmission programme: invitation only versus invitation plus tracing and postulated that invitation plus tracing would be more effective.

Methods: We did an unblinded, randomised, controlled trial assessing uptake of CHTC in the antenatal unit at Bwaila District Hospital, a maternity hospital in Lilongwe, Malawi. Women were eligible if they were pregnant, had just tested HIV-positive and therefore could initiate antiretroviral therapy, had not yet had CHTC, were older than 18 years or 16-17 years and married, reported a male sex partner in Lilongwe, and intended to remain in Lilongwe for at least 1 month. Women were randomly assigned (1:1) to either the invitation only group or the invitation plus tracing group with block randomisation (block size=4). In the invitation only group, women were provided with an invitation for male partners to present to the antenatal clinic. In the invitation plus tracing group, women were provided with the same invitation, and partners were traced if they did not present. When couples presented they were offered pregnancy information and CHTC. Women were asked to attend a follow-up visit 1 month after enrolment to assess social harms and sexual behaviour. The primary outcome was the proportion of couples who presented to the clinic together and received CHTC during the study period and was assessed in all randomly assigned participants. This study is registered with ClinicalTrials.gov, number NCT02139176.

Findings: Between March 4, 2014, and Oct 3, 2014, 200 HIV-positive pregnant women were enrolled and randomly assigned to either the invitation only group (n=100) or the invitation plus tracing group (n=100). 74 couples in the invitation plus tracing group and 52 in the invitation only group presented to the clinic and had CHTC (risk difference 22%, 95% CI 9-35; p=0.001) during the 10 month study period. Of 181 women with follow-up data, two reported union dissolution, one reported emotional distress, and none reported intimate partner violence. One male partner, when traced, was confused about which of his sex partners was enrolled in the study. No other adverse events were reported.

Interpretation: An invitation plus tracing strategy was highly effective at increasing CHTC uptake. Invitation plus tracing with CHTC could have many substantial benefits if brought to scale.

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Editor’s notes: A major challenge to the Option B+ prevention of mother-to-child-transmission programme is retaining women in HIV care. Lack of male partner support may be an important barrier to retention. Couples HIV testing and counselling (CHTC) can increase mutual disclosure, enhance behavioural HIV prevention, and ultimately improve maternal, child and male partner health outcomes.  However, uptake of CHTC in antenatal settings remains low throughout most of sub-Saharan Africa. This randomised controlled trial illustrates that combining an invitation for the male partner to present to the antenatal clinic with active tracing of the partner by the study team greatly increased uptake of CHTC. A unique feature of the programme was that the invitation and tracing messages focused on general health during pregnancy, rather than on HIV, which may have improved acceptability. Even in the invitation alone arm, over half of the male partners presented for CHTC. Both strategies found that over half the men who tested were HIV positive, and the majority were unaware of their status. Women in the invitation plus tracing arm had higher retention in the Option B+ programme at one month than individuals in the invitation alone arm, and were more likely to report safer sex behaviour. 

Although provider-based strategies for increasing couples testing are more expensive than patient-based strategies, they may be very cost-effective in settings of high HIV prevalence where few men are aware of their HIV status. Interestingly, most gains in partner uptake from tracing were a result of telephone contact, which is relatively low cost. Longer term follow-up is necessary to assess whether increases in retention are maintained over time but the results demonstrate the potential for provider-based strategies for increasing CHTC to help achieve UNAIDS 90-90-90 targets.

Africa
Malawi
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Routine opt-out HIV testing reduces missed diagnoses in children

The effectiveness of routine opt-out HIV testing for children in Harare, Zimbabwe.

Ferrand RA, Meghji J, Kidia K, Dauya E, Bandason T, Mujuru H, Ncube G, Mungofa S, Kranzer K. J Acquir Immune Defic Syndr. 2015 Oct 12. [Epub ahead of print]

Objective: HIV testing is the entry point to access HIV care. For HIV-infected children who survive infancy undiagnosed, diagnosis usually occurs on presentation to health care services. We investigated the effectiveness of routine opt-out HIV testing (ROOT) compared to conventional opt-in provider-initiated testing and counselling (PITC) for children attending primary care clinics.

Methods: Following an evaluation of PITC services for children aged 6 to 15 years in six primary health care facilities in Harare, Zimbabwe, ROOT was introduced through a combination of interventions. The change in the proportion of eligible children offered and receiving HIV tests, reasons for not testing, and yield of HIV positive diagnoses were compared between the two HIV testing strategies. Adjusted risk ratios for having an HIV test in the ROOT compared to the PITC period were calculated.

Results: There were 2831 and 7842 children eligible for HIV testing before and after the introduction of ROOT. The proportion of eligible children offered testing increased from 76% to 93% and test uptake improved from 71% to 95% in the ROOT compared to the PITC period. The yield of HIV diagnoses increased from 2.9% to 4.5%, and a child attending the clinics post intervention had a 1.99 increased adjusted risk (95% CI 1.85-2.14) of receiving an HIV test in the ROOT period compared to the pre-intervention period.

Conclusion: ROOT increased the proportion of children undergoing HIV-testing, resulting in an overall increased yield of positive diagnoses, compared to PITC. ROOT provides an effective approach to reduce missed HIV diagnosis in this age-group.

Abstract access 

Editor’s notes: The policy and practice of HIV testing in high HIV prevalence settings has evolved over the years, from a more cautious approach in the early years of the HIV epidemic to a more proactive one with the scale up of antiretroviral therapy (ART). Despite a marked increase in HIV testing following the introduction of provider-initiated testing and counselling (PITC) in clinical settings, coverage remains suboptimal. Routine opt-out testing (ROOT) describes a strategy of HIV testing as part of the routine clinical ‘work-up’, unless a person explicitly refuses to test. To date, ROOT has been confined to specialist clinical services, such as prevention of mother-to-child HIV transmission programmes, sexual health clinics and tuberculosis services.

This study in primary care facilities in Harare compared the effectiveness of ROOT with PITC in children aged six to 15 years, a group for whom opportunities to receive HIV testing have been limited. The authors found that a 22% increase in the proportion of eligible children offered testing following the introduction of ROOT; a 34% increase in the proportion of HIV test uptake; and a 55% increase in proportion of children testing HIV positive (yield).  Importantly, the increase in proportion of children to whom testing was offered, test uptake and yield compared to opt-in PITC was sustained over the 1.5 years follow-up period. Factors postulated to have resulted in improved testing and uptake included the removal of the decision of whether to test from the guardian and healthcare worker and decreased stigma associated with opt-out testing. The authors also acknowledge that investment in training and human resource capacity likely contributed to improvements seen. Further, as stated by the authors, HIV testing must be accompanied by effective strategies to ensure linkage to care in order to improve health outcomes in this population.

Africa
Zimbabwe
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Comparing strategies for HIV testing and counselling for children and adolescents

Uptake and yield of HIV testing and counselling among children and adolescents in sub-Saharan Africa: a systematic review.

Govindasamy D, Ferrand RA, Wilmore SM, Ford N, Ahmed S, Afnan-Holmes H, Kranzer K. J Int AIDS Soc. 2015 Oct 14;18(1):20182. doi: 10.7448/IAS.18.1.20182. eCollection 2015.

Introduction: In recent years children and adolescents have emerged as a priority for HIV prevention and care services. We conducted a systematic review to investigate the acceptability, yield and prevalence of HIV testing and counselling (HTC) strategies in children and adolescents (5 to 19 years) in sub-Saharan Africa.

Methods: An electronic search was conducted in MEDLINE, EMBASE, Global Health and conference abstract databases. Studies reporting on HTC acceptability, yield and prevalence and published between January 2004 and September 2014 were included. Pooled proportions for these three outcomes were estimated using a random effects model. A quality assessment was conducted on included studies.

Results and discussion: A total of 16 380 potential citations were identified, of which 21 studies (23 entries) were included. Most studies were conducted in Kenya (n=5) and Uganda (n=5) and judged to provide moderate (n=15) to low quality (n=7) evidence, with data not disaggregated by age. Seven studies reported on provider-initiated testing and counselling (PITC), with the remainder reporting on family-centred (n=5), home-based (n=5), outreach (n=5) and school-linked HTC among primary schoolchildren (n=1). PITC among inpatients had the highest acceptability (86.3%; 95% confidence interval [CI]: 65.5 to 100%), yield (12.2%; 95% CI: 6.1 to 18.3%) and prevalence (15.4%; 95% CI: 5.0 to 25.7%). Family-centred HTC had lower acceptance compared to home-based HTC (51.7%; 95% CI: 10.4 to 92.9% vs. 84.9%; 95% CI: 74.4 to 95.4%) yet higher prevalence (8.4%; 95% CI: 3.4 to 13.5% vs. 3.0%; 95% CI: 1.0 to 4.9%). School-linked HTC showed poor acceptance and low prevalence.

Conclusions: While PITC may have high test acceptability priority should be given to evaluating strategies beyond healthcare settings (e.g. home-based HTC among families) to identify individuals earlier in their disease progression. Data on linkage to care and cost-effectiveness of HTC strategies are needed to strengthen policies.

Abstract  Full-text [free] access

Editor’s notes: In sub-Saharan Africa children and adolescents are a priority group for HIV prevention and care services. Children and adolescents living with HIV are less likely than adults to know their HIV status, to access treatment and to achieve virologic suppression. As with adults, the first essential step to managing HIV in children and adolescents is to provide appropriate HIV testing and counselling services. This is the first systematic review to assess HIV testing and counselling strategies in this age group, 5-19 years. One key finding is the lack of data on testing and counselling services for this age group. Most services replicate strategies developed for adults with little consideration for the specific needs of children and adolescents. The studies illustrated that health care facility-based provider-initiated testing and counselling had relatively high acceptance, yield and linkage-to-care, but tended to identify individuals at a late stage of disease. In contrast, community-based approaches had the potential to diagnose asymptomatic children. Further work on innovative approaches, family-centred and mobile-based, should be assessed.  

HIV testing
Africa
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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.

Asia
China
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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. 

Africa
Malawi
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Awareness of HIV status and risk among key populations in India

HIV care continuum among men who have sex with men and people who inject drugs in India: barriers to successful engagement.

Mehta SH, Lucas GM, Solomon S, Srikrishnan AS, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. Clin Infect Dis. 2015 Aug 6. pii: civ669. [Epub ahead of print]

Background: We characterize the HIV care continuum for men who have sex with men (MSM) and people who inject drugs (PWID) across India.

Methods: We recruited 12 022 MSM and 14 481 PWID across 26 Indian cities using respondent-driven sampling (9/2012-12/2013). Participants were ≥18 years and either 1) self-identified as male and reported sex with a man in the prior year (MSM); or 2) reported injection drug use in the prior 2 years (PWID). Correlates of awareness of HIV positive status were characterized using multi-level logistic regression.

Results: 1146 MSM were HIV-infected of whom a median 30% were aware of their HIV positive status, 23% were linked to care, 22% were retained pre-ART, 16% initiated ART, 16% were currently on ART, and 10% had suppressed VL. There was site variability (awareness range: 0-90%; suppressed VL range: 0-58%). 2906 PWID were HIV-infected of whom a median 41% were aware, 36% linked to care, 31% were retained pre-ART, 20% initiated ART, 18% were currently on ART, and 15% had suppressed VL. Similar site variability was observed (awareness range: 2-93%; suppressed VL range: 0-47%). Factors significantly associated with awareness were region, older age, being married (MSM) or female (PWID), other service utilization (PWID), more lifetime sexual partners (MSM) and needle sharing (PWID). Ongoing injection drug use (PWID) and alcohol (MSM) were associated with lower awareness.

Conclusions: In this large sample, the major barrier to HIV care engagement was awareness of HIV positive status. Efforts should focus on linking HIV testing to other essential services.

Abstract access 

Editor’s notes: The UNAIDS target of 90-90-90 (90% of HIV positive individuals knowing their status, 90% of people being on ART and 90% of people on ART being virally suppressed) applies to all people living with HIV, including people in key populations who can be hard to reach in some settings. In India, declines in HIV prevalence have been seen among women attending antenatal clinics, but not in the key populations of gay men and other men who have sex with men and people who inject drugs. In this large, community-based, study of gay men and other men who have sex with men and people who inject drugs across India, the majority of people living with HIV (70% of gay men and other men who have sex with men and 59% of people who inject drugs) were unaware of their HIV status. Of people who were aware of their status, the proportions receiving sustained ART were relatively low (68% of gay men and other men who have sex with men and 52% of people who inject drugs). Notably, among people on ART, levels of viral suppression were high and comparable to that in high-income settings. The study highlights awareness of HIV status as the primary barrier to HIV care in these populations, and the importance of integrating HIV testing across healthcare services for vulnerable populations, using same-day rapid tests to maximise linkage-to-care. However, to have a real impact on outcomes across the HIV care continuum, additional strategies will be necessary. These are needed together with large-scale public policy changes to modify the broader social environment – such as decriminalisation of same-sex behaviour.

Asia
India
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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
Africa
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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.

Africa
Malawi
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HIV self-testing: A cost-saving approach?

Assessment of the potential impact and cost-effectiveness of self-testing for HIV in low-income countries.  

Cambiano V, Ford D, Mabugu T, Napierala Mavedzenge S, Miners A, Mugurungi O, Nakagawa F, Revill P, Phillips A. J Infect Dis. 2015 Aug 15;212(4):570-7. doi: 10.1093/infdis/jiv040. Epub 2015 Mar 12.

Background: Studies have demonstrated that self-testing for human immunodeficiency virus (HIV) is highly acceptable among individuals and could allow cost savings, compared with provider-delivered HIV testing and counseling (PHTC), although the longer-term population-level effects are uncertain. We evaluated the cost-effectiveness of introducing self-testing in 2015 over a 20-year time frame in a country such as Zimbabwe.

Methods: The HIV synthesis model was used. Two scenarios were considered. In the reference scenario, self-testing is not available, and the rate of first-time and repeat PHTC is assumed to increase from 2015 onward, in line with past trends. In the intervention scenario, self-testing is introduced at a unit cost of $3.

Results: We predict that the introduction of self-testing would lead to modest savings in healthcare costs of $75 million, while averting around 7000 disability-adjusted life-years over 20 years. Findings were robust to most variations in assumptions; however, higher cost of self-testing, lower linkage to care for people whose diagnosis is a consequence of a positive self-test result, and lower threshold for antiretroviral therapy eligibility criteria could lead to situations in which self-testing is not cost-effective.

Conclusions: This analysis suggests that introducing self-testing offers some health benefits and may well save costs.

Abstract  Full-text [free] access

Editor’s notes: In low-income countries 50% of people living with HIV are unaware of their HIV-status. Some barriers to diagnosis are associated with provider-based models and could potentially be overcome by introducing self-testing strategies. The cost of self-testing is expected to be lower than that of provider-based testing. However, self-testing may have a lower sensitivity, may necessitate provider-based diagnosis confirmation and may lead to lower linkages to care, among other potential disadvantages. This study assesses the cost-effectiveness of introducing self-testing in Zimbabwe over a 20-year time frame.

Two scenarios are modelled using an individual-based stochastic model of HIV transmission and infection progression and treatment: 1) a reference case where self-testing is not introduced, with continuous reliance on provider-based testing and 2) following self-testing introduction. Cost and health outcomes were compared.

The study suggests that introduction of self-testing would lead to a 7% higher proportion tested for HIV compared to the reference scenario. Also, it would lead to a cost reduction of 2.6% (USD 75 million) and to 7000 DALYs averted in a 20-year period. However, the costs and effects depend on a range of factors and in some scenarios (such as in situations of inadequate links to the care and treatment cascade) self-testing could result in worse outcomes than in the reference case. Sensitivity analyses illustrate that key determinants of the magnitude of health gains include the cost of self-testing, the initial level of HIV diagnosis and ART coverage, and self-testing availability.

This study contains some exciting findings that could lead to the use of resources more effectively. However, associated research needs to be carried out to ensure that the introduction of self-testing yields the greatest benefit. More work needs to be done in determining the cost of distribution and management of self-testing, as well as exploring the community acceptance. Further, given the importance of linkages to care, research on self-testing should be embedded into the larger literature around health system strengthening. 

HIV testing
Africa
Zimbabwe
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